(157 days)
No
The device description and performance studies focus on the physical properties and mechanical strength of a suture, with no mention of AI or ML capabilities.
No.
This device is a suture, used for approximating and ligating soft tissues during surgery, which is a supportive rather than therapeutic function.
No
Explanation: The device description states its purpose is to approximate and/or ligate soft tissues, functioning as a suture, not to diagnose medical conditions.
No
The device description clearly states it is a physical, non-absorbable 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 to "approximate and/or ligate soft tissues... for orthopaedic surgeries." This describes a surgical tool used directly on the patient's body during a procedure.
- Device Description: The device is a "non-absorbable suture composed 100% of ultra high molecular weight polyethylene (UHMWPE)." This is a physical material used for stitching tissue.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, or tissue samples) outside of the body to provide information about a patient's health status, diagnose conditions, or monitor treatment. The description of Stryker Suture Tape does not involve any such testing of specimens.
Therefore, Stryker Suture Tape is a surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Stryker Suture Tape is intended to approximate and/or ligate soft tissues, including the use of allograft tissue for orthopaedic surgeries.
Product codes
GAT
Device Description
Stryker Suture Tape (herein referred to as the proposed device(s)) is a non-absorbable suture composed 100% of ultra high molecular weight polyethylene (UHMWPE). These devices are braided to be flat in shape and offered in white/blue coloration patterns. Stryker Suture Tape complies with USP standards for #2 suture with the exception of size classifications. Each Suture Tape variation will be cut to length and provided to the end user in a single-use sterile barrier system (SBS).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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
Non-clinical benchtop testing was performed to verify that Stryker Suture Tapes exceed the minimum requirements of USP standards for knot pull tensile strength of nonabsorbable surgical sutures. Clinical testing was not required to demonstrate substantial equivalence for this submission.
Key Metrics
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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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name encircling a stylized image of an eagle with three human profiles incorporated into its design. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement around the emblem.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 13, 2015
Stryker Endoscopy Taylor White Regulatory Affairs Analyst 5900 Optical Court San Jose, California 95138
Re: K150584
Trade/Device Name: Stryker Suture Tape Regulation Number: 21 CFR 878.5000 Regulation Name: Nonabsorbable poly(ethylene terephthalate) surgical suture Regulatory Class: Class II Product Code: GAT Dated: July 15, 2015 Received: July 16, 2015
Dear White:
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.
Sincerely yours,
David Krause -S
- Binita S. Ashar, M.D., M.B.A., F.A.C.S. for 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) K150584
Device Name Stryker Suture Tape
Indications for Use (Describe)
Stryker Suture Tape is intended to approximate and/or ligate soft tissues, including the use of allograft tissue for orthopaedic surgeries.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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510(k) Summary
I. SUBMITTER
Stryker Endoscopy 5900 Optical Ct San Jose, CA 95138
Contact Person: Taylor White, Regulatory Affairs Analyst Phone: 303-336-7285 Fax: 303-993-6195
Date Prepared: March 23, 2015
II. DEVICE
| Name of Device: | Stryker Suture Tape
Model Numbers: 3910-900-017, 3910-900-018, 3910-900-019 |
|-----------------------|---------------------------------------------------------------------------------|
| Common or Usual Name: | Suture, Nonabsorbable, Synthetic, Polyethylene |
| Classification Name: | Nonabsorbable poly(ethylene terephthalate) surgical suture (21 CFR
878.5000) |
| Regulatory Class: | II |
| Product Code: | GAT |
III. PREDICATE DEVICES
Primary Predicate: Teleflex Force Fiber® Polyethylene Nonabsorbable Surgical Suture, K033654 This predicate has not been subject to a design-related recall.
Secondary Predicate: Teleflex Force Fiber® Blue Polyethylene Nonabsorbable Surgical Suture, K092533 This predicate has not been subject to a design-related recall.
Reference Device 1: 4.5mm X 55 mm Parallel Portal Cannula, Class I Exempt Device This predicate has not been subject to a design-related recall.
Reference Device 2: Stryker ICONIX All-Suture Anchors, K133671 This predicate has not been subject to a design-related recall.
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IV. DEVICE DESCRIPTION
Stryker Suture Tape (herein referred to as the proposed device(s)) is a non-absorbable suture composed 100% of ultra high molecular weight polyethylene (UHMWPE). These devices are braided to be flat in shape and offered in white/blue coloration patterns. Stryker Suture Tape complies with USP standards for #2 suture with the exception of size classifications. Each Suture Tape variation will be cut to length and provided to the end user in a single-use sterile barrier system (SBS).
V. INTENDED USE
Stryker Suture Tape is intended to approximate and/or ligate soft tissues, including the use of allograft tissue for orthopaedic surgeries.
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICES
The technological characteristics of Stryker Suture Tape are equivalent to the predicate devices. Both the proposed and the predicate devices feature a braided multifilament design and are composed of ultra high molecular weight polyethylene (UHMWPE). As such, Stryker Suture Tapes and the predicate devices are classified as Class 1 Sutures per USP standards. The proposed and predicate devices are manufactured in the same location using similar processes. Stryker Suture Tape products undergo wash processes identical to the predicate devices. The proposed and predicate devices have similar intended uses.
Proposed and Predicate Device Differences:
Device Geometry
The predicate devices are round suture products while the proposed devices are flat in shape. Both the predicate and proposed devices do not adhere to USP size classifications. The Stryker Suture Tape products meet minimum requirements of USP standards for knot pull tensile strength. As such, this dimensional deviation from the predicates does not adversely affect the safety and effectiveness of the proposed product.
Coloration
The predicate devices are offered in all white and all blue colors. The Stryker Suture Tape products are offered in white/blue coloration patterns created through braiding blue and white strands. The proposed and predicate devices are all composed of 100% UHMWPE. The blue colorant for the proposed and predicate devices is the same.
Stryker Suture Tape is substantially equivalent to the identified predicate devices in regard to intended use, materials of construct, performance attributes, and technological characteristics.
VII. PERFORMANCE DATA
Non-clinical benchtop testing was performed to verify that Stryker Suture Tapes exceed the minimum requirements of USP standards for knot pull tensile strength of nonabsorbable surgical sutures. Clinical testing was not required to demonstrate substantial equivalence for this
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submission.
VIII. CONCLUSIONS
The information presented within this traditional premarket submission demonstrates that Stryker Suture Tape is substantially equivalent to the predicate devices and will perform as designed within the intended use.