(176 days)
Not Found
No
The summary describes a suture product and does not mention any AI or ML components or functionalities.
No
The device, Arthrex FiberTape™ Family suture products, is intended for approximation and/or ligation of soft tissue during orthopedic surgeries, which is a surgical aid for repair, not a device that directly treats or prevents a disease or condition.
No
The device is described as a suture product used for approximation and/or ligation of soft tissue during orthopedic surgeries, which is a therapeutic function, not diagnostic.
No
The device description clearly states it is a "ribbon-like suture consisting of FiberWire components along with several needle types," indicating it is a physical medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "approximation and/or ligation of soft tissue... for orthopedic surgeries." This describes a surgical procedure performed directly on the patient's body.
- Device Description: The device is a "ribbon-like suture" used for surgical purposes.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, or tissue) outside of the body to provide information about a patient's health. The description of the Arthrex FiberTape™ Family does not involve any such testing or analysis of specimens.
Therefore, the Arthrex FiberTape™ Family suture products are surgical devices, not IVDs.
N/A
Intended Use / Indications for Use
The Arthrex FiberTape™ Family suture products, like it's predecessor the FiberWire Family, are intended for use in approximation and/or ligation of soft tissue, including use of allograft tissue for orthopedic surgeries.
Product codes
GAT
Device Description
Arthrex, Inc. FiberTape™ Family consists is a ribbon-like suture consisting of FiberWire components along with several needle types for specific surgical uses. r locatified of long chain polyesters which are braided and sterilized froos taps se. They are available in dyed and non-dyed varieties, with or without needles.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Arthrex K010673, Arthrex K012923, Arthrex K021434, Johnson & Johnson K012124, Ethicon Endo-Surgery Mersilene Tape
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.5000 Nonabsorbable poly(ethylene terephthalate) surgical suture.
(a)
Identification. Nonabsorbable poly(ethylene terephthalate) surgical suture is a multifilament, nonabsorbable, sterile, flexible thread prepared from fibers of high molecular weight, long-chain, linear polyesters having recurrent aromatic rings as an integral component and is indicated for use in soft tissue approximation. The poly(ethylene terephthalate) surgical suture meets U.S.P. requirements as described in the U.S.P. Monograph for Nonabsorbable Surgical Sutures; it may be provided uncoated or coated; and it may be undyed or dyed with an appropriate FDA listed color additive. Also, the suture may be provided with or without a standard needle attached.(b)
Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA.” See § 878.1(e) for the availability of this guidance document.
0
JAN 1 4 2004
Kφ32245
510(k) Summary
| 510(k) Number: | |
|---|---|
| Contact Person: | Ann Waterhouse, Regulatory Affairs Specialist |
| Date Prepared: | July, 2003 |
| Trade/Proprietary Name: | Arthrex FiberTape™ Family |
| Product Code: | GAT |
| Classification Name: | Suture, Non-absorbable, Synthetic, Polyester |
| Predicate Devices: | Arthrex K010673, Arthrex K012923, Arthrex K021434 |
| Johnson & Johnson K012124, and Ethicon Endo- | |
| Surgery Mersilene Tape |
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.
Intended Use:
The Arthrex FiberTape™ Family suture products, like it's predecessor the FiberWire Family, are intended for use in approximation and/or ligation of soft tissue, including use of allograft tissue for orthopedic surgeries.
Description:
Arthrex, Inc. FiberTape™ Family consists is a ribbon-like suture consisting of FiberWire components along with several needle types for specific surgical uses. r locatified of long chain polyesters which are braided and sterilized froos taps se. They are available in dyed and non-dyed varieties, with or without needles.
Substantial Equivalence:
The Arthrex, Inc. FiberTape™ Family is substantially equivalent to predicate devices where the basic features and intended uses are the same. Minor differences between the Arthrex suture tape and predicate devices do not raise any questions concerning safety and effectiveness and have no apparent effect on the performance, function, or intended use of this device.
1
Image /page/1/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 a stylized image of an eagle with three curved lines representing its wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 4 2004
Ms. Ann Waterhouse Regulatory Affairs Specialist Arthrex, Inc. 2885 South Horseshoe Drive Naples, Florida 34104
Re: K032245
Tradc/Device Name: Arthrex FiberTape™ Family Regulation Number: 21 CFR 878.5000 Regulation Name: Nonabsorbable Poly(ethylene) Terephthalate Surgical Suture Regulatory Class: II Product Code: GAT Dated: October 14, 2003 Received: October 16, 2003
Dear Ms. Waterhouse:
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). You may, thereforc, market the device, subject to the general controls provisions of the Act and the limitations described below. The general controls provisions of the provisions of the requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
The Office of Device Evaluation has determined that there is a reasonable likelihood that this 1 ho Other of Doctor an intended use not identified in the proposed labeling and that such use could cause harm. Therefore, in accordance with Section 513(i)(1)(E) of the Act, the following limitation must appear in the Warnings section of the device's labeling following the indications for use:
The safety and effectivencss of this device for use as an artificial ligament or tendon has not been established.
Please note that the above labeling limitations are required by Section 513(i)(1)(E) of the Act. Therefore, a new 510(k) is required before these limitations are modified in any way or removed from the device's labeling.
2
Page 2 - Ms. Ann Waterhouse
The FDA finding of substantial equivalence of your device to a legally marketed predicate I he I Dri mining of basification for your device and permits your device to proceed to the ucerted in a clussillearen to begin marketing your device as described in your Section 510(k) premarket notification if the limitation statement described above is added to your labeling.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it your device is etablined 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 1 toase of a rised a determination that your device complies with other requirements of the Act that I Drederal statutes and regulations administered by other Federal agencies. You must or any I vitated and the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic form in the qualisy by visions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific information about the application of other labeling requirements to your device (21 CFR Part 801), please contact the Office of Compliance at (301) 594-__ Also, at ree (21 the regulation entitled, "Misbranding by reference to premarket notification" (21 PICR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Daniel G. Schultz, M.D. Director Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name:__________________________________________________________________________________________________________________________________________________________________
Indications For Use:
The Arthrex FiberTape™ Family suture products, like it's predecessor the FiberWire™ Family, are intended for use in approximation and/or ligation of soft tissue, including use of allograft tissue for orthopedic surgeries.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
for Mark N. Millhuser
estorative
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