(272 days)
The Sumitomo Proton Therapy System is a medical device designed to produce and deliver a proton beam for treatment of patients with localized tumors and other conditions susceptible to treatment by radiation.
The Sumitomo Proton Therapy System (PTS) is a large-scale medical electrical system that consists of an integrated system of medical electrical equipment and nonmedical electrical components to provide proton beam radiation therapy. The Sumitomo PTS consists of a 230 MeV Cyclotron, an Energy Selection System, a Beam Transport System, and a Gantry Treatment System.
This 510(k) summary (K130426) describes the Sumitomo Proton Therapy System (PTS) and its substantial equivalence to predicate devices, rather than a study proving the device meets specific acceptance criteria in the context of diagnostic performance or AI model validation. The document focuses on establishing equivalence through technological characteristics and non-clinical performance testing.
Therefore, many of the requested categories related to clinical study design, AI performance metrics, ground truth establishment, and expert involvement are not applicable to this submission.
Here's an analysis based on the provided text, structured to address the requested information where applicable:
Acceptance Criteria and Device Performance
Since this is a submission for a proton therapy system and not a diagnostic AI device, the "acceptance criteria" discussed are primarily related to meeting design specifications and demonstrating performance and safety comparable to predicate devices. The document does not provide specific quantitative acceptance criteria for parameters like sensitivity or specificity.
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Overall Performance | "The Sumitomo PTS system was found to meet all performance requirement specifications for hardware, and safety requirements for a proton therapy system." |
| Design Specifications | "The Sumitomo PTS met the requirements of all design specifications." |
| Safety | "Nonclinical safety and performance testing performed demonstrates that the proposed device met all test specifications and is suitable for its intended use." |
| Technological Equivalence | "Has the same of intended use, similar operating parameters and similar system features compared to the predicate systems." |
| Differences Impact | "Differences between these devices are limited to design modifications... These design modifications are minor and raise no new issues of safety or effectiveness." |
2. Sample size used for the test set and the data provenance:
- Not Applicable. This submission is for a proton therapy system, not a diagnostic AI device that would utilize a "test set" in the context of data analysis. The "testing" referred to is engineering and system performance testing.
- The document mentions "A series of factory and on-site safety and performance studies were completed to assess the performance of the Sumitomo PTS." This refers to hardware and system-level validation, not data-driven testing with a specific "test set" like in AI.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. There is no "test set" or "ground truth" in the context of diagnostic interpretation for this type of device submission. The validation involves engineering specifications and performance against those specifications.
4. Adjudication method for the test set:
- Not Applicable. As there is no "test set" in the context of diagnostic AI, no adjudication method was used.
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:
- No. An MRMC study was not done. This device is a treatment system, not an AI diagnostic tool designed to assist human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a physical medical device (proton therapy system), not an algorithm. While it presumably has internal algorithms for beam control, the submission does not discuss them in the context of "standalone performance" as an AI device.
7. The type of ground truth used:
- Engineering Specifications and Physical Measurements: For the system performance testing, the "ground truth" would be established by the design specifications of the device and validated through physical measurements and engineering tests. For example, verifying the energy of the proton beam, accuracy of beam delivery, and safety interlocks.
- "The design outputs of the system and its components have met design specifications in a complete and verifiable manner."
8. The sample size for the training set:
- Not Applicable. This submission does not involve an AI model or a "training set."
9. How the ground truth for the training set was established:
- Not Applicable. There is no training set for an AI model in this submission.
Summary of Non-Clinical and Clinical Testing
- Non-Clinical Testing: "A series of factory and on-site safety and performance studies were completed to assess the performance of the Sumitomo PTS." These tests ensured the system met design and safety requirements.
- Clinical Testing: "No clinical testing was conducted or required in support of this premarket clearance notification." The clearance was based on substantial equivalence to predicate devices and validated non-clinical performance and safety.
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NOV 19 2013
510(k) Summary for the Sumitomo Proton Therpay System (per 21CFR 807.92)
1. SUBMITTER/510(K) HOLDER
| Sumitomo Heavy Industries, Ltd. |
|---|
| Quantum Equipment Division |
| 5-2, Sobiraki-cho |
| Niihama, Ehime, 792-8588 |
| Japan |
Contact Person: Katsuhiro Narasaki, Engineering Dept. Telephone: +81-897-32-6370
Date Prepared: February 15, 2013
2. DEVICE NAME
| Proprietary Name: | Sumitomo Proton Therapy System (PTS) |
|---|---|
| Common/Usual Name: | Proton Therapy System |
| Classification Name: | Medical charged-particle radiation therapy system |
3. PREDICATE DEVICES
- . M.D. Anderson Proton Therapy System (K053280)
- Northeast Proton Therapy Center/Mass. General Hospital (K983332) o
4. DEVICE DESCRIPTION
The Sumitomo Proton Therapy System (PTS) is a large-scale medical electrical system that consists of an integrated system of medical electrical equipment and nonmedical electrical components to provide proton beam radiation therapy.
The Sumitomo PTS consists of a 230 MeV Cyclotron, an Energy Selection System, a Beam Transport System, and a Gantry Treatment System.
5. INTENDED USE
The Sumitomo Proton Therapy System is a medical device designed to produce and deliver a proton beam for treatment of patients with localized tumors and other conditions susceptible to treatment by radiation.
