(30 days)
To provide dosimetry or to detect the dose delivered to a patient during therapeutic radiation procedures. The system is intended for the verification of the output of radiation producing devices.
Portable Dosimeter
This document is a 510(k) clearance letter from the FDA for a device called "Portable Dosimeter". This letter does not contain the detailed technical information such as acceptance criteria, study details, and performance metrics that would be present in a 510(k) summary or the original submission itself.
Therefore,Based on the provided text, I cannot extract the requested information. The document is an FDA clearance letter and does not contain details about:
- Acceptance criteria and reported device performance: This letter states that the device is "substantially equivalent" to a predicate device, but it does not provide specific performance metrics or acceptance criteria used in the substantial equivalent determination.
- Sample size used for the test set and data provenance: No study details are included.
- Number of experts used to establish the ground truth for the test set and their qualifications: No study details are included.
- Adjudication method for the test set: No study details are included.
- Multi-reader multi-case (MRMC) comparative effectiveness study: No study details are included, and given the nature of a dosimeter, an MRMC study is unlikely to be relevant.
- Standalone performance (algorithm only without human-in-the-loop performance): This is a hardware device (dosimeter), not an AI algorithm.
- Type of ground truth used: No study details are included.
- Sample size for the training set: This is a hardware device; a "training set" in the context of an AI algorithm is not applicable.
- How the ground truth for the training set was established: Not applicable.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
AUG 2 8 2009
Ms. Mary Herbert Quality and Regulatory Manager Best Medical Canada Ltd. 413 March Road Ottawa, Ontario K2K 0E4 CANADA
Re: K092285
Trade/Device Name: Portable Dosimeter Regulation Number: 21 CFR 892.5050 Regulation Name: Medical Charged-particle radiation therapy system Regulatory Class: II Product Code: TYE Dated: July 28, 2009 Received: July 29, 2009
Dear Ms. Herbert:
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.
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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical
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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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding 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/cdrl/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Lamme M. Thonak
Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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25 medical canada verification system MODIFICATION
ATTACHMENT 2
INDICATIONS FOR USE STATEMENT
510(K) NUMBER: KO92285
DEVICE NAME:
Portable Dosimeter
INDICATIONS FOR USE:
To provide dosimetry or to detect the dose delivered to a patient during therapeutic radiation procedures. The system is intended for the verification of the output of radiation producing devices.
Hulut Reime
(Division Sign-Off) (Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number_
§ 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.