GazelleTM PTFE (polytetrafluroethylene) suture and Delivery Device is indicated for use in general soft tissue approximation and/or ligation, including; cardiovascular, dental, general surgical procedures and repair of the dura mater. Gazelle™PTFE sutures are not indicated for use in microsurgery, ophthalmic procedures, or peripheral neural tissues. GazelleTM PTFE suture and Delivery Device is provided sterile as a single use device.

Device Description

The Gazelle PTFE surgical sutures are monofilament surgical sutures composed from expanded polytetrafluoroethylene (ePTFE) material. They are attached to a standard stainless steel surgical needle. The Gazelle Delivery Device is a Class I Manual Surgical Instrument that assists with suture placement. The PTFE suture is loaded into the Gazelle Delivery Device and is delivered to the desired location through the Gazelle device tip by pressing the actuation button on the Gazelle device handle.

AI/ML Overview

The provided document describes the FDA 510(k) premarket notification for the "Gazelle PTFE Suture and Delivery Device." This document details the device's characteristics, intended use, and a summary of performance data to demonstrate substantial equivalence to a predicate device, rather than a clinical study establishing AI performance or diagnostic accuracy.

Therefore, the requested information regarding acceptance criteria and a study proving a device meets these criteria, specifically in the context of AI performance, human reader improvement, and ground truth establishment, cannot be extracted from this document.

The document does provide information pertinent to medical device approval, such as:

Device Name: Gazelle PTFE Suture and Delivery Device
Regulation Number and Name: 21 CFR 878.5035, Nonabsorbable expanded polytetrafluoroethylene surgical suture
Regulatory Class: Class II
Product Code: NBY
Predicate Device: Riverpoint Medical MONOTEX PTFE Suture – K140415
Indications for Use: General soft tissue approximation and/or ligation, including cardiovascular, dental, general surgical procedures, and repair of the dura mater. Not indicated for microsurgery, ophthalmic procedures, or peripheral neural tissues.
Performance Data General Statement: "Gazelle PTFE Surgical Sutures meet the requirements specified in FDA's Class II Special Controls Guidance Document: Surgical Sutures, Guidance for Industry and FDA". It also states that "the PTFE suture has passed performance testing, including mechanical testing in accordance to USP for nonabsorbable suture and biocompatibility testing of the suture material in accordance with ISO 10993-1. Packaging and sterilization validation and shelf life testing have been successfully performed. The Gazelle Delivery Device was tested for Button Push Force, Distal Tip / Shaft Pull Force, Handle / Shaft Pull Force, Stylet / Button Pull Force and underwent surgeon evaluation."

However, none of this information relates to an AI/ML-based device or a study involving human readers and ground truth for diagnostic accuracy, which are the prerequisites for answering the specific questions about acceptance criteria and study design for AI-driven technologies.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the seal of the Department of Health & Human Services. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

February 8, 2018

Dura Tap, LLC % Ms. Vikki O'Connor Ambriel Associates, Inc. Regulatory Affairs Consultant 411 Walnut St., Unit 9236 Green Cove Springs, Florida 32043

Re: K173335

Trade/Device Name: Gazelle PTFE Suture and Delivery Device Regulation Number: 21 CFR 878.5035 Regulation Name: Nonabsorbable expanded polytetrafluoroethylene surgical suture Regulatory Class: Class II Product Code: NBY Dated: November 17, 2017 Received: November 21, 2017

Dear Ms. O'Connor:

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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);

{1}------------------------------------------------

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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

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

{2}------------------------------------------------

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) K173335

Device Name

Gazelle PTFE Suture and Delivery Device

Indications for Use (Describe)

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.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

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:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

FORM FDA 3881 (7/17)

Page 1 of 1

PSC Publushing Services (301) 443-6740 EF

{3}------------------------------------------------

510(k) Summary: Gazelle PTFE (polytetrafluroethylene) Suture and Delivery Device

In accordance with Title 21 of the Code of Federal Regulations, Part 807, and in particular, 21 CFR Part 807.92, the following summary of information is provided:

