(86 days)
No
The summary describes a mechanical suture anchor and its components, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is described as a 'suture anchor' intended for 'reattachment of soft tissue to bone' for medical conditions like 'rotator cuff tear repair', which are therapeutic interventions.
No
This device is a surgical implant (suture anchor) used for reattaching soft tissue to bone, not for diagnosing conditions.
No
The device description clearly outlines physical components made of materials like PEEK, Titanium, and stainless steel, indicating it is a hardware device, not software-only.
No, 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 the shoulder. This is a surgical procedure performed directly on the patient's body.
- Device Description: The description details a physical implant (anchor) and instruments for its insertion. This is consistent with a surgical device.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis. IVDs are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
This device is a surgical implant and associated instrumentation, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Smith & Nephew HEALICOIL Knotless Suture Anchor is intended for use only for the reattachment of soft tissue to bone for the following indications:
Shoulder
• Biceps tenodesis
• Rotator cuff tear repair
Product codes
MAI, MBI
Device Description
The HEALICOIL Knotless Suture Anchor consists of an anchor on an inserter fitted with a suture passer. The anchor consists of the following components: a proximal implant (REGENESORB or PEEK), a non-absorbable distal implant (PEEK or Titanium), and a nonabsorbable PEEK plug. The anchor is preloaded on a stainless steel inserter. This device is to be used with Smith & Nephew ULTRABRAID, ULTRATAPE, and MINITAPE Sutures. This device is provided sterile, for single use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Shoulder
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D)
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
Sterilization of the HEALICOIL Knotless Suture Anchor was compared to the predicate HEALICOIL REGENESORB Suture Anchor (K123393). Shelf-life of the HEALICOIL Knotless Suture Anchor was based on the configurations of the predicate HEALICOIL REGENESORB Suture Anchor (K123393) and reference devices MICRORAPTOR Knotless Suture Anchor (K181746) and BIORAPTOR 2.3 PK Suture Anchor (K071586). Bacterial endotoxin testing was completed and met acceptable endotoxin limits per ANSI/AAMI ST72:2011.
The biocompatibility of the HEALICOIL Knotless Suture Anchor was evaluated against the requirements per ISO 10993-1:2018. All acceptance criteria were met.
The performance data demonstrates that the HEALICOIL Knotless Suture Anchor had met performance specifications for insertion strength and pull-out strength. The HEALICIOL Knotless Suture Anchor met performance specifications for cyclic loading based on the primary predicate FOOTPRINT PK Suture Anchor (K073509).
Key Metrics
All acceptance criteria were met for biocompatibility. Met performance specifications for insertion strength, pull-out strength, and cyclic loading.
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
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March 18, 2020
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Smith & Nephew, Inc. Camille Black Regulatory Affairs Specialist II 7135 Goodlett Farms Parkway Cordova, Tennessee 38016
Re: K193558
Trade/Device Name: HEALICOIL Knotless Suture Anchor Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: MAI, MBI Dated: December 20, 2019 Received: December 23, 2019
Dear Camille Black:
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.
