(167 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 non-medical 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. The new Sumitomo PTS is a modification of the Sumitomo PTS cleared for marketing under K130426 in November 2013. The purpose of the current 510(k) premarket notification is to add the pencil beam scanning functionality to the cleared Sumitomo PTS. The pencil beam scanning function allows for precise treatment of complex cancers, such as tumors located near critical structures and tumors with special shapes, including multi-site targets, without the need for beam shaping devices such as collimators or compensators. The pencil beam scanning function also produces a radiation field directly from the beam scan path layer by layer, which shortens the treatment duration.
The Sumitomo Proton Therapy System with pencil beam scanning addresses the treatment of localized tumors and other conditions susceptible to radiation.
Here's an analysis based on the provided document:
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Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state "acceptance criteria" in a quantitative manner with pass/fail metrics. Instead, it describes general design specifications and performance requirements that the device met. It provides a side-by-side comparison of the new device with predicate devices, highlighting technological characteristics.
Characteristic Acceptance Criteria (Implied by meeting design specs) Reported Device Performance (as stated in the document) General Performance Met all performance requirement specifications for hardware, software, and safety. "The Sumitomo PTS with pencil beam scanning met the requirements of all design specifications." Safety Safe and effective operation. "The addition of the pencil beam scanning function raises no new issues of safety or effectiveness." and "The new device raises no new issues of safety and effectiveness." Usability Users can safely and effectively perform activities involved in pencil beam scanning. "The results confirmed that users can safely and effectively perform the activities involved in pencil beam scanning." and "The usability evaluation confirmed that users can safely and effectively use the new Sumitomo PTS for pencil beam scanning." Dose Rate (Wobbling Mode) > 2 Gy/min (110 to 230 MeV); > 0.5 Gy/min for 10 cm x 10 cm x 4 cm (SOBP) at 70 MeV. "> 2 Gy/min (110 to 230 MeV); > 0.5 Gy/min for 10 cm x 10 cm x 4 cm (SOBP) at 70 MeV" (This matches the predicate, indicating it meets or exceeds the previous performance). Dose Rate (Pencil Beam) > 2Gy/min/liter (>150 MeV); > 2Gy/min/(10cmx10cmx4cm) (110MeV); > 0.5 Gy/min/(10cmx10cmx4cm) (Max depth 5cm with snout degrader). "> 2Gy/min/liter (>150 MeV); > 2Gy/min/(10cmx10cmx4cm) (110MeV); > 0.5 Gy/min/(10cmx10cmx4cm) (Max depth 5cm with snout degrader)" (This is the specific performance for the new feature). -
Sample Size used for the test set and the data provenance:
- Test Set Sample Size: The document does not specify a quantitative "test set sample size" in terms of number of patients or cases. The testing involved "a series of factory and on-site safety and performance studies" and a "usability assessment." These appear to be engineering and system validation tests rather than clinical patient data analysis.
- Data Provenance: The testing was "performed at the unit level, subsystem level at the factory and on-site, and system level on-site." This indicates engineering and system testing data, not clinical patient data from a specific country or whether it was retrospective or prospective.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Since no clinical testing was conducted or described, there is no information about experts establishing ground truth for a clinical test set. The usability assessment involved "study participants," but their qualifications or number are not specified beyond them being "users" capable of simulating clinical treatment scenarios. For the engineering tests, "ground truth" would be established by design specifications and measurement standards.
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Adjudication method for the test set:
Not applicable. No clinical test set with adjudicated ground truth is described.
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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:
Not applicable. This device is a radiation therapy system, not an AI-assisted diagnostic or interpretation tool that would involve human readers. No MRMC study was conducted.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
The "pencil beam scanning functionality" is an integral part of the proton therapy system. Its performance was assessed as part of the overall system validation, rather than as a standalone algorithm in the typical sense of AI/image analysis. The device itself (the therapy system) operates "stand-alone" in delivering the therapy based on a treatment plan, but its development involved human design and engineering. The document focuses on the system's performance and safety, not on an algorithm's standalone diagnostic accuracy.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For the non-clinical performance testing, the "ground truth" would be defined by engineering design specifications, internationally recognized standards for radiation therapy equipment, and validated measurement techniques for beam characteristics (e.g., dose rate, energy, depth of penetration, beam stability). For the usability assessment, the "ground truth" was likely defined by predetermined safe and effective operational procedures. No clinical ground truth (e.g., pathology, outcomes data) was used or mentioned, as no clinical testing was performed for this 510(k).
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The sample size for the training set:
Not applicable. The document describes a medical device (proton therapy system), not a machine learning or AI model that requires a training set of data.
