The SANGRAY is an x-ray irradiation system intended for use in the irradiation of blood products packaged in transfusion bags to inactivate lymphocytes for the prevention of graft versus host disease (GVHD).

Device Description

The X-ray irradiation system SANGRAY consists of a power supply (high-voltage generation unit), controller panel (console), and a shielded protection unit which contains two vertically opposed X-ray tube assemblies that generate X-ray beams. Blood products are placed into a tray and irradiated with the X-rays in a sample chamber. The system has a built-in dosimeter which measures the exposure dose in real time and ensures that the X-ray irradiation is stopped automatically when the preset dose is reached. If the power supply fails during the X-ray irradiation, the dosimeter keeps the integral dose value in memory, which allows the operator to continue the X-ray irradiation after power is recovered.

AI/ML Overview

The provided text describes a 510(k) submission for the SANGRAY X-ray irradiation system. The document focuses on demonstrating substantial equivalence to predicate devices for regulatory clearance, rather than presenting a clinical study to prove the device meets specific performance criteria through a traditional clinical trial or AI algorithm validation study. Therefore, most of the requested information regarding acceptance criteria and studies proving the device meets them, especially in the context of AI, cannot be extracted from this document.

Here's what can be gathered, addressing your points where possible:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state acceptance criteria in the format of a clinical study or AI performance metrics. Instead, it presents a comparison of technological characteristics between the SANGRAY and two predicate devices (Rad Source X-ray Blood Irradiator, Model RS-3400 and Raycell X-ray Blood Irradiator). These characteristics serve as points of comparison to demonstrate substantial equivalence, rather than strict performance acceptance thresholds for a new, independent claim.

Characteristic	Acceptance Criteria (Implied by Predicate Comparison)	Reported Device Performance (SANGRAY)
Irradiation Method	Similar to predicate: X-rays, two opposing tubes	Two opposing X-ray tube assemblies
X-ray Tube voltage	Similar to predicate: 150 kV or 160 kV	150 kV
X-ray Tube Current	Similar to predicate: 25 mA or Not stated	30 mA
Measurement Method	Minimum Dose: 15 Gy (for SANGRAY)	Minimum Dose: 15 Gy
Dose Rate	Similar to predicate: 5 Gy/min or 7 Gy/min	5.7-7.9 Gy/min
Max/Min Dose Ratio	Less than 1:1.3 or 1:1.2	Less than 1:1.5
Radiation Safety	Pb shielding, interlocks	Pb shielding, interlocks
Radiation Leakage	Less than 5 µSv/h	Less than 1 µSv/h
Federal Regulatory Environment	Requires 510(k), comply with 21 CFR 1020.40	Requires 510(k), comply with 21 CFR 1020.40
Safety Standards Compliance	ANSI/AAMI ES 60601-1:2005+A2(R2012)+A1, IEC 60601-1-2:2007	In compliance with these standards

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document explicitly states: "6.8 Clinical Performance Test Summary: None." This indicates that no clinical performance study was conducted or presented in this submission. The "test set" in this context refers to non-clinical performance and safety tests, not a clinical data set for evaluating an AI algorithm or human reader performance. The provenance of such non-clinical test data is not detailed beyond compliance with specified safety standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. As no clinical performance study was conducted, there were no experts used to establish ground truth for a clinical test set.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No clinical performance study was conducted.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. The SANGRAY is an X-ray irradiation system, not an AI-powered diagnostic or assistive tool for human readers. No MRMC study was conducted.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. SANGRAY is a medical device for irradiating blood, not an AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the non-clinical performance tests mentioned (Section 6.7), the "ground truth" would be established by physical measurements and engineering standards, comparing the device's output (e.g., dose, dose rate, leakage) against pre-defined specifications and regulatory limits. For example, radiation leakage is compared against a specified maximum (e.g., less than 1 µSv/h). There's no clinical ground truth in the sense of disease diagnosis or outcomes.

8. The sample size for the training set

Not applicable. SANGRAY is not an AI algorithm that requires a training set.

9. How the ground truth for the training set was established

Not applicable. SANGRAY is not an AI algorithm.

