(79 days)
No
The summary describes a mechanical suture anchor device and its intended uses. There is no mention of any software, algorithms, or data processing that would indicate the use of AI or ML. The performance studies focus on mechanical properties and equivalence to a predicate device.
No
The device is a soft-tissue fixation device used for reattaching or reconstructing tissues, not for treating or rehabilitating a condition.
No
This device is described as a soft-tissue fixation device used for reattaching tendons and ligaments, indicating it is an orthopedic implant for treatment, not diagnosis. The "Intended Use / Indications for Use" section lists various repair and reconstruction procedures.
No
The device description explicitly states it is a "soft-tissue fixation device with a push-in design, provided preloaded on a disposable inserter" and is composed of a "sheath structure that contains one or more working sutures." This describes a physical, implantable medical device, not a software-only device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood or tissue, to detect diseases, conditions, or infections.
- Device Description: The description clearly states the device is a "soft-tissue fixation device" used for surgical procedures to reattach or reconstruct ligaments and tendons in various joints.
- Intended Use: The intended use lists specific surgical procedures on anatomical sites like the elbow, shoulder, hand/wrist, foot/ankle, knee, and hip. These are all surgical interventions, not diagnostic tests performed on samples.
The device is a surgical implant used during a procedure, not a test performed on a sample to diagnose something.
N/A
Intended Use / Indications for Use
Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction
Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Acromio-Clayicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Repair
Hand/Wrist: Scaphulolunate Ligament Reconstruction, Carpal Ligament Reconstruction, Repair/Reconstruction of Collateral Ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP and MCP Joints for All Digits, Digital Tendon Repair
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Metatarsal Ligament Repair, Hallux Valgus Reconstruction, Digital Tendon Transfers, Mid-Foot Reconstruction
Knee: Medial Collateral Ligament Repair, Lateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis
Hip: Capsular Repair, Acetabular Labral Repair, Gluteal Tendon Repair
The ICONIX TT All Suture Anchors are intended for single use only.
Product codes
MBI
Device Description
The Stryker ICONIX TT All Suture Anchors are a line extension of the legally marketed Stryker ICONIX All Suture Anchors. The ICONIX TT All Suture Anchors are soft-tissue fixation devices with a push-in design, provided preloaded on a disposable inserter. They are composed of a sheath structure that contains one or more working sutures. The sheath bunches as the anchor is deployed to fixate in bone.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
foot, ankle, knee, hip, wrist, elbow, and 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 verification and validation testing was performed to assess the efficacy of the proposed Stryker ICONIX TT All Suture Anchors as compared to the predicate device. This testing included inserter removal force, extension during cyclic loading, ultimate tensile strength following cyclic loading, ultimate tensile strength, angled insertion, design validation, packaging validation, sterilization validation, and biocompatibility testing. The ICONIX TT All Suture Anchors have been evaluated to be non-pyrogenic.
The results of all testing demonstrate that the ICONIX TT anchors are substantially equivalent to the predicate device. 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/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" around the perimeter. Inside the circle is a stylized symbol of three human profiles facing to the right, arranged in a stacked formation.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 31, 2017
Stryker Endoscopy Mr. Taylor White Senior Regulatory Affairs Specialist 5670 Greenwood Plaza Blvd.. Suite 200 Greenwood Village, Colorado 80111
Re: K170098
Trade/Device Name: ICONIX TT All Suture Anchor Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI Dated: March 6, 2017 Received: March 7, 2017
Dear Mr. White:
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 (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
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Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
See PRA Statement below.
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
K170098
Device Name
Stryker ICONIX TT All Suture Anchor
Indications for Use (Describe)
Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction
Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Acromio-Clayicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Repair
Hand/Wrist: Scaphulolunate Ligament Reconstruction, Carpal Ligament Reconstruction, Repair/Reconstruction of Collateral Ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP and MCP Joints for All Digits, Digital Tendon Repair
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Metatarsal Ligament Repair, Hallux Valgus Reconstruction, Digital Tendon Transfers, Mid-Foot Reconstruction
Knee: Medial Collateral Ligament Repair, Lateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis
Hip: Capsular Repair, Acetabular Labral Repair, Gluteal Tendon Repair
The ICONIX TT All Suture Anchors are intended for single use only.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW *
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510(k) Summary
I. SUBMITTER
Stryker Endoscopy 5900 Optical Ct San Jose, CA 95138
Contact Person: Taylor White, Senior Regulatory Affairs Specialist Phone: 303-336-7285 Fax: 303-993-6195
Date Prepared: February 16, 2017
II. DEVICE
| Name of Device: | Stryker ICONIX TT All Suture Anchor
Model Numbers: 3910-500-312, 3910-500-322 |
|-----------------------|----------------------------------------------------------------------------------|
| 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 Device: Stryker ICONIX All Suture Anchors, K133671 This predicate has not been subject to a design-related recall.
Reference Device: XBraid TT Suture Tape, K162310 This device has not been subject to a design-related recall.
IV. DEVICE DESCRIPTION
The Stryker ICONIX TT All Suture Anchors are a line extension of the legally marketed Stryker ICONIX All Suture Anchors. The ICONIX TT All Suture Anchors are soft-tissue fixation devices with a push-in design, provided preloaded on a disposable inserter. They are composed of a sheath structure that contains one or more working sutures. The sheath bunches as the anchor is deployed to fixate in bone.
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The Stryker ICONIX TT All Suture Anchors are intended to be used for soft-tissue to bone fixation in the foot, ankle, knee, hip, wrist, elbow, and shoulder. See indications below.
V. INDICATIONS FOR USE
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
Hand/Wrist: Scaphulolunate Ligament Reconstruction, Carpal Ligament Reconstruction, Repair/Reconstruction of Collateral Ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP and MCP Joints for All Digits, Digital Tendon Repair
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Metatarsal Ligament Repair, Hallux Valgus Reconstruction, Digital Tendon Transfers, Mid-Foot Reconstruction
Knee: Medial Collateral Ligament Repair, Lateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis
Hip: Capsular Repair, Acetabular Labral Repair, Gluteal Tendon Repair
The ICONIX TT All Suture Anchors are intended for single use only.
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
The intent of this premarket submission is to expand the ICONIX All Suture Anchor product line to include anchor devices that feature flat working sutures. The dimensions and colorant of the sutures have been modified, and associated manufacturing processes have been modified from the predicate device. All materials used in the construction of the proposed device have been shown to be biologically safe. All device modifications have been assessed through tisk analysis, and where necessary, verification and validation activities were performed. These activities did not raise new questions of safety or effectiveness. Given this, the proposed ICONIX TT All Suture Anchor products are substantially equivalent to the legally marketed predicate device in regard to intended use, fundamental scientific technology, operational principles, and performance attributes.
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VII. PERFORMANCE DATA
Non-clinical verification and validation testing was performed to assess the efficacy of the proposed Stryker ICONIX TT All Suture Anchors as compared to the predicate device. This testing included inserter removal force, extension during cyclic loading, ultimate tensile strength following cyclic loading, ultimate tensile strength, angled insertion, design validation, packaging validation, sterilization validation, and biocompatibility testing. The ICONIX TT All Suture Anchors have been evaluated to be non-pyrogenic.
The results of all testing demonstrate that the ICONIX TT anchors are substantially equivalent to the predicate device. Clinical testing was not required to demonstrate substantial equivalence for this submission.
VIII. CONCLUSIONS
The information presented within this special premarket submission demonstrates that Stryker ICONIX TT All Suture Anchors are substantially equivalent to the predicate device.