(29 days)
No
The description focuses on the material composition and physical properties of a surgical suture, with no mention of AI/ML capabilities or data processing.
No.
The device is a non-absorbable surgical suture used for approximation and/or ligation of soft tissues, which is a supportive function rather than a therapeutic one (e.g., treating a disease or condition).
No
This device is a surgical suture used for approximation and/or ligation of soft tissues, not for diagnosing medical conditions.
No
The device description clearly states it is a physical surgical suture made of UHMWPE, 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 and/or ligation of soft tissues," which is a surgical procedure performed in vivo (within the living body).
- Device Description: The device is a surgical suture, a physical material used to close wounds or hold tissues together during surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or screening.
IVD devices are specifically designed to be used in vitro (outside the living body) for diagnostic purposes. This device is clearly intended for use in vivo during surgery.
N/A
Intended Use / Indications for Use
Force Fiber® 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 orthopedic surgeries.
Product codes
GAT
Device Description
Force Fiber Suture - Black is a non-absorbable, sterile, surgical suture composed of Ultra High Molecular Weight Polyethylene (UHMWPE) dyed black using D&C Black #4 not to exceed 1.0% by weight. It is an uncoated braid offered in a variety of cut lengths, with or without needles, and provided sterile for single use only. Force Fiber Suture - Black is available in sizes 0, 1 and 2, and meets all surgical suture requirements established by the USP for non-absorbable surgical sutures except for oversize diameter.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissues
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
Force Fiber Suture - Black is tested in accordance with USP - non-absorbable surgical sutures for suture diameter, tensile strength and needle attachment, 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 Suture - Black were evaluated through biological qualification safety tests as outlined in ISO 10993-1: 2018 --Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing.
Force Fiber Suture - Black is tested to demonstrate it is "MR Safe" and poses no known hazards in MR environments.
Key Metrics
Not Found
Predicate Device(s)
K033654, K063778, K070673, K092533, K100506, K181774
Reference Device(s)
Not Found
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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June 11, 2019
Teleflex Medical Incorporated Ms. Andrea Curria Senior Regulatory Affairs Specialist 375 Forbes Boulevard Mansfield, Massachusetts 02048
Re: K191268
Trade/Device Name: Force Fiber Suture Regulation Number: 21 CFR 878.5000 Regulation Name: Nonabsorbable Poly(Ethylene Terephthalate) Surgical Suture Regulatory Class: Class II Product Code: GAT Dated: May 10, 2019 Received: May 13, 2019
Dear Ms. Andrea Curria:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For David Krause, Ph.D. Acting Division Director Division of Infection Control and Plastic Surgery Devices Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known)
Device Name Force Fiber® Suture
Indications for Use (Describe)
Force Fiber® 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 orthopedic surgeries.
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
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CONFIDENTIAL
3
Section 8 – 510(k) Summary
510(k) Summary of Safety and Effectiveness
This 510(k) Summary for Teleflex Force Fiber® Suture – Black is provided as required by section 807.92(c).
| Sponsor/Applicant: | Teleflex Medical Inc.
375 Forbes Boulevard
Mansfield, MA 02048 USA
FDA Establishment Registration #: 1221601 |
|-----------------------|------------------------------------------------------------------------------------------------------------------------------------------|
| Date Prepared: | May 10, 2019 |
| Contact: | Andrea Curria
Senior Regulatory Affairs Specialist, OEM
Phone: 1-508-964-6030
Fax: 1-508-964-6078
Andrea.curria@teleflex.com |
| Proprietary Name: | Force Fiber® Suture |
| Common Name: | Polyethylene nonabsorbable surgical suture |
| Classification Name: | Suture, nonabsorbable, synthetic, polyethylene |
| Regulation Number: | 21CFR § 878.5000 |
| Product Code: | GAT |
| Device Class: | Class II |
| Classification Panel: | General and Plastic Surgery |
Device Description Force Fiber Suture - Black is a non-absorbable, sterile, surgical suture composed of Ultra High Molecular Weight Polyethylene (UHMWPE) dyed black using D&C Black #4 not to exceed 1.0% by weight. It is an uncoated braid offered in a variety of cut lengths, with or without needles, and provided sterile for single use only. Force Fiber Suture - Black is available in sizes 0, 1 and 2, and meets all surgical suture requirements established by the USP for non-absorbable surgical sutures except for oversize diameter.
4
Section 8 - 510(k) Summary
Indications for Use
Force Fiber Suture - Black is 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.
Substantial Equivalence
Force Fiber Suture - Black is substantially equivalent in intended use and fundamental scientific technology to the Force Fiber Suture predicate devices cleared under 510(k) #K033654 on 1/15/2004, K063778 on 2/09/2007, K070673 on 4/2/2007, K092533 on 9/15/2009, K100506 on 3/10/2010 and K181774 on 10/10/2018.
Technological Characteristics
Force Fiber Suture – Black is substantially equivalent to its predicate Force Fiber Suture devices because there are no differences in technological characteristics and performance characteristics between the proposed and predicate devices. The proposed sutures have the same fundamental design and intended use as the predicate devices.
The difference between Force Fiber Suture - Black and its predicate Force Fiber Suture devices is the addition of black dye (D&C Black #4 not to exceed 1.0% by weight) to the white UHMWPE fibers. This difference does not raise new questions of safety or efficacy. Therefore, Force Fiber Suture - Black is as safe and effective as its currently marketed predicate devices.
Summary of Testing
Force Fiber Suture - Black is tested in accordance with USP - non-absorbable surgical sutures for suture diameter, tensile strength and needle attachment, 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 Suture - Black were evaluated through biological qualification safety tests as outlined in ISO 10993-1: 2018 --Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing.
Force Fiber Suture - Black is tested to demonstrate it is "MR Safe" and poses no known hazards in MR environments.