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
1
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 mediation-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,
For; Laurence Coyne Acting Director DHT6C: Division of Restorative, Repair, and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K193558
Device Name HEALICOIL Knotless Suture Anchor
Indications for Use (Describe)
The Smith & Nephew HEALICOIL Knotless Suture Anchor is intended for use only for the reattachment of soft tissue to bone for the following indications:
Shoulder
• Biceps tenodesis
· Rotator cuff tear repair
| Type of Use (Select one or both, as applicable) |
|---|
| Research Use Only: CFR 211 Subpart A |
| Compounding Authority: CFR 211 Subpart C |
|× | Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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Smith & Nephew, Inc. 150 Minuteman Road Andover, MA 01810 Massachusetts, USA
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: 05 March 2020
| Submitter Information | Contact Information |
|---|---|
| Smith & Nephew, Inc. | Camille Black |
| Endoscopy Division | Regulatory Affairs Specialist II |
| 150 Minuteman Road | Phone: (978) 749-1057 |
| Andover, MA 01810 | Fax: (978) 749-1443 |
| Device Name & Classification | |
|---|---|
| Proprietary Name | HEALICOIL ° Knotless Suture Anchor |
| Common Name | Soft Tissue Fixation Device |
| Classification Name | Fastener, fixation, biodegradable, soft tissue; fastener, fixation, nondegradable, soft tissue |
| Classification Regulation | 21 CFR 888.3030 ; 21 CFR 888.3040 |
| Class | II |
| Product Code(s) | MAI; MBI |
| Panel | Orthopedic |
Legally Marketed Predicate Devices
The Smith & Nephew HEALICOIL Knotless Suture Anchor is substantially equivalent in intended use and fundamental scientific technology to the following legally marketed devices in commercial distribution:
| Description | Submission
Number | Clearance Date |
|------------------------------------|----------------------|----------------|
| FOOTPRINT PK FP Suture Anchor | K073509 | 04 MAR 2008 |
| HEALICOIL REGENESORB Suture Anchor | K123393 | 11 APR 2013 |
| TWINFIX Ultra Ti Suture Anchor | K100159 | 19 APR 2010 |
Legally Marketed Reference Devices
| Description | Submission
Number | Clearance Date |
|------------------------------------|----------------------|----------------|
| MICRORAPTOR Knotless Suture Anchor | K181746 | 28 SEP 2018 |
| BIORAPTOR 2.3 PK Suture Anchor | K071586 | 17 AUG 2007 |
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Device Description
The HEALICOIL Knotless Suture Anchor consists of an anchor on an inserter fitted with a suture passer. The anchor consists of the following components: a proximal implant (REGENESORB or PEEK), a non-absorbable distal implant (PEEK or Titanium), and a nonabsorbable PEEK plug. The anchor is preloaded on a stainless steel inserter. This device is to be used with Smith & Nephew ULTRABRAID, ULTRATAPE, and MINITAPE Sutures. This device is provided sterile, for single use only.
Intended Use
The Smith & Nephew HEALICOIL Knotless Suture Anchor is intended for use only for the reattachment of soft tissue to bone for the following indications:
Shoulder
- . Biceps tenodesis
- Rotator cuff tear repair .
Technological Characteristics
The Smith & Nephew HEALICOIL Knotless Suture Anchor is substantially equivalent in intended use and fundamental scientific technology as the legally marketed primary predicate device - the Smith & Nephew FOOTPRINT PK Suture Anchor (K073509) and the additional predicates - the Smith & Nephew HEALICOIL REGENESORB Suture Anchor (K123393) and the Smith & Nephew TWINFIX Ultra Ti Suture Anchor (K100159), and raise no new questions of safety and efficacy. The Smith & Nephew HEALICOIL Knotless Suture Anchor and the predicate devices use identical implant materials.
Summary Performance Data
Sterilization of the HEALICOIL Knotless Suture Anchor was compared to the predicate HEALICOIL REGENESORB Suture Anchor (K123393). Shelf-life of the HEALICOIL Knotless Suture Anchor was based on the configurations of the predicate HEALICOIL REGENESORB Suture Anchor (K123393) and reference devices MICRORAPTOR Knotless Suture Anchor (K181746) and BIORAPTOR 2.3 PK Suture Anchor (K071586). Bacterial endotoxin testing was completed and met acceptable endotoxin limits per ANSI/AAMI ST72:2011.
The biocompatibility of the HEALICOIL Knotless Suture Anchor was evaluated against the requirements per ISO 10993-1:2018. All acceptance criteria were met.
The performance data demonstrates that the HEALICOIL Knotless Suture Anchor had met performance specifications for insertion strength and pull-out strength. The HEALICIOL Knotless Suture Anchor met performance specifications for cyclic loading based on the primary predicate FOOTPRINT PK Suture Anchor (K073509).
Therefore, the HEALICOIL Knotless Suture Anchor is considered substantially equivalent to the currently marketed predicates.
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K193558 Page 3 of 3
Substantial Equivalence Information
The substantial equivalence of the HEALICOIL Knotless Suture Anchor is based on similarities in indications for use, design features, operational principles, material biocompatibility and composition, and performance to the predicate devices listed above. Based on the similarities to the predicates, the HEALICOIL Knotless Suture Anchor is equivalent to its predicates.