The TissueStat PTFE (polytetrafluroethylene) Suture and Delivery Device is indicated for use in all types of soft tissue approximation and / or ligation, including cardiovascular, dental, general surgical procedures and repair of the dura mater. TissueStat PTFE Sutures are not indicated for use in microsurgery, ophthalmic procedures, or peripheral neural tissues. TissueStat PTFE Sutures are provided sterile as a single use device.

Device Description

The TissueStat PTFE surgical sutures are monofilament surgical sutures composed from expanded polytetrafluoroethylene (ePTFE) material. They are available uncoated and undyed in USP size 2/0. The sutures are attached to standard stainless steel surgical needles. The TissueStat Suture Delivery Device is a Class I Manual Surgical Instrument that assists with suture placement. The PTFE suture is loaded into the Suture Delivery Device and is delivered to the desired location through the device tip by pressing the actuation button on the device handle.

AI/ML Overview

The provided documentation is a 510(k) premarket notification for a medical device called "TissueStat PTFE Suture and Delivery Device." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific acceptance criteria through a standalone clinical study with defined performance metrics.

Therefore, many of the requested details about acceptance criteria, specific study designs, sample sizes for test sets, expert ground truth establishment, adjudication methods, or MRMC studies are not applicable to this type of regulatory submission and are not present in the provided text.

The "Performance Data" section outlines verification and validation testing conducted to support substantial equivalence, not a comparative effectiveness study or a study to meet specific clinical acceptance criteria in the way typically expected for an AI/ML device.

Here's the information that can be extracted or inferred from the provided text, and where the requested information is not available:

1. A table of acceptance criteria and the reported device performance

The document does not present a table of acceptance criteria and reported device performance in terms of clinical outcomes or diagnostic accuracy. Instead, it lists the types of performance testing conducted to verify that the device meets engineering and material standards for substantial equivalence.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable or not mentioned. The document primarily focuses on mechanical and biocompatibility testing for substantial equivalence, not a clinical study with a "test set" in the context of AI/ML or diagnostic performance. Therefore, there is no information about data provenance or sample sizes for such a clinical test set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable or not mentioned. The concept of "ground truth" established by experts is typically relevant for diagnostic or AI/ML device evaluations. This document describes a surgical suture and delivery device, where "ground truth" would relate to material properties and mechanical performance, established through standardized testing, not expert consensus on interpretations.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable or not mentioned. Adjudication methods are relevant for expert consensus in clinical studies, which is not the type of study described here.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. The "TissueStat PTFE Suture and Delivery Device" is a physical medical device (suture and delivery system), not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study comparing human reader performance with and without AI assistance is irrelevant to this device and was not performed.

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

Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the mechanical and biocompatibility testing mentioned, the "ground truth" or reference would be established by:

USP standards: For Suture Diameter (USP <861>), Suture Tensile Testing (USP <881>), and Needle Attachment Testing (USP <871>). These are standardized testing protocols.
ISO 10993 and FDA Guidance: For Biocompatibility Risk Assessment, adherence to these standards forms the basis for demonstrating safety.

8. The sample size for the training set

Not applicable. The device is not an AI/ML product developed using training data.

9. How the ground truth for the training set was established

Not applicable. The device is not an AI/ML product.

Summary of Relevant Information from the Document:

While the document does not present acceptance criteria and performance in the format of an AI/ML device evaluation, it does outline the type of performance data collected to demonstrate substantial equivalence:

Verification and Validation Testing Conducted:

Mechanical Testing:
- Suture Diameter Testing per USP <861>
- Suture Tensile Testing per USP <881>
- Needle Attachment Testing per USP <871>
Biocompatibility Testing:
- Conducted a Biocompatibility Risk Assessment in accordance with ISO 10993-1 (2018) and FDA Guidance (2020).
- The PTFE suture is an implant with permanent (>30 days) contact with tissue.

Conclusion:

The submission concludes that, based on the indications for use, technological characteristics, and performance testing in comparison to the predicate device, the TissueStat PTFE Suture and Delivery Device has been shown to be substantially equivalent to the legally marketed predicate device for its intended use. This means the testing demonstrated that the device meets the established engineering and safety standards equivalent to the predicate, and therefore, does not raise new questions of safety or effectiveness.

Summary

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November 9, 2023

DuraStat LLC Adam Azzara Chief Executive Officer 1101 E 6th St Unit B Austin, Texas 78702

Re: K231277

Trade/Device Name: TissueStat Regulation Number: 21 CFR 878.5035 Regulation Name: Nonabsorbable Expanded Polytetrafluoroethylene Surgical Suture Regulatory Class: Class II Product Code: NBY Dated: May 2, 2023 Received: May 3, 2023

Dear Adam Azzara:

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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn).

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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 (https://www.fda.gov/medical-devices/deviceadvice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Alexander Nguyen -S 2023.11.09 16:43:36 -05'00'

for Tek N. Lamichhane, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic and Reconstructive Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K231277

Device Name

TissueStat PTFE (polytetrafluroethylene) Suture and Delivery Device

Indications for Use (Describe)

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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I. SUBMITTER

DuraStat, LLC 1101 E 6th St Unit B Austin, TX USA 78702

Phone: 1 (800) 804-8018 Fax: 1 (800) 804-8018

Contact Person: Adam Azzara Date Prepared: October 26, 2023

II. DEVICE

Name of Device: TissueStat™ PTFE (polytetrafluoroethylene) Suture and Delivery Device Common or Usual Name: PTFE Nonabsorbable Surgical Sutures; Needle, Needle Guide and Knot Pusher Classification Name: Suture, Surgical, Nonabsorbable, Expanded, Polytetrafluoroethylene, 878.5035; Manual Surgical Instruments for General Use, 878.4800 Regulatory Class: II Product Code: NBY

III. PREDICATE DEVICE

DuraStat® Gazelle PTFE Suture and Delivery Device (K173335) formerly DuraTap Gazelle PTFE Suture and Delivery Device.

