McLaren Proton Therapy System

• K Number: K160063
• Device Name: McLaren Proton Therapy System
• Manufacturer: McLaren Health Care Corporation
• Date Cleared: 2016-02-25 ( 43 days)
• Product Code: LHN
• Regulation Number: 892.5050

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.

Device Description

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

Predicate Devices

K134052

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a proton therapy system focused on beam production and delivery, with no mention of AI/ML in the device description, intended use, or performance studies.

Therapeutic

Yes

The device is designed for the "treatment of patients with localized tumors and other conditions susceptible to treatment by radiation," which directly indicates a therapeutic purpose.

Diagnostic

No

The device is described as a "medical device designed to produce and deliver a proton beam for the treatment of patients," indicating a therapeutic rather than diagnostic purpose.

SaMD (Software as a Medical Device)

No

The device description clearly outlines numerous hardware components, including a synchrotron, beam transport system, gantry, and patient positioning system, indicating it is a complex hardware system with integrated software, not a software-only device.

IVD (In Vitro Diagnostic)

Based on the provided information, the McLaren Proton Therapy System is not an IVD (In Vitro Diagnostic) device.

Here's why:

• Intended Use: The intended use is for the treatment of patients with localized tumors and other conditions using a proton beam. This is a therapeutic application, not a diagnostic one.
• Device Description: The description details a system for producing and delivering a proton beam for radiation therapy. It does not involve the examination of specimens derived from the human body for diagnostic purposes.
• Lack of IVD Characteristics: The document does not mention any activities related to in vitro diagnostics, such as analyzing blood, urine, tissue samples, or other bodily fluids or substances outside of the body to provide information for diagnosis, monitoring, or treatment decisions.

Therefore, the McLaren Proton Therapy System is a therapeutic medical device, not an IVD.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for 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.

Product codes

LHN

Device Description

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

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

Not Found

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)

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:

• 1. Creation and direction the proton beam appropriately to the patient treatment location;
• 2. Production of a transverse and longitudinal distribution appropriate for the patient treatment; and
• 3. 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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K134052

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 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.

Summary

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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 [phone] or [phone] 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 [phone] or [phone] 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: [phone] 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.

4

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:

• 1. Creation and direction the proton beam appropriately to the patient treatment location;
• 2. Production of a transverse and longitudinal distribution appropriate for the patient treatment; and
• 3. 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.