(91 days)
The ICONIX All Suture Anchor System is intended to be used for soft-tissue to bone fixation in the foot, ankle, knee, hip, hand, wrist, elbow and shoulder. Specific Indications are listed 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
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 Collateral Ligament Repair. Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis.
Hip: Capsular Repair, Acetabular Labral Repair, Gluteal Tendon Repair
The ICONIX All Suture Anchors are intended for single use only.
The ICONIX 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. As the anchor is deployed, the sheath bunches and fixates in bone.
The provided text describes the ICONIX All Suture Anchor System and its expanded indications for use. However, it does not include information about acceptance criteria or a study that specifically proves the device meets such criteria in terms of performance metrics like sensitivity, specificity, or reader improvement. This is likely because the device is a medical implant (suture anchor) and not an AI-powered diagnostic or assistive tool, which typically have performance metrics and studies as detailed in the prompt.
The "study" mentioned here is confined to non-clinical comparative bench testing to support expanded indications, not a clinical study involving human performance or diagnostic accuracy.
Here's an analysis based on the provided document, addressing the prompt's questions where possible and noting where information is not applicable or unavailable:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Stated Goal) | Reported Device Performance |
|---|---|
| Statistically equivalent fixation strength to predicate devices for Gluteal Tendon Repair of the Hip in non-clinical bench testing. | The results of the non-clinical evaluation indicate that the ICONIX All Suture Anchors provide statistically equivalent fixation strength to the predicate devices, and will be functional within the intended use. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not explicitly stated in the document. The text only mentions "comparative bench testing" for "cyclic testing followed by ultimate tensile strength".
- Data Provenance: The study was "non-clinical comparative bench testing," implying it was conducted in a lab setting, likely within the United States where Stryker Endoscopy is based (San Jose, CA). It is prospective in nature for device validation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- This question is not applicable to this type of device and study. The testing involved mechanical properties (fixation strength, tensile strength) which are measured quantitatively, not subjectively assessed by human experts for ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- This question is not applicable as the "test set" involves physical device performance, not human interpretation or diagnostic assessment.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic or AI-assisted devices that involve human interpretation of medical images or data. The ICONIX All Suture Anchor System is a physical surgical implant.
- Therefore, an effect size of human improvement with/without AI assistance is not applicable.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- This question is not applicable. This device is a physical medical implant, not an algorithm, and does not have standalone "algorithm only" performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for this device's performance was established via objective mechanical measurements of fixation strength and ultimate tensile strength in a bench testing environment according to engineering principles. It was compared against the performance of predicate devices.
8. The sample size for the training set
- This question is not applicable as there is no "training set" in the context of mechanical bench testing for a physical medical device. This term is specific to machine learning and AI model development.
9. How the ground truth for the training set was established
- This question is not applicable since there is no training set for this type of device validation.
Summary of the Study:
The "study" described in the document is a non-clinical comparative bench test. Its purpose was to demonstrate that the ICONIX All Suture Anchors, when used for Gluteal Tendon Repair of the Hip (an expanded indication), show equivalent mechanical fixation strength to predicate devices. This type of testing is standard for demonstrating substantial equivalence for physical medical devices, especially when expanding indications without significant design changes. Clinical testing was explicitly stated as "not required for this submission." The FDA's 510(k) clearance (K133671) acknowledges this bench testing as sufficient to support the claim of substantial equivalence.
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| Endoscopy510(k) Summary of Safety and Effectiveness | |
|---|---|
| Proprietary Name: | ICONIX All Suture Anchor System |
| Common Name: | Fastener, Fixation, Nondegradable, Soft Tissue |
| Classification Name and Reference: | Smooth or threaded metallic bone fixation fastener21 CFR §888.3040 |
| Proposed Regulatory Class: | Class II |
| Product Codes: | MBI: Fastener, Fixation, Nondegradable, Soft Tissue |
| Device Owner: | Stryker Endoscopy5900 Optical CourtSan Jose, CA 95138 |
| For Information Contact: | Kelly KucharczykRegulatory Affairs SpecialistHowmedica Osteonics Corp.3201 E. 3rd AveDenver, CO 80210Phone: (303) 336-7285; Fax (303) 370-5775Email: kelly.kucharczyk@stryker.com |
| Legally Marketed Devices to WhichSubstantial Equivalence Is Claimed: | K120509 – Stryker All Suture AnchorsK110545 - Smith & Nephew Next Generation FullyThreaded PEEK Suture Anchor (marketed as theHealicoil PK Suture Anchor) |
| Date Prepared: | November 26, 2013 |
Description
This Traditional 510(k) is being supplied to the U.S. FDA to expand the indications of the Stryker All Suture Anchors (K120509) (currently marketed as the ICONIX All Suture Anchor System) to include Gluteal Tendon Repair of the Hip. The ICONIX All Suture Anchors are softtissue 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. As the anchor is deployed, the sheath bunches and fixates in bone. There have been no design modifications to the ICONIX All Suture Anchors since the original clearance (K120509).
Intended Use
The ICONIX All Suture Anchor System is intended to be used for soft-tissue to bone fixation in the foot, ankle, knee, hip, hand, wrist, elbow and shoulder. Specific Indications are listed below.
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Indications
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 Collateral Ligament Repair. Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis.
Hip: Capsular Repair, Acetabular Labral Repair, Gluteal Tendon Repair
The ICONIX All Suture Anchors are intended for single use only.
Summary of Technologies
The ICONIX All Suture Anchors are substantially equivalent in design, materials of construct, performance attributes, and operational principles to its currently marketed predicate devices, the Stryker All Suture Anchors (currently marketed as the ICONIX All Suture Anchor System) and the Smith and Nephew Next Generation Fully Threaded PEEK Suture Anchor (currently marketed as the Healicoil PK Suture Anchor).
Non-Clinical Testing
In order to support the additional indication, non-clinical comparative bench testing was performed to verify the fixation strength of the ICONIX All Suture Anchors. Cyclic testing followed by ultimate tensile strength was evaluated in order to support the efficacy of the ICONIX All Suture Anchors as compared to the predicate devices identified within this premarket notification. The results of this evaluation indicate that the ICONIX All Suture Anchors provide statistically equivalent fixation strength to the predicate devices, and will be functional within the intended use.
Clinical Testing
Clinical testing was not required for this submission.
Conclusion
Based on the information discussed above, the ICONIX All Suture Anchors are as safe, as effective, and perform as well or better to the predicate devices listed within this submission.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 28, 2014
Stryker Endoscopy Ms. Kelly Kucharczyk Regulatory Affairs Specialist 5900 Optical Court San Jose. California 95138
Re: K133671
Trade/Device Name: ICONIX All Suture Anchor System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI Dated: November 26, 2013 Received: December 4, 2013
Dear Ms. Kucharczyk:
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-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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Page 2 - Ms. Kelly Kucharczyk
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 Small Manufacturers, International and Consumer Assistance at its tollfree 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" (21CFR 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/ReportalProblem/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 Small Manufacturers, International and Consumer Assistance 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 yours,
Vincent到
- for
and and the first the state of the states
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K133671
Device Name: ICONIX All Suture Anchor System
Elbow: Biceps Tendon Re-attachment, 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 Collateral Ligament Repair. Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis.
- Hip: Capsular Repair. Acetabular Labral Repair. Gluteal Tendon Repair
The ICONIX All Suture Anchors are intended for single use only.
Prescription Use X Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH. Office of Device Evaluation (ODE)
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રવ
§ 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.