(23 days)
Hitachi's PROBEAT with MGCS is a medical device designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation.
The PROBEAT with MGCS is a proton beam irradiation system, which provides a therapeutic proton beam for clinical treatment. It is designed to deliver a proton beam with the prescribed dose, dose distribution and directed to the prescribed patient treatment site. The PBTS is designed to be safe and reliable. The equipment to perform the above work is comprised of two main components. One is a beam delivery system whose primary responsibility is to ensure that the above listed prescription parameters are properly delivered. The other is the equipment necessary to generate the proton beam and direct it to the beam delivery system. The only difference between the PROBEAT with MGCS and the cleared PROBEAT is the addition of the MGCS that converts the scale and format of the dimensional data of the patient specific aperture and/or compensator generated by commercially available patient treatment planning/management software into the scale and format used by an industrial, computer controlled milling machine to enable the milling machine to fashion the required aperture or compensator for patient treatment.
The acceptance criteria and study proving device performance are not explicitly detailed in the provided text in the structured format requested. However, based on the information given for the Hitachi PROBEAT with MGCS, we can infer some aspects of the performance and the nature of the study.
Key takeaway: This document is a 510(k) summary for a modification to an already cleared proton beam therapy system. The primary goal is to demonstrate "substantial equivalence" to a predicate device, rather than present a de novo clinical study with detailed acceptance criteria and performance metrics typically seen for novel devices. The modification (MGCS) is described as an addition that "converts the scale and format of the dimensional data... into the scale and format used by an industrial, computer controlled milling machine." The document asserts that this modification "does not raise any new questions of safety or effectiveness."
Here's an attempt to structure the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Maintain safety and effectiveness (no new questions of safety or effectiveness raised by MGCS) | "Performance data demonstrate that the PROBEAT with MGCS is as safe and effective as the cleared PROBEAT." |
| Proper delivery of prescribed proton beam parameters (dose, dose distribution, directed to prescribed site) | The device "is a proton beam irradiation system, which provides a therapeutic proton beam for clinical treatment. It is designed to deliver a proton beam with the prescribed dose, dose distribution and directed to the prescribed patient treatment site." The submission includes "performance testing that Hitachi conducted to demonstrate that the device meets its performance specifications." |
| Accuracy and fidelity of dimensional data conversion by MGCS for aperture/compensator milling | The MGCS "converts the scale and format of the dimensional data... into the scale and format used by an industrial, computer controlled milling machine to enable the milling machine to fashion the required aperture or compensator for patient treatment." The implication is that this conversion is accurate to enable proper treatment delivery. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified. The document states "The submission includes performance testing," but does not detail the number of cases or patients involved in this testing. Given the nature of the modification (data conversion for milling), the "test set" likely refers to engineering tests validating the MGCS's output and the resulting milled components, rather than a patient-based test set.
- Data Provenance: Not specified. Based on the context of a 510(k) submission for a medical device manufacturer, this would typically involve internal company testing and validation. It's not explicitly stated as retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- This information is not provided. Given the nature of the device modification and the type of performance testing indicated (validation of data conversion and mechanical output for aperture/compensator milling), "ground truth" would likely be established through engineering specifications, reference measurements, and quality control checks on the milled components, rather than expert evaluation of clinical images or outcomes.
4. Adjudication Method for the Test Set
- This information is not provided. As above, the nature of the testing suggests engineering validation rather than human reader adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
- No, an MRMC comparative effectiveness study was not done. The document focuses on demonstrating substantial equivalence through technical characteristics and internal performance testing, not a clinical study comparing human readers with and without AI assistance. The device modification (MGCS) is a technical component for manufacturing patient-specific treatment accessories, not directly an AI for image interpretation or diagnosis that would typically involve human reader studies.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- The information available indicates that "performance testing that Hitachi conducted to demonstrate that the device meets its performance specifications" was performed. This implies testing of the system, including the MGCS component, in a standalone capacity to ensure it performs its function of converting data for milling correctly and ensures the overall system maintains its designed delivery parameters. However, the details of this "standalone" testing are not elaborated upon. The MGCS's function itself is an "algorithm only" task of data conversion.
7. The Type of Ground Truth Used
- The type of ground truth used would be based on engineering specifications, physical measurements, and quality control standards for the proton beam delivery system and the milled patient-specific apertures/compensators. Specifically for the MGCS, the ground truth would be the accurate conversion of dimensional data from treatment planning software to the milling machine's format, ensuring the resulting milled components precisely match the design.
8. The Sample Size for the Training Set
- This information is not applicable/not provided. The MGCS is described as a data conversion system for manufacturing. It does not appear to be a machine learning or AI algorithm that requires a "training set" in the conventional sense of learning from data. Its function is deterministic: converting specified data formats, not learning patterns from a large dataset.
