(155 days)
The RAYCAST® Immobilization Systems Hardware and Thermoplastic Materials are used to retain and reproduce a patient's position during radiation therapy.
RAYCAST® Immobilization Systems Hardware and Thermoplastic Materials
The provided text is a 510(k) premarket notification letter from the FDA regarding the RAYCAST® Immobilization Systems Hardware and Thermoplastic Materials. This document does not contain information about acceptance criteria or a study proving device performance as typically expected for software or AI/ML-based medical devices.
The letter explicitly states:
- Regulatory Class: II (TWO)
- Product Code: 90 IYE, 21 CFR 892.5050
- Description: "Immobilization Systems Hardware and Thermoplastic Materials are used to retain and reproduce a patient's position during radiation therapy."
This device is an immobilization system for radiation therapy, which is a physical device, not an AI/ML-based diagnostic or prognostic tool. Therefore, the specific questions about acceptance criteria, device performance tables, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, training sets, and ground truth establishment for AI/ML are not applicable to the information contained in this document.
The FDA's review for this type of device (a Class II physical device) primarily focuses on:
- Substantial Equivalence: Comparing the device to legally marketed predicate devices to ensure similar safety and effectiveness.
- General Controls: Compliance with regulations like annual registration, device listing, good manufacturing practices (Quality System Regulation), labeling, and prohibitions against misbranding and adulteration.
To reiterate, the provided document does not contain the information requested in the prompt, as it pertains to a different type of medical device than what the questions are designed for.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration
9200 Corporate Boulevard Rockville MD 20850
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SEP 2 1 1999
ORFIT Industries C/O Cynthia J.M. Nolte, Ph.D., RAC Medical Device Consultants, Inc. 49 Plain Street North Attleboro, MA 02760
Re:
K991319 RAYCAST® Immobilization Systems Hardware and Thermoplastic Materials Dated: July 30, 1999 Received: August 2, 1999 Requiatory Class: II (TWO) Product Code: 90 IYE 21 CFR 892.5050
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 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 Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
CAPT Daniel S. Scheidt, M.D.
CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Dear Dr. Nolte:
Enclosure
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991819 510(k) Number (if known):
Immobilization Systems_Hardware_and_Thermoplastic Device Name: RAYCAST® Materials
Indications For Use:
The RAYCAST® Immobilization Systems Hardware and Thermoplastic Materials are used to retain and reproduce a patient's position during radiation therapy.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David A. Segerson
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number K991319
Prescription Use
OR
Over-The-Counter Use
(Per 21 CFR 801.109)
§ 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.