The currently marketed Surgical Dynamics Ogden Suture Anchor with Suture is a nonabsorbable repair device used to attach soft tissue to bone using sutures. The device is a self tapping, Ti-6A1-4V threaded implant with a central cannulation to accommodate one or two sutures. The sterile package includes a Suture Anchor, Suture Passer, and Surgidac suture.

AI/ML Overview

The provided text does not contain information about acceptance criteria or a study proving that the device meets acceptance criteria. The document is a 510(k) summary and FDA clearance letter for a medical device (Surgical Dynamics Ogden Suture Anchor with Suture). It focuses on the device description, indications for use, and a claim of substantial equivalence to a legally marketed predicate device, as required for FDA clearance.

Therefore, I cannot provide the requested information. The text does not include:

A table of acceptance criteria and reported device performance.
Sample sizes or data provenance for any test set.
Number or qualifications of experts for ground truth establishment.
Adjudication methods.
Information about multi-reader multi-case (MRMC) comparative effectiveness studies.
Information about standalone algorithm performance.
The type of ground truth used.
Sample size for the training set.
How ground truth for the training set was established.

This type of information is typically found in design validation reports or clinical study summaries, which are not part of this 510(k) summary document. The 510(k) process primarily relies on demonstrating substantial equivalence to a predicate device, often through bench testing and comparison of technical characteristics, rather than extensive clinical efficacy studies akin to those required for new drug applications or PMA devices.

Summary

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Attachment 4

FEB 2 6 2002

K 020352

510(k) Summary

Surgical Dynamics Ogden Suture Anchor with Suture

United States Surgical 150 Glover Avenue Norwalk, CT 06856 USA

DEVICE DESCRIPTION

INDICATIONS FOR USE

The Surgical Dynamics Ogden Suture Anchor with Suture is indicated for the reapproximation of soft tissuue.

SUBSTANTIAL EQUIVALENCE*

The modified Surgical Dynamics Ogden Suture Anchor with Suture was claimed to be substantially equivalent* to the currently marketed version of the device. Information pertaining to this device was provided in the submission.

Any claim of substantial equivalence is made exclusively in regard to the U.S. Food, Drug and Cosmetic Act and should not be viewed in any other light.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized eagle-like symbol with three curved lines representing its body and wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 6 2002

Ms. Tina Rideout Regulatory Affairs Senior Associate Surgical Dynamics 150 Glover Ave. Norwalk, CT 06856

Re: K020352

Trade/Device Name: Surgical Dynamics Ogden Suture Anchor Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HWC Dated: January 31, 2002 Received: February 4, 2002

Dear Ms. Rideout:

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 for the enated in the 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 comply 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 - Ms. Tina Rideout

This letter will allow you to begin marketing your device as described in your Section 510(k) I has lotter with ation. The FDA finding of substantial equivalence of your device to a legally premaince nodicate 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 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,

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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Attachment 2

Indications for Use Statement

510(k) Number

Device Name

Surgical Dynamics Ogden Suture Anchor with Suture

Indications For Use

The Surgical Dynamics Ogden Suture Anchor with Suture is intended for the reapproximation of soft tissue.

(Please do not write below this line - continue on another page if needed)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use: ya OR Over-The-Counter Use: No
(Per 21 CFR 801.109)

for Mark n Millen
(Division Sign-Off)
Division of General. Restorative
and Neurological Devices
510(k) Number: K020352

Regulation Number and Section

§ 888.3040 Smooth or threaded metallic bone fixation fastener.

(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.