(29 days)
The HEALICOIL◊ PK Suture Anchor with Needles, ULTRATAPE® (Blue) and HEALICOIL◊ PK Suture Anchor with Needles, ULTRATAPE (Blue Cobraid) are intended for use only for the reattachment of soft tissue to bone for the following indications:
Foot & Ankle
- Medial or lateral instability repairs/reconstructions
- Achilles tendon repairs/reconstructions
The Smith & Nephew HEALICOIL® PK Suture Anchor with Needles, ULTRATAPE® (Blue) and HEALICOIL® PK Suture Anchor with Needles, ULTRATAPE® (Blue Cobraid) is a fixation device intended to provide reattachment of soft tissue to bone. The device consists of a suture anchor with a preloaded ULTRATAPE suture with needles assembled on an insertion device.
This document is a 510(k) Premarket Notification from the FDA regarding a medical device, specifically a suture anchor. The information provided heavily focuses on regulatory compliance, device description, intended use, and comparison to predicate devices, rather than detailed performance study data against acceptance criteria typically seen for AI/ML-driven devices.
Therefore, many of the requested details about acceptance criteria, study design for proving device performance, sample sizes, expert involvement, and ground truth establishment (especially in the context of an AI/ML algorithm) are not present in this document. This is because the device described is a physical medical device (suture anchor), not an AI/ML diagnostic or predictive tool.
I will address the elements based on the information that can be inferred for a physical device, and clearly state when information is not available or not applicable given the nature of the device.
Device: HEALICOIL® PK Suture Anchor with Needles, ULTRATAPE® (Blue); HEALICOIL® PK Suture Anchor with Needles, ULTRATAPE® (Blue Cobraid)
Device Type: Soft Tissue Fixation Device (Suture Anchor)
Overall Conclusion from Document: The device is deemed substantially equivalent to a legally marketed predicate device (HEALICOIL PK Suture Anchor, K152566). This determination is based on similarities in indications for use, design features, operational principles, material biocompatibility, and composition. The changes (new inserter and addition of needles to the preloaded suture) are considered minor and do not raise new questions of safety or effectiveness.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Inferred for a physical device like a suture anchor) | Reported Device Performance (Summary from document) |
|---|---|
| Mechanical Performance: | |
| - Fixation Strength/Integrity | "met the required specifications" |
| - Insertion & Fixation Capability | "met the required specifications" |
| - Cyclic Loading Endurance | "met the required specifications" |
| - Needle Attachment Strength | "met the required specifications" |
| Biocompatibility: | "material biocompatibility and composition" (stated as similarity to predicate) |
| - Material Safety | |
| Functional Equivalence: | "substantially equivalent in intended use and fundamental scientific technology" |
| - Similar Intended Use | "similar in intended use, indications for use, materials, design, and manufacturing process" |
| - Similar Indications for Use | "Similar to predicate" |
| - Similar Materials | "Similar to predicate" |
| - Similar Design | "Similar to predicate" |
| - Similar Manufacturing Process | "Similar to predicate" |
Note: The document provides a high-level summary that "all components met the required specifications for the completed tests" and that "The results for all testing were passing." Specific quantitative acceptance criteria values (e.g., minimum load force, cycle count) and reported numerical performance metrics are not provided in this summary.
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not specified in the document. The document states "Mechanical testing performed on the device and all components" but does not give sample sizes (e.g., number of anchors tested for each type of mechanical test).
- Data Provenance: Not specified. For mechanical testing of a manufactured physical device, the data would typically originate from in-vitro lab testing, not patient data. The document does not mention the country of origin of the data or whether it was retrospective or prospective, as these concepts are generally not applicable to the type of testing described for this device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This question is not applicable to this type of device. The "ground truth" for a physical medical device like a suture anchor is established through engineering specifications, material science standards, and biomechanical testing standards, not expert consensus on diagnostic images or patient outcomes in the way an AI/ML device would require. Performance is measured against physical test standards (e.g., ASTM, ISO standards for implantable devices), not judgments made by experts in a conciliation process.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- This question is not applicable. Adjudication methods like 2+1 or 3+1 are used in studies involving human readers or evaluators to resolve discrepancies in interpretation (e.g., in radiology image reading). For the mechanical testing of a suture anchor, performance is objectively measured against pre-defined engineering and material specifications. There is no subjective interpretation requiring adjudication.
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
- This question is not applicable. This device is a physical medical implant (suture anchor), not an AI-assisted diagnostic or treatment planning tool. Therefore, MRMC studies and the concept of human readers improving with AI assistance do not apply here.
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 or software.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" for this device's performance is based on predefined engineering specifications, material properties, and biomechanical testing standards (e.g., tensile strength, fatigue life, pull-out strength in a synthetic bone model). This is not derived from expert consensus, pathology, or outcomes data in the usual sense. The document states "all components met the required specifications," implying these engineering-defined benchmarks served as the ground truth.
8. The sample size for the training set
- This question is not applicable to this device. A "training set" refers to data used to train an AI/ML algorithm. This device is a manufactured physical product. Its design and validation rely on engineering principles, material science, and mechanical testing, not a data-driven training process in the AI/ML context.
9. How the ground truth for the training set was established
- This question is not applicable, as there is no "training set" for a physical medical device.
