(43 days)
The McLaren Proton Therapy System 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 McLaren Proton Therapy System consists primarily of Beam Delivery and Beam Production systems. These systems are comprised of various components and/or accessories designed to produce and deliver a proton beam appropriate for patient treatment. The system components include:
- Beam Production System. This system produces the proton beam and directs it to the appropriate treatment room and is comprised of the following subsystems:
- Synchrotron subsystem. The accelerator unit is the source of the proton beam and is composed of the injector (which generates the proton beam) and the synchrotron (which accumulates, accelerates, and extracts the proton beam).
- Beam Transport subsystem. This subsystem guides the proton beam extracted from the synchrotron to the treatment room.
- Beam Delivery System. This system controls the irradiation dose and shapes the proton beam supplied through the beam transportation system into the configuration required for patient treatment, and directs the beam appropriately. It is comprised of the following subsystems:
- Scan/Dose subsystem
- Gantry subsystem
- Patient Positioning subsystem.
- Treatment Delivery Control subsystem
The provided text does not contain detailed information about specific acceptance criteria and a study proving a device meets these criteria in the typical format where performance metrics are reported against defined thresholds.
Instead, the document is a 510(k) summary for the McLaren Proton Therapy System, stating its substantial equivalence to a predicate device (ProTom Radiance 330™ Proton Beam Therapy System, K134052). In this regulatory context, proving substantial equivalence means demonstrating that the new device is as safe and effective as a legally marketed predicate device.
Here's an attempt to extract and infer the requested information based on the provided text, acknowledging that much of it is not explicitly stated in the detail typically found for AI/imaging device performance studies:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not provide a table with specific quantitative acceptance criteria or detailed performance metrics. It generally states that the device "met its specifications for its intended use."
| Acceptance Criteria (Inferred from regulatory requirements for medical devices) | Reported Device Performance (General Statement from 510(k) Summary) |
|---|---|
| Safety: Device operates without undue harm to patients or users. | "Testing to evaluate electrical safety and electromagnetic compatibility was performed in accordance with IEC 60601-1 and IEC 60601-1-2." "All testing demonstrated that the system met its specifications for its intended use." |
| Effectiveness: Device performs its intended function as designed (producing and delivering a proton beam for cancer treatment). | "Each individual subsystem of the McLaren Proton Therapy System was verified and validated, and full system verification and validation was also performed." "Beam performance testing to validate complete system integration under nominal and non-nominal conditions was performed on the full system." Beam delivery testing evaluated: - Creation and direction of the proton beam appropriately to the patient treatment location - Production of a transverse and longitudinal distribution appropriate for the patient treatment - Delivery of the designated dose to the patient's treatment site. "All testing demonstrated that the system met its specifications for its intended use." |
| Usability: Users can interact with the system effectively and safely. | "A usability evaluation was conducted to confirm that users can interact with the system user interface to perform treatment with the device system." "All testing demonstrated that the system met its specifications for its intended use." |
| Substantial Equivalence to Predicate Device: Shares identical intended use, indications, principles of operation, and technological characteristics. | "Except for the device name, the McLaren Proton Therapy System has the identical intended use, indications, principles of operation, and technological characteristics as the ProTom Radiance 330™ Proton Beam Therapy System (K134052)." "The McLaren Proton Therapy System is identical to the ProTom Radiance 330™ Proton Beam Therapy System and there are no new questions of safety or effectiveness." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a "test set" in the context of patient data or image datasets, as would be common for AI/imaging devices. The testing described is primarily for the physical and functional aspects of the proton therapy system itself. Therefore, sample sizes for medical data are not applicable here.
- Test Set Sample Size: Not applicable in the context of device performance testing described. The "test set" here refers to the actual device and its components undergoing engineering verification and validation.
- Data Provenance: Not applicable. The "data" comes from the performance measurements of the physical device during engineering tests.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided. "Ground truth" in this context would likely refer to engineering specifications or established physics principles against which the proton beam performance is measured. The experts involved would be engineers, physicists, and medical physicists, but their numbers and specific qualifications are not detailed.
4. Adjudication Method for the Test Set
Not specified or applicable in the sense of expert consensus for a medical diagnosis or interpretation. Adjudication would refer to the process of determining if the device met its engineering specifications, which is typically done through measurement and comparison to predefined thresholds by testing personnel.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not performed or mentioned. This type of study is specifically designed for evaluating the impact of AI on human reader performance, typically in diagnostic imaging, which is not the primary function of a proton therapy system.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This concept is not directly applicable to a proton therapy system in the way it is for an AI algorithm. The McLaren Proton Therapy System is a physical medical device. Its "standalone" performance refers to its ability to produce and deliver a proton beam according to specifications, which was indeed tested. The "Performance Data" section describes this: "Each individual subsystem... was verified and validated, and full system verification and validation was also performed."
