(93 days)
No
The device description and performance studies focus on the mechanical properties of a surgical suture, 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 rather than a direct therapeutic intervention.
No
The device is a surgical suture used for approximation and ligation of soft tissues. Its intended use is to secure reattached tendons to bone, which is a therapeutic function rather than a diagnostic one.
No
The device description clearly states it is a physical surgical suture made of UHMW polyethylene, 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 allograft tissue for orthopedic surgeries." This describes a surgical procedure performed directly on the patient's body.
- Device Description: The device is a "non-absorbable, sterile, synthetic surgical suture." This is a physical material used to 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 treatment.
IVDs are used in vitro (outside the body) to analyze samples. This device is used in vivo (inside the body) during surgery.
N/A
Intended Use / Indications for Use
Smith & Nephew ULTRATAPE is indicated for use in approximation and/or ligation of soft tissues, including allograft tissue for orthopedic surgeries.
Product codes
GAT
Device Description
Smith & Nephew ULTRATAPE is a non-absorbable, sterile, synthetic surgical suture composed of UHMW (Ultra High Molecular Weight) polyethylene, offered braided, in both blue and a co-braid of blue/ white. ULTRATAPE is flat in shape, and has a width of 2mm, meeting USP tensile strength requirement for size #2 surgical suture. ULTRATAPE does not comply with USP size classifications. When used with various anchoring implants in orthopedic procedures, it secures and holds the reattached tendon to bone.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissues, including allograft tissue
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)
Mechanical testing data for Knot Tensile Strength according to USP standard for nonabsorbable, #2 size surgical suture demonstrates the device has met the performance specifications and therefore, is substantially equivalent to the currently marketed predicate devices,
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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.
0
OCT 3 0 2013
Endoscopy Smith & Nephew, Inc. 150 Minuteman Road Andover, MA 01810 USA
T 978 749 1000 F 978 749 1443 www.smith-nephew.com
> We are smith&nephew
510(k) Summary
Date Prepared: October 21, 2013
| Submitter Information | Contact Information |
|---|---|
| Smith & Nephew, Inc. | |
| 150 Minuteman Road | |
| Andover, MA 01810 | Melody Bi |
| Senior Regulatory Affairs Specialist | |
| Phone: (508) 337-4035 | |
| Fax: (978) 749-1443 |
| Device Name (Unmodified) | |
|---|---|
| Trade or proprietary name | Smith & Nephew ULTRATAPE |
| Common or usual name | Non-absorbable Surgical Suture |
| Classification name | Polyethylene Non-absorbable Surgical Suture |
Legally Marketed Predicate Device
The Smith & Nephew ULTRATAPE surgical suture is substantially equivalent in intended use and Fundamental Scientific Technology to the following legally marketed devices in commercial distribution:
K101377 Smith & Nephew ULTRABRAID II Suture (Cleared on April 8, 2011)
K041216 Smith & Nephew ULTRABRAID Suture (Cleared on June 7, 2004)
Device Description
Smith & Nephew ULTRATAPE is a non-absorbable, sterile, synthetic surgical suture composed of UHMW (Ultra High Molecular Weight) polyethylene, offered braided, in both blue and a co-braid of blue/ white. ULTRATAPE is flat in shape, and has a width of 2mm, meeting USP tensile strength requirement for size #2 surgical suture. ULTRATAPE does not comply with USP size classifications. When used with various anchoring implants in orthopedic procedures, it secures and holds the reattached tendon to bone.
Intended Use
Smith & Nephew ULTRATAPE is indicated for use in approximation and/or ligation of soft tissues, including allograft tissue for orthopedic surgeries.
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Technological Characteristics
Smith & Nephew ULTRATAPE is substantially equivalent to its predicate devices, ULTRABRAID suture (K041216) and ULTRABRAID II suture (K101377) based on the same intended use, and the following commonalities in technological characteristics:
- . Same UHMWPE material is used in the manufacture of proposed and predicate devices.
- Both proposed and predicates have braided configurations. .
- . The test method used to confirm the performance specifications of Knot Tensile Strength for both the proposed and predicate devices were conducted in accordance with USP requirements.
The differences between ULTRATAPE and its predicate devices include that ULTRATAPE has a different braiding configuration, which provides a flat, 2mm wide suture. ULTRATAPE does not comply with USP size classifications. These differences do not raise new questions of safety or efficacy. Therefore, ULTRATAPE is as safe and effective as its currently marketed predicate devices.
Performance Data
Mechanical testing data for Knot Tensile Strength according to USP standard for nonabsorbable, #2 size surgical suture demonstrates the device has met the performance specifications and therefore, is substantially equivalent to the currently marketed predicate devices,
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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized design of three curved lines, resembling an abstract representation of the human form or a symbol of interconnectedness. The logo is black and white.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 30, 2013
Smith & Nephew Incorporated Ms. Melody Bi Senior Regulatory Affairs Specialist 150 Minuteman Road Andover, Massachusetts 01810
Re: K132357
Trade/Device Name: Smith & Nephew ULTRATAPE Regulation Number: 21 CFR 878.5000 Regulation Name: Nonabsorbable poly (ethylene terephthalate) surgical suture Regulatory Class: Class II Product Code: GAT Dated: September 25, 2013 Received: October 2, 2013
Dear Ms. Bi:
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
3
Page 2 - Ms. Melody Bi
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 Small Manufacturers, International and Consumer Assistance at its tollfree 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" (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 Small Manufacturers, International and Consumer Assistance 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.
Sincerely yours,
Mark N. Melkerson -S
Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation 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: December 31, 2013 See PRA Statement on last page.
510(k) Number (if known) K132357
Device Name Smith & Nephew ULTRATAPE
Indications for Use (Describe)
Smith & Nephew ULTRATAPE is indicated for use in approximation and/or ligation of soft tissues, including 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)
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)