(29 days)
The Arthrex MicroSuture Anchors is intended to be used for suture or tissue fixation in the foot/ankle, knee, hand/wrist, elbow, and shoulder. Specific indications are listed below:
Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction
Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction
Hand/Wrist: Scapholunate Ligament Reconstruction, Repair/Reconstruction of collateral ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP and MCP joints for all digits, digital tendon transfers, Carpal Ligament Reconstruction and Carpometacarpal joint arthroplasty (basal thumb joint arthroplasty)
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Metatarsal Ligament Repair, Hallux Valgus reconstruction, digital tendon transfers, Mid-foot reconstruction
Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis
The Arthrex MicroSuture Anchors consist of four anchors which are line extensions to existing anchors. The new anchors are comprised of titanium or PLA/ βTCP and are provided preloaded on a driver with suture. The anchors range from 2.2-2.7mm in diameter and 4-7mm in length.
The provided document is a 510(k) summary for the Arthrex MicroSuture Anchors. This document describes a medical device rather than an AI/ML device, and therefore does not contain information typically found in an AI/ML device submission, such as acceptance criteria based on performance metrics like sensitivity/specificity, sample sizes for training/test sets, expert qualifications for ground truth establishment, or details about comparative effectiveness studies (MRMC).
Instead, this document focuses on demonstrating substantial equivalence to predicate devices through technical characteristics and mechanical testing.
Here's a breakdown of the information that is relevant to the device's acceptance, based on the provided text, and an explanation of why other requested information (common for AI/ML devices) is not present:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implicit from Substantial Equivalence Claim) | Reported Device Performance (Mechanical Testing) |
|---|---|
| Mechanical properties (specifically pull-out strength) meet or exceed predicate devices. | "The mechanical testing demonstrates that the pull-out strength of the proposed devices meets or exceeds the pull-out strength of the predicate devices." |
| Basic features are the same as predicate devices. | (Claimed as part of substantial equivalence) |
| Intended uses are the same as predicate devices. | (Claimed as part of substantial equivalence) |
| Differences between the MicroSuture Anchors and predicates are minor and do not raise questions concerning safety and effectiveness. | (Claimed as part of substantial equivalence after mechanical testing) |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
This information is not explicitly stated in the document. For a physical medical device, "test set" typically refers to the samples used in mechanical or biocompatibility testing rather than a patient dataset. The document mentions "mechanical testing" but does not specify the number of anchors or the materials tested.
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)
This is not applicable as this is a physical medical device, not an AI/ML diagnostic tool requiring expert interpretation for ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable for a physical medical device's mechanical testing. Adjudication methods are typically associated with human interpretation of medical images or data.
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 an AI/ML device, so an MRMC study comparing human readers with AI assistance would not be performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No. This is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For this device, the "ground truth" for its performance evaluation comes from mechanical testing results, specifically pull-out strength measurements. This is compared against the performance of legally marketed predicate devices.
8. The sample size for the training set
This is not applicable as this is a physical medical device, not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
This is not applicable, as there is no training set for a physical medical device.
Summary of the Study Proving Acceptance:
The acceptance of the Arthrex MicroSuture Anchors is based on demonstrating substantial equivalence to three predicate devices: Arthrex Corkscrew Suture Anchor (K061863), Arthrex Mini PushLock (K063479), and Arthrex Micro BioComposite Suture Tak (K091844).
The primary study proving this equivalence, as stated in the document, is:
- Mechanical Testing: This testing focused on comparing the pull-out strength of the proposed MicroSuture Anchors to that of the predicate devices. The study concluded that "the mechanical testing demonstrates that the pull-out strength of the proposed devices meets or exceeds the pull-out strength of the predicate devices."
The document implicitly states that other factors like basic features, intended uses, and technological characteristics were also compared and determined to be equivalent, with any differences considered minor and not raising new questions of safety or effectiveness.
