(108 days)
No
The description focuses on the hardware components and basic control mechanisms (dosimeter, automatic shut-off) without mentioning any AI/ML algorithms or data processing for decision making beyond simple thresholding.
No.
The device irradiates blood products to inactivate lymphocytes for disease prevention, but it does not directly treat a patient's disease or condition within the body; it acts on external biological material.
No
The device is an x-ray irradiation system used to inactivate lymphocytes in blood products, not to diagnose a condition or disease.
No
The device description clearly outlines hardware components such as a power supply, controller panel, shielded protection unit, X-ray tube assemblies, tray, sample chamber, and a built-in dosimeter. This indicates it is a physical system, not software-only.
Based on the provided information, the SANGRAY device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to irradiate blood products packaged in transfusion bags to inactivate lymphocytes. This is a treatment or processing step applied to a biological product outside of the body, but it's not a diagnostic test performed on a sample to gain information about a patient's health or condition.
- Device Description: The description details an X-ray irradiation system designed to deliver a specific dose of radiation to blood products. It focuses on the physical process of irradiation and dose control, not on analyzing or testing a sample for diagnostic purposes.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information about a patient. The device's function is purely to modify the blood product itself.
IVD devices are typically used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnostic, monitoring, or screening purposes. The SANGRAY's function falls outside of this definition.
N/A
Intended Use / Indications for Use
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).
Product codes
MOT
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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 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.
Clinical Performance Test Summary: None.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
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
1
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
2
Indications for Use
510(k) Number (if known) K172087
Device Name SANGRAY
Indications for Use (Describe)
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).
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.
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
SECTION 6: 510(k) Summary
6.1 Submitter
| Date Prepared: | July 7, 2017 |
|---|---|
| 510(k) Owner/Applicant: | Hitachi Ltd., Medical System Operations Group |
| 2-1, Shintoyofuta, Kashiwa-Shi | |
| Chiba-Ken, 277-0804, Japan | |
| Tel: +81-4-7131-4159 | |
| Contact Person: | Kazuaki Tsuchiya |
| Hitachi Ltd., Medical System Operations Group | |
| Tel: +81-4-7131-4159 | |
| Email: kazuaki.tsuchiya.wy@hitachi.com | |
| Official Correspondent: | Takahiro Haruyama |
| Globizz Corporation | |
| Tel: (310) 538-3860 | |
| Email: 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 |
4
6.4 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.
6.5 Indications for Use Statement
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).
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 Device
SANGRAY | 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 Regulatory
Environment | 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
5
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.