Gazelle™ Polypropylene Suture and Delivery Device is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic, and neurosurgical procedures. Gazelle™ Polypropylene Suture and Delivery Device is provided sterile as a single use device.

Device Description

The Gazelle Polypropylene surgical sutures are sterile, nonabsorbable suture composed of an isotactic crystalline stereoisomer of polypropylene, a synthetic linear polyolefin. The pigmented suture is pigmented blue (with [Phthalocyaninato(2-)] copper, Color Index Number 74160) to enhance visibility. The sutures are attached to a The Gazelle Suture Delivery Device is a Class I Manual Surgical Instrument that assists with suture placement. The Polypropylene suture is loaded into the Gazelle Delivery Device and is delivered to the desired location through the tip of the Gazelle Delivery Device. A standard knot pusher may be included with the Gazelle Polypropylene Suture and Delivery Device.

AI/ML Overview

This document describes the FDA's acceptance of the Gazelle Polypropylene Suture and Delivery Device (K173644) as substantially equivalent to a predicate device. The information details the acceptance criteria and the studies performed to demonstrate this equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Gazelle Polypropylene Suture and Delivery Device are primarily based on meeting the requirements specified in the "FDA Guidance, 'Class II Special Controls Guidance Document: Surgical Sutures, Guidance for Industry and FDA'". Additionally, the device had to pass various performance tests.

Acceptance Criteria / Standard	Reported Device Performance
Suture Material (Polypropylene)
Compliance with FDA Guidance: "Class II Special Controls Guidance Document: Surgical Sutures"	Met: "Gazelle Polypropylene Sutures meet the requirements specified in FDA's Class II Special Controls Guidance Document: Surgical Sutures, Guidance for Industry and FDA'."
Performance Testing in accordance with USP for nonabsorbable suture	Passed: "Gazelle Polypropylene Suture has passed performance testing, including mechanical testing in accordance to USP for nonabsorbable suture." This includes USP requirements for Nonabsorbable Surgical Sutures, Tensile Strength and Needle Attachment.
Biocompatibility testing of suture material in accordance with ISO 10993-1	Passed: "biocompatibility testing of the suture material in accordance with ISO 10993-1."
Packaging and Sterilization Validation	Successfully Performed: "Packaging and sterilization validation...have been successfully performed."
Shelf Life Testing	Successfully Performed: "shelf life testing have been successfully performed."
Delivery Device Performance
Button Push Force Testing	Tested: "The Gazelle Delivery Device was tested for Button Push Force..."
Distal Tip / Shaft Pull Force Testing	Tested: "...Distal Tip / Shaft Pull Force..."
Handle / Shaft Pull Force Testing	"...Handle / Shaft Pull Force..."
Stylet / Button Pull Force Testing	"...Stylet / Button Pull Force..."
Surgeon Evaluation	Underwent: "and underwent surgeon evaluation."
Overall Performance for Substantial Equivalence and User Requirements	Confirmed: "All testing has confirmed that the Gazelle Polypropylene Suture and Delivery Device is substantially equivalent and will meet customer / user performance requirements."
Equivalence to Predicate Device (Riverpoint Medical RIVERPRO Suture – K100006) for indications for use, technological characteristics, and required performance testing	Shown to be Substantially Equivalent: "Based on the indications for use, technological characteristics, required performance testing and comparison to the predicate device, Gazelle Polypropylene Suture and Delivery Device has been shown to be substantially equivalent to legally marketed predicate devices for its intended use."

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state specific sample sizes for the mechanical, biocompatibility, packaging, sterilization, or shelf-life testing of the suture. For the delivery device, the number of devices tested for "Button Push Force, Distal Tip / Shaft Pull Force, Handle / Shaft Pull Force, Stylet / Button Pull Force" is not specified.

The data provenance is from Dura Tap LLC in Wayne, PA, USA. The studies are retrospective in the sense that they were conducted by the manufacturer prior to submission, and the results are presented in the 510(k) summary as already completed performance data. The country of origin of the data is implied to be the USA, where Dura Tap LLC is located.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

The document mentions "surgeon evaluation" for the Gazelle Delivery Device. However, it does not specify:

The exact number of surgeons involved in this evaluation.
The specific qualifications of these surgeons (e.g., years of experience, specialty).
How their evaluations were quantitatively or qualitatively used to establish 'ground truth' or acceptance.

For the other tests (mechanical, biocompatibility, etc.), the "ground truth" is established by adherence to recognized standards (USP, ISO 10993-1, FDA Guidance), not through expert consensus in a clinical sense.

4. Adjudication Method for the Test Set

The document does not describe a formal adjudication method (like 2+1 or 3+1 consensus) for establishing ground truth, as none was applicable given the nature of the tests (physical, chemical, and biological performance against standards). For the "surgeon evaluation," no specific adjudication method is mentioned.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This premarket notification is for a surgical suture and delivery device, not an AI/CAD imaging device that would typically involve MRMC studies to evaluate human reader performance with and without AI assistance. The testing focuses on the physical and biological characteristics of the device and its equivalence to a predicate.