7. The Type of Ground Truth Used
The ground truth used for validating the McLaren Proton Therapy System is based on:
- Engineering Specifications: Pre-defined design requirements for parameters like beam energy, dose delivery accuracy, beam uniformity, and patient positioning precision.
- Physical Laws and Standards: Compliance with established principles of physics for radiation therapy and relevant international standards (e.g., IEC 60601-1, IEC 60601-1-2 for electrical safety and EMC).
- Functional Requirements: The ability to achieve the intended clinical function of producing and delivering a proton beam for cancer treatment.
8. The Sample Size for the Training Set
Not applicable. This device is a physical system, not an AI algorithm trained on a dataset.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" for this physical device. The device's design and operation are based on established scientific and engineering principles, not machine learning from a training dataset.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 25, 2016
McLaren Health Care Corporation % Daniel Gottlieb, Esq. Attorney Epstein Becker & Green, P.C. 1227 25th Street NW, Suite 700 WASHINGTON DC 20037
Re: K160063
Trade/Device Name: McLaren Proton Therapy System Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: LHN Dated: January 11, 2016 Received: January 13, 2016
Dear Mr. Gottlieb:
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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Indications for Use
510(k) Number (if known) K160063
Device Name McLaren Proton Therapy System
Indications for Use (Describe)
The McLaren Proton Therapy System 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.
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) |
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510(k) Summary
McLaren Proton Therapy System
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
Epstein Becker Green 1227 25th St. NW Ste. 700 Washington, DC 20037
Telephone: 202-861-1881 Facsimile: 202-861-3581
Contact Person: Daniel Gottlieb Date Prepared: January 11, 2016
Name of Device Name/Address of Sponsor
McLaren Proton Therapy System
McLaren Health Care Corporation G-3235 Beecher Rd., Suite B Flint, MI 48532
Common or Usual Name
Proton beam therapy systems
Classification Name
Medical Charged-Particle Radiation Therapy System, 21 CFR 892.5050, Product Code LHN
Predicate Device
ProTom Radiance 330™ Proton Beam Therapy System (K134052) Cleared Mar 14, 2014
Intended Use
The McLaren Proton Therapy System 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.
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510(k) Summary
McLaren Proton Therapy System
Technological Characteristics
The McLaren Proton Therapy System consists primarily of Beam Delivery and Beam Production systems. These systems are comprised of various components and/or accessories designed to produce and deliver a proton beam appropriate for patient treatment. The system components include:
- . Beam Production System. This system produces the proton beam and directs it to the appropriate treatment room and is comprised of the following subsystems:
- . Synchrotron subsystem. The accelerator unit is the source of the proton beam and is composed of the injector (which generates the proton beam) and the synchrotron (which accumulates, accelerates, and extracts the proton beam).
- . Beam Transport subsystem. This subsystem guides the proton beam extracted from the synchrotron to the treatment room.
- Beam Delivery System. This system controls the irradiation dose and shapes the proton beam supplied through the beam transportation system into the configuration required for patient treatment, and directs the beam appropriately. It is comprised of the following subsystems:
- . Scan/Dose subsystem
- Gantry subsystem .
- Patient Positioning subsystem. .
- Treatment Delivery Control subsystem
Performance Data
Each individual subsystem of the McLaren Proton Therapy System was verified and validated, and full system verification and validation was also performed. Beam performance testing to validate complete system integration under nominal and non-nominal conditions was performed on the full system. Beam delivery testing evaluated the following:
-
- Creation and direction the proton beam appropriately to the patient treatment location;
-
- Production of a transverse and longitudinal distribution appropriate for the patient treatment; and
-
- Delivery of the designated dose to the patient's treatment site.
Testing to evaluate electrical safety and electromagnetic compatibility was performed in accordance with IEC 60601-1 and IEC 60601-1-2, and a usability evaluation was conducted to confirm that users can interact with the system user interface to perform treatment with the device system.
All testing demonstrated that the system met its specifications for its intended use.
Substantial Equivalence
Except for the device name, the McLaren Proton Therapy System has the identical intended use, indications, principles of operation, and technological characteristics as the ProTom Radiance 330'''' Proton Beam Therapy System (K134052).
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510(k) Summary
McLaren Proton Therapy System
The McLaren Proton Therapy System is identical to the ProTom Radiance 330™ Proton Beam Therapy System and there are no new questions of safety or effectiveness.
Thus, the McLaren Proton Therapy System is substantially equivalent to its predicate device.
§ 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.