(42 days)
Not Found
No
The device description and performance studies focus on the physical properties and mechanical performance of a surgical suture, with no mention of AI or ML capabilities.
No
This device is a surgical suture, which is used for approximation and/or ligation of soft tissues. While it aids in the healing process, it does not directly treat a disease or condition; rather, it is a tool used during surgery.
No
The device description indicates that the Force Fiber OrthoTape Suture is used for "approximation and/or ligation of soft tissues," which means it is used to hold tissues together during surgery. This is a therapeutic function, not a diagnostic one.
No
The device description clearly indicates it is a physical suture made of UHMWPE and/or Polyester, not a software product.
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... for orthopaedic surgeries." This describes a device used in vivo (within the body) during a surgical procedure.
- Device Description: The description details a surgical suture, a physical device used to hold tissues together.
- 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 used in vitro (outside the body) to analyze biological samples. This device is clearly designed for use in vivo during surgery.
N/A
Intended Use / Indications for Use
Force Fiber® OrthoTape™ Suture is indicated for use in approximation and/or ligation of soft tissues, including use of allograft tissue for orthopaedic surgeries.
Product codes
GAT
Device Description
Force Fiber OrthoTape 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 OrthoTape suture is flat in shape and differs from USP requirements (not USP). It is available in 1mm, 1.5mm, 2mm, 2.5mm, 3.5mm, 4mm and 5mm tape sizes and composed of undyed or blue Ultra High Molecular Weight Polyethylene (UHMWPE), or UHMWPE/ Green Polyester co-braid. Force Fiber OrthoTape suture sizes meet USP tensile strength requirements and USP needle attachment requirements for USP size #2 suture.
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 OrthoTape 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 OrthoTape 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
Not Found
Predicate Device(s)
K033654, K063778, K092533, K100506
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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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features the department's name encircling a stylized representation of a human figure. The figure is composed of three profiles facing right, symbolizing the department's focus on health and well-being. The text is arranged in a circular pattern around the central emblem.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 2, 2015
Teleflex Medical Incorporated Vladislava Zaitseva Senior Regulatory Affairs Specialist, OEM 375 Forbes Boulevard Mansfield, Massachusetts 02048
Re: K150438
Trade/Device Name: Force Fiber® OrthoTape™ Suture Regulation Number: 21 CFR 878.5000 Regulation Name: Nonabsorbable poly(ethylene terephthalate) surgical suture Regulatory Class: Class II Product Code: GAT Dated: March 3, 2015 Received: March 4, 2015
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
1
device-related 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.
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 at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 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.
for
Sincerely yours,
David Krause -S
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
2
Indications for Use
510(k) Number (if known) K150438
Device Name Force Fiber® OrthoTape™ Suture
Indications for Use (Describe)
Force Fiber® OrthoTape™ 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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Image /page/3/Picture/1 description: The image shows the logo for Teleflex Medical OEM. The logo is in blue and consists of the word "Teleflex" in a stylized font, with the letters connected. To the right of "Teleflex" is the registered trademark symbol. Below "Teleflex" is the text "MEDICAL OEM" in a smaller, sans-serif font.
510(k) Summary
This 510(k) Summary for Teleflex Force Fiber® OrthoTape™ 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: | March 31, 2015 |
| 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® OrthoTape™ Suture |
| Common Name: | Polyethylene synthetic non-absorbable surgical sutures |
| 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 OrthoTape 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 OrthoTape suture is flat in shape and differs from USP requirements (not USP). It is available in 1mm, 1.5mm, 2mm, 2.5mm, 3.5mm, 4mm and 5mm tape sizes and composed of undyed or blue Ultra High Molecular Weight Polyethylene (UHMWPE), or UHMWPE/ Green Polyester co-braid. Force Fiber OrthoTape suture sizes meet USP tensile strength requirements and USP needle attachment requirements for USP size #2 suture.
4
Image /page/4/Picture/1 description: The image shows the logo for Teleflex Medical OEM. The logo is in blue and consists of the word "Teleflex" in a bold, sans-serif font, with the letters connected. Below the word "Teleflex" is the phrase "MEDICAL OEM" in a smaller, sans-serif font, also in blue. The logo is simple and professional, and it is likely used to represent the company on its website, marketing materials, and products.
Indications for Use
Force Fiber OrthoTape 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 OrthoTape suture is substantially equivalent in intended use and fundamental scientific technology to the Force Fiber predicate devices cleared under 510(k) #K033654 on 1/15/2004, K063778 on 2/09/2007, K092533 on 9/15/2009, and K100506 on 3/10/2010.
Technological Characteristics
The substantial equivalence of Force Fiber OrthoTape suture is supported by having the same intended use, suture material, and equivalent design and performance characteristics to the previously cleared predicate device.
- Intended Use/ Indications for use. The modified Force Fiber OrthoTape suture is . substantially equivalent in intended use to the Force Fiber predicate device.
- Materials. Modified Force Fiber OrthoTape suture and Force Fiber predicate suture device are composed of the same materials.
- Sterilization processes. Modified Force Fiber OrthoTape suture and Force Fiber ● predicate suture devices are sterilized using same sterilization processes conforming to recognized industry standards.
- Performance specifications. 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 differences between Force Fiber OrthoTape suture and its predicate devices include that Force Fiber OrthoTape suture has a different braiding configuration, which provides a flat in shape suture. Force Fiber OrthoTape suture does not comply with USP size classifications. These differences do not raise new questions of safety or efficacy. Therefore, Force Fiber OrthoTape suture is substantially equivalent to its currently marketed predicate devices.
Summary of Testing
Force Fiber OrthoTape 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 OrthoTape 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.
Substantial Equivalence Conclusion
Results from testing and engineering analyses provided within this 510(k) demonstrate that the Force Fiber OrthoTape suture is substantially equivalent to the identified predicate devices.