(17 days)
The Model SR-115 Portable X-Ray System is intended for General Purpose Portable Radiographic Applications.
X-Ray System, Portable
I am sorry, but based on the provided text, there is no information about acceptance criteria or a study related to device performance. The document is an FDA 510(k) clearance letter for the "Model SR-115 Portable X-Ray System," which states that the device is substantially equivalent to legally marketed predicate devices.
The letter primarily focuses on:
- Device identification: Trade/Device Name, Regulation Number, Regulation Name, Regulatory Class, Product Code, Date Received.
- Regulatory status: Substantial equivalence determination to predicate devices.
- Post-market requirements: General controls, additional controls for Class II/III devices, good manufacturing practices, labeling, electronic product radiation control provisions.
- Contact information: For specific advice and general information.
- Indications for Use: The Model SR-115 Portable X-Ray System is intended for General Purpose Portable Radiographic Applications.
There is no mention of:
- A table of acceptance criteria or reported device performance.
- Sample sizes or data provenance for any test sets.
- Number or qualifications of experts for establishing ground truth.
- Adjudication methods.
- Multi-reader multi-case (MRMC) comparative effectiveness studies.
- Standalone algorithm performance studies.
- Type of ground truth used.
- Sample size for a training set.
- How ground truth for a training set was established.
This document is a regulatory approval, not a scientific study detailing performance metrics or clinical trial results. Therefore, I cannot fulfill your request for that specific information based on the text provided.
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Image /page/0/Picture/1 description: The image shows a circular logo with text around the perimeter and a symbol in the center. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The symbol in the center appears to be a stylized depiction of an eagle or bird with three curved lines representing its wings or body.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Ray Manez Director, Operations Source-Ray, Inc. 167 Keyland Court BOHEMIA NY 11716 Re: K052001
AUG 1 1 2005
Trade/Device Name: Model SR-115 Portable X-Ray System Regulation Number: 21 CFR 892.1720 Regulation Name: Mobile x-ray system Regulatory Class: II Product Code: IZL Dated: July 22, 2005 Received: July 27, 2005
Dear Mr. Manez:
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 (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.
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 fimited to registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) 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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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 prematicate 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.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). You may obtain other general information on your responsibilities under the Act from the 00 : 17 / 1 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely 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
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Ver/ 3 - 4/24/96
Applicant: Source-Ray, Inc.
510(k) Number (if known): Kost2001
Device Name: X-Ray System, Portable
Indications For Use: The Model SR-115 Portable X-Ray System is intended for General Purpose Portable Radiographic Applications.
Prescription use ✓
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) (Per 21 CFR 801.109)
David h. lyson
(Division Sign-Off Dunsine in Donrod 515k) Number Format 1-2-96)
§ 892.1720 Mobile x-ray system.
(a)
Identification. A mobile x-ray system is a transportable device system intended to be used to generate and control x-ray for diagnostic procedures. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.