(92 days)
Not Found
No
The description focuses on the physical properties and materials of the suture, with no mention of AI or ML.
No
The device, Force Fiber Fusion™ Suture, is used for "approximation and/or ligation of soft tissues." While it's a medical device, its primary function is to hold tissues together, not to treat, cure, mitigate, or prevent disease or directly restore a function in a therapeutic manner beyond mechanical apposition.
No
Explanation: The device is a surgical suture used for tissue approximation and ligation, which is a therapeutic function, not a diagnostic one.
No
The device description clearly describes a physical suture made of materials like UHMWPE and polyester, indicating it is a hardware medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood, tissue, and urine, from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
- Device Description and Intended Use: The description and intended use of the Force Fiber Fusion Suture clearly state it is a surgical suture used for "approximation and/or ligation of soft tissues" during orthopaedic surgeries. This is a device used within the body during a surgical procedure, not for testing specimens outside the body.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens (blood, tissue, etc.)
- Providing diagnostic information
- Using reagents or assays
- Measuring analytes
The Force Fiber Fusion Suture is a surgical implant/device used for mechanical support and tissue repair.
N/A
Intended Use / Indications for Use
Force Fiber Fusion™ Suture is indicated for use in approximation and/or ligation of soft tissues, including use of allograft tissue for orthopaedic surgeries.
Product codes (comma separated list FDA assigned to the subject device)
GAT
Device Description
Force Fiber Fusion suture is an uncoated braid offered in a variety of cut lengths, with or without needles, and provided sterile for single use only. Force Fiber Fusion Suture is braided to transition from round suture to tape suture and back to round suture within the same braid construction. The tape section(s) are flat in shape and differ from USP requirements. The round section(s) exceed USP for diameter. The suture meets USP tensile strength requirements and USP needle attachment requirements. Force Fiber Fusion suture is available in sizes 1 through 5 and composed of undyed or blue Ultra High Molecular Weight Polyethylene (UHMWPE), UHMWPE/blue polyester co-braid, UHMWPE/black Nylon co-braid or UHMWPE/green Polyester co-braid.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Force Fiber Fusion suture is tested in accordance with USP - non-absorbable surgical sutures for 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 Fusion suture were evaluated through biological qualification safety tests as outlined in AAMI ANSI ISO 10993-1: 2009/(R) 2013 -- Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing.
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.
K150438, K063778, K070673, K092533, K100506
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of three human profiles facing right, arranged in a stacked formation. The profiles are rendered in a dark color, creating a sense of depth and unity. Encircling the profile graphic is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 3, 2017
Teleflex Medical Incorporated Ms. Vladislava Zaitseva Senior Regulatory Affairs Specialist 375 Forbes Boulevard Mansfield, Massachusetts 02048
Re: K172016
Trade/Device Name: Force Fiber Fusion Suture Regulation Number: 21 CFR 878.5000 Regulation Name: Nonabsorbable Poly(Ethylene Terephthalate) Surgical Suture Regulatory Class: Class II Product Code: GAT Dated: June 30, 2017 Received: July 3, 2017
Dear Ms. Zaitseva:
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. 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 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); 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.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely.
David Krause -S
for Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K172016
Device Name Force Fiber Fusion™ Suture
Indications for Use (Describe)
Force Fiber Fusion™ Suture is indicated for use in approximation and/or ligation of soft tissues, including use of allograft tissue for orthopaedic surgeries.
| Type of Use (Select one or both, as applicable) | |
|---|---|
X Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary of Safety and Effectiveness
This 510(k) Summary for Teleflex Force Fiber Fusion™ Suture 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: | September 7, 2017 |
| Contact: | Vladislava Zaitseva
Senior Regulatory Affairs Specialist, OEM
Phone: 1-508-964-6030
Fax: 1-508-964-6078
vladislava.zaitseva@teleflex.com |
| Proprietary Name: | Force Fiber Fusion™ Suture |
| Common Name: | Polyethylene synthetic non-absorbable 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 Fusion suture is an uncoated braid offered in a variety of cut lengths, with or without needles, and provided sterile for single use only. Force Fiber Fusion Suture is braided to transition from round suture to tape suture and back to round suture within the same braid construction. The tape section(s) are flat in shape and differ from USP requirements. The round section(s) exceed USP for diameter. The suture meets USP tensile strength requirements and USP needle attachment requirements. Force Fiber Fusion suture is available in sizes 1 through 5 and composed of undyed or blue Ultra High Molecular Weight Polyethylene (UHMWPE), UHMWPE/blue polyester co-braid, UHMWPE/black Nylon co-braid or UHMWPE/green Polyester co-braid.
4
Indications for Use
Force Fiber Fusion suture is indicated for use in approximation and/or ligation of soft tissues, including use of allograft tissue for orthopaedic surgeries.
Substantial Equivalence
Force Fiber Fusion suture is substantially equivalent in intended use and fundamental scientific technology to its primary predicate Force Fiber OrthoTape suture cleared under K150438 on 04/02/2015. The other listed predicates are part of the same Force Fiber suture family cleared under 510(k)s K063778 on 2/09/2007, K070673 on 4/2/2007, K092533 on 9/15/2009, and K100506 on 3/10/2010.
Technological Characteristics
Force Fiber Fusion suture is substantially equivalent to its predicate device Force Fiber OrthoTape suture cleared under K150438, and other Force Fiber suture predicates cleared under K063778, K070673, K092533, K100506 based on the same intended use, and the following commonalities in technological characteristics:
- . Same UHMWPE, PP, PET and Nylon materials are used in the manufacture of proposed and predicate devices.
- Both, proposed and predicates, have braided configurations. .
- Both, Force Fiber and Force Fiber Fusion, are oversized for diameter. ●
- The test method used to confirm the performance specifications of tensile ● strength and needle attachment for both the proposed and predicate devices were conducted in accordance with USP requirements.
The difference between proposed Force Fiber Fusion and the currently legally marketed Force Fiber and Force Fiber OrthoTape sutures is that Force Fiber Fusion Suture is braided to transition from round suture to tape suture and back to round suture within the same braid construction. This difference does not raise new questions of safety or efficacy. The proposed Force Fiber Fusion suture is substantially equivalent in intended use and fundamental scientific technology to the Force Fiber and Force Fiber OrthoTape predicate devices.
Summary of Testing
Force Fiber Fusion suture is tested in accordance with USP - non-absorbable surgical sutures for 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 Fusion suture were evaluated through biological qualification safety tests as outlined in AAMI ANSI ISO 10993-1: 2009/(R) 2013 -- Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing.
5
Conclusion
Based upon the comparative test results, the proposed Force Fiber Fusion Sutures are substantially equivalent in performance to the legally marketed predicate devices.