5.0 CANNULATED DRILL PIN, 6.0 CANNULATED DRILL-PIN by PETER STEVENS, MD

1. To engage long bones including the femur, tibia, humerus, radius or ulna and permit the bone(s) to be secured to an external fixator or frame via a locking bolt.
1. Thus to stabilize bone fragments to provide fracture alignment and stability; or
1. Thus to stabilize bones that have been surgically cut in order to correct deformities including angular, rotational or length discrepancy.

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a medical device (5.0mm and 6.0mm Cannulated Drill Pins), along with its Indications for Use. This document does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or any of the other specific details required to answer your request regarding a study that proves the device meets acceptance criteria.

The FDA 510(k) clearance process focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring detailed performance studies against pre-defined acceptance criteria as would be typical for a novel device or a significantly different technology.

Therefore, I cannot extract the requested information from the provided text.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles three overlapping human figures.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN - 7 2005

Peter M. Stevens, M.D. P.O. Box 58246 Salt Lake City, Utah 84158

Re: K033856 Trade/Device Name: 5.0mm Cannulated Drill Pin 6.0mm Cannulated Drill Pin Regulation Number: 21 CFR 888.3030; 888.3040 Regulation Name: Single/multiple component metallic bone fixation appliances and Accessories, Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: KTT, HWC Dated: December 3, 2003 Received: January 8, 2004

Dear Dr. Stevens:

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 10 rate rise 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 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 corply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); 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.

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Page 2 - Peter M. Stevens, M.D.

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 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), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours.

lily and

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K033856 __

Device Name: 5.0mm Cannulated Drill-Pin 6.0mm Cannulated Drill-Pin ___________________________________________________________________________________________________________________________________________________

Indications for Use:

This pediatric surgical implant is designed for the following intended purposes:

1. To engage long bones including the femur, tibia, humerus, radius or ulna and permit the bone(s) to be secured to an external fixator or frame via a locking bolt.
1. Thus to stabilize bone fragments to provide fracture alignment and stability; or
1. Thus to stabilize bones that have been surgically cut in order to correct deformities including angular, rotational or length discrepancy.

Prescription Use __ × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Ola Wib

Division of General, Restorative, and Neurological Devices

510(k) Number_________________________________________________________________________________________________________________________________________________________________

Regulation Number and Section

N/A