{0}------------------------------------------------
SEP - 2 2011
Arthrex SPECIAL 510(K): Arthrex MicroSuture Anchors
2 510(k) Summary of Safety and Effectiveness
| Date Summary Prepared | August 2, 2011 |
|---|---|
| Manufacturer/Distributor/Sponsor | Arthrex, Inc.1370 Creekside BoulevardNaples, FL 34108-1945 USA |
| 510(k) Contact | Courtney SmithManager, Regulatory AffairsArthrex, Inc.1370 Creekside BoulevardNaples, FL 34108-1945 USATelephone: 239/643.5553, ext. 1720Fax: 239/598.5508Email: courtney.smith@arthrex.com |
| Trade Name | MicroSuture Anchors |
| Common Name | Screw, Fixation, Bone |
| Product Code -Classification Name | HWC – Screw, fixation, boneMAI – Fastener, fixation, biodegradable, soft tissueMBI – Fastener, fixation, nondegradable, soft tissue21 CFR 888.3030: Single/multiple component metallic bonefixation appliances and accessories.21 CFR 888.3040: Smooth or threaded metallic bone fixationfastener |
| Predicate Devices | K061863: Arthrex Corkscrew Suture AnchorK063479: Arthrex Mini PushLockK091844: Arthrex Micro BioComposite Suture Tak |
| Device Description andIntended Use | The Arthrex MicroSuture Anchors consist of four anchorswhich are line extensions to existing anchors. The new anchorsare comprised of titanium or PLA/ βTCP and are providedpreloaded on a driver with suture. The anchors range from 2.2-2.7mm in diameter and 4-7mm in length.The Arthrex MicroSuture Anchors are intended to be used forsuture or tissue fixation in the foot/ankle, knee, hand/wrist,elbow, and shoulder. Specific indications are listed below:Elbow: Biceps Tendon Reattachment, Ulnar or RadialCollateral Ligament ReconstructionShoulder: Rotator Cuff Repair, Bankart Repair, SLAP LesionRepair, Biceps Tenodesis, Acromio-ClavicularSeparation Repair, Deltoid Repair, Capsular Shift orCapsulolabral Reconstruction |
| Repair/Reconstruction of collateral ligaments, Repairof Flexor and Extensor Tendons at the PIP, DIP andMCP joints for all digits, digital tendon transfers,Carpal Ligament Reconstruction and Carpometacarpaljoint arthroplasty (basal thumb joint arthroplasty) | |
| Foot/Ankle: | Lateral Stabilization, Medial Stabilization, AchillesTendon Repair, Metatarsal Ligament Repair, HalluxValgus reconstruction, digital tendon transfers, Mid-foot reconstruction |
| Knee: | Medial Collateral Ligament Repair, Lateral CollateralLigament Repair, Patellar Tendon Repair, PosteriorOblique Ligament Repair, Iliotibial Band Tenodesis |
| Substantial EquivalenceSummary | The Arthrex MicroSuture Anchors are substantially equivalentto the Arthrex Corkscrew, Arthrex Mini PushLock and MicroBioComposite Suture Tak predicates, in which the basicfeatures, and intended uses are the same. Any differencesbetween the MicroSuture Anchors and the predicates areconsidered minor and do not raise questions concerning safetyand effectiveness. |
| The mechanical testing demonstrates that the pull-out strength ofthe proposed devices meets or exceeds the pull-out strength ofthe predicate devices. Based on the indication for use,technological characteristics, and the comparison to the predicatedevice, Arthrex, Inc. has determined that the ArthrexMicroSuture Anchors are substantially equivalent to currently |
1/2
K川2237
{1}------------------------------------------------
Arthrex SPECIAL 510(k): Arthrex MicroSuture Anchors
17 - 14
KII2237
{2}------------------------------------------------
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. 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 that resembles an eagle or bird in flight, with three stylized wings or feathers.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Arthrex, Inc. % Ms. Courtney Smith 1370 Creekside Blvd. Naples. Florida 34108-1945
SEP - 2 2011
Re: K112237
Trade/Device Name: Arthrex MicroSuture Anchors-Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC, MAI, MBI Dated: August 2, 2011 Received: August 4, 2011
Dear Ms. Smith:
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 (reporting of medical
{3}------------------------------------------------
Page 2 – Ms. Courtney Smith
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. 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/ReportalProblem/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,
Erine D. Keith
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
Indications for Use Form 1
Indications for Use
510(k) Number:
Device Name:
Arthrex MicroSuture Anchors
Indications For Use:
Indications for Use:
The Arthrex MicroSuture Anchors is intended to be used for suture or tissue fixation in the foot/ankle, knee, hand/wrist, elbow, and shoulder. Specific indications are listed below:
| Elbow: | Biceps Tendon Reattachment, Ulnar or Radial Collateral LigamentReconstruction |
|---|---|
| Shoulder: | Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, BicepsTenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair,Capsular Shift or Capsulolabral Reconstruction |
| Hand/Wrist: | Scapholunate Ligament Reconstruction, Repair/Reconstruction ofcollateral ligaments, Repair of Flexor and Extensor Tendons at the PIP,DIP and MCP joints for all digits, digital tendon transfers, CarpalLigament Reconstruction and Carpometacarpal joint arthroplasty (basalthumb joint arthroplasty) |
| Foot/Ankle: | Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair,Metatarsal Ligament Repair, Hallux Valgus reconstruction, digitaltendon transfers, Mid-foot reconstruction |
| Knee: | Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair,Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial |
Prescription Use X _ AND/OR Over-The-Counter Use
(Per 21 CFR 801 Subpart D)
Band Tenodesis
(21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
PAGE 1 of 1
for M. Melleveron
(Division Sigh Oft) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K112237
§ 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.