RefleXion Medical, Inc March 12, 2020.

℅ Kathy O'Shaughnessy, PhD

V.P. Regulatory, Quality Assurance, Clinical
25841 Industrial Blvd, Suite 275
HAYWARD CA 94545

Re: K190978
Trade/Device Name: RefleXion Medical Radiotherapy System
Regulation Number: 21 CFR 892.5050
Regulation Name: Medical charged-particle radiation therapy system
Regulatory Class: Class II
Product Code: IYE, MUJ
Dated: February 13, 2020
Received: February 14, 2020

Dear Dr. O'Shaughnessy:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced
above and have determined the device is substantially equivalent (for the indications for use stated in the
enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the
enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance
with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a
premarket approval application (PMA). You may, therefore, market the device, subject to the general
controls provisions of the Act. Although this letter refers to your product as a device, please be aware that
some cleared products may instead be combination products. The 510(k) Premarket Notification Database
located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination
product submissions. The general controls provisions of the Act include requirements for annual registration,
listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and
adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We
remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be
subject to additional controls. Existing major regulations affecting your device can be found in the Code of
Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements
concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA
has made a determination that your device complies with other requirements of the Act or any Federal
statutes and regulations administered by other Federal agencies. You must comply with all the Act's
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803) for
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see

U.S. Food & Drug Administration

10903 New Hampshire Avenue Doc ID# 04017.04.13
Silver Spring, MD 20993
www.fda.gov
K190978 – Dr. Kathy O'Shaughnessy Page 2

https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-
combination-products); good manufacturing practice requirements as set forth in the quality systems (QS)
regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for
combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-
542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part
807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part
803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-
mdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including
information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-
devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn
(https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the
Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See
the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-
assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE
by email ([email protected]) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

For
Thalia T. Mills, Ph.D.
Director
Division of Radiological Health
OHT7: Office of In Vitro Diagnostics
and Radiological Health
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

Enclosure
 DEPARTMENT OF HEALTH AND HUMAN SERVICES Form Approved: OMB No. 0910-0120
Food and Drug Administration Expiration Date: 06/30/2020
Indications for Use See PRA Statement below.

510(k) Number (if known)

K190978

Device Name
RefleXion Medical Radiotherapy System

Indications for Use (Describe)

The RefleXion Medical Radiotherapy System is indicated for treatment planning and precise delivery of image-guided
radiation therapy, stereotactic radiotherapy, or stereotactic radiosurgery for tumors or other targeted tissues anywhere in
the body when radiation treatment is indicated, while minimizing the delivery of radiation to vital healthy tissue. The
megavoltage X-ray radiation is delivered in a rotational, modulated, image-guided format in accordance with the
physician approved plan.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.
*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*
The burden time for this collection of information is estimated to average 79 hours per response, including the
time to review instructions, search existing data sources, gather and maintain the data needed and complete
and review the collection of information. Send comments regarding this burden estimate or any other aspect
of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
[email protected]
“An agency may not conduct or sponsor, and a person is not required to respond to, a collection of
information unless it displays a currently valid OMB number.”

FORM FDA 3881 (7/17) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF
 K190978

Premarket Notification [510(k)] Summary

RefleXion Medical Radiotherapy System RXM1000
SUBMITTER RefleXion Medical, Inc.
25841 Industrial Blvd, Suite 275
Hayward, CA 94545

Contact Name: Kathy O’Shaughnessy, PhD

Phone: (650) 239-9070 x1035
Fax: (650) 521-5916
Date of preparation: March 11, 2020

DEVICE Name of Device: RefleXion Medical Radiotherapy System

Trade or Brand Name: RefleXion System One, RefleXion System RXM1000
Common/usual Name: Medical Linear Accelerator
Regulation Number: 21 CFR 892.5050
Classification Name: Medical charged-particle radiation therapy system
Regulatory Class: Class II
Product Code IYE (radiation therapy), MUJ (planning)
PREDICATE DEVICE TomoTherapy Treatment System (K121934)

DEVICE DESCRIPTION

The RefleXion Medical Radiotherapy System (RMRS), a hybrid imaging-therapy system, is capable of
delivering intensity-modulated radiation therapy (IMRT), stereotactic body radiation therapy (SBRT),
stereotactic radiotherapy (SRT) and stereotactic radiosurgery (SRS) utilizing an on-board kilovoltage CT
(kVCT) system for patient localization and field sizes based on jaws which are 40 cm wide, with slice width
choices of 1.0 cm and 2.0 cm to optimize patient treatment. It is also equipped with a binary multileaf
collimator (MLC) used to create intensity modulated radiation fields at a source-axis distance of 85 cm. It
can achieve a nominal dose rate of 850 cGy/min.

