(56 days)
No
The description focuses on the mechanical design and performance of a surgical anchor, with no mention of AI or ML capabilities.
No.
The device is a surgical anchor used for fixation in soft tissue to bone and is not intended to treat, mitigate, or cure a disease or condition.
No
Explanation: The device is an anchor used for soft-tissue to bone fixation in the shoulder, specifically for rotator cuff repair. It is a surgical implant designed for treatment, not for diagnosis.
No
The device description clearly states it is a physical anchor made of polyester and sutures, preloaded on a disposable inserter, and used for soft-tissue to bone fixation. It is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The Stryker Self-Punching ICONIX Anchors are physical implants used for soft-tissue to bone fixation during surgery. They are inserted directly into the body.
- Intended Use: The intended use is for surgical repair (rotator cuff repair), not for analyzing samples outside the body.
The provided information clearly describes a surgical implant, not a device used for in vitro testing.
N/A
Intended Use / Indications for 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.
Product codes
MBI
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).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
shoulder
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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.
Clinical testing was not required to demonstrate substantial equivalence for this submission.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.
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);
1
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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| DEPARTMENT OF HEALTH AND HUMUN SERVICES
ndications for Use
Food and Drug Administration | | Form Approved: OMB
ree PRA Statement below.
xpiration Doate: 06/80/2020
No. 0910-0120 |
| 510(k) Number (if known
X 77921 | | |
| Stryker Self-Punching ICONIX
Device Name | | |
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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 (21 |
| CFR 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
4
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.
5
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.