(44 days)
The Smith & Nephew Knotless Instability Anchor is intended for use in the attachment or reattachment of soft tissue to bone for the following indications:
Hip
Hip capsule repair (Acetabular labrum reattachment)
Shoulder
Capsular stabilization (Bankart repair, Anterior shoulder instability, SLAP lesion repairs, Capsular shift or capsulolabral reconstructions), Acromioclavicular separation repairs, Deltoid repairs, Rotator cuff tear repairs, Biceps tenodesis
Foot and Ankle
Hallux valgus repairs, Medial or lateral instability repairs/reconstructions, Achilles tendon repairs/reconstructions, Midfoot reconstructions, Metatarsal ligament/tendon, repairs/reconstructions, Bunionectomy
Elbow, Wrist, and Hand
Biceps tendon reattachment, Ulnar or radial collateral ligament reconstructions, Lateral epicondylitis repair
Knee
Extra-capsular repairs ( Medial collateral ligament, Lateral ligament, Posterior oblique ligament), Patellar realignment and tendon repairs (Vastus medialis obliquous advancement), Iliotibial band tenodesis
The Smith & Nephew Knotless Instability Anchor is a tap in anchor that is manufactured from PEEK and comes pre-assembled on an inserter, sized appropriately to facilitate both hip and shoulder procedures. The device allows for knotless tissue attachment and reapproximation in surgical repairs of soft tissue to bone.
The provided document is a 510(k) Summary for the Smith & Nephew Knotless Instability Anchor. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel clinical effectiveness with detailed acceptance criteria and standalone performance studies typically seen with AI/ML medical devices.
Therefore, the information requested regarding acceptance criteria, study design for AI evaluation (sample size for test/training, ground truth establishment, expert qualifications, adjudication, MRMC studies, standalone performance) is not applicable and not present in this document.
Instead, the document focuses on biomechanical equivalence to predicate devices. Here's what can be extracted:
Device Performance and Equivalence Study
1. Table of Acceptance Criteria and Reported Device Performance:
Since this is a 510(k) for a physical medical device, not an AI/ML diagnostic, there are no specific "acceptance criteria" in the sense of accuracy, sensitivity, or specificity. Instead, the "acceptance criteria" for this device are demonstrating substantial equivalence in biomechanical parameters to predicate devices.
| Performance Parameter | Acceptance Criteria (Implicit) | Reported Device Performance (Summary) |
|---|---|---|
| Biomechanical | Substantially equivalent to the corresponding parameters of the predicate devices: Smith & Nephew BIORAPTOR 2.3PK, TwinFix FootPrint PK, and Mitek BioKnotless. | "The performance testing demonstrates that the biomechanical parameters of the Smith & Nephew Knotless Instability Anchor are substantially equivalent to the corresponding parameters of the Smith & Nephew BIORAPTOR 2.3PK(K071586), the Smith & Nephew TwinFix FootPrint PK(K073509), and the Mitek BioKnotless (K002639)." |
2. Sample size used for the test set and the data provenance:
- Sample size: Not specified in the provided summary. Biomechanical testing typically involves a number of samples for each test (e.g., specific number of anchors for pull-out strength).
- Data provenance: Not specified. This would typically be laboratory-based biomechanical testing.
3. 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):
- Not Applicable. Ground truth, in the context of AI/ML, refers to expert-validated labels. For a physical device's biomechanical testing, "ground truth" would be the measured physical properties.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. Adjudication methods are for resolving discrepancies in expert labeling or diagnoses, which is not relevant for biomechanical testing.
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:
- No. This is not relevant for a physical medical device. MRMC studies are for evaluating diagnostic performance, especially with AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is not relevant for a physical medical device as there is no algorithm involved.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For biomechanical testing, the "ground truth" is typically the objective measurement of physical properties (e.g., tensile strength, pull-out force, stiffness) under controlled laboratory conditions, using calibrated equipment and standardized testing protocols.
8. The sample size for the training set:
- Not Applicable. There is no "training set" for a physical medical device; this concept is specific to machine learning.
9. How the ground truth for the training set was established:
- Not Applicable. As there is no training set, this question is irrelevant.
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Endoscopy Smith & Nephew, Inc. 150 Minuteman Road Andover, MA 01810
978 749 1000 978 749 1599 Fax www.smith-nephew.com
- We are smith&nephew
K093428 (1/2)
1
DEC 1 7 """
SECTION IV
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION
510(k) Submission for the Smith & Nephew Knotless Instability Anchor
Date Prepared:
October 30, 2009
- A. Submitter's Name:
Smith & Nephew, Inc., Endoscopy Division 150 Minuteman Road Andover, MA 01810
B. Company Contact
Kathy Reddig Regulatory Affairs Specialist II 978-749-1321 Phone 978-749-1443 Fax
C. Device Name
| Trade Name: - | Smith & Nephew Knotless Instability Anchor |
|---|---|
| Common Name: | Fastener, Fixation, Non-degradable, Soft Tissue |
| Classification Name: | Smooth or threaded metallic bone fixation fastener |
Predicate Devices D.
