(185 days)
No
The summary describes a standard surgical suture and does not mention any AI or ML components or functionalities.
No
The device is a surgical suture used for approximation or ligation of soft tissues. Its primary function is to hold tissues together, which is part of a surgical procedure, but it does not directly treat a disease or condition itself.
No
The device is a surgical suture used for approximation or ligation of soft tissues, not for diagnosing medical conditions.
No
The device description clearly states it is a physical suture made of braided long chain polyesters, 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 "approximation or ligation of soft tissues" during orthopedic surgeries. This describes a surgical procedure performed directly on the patient's body.
- Device Description: The device is a surgical suture, which is a physical material used to close wounds or hold tissues together.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue samples) outside of the body to provide information about a patient's health status, which is the defining characteristic of an IVD.
Therefore, the Fiberwire™ suture is a surgical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Fiberwire™ USP sizes are intended for use in approximation or ligation of soft tissues, including use of allograft tissue for orthopedic surgeries.
Product codes
GAT
Device Description
Arthrex, Inc. Fiberwire™ suture consists of a family of varying length, needle type, and standard USP diameter sutures. They are made of long chain polyesters which are braided 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
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, Grams American Suture K003590
Reference Device(s)
Arthrex K012923, ARC Medical Supplies K000540, Genzyme Surgical Product K001434
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
NOV 7 2002
510(k) Summary
K021434 510(k) Number: Ann Waterhouse, Requlatory Affairs Specialist Contact Person: Date Prepared: December 13, 2001
Trade/Proprietary Name: Arthrex Fiberwire™ USP suture family Product Code: GAT Classification Name: Suture, Non-absorbable, Synthetic, Polyester Arthrex K010673, Arthrex K012923, Grams American Predicate Devices: Suture K003590 Arthrex K012923, ARC Medical Supplies K000540, Genzyme Surgical Product K001434.
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.
Intended Use:
Fiberwire™ USP sizes are intended for use in approximation or ligation of soft tissues, including use of allograft tissue for orthopedic surgeries.
Description:
Arthrex, Inc. Fiberwire™ suture consists of a family of varying length, needle type, and standard USP diameter sutures. They are made of long chain polyesters which are braided and sterilized for surgical use. They are available in dyed and non-dyed varieties, with or without needles.
Substantial Equivalence:
The Arthrex, Inc. Fiberwire™ Family USP suture(s) are 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
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 features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 7 2002
Anthrex. Inc. Ann Waterhouse Regulatory Affairs Specialist 2885 South Horseshoe Drive Naples, Florida 34104
Re: K021434
Trade/Device Name: Anthrex Fiberwire™ Family, USP Size Sutures Regulation Number: 878.5000 Regulation Name: Nonabsorbable poly(ethylene terephthalate) surgical suture Regulatory Class: Class II Product Code: GAT Dated: August 15, 2002 Received: August 16, 2002
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 ( FR 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
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" (21 CFR 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,
Miriam C. Provost
for G.M. Witte, Ph.D., M.D.
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
510(k) Number (if known): K021434
Device Name: Arthrex Fiberwire™Family, USP size sutures
Indications for Use:
Fiberwire™ USP sizes are intended for use in approximation or ligation of soft tissues, including use of allograft tissue for orthopedic surgeries.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Miriam C. Provost
(Option Format 3-10-98)
(Division Sign-Off) Division of General, Restorative and Neurological Devices
110(k) Norther.