(55 days)
No
The summary describes a surgical suture made of standard materials and does not mention any AI/ML components or functionalities.
No
The device, Arthrex Fiberwire® and FiberTape™, is a surgical suture used for soft tissue approximation and ligation, which is a tool for surgical procedures rather than a device that provides therapy or treatment itself.
No
Explanation: The device description and intended use indicate it is a surgical suture used for soft tissue approximation and ligation, which is a treatment/implant function, not a diagnostic one.
No
The device description clearly states it is a physical suture made of braided materials, which is a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "soft tissue approximation and or ligation including allograft tissue." This describes a surgical procedure performed on the body, not a test performed on a sample taken from the body.
- Device Description: The device is a surgical suture, designed to be implanted or used directly in a surgical setting. IVDs are typically reagents, instruments, or systems used to examine specimens (like blood, urine, or tissue) in vitro (outside the body).
- Lack of IVD Characteristics: The description doesn't mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples.
- Detecting or measuring substances in samples.
- Providing information for diagnosis, monitoring, or screening.
Therefore, the Arthrex Fiberwire® and FiberTape™ Families are surgical devices, not In Vitro Diagnostic devices.
N/A
Intended Use / Indications for Use
The Arthrex Fiberwire® Family is intended for use in soft tissue approximation and or ligation including allograft tissue.
Product codes
GAT, GAP, GAW
Device Description
Arthrex Fiberwire® and FiberTape™ sutures of varying lengths, diameters, and needle types are made of long chain polyesters, braided with nylon or silk, and sterilized for surgical use. 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
soft tissue
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 K021434, Johnson & Johnson K012124, AuroLab K024091
Reference Device(s)
Not Found
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
§ 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
AUG - 5 2004
510(k) Summary
| 510(k) Number: | K041589 |
|---|---|
| Contact Person: | Ann Waterhouse, Regulatory Affairs Specialist |
| Sponsor: | Arthrex, Inc. 1370 Creekside Boulevard Naples, FL 34108 |
| Date Prepared: | June 2004 |
| Trade/Proprietary Name: | Arthrex FiberWire® Family |
|---|---|
| Product Code: | GAT, GAP, GAW |
| Classification Name: | Suture, Non-absorbable, Synthetic, Polyester and Silk |
| Predicate Devices: | Arthrex K021434, Johnson & Johnson K012124, |
| AuroLab K024091 |
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 Fiberwire® Family is intended for use in soft tissue approximation and or ligation including allograft tissue.
Description:
Arthrex Fiberwire® and FiberTape™ sutures of varying lengths, diameters, and needle types are made of long chain polyesters, braided with nylon or silk, and sterilized for surgical use. They are available in dyed and non-dyed varieties, with or without needles.
Technical Differences in Regards to Predicate Devices:
The Arthrex FiberWire Family is made up of several sutures which have similar or identical material make up. The difference in the predicate K021434 Arthrex FiberWire Family of sutures, when compared to the subject of this submission. consists of a marker thread of silk instead of nylon.
Substantial Equivalence:
The Arthrex, Inc. FiberWire™ Family of sutures is substantially equivalent to predicate devices where the basic features and intended uses are the same. Minor differences between the Arthrex suture products and the predicate devices do not raise any questions concerning safety and effectiveness and have no apparent effect on the performance, function, or intended use of these devices.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of a human figure with three arms.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG - 5 2004
Ms. Ann Waterhouse Senior Regulatory Affairs Specialist Arthrex, Inc. 1370 Creekside Boulevard Naples, Florida 34108-1945
Re: K041589
Trade/Device Name: Arthrex FiberWire Regulation Number: 21 CFR 878.5000 Regulation Number: 21 CFX 876:5000
Regulation Name: Non-absorbable polyethylene terephthalate surgical suture Regulatory Class: II Product Code: GAT Dated: June 10, 2004 Received: June 11, 2004
Dear Ms. Waterhouse:
We have reviewed your Section 510(k) premarket notification of intent to market the indication We have reviewed your Section 5 Iv(c) prematially equivalent (for the indications
referenced above and have determined the devices merketed in interstate referenced above and have determined the devices marketed in interstate
for use stated in the enclosure) to legally marketed predical Device Amendments for use stated in the encrosule for tegally mancess profits | Device Amendments, or to
commerce prior to May 28, 1976, the enactment date of the Federal Food. Drug commerce prior to May 28, 1970, the charactering and the provisions of the Federal Food, Drug, devices that have been reclassified in accordance with the previous of the Act . (PMA).
and Cosmetic Act (Act) that do not require approval of a previsions of the Act . and Cosment Act (Act) that do not require subject to the general controls provisions of the Act. The You may, inerelore, market the devree, babyer to the go
general controls provisions of the Act include requirements for annual registration adjus and general controls provisions of the free networks. I prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it if your device is Classifica (see above) and existing major regulations affecting your device can
may be subject to such additional controls. Existing major may be subject to such additional ochaoist. Extoking and to 898. In addition, FDA may be found in the Oous of reasts concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that I DA s issualled of a basedin.
that FDA has made a determination that your device complies with other requirements of the Act that FDA has made a determination and Journer Federal agencies. You must or any Federal statutes and regulations and limited to: registration and listing (21 comply with an the Act 3 requirements) not 801); good manufacturing practice requirements as set CFK Part 807), labeling (21 CFR Part 820); and 1f applicable, the electronic form in the quality systems (QD) regalantin (Sections 531-542 of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1
2
Page 2 - Ms. Ann Waterhouse
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will and w yourse FDA finding of substantial equivalence of your device to a legally prematice notification. The 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), please If you desire spocitie aarrosis - J 01) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general 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,
Miriam C. Provost
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Page 1 of 1
510(k) Number (if known): КоЧ / 589
Device Name: Arthrex FiberWire™
Indications for Use:
The Arthrex Fiberwire™ and FiberTape™ Families are intended for use in soft tissue approximation and/or ligation including allograft tissue.
AND/OR Over-The-Counter Use Prescription Use _____________________________________________________________________________________________________________________________________________________________ x (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Miriam C. Provost
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K041589