The DePuy OrthoTech Catera Suture Anchor is intended for use in the shoulder for soft tissue re-attachment and capsular repair, including rotator cuff repairs, Bankart lesion repairs and SLAP lesion repairs.

Device Description

The Catera Suture Anchor is a titanium 6Al-4V alloy, self-threading, cancellous screw available in diameters of 3.5mm and 4.5mm with a 0.030 inch diameter cylindrical eyelet at the end. The eyelet has two semicircular slots milled in the side of the head for suture clearance. A 34 inch U.S.P. #2 nonabsorbable polyester suture is supplied pre-threaded through the eyelet with a single loop at the end of the screw. The suture anchors that are supplied with needles attached to the suture will have a Sulzle needle #394475 swedged onto one or both ends of the suture. The suture anchor's tip threads are on an incline to the full diameter (body threads). The body threads which provide the main resistance to pullout are on a slight incline. The suture anchors are supplied either pre-loaded on a driver or separately.

AI/ML Overview

The DePuy OrthoTech Catera Suture Anchor is a bone fixation staple and its performance was evaluated through mechanical testing.

1. Table of Acceptance Criteria and Reported Device Performance:

Test	Acceptance Criteria	Reported Device Performance
Pull-out loads (porcine bone)	Comparable to the Zimmer Statak anchor	Pull-out loads for the Catera Suture Anchor were comparable to the pull-out loads for the Statak anchors. Exceeded those for the Stryker and Mitek suture anchors.
Pull-out loads (human cadaver bone)	Comparable to the Zimmer Statak anchor	Pull-out loads for the Catera Suture Anchor were comparable to the pull-out loads for the Statak anchors.
Maximum torque to failure	Better than or comparable to predicate devices (specific criteria not explicitly stated, but "better than" implies it met an internal standard or exceeded the predicate)	Maximum torque to failure results for the Catera Suture Anchor were better than those for the Statak anchors.

2. Sample size used for the test set and the data provenance:

The document does not explicitly state the numerical sample size for each test (e.g., number of anchors tested for pull-out).
Data Provenance: The mechanical testing was performed using:
- Porcine bone: This is animal tissue, typically used in lab settings.
- Human cadaver bone: This is human tissue, likely obtained from tissue banks.
- The origin country is not specified, but the firm is located in the US. The tests were likely conducted in a laboratory setting.
Retrospective/Prospective: This was a prospective mechanical study, as the tests were conducted specifically to evaluate the performance of the Catera Suture Anchor against predicate devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

The concept of "experts" and "ground truth" as typically applied to clinical or diagnostic studies is not directly relevant here. This study involved mechanical testing of a medical device.
The "ground truth" for mechanical testing is established by standard engineering and biomechanical testing protocols, interpreted by engineers and scientists with expertise in materials science and biomechanics. The document does not specify the number or qualifications of individuals involved in generating or interpreting these mechanical test results, which is common for this type of submission.

4. Adjudication method for the test set:

Not applicable. Adjudication methods (like 2+1, 3+1 consensus) are typically used in clinical studies where expert review is needed to establish a definitive diagnosis or assessment for each case. This submission describes mechanical lab testing, where raw data is collected and analyzed according to scientific methodologies.

5. If a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done:

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This study is a mechanical comparison of a new device against predicate devices, not an evaluation of human reader performance with or without AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This device is a physical suture anchor, not an AI algorithm. Its performance is intrinsic to the device's material properties and design, evaluated through mechanical tests.

7. The type of ground truth used:

For this mechanical testing, the "ground truth" is defined by the objective, quantifiable measurements obtained during the mechanical tests (e.g., force required for pull-out, torque to failure). These measurements are direct observations of the device's physical performance under specified conditions, rather than an interpretation of an image or a clinical diagnosis.

8. The sample size for the training set:

Not applicable. This is not a machine learning model, so there is no "training set." The device itself (the Catera Suture Anchor) is the product being evaluated.

9. How the ground truth for the training set was established:

Not applicable, as there is no training set for this type of device submission.

Summary

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1980595

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

NAME OF FIRM:	DePuy, Inc.700 Orthopaedic Drive, P.O. Box 988Warsaw, IN 46581-0988
510(k) CONTACT:	Sally FoustRegulatory Submissions AssociateDePuy Orthopaedics, Inc.(219) 372-7455FAX: (219) 267-7098E-Mail: Sally_Foust@ccgate.depuy.com
TRADE NAME:	DePuy OrthoTech Catera Suture Anchor
CLASSIFICATION NAME:	Bone Fixation Staple
PRODUCT CODE:	79 JDR
SUBSTANTIALLY EQUIVALENT DEVICES:	Zimmer Statak (K926384)Stryker 2.7mm (K???????)Mitek Surgical Products, Inc. (K902751, K920213)

INTENDED USE AND DEVICE DESCRIPTION:

BASIS OF SUBSTANTIAL EQUIVALENCE:

The DePuy OrthoTech Catera Suture Anchor is substantially equivalent to the Zimmer Statak in that both of these devices are threaded suture anchors manufactured from Ti-6Al-4V alloy which are intended for soft tissue re-attachment in the shoulder. Mechanical testing in porcine and human cadaver bone showed that the pull-out loads for the Catera Suture Anchor were comparable to the pull-out loads for the Statak anchors. Mechanical testing in porcine bone showed that the maximum torque to failure results for the Catera Suture Anchor were better than those for the Statak anchors. Mechanical testing in porcine bone showed that the Catera Suture Anchor pull-out force results exceeded those for the Stryker and Mitek suture anchors.

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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an emblem of an eagle with its wings spread. The eagle is facing to the left.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 1 1 1998

Ms. Sally Foust Requlatory Submissions Associate DePuv Orthopaedics, Inc. P.O. Box 988 700 Orthopaedic Drive 46581-0988 Warsaw, Indiana

Re : K980595 DePuy OrthoTech Catera Suture Anchor Trade Name: Requlatory Class: II Product Code: MBI February 13, 1998 Dated: Received: February 17, 1998

Dear Ms. Foust:

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 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 The general controls provisions of the Act 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 requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895... A.. 1. .. - - - substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical General requlation (21 CFR Part 820) and that, Devices: through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. 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 requlations.

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Page 2 - Ms. Sally Foust

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) 594-4659. 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" (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.qov/cdrh/dsmamain.html".

Sincerely yours,

C. Colin M. Whitten, Ph.D.

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

Enclosure

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510(k) Number (if known) Ka80595

DePuy OrthoTech Catera Suture Anchor Device Name

Indications for Use:

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The DePuy OrthoTech Catera Suture Anchor is intended for use in the shoulder for soft tissue reattachment and capsular repair, including rotator cuff repairs, Bankart lesion repairs and SLAP lesion repairs.

Concurrence of CDRH, Office of Device Evaluation

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(Divisio Division દર્શને સ્ટે 510(k) Nu

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Prescription Use _ × (Per 21 CFR 801.109)

Over-The Counter Use _________________________________________________________________________________________________________________________________________________________

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Regulation Number and Section

N/A