Summary

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Image /page/0/Picture/10 description: The image contains the logos of two U.S. government agencies. On the left is the logo for the Department of Health & Human Services, featuring a stylized caduceus-like symbol. To the right is the logo for the U.S. Food & Drug Administration (FDA), with the FDA acronym in a blue square and the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

Hitachi Ltd. % Takahiro Haruyama President Globizz Corporation 1411 W. 190th St., Suite 200 GARDENA CA 90248

Re: K172087

Trade/Device Name: SANGRAY Regulatory Class: Unclassified Product Code: MOT Dated: September 26, 2017 Received: September 27, 2017

Dear Takahiro Haruyama:

We have reviewed vour 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. 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.qov

October 27, 2017

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevicesforYou/Industry/default.htm. 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely.

Robert Oaks

Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K172087

Device Name SANGRAY

Indications for Use (Describe)

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

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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SECTION 6: 510(k) Summary

6.1 Submitter

Date Prepared:	July 7, 2017
510(k) Owner/Applicant:	Hitachi Ltd., Medical System Operations Group2-1, Shintoyofuta, Kashiwa-ShiChiba-Ken, 277-0804, JapanTel: +81-4-7131-4159
Contact Person:	Kazuaki TsuchiyaHitachi Ltd., Medical System Operations GroupTel: +81-4-7131-4159Email: kazuaki.tsuchiya.wy@hitachi.com
Official Correspondent:	Takahiro HaruyamaGlobizz CorporationTel: (310) 538-3860Email: register@globizz.net

6.2 Device Identification

Trade Name:	SANGRAY
Common Name:	Blood Irradiator
Review Panel:	Radiology
Classification Name:	Irradiator, Blood to Prevent Graft Versus Host Disease
Device Class:	Unclassified
Product Code:	MOT

6.3 Predicate Devices

Trade Name:	Rad Source X-ray Blood Irradiator, Model RS-3400
Manufacturer:	Rad Source Technologies, Inc.
Reference:	K082921
Trade Name:	Raycell X-ray Blood Irradiator
Manufacturer:	MDS Nordion
Reference:	K051065

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6.4 Device Description

6.5 Indications for Use Statement

6.6 Comparison of Technological Characteristics

SANGRAY is substantially equivalent to the Rad Source X-ray Blood Irradiator, Model RS-3400 (K082921) and the Raycell™ X-ray Blood Irradiator (K051065). All three devices use X-rays to irradiate blood products to reduce the risk of Graft Versus Host Disease (GVHD) associated with transfusion. Both SANGRAY and RS-3400 have similar device specifications and bench testing, while SANGRAY and Raycell™ both use an irradiation method through which two opposing X-ray tubes deliver uniform irradiation.

Characteristic	Subject DeviceSANGRAY	Predicate Devices
		RS-3400	Raycell™
Irradiation Method	Two opposing X-ray tube assemblies	One X-ray tube emits radiation in a 360°	Two vertically opposed X-ray tubes.
X-ray Tube voltage	150 kV	150 kV	160 kV
X-ray Tube Current	30 mA	25 mA	Not stated on 510(k) submission
Measurement Method	Minimum Dose:15 Gy	Central Dose:25 Gy	Central Dose:25 Gy
Dose Rate	5.7-7.9 Gy/min	7 Gy/min	5 Gy/min
Max/Min Dose Ratio	Less than 1:1.5	Less than 1:1.3	Less than 1:1.2
Radiation Safety	Pb shielding, interlocks	Pb shielding, interlocks	Pb shielding, interlocks
Radiation Leakage	Less than 1 µSv/h	Not stated on 510(k)	Less than 5 µSv/h
Federal RegulatoryEnvironment	Requires 510(k). Must comply with 21 CFR 1020.40	Requires 510(k). Must comply with 21 CFR 1020.40	Requires 510(k). Must comply with 21 CFR 1020.40

Table 6-1: Comparison of Subject and Predicate Devices

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6.7 Non-Clinical Performance Test Summary

Safety of SANGRAY is demonstrated through the conducted safety tests. SANGRAY is in compliance with the following safety standards:

ANSI/AAMI ES 60601-1:2005+A2(R2012)+A1 (Appendix I) O
O IEC 60601-1-2:2007 (Appendix J)

In addition, the results of the non-clinical performance tests demonstrate that SANGRAY is substantially equivalent to the predicate devices.

6.8 Clinical Performance Test Summary

None.

6.9 Statement of Substantial Equivalence

SANGRAY is substantially equivalent to the Rad Source X-ray Blood Irradiator, Model RS-3400 (K082921) and the Raycel™ X-ray Blood Irradiator (K051065). The subject and predicate devices are indicated for the X-ray irradiation of blood products to reduce the risk of Graft Versus Host Disease associated with transfusion. In addition, SANGRAY and the predicate devices are similar in their 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