(257 days)
Not Found
No
The summary describes a standard proton therapy system with subsystems for beam production, delivery, patient positioning, and control. There is no mention of AI or ML in the device description, intended use, or performance studies. The testing focuses on mechanical, beam, safety, and integration aspects, not on AI/ML performance metrics.
Yes
The device is designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation. This explicitly states its therapeutic purpose.
No
This device is described as a proton therapy system for the treatment of patients with localized tumors, producing and delivering a proton beam. While it includes imaging components (CT and X-ray) for patient positioning, these are for treatment delivery, not for diagnosing disease.
No
The device description clearly outlines multiple hardware components including a synchrotron-based accelerator, beam delivery system, patient positioning system with CT and X-ray, and various control and safety hardware. While it includes software components, it is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is designed to "produce and deliver a proton beam for the treatment of patients with localized tumors and other condition susceptible to treatment by radiation." This describes a therapeutic device used directly on a patient for treatment, not a device used to examine specimens derived from the human body for diagnostic purposes.
- Device Description: The description details a system for generating and delivering a proton beam, patient positioning, and control/safety systems. These are all components of a radiation therapy system, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on in vitro testing.
Therefore, the P-Cure Proton Therapy System is a therapeutic medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
LHN
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
- 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT (3D) and X-ray (2D)
Anatomical Site
head, neck and thorax
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
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
- 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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA) along with the Department of Health & Human Services. The FDA logo features a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG" in blue, and "ADMINISTRATION" in a smaller font size below. To the left of the FDA logo is the symbol of the Department of Health & Human Services, which consists of a stylized human figure.
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
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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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3
510(k) SUMMARY P-Cure, Ltd.'s Proton Beam Therapy System
Submitter
P-Cure, Ltd. 14 Carmel St. Shilat Industrial Zone, 7318800 lsrael
Phone: +972 54 488 1399
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
4
- 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
Therapy System |
|-----------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K221996 | K191521 |
| Device | P-CURE System | Radiance 330 Proton Beam
Therapy System |
| 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. | The ProTom Radiance 330 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 |
| Accelerator | Synchrotron | Synchrotron |
| Particle | Protons | Protons |
| Variable
Energy | Yes; 70-250 MeV | Yes; 70-250 MeV |
| Cycle Time | Variable | Variable |
| Beam
Transport | Bending and focusing magnets | Bending and focusing magnets |
| Nozzles | Pencil Beam Scanning | Pencil Beam Scanning |
| Beam Range
in Patient
(Tissue
Depth) | 3 cm to 38 cm clinical use | 3 cm to 38 cm clinical use |
| Range Verifier | Optional | Optional |
| Control and
Safety System | Software controls accelerator,
beam transport and delivery,
sets operational parameters,
monitors systems and
provides alerts regarding error | Software controls accelerator,
beam transport and delivery,
sets operational parameters,
monitors systems and provides
alerts regarding error conditions. |
| Mechanical
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
rotating | N/A. Fixed beam | Rotating gantry |
| Patient
Positioner | Yes - floor mounted chair | Yes - floor mounted couch |
| Imaging | Yes - Diagnostic quality CT and
x-ray system | Yes - couch mounted CBCT
and x-ray system |
| Treatment
Room | Fixed beam orientation
and rotating chair | Fixed couch position and
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
6
- 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.