(265 days)
No
The description focuses on the mechanical and physical function of the device as an accessory for proton therapy, and there are no mentions of AI, ML, or related concepts.
No
The device is described as an "accessory" to a proton beam therapy system, intended to assist in the delivery of radiation, not to directly treat a condition itself. Its function is to sharpen the penumbra of the radiation for more precise delivery.
No.
The device is an accessory for the delivery of proton radiation therapy, designed to improve the sharpness of the radiation field and spare normal tissue. It is used in treatment, not for diagnosis.
No
The device description explicitly states it is composed of physical components (cylinder part, 4-legged table, plate part) and is an accessory to a proton beam therapy system, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to assist in the delivery of proton radiation therapy to defined target volumes. This is a therapeutic application, not a diagnostic one.
- Device Description: The device is an accessory to a proton beam therapy system used to shape the radiation beam and improve dose distribution. This is a physical component used in a treatment process.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's condition.
- Focus on Therapy Delivery: The description and performance studies focus on the mechanical function, interface with the therapy system, dose distribution, and clinical workflow related to delivering radiation.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Small Field Applicator 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.
Product codes
LHN
Device Description
Small Field Applicator is an optional accessory to the proton beam therapy system which can be added to the nozzle configuration of the cleared PROBEAT-V system to make the lateral penumbra sharp, as needed. The Small Field Applicator may be used in place of the optional removable Applicator having an aperture (collimator) that has been cleared as part of the PROBEAT-V system.
The Small Field Applicator is composed of a cylinder part with touch sensors, a 4-legged table, and a plate part. The Small Field Applicator is inserted at the end of the nozzle to obtain a sharp lateral penumbra in the lateral dose distribution, and it can reduce the dose to the surrounding normal tissue than the case in which the Small Field Applicator is not used.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
radiation oncologist
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Mechanical testing as well as evaluations to assess the interface with the control system, dose distribution, end-to-end testing to evaluate use in the clinical workflow, and radiation safety have been performed. In all instances, the PROBEAT-V with the Small Field Applicator performed as intended and as safe and effective as the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
PROBEAT-V (K151132)
Reference Device(s)
Extended Range Shifter (K152207)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
December 15, 2022
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym along with the full name of the agency on the right. The FDA acronym and the words "U.S. FOOD & DRUG" are in a blue sans-serif font, with "ADMINISTRATION" in a smaller font below.
Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha % Jonathan Kahan Partner Hogan Lovells US LLP 555 Thirteenth Street, NW WASHINGTON DC 20004
Re: K220883
Trade/Device Name: Small Field Applicator Regulation Number: 21 CFR 892.5050 Regulation Name: Medical Charged-Particle Radiation Therapy System Regulatory Class: Class II Product Code: LHN Dated: March 25, 2022 Received: March 25, 2022
Dear Jonathan 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. 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
1
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) 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 medical devices and radiation-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,
Lora D. Weidner -S Digitally signed by Lora D. Weidner -S Date: 2022.12.15 21:15:47 -05'00'
Lora Weidner Assistant Director DHT8C: Division of Radiological Imagaing and Radiation Therapy Devices OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
510(k) Number (if known)
Device Name
| Small Field Applicator |
|---|
| ------------------------ |
Indications for Use (Describe)
The Small Field Applicator 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)
区 Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) SUMMARY
Hitachi Ltd.'s PROBEAT-CR Proton Beam Therapy Device
K220883
Submitter
Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha 226-44-141-1, Wakashiba, Kashiwa-shi Tiba, 277-0871, Japan Telephone: +81 80-8841-0068 Facsimile: +81 4-7135-7346
Contact Person: Tomoko Irisa
Date Prepared: November 16, 2022
Name of Device:
Small Field Applicator
Common or Usual Name:
Proton Beam Therapy Device
Classification Name:
System, Radiation Therapy, Charged-Particle, Medical
Regulatory Class:
Class II
Product Code:
LHN
Predicate Device
PROBEAT-V (K151132)
Reference Device
Extended Range Shifter (K152207)
Device Description
Small Field Applicator is an optional accessory to the proton beam therapy system which can be added to the nozzle configuration of the cleared PROBEAT-V system to make the lateral penumbra sharp, as needed. The Small Field Applicator may be used in place of the optional
4
removable Applicator having an aperture (collimator) that has been cleared as part of the PROBEAT-V system.
The Small Field Applicator is composed of a cylinder part with touch sensors, a 4-legged table, and a plate part. The Small Field Applicator is inserted at the end of the nozzle to obtain a sharp lateral penumbra in the lateral dose distribution, and it can reduce the dose to the surrounding normal tissue than the case in which the Small Field Applicator is not used.
Intended Use / Indications for Use
The Small Field Applicator 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.
Summary of Technological Characteristics and Comparison to the Predicate device
Both the subject and the predicate device's applicator are accessories to a proton beam therapy system to better direct the proton irradiation to the target anatomy. In each case, the accessories focus the beam by placing an object either in the beam line or surrounding the beam in order to shape the beam. The Small Field Applicator has an aperture (patient collimator) inside similar to PROBEAT-V's applicator. The Small Field Applicator can also optionally be equipped with a range shifter on the nozzle side, and its placement is similar to the PROBEAT-V's applicator. The Small Field Applicator achieves a sharp beam by setting the collimator closer to the patient. Both the Small Field Applicator and the PROBEAT-V's applicator include a touch sensor that will stop the gantry and PPS when the applicator touches the patient. The touch sensor function is same between the Small Field Applicator and PROBEAT-V's applicator. In conclusion, the Small Field Applicator's structure is similar to the PROBEAT-V's applicator and does not affect the Indications for Use and safety function of the device as a whole.
Performance Data
Mechanical testing as well as evaluations to assess the interface with the control system, dose distribution, end-to-end testing to evaluate use in the clinical workflow, and radiation safety have been performed. In all instances, the PROBEAT-V with the Small Field Applicator performed as intended and as safe and effective as the predicate device.
Conclusions
The Small Field Applicator has the same intended use and indications for use as the predicate device. Both devices are accessories to Proton Beam Therapy System and intended to assist radiation oncologist in the delivery of proton radiation to defined target volumes. Performance testing has demonstrated that the Small Field Applicator performs as intended and raises no new questions of safety and effectives compared to the predicate device. Thus, the device can be found substantially equivalent to the identified predicate.