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How the ground truth for the training set was established:
Not applicable. There was no training set for a machine learning model.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines suggesting hair or fabric.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Auqust 17, 2016
Sumitomo Heavy Industries, Ltd. % Cynthia Nolte, Ph.D., RAC Senior Director, Regulatory Affairs ICON Clinical Research LCC 62 Forest Street, Suite 300 MARLBOROUGH MA 01752
Re: K160612
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: August 3, 2016 Received: August 4, 2016
Dear Dr. Nolte:
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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4. INDICATIONS FOR USE
| DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration | Form Approved: OMB No. 0910-0120 | |
|---|---|---|
| Indications for Use | Expiration Date: January 31, 2017See PRA Statement below. | |
| 510(k) Number (if known) | ||
| K160612 | ||
| Device Name | ||
| Sumitomo Proton Therapy System | ||
| Indications for Use (Describe) | ||
| patients with localized tumors and other conditions susceptible to treatment by radiation. | The Sumitomo Proton Therapy System is a medical device designed to proton beam for treatment of | |
| Type of Use (Select one or both, as applicable) | ||
| > 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) | ||
| 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. | ||
| of this information collection, including suggestions for reducing this burden, to: | The burden time for this collection of information is estimated to average 79 hours per response, including thetime to review instructions, search existing data sources, gather and maintain the data needed and completeand review the collection of information. Send comments regarding this burden estimate or any other aspect | |
| Department of Health and Human Services | ||
| Food and Drug AdministrationOffice 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 ofinformation unless it displays a currently valid OMB number." | ||
| FORM FDA 3881 (1/14) | Page 1 of 1 | PSC Publishing Services (301) 443-6740 |
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510(K) SUMMARY Sumitomo Heavy Industries, Ltd. Sumitomo Proton Therapy System (per 21CFR 807.92)
1. SUBMITTER/510(K) HOLDER
Sumitomo Heavy Industries, Ltd. 5-2, Sobiraki-cho Niihama, Ehime, 792-8588 Japan Establishment Registration No: 3002674566 Katsuhiro Narasaki, Engineering Dept. Contact: Contact Phone: +81-897-32-6370
Contact Email: kth narasaki@shi.co.jp
June 27, 2016 Date Prepared:
2. DEVICE NAME
| Proprietary Name: | Sumitomo Proton Therapy System |
|---|---|
| Common Name: | Proton therapy system |
| Classification Name: | Medical charged-particle radiation therapy system |
| Classification Regulation: | 21 CFR 892.5050 |
| Product Code: | LHN |
3. PREDICATE DEVICE
- Sumitomo Proton Therapy System, Sumitomo Heavy Industries, Ltd. (K130426) ●
- IBA Proton Therapy System- Proteus 235, Ion Beam Applications, S.A. (K082416) ●
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 non-medical 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. The new Sumitomo PTS is a modification of the Sumitomo PTS cleared for marketing under K130426 in November 2013. The purpose of the current 510(k) premarket notification is to add the pencil beam scanning functionality to the cleared Sumitomo PTS. The pencil beam scanning function allows for precise treatment of complex cancers, such as tumors located near critical structures and tumors with special shapes, including multi-site targets, without the need for beam shaping devices such as collimators or compensators. The pencil beam scanning function also produces a radiation field directly from the beam scan path layer by layer, which shortens
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the treatment duration.
5. INDICATION FOR USE/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.
6. SUMMARY OF TECHNOLOGICAL CHARACTERISTICS COMPARED TO THE PREDICATE DEVICE/S
The Sumitomo PTS with pencil beam scanning and predicate Sumitomo PTS are identical except for the pencil beam scanning functionality. The major features of both the new device and the predicate Sumitomo PTS include:
- Cyclotron (230 MeV)
- · Energy selection system (ESS)
- · Beam transport system (BTS)
- Multipurpose Nozzle
- · Respiratory Gating System
- Multi Leaf Collimator
- · Online PET (Gamma ray detector)
- Compact Gantry
- · Patient Positioning System
The operational characteristics of the new and predicate Sumitomo PTS are identical. The accelerator energies are in the same range (70 to 250 MeV). The beam transport systems are identical and deliver the accelerated protons to the gantries to be used for treatment in the same manner. The gantries are identical, and direct the radiation through treatment heads to patients in the same manner. The interface between the treatment planning software and the treatment heads, and the treatment planning software itself, are also identical.
The multi-purpose nozzle described in the current 510(k) premarket notification provides both wobbling and pencil beam scanning functions. The nozzle described in the original 510(k) for the predicate device was limited to the wobbling scanning function only. The user selects whether to use wobbling scanning or pencil beam scanning when planning for treatment.
In pencil beam scanning mode, proton beams delivered by the ESS, BTS, and GTS (Gantry Transport System) are irradiated to the isocenter without any scatter, focused by quadrupole magnets installed at the entrance of the nozzle. The beam is scanned laterally in two orthogonal directions continuously, controlled by a pair of scanning magnets.
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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 new Sumitomo PTS with pencil beam scanning. 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 performed at the unit level, subsystem level at the factory and on-site, and system level on-site. The extensive factory testing and on-site testing demonstrates that the Sumitomo PTS with pencil beam scanning met all performance requirement specifications for hardware, software, and safety requirements for a proton therapy system. The Sumitomo PTS with pencil beam scanning met the requirements of all design specifications.
