PENSIL TRAUMA, MODEL WWS6100

K993962 · Wuestec Medical, Inc. · KPR · Dec 21, 1999 · Radiology

Device Facts

• Record ID: K993962
• Device Name: PENSIL TRAUMA, MODEL WWS6100
• Applicant: Wuestec Medical, Inc.
• Product Code: KPR · Radiology
• Decision Date: Dec 21, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1680
• Device Class: Class 2

Intended 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.

Device Story

Pensil Trauma (Model WW56100) is a wall-mounted radiographic cassette holder. Device functions as a mechanical support system to hold and position radiographic cassettes during medical imaging procedures. Operated by radiology technicians or clinicians in clinical environments. Device facilitates proper alignment of cassettes for radiographic exposure; assists in obtaining diagnostic images. No electronic, software, or algorithmic components involved.

Clinical Evidence

No clinical data provided; device is a mechanical radiographic accessory.

Technological Characteristics

Wall-mounted mechanical radiographic cassette holder. Device is a passive mechanical support structure. No energy source, software, or connectivity features. Materials and construction are standard for radiographic positioning equipment.

Indications for Use

Indicated for holding and positioning radiographic cassettes for medical radiographic exposures in clinical settings.

Regulatory Classification

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.

Special Controls

*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.

Submission Summary (Full Text)

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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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone], 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

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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)