P-Cure Proton Beam Therapy System

K221996 · P-Cure, Ltd. · LHN · Mar 20, 2023 · Radiology

Device Facts

• Record ID: K221996
• Device Name: P-Cure Proton Beam Therapy System
• Applicant: P-Cure, Ltd.
• Product Code: LHN · Radiology
• Decision Date: Mar 20, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5050
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The P-CURE system is a medical device designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other condition susceptible to treatment by radiation in the head, neck and thorax.

Device Story

P-Cure Proton Beam Therapy System generates/delivers proton beams for radiation therapy; utilizes synchrotron-based accelerator to produce protons; beam delivery system steers/monitors pencil beam via nozzle. Patient positioning system (P-ARTIS) uses robotic arm/chair (6-degree-of-freedom) to orient seated patients; integrates CT (3D) and X-ray (2D) for registration. Control subsystem (TSM) synchronizes components, interfaces with hospital oncology information systems/PACS; safety subsystem manages interlocks/monitoring. Used in clinical settings by radiation oncology staff. Output consists of controlled proton radiation dose to target site; enables precise tumor treatment while sparing surrounding tissue. Benefits include localized dose delivery for head, neck, and thorax malignancies.

Clinical Evidence

Bench testing only. Verification included mechanical performance of positioning system, beam dose/shape/rate/monitoring, spot positioning, safety interlocks, and integration with oncology information/treatment planning systems. Compliance with IEC 60601-1, 60601-1-2, 60601-2-44, 60601-1-3, 60601-1-8, 60601-2-54, 60601-1-64, 60601-2-68, 62667, and AAPM TG-224 verified.

Technological Characteristics

Synchrotron-based accelerator; 70-250 MeV variable energy; pencil beam scanning nozzle; steel/concrete shielding. Robotic 6-DOF chair for seated patient positioning. Integrated CT and X-ray imaging. Software-controlled beam transport and safety interlocks. Connectivity with hospital oncology information systems and PACS.

Indications for Use

Indicated for patients with localized tumors and other conditions susceptible to radiation therapy in the head, neck, and thorax.

Regulatory Classification

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.

Predicate Devices

• ProTom International Holding Corp. Radiance 330 Proton Beam Therapy System (K191521)

Submission Summary (Full Text)

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March 20, 2023

P-Cure Ltd. % Jonathan Kahan Partner Hogan Lovells US LLP 555 Thirteenth Street. N.W. WASHINGTON DC 20004

Re: K221996

Trade/Device Name: P-Cure Proton Beam Therapy System Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: Class II Product Code: LHN Dated: February 16, 2023 Received: February 17, 2023

Dear Jonathan 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Digitally signed by Lora D. Weidner -S Lora D. Weidner -S
Date: 2023.03.20 09:44:39 -04'00'

Lora D. Weidner, Ph.D. Assistant Director Radiation Therapy Team DHT8C: Division of Radiological Imaging and Radiation Therapy Devices OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K221996

#### Device Name

P-Cure Proton Beam Therapy System

#### Indications for Use (Describe)

The P-Cure 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 condition susceptible to treatment by radiation in the head, neck and thorax.

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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#### 510(k) SUMMARY P-Cure, Ltd.'s Proton Beam Therapy System

#### Submitter

P-Cure, Ltd. 14 Carmel St. Shilat Industrial Zone, 7318800 lsrael

Phone: [phone]

Contact Person: Ori Lubin Date Prepared: March 15, 2023

#### Name of Device:

P-Cure Proton Beam Therapy System

## Common or Usual Name:

Proton beam therapy systems

## Classification Name:

Medical Charged-Particle Radiation Therapy System, 21 CFR 892.5050

# Regulatory Class:

Class II

#### Product Code:

LHN

# Predicate Device

ProTom International Holding Corp. Radiance 330 Proton Beam Therapy System (K191521)

#### Device Description:

The P-CURE system is a medical device designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other condition susceptible to treatment by radiation in the head, neck and thorax.

The P-CURE proton beam therapy system comprises four main subsystems that function in tandem to generate the desired dose level and distribution at the target site:

#### Beam production system (Synchrotron based accelerator) .

- o Injector produces and delivers protons to the synchrotron
- Synchrotron ring accelerates the proton beam in circular orbit (within the o ring) to the desired energy level

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- Extraction system extracts the beam from the ring to the beam delivery o subsvstem
- Beam delivery system for a single fixed beam treatment room. Steers and . monitors the extracted proton pencil beam from the synchrotron to the desired treatment location (Nozzle).
- . Patient Positioning System (P-ARTIS). Mechanically orients the seated patient; provides independent means of patient registration using CT (3D) and X-ray (2D)
- CT system (P-ARTIS CT) o
- Robotic arm and chair (6 Degree of freedom Couch) (P-ARTIS PPS) o
- o X-ray system (P-ARTIS XR)
- Positioning Software (P-ARTIS SW) O

# · Control and Safety Systems

- Control Subsystem (TSM). Synchronizes the various subsystem actions and o connects with hospital oncology information systems and PACS.
- Safety Subsystem. Includes hardware and software means to ensure safe o system operation for patient and personnel. It includes subsystem interlocks, treatment beam parameters monitoring, and others.

