(57 days)
The Pensil Trauma is a wall-mounted radiographic cassette holder device that is a 1110 Total Tradition 10 and position radiographic cassettes for a radiographic exposure for medical use.
The Pensil Trauma is a wall-mounted radiographic cassette holder device.
I am sorry, but the provided text does not contain the detailed information required to answer your request about the acceptance criteria and study proving device performance. The document is an FDA 510(k) clearance letter for the "Pensil Trauma, Model WW56100" device, identifying it as a wall-mounted radiographic cassette holder.
While it mentions the device is "substantially equivalent" to legally marketed predicate devices, it does not include any specific performance metrics, acceptance criteria, or details regarding studies (sample sizes, ground truth, expert qualifications, etc.) that would prove the device meets such criteria.
The letter focuses on regulatory approval based on substantial equivalence, general controls, and compliance with manufacturing practices, rather than providing a technical performance evaluation.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a snake winding around it, overlaid on three horizontal bars. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the symbol.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 2 1 1999
Brenda S.D. Davis Quality and Regulations Manager Wuestec Medical, Inc. 5600 Commerce Boulevard East Mobile, AL 36619
Re:
K993962 Pensil Trauma, Model WW56100 Dated: October 22, 1999 Received: October 25, 1999 Regulatory class: II 21 CFR 892.1680/Procode: 90 KPR
Dear Ms. Davis:
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 Regulations, 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 requlatory 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 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
Enclosure
{1}------------------------------------------------
Food and Drug Administration Document Mail Center (HFZ-401) Center for Devices and Radiological Health 9200 Corporate Boulevard Rockville, MD 20850
4 Intended of Use
The Pensil Trauma is a wall-mounted radiographic cassette holder device that is a 1110 Total Tradition 10 and position radiographic cassettes for a radiographic exposure for medical use.
David h. Seger
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Device 510(k) Number
Over-the-Counter Use
Prescription Use
(Per 21 CFR 801.109)
§ 892.1680 Stationary x-ray system.
(a)
Identification. A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.