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August 4, 2023
Smith & Nephew, Inc. Camille Fleischer Senior Regulatory Affairs Specialist 150 Minuteman Road Andover, Massachusetts 01810
Re: K232005
Trade/Device Name: HEALICOIL® PK Suture Anchor with Needles, ULTRATAPE' (Blue); HEALICOIL PK Suture Anchor with Needles, ULTRATAPE® (Blue Cobraid) Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: MBI Dated: July 6, 2023 Received: July 6, 2023
Dear Camille Fleischer:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
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/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Jesse Muir -S
Jesse Muir, Ph.D. Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K232005
Device Name
HEALICOIL◊PK Suture Anchor with Needles, ULTRATAPE◊ (Blue); HEALICOILS PK Suture Anchor with Needles, ULTRATAPES (Blue Cobraid)
Indications for Use (Describe)
The HEALICOIL◊ PK Suture Anchor with Needles, ULTRATAPE® (Blue) and HEALICOIL◊ PK Suture Anchor with Needles, ULTRATAPE (Blue Cobraid) are intended for use only for the reattachment of soft tissue to bone for the following indications:
Foot & Ankle
- Medial or lateral instability repairs/reconstructions
- Achilles tendon repairs/reconstructions
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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T:+ 1 978 749 1000 T:+ 1 800 343 8386 (USA toll free) www.smith-nephew.com
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510(k) Summary
Prepared: 03 August 2023
| Submitter Information | Contact Information |
|---|---|
| Smith & Nephew, Inc. | Mrs. Camille Fleischer |
| Endoscopy Division | Senior Regulatory Affairs Specialist |
| 150 Minuteman Road | Phone: (978) 749-1057 |
| Andover, MA 01810 |
| Device Name & Classification | |
|---|---|
| Proprietary Name | HEALICOIL ® PK Suture Anchor with Needles, ULTRATAPE® (Blue)HEALICOIL® PK Suture Anchor with Needles, ULTRATAPE® (Blue Cobraid) |
| Common Name | Soft Tissue Fixation Device |
| Classification Name | Fastener, fixation, biodegradable, soft tissue; fastener, fixation,nondegradable, soft tissue |
| Classification Regulation | 21 CFR 888.3040 |
| Class | II |
| Product Code(s) | MBI |
| Panel | Orthopedic |
Legally Marketed Predicate Devices
The Smith & Nephew HEALICOIL® PK Suture Anchor with Needles, ULTRATAPE® (Blue) and HEALICOIL® PK Suture Anchor with Needles, ULTRATAPE® (Blue Cobraid) is substantially equivalent in intended use and fundamental scientific technology to the following legally marketed devices in commercial distribution:
| Description | Submission Number | Clearance Date |
|---|---|---|
| HEALICOIL PK Suture Anchor | K152566 | 02DEC2015 |
Legally Marketed Reference Devices
| Description | Submission Number | Clearance Date |
|---|---|---|
| TWINFIX Ti 3.5 Suture Anchor with twoULTRABRAID Sutures #2 and Needles, SL | K123425 | 20FEB2013 |
| FAST-FIX FLEX | K203393 | 01FEB2021 |
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Device Description
The Smith & Nephew HEALICOIL® PK Suture Anchor with Needles, ULTRATAPE® (Blue) and HEALICOIL® PK Suture Anchor with Needles, ULTRATAPE® (Blue Cobraid) is a fixation device intended to provide reattachment of soft tissue to bone. The device consists of a suture anchor with a preloaded ULTRATAPE suture with needles assembled on an insertion device.
Intended Use
The HEALICOIL® PK Suture Anchor with Needles, ULTRATAPE® (Blue) and HEALICOIL® PK Suture Anchor with Needles, ULTRATAPE® (Blue Cobraid) is intended for use for the reattachment of soft tissue to bone.
Indications for Use
The HEALICOIL® PK Suture Anchor with Needles, ULTRATAPE® (Blue) and HEALICOIL® PK Suture Anchor with Needles, ULTRATAPE® (Blue Cobraid) are intended for use only for the reattachment of soft tissue to bone for the following indications:
Foot & Ankle
- Medial or lateral instability repairs/reconstructions
- Achilles tendon repairs/reconstructions ●
Technological Characteristics
The change is modifying the design of the Smith & Nephew HEALICOIL PK Suture Anchor (K152566) to include a new inserter and the addition needles to the preloaded ULTRATAPE suture. The Smith & Nephew HEALICOIL® PK Suture Anchor with Needles, ULTRATAPE' (Blue) and HEALICOIL® PK Suture Anchor with Needles, ULTRATAPE® (Blue Cobraid) is similar in intended use, indications for use, materials, design, and manufacturing process as the predicate; some of the same components as the reference device TWINFIX Ti 3.5 Suture Anchor with two ULTRABRAID Sutures #2 and Needles, SL (K123425) and the same packaging configuration as the reference device FAST-FIX FLEX (K203393) will be used. HEALICOIL® PK Suture Anchor with Needles, ULTRATAPE® (Blue) and HEALICOIL® PK Suture Anchor with Needles, ULTRATAPE° (Blue Cobraid) are substantially equivalent the predicate. The differences between the proposed device and predicate device are considered minor and do not raise new questions of safety or effectiveness.
Performance Data
Mechanical testing performed on the device and all components met the required specifications for the completed tests. A summary of the test results has been provided for fixation, insertion & fixation, cyclic loading and needle attachment. The results for all testing were passing.
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Conclusion
The substantial equivalence of the HEALICOIL° PK Suture Anchor with Needles, ULTRATAPE® (Blue) and HEALICOIL® PK Suture Anchor with Needles, ULTRATAPE® (Blue Cobraid) is based on similarities in indications for use, design features, operational principles, material biocompatibility and composition. Modifications in design are minor and do not raise additional questions of safety or effectiveness compared to the predicate device. Based on the similarities the HEALICOIL® PK Suture Anchor with Needles, ULTRATAPE® (Blue) and HEALICOIL® PK Suture Anchor with Needles, ULTRATAPE® (Blue Cobraid) is substantially equivalent to the predicate.
N/A