(37 days)
The Smith & Nephew SUTUREFIX Curved Suture Anchors are intended for the secure fixation of soft tissue to bone for the following indications:
Hip
• Acetabular labrum repair/reconstruction
Shoulder
- · Capsular stabilization
- Bankart repair
- Anterior shoulder instability
- SLAP lesion repairs
- Capsular shift or capsulolabral reconstructions
- Rotator cuff tear repairs
- Bicepts tenodesis
The Smith & Nephew SUTUREFIX Curved suture anchor system consists of an all suture based implant, hole preparation, and curved insertion accessory instruments. The implant will be offered in multiple suture configurations including single and double loaded suture options. The instruments will include sterile flexible drills and reusable curved drill guides and obturators.
This document is a 510(k) premarket notification for a medical device, specifically the Smith & Nephew SUTUREFIX Curved Suture Anchor. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study of the device's performance against specific acceptance criteria.
Therefore, much of the requested information regarding acceptance criteria, study design, sample sizes, expert involvement, and ground truth establishment is not present in this type of regulatory submission. The document states that performance data exists, but does not provide the specifics of those studies.
Here's a breakdown of the available information based on your request:
1. A table of acceptance criteria and the reported device performance
| Performance Metric | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Bacterial Endotoxin | Acceptable limits per ANSI/AAMI ST72:2011 | Met acceptable endotoxin limits |
| Insertion Strength | Performance specifications (not detailed) | Met performance specifications |
| Pull-out Strength | Performance specifications (not detailed) | Met performance specifications |
Note: The specific numerical acceptance criteria and reported values for insertion and pull-out strength are not provided in this summary.
2. Sample sized used for the test set and the data provenance
Not provided in this document. The document mentions "Performance data demonstrates," but does not specify the sample sizes or the provenance (e.g., country of origin, retrospective/prospective nature) of the data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable/Not provided. This is a physical device, and the "ground truth" would relate to its physical and mechanical properties, not an assessment by human experts in the way an AI or diagnostic device would require.
4. Adjudication method for the test set
Not applicable/Not provided. See point 3.
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
Not applicable. This is a surgical implant, not an AI or diagnostic device that involves human readers/interpreters.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a surgical implant, not an algorithm.
7. The type of ground truth used
For the physical performance tests (insertion strength, pull-out strength, bacterial endotoxin), the "ground truth" would be established by objective laboratory measurements following validated test methods.
8. The sample size for the training set
Not applicable. This is a medical device, not an AI model that requires a training set.
9. How the ground truth for the training set was established
Not applicable. See point 8.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 7, 2016
Smith and Nephew, Inc. Ms. Anne-Marie Keefe Senior Regulatory Affairs Specialist 150 Minuteman Road Andover, Massachusetts 01810
Re: K163034
Trade/Device Name: SUTUREFIX Curved 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: October 28, 2016 Received: October 31, 2016
Dear Ms. Keefe:
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 and 8091); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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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/Resourcesfor You/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/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 yours.
Mark N. Melkerson -S
Mark N. Melkerson Division Director Division of Orthopaedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K163034
Device Name
SUTUREFIX Curved Suture Anchor
Indications for Use (Describe)
The Smith & Nephew SUTUREFIX Curved Suture Anchors are intended for the secure fixation of soft tissue to bone for the following indications:
Hip
• Acetabular labrum repair/reconstruction
Shoulder
- Capsular stabilization
- Bankart repair
- Anterior shoulder instability
- SLAP lesion repairs
- Capsular shift or capsulolabral reconstructions
- Rotator cuff tear repairs
- Bicepts tenodesis
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) |
|---|---|
| ☑ | ☐ |
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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T 978-749-1000 978-749-1443 www.smith-nephew.com
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510(k) Summary
Prepared: 29 November 2016
| Submitter Information | Contact Information |
|---|---|
| Smith & Nephew, Inc.Endoscopy Division150 Minuteman RoadAndover, MA 01810 | Anne-Marie KeefeSenior Regulatory Affairs SpecialistPhone: (508) 261-3713Fax: (978) 749-1443 |
| Device Name & Classification | |
|---|---|
| Proprietary Name | SUTUREFIX Curved Suture Anchor |
| Common Name | Soft Tissue Fixation Device |
| Classification Name | 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 SUTUREFIX Curved Suture Anchor is substantially equivalent in intended use and Fundamental Scientific Technology to the following legally marketed devices in commercial distribution:
| Description | SubmissionNumber | Clearance Date |
|---|---|---|
| SUTUREFIX All Suture Anchor | K122059 | March 18, 2013 |
| BIORAPTOR 2.3 PK Suture Anchor | K102660 | December 13, 2010 |
Device Description
The Smith & Nephew SUTUREFIX Curved suture anchor system consists of an all suture based implant, hole preparation, and curved insertion accessory instruments. The implant will be offered in multiple suture configurations including single and double loaded suture options. The instruments will include sterile flexible drills and reusable curved drill guides and obturators.
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Intended Use
The Smith & Nephew SUTUREFIX Curved Suture Anchors are intended for the secure fixation of soft tissue to bone for the following indications:
Hip
• Acetabular labrum repair/reconstruction
Shoulder
- · Capsular stabilization
- Bankart repair
- Anterior shoulder instability
- SLAP lesion repairs
- Capsular shift or capsulolabral reconstructions
- Rotator cuff tear repairs
- Bicepts tenodesis
Technological Characteristics
The Smith & Nephew SUTUREFIX Curved Suture Anchor is substantially equivalent in intended use and fundamental scientific technology to the legally marketed predicate devices - Smith and Nephew SUTUREFIX Ultra Suture Anchor (K122059), and the BIORAPTOR 2.3 PK Suture Anchor (K102660), and raises no new issues of safety and efficacy. The Smith & Nephew SUTUREFIX Curved Suture Anchor and the predicate SUTUREFIX Ultra Suture Anchor use the identical component materials, and all-suture based implant configurations. The Smith & Nephew SUTUREFIX Curved Suture Anchor and the predicate BIORAPTOR 2.3 PK Suture Anchor share the same curved, anchor delivery system.
Summary Performance Data
Bacterial endotoxin testing was completed and met acceptable endotoxin limits per ANSI/AAMI ST72:2011. Performance data demonstrates that the SUTUREFIX Curved Suture Anchor has met performance specifications for insertion strength and pull-out strength and therefore, is considered substantially equivalent to the currently marketed predicate devices.
Substantial Equivalence Information
The substantial equivalence of the SUTUREFIX Curved 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 SUTUREFIX Curved Suture Anchor is substantially equivalent to its predicates.
§ 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.