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)

Device 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.

AI/ML Overview

The provided text is a 510(k) Summary for the RadGil2 US X-ray blood irradiator. It focuses on demonstrating substantial equivalence to a predicate device (SANGRAY) based on technical characteristics and non-clinical performance tests.

Crucially, the document explicitly states "Clinical Performance Test Summary None". This indicates that no clinical studies (which would involve human participants or human-in-the-loop performance evaluations) were conducted to prove the device meets specific acceptance criteria based on human performance or diagnostic accuracy.

Therefore, the requested information regarding acceptance criteria, study that proves the device meets the acceptance criteria (specifically performance metrics like sensitivity, specificity, AUC, or reader improvement), sample sizes for test sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth for training data cannot be extracted from this document. These types of data are typically found in clinical validation reports for AI/CADe devices, not premarket notifications for radiation-emitting medical devices like blood irradiators.

The acceptance criteria and performance data provided in this document relate solely to the physical specifications and non-clinical performance of the blood irradiator itself, such as:

Dose Delivery: Central dose of 30 Gy, minimum dose >15 Gy, maximum dose < 50 Gy.
Irradiation Method: One X-Ray tube with a rotating canister.
X-Ray Tube Voltage/Current: 180-200 Kv, 5-20 mA.
Dose Rate: Up to 6.0 Gy/min.
Max/Min Dose Ratio: Less than 1:1.5.
Radiation Safety: Pb shielding, interlocks.
Radiation Leakage: <1.0 µSv/h.
Compliance with Standards: UL 61010-1, IEC 61010-2-091, 21 CFR 1020.40, etc.

Below is a table summarizing the "acceptance criteria" and "reported device performance" purely based on the physical and non-clinical specifications mentioned in the document, as no clinical performance data is available.

Acceptance Criteria and Reported Device Performance for RadGil2 US (Based on Non-Clinical Specifications)

Acceptance Criteria Category	Specific Criteria (Target)	Reported Device Performance (Result)
Dose Delivery	Central Dose	30 Gy
	Minimum Dose	>15 Gy
	Maximum Dose	< 50 Gy
Irradiation Method	Functional method for blood irradiation	One X-Ray Tube with a rotating canister
X-Ray Tube Voltage	Operational voltage range	180-200 Kv
X-Ray Tube Current	Operational current range	5-20 mA
Dose Rate	Achievable dose rate	Up to 6.0 Gy/min (measured at the center of the canister)
Max/Min Dose Ratio	Uniformity of dose	Less than 1:1.5
Radiation Safety	Shielding and safety mechanisms	Pb shielding, interlocks
Radiation Leakage	Maximum permissible leakage at 5 cm from unit	<1.0 µSv/h – measured at 5 cm from any external point of the unit
Compliance with Standards	Adherence to relevant safety and performance standards	UL 61010-1, CAN/CSA C22.2 No. 61010-1-12, IEC 61010-2-091, 21 CFR 1020.40, 21 CFR 1010

Regarding the specific questions about clinical performance and AI/algorithm validation, the document explicitly states "Clinical Performance Test Summary None," meaning these data points are not provided or applicable for this submission:

A table of acceptance criteria and the reported device performance: Provided above for non-clinical and physical performance. Clinical/AI performance data is not available.
Sample sized used for the test set and the data provenance: Not applicable for clinical performance. Clinical test sets are not mentioned.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No clinical test set where ground truth based on expert consensus would be established.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
If a multi reader multi case (MRMC) comparative effectiveness study was done: "Clinical Performance Test Summary None." No MRMC study was performed.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: "Clinical Performance Test Summary None." This device is a radiation therapy device, not an AI/CADe algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
The sample size for the training set: Not applicable. This device is not an AI/ML algorithm that requires a training set.
How the ground truth for the training set was established: Not applicable.

Summary

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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)

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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 (DICE@fda.hhs.gov) 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

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Indications for Use

510(k) Number (if known) K201177

Device Name RadGil2 US

Indications for Use (Describe)

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)

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510(k) SUMMARY

Date Summary Prepared	April 23, 2020
Submitted By/Contact Person	Robert HaseR3 X-Ray LLC+1 (520) 771-08822730 E Broadway STE 160Tucson, AZ 85716rhase@r3xray.com
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

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.

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Characteristic	Subject Device	Predicate Device
	RadGil2 US	SANGRAY
Irradation Method	One X-Ray Tubewith a rotatingcanister	2 opposing X-Raytube assemblies
X-Ray Tube Voltage	180-200 Kv	150Kv
X-Ray Tube Current	5-20 mA	30mA
MeasurementMethod	2-min exposure	Minimum Dose15Gy
Dose Rate	Up to 6.0 Gy/min(measured at thecentre of thecanister)	5.7-7.9 Gy/min
Max/Min Dose Ratio	less than 1:1.5	Less than 1:1.5
Radiation Safety	Pb shielding,interlocks	Pb shielding,interlocks
Radiation Leakage	<1,0 μSv/ h –measured at 5 cmfrom any externalpoint 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.

Regulation Number and Section

N/A