Sumitomo conducted a usability assessment of the Sumitomo PTS with pencil beam scanning. Study participants completed two simulated clinical treatment scenarios as well as tasks identified as essential and critical. The results confirmed that users can safely and effectively perform the activities involved in pencil beam scanning.
8. SUMMARY OF CLINICAL TESTING AS BASIS FOR SUBSTANTIAL EQUIVALENCE
No clinical testing was conducted in support of this 510(k) premarket notification.
9. SUMMARY OF OTHER INFORMATION
No other information is submitted in support of this 510(k) premarket notification.
10. CONCLUSIONS DRAWN FROM NON-CLINICAL AND CLINICAL TESTS
Based on the information provided in this 510(k), Sumitomo believes that the new Sumitomo PTS with pencil beam scanning is substantially equivalent to the previously cleared Sumitomo PTS. The Sumitomo PTS with pencil beam scanning has the same intended use, similar design, principle of operation, and technological characteristics as the predicate device. The only difference between the Sumitomo PTS with pencil beam scanning and the predicate Sumitomo PTS is the addition of the pencil beam scanning function to the multi-purpose nozzle. The addition of the pencil beam scanning function raises no new issues of safety or effectiveness. The Sumitomo PTS with pencil beam scanning met all performance requirements with no usability issues. Thus, the Sumitomo PTS with pencil beam scanning is substantially equivalent to the predicate Sumitomo PTS.
The new device raises no new issues of safety and effectiveness. The non-clinical safety and performance testing performed demonstrates that the new device met all test specifications and is suitable for its intended use. The usability evaluation confirmed that users can safely and effectively use the new Sumitomo PTS for pencil beam scanning.
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Table 5-1. Side-by-Side Comparison of New and Predicate Sumitomo Proton Therapy Systems with Reference Device
| Characteristic | Sumitomo Proton Therapy System with Pencil Beam ScanningNEW | Sumitomo Proton Therapy System (K130426)PREDICATE | Proteus 235 Proton Therapy System (K082416)REFERENCE |
|---|---|---|---|
| Manufacturer | Sumitomo Heavy Industries, Ltd. | Sumitomo Heavy Industries, Ltd. | IBA |
| Indication for 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. | 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 PTS 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. |
| Accelerator Type | Cyclotron | Cyclotron | Cyclotron |
| Particle | Proton | Proton | Proton |
| Accelerator: Energy (MeV) | 70 - 230 continuous | 70 – 230 continuous | 70-230 continuous |
| Depth of penetration | 3 cm-32cm | 3cm - 32cm | 5cm - 28cm |
| Field Shaping System | Wobbling, Pencil Beam Scanning | Wobbling | Double and Single Scattering, Uniform Scanning, Pencil Beam Scanning |
| Dose Rate: (Gy/min) | For Wobbling> 2 Gy/min (110 to 230 MeV)> 0.5 Gy/min for 10 cm x 10 cm x 4 cm (SOBP) at 70 MeVFor pencil beam scanning functionality> 2Gy/min/liter (>150 MeV)> 2Gy/min/(10cmx10cmx4cm) (110MeV)> 0.5 Gy/min/(10cmx10cmx4cm)(Max depth 5cm with snout degrader) | For Wobbling> 2 Gy/min (110 to 230 MeV)> 0.5 Gy/min for 10 cm x 10 cm x 4 cm (SOBP) at 70 MeV | > 2Gy/min. |
| Safety System | Hard-wired relay and programmable logic controller (PLC) based interlock systems | Hard-wired relay and programmable logic controller (PLC) based interlock systems | Hard-wired relay-based interlock system |
| Treatment Geometry | Isocentric gantry or fixed horizontal beam delivery | Isocentric gantry or fixed horizontal beam delivery | Isocentric gantry or fixed horizontal beam delivery |
| Proton Beam current stability | Stable (Cyclotron) | Stable (Cyclotron) | Stable (Cyclotron) |
| Proton beam time structure | CW beam | CW beam | CW (Continues Wave) beam |
| Respiratory gating for wobbling mode | Simple(Respiratory gating+ Wobbling timing )(Passive ridge filter) | Simple(Respiratory gating+ Wobbling timing )(Passive ridge filter) | Not simple(Range modulator + Respiratory gating + Wobbling timing) |
| Pencil beam scanning | Line scanning + spot scanning | N/A | Line scanning + spot scanning |
| Gantry size | Short axis gantry (Similar to Loma Linda gantry) | Short axis gantry (Similar to Loma Linda gantry) | Long axis gantry |
| Delivery proton dose distribution measurement | Off line phantom measurement + On line PET measurement | Off line phantom measurement + On line PET measurement | Off line phantom measurement |
| Accessibility to the patient in gantry in | Quick access(Caterpillar floor) | Quick access(Caterpillar floor) | Need time to access patient (in case nozzle is lower position) |
N/A: Not available
§ 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.