(359 days)
Not Found
Not Found
No
The summary describes a physical implantable device for tissue fixation and does not mention any software, algorithms, or data processing that would indicate AI/ML.
No.
The device is described as an implant for tissue fixation, not for providing therapy. It physically attaches tissue rather than treating a disease or condition therapeutically.
No
The device is described as being "intended for fixation of soft tissue to bone for reattachment," which is a treatment or repair function, not a diagnostic one.
No
The device description clearly states it is a physical implant manufactured using Poly (L, DL-lactide) with specific physical features (cannulated, oblong head, ridges, spikes). This indicates it is a hardware device, not software only.
Based on the provided information, the TissueTak is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for the "fixation of soft tissue to bone" during surgical procedures. This is a therapeutic/surgical device, not a diagnostic one.
- Device Description: The description details a physical implantable device made of Poly (L, DL-lactide) with features for surgical fixation. This is consistent with a surgical implant.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, tissue, etc.) or providing diagnostic information about a patient's condition.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The TissueTak's function is purely mechanical and surgical.
N/A
Intended Use / Indications for Use
The TissueTak is intended for fixation of soft tissue to bone for reattachment of the glenoid labrum or inferior glenohumeral ligament in patients with primary or recurrent anterior dislocation or subluxation of the shoulder in association with adequate post operative immobilization
The TissueTak™ is intended for fixation of soft tissue to bone for reattachment of the glenoid labrum or inferior glenohumeral ligament in patients with primary or recurrent anterior dislocation or subluxation of the shoulder in association with adequate post operative immobilization
Product codes (comma separated list FDA assigned to the subject device)
MAI and HWC
Device Description
The Arthrex TissueTak is manufactured using Poly (L, DL-lactide). It is cannulated with an oblong head and seven raised ridges along the circumference of the central shaft. There are two spikes on the head of the device to aid in soft tissue fixation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue to bone for reattachment of the glenoid labrum or inferior glenohumeral ligament
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
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.
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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.
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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
JAN 2 8 2000
510(k) Summary
1/28/1999
| Company: | Arthrex, Inc. |
|---|---|
| Address: | 2885 S. Horseshoe Drive, Naples, FL 34104 |
| Phone: | (941) 643-5553 |
| Fax: | (941) 643-6218 |
| Contact: | Vernon C. Brown |
| Regulatory Affairs Manager (ext. 117) |
| Trade Name: | Arthrex TissueTak |
|---|---|
| Common Name: | NA |
| Classification: | Fastener, Fixation, Biodegradable, Soft Tissue |
Description:
The Arthrex TissueTak is manufactured using Poly (L, DL-lactide). It is cannulated with an oblong head and seven raised ridges along the circumference of the central shaft. There are two spikes on the head of the device to aid in soft tissue fixation.
Intended Use:
The TissueTak is intended for fixation of soft tissue to bone for reattachment of the glenoid labrum or inferior glenohumeral ligament in patients with primary or recurrent anterior dislocation or subluxation of the shoulder in association with adequate post operative immobilization
Substantial Equivalence:
By definition, substantial equivalence means that a device has the same intended use and the same technological characteristics as the predicate device, or has the same intended use and different technological characteristics, but it can be demonstrated that the device is as safe and effective as the predicate device and does not raise different questions regarding safety and effectiveness from the predicate device.
The material for the TissueTak, Poly (L,DL-Lactide), is currently used in the Synthes Polypin, which has received FDA marketing clearance and has undergone extensive in-vitro and in-vivo testing. Further evaluation of the material was conducted by Claes et. al. ("New bioresorbable pin for the reduction of small bony fragments: design, mechanical properties and in vitro degradation" - Biomaterials, 1996, Vol. 17 No. 16).
The Arthrex TissueTak has the same intended use as the Acufex Suretac and the Bionx Bankart Tack, and the technological differences between these products do not raise different concerns regarding the safety and efficacy of the Arthrex TissueTak.
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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing its wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 2 8 2000
Mr. Vernon C. Brown Manager of Regulatory Affairs and Quality Assurance Arthrex, Incorporated 2885 South Horseshoe Drive Naples, Florida 34104
Re: K990340 Trade Name: TissueTak™M Regulatory Class: II Product Code: MAI and HWC Dated: October 29, 1999 Received: November 1, 1999
Dear Mr. Brown:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations. Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed
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Page 2 – Mr. Vernon C. Brown
predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or at (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Russell L. Page
James E. Dillard III Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/3/Picture/0 description: The image shows the logo for Arthrex. The logo consists of the word "Arthrex" in a bold, sans-serif font. To the right of the word is an image of a surgical tool. The logo is simple and professional, and it is likely used to represent a medical device company.
Indications for Use
The TissueTak™ is intended for fixation of soft tissue to bone for reattachment of the glenoid labrum or inferior glenohumeral ligament in patients with primary or recurrent anterior dislocation or subluxation of the shoulder in association with adequate post operative immobilization
Vernell S. Payne
Prescription Use
(Per 21 CFR 801.109)
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