(57 days)
The Extended Range Shifter is an accessory to the PROBEAT-V system that is intended to assist the radiation oncologist in the delivery of proton radiation to defined target volumes while sparing surrounding normal tissue and critical organs from excess radiation.
This accessory is added to the nozzle of the cleared PROBEAT-V to suppress the beam spreading further compared to use of the standard range shifter.
The provided text is a 510(k) summary for the "Extended Range Shifter" device. It describes the device, its intended use, and its technological characteristics. However, it does not contain the type of information typically found in a study proving a device meets specific acceptance criteria, especially for AI/ML-based medical devices.
Specifically, the text is about a physical accessory for a proton therapy system, not a software or AI device that would require detailed performance metrics like sensitivity, specificity, or human reader improvement with AI assistance. The "Performance Data" section simply states that "All the tests were successfully conducted and confirmed the performance of the ERS." without providing any quantitative data or details about the sample size, ground truth, or expert evaluation methods.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and reported device performance: The document only generically states tests were "successfully conducted" but provides no specific criteria or performance numbers.
- Sample size and data provenance: Not mentioned.
- Number of experts and qualifications: Not relevant for this type of physical device's performance testing described here.
- Adjudication method: Not applicable.
- MRMC comparative effectiveness study: Not applicable.
- Standalone performance: Not applicable.
- Type of ground truth: Not specified beyond physical measurements.
- Training set sample size and ground truth establishment: Not applicable, as this is not an AI/ML device.
In summary, the provided document does not contain the information required to answer your questions about acceptance criteria and study details for an AI/ML device demonstrating performance. It is a premarket notification for a physical medical device accessory.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 2, 2015
Hitachi, Ltd., Health Care Company % Mr. Jonathan Kahan Regulatory Counsel Hogan Lovells US LLP 555 13th Street NW WASHINGTON DC 20016
Re: K152207
Trade/Device Name: Extended Range Shifter Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: LHN Dated: August 6, 2015 Received: August 6, 2015
Dear Mr. Kahan:
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. 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); 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.
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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 at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/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 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 yours.
Michael D'Hara
For
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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510(k) Number (if known)
K152207
Device Name
Extended Range Shifter
Indications for Use (Describe)
The Extended Range Shifter is an accessory to the PROBEAT-V system that is intended to assist the radiation oncologist in the delivery of proton radiation to defined target volumes while sparing surrounding normal tissue and critical organs from excess radiation.
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)
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510(k) SUMMARY
Extended Range Shifter
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
Hitachi, Ltd., Health Care Company 4-14-1 Sotokanda, Chiyodaku,Tokyo, 101-8010, Japan Telephone: +81 (3) 45643563 Facsimile: +81 (3) 45642882
Contact Person: Naoya Nishimura
Date Prepared: August 6, 2015
Name of Device and Name/Address of Sponsor
Extended Range Shifter
Hitachi, Ltd. Power Systems Company 3-1-1 Saiwai-cho, Hitachi-shi, Ibaraki-ken, 317-8511 Japan
Common or Usual Name
Accessory to proton beam therapy system
Classification Name
Medical Charged-Particle Radiation Therapy System, 21 CFR 892.5050, Product Code LHN
Predicate Devices
Hitachi Ltd. PROBEAT-V (K151132)
Varian Proton Therapy Multileaf Collimator (K093250)
Intended Use / Indications for Use
The Extended Range Shifter is an accessory to the PROBEAT-V system that is intended to assist the radiation oncologist in the delivery of proton radiation to defined target volumes while sparing surrounding normal tissue and critical organs from excess radiation.
Technological Characteristics
This accessory is added to the nozzle of the cleared PROBEAT-V to suppress the beam spreading further compared to use of the standard range shifter.
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Performance Data
The company performed testing to evaluate range loss, distal dose falloff, and beam spot size. All the tests were successfully conducted and confirmed the performance of the ERS.
Substantial Equivalence
The ERS is an accessory that may be used with the PROBEAT-V, and is substantially equivalent to the Range Shifter component of the PROBEAT-V (K151132) and the Varian Proton Therapy Multileaf Collimator (K093250). The ERS has the exact same intended use and substantially similar indications for use and technological characteristics as the previously cleared predicate devices. Any minor differences in the technology of these devices and how they are used in a proton beam therapy system do not raise different questions of safety or efficacy. Thus, the ERS is substantially equivalent to its predicates.
§ 892.5050 Medical charged-particle radiation therapy system.
(a)
Identification. A medical charged-particle radiation therapy system is a device that produces by acceleration high energy charged particles (e.g., electrons and protons) intended for use in radiation therapy. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.(b)
Classification. Class II. When intended for use as a quality control system, the film dosimetry system (film scanning system) included as an accessory to the device described in paragraph (a) of this section, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.