RadGil2

K201177 · R3 X-Ray L.L.C · MOT · Aug 17, 2020 · RA

Device Facts

• Record ID: K201177
• Device Name: RadGil2
• Applicant: R3 X-Ray L.L.C
• Product Code: MOT · RA
• Decision Date: Aug 17, 2020
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Indications for Use

Radgil2 US is an X-Ray irradiation device intended for use in the irradiation of blood and blood products packaged in transfusion bags to inactivate lymphocytes for the prevention of graft vs host disease (GVHD).

Device Story

RadGil2 US is a lead-shielded cabinet X-ray blood irradiator for use in hospitals, medical centers, and blood banks. It accommodates a rotating canister holding up to six 300 mL blood bags. The device uses a single X-ray tube (180-200 kV, 5-20 mA) to deliver a central dose of 30 Gy (range 15-50 Gy) to blood products. An integrated computer manages data, and an operator control panel allows authorized personnel to adjust X-ray settings. The rotating canister ensures uniform dose distribution. By inactivating lymphocytes, the device prevents transfusion-associated graft vs host disease. Safety features include lead shielding and interlocks to prevent radiation leakage.

Clinical Evidence

No clinical data. Substantial equivalence is supported by non-clinical performance testing, including compliance with UL 61010-1, CAN/CSA-C22.2 No. 61010-1-12, IEC 61010-2-091, 21 CFR 1020.40, and 21 CFR 1010.

Technological Characteristics

Lead-shielded cabinet X-ray system. Single X-ray tube (180-200 kV, 5-20 mA). Rotating canister mechanism. Dose rate up to 6.0 Gy/min. Radiation leakage <1.0 μSv/h at 5 cm. Standards: UL 61010-1, CAN/CSA-C22.2 No. 61010-1-12, IEC 61010-2-091, 21 CFR 1020.40, 21 CFR 1010. Includes control electronics and computer for data management.

Indications for Use

Indicated for the irradiation of blood and blood products in transfusion bags to inactivate lymphocytes for the prevention of graft vs host disease (GVHD).

Predicate Devices

• SANGRAY (K172087)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

August 17, 2020

R3 X-Ray L.L.C % Mr. Robert Hase Owner 2730 E. Broadway Blvd., Suite 160 TUCSON AZ 85716

Re: K201177

Trade/Device Name: RadGil2 US Regulatory Class: Unclassified Product Code: MOT Dated: July 12, 2020 Received: July 23, 2020

Dear Mr. Hase:

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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS)

{1}------------------------------------------------

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-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/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-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] 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

{2}------------------------------------------------

## Indications for Use

510(k) Number (if known) K201177

Device Name RadGil2 US

Indications for Use (Describe)

RadGil2 US is an X-Ray irradiation device intended for use in the irradiation of blood products packaged in transfusion bags to inactivate lymphocytes for the prevention of graft vs host disease (GVHD)

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 PRAStaff(@fda.hhs.gov

"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."

{3}------------------------------------------------

# 510(k) SUMMARY

| Date Summary Prepared | April 23, 2020 |
|-----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitted By/Contact Person | Robert Hase<br>R3 X-Ray LLC<br>[phone]<br>2730 E Broadway STE 160<br>Tucson, AZ 85716<br><a href="mailto:[e-mail]">[e-mail]</a> |
| Trade Name | RadGil2 US |
| Common Name | RadGil2 US |
| Classification Name: | Blood irradiators have not been classified |
| Legally Marketed Predicate Device | SANGRAY (K172087) |
| Device Class: | None |
| Product Code | MOT |

### Description

The RADGIL 2 US x-ray blood irradiator is for use in Hospitals, Medical Centers and blood banks. The RADGIL 2 US x-ray blood irradiator consists of one lead-shielded cabinet containing one monoblock with one X-ray tube inside, one irradiation chamber, one control electronics, one computer for data management and one operator controls panel for the X-ray settings. The RADGIL 2 US x-ray blood irradiator is designed to accommodate a rotating canister of approximately 2.5 litres, to accommodate up to six standard 300 mL blood bags provided the bags are not frozen and the blood bag tubing is not an obstruction. The RADGIL 2 US x-ray blood irradiator is capable of irradiating the blood products to a central dose of 30 Gy, granting a minimum dose >15 Gy and a maximum dose < 50 Gy as required by US clinics, hospitals and blood banks. The RADGIL 2 US has a lockable panel to ensure that only authorized personnel make adjustments.

#### Intended Use of Device

Radgil2 US is an X-Ray irradiation device intended for use in the irradiation of blood and blood products packaged in transfusion bags to inactivate lymphocytes for the prevention of graft vs host disease (GVHD).

#### Summary of Technological Characteristics

Radgil2 US is substantially equivalent to the SANGRAY Blood Irradiator (K172087). Both devices use X-rays to irradiate blood products to reduce the risk of Graft Versus Host Disease (GVHD) associated with transfusion. RadGil2 US has similar device specifications and bench testing to SANGRAY with he exception that SANGRAY uses two opposing X-Ray tube assemblies and RadGil2 US has one tube emitting radiation with a rotating canister.

{4}------------------------------------------------

| Characteristic | Subject Device | Predicate Device |
|-----------------------|-----------------------------------------------------------------------------|-------------------------------------|
| | RadGil2 US | SANGRAY |
| Irradation Method | One X-Ray Tube<br>with a rotating<br>canister | 2 opposing X-Ray<br>tube assemblies |
| X-Ray Tube Voltage | 180-200 Kv | 150Kv |
| X-Ray Tube Current | 5-20 mA | 30mA |
| Measurement<br>Method | 2-min exposure | Minimum Dose<br>15Gy |
| Dose Rate | Up to 6.0 Gy/min<br>(measured at the<br>centre of the<br>canister) | 5.7-7.9 Gy/min |
| Max/Min Dose Ratio | less than 1:1.5 | Less than 1:1.5 |
| Radiation Safety | Pb shielding,<br>interlocks | Pb shielding,<br>interlocks |
| Radiation Leakage | <1,0 μSv/ h –<br>measured at 5 cm<br>from any external<br>point of the unit | Less than 1 µSv/h |

## Comparison of Subject and Predicate Devices

## Non-Clinical Performance Test Summary

- Base Standard(s): UL 61010-1, 3rd Edition, May 11, 2012, Revised April 29 2016, ● CAN/CSAC22.2 No. 61010-1-12, 3rd Edition, Revision dated April 29 2016
- . Additional Standards: IEC 61010-2-091: 2012 (first Edition)
- 21 CFR 1020.40 Cabinet X-Ray Systems
- 21.CFR 1010 Performance Standards For Electronic Products: General ●

In addition, the results of the Non-Clinical Performance tests demonstrate substantial equivalence to predicate device.

#### Clinical Performance Test Summary None

#### Statement of Substantial Equivalence

RadGil2 US is substantially equivalent to the SANGRAY (K172087). The subject and predicate devices are indicated for the X-ray irradiation of blood products to reduce the risk of Graft Versus Host Disease. In addition, the SANGRAY is similar in operating principles and technological characteristics. Standardized performance testing, as well as differences between the devices, did not raise any new concerns regarding safety and effectiveness. The results of the non-clinical performance tests demonstrate that SANGRAY is substantially equivalent to the referenced predicate devices.