Submitter:	Dura Tap LLCWayne, PAUSA
Contact Person	Ms. Vikki M. O'ConnorRegulatory Affairs ConsultantPhone: 1-207-214-8535Email: vikki0730@yahoo.com
Date Prepared	January 12, 2017
Trade Name	Gazelle PTFE Suture and Delivery Device
Proposed Class	Class II (special controls); General and Plastic Surgery
Classification Nameand Number	Suture, Surgical, Nonabsorbable, Expanded,Polytetraflouroethylene, 878.5035
Common Name	PTFE Nonabsorbable Surgical Sutures
Product Code	NBY
Predicate Device	Riverpoint Medical MONOTEX PTFE Suture – K140415
Special Controls	FDA Guidance, “Class II Special Controls GuidanceDocument: Surgical Sutures, Guidance for Industry andFDA" was followed during the preparation of thissubmission.
Device Description	The Gazelle PTFE surgical sutures are monofilamentsurgical sutures composed from expandedpolytetrafluoroethylene (ePTFE) material. They are
	The sutures are attached to a standard stainless steelsurgical needle.
	The Gazelle Delivery Device is a Class I ManualSurgical Instrument that assists with suture placement.
	The PTFE suture is loaded into the Gazelle DeliveryDevice and is delivered to the desired location throughthe Gazelle device tip by pressing the actuation buttonon the Gazelle device handle.
Intended Use	The Gazelle PTFE (polytetrafluroethylene) Suture andDelivery Device are indicated for use in general soft tissueapproximation and / or ligation, including cardiovascular,dental, general surgical procedures and repair of the duramater. Gazelle PTFE Sutures are not indicated for use inmicrosurgery, ophthalmic procedures, or peripheral neuraltissues. Gazelle PTFE Sutures are provided sterile as asingle use device.
Summary of theTechnologicalCharacteristics	Gazelle PTFE Surgical Sutures are uncoated, undyedmonofilament sutures composed from expandedpolytetrafluoroethylene (ePTFE) material. The sutures areprovided sterile for single use and meet all applicable USPrequirements.
Performance Data	Gazelle PTFE Surgical Sutures meet the requirementsspecified in FDA's Class II Special Controls GuidanceDocument: Surgical Sutures, Guidance for Industry andFDA". In addition, the PTFE suture has passedperformance testing, including mechanical testing inaccordance to USP for nonabsorbable suture andbiocompatibility testing of the suture material inaccordance with ISO 10993-1. Packaging andsterilization validation and shelf life testing have beensuccessfully performed. The Gazelle Delivery Devicewas tested for Button Push Force, Distal Tip / Shaft Pull
	Force, Handle / Shaft Pull Force, Stylet / Button Pull Forceand underwent surgeon evaluation. All testing has confirmedthat the Gazelle PTFE Suture and Delivery System issubstantially equivalent to it's predicate and will meetcustomer / user performance requirements.
Summary ofSimilarities andDifferences	Both the subject and predicate are monofilament PTFE(polytetrafluroethylene) Nonabsorbable Surgical Sutures.Both are available in USP size 5-0 and 6-0 and areattached to stainless steel surgical needles. Both areuncoated and undyed. Both are provided sterilized forsingle use. Both meet USP requirements for NonabsorbaleSurgical Sutures, Tensile Strength and Needle Attachment.Riverpoint Surgical MONOTEX PTFE Sutures may notmeet the USP requirement for diameter where GazellePTFE Sutures do meet the USP requirement for diameter.The only other difference is that the Gazelle PTFE suture ispre-loaded into the Gazelle Delivery Device.
Conclusion	Based on the indications for use, technologicalcharacteristics, required performance testing andcomparison to the predicate device, Gazelle PTFE Sutureand Delivery Device has been shown to be substantiallyequivalent to legally marketed predicate devices for itsintended use.

{4}------------------------------------------------

{5}------------------------------------------------

Regulation Number and Section

§ 878.5035 Nonabsorbable expanded polytetrafluoroethylene surgical suture.

(a)
Identification. Nonabsorbable expanded polytetrafluoroethylene (ePTFE) surgical suture is a monofilament, nonabsorbable, sterile, flexible thread prepared from ePTFE and is intended for use in soft tissue approximation and ligation, including cardiovascular surgery. It may be undyed or dyed with an approved color additive and may be provided with or without an attached needle(s).(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.