The RMRS consists of the following clinical subsystems: 6 MV photon radiotherapy delivery, Kilovoltage
(kV) X-ray CT imaging, MV X-ray detection, and treatment planning. The LINAC along with the fixed primary
collimator, adjustable collimators, and multileaf collimator (MLC) mount in the therapy plane. The kVCT
imaging plane is separate from the therapy plane and provides images used to localize the patient prior
to treatment. Additionally, the system is designed architecturally to include PET imaging components for
future product enhancements. Although the PET subsystem hardware is present in the system, its
functionality is currently disabled.

Page 1 of 5
INDICATIONS FOR USE/INTENDED USE STATEMENT

The RefleXion Medical Radiotherapy System is indicated for treatment planning and precise delivery of
image-guided radiation therapy, stereotactic radiotherapy, or stereotactic radiosurgery for tumors or
other targeted tissues anywhere in the body when radiation treatment is indicated, while minimizing the
delivery of radiation to vital healthy tissue. The megavoltage X-ray radiation is delivered in a rotational,
modulated, image-guided format in accordance with the physician approved plan.

COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

The RefleXion Medical Radiotherapy System and the predicate device employ the same fundamental
scientific principles and have substantially equivalent principles of operation and technological
characteristics.

The treatment delivery components of the RefleXion and TomoTherapy devices are the same or
equivalent with regards to energy, beam properties, materials and other physical properties.

Key differences between the subject device and the predicate device include the following:

• Faster rotation of the system at 60 RPM.

• Use of a new faster-speed binary MLC design.
• Addition of a kVCT subsystem for patient positioning.
• Addition of a method to correct for pitch and yaw set-up errors.

Device Predicate Device: Subject Device: Analysis

Characteristic TomoTherapy Treatment RefleXion Medical
System Radiotherapy System
510(k) number K121934 K190978
Ring Gantry

Bore Diameter 85 cm 85 cm Same

Speed of Rotation Substantially equivalent.
Treatment 1 to 5 RPM 60 RPM
Imaging 6 RPM 60 RPM

Photon Beam

Beam energy 6 MV (single energy) 6 MV (single energy) Same

Fixed Field Size 1.0 cm x 40 cm 1.0 cm x 40 cm The field sizes for clinical use
2.5 cm x 40 cm 2.0 cm x 40 cm are substantially equivalent.
5.0 cm x 40 cm 3.0 cm x 40 cm (QA mode) Differences do not inhibit it’s
intended use.
Isocenter distance 85 cm 85 cm Same
Nominal Dose Rate 850 cGy/min 850 cGy/min Same
Collimation
Primary Tungsten block with Tungsten block with Same
Collimation rectangular, fixed aperture rectangular, fixed aperture
Jaw placement Jaws are placed after the MLC Split jaw design – the lower Substantially equivalent.
jaws are placed after the MLC Subject device uses a split jaw
design.

Page 2 of 5
 Device Predicate Device: Subject Device: Analysis
Characteristic TomoTherapy Treatment RefleXion Medical
System Radiotherapy System
Jaw - movement Static Mode Static mode Substantially equivalent.
Dynamic Mode Subject device is static only.
Multileaf 0 to 400 mm wide by 5 to 20 0 to 400 mm wide by 10 to 30 Substantially equivalent. Minor
Collimator mm long mm long differences are negligible.
Binary (fully in or fully out); Binary (fully in or fully out);
pneumatic spring-loaded pneumatic
64 tungsten leaves (tongue and 64 tungsten leaves (tongue and
groove), 10cm thick groove), 11cm thick
Leaf Resolution at 0.625 cm in IEC-x direction at 0.625 cm in IEC-x direction at Same
isocenter isocenter isocenter (leaf width is 0.614
cm)
MLC Leaf transition <20 msec <7 msec Substantially equivalent. The
time subject device’s MLC leaves
move faster to accommodate
faster gantry rotation.
Imaging – for patient positioning

