(306 days)
The Arthrex Short Suture Anchors are intended to be used for suture (soft tissue) fixation to bone in the hip. Specifically, acetabular labral repair.
The Arthrex Short Suture Anchors share the same design features, materials, and intended use as the predicate. The anchors consist of cannulated anchors with an integral or separate eyelet. They are pre-loaded on a handle inserter. Suture, with or without needles, and a suture threader may be provided. The anchors are made from polyetheretherketone (PEEK) and range from 2.0mm - 2.4mm in diameter and 8.6 - 9.0mm in length (including eyelet).
This document (K151092) is a 510(k) premarket notification for a medical device called "Arthrex Short Suture Anchors." It primarily focuses on demonstrating substantial equivalence to a predicate device, rather than describing a study with acceptance criteria for a new AI/software device. Therefore, many of the requested fields are not applicable to the content of this document.
However, I can extract the relevant information from the document regarding the device's performance demonstration.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Performance meets or exceeds predicate device for desired indications | "The submitted tensile testing data demonstrates that the performance of the proposed devices meets or exceeds the predicate device for the desired indications." This implies that the tensile strength of the Arthrex Short Suture Anchors was at least equivalent to, if not better than, the predicate device. |
2. Sample size used for the test set and the data provenance:
- Sample size: Not explicitly stated in the provided document. The document refers to "tensile testing data," but does not specify the number of anchors or tests performed.
- Data provenance: Not explicitly stated. Given that it's a submission for a medical device, it's highly likely that the testing was conducted in a controlled laboratory environment. The document is from the US.
- Retrospective or prospective: Not applicable for mechanical testing of a physical medical device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. Ground truth in this context would be the measured tensile strength, which is objectively quantifiable through mechanical testing, not expert consensus.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods are typically relevant for subjective evaluations or complex medical interpretations, not for objective mechanical tensile 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:
- Not applicable. This document is about a physical medical device (suture anchors), not an AI or software device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an algorithm or software. The "standalone" performance here refers to the device's mechanical properties, which were evaluated.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth would be the measured tensile strength from mechanical testing.
8. The sample size for the training set:
- Not applicable. This device does not involve a training set as it is a physical medical device, not a machine learning model.
9. How the ground truth for the training set was established:
- Not applicable. This device does not involve a training set.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three faces in profile, overlapping each other to create a sense of depth and unity. The faces are simple and abstract, with no distinct features other than the outline of the head and neck.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 23, 2016
Arthrex, Incorporated Mr. David Rogers Regulatory Affairs Associate 1370 Creekside Boulevard Naples, Florida 34108-1945
Re: K151092
Trade/Device Name: Arthrex Short Suture Anchors Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI Dated: January 15, 2016 Received: January 19, 2016
Dear Mr. Rogers:
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 Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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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 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/ResourcesforYou/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 Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K151092
Device Name Arthrex Short Suture Anchors
Indications for Use (Describe)
The Arthrex Short Suture Anchors are intended to be used for suture (soft tissue) fixation to bone in the hip. Specifically, acetabular labral repair.
| 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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| 2.6 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS | |
|---|---|
| Date Summary Prepared | April 21, 2015 |
| Manufacturer/Distributor/Sponsor | Arthrex, Inc.1370 Creekside BoulevardNaples, FL 34108-1945 USA |
| 510(k) Contact | David L RogersRegulatory Affairs AssociateArthrex, Inc.1370 Creekside BoulevardNaples, FL 34108-1945 USATelephone: 239/643.5553, ext. 71924Fax: 239/598.5508Email: david.rogers@Arthrex.com |
| Trade Name | Arthrex Short Suture Anchors |
| Common Name | Suture Anchor |
| Product Code -Classification NameCFR | MBI21 CFR 888.3040: Smooth or threaded metallic bonefixation fastener |
| Predicate Device | K140855: Arthrex SutureTak Suture Anchors |
| Reference Predicate Device | K110473: Pivot Nanotak Suture Anchor |
| Purpose of Submission | This Special 510(k) premarket notification is intendedto address the Arthrex Short Suture Anchors as a lineextension to the Arthrex SutureTak Suture Anchors,K140855. The intended use, material, andfundamental technological characteristics of theproposed Arthrex Short Suture Anchors aresubstantially equivalent to the predicate. |
| Device Description | The Arthrex Short Suture Anchors share the samedesign features, materials, and intended use as thepredicate. The anchors consist of cannulated anchorswith an integral or separate eyelet. They are pre-loaded on a handle inserter. Suture, with or withoutneedles, and a suture threader may be provided. Theanchors are made from polyetheretherketone (PEEK)and range from 2.0mm - 2.4mm in diameter and 8.6 -9.0mm in length (including eyelet). |
| Indications For Use | The Arthrex Short Suture Anchors are intended to beused for suture (soft tissue) fixation to bone in the hip. |
| Specifically, acetabular labral repair | |
| Substantial Equivalence Summary | The Arthrex Short Suture Anchors are substantiallyequivalent to the predicate devices in which the basicdesign features and intended uses are the same. Anydifferences between the Arthrex Short Suture Anchorsand the predicates are considered minor and do notraise questions concerning safety and effectiveness. |
| The submitted tensile testing data demonstrates thatthe performance of the proposed devices meets orexceeds the predicate device for the desiredindications. | |
| Based on the indications for use, technologicalcharacteristics, and the summary of data submitted,Arthrex, Inc. has determined that the Arthrex ShortSuture Anchors are substantially equivalent to thepredicate. |
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§ 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.