The Smith & Nephew MICRORAPTOR Suture Anchor consists of an anchor on a flexible and/or straight inserter, flexible and/or straight drill, and curved and/or straight insertion accessory instruments. The implant will be offered in an absorbable material (REGENESORB), single loaded #1 ULTRABRAID suture with multiple suture color offerings. This device is provided sterile, for single use only.

AI/ML Overview

This document is a 510(k) Pre-Market Notification for a medical device called the "MICRORAPTOR REGENESORB Suture Anchor". It describes the device's intended use and demonstrates its substantial equivalence to previously cleared predicate devices, rather than a clinical study evaluating the performance of an AI/ML powered device.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, ground truth, expert involvement, and comparative effectiveness studies for an AI device is not applicable to this document.

This document describes the following for the MICRORAPTOR REGENESORB Suture Anchor:

1. Acceptance Criteria and Reported Device Performance (Summary):

The performance of the MICRORAPTOR REGENESORB Suture Anchor was evaluated against performance specifications derived from its predicate devices.

Acceptance Criteria	Reported Device Performance
Bacterial Endotoxin Limits (per ANSI/AAMI ST72:2011)	Met acceptable endotoxin limits.
Insertion Strength (based on Pivot NANOTACK Suture Anchor, 1.4mm - K131769)	Met performance specifications for insertion strength.
Cyclic Loading (based on OSTEORAPTOR Suture Anchor - K082215)	Met performance specifications for cyclic loading.

Study Description (Summary per the provided text):

The submission refers to "Performance data" to demonstrate that the MICRORAPTOR REGENESORB Suture Anchor met the specified criteria. These appear to be benchtop or laboratory tests, not clinical studies involving human subjects or AI algorithms.

Bacterial Endotoxin Testing: Was completed and met acceptable endotoxin limits per ANSI/AAMI ST72:2011.
Insertion Strength Testing: Performance data demonstrates the device met specifications based on the predicate Pivot NANOTACK Suture Anchor, 1.4mm (K131769).
Cyclic Loading Testing: Performance data demonstrates the device met specifications based on the predicate OSTEORAPTOR Suture Anchor (K082215).

Given that this document describes a traditional medical device (suture anchor) and not an AI/ML powered device, the following points are not applicable and are therefore marked as "N/A":

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): N/A (This is for an AI/ML powered device, not a suture anchor)
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): N/A
Adjudication method (e.g. 2+1, 3+1, none) for the test set: N/A
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: N/A
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: N/A
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): N/A (The "ground truth" here is the performance of specified predicate devices and standard endotoxin limits for a physical device)
The sample size for the training set: N/A
How the ground truth for the training set was established: N/A

Summary

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May 30, 2018

Smith and Nephew, Inc. Katherine Marcaccio Senior Regulatory Affairs Specialist 7135 Goodlett Farms Parkway Cordova, Tennessee 38016

Re: K180361

Trade/Device Name: MICRORAPTOR REGENESORB 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 Dated: April 26, 2018 Received: April 27, 2018

Dear Ms. Marcaccio:

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 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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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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Katherine D. Kavlock -S

for

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) K180361

Device Name

MICRORAPTOR REGENESORB Suture Anchor

Indications for Use (Describe)

The Smith & Nephew MICRORAPTOR Suture Anchor is intended for the reattachment of soft tissue to the following indications:

Hip

Acetabular labrum repair/reconstruction

Shoulder

Capsular stabilization
Bankart repair
Anterior shoulder instability
SLAP lesion repairs
Capsular shift or capsulolabral reconstructions
Biceps tenodesis

Type of Use (Select one or both, as applicable)
-------------------------------------------------	--

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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T 978-749-1000 F 978-749-1443 www.smith-nephew.com

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510(k) Summary

Prepared: 26 APRIL 2018

Submitter Information	Contact Information
Smith & Nephew, Inc.	Katherine Marcaccio
Endoscopy Division	Senior Regulatory Affairs Specialist
150 Minuteman Road	Phone: (508) 261-3602
Andover, MA 01810	Fax: (978) 749-1443

Device Name & Classification
Proprietary Name	MICRORAPTOR REGENESORB Suture Anchor
Common Name	Soft Tissue Fixation Device
Classification Name	Fastener, fixation, biodegradable, soft tissue
Classification Regulation	21 CFR 888.3030
Class	II
Product Code(s)	MAI
Panel	Orthopedic

Legally Marketed Predicate Devices

The Smith & Nephew MICRORAPTOR REGENESORB 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
OSTEORAPTOR OS Suture Anchor	K101459	January 27, 2011
OSTEORAPTOR Suture Anchor	K082215	November 3, 2008
NANOTACK Suture Anchor, 1.4mm	K131769	October 7, 2013

Device Description

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Intended Use

The Smith & Nephew MICRORAPTOR Suture Anchor is intended for the reattachment 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
· Biceps tenodesis

Technological Characteristics

The Smith & Nephew MICRORAPTOR REGENESORB Suture Anchor is substantially equivalent in intended use and fundamental scientific technology to the legally marketed predicate devices - Smith and Nephew OSTEORAPTOR OS Suture Anchor (K101459), and the Pivot NANOTACK Suture Anchor, 1.4mm (K131769), and raises no new issues of safety and efficacy. The Smith & Nephew MICRORAPTOR REGENESORB Suture Anchor and the predicate OSTEORAPTOR OS Suture Anchor (K101459) use identical implant materials. The Smith & Nephew OSTEORAPTOR Suture Anchor (K082215) has identical geometry to the OSTEORAPTOR OS Suture Anchor (K101459), and is composed of absorbable PLLA/HA material. The Smith & Nephew MICRORAPTOR REGENESORB Suture Anchor and the predicate NANOTACK Suture Anchor, 1.4mm (K131769) have similar geometry.

Summary Performance Data

Bacterial endotoxin testing was completed and met acceptable endotoxin limits per ANSI/AAMI ST72:2011. Performance data demonstrates that the MICRORAPTOR REGENESORB Suture Anchor has met performance specifications for insertion strength based on the predicate Pivot NANOTACK Suture Anchor, 1.4mm (K131769). Performance data demonstrates that the MICRORAPTOR REGENESORB Suture Anchor has met performance specifications for cyclic loading based on the predicate OSTEORAPTOR Suture Anchor (K082215). Therefore, the MICRORAPTOR REGENESORB Suture Anchor is considered substantially equivalent to the currently marketed predicate devices.

Substantial Equivalence Information

The substantial equivalence of the MICRORAPTOR REGENESORB 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 MICRORAPTOR REGENESORB Suture Anchor is substantially equivalent to its predicates.

Regulation Number and Section

§ 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.