(98 days)
No
The summary describes a mechanical suture anchor and its insertion mechanism. There is no mention of any software, data processing, or algorithms that would suggest the use of AI or ML.
No
The device is a surgical anchor used for soft-tissue to bone fixation during various repair and reconstruction procedures, which are corrective interventions, not therapeutic in nature.
No
The device is a surgical anchor used for soft-tissue to bone fixation, not for diagnosing conditions.
No
The device description clearly states it is a physical suture anchor made of polyester and non-absorbable sutures, preloaded on a disposable inserter. It is a hardware device for soft-tissue to bone fixation.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "soft-tissue to bone fixation in the elbow, shoulder, knee and hip." This describes a surgical procedure performed directly on the patient's body.
- Device Description: The device is a "suture anchor" used to physically attach soft tissue to bone. This is a surgical implant.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze samples (like blood, urine, or tissue) to provide diagnostic information about a patient's health. IVDs are used in vitro (outside the body) for diagnostic purposes.
The description clearly indicates a surgical device used for repair and reconstruction within the body, not a diagnostic tool used on biological samples.
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 elbow, shoulder, knee and hip. See indications below.
Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction
Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Repair
Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis
Hip: Capsular Repair, Acetabular Labral Repair, Gluteal Tendon Repair
Product codes
MBI
Device Description
The Self-Punching ICONIX Anchors (herein referred to as the proposed device(s)) 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 preloaded on the inserter is packaged in a single-use sterile barrier system (SBS).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
elbow, shoulder, knee, hip
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 Self-Punching ICONIX products. This fixation strength was compared to that of Predicate A through statistical analysis. The comparison indicates that the proposed devices provide statistically higher fixation strength than the devices of Predicate A. and will be functional within the intended use.
Benchtop testing was also performed to verify the insertion effort required for use of the Self-Punching ICONIX products. Due to the equivalent self-punching insertion mechanism, this was compared to that of Predicate B. The comparison indicates that the proposed devices require reduced insertion effort compared to the devices of Predicate B, and will be functional within the intended use.
Clinical testing was not required to demonstrate substantial equivalence for this submission.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
K170098, K063778, K092533, K162310
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/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 24, 2017
Stryker Katie Farraro Regulatory Affairs Specialist 5900 Optical Court San Jose, California 95138
Re: K171465
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: July 7, 2017 Received: July 10, 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
1
related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
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| | ОЭСЭН ЭГЭЭАЧ ЭТАЯАЧЭГ А ИО ЭНИГТИОЭ | |
| (วันธุ์ เป็นสินค้า เป็นความที่ต้างอิง (วันเทอร์) อาจาก (ว | Type of Use (Sleech one or Doth, as applicable)
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| | ตอนาวมารถอวรรี เตอนเธรูไป โรเจเรไโดว์ โธเทรนี จารย์ปี สุทธศหวรฝราย : พอปเรื | |
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| | | Stryker Self-Punching ICONIX
Device Name |
| | | 377465
510(k) Number (if known |
| See PRA Statement below | indications for Use | |
| Expiration Date: January 31, 2017
Form Approved: OMB No. 0810-0120 | ЭЭЛУЯЭГ ИАМИН ОНА НТТАЭН ТО ТИЗМТЯАРЭС
Food and Drug Administration | |
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3
510(k) Summary
I. SUBMITTER
Stryker Endoscopy 5900 Optical Ct San Jose, CA 95138 Katie Farraro, Regulatory Affairs Specialist Contact Person: Phone: 408-754-2285 Fax: 408-754-2507 July 7, 2017 Date Prepared:
II. DEVICE
| Name of Device: | Stryker Self-Punching ICONIX |
|---|---|
| Model Numbers: | 3910-500-921, 3910-500-922 |
| 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 DEVICES
Predicate Devices:
Predicate A (Primary Predicate): Device Name: ICONIX All Suture Anchors Company Name: Stryker 510(k) #: K133671
Predicate B: Device Name: Y-Knot RC All-Suture Anchor, 2.8mm - Double Loaded and Triple Loaded w/ #2 Hi-Fi Sutures Company Name: ConMed Corporation 510(k) #: K133224
Predicate devices have not been subject to a recall.
4
Reference Devices:
Reference Device 1 Device Name: Stryker ICONIX TT All Suture Anchor Company Name: Stryker 510(k) #: K170098
Reference Device 2 Device Name: Force Fiber Polyethylene Non-Absorbable Suture Company Name: Teleflex Medical 510(k) #: K063778
Reference Device 3 Device Name: Force Fiber Blue Polyethylene Non-Absorbable Surgical Suture Company Name: Beere Precision Medical Instruments, Kmedic, Telef 510(k) #: K092533
Reference Device 4 Device Name: XBraid TT Suture Tape Company Name: Stryker 510(k) #: K162310
Reference devices have not been subject to a recall.
IV. DEVICE DESCRIPTION
The Self-Punching ICONIX Anchors (herein referred to as the proposed device(s)) 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 preloaded on the inserter is packaged in a single-use sterile barrier system (SBS).
V. INTENDED USE
The Stryker Self-Punching ICONIX Anchors are intended to be used for soft-tissue to bone fixation in the elbow, shoulder, knee and hip. See indications below.
Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction
5
Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Repair
Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis
Hip: Capsular Repair, Acetabular Labral Repair, Gluteal Tendon Repair
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE AND REFERENCE DEVICES
The Self-Punching ICONIX Anchors are substantially equivalent to Predicate A (the Primary Predicate) with regard to intended use, materials of construct, anchor design and deployment method, and performance attributes.
The proposed devices are substantially equivalent to Predicate B in regard to operational principle (specifically, insertion method). The Self-Punching ICONIX products utilize a self-punching insertion mechanism, such that the device can be directly inserted into bone without the use of a drill or guide.
Reference Devices 1-4 were selected to support scientific methodology throughout this submission, as these legally marketed devices utilize identical components to the proposed devices. Reference Device 1 is another suture anchor in the ICONIX product family that utilizes identical suture tape (XBraid TT) material and anchor sheath material, and Reference Devices 2-4 represent each of the suture components used in the proposed devices as standalone medical devices.
The differences between the proposed products and the predicate devices are summarized below, and do not raise new questions of safety and effectiveness.
Proposed and Predicate Device Differences:
Suture Configurations
The proposed devices include 2.3mm diameter polyester sheaths that are identical to the 2.3mm anchors of Predicate A. However, another suture configuration is available in the proposed devices that includes flat sutures woven into the sheath. This configuration is unique compared to Predicate A.
Inserter
In order to achieve the self-punching insertion mechanism, the inserter of Predicate A has been modified to include a larger diameter, sharper tips, and a longer handle. The
6
working length of the inserter shaft also features an increased shaft diameter compared to Predicate B.
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 Self-Punching ICONIX products. This fixation strength was compared to that of Predicate A through statistical analysis. The comparison indicates that the proposed devices provide statistically higher fixation strength than the devices of Predicate A. and will be functional within the intended use.
Benchtop testing was also performed to verify the insertion effort required for use of the Self-Punching ICONIX products. Due to the equivalent self-punching insertion mechanism, this was compared to that of Predicate B. The comparison indicates that the proposed devices require reduced insertion effort compared to the devices of Predicate B, and will be functional within the intended use.
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 Stryker Self-Punching ICONIX products are substantially equivalent to the predicate devices and will perform safely and effectively within the intended use.