9. How the Ground Truth for the Training Set Was Established
- This question is not applicable, as there is no indication of a "training set" for the MGCS. The ground truth for its function would be derived from the pre-defined standards and specifications for dimensional data conversion and the physical requirements for the apertures/compensators.
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Attachment 7
APR 1 0 2006
510(k) SUMMARY PROBEAT with MGCS
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
Ko60834
Hitachi, Ltd., Power Systems Group Advanced Medical Technology and Solutions Division, Proton Therapy 18-13, Sotokanda 1-chome, chiyoda-ku Tokyo, 101-8608 Japan
Phone : 011-81-3-4564-3565 Facsimile: 011-81-3-4564-2882
Contact Person: Naoya Nishimura
Date Prepared: March 27, 2006
Name of Device and Name/Address of Sponsor
PROBEAT
Hitachi, Ltd., Power Systems Group Advanced Medical Technology and Solutions Division, Proton Therapy 18-13, Sotokanda 1-chome, chivoda-ku Tokyo, 101-8608 Japan
Common or Usual Name: Proton Beam Therapy System ("PBTS") Classification Name: Medical Charged-Particle Radiation Therapy System Predicate Device: Hitachi's PROBEAT (K053280) Purpose of the Special 510(k) notice.
The PROBEAT with MGCS is a modification to Hitachi's cleared PROBEAT.
Intended Use
The PROBEAT with MGCS is a medical device designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation. The only difference between the PROBEAT with MGCS and the cleared PROBEAT is the addition of the MGCS that
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converts the scale and format of the dimensional data of the patient specific aperture and/or compensator generated by commercially available patient treatment planning/management software into the scale and format used by an industrial, computer controlled milling machine to enable the milling machine to fashion the required aperture or compensator for patient treatment, do not raise any new questions of safety or effectiveness.
Technological Characteristics
The PROBEAT with MGCS is a proton beam irradiation system, which provides a therapeutic proton beam for clinical treatment. It is designed to deliver a proton beam with the prescribed dose, dose distribution and directed to the prescribed patient treatment site. The PBTS is designed to be safe and reliable. The equipment to perform the above work is comprised of two main components. One is a beam delivery system whose primary responsibility is to ensure that the above listed prescription parameters are properly delivered. The other is the equipment necessary to generate the proton beam and direct it to the beam delivery system
Performance Data
The submission includes performance testing that Hitachi conducted to demonstrate that the device meets its performance specifications.
Substantial Equivalence
The PROBEAT with MGCS device has the same intended use and indications for use, similar principles of operation, and similar technological characteristics as the previously cleared predicate PROBEAT. The only difference between the PROBEAT with MGCS and the cleared PROBEAT is the addition of the MGCS that converts the scale and format of the dimensional data of the patient specific aperture and/or compensator generated by commercially available patient treatment planning/management software into the scale and format used by an industrial, computer controlled milling machine to enable the milling machine to fashion the required aperture or compensator for patient treatment. The addition of the MGCS to the PROBEAT does not raise any new questions of safety or effectiveness. Performance data demonstrate that the PROBEAT with MGCS is as safe and effective as the cleared PROBEAT. Thus, the PROBEAT with MGCS is substantially equivalent to its predicate device.
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services (USA). The logo is a circular seal with the department's name written around the perimeter. Inside the circle is a stylized image of an eagle or other bird, with its wings spread and its head turned to the right.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
APR 1 0 2006
Hitachi, Ltd. Power Systems Group % Mr. Jonathan S. Kahan, Esq. Regulatory Counsel Hogan & Hartson L.L.P 555 Thirteenth Street, NW WASHINGTON DC 20004
Rc: K060834
Trade/Device Name: PROBEAT with MGCS Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: LHN Dated: March 27, 2006 Received: March 27, 2006
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.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such 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.
Image /page/2/Picture/10 description: The image is a circular logo with the letters "FDA" in large, bold font in the center. Above the letters, the years "1906 - 2006" are printed. Below the letters, the word "Centennial" is printed in cursive font, with three stars underneath. The logo is surrounded by text that reads "A Century of Consumer Protection & Public Health".
Protecting and Promoting Public Health
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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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology). | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
Sincerely yours,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Attachment 8
Indications for Use Statement
510(k) Number (if known): K060834
Device Name: PROBEAT with MGCS
Indications for Use: Hitachi's PROBEAT with MGCS is a medical device designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation.
Prescription Use
(Per 21 C.F.R. 801.109)
Over-The-C
(Per 21 C.F
Over-The-Counter Use (Per 21 C.F.R. 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
AND/OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
David M. Heggem
いい)OC - 991508001 - 2279360 v2
(Division Sign-Off) 1
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number
K060834
HI 0076
§ 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.