(306 days)
No
The summary describes a mechanical suture anchor and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
No
The device is described as a suture anchor for soft tissue fixation to bone, specifically for acetabular labral repair in the hip, which is a structural repair and not a therapeutic function.
No
The provided information describes a surgical device (suture anchors) used for fixation during a repair procedure, not for diagnosing a condition.
No
The device description clearly states it is a physical medical device (suture anchors made of PEEK) and does not mention any software component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside the body (in vitro).
- Device Description: The Arthrex Short Suture Anchors are physical implants designed to fix soft tissue to bone within the body. They are used in a surgical procedure.
- Intended Use: The intended use is for "suture (soft tissue) fixation to bone in the hip," specifically for "acetabular labral repair." This is a surgical intervention, not a diagnostic test performed on a sample.
The description clearly indicates a device used in vivo (within the living body) for a surgical repair, not a diagnostic test performed in vitro.
N/A
Intended Use / Indications for Use
The Arthrex Short Suture Anchors are intended to be used for suture (soft tissue) fixation to bone in the hip. Specifically, acetabular labral repair.
Product codes (comma separated list FDA assigned to the subject device)
MBI
Device Description
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).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hip, Specifically, acetabular labral repair
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
The submitted tensile testing data demonstrates that the performance of the proposed devices meets or exceeds the predicate device for the desired indications.
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.
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
§ 888.3040 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.
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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
1
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) | |
| CONTINUE ON A SEPARATE PAGE IF NEEDED. | ||
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| DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW. | ||
| The burden time for this collection of information is estimated to average 79 hours per response, including the | ||
| time to review instructions, search existing data sources, gather and maintain the data needed and complete | ||
| and review the collection of information, Send comments regarding this burden estimate or any other aspect | ||
| of this information collection, including suggestions for reducing this burden, to: | ||
| Department of Health and Human Services | ||
| Food and Drug Administration | ||
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| information unless it displays a currently valid OMB number." |
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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 Boulevard | |
| Naples, FL 34108-1945 USA | |
| 510(k) Contact | David L Rogers |
| Regulatory Affairs Associate | |
| Arthrex, Inc. | |
| 1370 Creekside Boulevard | |
| Naples, FL 34108-1945 USA | |
| Telephone: 239/643.5553, ext. 71924 | |
| Fax: 239/598.5508 | |
| Email: david.rogers@Arthrex.com | |
| Trade Name | Arthrex Short Suture Anchors |
| Common Name | Suture Anchor |
| Product Code -Classification Name | |
| CFR | MBI |
| 21 CFR 888.3040: Smooth or threaded metallic bone | |
| fixation 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 intended |
| to address the Arthrex Short Suture Anchors as a line | |
| extension to the Arthrex SutureTak Suture Anchors, | |
| K140855. The intended use, material, and | |
| fundamental technological characteristics of the | |
| proposed Arthrex Short Suture Anchors are | |
| substantially equivalent to the predicate. | |
| Device Description | 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). | |
| Indications For Use | The Arthrex Short Suture Anchors are intended to be |
| used for suture (soft tissue) fixation to bone in the hip. | |
| Specifically, acetabular labral repair | |
| Substantial Equivalence Summary | The Arthrex Short Suture Anchors are substantially |
| equivalent to the predicate devices in which the basic | |
| design features and intended uses are the same. Any | |
| differences between the Arthrex Short Suture Anchors | |
| and the predicates are considered minor and do not | |
| raise questions concerning safety and effectiveness. | |
| The submitted tensile testing data demonstrates that | |
| the performance of the proposed devices meets or | |
| exceeds the predicate device for the desired | |
| indications. | |
| Based on the indications for use, technological | |
| characteristics, and the summary of data submitted, | |
| Arthrex, Inc. has determined that the Arthrex Short | |
| Suture Anchors are substantially equivalent to the | |
| predicate. |
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