(29 days)
No
The 510(k) summary describes a mechanical suture anchor and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes.
The device is intended for the reattachment of soft tissue to bone, specifically for medial or lateral instability repairs/reconstructions and Achilles tendon repairs/reconstructions in the Foot & Ankle, which are therapeutic interventions.
No
The device is a fixation device intended for reattachment of soft tissue to bone, which is a therapeutic function, not diagnostic.
No
The device description clearly states it is a "fixation device" consisting of a "suture anchor with a preloaded ULTRATAPE suture with needles assembled on an insertion device," which are all physical components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for the "reattachment of soft tissue to bone" in specific anatomical locations (Foot & Ankle). This is a surgical procedure performed directly on the patient's body.
- Device Description: The description details a "fixation device" consisting of a "suture anchor with a preloaded ULTRATAPE suture with needles assembled on an insertion device." This is a physical implant and delivery system used in surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information about a physiological state, health, or disease.
IVD devices are used to perform tests on samples taken from the body to diagnose or monitor conditions. This device is a surgical implant used to repair tissue within the body.
N/A
Intended Use / 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
Product codes (comma separated list FDA assigned to the subject device)
MBI
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Foot & Ankle
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
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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.
1
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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3
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 two | ||
| ULTRABRAID 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.
5
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.