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6. TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE
The initial Sumitomo Proton Therapy System installed and commissioned includes a compact gantry and a multi-purpose nozzle. The single gantry system is expandable to a multi-gantry system. The multi-purpose nozzle provides both wobbling scanning function and pencil beam scanning function. The scope of this 510(k) submission is the wobbling scanning function only. The major PTS system features include:
- · Cyclotron (230 MeV)
- · Energy selection system
- · Beam transport system
- · Multipurpose Nozzle (Initially Wobbling Scanning only)
- · Respiratory Gating System
- · Multi Leaf Collimator
- · Online PET (Gamma ray detector)
- · Compact Gantry
- · Patient Positioning System
A comparison was made to two predicate systems, the M.D. Anderson Proton Therapy System (K053280) manufactured by Hitachi Ltd. and the Northeast Proton Therapy Center (NPTC) (K983332) manufactured by IBA. The Sumitomo PTS system has the same of intended use, similar operating parameters and similar system features compared to the predicate systems. The proposed and predicate systems have a proton source, a synchrotron for the M.D. Anderson Center, and a cyclotron for the NPTC and the Sumitomo PTS. The radiation generated by the proton sources is then directed to gantries and into treatment rooms.
The operational characteristics of the proposed and predicated devices are similar. The accelerator energies are in the same range (70 to 250 MeV). The beam transport systems for all three devices deliver the accelerated protons to the gantries to be used for treatment. The gantries direct the radiation through treatment heads to patients. The treatment heads direct the radiation to treatment sites determined by treatment planning software. The operation of all three cited systems is the same with protons accelerated and directed to patients for safe and effective treatments.
The gantries in the Sumitomo PTS are of a compact design which saves space and resources without impacting effectiveness and safety. The gantries of the predicate devices are of a conventional size and design. The treatment heads mounted on the gantries are of similar design and allow various patterns of radiation for different treatments. Overall, the technological characteristics of all three cited systems are similar and allow for safe and effective treatments. The Sumitomo system will
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include a gamma ray detector system (online PET) that uses technology based on the positron emission tomography (PET). The online PET system detects gamma ray emissions from two sides of the treated tumor to provide a projection image of the treated area. This system generates a limited spatial resolution image of original gamma ray source position by inverse calculation for confirming that the proton beam reached the intended tumor tissue. This PET system is used just after treatment and does not provide real-time control of the proton beam.
7. SUMMARY OF NON-CLINICAL PERFORMANCE TESTING AS BASIS FOR SUBSTANTIAL EQUIVALENCE
A series of factory and on-site safety and performance studies were completed to assess the performance of the Sumitomo PTS. Testing was performed and documented to ensure the design outputs of the system and its components have met design specifications in a complete and verifiable manner. Testing was peformed at the unit level and subsystem level at the factory and on-site. Based on the extensive factory testing and on-site testing performed, the Sumitomo PTS system was found to meet all performance requirement specifications for hardware, and safety requirements for a proton therapy system.
The Sumitomo PTS met the requirements of all design specifications.
8. SUMMARY OF CLINICAL TESTING AS BASIS FOR SUBSTANTIAL EQUIVALENCE
No clinical testing was conducted or required in support of this premarket clearance notification.
9. SUMMARY OF OTHER INFORMATION
This submission includes comparison of intended use statements, proposed product labeling and summary information and labeling on predicate devices.
10. CONCLUSIONS DRAWN FROM NON-CLINICAL AND CLINICAL TESTS
Based on the information provided in this 510(k), Sumitomo believes that the proposed proton therapy system is substantially equivalent to the previously cleared Hitachi and IBA proton therapy systems. The Sumitomo PTS has the same intended use, similar design, principle of operation, and technological characteristics as its predicate devices. The minor technological difference between the Sumitomo PTS and its predicate devices is the compact gantry. The compact gantry uses similar principles to the predicate devices. The Sumitomo system also uses an online PET system that is used post treatment and does not provide real time control of the proton beam. The overall design of the proposed and predicate devices is similar. The
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· differences between these devices are limited to design modifications implemented to the same of the subscription of the improve the convenience and ease of use of the proposed device. These design modifications are minor and raise no new issues of safety or effectiveness. Thus, the Sumitomo Proton Therapy System is substantial equivalent to the previously cleared predicate devices.
The proposed device raises no new issues of safety and effectiveness. The nonclinical safety and performance testing performed demonstrates that the proposed device met all test specifications and is suitable for its intended use.
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Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a bird in flight. The image is in black and white.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 19, 2013
Sumitomo Heavy Industries, Ltd. % Mr. Ronald S. Warren Director, Regulatory Services 11440 W. Bernardo Court, Suite 300 SAN DIEGO CA 92127
Re: K130426
Trade/Device Name: Sumitomo Proton Therapy System Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: LHN Dated: October 29, 2013 Received: October 31, 2013
Dear Mr. Warren:
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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Page 2-Mr. Warren
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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 Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/ReportalProblem/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 Small Manufacturers, International and Consumer Assistance 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. O'Hara
Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
for
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K130426
Device Name
Sumitomo Proton Therapy System
Indications for Use (Describe)
The Sumitomo Proton Therapy System is a medical device designed to produce and deliver a proton beam for treatment of patients with localized tumors and other conditions susceptible to treatment by radiation.
Type of Use (Select one or both, as applicable)
[8] Prescription Use (Part 21 CFR 801 Subpart D)
[] Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Michael D. O'Hara
FORM FDA 3881 (9/13)
Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.
N/A