(79 days)
Not Found
No
The summary describes a proton therapy system with various hardware and software subsystems for beam delivery and patient positioning. There is no mention of AI, ML, or related concepts in the device description, intended use, or performance studies. The focus is on the physical and control systems for delivering radiation.
Yes
The device is intended to deliver proton radiation treatment to patients with solid tumors or other diseases susceptible to radiation, which aligns with the definition of a therapeutic device.
No
Explanation: The device is described as a "Proton Therapy System" intended to "deliver proton radiation treatment to patients," indicating it is a therapeutic device, not a diagnostic one.
No
The device description clearly outlines multiple hardware components including a cyclotron, gantry, beam delivery system, patient positioning system, and various other physical subsystems. While software is mentioned for control, the device is fundamentally a complex hardware system for delivering radiation therapy.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "deliver proton radiation treatment to patients with solid tumors or other diseases susceptible to radiation." This describes a therapeutic treatment delivered directly to a patient's body.
- Device Description: The description details a system for generating and delivering a proton beam for radiation therapy. This is an external treatment method.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not interact with or analyze such specimens.
The device described is a therapeutic medical device used for radiation therapy.
N/A
Intended Use / Indications for Use
The IUCF PTS is intended to deliver proton radiation treatment to patients with solid tumors or other diseases susceptible to radiation.
Product codes
LHN
Device Description
IUCF's PTS is a charged particle radiation therapy system. The PTS contains three major systems: the Cyclotron System (CYS), JUSTIS, and the Treatment Systems (TS). The TS is divided into seven subsystems to carry out the proton treatment process: the Treatment Room Control System (TRCS); the Kicker Enable System (KES); the Beam Delivery System (BDS); the Dose Delivery System (DDS); the Patient Positioning System (PPS); the MPRI Radiation Interlock System (MIRS); and the Emergency Stop System (ESS). These subsystems work together to generate the desired dose level and distribution at the target site. Treatment System 2 (TS2) of the PTS, the subject of this 510(k) notice, employs a rotating gantry, which allows the proton radiation beam to be delivered to the target site from any direction in a plane. The gantry includes the gantry structure; retractable gantry floor; Digital Radiography panel positioning systems; gantry safety mechanisms; and gantry rotation controls. Computer control of the gantry is provided by the PPS.
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)
Extensive performance testing conducted at the system and subsystem (hardware and software) levels, and electromagnetic compatibility, electromagnetic interference ("EMC/EMI") and electrical safety demonstrated that the system and subsystems met or exceeded design specifications, clinical performance requirements and EMC/EMI and electrical safety applicable standards. In all instances, the IUCF PTS functioned as intended.
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.
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KDb289v
510(k) SUMMARY
Indiana University Cyclotron Facility's Proton Therapy System
DEC 1 4 2006
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
Indiana University Cyclotron Facility 2401 Milo B. Sampson Lane Bloomington, Indiana 47408
Phone: (812) 855-2881 Facsimile: (812) 855-6645
Paul E. Sokol, IUCF Director Contact Person:
September 26, 2006 Date Prepared:
Name of Device and Name/Address of Sponsor
Proton Therapy System (PTS)
Indiana University Cyclotron Facility 2401 Milo B. Sampson Lane Bloomington, Indiana 47408-1398
Common or Usual Name
Proton Beam Therapy System (PBTS)
Classification Name
Medical Charged-Particle Radiation Therapy System
Predicate Devices
The Indiana University Cyclotron Facility PTS is substantially equivalent to the Loma Linda Medical Center Proton Beam Therapy System (K872369) and Ion Beam Applications, SA's, Proton Therapy Systems (K983024, K060695).
Intended Use / Indications for Use
The IUCF PTS is intended to deliver proton radiation treatment to patients with solid tumors or other diseases susceptible to radiation.
1
Technological Characteristics
IUCF's PTS is a charged particle radiation therapy system. The PTS contains three major systems: the Cyclotron System (CYS), JUSTIS, and the Treatment Systems (TS). The TS is divided into seven subsystems to carry out the proton treatment process: the Treatment Room Control System (TRCS); the Kicker Enable System (KES); the Beam Delivery System (BDS); the Dose Delivery System (DDS); the Patient Positioning System (PPS); the MPRI Radiation Interlock System (MIRS); and the Emergency Stop System (ESS). These subsystems work together to generate the desired dose level and distribution at the target site. Treatment System 2 (TS2) of the PTS, the subject of this 510(k) notice, employs a rotating gantry, which allows the proton radiation beam to be delivered to the target site from any direction in a plane. The gantry includes the gantry structure; retractable gantry floor; Digital Radiography panel positioning systems; gantry safety mechanisms; and gantry rotation controls. Computer control of the gantry is provided by the PPS.
Performance Data
Extensive performance testing conducted at the system and subsystem (hardware and software) levels, and electromagnetic compatibility, electromagnetic interference ("EMC/EMI") and electrical safety demonstrated that the system and subsystems met or exceeded design specifications, clinical performance requirements and EMC/EMI and electrical safety applicable standards. In all instances, the IUCF PTS functioned as intended.
Substantial Equivalence
The IUCF PTS is as safe and effective as the Loma Linda Medical Center Proton Beam Therapy System (K872369) and Ion Beam Applications, SA's, Proton Therapy Systems (K983024. K060695). The IUCF PTS has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate devices. The minor technological differences between the IUCF PTS and its predicate devices raise no new questions of safety or effectiveness. Performance data demonstrate that the IUCF PTS is as safe and effective as the predicate devices listed above. Thus, the IUCF PTS is substantially equivalent.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three tail feathers, representing the department's commitment to health, human services, and well-being. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
Indiana University Cyclotron Facility c/o Jonathan S. Kahan Hogan & Hartson LLP Columbia Square 555 Thirteenth Street, N.W. WASHINGTON DC 20004
DEC 1 4 2006
Re: K062891
Trade/Device Name: Proton Therapy System 、シ Regulation Number: 21 CFR §892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: LHN Dated: December 1, 2006 Received: December 4, 2006
Dear Mr. 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 arior 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.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such 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.
Image /page/2/Picture/10 description: The image shows a circular logo with the text "1906 - 2006" at the top. The letters "FDA" are prominently displayed in the center of the logo. Below the letters, the word "Centennial" is written in a cursive font. Three stars are arranged in a horizontal line beneath the word "Centennial".
rotecting and Promoting Puthic 9
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Page 2 --
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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150
or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.
Sincercly yours,
Nancy C. Hogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement
510(k) Number (if known):___
Device Name: Proton Therapy System
Indications for Use:
Indiana University Cyclotron Facility's Proton Therapy System is a medical device intended to deliver proton radiation treatment to patients with solid tumors or other diseases susceptible to radiation.
Prescription Use _X (Part 21 C.F.R. 801 Subpart D) AND/OR
Over-The-Counter Use_ (21 C.F.R. 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancy Brogdon
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
5 : 0(k) Number ______________________________________________________________________________________________________________________________________________________________
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