(34 days)
Not Found
No
The description is for a surgical suture, a physical medical device, and contains no mention of software, algorithms, or data processing that would indicate AI/ML.
No
This device is a suture used for soft tissue approximation and ligation, which is a supportive material for therapeutic procedures rather than a therapeutic device itself.
No
The device, Arthrex Fiberwire™USP size 5 suture, is intended for soft tissue approximation and ligation, which are surgical procedures, not diagnostic ones. Its description as a surgical suture confirms its therapeutic rather than diagnostic function.
No
The device description clearly states it is a physical suture made of braided polyesters, indicating it is a hardware 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 "in soft tissue approximation and or ligation." This describes a surgical procedure performed directly on a patient's body.
- Device Description: The description details a surgical suture, a physical material used to join tissues during surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information about a patient's health.
IVDs are used to diagnose, monitor, or screen for diseases or conditions by analyzing samples taken from the body. This device is a surgical tool used during a procedure on the body.
N/A
Intended Use / Indications for Use
The Arthrex Fiberwire™USP size 5 suture is intended for use in soft tissue approximation and or ligation.
Product codes (comma separated list FDA assigned to the subject device)
GAT
Device Description
Arthrex, Inc. Fiberwire™ suture is 38 " in length and has a diameter of 0.700 to 0.799 mm. It is made of long chain polyesters which are braided and sterilized and for surqical use. It is 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): 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.
K010673, K003590, K990088, K000540, K001434, K001172
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
OCT - 4 2001
510(k) Summary
| 510(k) Number: | |
|---|---|
| Contact Person: | Ann Waterhouse, Regulatory Affairs Specialist |
| Date Prepared: | August 29, 2001 |
Trade/Proprietary Name: Arthrex Fiberwire™ USP size 5 suture Product Code: GAT Suturem Nonabsorbable, Synthetic, Polyester Classification Name: Arthrex, K010673, Grams American Suture, K003590, Predicate Devices: Aesculap, Inc., K990088, ARC Medical Supplies, K000540, Genzyme Surgical Product, K001434, and C.P. Medical. K001172
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™USP size 5 suture is intended for use in soft tissue approximation and or ligation.
Description:
Arthrex, Inc. Fiberwire™ suture is 38 " in length and has a diameter of 0.700 to 0.799 mm. It is made of long chain polyesters which are braided and sterilized and for surqical use. It is available in dyed and non-dyed varieties, with or without needles.
Substantial Equivalence:
The Arthrex. Inc. Fiberwire™ USP size 5 substantially equivalent to predicate devices where the basic features and intended uses are the same. Minor differences between the Arthrex suture 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 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 a bird or abstract shape, composed of three curved lines. The logo is black and white.
OCT - 4 2001
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Ann Waterhouse Regulatory Affairs Specialist Arthrex, Inc. 2885 South Horseshoe Drive Naples, Florida 34104
Re: K012923
Trade/Device Name: Arthrex Fiberwire™ USP Size 5 Suture Regulation Number: 878.5000 Regulation Name: Nonabsorbable Poly (ethylene terephthalate) Surgical Suture Regulatory Class: II Product Code: GAT Dated: August 28, 2001 Received: August 31, 2001
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 (OS) 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
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 and additionally 21 CFR Part 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,
Susan Walker, MD
C
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
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Page 1 of 1
510(k) Number (if known): K O12923
Device Name: Arthrex Fiberwire™, USP size 5
Indications for Use:
The Arthrex Fiberwire™USP size 5 suture is intended for use in soft tissue approximation and or ligation.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Option Format 3-10-98)
Division Sign Off
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number $\frac{K012923}{(.0088}$