(184 days)
No
The summary describes a surgical suture and grafting kit, which are physical medical devices and do not involve software or data processing that would typically incorporate AI/ML. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
No
The device is a surgical suture used for soft tissue approximation and ligation, which is a tool used during treatment, but not a therapeutic device itself that directly provides therapy or treatment to the patient.
No
Explanation: The device is described as sutures used for soft tissue approximation and ligation in surgical procedures, not for identifying the nature of a disease or condition.
No
The device description clearly states it is a suture grafting kit containing physical sutures made of polyester and braided fiber material, available with or without needles. This indicates a physical medical device, not a software-only one.
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" and "incorporated, as components, into surgeries". This describes a surgical device used directly on the patient's body during a procedure.
- Device Description: The description details surgical sutures made of polyester and braided fibers, available with or without needles. This aligns with a surgical implant or device, not a diagnostic test performed on samples outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing samples (like blood, urine, tissue), detecting biomarkers, or providing diagnostic information about a patient's health status.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is purely mechanical and structural within a surgical context.
N/A
Intended Use / Indications for Use
The Arthrex Fiberwire™ and FiberTape™ Families 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
GAT
Device Description
Arthrex, Inc. suture grafting kits contain Fiberwire™ and FiberTape™ sutures of varying lengths and needle types, as components. The sutures are made of long chain polyesters and braided with a variety of cleared fiber material 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 K032245, Arthrex K021434, Arthrex K010673, Arthrex K012923, Grams American Suture K003590, ARC Medical Supplies K000540
Reference Device(s)
Genzyme Surgical Product K001434
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
DEC 1 0 2004
510(k) Summarv
| 510(k) Number: | K041553 |
|---|---|
| Contact Person: | Ann Waterhouse, Regulatory Affairs Specialist |
| Address: | 1370 Creekside Boulevard, Naples, FL 34108 |
| Telephone: | (239) 643-5553 |
| Date Prepared: | May 2004 |
| Trade/Proprietary Name: | Arthrex Suture Grafting Kit |
| Product Code: | GAT |
| Classification Name: | Suture, Non-absorbable, Synthetic, Polyester |
| Predicate Devices: | Arthrex K032245, Arthrex K021434, Arthrex K010673 |
| Arthrex K012923, Grams American Suture K003590 | |
| Arthrex K012923, ARC Medical Supplies K000540 |
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.
Genzyme Surgical Product K001434.
Intended Use:
The Arthrex Fiberwire™ and FiberTape™ Families 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.
Description:
Arthrex, Inc. suture grafting kits contain Fiberwire™ and FiberTape™ sutures of varying lengths and needle types, as components. The sutures are made of long chain polyesters and braided with a variety of cleared fiber material and sterilized for surgical use. They are available in dyed and non-dyed varieties, with or without needles.
Substantial Equivalence:
The Arthrex, Inc. Suture Grafting Kit is substantially equivalent to predicate devices where the basic features and intended uses are the same. Minor differences between the Arthrex FiberWire sutures and FiberTapes 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 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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles three stylized lines, possibly representing an eagle or a similar bird-like figure.
DEC 1 0 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Public Health Service
Ms. Ann Waterhouse Regulatory Affairs Specialist Arthrex, Inc. 1370 Creekside Boulevard Naples, Florida 34108
Re: K041553
Trade/Device Name: Arthrex Suture Grafting Kit Regulation Number: 21 CFR 878.5000 Regulation Name: synthetic non-absorbable PET suture Regulatory Class: II Product Code: GAT Dated: October 21, 2004 Received: October 22, 2004
Dear Ms. Waterhouse:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreativent of the enactment date of the Medical Device Amendments, or to conimoted prox to rialy 2011-12-11 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 rou may, dierelove, mains of the Act include requirements for annual registration, listing of general controlly provisions of ractice, 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 If your device is onastined (600 as 30 mg . Existing major regulations affecting your device can thay be subject to back acated 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 r trass be actived that I Dr mination that your device complies with other requirements of the Act that I DT has made a aond regulations administered by other Federal agencies. You must or any I catales and equirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set OF N Fart 607), havemes (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) I has letter with a a my of substantial equivalence of your device of your device to a legally prematicated predicated on "The 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 it you active 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 (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): K041553
Device Name: Arthrex Suture Grafting Kit
Indications for Use:
The Arthrex Fiberwire™ and FiberTape™ Families 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 AND/OR x (Part 21 CFR 801 Subpart D)
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)
Miriam C. Provost
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) NumberK041553