(88 days)
Not Found
No
The summary describes a mechanical suture anchor and its components, with no mention of AI or ML technology in its design, function, or performance studies.
No.
The device is intended for the reattachment of soft tissue to bone and is a mechanical anchor, not a therapeutic agent or treatment modality in itself.
No
Explanation: This device is a surgical implant designed for reattaching soft tissue to bone (e.g., in hip and shoulder repairs), not for diagnosing conditions.
No
The device description clearly states it consists of physical components like an anchor, inserter, suture passer, and drills, which are hardware.
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" for specific anatomical sites (Hip and Shoulder). This is a surgical procedure performed in vivo (within the body).
- Device Description: The description details a physical implantable device (suture anchor) and its associated tools for insertion. This is consistent with a surgical device, not a diagnostic test performed on samples in vitro (outside the body).
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's condition based on laboratory testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a surgical tool used for repair within the body.
N/A
Intended Use / Indications for Use
The Smith & Nephew MICRORAPTOR Knotless Suture Anchor is intended for use only 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
- · Rotator cuff tear repairs
Product codes (comma separated list FDA assigned to the subject device)
MAI, MBI
Device Description
The MICRORAPTOR Knotless Suture Anchor consists of an anchor on an inserter fitted with a suture passer, and two accessory drills. The anchor consists of the following components: a proximal anchor body (REGENESORB or PEEK), and a non-absorbable PEEK distal anchor tip. The anchor is preloaded on a stainless steel inserter. 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
Hip, Shoulder
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)
Bacterial endotoxin testing was completed and met acceptable endotoxin limits per ANSI/AAMI ST72:2011. The performance data demonstrates that the MICRORAPTOR Knotless Suture Anchor had met performance specifications for insertion strength and pullout strength. The MICRORAPTOR Knotless Suture Anchor met performance specifications for cyclic loading based on the predicate BIORAPTOR 2.3 PK Suture Anchor (K071586). Therefore, the MICRORAPTOR Knotless Suture Anchor is considered substantially equivalent to the currently marketed predicate devices.
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.
Not Found
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
§ 888.3030 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.
0
September 28, 2018
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is a blue square with the letters FDA in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Smith and Nephew, Inc. Camille Black Regulatory Affairs Specialist I 150 Minuteman Road Andover, Massachusetts 01810
Re: K181746
Trade/Device Name: MICRORAPTOR 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: June 29, 2018 Received: July 2, 2018
Dear Ms. 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 devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see
1
https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
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/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,
Sarah B. Nelson -S
For:
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2020
See PRA Statement below.
Indications for Use
510(k) Number (if known) K181746
Device Name MICRORAPTOR Knotless Suture Anchor
Indications for Use (Describe)
The Smith & Nephew MICRORAPTOR Knotless Suture Anchor is intended for use only 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
- · Rotator cuff tear repairs
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) |
|---|---|
| ----------------------------------------------------------------------------------------------------------------------------------------- | ----------------------------------------------------------------------------------------- |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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3
T 978-749-1000 F 978-749-1443 www.smith-nephew.com
Image /page/3/Picture/2 description: The image shows the Smith & Nephew logo. The logo consists of an orange flower-like symbol on the left, followed by the text "We are" in gray, and "smith&nephew" in orange. The text is aligned horizontally, with the flower symbol positioned to the left of the text.
510(k) Summary
Prepared: 28 September 2018
| Submitter Information | Contact Information |
|---|---|
| Smith & Nephew, Inc. | Camille Black |
| Endoscopy Division | Regulatory Affairs Specialist I |
| 150 Minuteman Road | Phone: (978) 749-1057 |
| Andover, MA 01810 | Fax: (978) 749-1443 |
| Device Name & Classification | |
|---|---|
| Proprietary Name | MICRORAPTOR ® 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 MICRORAPTOR 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 |
|-----------------------------------------|----------------------|-----------------|
| MICRORAPTOR REGENESORB Suture
Anchor | K180361 | May 30, 2018 |
| BIORAPTOR 2.3 PK Suture Anchor | K071586 | August 17, 2007 |
Device Description
The MICRORAPTOR Knotless Suture Anchor consists of an anchor on an inserter fitted with a suture passer, and two accessory drills. The anchor consists of the following components: a proximal anchor body (REGENESORB or PEEK), and a non-absorbable PEEK distal anchor tip. The anchor is preloaded on a stainless steel inserter. This device is provided sterile, for single use only.
4
Intended Use
The Smith & Nephew MICRORAPTOR Knotless Suture Anchor is intended for use only 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
- · Rotator cuff tear repairs
Technological Characteristics
The Smith & Nephew MICRORAPTOR Knotless Suture Anchor is substantially equivalent in intended use and fundamental scientific technology to the legally marketed predicate devices - Smith & Nephew MICRORAPTOR REGENESORB Suture Anchor (K180361), and the Smith & Nephew BIORAPTOR 2.3 PK Suture Anchor (K071586), and raises no new issues of safety and efficacy. The Smith & Nephew MICRORAPTOR Knotless Suture Anchor and the predicate MICRORAPTOR REGENESORB Suture Anchor and BIORAPTOR 2.3 PK Suture Anchor use identical implant materials.
Summary Performance Data
Bacterial endotoxin testing was completed and met acceptable endotoxin limits per ANSI/AAMI ST72:2011. The performance data demonstrates that the MICRORAPTOR Knotless Suture Anchor had met performance specifications for insertion strength and pullout strength. The MICRORAPTOR Knotless Suture Anchor met performance specifications for cyclic loading based on the predicate BIORAPTOR 2.3 PK Suture Anchor (K071586). Therefore, the MICRORAPTOR Knotless Suture Anchor is considered substantially equivalent to the currently marketed predicate devices.
Substantial Equivalence Information
The substantial equivalence of the MICRORAPTOR 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 MICRORAPTOR Knotless Suture Anchor is substantially equivalent to its predicates.