(73 days)
Not Found
No
The summary describes a proton therapy system with standard components for beam production and delivery. There is no mention of AI, ML, or related concepts in the device description, intended use, or performance studies.
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, which indicates a therapeutic purpose.
No
The device is designed to produce and deliver a proton beam for treatment of patients with localized tumors, not for diagnosis.
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.
Based on the provided information, the ProTom Radiance 330 is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The device is designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions. This is a therapeutic application, not a diagnostic one.
- Device Description: The description details systems for producing and delivering a proton beam directly to a patient. There is no mention of analyzing samples (blood, tissue, etc.) outside of the body, which is the core function of an IVD.
- Performance Studies: The performance studies focus on the accuracy and delivery of the proton beam for treatment, not on the accuracy of diagnostic measurements from biological samples.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The ProTom Radiance 330 is a therapeutic device used to directly treat patients with radiation.
N/A
Intended Use / Indications for Use
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 conditions susceptible to treatment by radiation.
Product codes
LHN
Device Description
The Radiance 330 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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Each individual subsystem of the Radiance 330™ was verified and validated, and full system verification and validation was also performed. Beam performance testing to vaiidate 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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
MAR 1 4 201
510(k) SUMMARY
ProTom Radiance 330™ Proton Beam Therapy System
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
ProTom International Inc. 1100 Parker Square, Suite 230 Flower Mound, Texas 75028
Telephone: 972 410 3551 Facsimile: 972 534 1299
Cheryl Smith Contact Person:
October 18, 2013 Date Prepared:
Name of Device Name/Address of Sponsor
Radiance 330™ Proton Beam Therapy System
Name/Address of Sponsor
ProTom International Inc. 1100 Parker Square, Suite 230 Flower Mound, Texas 75028
Common or Usual Name
Proton beam therapy systems
Classification Name
Medical Charged-Particle Radiation Therapy System, 21 CFR 892.5050, Product Code LHN
Predicate Devices
lon Beam Applications Proton Therapy System with PPBS (K082416) Hitachi Ltd.'s PROBEAT with DSSS (K073059) Loma Linda Optivus Technology Proton Beam Therapy System (K992414)
SDC - 0316487000001 - 5207981 ↓ 1
1
Intended Use
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 conditions susceptible to treatment by radiation.
Technological Characteristics
The Radiance 330 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 o 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 O 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 o
- Gantry subsystem O
- Patient Positioning subsystem. o
- Treatment Delivery Control subsystem o
Performance Data
Each individual subsystem of the Radiance 330™ was verified and validated, and full system verification and validation was also performed. Beam performance testing to vaiidate 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.
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K134052
Page 3 of 3
All testing demonstrated that the system met its specifications for its intended use.
Substantial Equivalence
The ProTom Radiance 330™ has the same intended use and similar indications, principles of operation, and technological characteristics as the lon Beam Applications Proton Therapy System with PPBS (K082416), Hitachi Ltd.'s PROBEAT with DSSS (K073059); and the Loma Linda Optivus Technology Proton Beam Therapy System (K992414). The minor differences between the Radiance 330™ and the predicate devices do not raise any new questions of safety or effectiveness. Performance data demonstrates that the Radiance 330™ is as safe and effective as the predicate devices. Thus, the ProTom Radiance 330™ is substantially equivalent to its predicates.
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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the department's name around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 14. 2014
ProTom International, Inc. % John J. Smith, MD, JD, Partner Hogan Lovells US 1.1.P 555 13th Street. NW WASHINGTON DC 20001
Re: K134052
Trade/Device Name: Radiance 330 Proton Therapy System Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: LHN Dated: December 31, 2013 Received: December 31, 2013
Dear Dr. Smith:
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 FI>A '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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Page 2-Dr. Smith
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Mishranding by reference to premarket notification" (21CFR 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/Safetw/ReportalProblem/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 Small Manufacturers, International and Consumer Assistance 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.hum.
Sincerely yours.
Michael D. O'Hara
for
Janine M. Morris Director. Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): K134052
Device Name: Radiance 330@ Proton Therapy System
Indications For Use:
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 conditions susceptible to treatment by radiation.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of Center for Devices and Radiological Health (CDRH)
Michael D. O'Hara
Page 1 of ____________________________________________________________________________________________________________________________________________________________________
(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health 510(k) _______________________________________________________________________________________________________________________________________________________________________ K134052