(19 days)
Not Found
No
The summary describes a surgical suture and its configurations, with no mention of AI, ML, image processing, or data-driven performance metrics typically associated with AI/ML devices.
No.
The device, Arthrex FiberWire® suture configurations, is intended for soft tissue approximation and ligation, which is a surgical tool rather than a device designed to deliver a therapeutic effect in itself.
No
The 'Intended Use' states that the sutures are for "soft tissue approximation and or ligation" and "incorporated, as components, into surgeries where constructs including those with allograft or autograft tissues are used for repair." This describes a therapeutic or repair function, not a diagnostic one.
No
The device description clearly states it consists of physical components like suture strands, needles, and tape, indicating it is a hardware medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "soft tissue approximation and or ligation." This describes a surgical procedure performed directly on the patient's body.
- Device Description: The device is a suture, which is a surgical tool used to close wounds or tie off blood vessels.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) outside of the body to provide information about a patient's health. IVDs are typically used for diagnosis, monitoring, or screening.
Therefore, the Arthrex FiberWire® suture configurations are surgical devices, not IVDs.
N/A
Intended Use / Indications for Use
The Arthrex FiberWire® suture configurations are intended for use in soft tissue approximation and or ligation. These sutures may be incorporated, as components, into surgeries where constructs including those with allograft or autograft tissues are used for repair.
Product codes (comma separated list FDA assigned to the subject device)
GAT, GAP
Device Description
Arthrex FiberWire® configurations consist of single strand suture with or without needles, suture with stiffened ends, suture chains, and FiberTape®.
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): 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.
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
JUL - 3 2007
Image /page/0/Picture/1 description: The image shows the text "K071622 Page 191" in a handwritten style. The text is black and the background is white. The text is slightly slanted to the right. The word "Page" is written in cursive.
4 510(k) Summary of Safety and Effectiveness
| Manufacturer/Sponsor | Arthrex, Inc.1370 Creekside Boulevard Naples, Florida 34108-1945 |
|---|---|
| 510(k) Contact | Ann Waterhouse, RAC |
| Regulatory Affairs Project Manager | |
| Telephone: 239/643.5553, ext. 1179 | |
| Fax: 239/598.5508 | |
| Email: awaterhouse@arthrex.com | |
| Trade Name | Arthrex FiberWire® |
| Common Name | Suture, non-absorbable |
| Product Code - | |
| Classification Name | GAT, Suture, Non-absorbable, Synthetic, Polyethylene: 21 CFR 878.5000 |
| GAP, Suture Non-absorbable, Silk: 21 CFR 878.5030 | |
| Predicate Device | K041589, FiberWire® |
| K041553, FiberWire® Suture Grafting Kit | |
| Device Description | |
| and Intended Use | Arthrex FiberWire® configurations consist of single strand suture with or |
| without needles, suture with stiffened ends, suture chains, and FiberTape®. | |
| The Arthrex FiberWire® suture configurations are intended for use in soft | |
| tissue approximation and or ligation. These sutures may be incorporated, | |
| as components, into surgeries where constructs including those with | |
| allograft or autograft tissues are used for repair. | |
| Substantial | |
| Equivalence Summary | The Arthrex FiberWire® is substantially equivalent to the predicate Arthrex |
| FiberWire® in which the basic features and intended uses are the same. | |
| Any differences between the FiberWire and the predicate | |
| K041589/K041553 are considered minor and do not raise questions | |
| conceming safety and effectiveness. Based on the information submitted, | |
| Arthrex, Inc. has determined that the new FiberWire® is substantially | |
| equivalent to the currently marketed predicate 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 stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the emblem.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL - 3 2007
Arthrex, Inc. % Ms. Ann Waterhouse, RAC Regulatory Affairs Project Manager 1370 Creekside Boulevard Naples, Florida 34108-1945
Re: K071622
Trade/Device Name: Arthrex FiberWire® Regulation Number: 21 CFR 878.5010 Regulation Name: Nonabsorbable polypropylene surgical suture Regulatory Class: II Product Code: GAT Dated: June 13, 2007 Received: June 19, 2007
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) 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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 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 Part 801); good manufacturing practice requirements as set 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.
2
Page 2 - Ms. Ann Waterhouse, RAC
This letter will allow you to begin marketing your device as described in your Section 510/k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed 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), please contact the Office of Compliance at (240) 276-0115. 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 Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N. Melkerson
Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
3 Indications for Use Form
Indications for Use
| 510(k) Number: | K071622 |
|---|---|
| Device Name: | Arthrex FiberWire® |
The Arthrex FiberWire® suture configurations are intended for use in soft tissue approximation and or ligation. These sutures may be incorporated, as components, into surgeries where constructs including those with allograft or autograft tissues are used for repair.
Prescription Use _X_AND/OR Over-The-Counter Use (Per 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ØDE)
CDRH, Office of Device Evaluation (ODE)
PAGE 1 of 3
(División Sig
Division of General, Restorataώς,
and Neurological Devices
Acime De
кожа
22
510(k) Number.