Reference Devices: Riverpoint Medical MonoTex ® PTFE Suture (K140415) and (K100006)

IV. DEVICE DESCRIPTION

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V. INDICATIONS FOR USE

The TissueStat PTFE (polytetrafluoroethylene) Suture and Delivery Device are indicated for use in all types of soft tissue approximation and / or ligation, including cardiovascular, dental, general surgical procedures and repair of the dura mater. TissueStat PTFE Sutures are not indicated for use in microsurgery, ophthalmic procedures, or peripheral neural tissues. TissueStat PTFE Sutures are provided sterile as a single use device.

Attribute	PredicateDuraStat (Gazelle)(K173335)	Subject DeviceTissueStat(K223489)	Comparison
Manufacturer	DuraStat LLC	DuraStat LLC	Equivalent
Class	II	II	Equivalent
Product Code	NBY	NBY	Equivalent
Indication	The TissueStat PTFE(polytetrafluoroethylene)Suture and DeliveryDevice are indicated foruse in all types of softtissue approximation and/ or ligation, includingcardiovascular, dental,general surgicalprocedures and repair ofthe dura mater.TissueStat PTFE Suturesare not indicated for usein microsurgery,ophthalmic procedures,or peripheral neuraltissues. TissueStat PTFESutures are providedsterile as a single usedevice.	The TissueStat PTFE(polytetrafluoroethylene)Suture and DeliveryDevice are indicated foruse in all types of softtissue approximation and/ or ligation, includingcardiovascular, dental,general surgicalprocedures and repair ofthe dura mater.TissueStat PTFE Suturesare not indicated for usein microsurgery,ophthalmic procedures,or peripheral neuraltissues. TissueStat PTFESutures are providedsterile as a single usedevice.	Equivalent
Delivery DeviceMaterials	ABS; Delrin; Nitinol;Stainless Steel	ABS; Delrin; Nitinol;Stainless Steel	Equivalent
Suture Material	PTFE(polytetrafluoroethylene)	PTFE(polytetrafluoroethylene)	Equivalent
Suture Size	5/0 and 6/0	2/0	Different
Needle Material	302 Stainless Steel	302 Stainless Steel	Equivalent
DeviceCharacteristics	Suture delivery devicehas a distal curved tip	Suture delivery devicehas an elongated distal	Different
	with a needle andattached suture retainedwithin the tip.Depressing the Delrinbutton releases the styletrod which deploys theneedle from the tip.	curved tip that includes adistal brace for rigiditywith a needle andattached suture retainedwithin the tip.Depressing the primer atthe proximal end of thedevice loads the springwith a known force.Depressing the Delrinbutton releases the styletrod which deploys theneedle from the tip.
Packaging(Implantcontacting)	HDPE	HDPE	Same
Packaging (WholeKit)	HDPE	HDPE and PETG	Different
Primary SterileBarrier	Tyvek(1059B)/PolyethylenePeel Pouch.	Tyvek(1059B)/PolyethylenePeel Pouch.	Same
SterilizationMethod	Ethylene Oxide	Ethylene Oxide	Same
SterilizationAssurance	10-6	10-6	Same
Single Use	Yes	Yes	Same

VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

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DuraStat (formerly Gazelle) and TissueStat are both manufactured by DuraStat LLC and have similar technical characteristics and surgical use steps. The TissueStat device utilizes a larger suture, expanding the versatility of the tissue approximation technology with identical indications for use. Minor modifications to the needle and device characteristics facilitate the addition of the larger suture.

The following technological characteristics remain the same between the two devices.

Device, suture, and needle materials
Procedural steps and principles of operation
Sterilization and delivery method

The following technological differences exist between the subject and predicate devices:

Suture Size: Larger 2/0 Suture allows for approximation and/or ligation of soft tissue that ● require larger/stronger sutures with the same indications for use as the predicate.
Needle Characteristics: Minor changes to the needle allow for approximation and/or . ligation of thicker, soft tissue with the larger 2/0 suture compared to the predicate device.

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Delivery Device Characteristics: The larger 2/0 suture and associated needle are accommodated by an elongated tip with a brace that allows for easy removal for the device after the suture needle is deployed. The updated button deployment enhances ergonomics while facilitating post-deployment needle/suture positioning.
Packaging: The device's internal packaging was changed to a Tyvek lidded tray from a ● backer card to improve the appearance of the packaging and to facilitate easier device removal while providing more support to the device.

These differences do not raise new questions of safety and effectiveness and were assessed by the standardized verification and validation testing described below.

VII. PERFORMANCE DATA

The following performance testing was conducted in support of the substantial equivalence determination.

Mechanical Testing

Suture Diameter Testing per USP <861> ●
. Suture Tensile Testing per USP <881>
Needle Attachment Testing per USP <871> ●

Biocompatibility Testing

PTFE suture is an implant with permanent (>30days) contact with tissue. A Biocompatibility Risk Assessment was conducted in accordance with ISO 10993, Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing within a Risk Management Process (2018) and the FDA Guidance "Use of International Standard ISO 10993- 1, "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing within a Risk Management Process" (2020).

VIII. CONCLUSIONS

Based on the indications for use, technological characteristics, and performance testing in comparison to the predicate device, the TissueStat PTFE Suture and Delivery Device has been shown to be substantially equivalent to the legally marketed predicate device for its intended use.

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.