(50 days)
No
The summary describes a surgical suture and its physical properties and performance testing, with no mention of AI or ML.
No
The device is a surgical suture used for approximation and/or ligation of soft tissues, which is a supportive function during medical procedures, not a direct therapeutic treatment itself.
No
This device is a surgical suture used for approximation and ligation of tissues, not for diagnosing conditions.
No
The device description clearly states it is a physical surgical suture made of UHMWPE, 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 for "approximation and/or ligation of soft tissues, including use in cardiovascular surgeries and the use of allograft tissue for orthopaedic surgeries." This describes a device used within the body during surgical procedures.
- Device Description: The description details a surgical suture, which is a physical material used to close wounds or tie off vessels.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens outside the body (in vitro) to provide information for diagnosis, monitoring, or screening. IVDs typically involve tests on blood, urine, tissue samples, etc.
Therefore, the Force Fiber® Polyethylene Non-Absorbable Surgical Suture is a surgical device used for physical manipulation of tissues, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Force Fiber® Polyethylene Non-Absorbable Surgical Sutures are indicated for use in approximation and/or ligation of soft tissues, including use in cardiovascular surgeries and the use of allograft tissue for orthopaedic surgeries.
Product codes
GAT
Device Description
The Force Fiber® Polyethylene is non-absorbable, sterile, surgical suture composed of ultra high molecular weight polyethylene (UHMWPE). It is available in white or white/blue cobraid, sizes 5-0 through 5 meeting USP requirements except for oversized diameter.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissues, cardiovascular surgeries, orthopaedic surgeries
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)
All sizes of Force Fiber® Polyethylene Non-Absorbable Surgical Suture have been tested in accordance with USP 30 - Absorbable Surgical Sutures for Knot Pull Tensile Strength, Needle Attachment and Diameter, and meet the requirements of the Class II Special Controls Guidance: Surgical Sutures; Guidance for Industry and FDA; June 3, 2003.
All materials used in the fabrication of the Force Fiber® Polyethylene Non-Absorbable Surgical Suture were evaluated through biological qualification safety tests as outlined in ISO 10993 Part 1 "Biological Evaluation of Medical Devices".
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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.
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Ko63778 1/2
Teleflex Medical Force Fiber® Non-Absorbable Surgical Suture Abbreviated PreMarket Notification (510(k)) Submission
SECTION 5 - 510(K) SUMMARY 9 2007 FEB
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Force Fiber® Polyethylene Non-Absorbable Surgical Sutures
A. Name, Address, Phone and Fax Number of Applicant
Teleflex Medical 2345 Waukegan Road Bannockburn, IL 60015 USA Phone: 847-572-8002 Fax: 847-572-8001
B. Contact Person
Lori Hays Director, Regulatory Affairs
C. Date Prepared
December 19, 2006
D. Device Name
Trade Name: Force Fiber® Polyethylene Non-Absorbable Surgical Suture
Common Name: Polyethylene Synthetic Non-Absorbable Surgical Suture
Classification Name: Nonabsorbable poly(ethylene terephthalate) surgical suture
E. Device Description
The Force Fiber® Polyethylene is non-absorbable, sterile, surgical suture composed of ultra high molecular weight polyethylene (UHMWPE). It is available in white or white/blue cobraid, sizes 5-0 through 5 meeting USP requirements except for oversized diameter.
F. Indications for Use
Force Fiber® Polyethylene Non-Absorbable Surgical Sutures are indicated for use in approximation and/or ligation of soft tissues, including use in cardiovascular surgeries and the use of allograft tissue for orthopaedic surgeries.
G. Substantial Equivalence
The device is similar in intended use, materials, design, and performance characteristics to the Teleflex Medical Force Fiber® Polyethylene Non-absorbable Surgical Sutures (K033654, K040472), the United States Surgical Surgipro II Non-Absorbable Surgical Sutures (K050947) and the Arthrex Fiberwire Polyethylene Non-absorbable Surgical Sutures
1
K06577X 2
Teleflex Medical
Force Fiber® Non-Absorbable Surgical Suture Abbreviated PreMarket Notification (510(k)) Submission
(K021434). The determination of substantial equivalence for this device was based on a detailed device description, performance testing and conformance with voluntary performance standards.
H. Summary of Testing
All sizes of Force Fiber® Polyethylene Non-Absorbable Surgical Suture have been tested in accordance with USP 30 - Absorbable Surgical Sutures for Knot Pull Tensile Strength, Needle Attachment and Diameter, and meet the requirements of the Class II Special Controls Guidance: Surgical Sutures; Guidance for Industry and FDA; June 3, 2003.
All materials used in the fabrication of the Force Fiber® Polyethylene Non-Absorbable Surgical Suture were evaluated through biological qualification safety tests as outlined in ISO 10993 Part 1 "Biological Evaluation of Medical Devices".
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird-like figure. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Teleflex Medical Group Headquarters % Ms. Lori Hays, MT, RAC Director, Regulatory Affairs 2345 Waukegan Road Bannockburn, Illinois 60015
9 2007 FEB
Re: K063778
Trade/Device Name: Force Fiber® Polyethylene Non-Absorbable Surgical Suture Regulation Number: 21 CFR 878.5000 Regulation Name: Nonabsorbable poly(ethylene terephthalate) surgical suture Regulatory Class: II Product Code: GAT Dated: December 19, 2006 Received: January 8, 2006
Dear Ms. Hays:
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.
3
Page 2 - Ms. Lori Hays, MT, 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
4
Teleflex Medical Force Fiber® Non-Absorbable Surgical Suture Abbreviated PreMarket Notification (510(k)) Submission
SECTION 4 - INDICATIONS FOR USE STATEMENT
510(k) Number (if known): KO63778
Device Name: __ Force Fiber® Polyethylene Non-Absorbable Surgical Suture
Indications for Use:
Force Fiber® Polyethylene Non-Absorbable Surgical Sutures are indicated for use in approximation and/or ligation of soft tissues, including use in cardiovascular surgeries and the use of allograft tissue for orthopaedic surgeries.
| Prescription Use | X | AND/OR | Over-The-Counter Use |
|---|---|---|---|
| (Part 21 CFR 801 Subpart D) | (21 CFR 801 Subpart C) |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CRXH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
| 510(k) Number | K063778 | Page | of |
|---|---|---|---|
| --------------- | --------- | ------ | ---- |
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