The Stryker Self-Punching ICONIX Anchors are intended to be used for soft-tissue to bone fixation in the shoulder. They are indicated for use in rotator cuff repair.

Device Description

The Self-Punching ICONIX Anchors are all suture anchors with a push-in design, provided sterile and preloaded on a disposable inserter. The anchors consist of a polyester sheath interwoven over non-absorbable working sutures, which are folded over and mounted on the forked tip of the inserter. The anchor is inserted into the bone using a self-punching mechanism, and the polyester sheath bunches as the anchor is deployed to allow for fixation in bone. The anchor pre-loaded on the inserter is packaged in a singleuse sterile barrier system (SBS).

AI/ML Overview

The provided text is a 510(k) summary for the Stryker Self-Punching ICONIX device. It details the device's characteristics and its substantial equivalence to a predicate device, focusing on non-clinical benchtop testing. The document explicitly states that clinical testing was NOT required for this submission. Therefore, it does not describe a study that proves the device meets specific acceptance criteria based on human or clinical performance, nor does it provide information related to AI or a multi-reader multi-case study.

However, based on the non-clinical benchtop testing described, here's an attempt to extract relevant information for the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Equivalent fixation strength to predicate device at time zero.	Proposed devices provide equivalent fixation strength compared to the predicate device.
Equivalent fixation strength to predicate device following cyclic loading.	Proposed devices provide equivalent fixation strength compared to the predicate device.
Equivalent insertion effort to predicate device.	Proposed devices require equivalent insertion effort compared to the predicate device.
Material-mediated pyrogenicity within required limits.	Passing results below the required limits.
Bacterial endotoxins within required limits.	Passing results below the required limits.

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

The document does not specify the exact sample sizes used for the benchtop tests (e.g., number of anchors tested for fixation strength or insertion effort). The data provenance is from non-clinical benchtop testing, meaning it's laboratory-generated data, not from human subjects or clinical settings.

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

Not applicable. This was non-clinical benchtop testing, not involving expert consensus on images or medical findings. The "ground truth" was established by objective physical measurements (e.g., force, strength, material testing results) against predefined engineering specifications and comparison to the predicate device.

4. Adjudication method for the test set

Not applicable. As this was non-clinical benchtop testing, there was no need for adjudication by experts. Results were likely determined by instrument readings and comparisons.

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. The document explicitly states: "Clinical testing was not required to demonstrate substantial equivalence for this submission."

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

No, this pertains to a physical medical device (suture anchor), not an algorithm or AI.

7. The type of ground truth used

The ground truth used for these non-clinical tests was based on objective physical measurements (e.g., force, strength values) and material testing results against established engineering specifications and comparison to the predicate device's performance.

8. The sample size for the training set

Not applicable. This is a physical medical device submission, not an AI/algorithm where training sets are relevant.

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

Not applicable.

Summary

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November 20, 2017

Stryker Endoscopy Ms. Katie Farraro Senior Regulatory Affairs Specialist 5900 Optical Court San Jose, California 95138

Re: K172921

Trade/Device Name: Stryker Self-Punching ICONIX Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI Dated: September 22, 2017 Received: September 25, 2017

Dear Ms. Farraro:

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 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) 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);

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and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Mark N. Melkerson -S

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Summary

I. SUBMITTER

Stryker Endoscopy
5900 Optical Ct
San Jose, CA 95138

Contact Person:	Katie Farraro, Senior Regulatory Affairs Specialist
	Phone: 408-754-2285
	Fax: 408-754-2507
Date Prepared:	November 17, 2017

II. DEVICE

Name of Device:	Stryker Self-Punching ICONIX
Model Numbers:	3910-500-920, 3910-500-931
Common or Usual Name:	Suture, Fastener, Fixation, Nondegradable, Soft Tissue
Classification Name:	Smooth or threaded metallic bone fixation fastener (21CFR 888.3040)
Regulatory Class:	II
Product Code:	MBI

III. PREDICATE AND REFERENCE DEVICE

Predicate Device: Device Name: Stryker Self-Punching ICONIX Company Name: Stryker 510(k) #: K171465

Reference Device: Device Name: XBraid TT Suture Tape Company Name: Stryker 510(k) #: K162310

Predicate and reference devices have not been subject to a recall.

IV. DEVICE DESCRIPTION

The Self-Punching ICONIX Anchors are all suture anchors with a push-in design, provided sterile and preloaded on a disposable inserter. The anchors consist of a polyester

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sheath interwoven over non-absorbable working sutures, which are folded over and mounted on the forked tip of the inserter. The anchor is inserted into the bone using a self-punching mechanism, and the polyester sheath bunches as the anchor is deployed to allow for fixation in bone. The anchor pre-loaded on the inserter is packaged in a singleuse sterile barrier system (SBS).

As the Self-Punching ICONIX product line includes both predicate and proposed devices, Model Numbers 3910-500-920 and 3910-500-931 are herein referred to as the proposed device(s), and Model Numbers 3910-500-921 and 3910-500-922 are the predicate devices.

V. INTENDED USE

The Stryker Self-Punching ICONIX Anchors are intended to be used for soft-tissue to bone fixation in the shoulder. They are indicated for use in rotator cuff repair.

VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

The proposed Self-Punching ICONIX products are substantially equivalent to the predicate devices with regard to intended use, materials of construct, device design, insertion and deployment method, sterilization method, and performance attributes.

The proposed devices differ from the predicate device only in the configurations of sutures woven into the anchor sheath. This difference does not raise new questions of safety and effectiveness within the Intended Use.

VII. PERFORMANCE DATA

Non-clinical benchtop testing was performed to verify the fixation strength at time zero as well as following cyclic loading of the proposed products. The fixation strength was compared to that of the Predicate device through statistical analysis. The comparison indicates that the proposed devices provide equivalent fixation strength compared to the predicate device, and will be functional within the intended use.

Benchtop testing was also performed to verify the insertion effort required for use of the proposed products. The comparison indicates that the proposed devices require equivalent insertion effort compared to the Predicate device, and will be functional within the intended use.

Testing was also performed on the final finished devices for material-mediated pyrogenicity and bacterial endotoxins, with passing results below the required limits.

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Clinical testing was not required to demonstrate substantial equivalence for this submission.

VIII. CONCLUSIONS

The information presented within this traditional premarket submission demonstrates that the proposed Stryker Self-Punching ICONIX products are substantially equivalent to the predicate devices and will perform as safely and effectively within the intended use.

Regulation Number and Section

N/A