# Intended Use / Indications for Use

The P-CURE system is a medical device designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other condition susceptible to treatment by radiation in the head, neck and thorax.

# Summary of Technological Characteristics and Comparison to the Predicate

The P-Cure proton beam therapy system and its predicate Protom Radiance 330 (K191521) are based on the same technological elements where the system is designed to achieve radiation therapy by accelerating protons for delivery through a nozzle to the patient for the treatment of conditions which are susceptible to radiation. The P-cure system uses a similar synchrotron as utilized by the predicate. Both systems use CT to obtain 3D images for planning and positioning. The P-Cure system delivers a treatment by a fixed beam assembly, and uses a robotic patient positioning system to move the patient to ensure delivery of the beam to the target area whereas the predicate system incorporates a gantry to move the beam in conjunction with a robotic patient positioning system. The P-Cure system positions the patient in a seated position compared to the supine position used with the predicate system. These differences do not raise different questions of safety or efficacy and testing demonstrates substantially equivalent performance compared to the predicate. A table comparing the key features of the subject and predicate devices is provided below.

| Device | P-CURE System | Radiance 330 Proton Beam<br>Therapy System |
|-----------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K221996 | K191521 |
| Device | P-CURE System | Radiance 330 Proton Beam<br>Therapy System |
| Intended Use/<br>Indications for<br>Use | The P-CURE system is a medical<br>device designed to produce and<br>deliver a proton beam for the<br>treatment of patients with localized<br>tumors and other condition<br>susceptible to treatment by<br>radiation in the head, neck and<br>thorax. | The ProTom Radiance 330 is a<br>medical device designed to<br>produce and deliver a proton<br>beam for the treatment of<br>patients with localized tumors<br>and other condition susceptible<br>to treatment by radiation |
| Accelerator | Synchrotron | Synchrotron |
| Particle | Protons | Protons |
| Variable<br>Energy | Yes; 70-250 MeV | Yes; 70-250 MeV |
| Cycle Time | Variable | Variable |
| Beam<br>Transport | Bending and focusing magnets | Bending and focusing magnets |
| Nozzles | Pencil Beam Scanning | Pencil Beam Scanning |
| Beam Range<br>in Patient<br>(Tissue<br>Depth) | 3 cm to 38 cm clinical use | 3 cm to 38 cm clinical use |
| Range Verifier | Optional | Optional |
| Control and<br>Safety System | Software controls accelerator,<br>beam transport and delivery,<br>sets operational parameters,<br>monitors systems and<br>provides alerts regarding error | Software controls accelerator,<br>beam transport and delivery,<br>sets operational parameters,<br>monitors systems and provides<br>alerts regarding error conditions. |
| Mechanical<br>Beam | Yes | Yes |
| Beam | Continuously variable over range | Continuously variable over |
| Intensities | up to 1E10 protons per cycle time. | range up to 1E10 protons per cycle time. |
| Shielding | Steel and Concrete | Steel and Concrete |
| Gantry<br>rotating | N/A. Fixed beam | Rotating gantry |
| Patient<br>Positioner | Yes - floor mounted chair | Yes - floor mounted couch |
| Imaging | Yes - Diagnostic quality CT and<br>x-ray system | Yes - couch mounted CBCT<br>and x-ray system |
| Treatment<br>Room | Fixed beam orientation<br>and rotating chair | Fixed couch position and<br>rotating gantry |

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# Performance Data

The Company performed testing as follows:

- Mechanical testing to verify performance of the positioning system .
- Beam performance testing to evaluate beam dose shape, beam dose, dose rate, . dose monitoring, and spot positioning
- · Safety interface testing to verify collision sensors, mechanical interlocks

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- Simulation and validation testing to verify integration with oncology information . systems
- · Validation testing to verify integration with positioning system and treatment planning svstem
- · Testing to support repeatability and reproducibility of patient positioning and immobilization

Product safety and essential performance electrical testing was conducted based upon the following consensus standards: IEC 60601-1, IEC 600601-1-2, EN 606601-2-44, IEC 60601-1-3, IEC 60601-1-8, IEC 60601-2-54, IEC 60601-1-64, IEC 60601-2-68, IEC 62667, and AAPM TG-224.

In all instances, the P-Cure System functioned as intended and met its specifications. Testing demonstrated substantial equivalence in terms of performance and safety to the predicate.

## Substantial Equivalence

The P-Cure System is as safe and effective as the ProTom International Holding Corp. Radiance 330 Proton Beam Therapy System (K191521). The P-Cure System has the same intended use and substantially similar indications for use technological characteristics, and principles of operation as its predicate device. The minor differences in the specific indications for use statement and technological differences between the P-Cure System and its predicate devices do not raise different questions of safety or effectiveness. Performance data demonstrate that the P-Cure System is as safe and effective as the Radiance 330 Proton Beam Therapy System. Thus, the P-Cure System is substantially equivalent.