Energy MVCT – 3.5 MV (nominal for kVCT – 120 kV Substantially equivalent.

positioning) Separate system located in a
Provided by the therapy beam plane approx. 40 cm from
(at lower energy) therapy plane
Dose per image 0.5 – 3.0 cGy depending on 2.45 cGy (body), 5.13 cGy Similar; physician chooses at
(typical) resolution and body thickness (head) (CTDIvol, nominal time of treatment planning
settings)
High contrast 3 lp/cm (typical) 4 lp/cm Similar
spatial resolution
Low contrast 2% density for 2 cm object Visibility of 5 mm object for 1% Subject device increases
resolution (typical) contrast visibility of lower
contrast/smaller objects
Treatment Planning

Associated Determines treatment planning Determines treatment planning Same function for each system
Treatment Delivery and dose distribution for the and dose distribution for the
System Tomotherapy System. RefleXion System.
Planning 6 MV External beam x-ray and 6 MV External beam x-ray and Same
inverse planning inverse planning
Image Series Used Image series (CT) Image series (CT) Same
Treatment Delivery Software
Delivery Modes IMRT, SRS, SRT, SBRT IMRT, SRS, SRT, SBRT Same
Supported
Patient Setup and Yes Yes Same
Localization
Patient Couch
Biocompatible Yes Yes - Couch top is Same
biocompatible
Degrees of Y, Z (software control) X, Y, Z, pitch, yaw (software The subject device adds
Freedom X (manual) control) software correction in the x,
Roll (adjust initial gantry angle) Roll (adjust initial gantry angle) pitch and yaw axes.
Pitch, yaw (rotate patient)

Page 3 of 5
PERFORMANCE DATA

Verification and validation testing have been conducted to demonstrate that the device performs as
intended.

Bench testing included system and subsystem tests including:

• Performance tests to applicable standards (including electrical safety and electromagnetic

compatibility).
• Safety/Interlock tests to ensure risk mitigations performed as specified.
• Dosimetric performance evaluation of the RefleXion system.
• Treatment Planning System Dose accuracy tests to evaluate the accuracy of the RefleXion
treatment planning system.
• Geometric localization accuracy tests for the RefleXion system.
• Imaging performance testing.
• Validation testing including end-to-end tests, usability testing, and tests to ensure the system
performance checks function as intended.

Results of bench testing showed conformance to applicable requirements and specifications.

Specifications of key performance tests are provided below:

Performance Test Specification

Coincidence of mechanical and radiation isocenter ≤ 1mm
kVCT imaging to MV treatment plane localization accuracy ≤ 1mm
kVCT geometric accuracy ≤ 1mm
Dosimetric accuracy >90% of points passing 3%/3mm (for points
greater than 10% maximum dose)
Dose rate output constancy ≤ 2%
Dose output linearity ± 2% ≥5MU
± 5% (2-4 MU)

Software verification and validation documentation was provided as recommended by FDA’s Guidance
for Industry and FDA Staff, “Guidance for the Content of Premarket Submissions for Software Contained
in Medical Devices.” The software for this device was considered as a “major” level of concern.

The subject device conforms in whole or in part with the following standards: IEC60601-1, IEC60601-1-2,
IE60601-1-3, IEC60601-1-6, IEC60601-2-1, IEC60601-2-44, IEC60601-2-68, IEC62304, IEC62366-1,
IEC60976, IEC61217, IEC62083, IEC62274. For those recognized standards in which there are clauses that
are not applicable, summary reports with justifications have been included in the submission.

No animal studies or clinical tests have been included with this pre-market submission.

Page 4 of 5
CONCLUSION

The non-clinical data support the safety of the device and the verification and validation testing performed
demonstrates that the RefleXion Medical Radiotherapy System performs as intended in the specified use
conditions. RefleXion therefore considers the RefleXion Medical Radiotherapy System to be substantially
equivalent to the predicate device.

Page 5 of 5