6. If a Standalone (algorithm only without human-in-the-loop performance) was done

This question is not applicable to a physical surgical suture and delivery device. The device itself is an instrument used by a human, and there is no "algorithm only" component to test in isolation in the context of AI performance.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established by:

Compliance with recognized standards and guidance documents: Specifically, the "FDA Guidance, 'Class II Special Controls Guidance Document: Surgical Sutures, Guidance for Industry and FDA'", USP (United States Pharmacopeia) requirements for nonabsorbable sutures (including tensile strength and needle attachment), and ISO 10993-1 for biocompatibility.
Validation of manufacturing processes: Packaging and sterilization validation.
Empirical testing results: Mechanical testing of the suture materials and individual components of the delivery device (e.g., Button Push Force).
Comparison to a legally marketed predicate device: The Riverpoint Medical RIVERPRO Suture (K100006) serves as a benchmark for equivalence in indications for use, technological characteristics, and performance.

There is no mention of pathology, outcomes data, or expert consensus in the typical sense for establishing clinical ground truth for diagnostic accuracy, as this is a surgical tool.

8. The Sample Size for the Training Set

This question is not applicable. The device is a physical medical device, not an AI/machine learning algorithm that requires a training set. The "training set" concept does not apply here.

9. How the Ground Truth for the Training Set was Established

This question is not applicable, as there is no training set for a physical surgical device.

Summary

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February 15, 2018

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

Re: K173644

Trade/Device Name: Gazelle Polypropylene Suture and Delivery Device Regulation Number: 21 CFR 878.5010 Regulation Name: Nonabsorbable Polypropylene Surgical Suture Regulatory Class: Class II Product Code: GAW Dated: November 22, 2017 Received: November 27, 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);

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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 mediation-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

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Dura Tap LLC Polypropylene Suture 510K

Abbreviated 510(k) Premarket Notification

Section 2A - Indications for Use

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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: 06/30/2020 See PRA Statement below.

510(k) Number (if known)

K173644

Device Name

Gazelle™ Polypropylene 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.

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FORM FDA 3881 (7/17)

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510(k) Summary: Gazelle Polypropylene and Suture 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 17, 2018
Trade Name	Gazelle Polypropylene Suture and Delivery Device
Proposed Class	Class II (special controls); General and Plastic Surgery
Classification Nameand Number	Suture, Nonabsorbable, Synthetic, Polypropylene878.5010
Common Name	Polypropylene Nonabsorbable Surgical Sutures
Product Code	GAW
Predicate Device	Riverpoint Medical RIVERPRO Suture – K100006
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 Polypropylene surgical sutures are sterile, nonabsorbable suture composed of an isotactic crystalline stereoisomer of polypropylene, a synthetic linear polyolefin. The pigmented suture is pigmented blue (with [Phthalocyaninato(2-)] copper, Color Index Number 74160) to enhance visibility. The sutures are attached to a
	The Gazelle Suture Delivery Device is a Class I ManualSurgical Instrument that assists with suture placement.The Polypropylene suture is loaded into the GazelleDelivery Device and is delivered to the desired locationthrough the tip of the Gazelle Delivery Device. A standardknot pusher may be included with the GazellePolypropylene Suture and Delivery Device.
Intended Use	The Gazelle™ Polypropylene Suture and Delivery Deviceis indicated for use in general soft tissue approximationand / or ligation, including cardiovascular, ophthalmic andneurosurgical procedures. Gazelle™ Polypropylene Sutureand Delivery Device is provided sterile as a single usedevice.
Summary of theTechnologicalCharacteristics	Gazelle polypropylene Sutures are monofilament suturescomposed of an isotactic crystalline stereoisomer ofspropylene, a synthetic linear olefin. The pigmented sutureis pigmented blue with [Phthalocyaninato(2-)] copper,Color Index Number 74160. The Gazelle PolypropyleneSuture and Delivery Device is provided sterile for singleuse and meet all applicable USP requirements.
Performance Data	Gazelle Polypropylene Sutures meet the requirementsspecified in FDA's Class II Special Controls GuidanceDocument: Surgical Sutures, Guidance for Industry andFDA". In addition, the Gazelle Polypropylene Suture haspassed performance testing, including mechanical testingin accordance to USP for nonabsorbable suture andbiocompatibility testing of the suture material inaccordance with ISO 10993-1. Packaging and sterilizationvalidation and shelf life testing have been successfullyperformed. 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. All testing has confirmed that the
	Gazelle Polypropylene Suture and Delivery Device is
	substantially equivalent and will meet customer / user
	performance requirements.
Summary of	Both the subject and predicate are monofilament
Similarities and	Polypropylene Nonabsorbable Surqical Sutures. Both are
Differences	available in USP size 5-0 and 6-0 and are attached to
	stainless steel surgical needles. Both are undyed or dyed
	with pigmented blue with [Phthalocyaninato(2-)] copper,
	Color Index Number 74160. Both are provided sterilized for
	single use. Both meet USP requirements for Nonabsorbale
	Surgical Sutures, Tensile Strength and Needle
	Attachment. The only other difference is that the Gazelle
	suture is pre-loaded into the delivery device.
Conclusion	Based on the indications for use, technological
	characteristics, required performance testing and
	comparison to the predicate device, Gazelle Polypropylene
	Suture and Delivery Device has been shown to be
	substantially equivalent to legally marketed predicate
	devices for its intended use.

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Regulation Number and Section

§ 878.5010 Nonabsorbable polypropylene surgical suture.

(a)
Identification. Nonabsorbable polypropylene surgical suture is a monofilament, nonabsorbable, sterile, flexible thread prepared from long-chain polyolefin polymer known as polypropylene and is indicated for use in soft tissue approximation. The polypropylene surgical suture meets United States Pharmacopeia (U.S.P.) requirements as described in the U.S.P. Monograph for Nonabsorbable Surgical Sutures; it may be undyed or dyed with an FDA approved color additive; and 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.