The Smith & Nephew Knotless Instability Anchor is substantially equivalent in Intended Use and Fundamental Scientific Technology to the following legally marketed devices in commercial distribution: Smith & Nephew BIORAPTOR 2.3PK , Smith & Nephew TwinFix PK FP, and the Mitek BioKnotless anchor.
E. Description of Device
The Smith & Nephew Knotless Instability Anchor is a tap in anchor that is manufactured from PEEK and comes pre-assembled on an inserter, sized appropriately to facilitate both hip and shoulder procedures. The device allows for knotless tissue attachment and reapproximation in surgical repairs of soft tissue to bone.
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K093428(2/2)
F. Intended Use
The Smith & Nephew Knotless Instability Anchor is intended for use in the attachment or reattachment of soft tissue to bone for the following indications:
Hip
Hip capsule repair (Acetabular labrum reattachment)
Shoulder
Capsular stabilization (Bankart repair, Anterior shoulder instability, SLAP lesion repairs, Capsular shift or capsulolabral reconstructions), Acromioclavicular separation repairs, Deltoid repairs, Rotator cuff tear repairs, Biceps tenodesis
Foot and Ankle
Hallux valgus repairs, Medial or lateral instability repairs/reconstructions, Achilles tendon repairs/reconstructions, Midfoot reconstructions, Metatarsal ligament/tendon, repairs/reconstructions, Bunionectomy
Elbow, Wrist, and Hand
Biceps tendon reattachment, Ulnar or radial collateral ligament reconstructions, Lateral epicondylitis repair
Knee
Extra-capsular repairs ( Medial collateral ligament, Lateral ligament, Posterior oblique ligament), Patellar realignment and tendon repairs (Vastus medialis obliquous advancement), Iliotibial band tenodesis
ﻦ Comparison of Technological Characteristics
The Smith & Nephew Knotless Instability Anchor is substantially equivalent in intended use, technological characteristics, and are as safe and as effective as their currently marketed predicate devices, the Smith & Nephew BIORAPTOR 2.3PK(K071586), the Smith & Nephew TwinFix FootPrint PK(K073509), and the Mitek BioKnotless(K002639).
H. Summary Performance Data
The performance testing demonstrates that the biomechanical parameters of the Smith & Nephew Knotless Instability Anchor are substantially equivalent to the corresponding parameters of the Smith & Nephew BIORAPTOR 2.3PK(K071586), the Smith & Nephew TwinFix FootPrint PK(K073509), and the Mitek BioKnotless (K002639).
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or a stylized human figure, composed of flowing lines.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
Smith and Nephew Endoscopy, Inc. % Ms. Kathy Reddig Regulatory Affairs Specialist 150 Minuteman Road Andover, Massachusetts 01810
Re: K093428
Trade/Device Name: Smith & Nephew Knotless Instability Anchor Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: MBI Dated: October 30, 2009 Received: November 3, 2009
Dear Ms. Reddig:
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.
DEC 1 7 2009
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 (QS) 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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.
Sincerely yours,
Joxita 7
Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): _ K093428
Smith & Nephew Knotless Instability Anchor Device Name:
Indications For Use:
The Smith & Nephew Knotless Instability Anchor is intended for the reattachment of soft tissue to bone for the following indications:
Hip
.
Hip capsule repair
- . Acetabular labrum reattachment
Shoulder
Capsular stabilization
- Bankart repair .
- Anterior shoulder instability .
- SLAP lesion repairs .
- Capsular shift or capsulolabral . reconstructions
Acromioclavicular separation repairs Deltoid repairs Rotator Cuff repairs Biceps Tenodesis
Elbow, Wrist, and Hand
Biceps tendon reattachment Ulnar or radial collateral ligament reconstructions Lateral epicondylitis repair
Knee
Extra-capsular repairs
- . Medial collateral ligament
- Lateral collateral ligament ●
- Posterior oblique ligament .
Patellar realignment and tendon repairs
Vastus medialis obliquous advancement . Iliotibial band tenodesis
Foot and Ankle
Hallux valgus repairs Medial or lateral instability repairs/reconstructions Achilles tendon repairs/reconstructions Midfoot reconstructions Metatarsal ligament/tendon repairs/reconstructions Bunionectomy
Prescription Use x x
Over-The-Counter Use
· (Per 21 CFR 801 Subpart D)
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
AND/OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
Sonetti for men
(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K093428
Page 20 of 82
§ 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.