The DemeTECH PTFE Suture is indicated for use in all types of soft tissue approximation and/or ligation, including dental and general surgeries. The device is not indicated for use in ophthalmic surgery, microsurgery, and peripheral neural tissue.

Device Description

DemeTECH PTFE Suture is a nonabsorbable, sterile surgical monofilament suture composed of polytetrafluoroethylene. The DemeTECH PTFE Suture meets or exceeds all requirements in the latest edition of the USP monograph for nonabsorbable surgical sutures and is provided sterile in various sizes and configurations. The material is undyed and contains no additives and is white in appearance and may be provided with or without an attached needle(s).

AI/ML Overview

The provided document describes the FDA 510(k) clearance for the DemeTECH PTFE Nonabsorbable Surgical Suture. This is a medical device, not an AI/ML device, therefore, many of the requested criteria are not applicable. However, I can extract the relevant information regarding acceptance criteria and the studies performed.

Here's the information based on the document:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (USP 39)	Reported Device Performance (Demetech PTFE Suture)
Nonabsorbable Surgical Suture requirements	Meets or exceeds performance requirements
Tensile Strength Requirements (<881>)	Meets or exceeds performance requirements
Needle Attachment Requirements (<871>)	Meets or exceeds performance requirements
Suture Length Requirement (95% of stated label length)	Meets or exceeds performance requirements
Biocompatibility (ISO 10993-1)	Conforms to requirements
Sterility	Conforms to requirements
Suture Diameter	Conforms to requirements
Extractable Color	Conforms to requirements

2. Sample size used for the test set and the data provenance:

The document does not specify the exact sample sizes for the non-clinical tests (e.g., number of sutures tested for tensile strength, needle attachment).
The data provenance is not explicitly stated in terms of country of origin, but the testing was conducted to meet USP (United States Pharmacopeia) and ISO (International Organization for Standardization) standards, which are internationally recognized. The studies were non-clinical (laboratory/bench top) and in-vitro/in-vivo.
The study was not a "test set" in the context of an AI/ML model; rather, it was a series of physical and biological tests on the device itself.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This question is not applicable as the device is a surgical suture, not an AI/ML system that requires expert ground truth for image interpretation or diagnosis. The "ground truth" for this device is its physical and biological performance as measured by established standards.

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

This is not applicable as there was no "test set" in the context of human interpretation or AI/ML model output requiring adjudication. The tests involved direct measurement against predefined standards.

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:

This is not applicable. No MRMC study was conducted as this is a physical medical device (suture), not an AI/ML diagnostic or assistive tool. No human "readers" are involved in its performance assessment in this context.

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

This is not applicable. This is a physical nonabsorbable surgical suture, not a software algorithm or AI/ML device.

7. The type of ground truth used:

The "ground truth" for the device's performance was established by internationally recognized standards:
- United States Pharmacopeia (USP 39) monograph for nonabsorbable surgical sutures: This defines the physical and performance characteristics such as diameter, length, knot pull tensile strength, and needle attachment strength.
- ISO 10993-1 for Biocompatibility: This defines the standards for evaluating the biological safety of medical devices.

8. The sample size for the training set:

This is not applicable as the device is a physical medical device and does not involve AI/ML models that require training sets.

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

This is not applicable for the same reason as point 8.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. 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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

October 11, 2018

Demetech Corporation Ms. Linda Hernandez Head of Quality 14175 NW 60th Ave. Miami Lakes, Florida 33014

Re: K181578

Trade/Device Name: DemeTECH PTFE Nonabsorbable Surgical Suture Regulation Number: 21 CFR 878.5035 Regulation Name: Nonabsorbable Expanded Polytetrafluoroethylene Surgical Suture Regulatory Class: Class II Product Code: NBY Dated: April 6, 2018 Received: June 15, 2018

Dear Ms. Hernandez:

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. 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 located 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.

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

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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 devicerelated adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see

https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 4, Subpart A) for combination products; 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 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,

Peter L. Hudson -S 2018.10.11 09:33:52 -04'00'

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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Indications for Use

510(k) Number (if known) K181578

Device Name DemeTECH PTFE Suture

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
Exempted from/Qualified for SEE Waiver (Attach Sheet)
Long-Term Agreement with SEE Waiver

| | Prescription Use (Part 21 CFR 801 Subpart D)

| | Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/1 description: The image contains the logo for "DemeTECH". The logo consists of a light blue triangle on the left side and the company name in bold, black letters on the right side. The triangle is a three-dimensional shape with a gradient of light blue, giving it a modern and technological appearance.

Section 5 - 510(k) Summary

This summary is submitted in accordance with the Safe Medical Device Act (SMDA) of 1990 and Title 21 CFR § 807.92. This summary demonstrates the equivalence of Demetech Sutures to those of the legally marked devices listed.

A.	Applicant:	Demetech Corporation,14175 NW 60th Ave.Miami Lakes FL. 33014
B.	Contact Person:	Luis ArguelloPhone: 305-824-1048 Ext 113luis@demetech.us
C.	Date Summary Prepared:	April 6, 2018
	Trade Name:	XXX
	Common Name:	PTFE Nonabsorbable Surgical Suture
	Classification Name:	Non-absorbable expanded polytetrafluorethylenesurgical suture
	Product Code:	NBY21 CFR 878.5035Class II

D. Predicate Devices: The DemeTECH PTFE Suture is substantially equivalent to the predicates Cytoplast PTFE suture and Look PTFE Suture in which the basic features and intended uses are the same. Any differences between the DemeTECH PTFE Suture and the predicates are considered minor and do not raise questions concerning safety and effectiveness.
- Osteogenics Biomedical, Inc. Cytoplast PTFE Suture reference 510k number K072076
- . Surgical Specialties Corporation LOOK PTFE Suture reference 510k number K160744

E. Device Description:

F. Intended Use:

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Non-Clinical Tests Performed: G.

Non-clinical testing was conducted on the device per FDA's Special Control Guidance Document: Surgical Sutures, to prove conformance to the requirements of USP for synthetic absorbable suture, biocompatibility testing in accordance to ISO 10993-1 and in-vitro and in-vivo resorption to further demonstrate substantial equivalence to the predicate devices. Physical properties and functionality testing assured that the device conformed with suture diameter, suture length, knot pull tensile strength, needle attachment strength, extractable color and sterility to methods outlined in USP 39.

COMPARISON TABLE
Comparison Items	Demetech PTFENonabsorbable Suture	Look PTFENonabsorbableSuture	Cytoplast PTFENonabsorbableSuture
Product Code	NBY	Same	Same
Common Name	PTFE nonabsorbable suture	Same	Same
Suture Characteristic	Nonabsorbablepolytetrafluoroethylenesurgical suture	Same	Same
Labeling	Sterile, Single Use	Same	Same
Intended Use	Approximation or ligation ofsoft tissues	Same	Same
Technical Characteristics	Monofilament, uncoated,synthetic nonabsorbablesuture	Same	Same
Material	High-densitypolytetrafluoroethylene(PTFE)	Same	Same
Sizes	2-0	Same	Same
Sterilization	Ethylene Oxide (EO)	Same	Same

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Image /page/5/Picture/1 description: The image shows the DemeTECH logo. The logo consists of a blue circle with a white triangle inside on the left and the word "DemeTECH" in black on the right. The word "DemeTECH" is in a bold, sans-serif font, and the "R" in "TECH" has a registered trademark symbol next to it.

USP Performance Requirements	Suture Material meets orexceeds performancerequirements for"Nonabsorbable SurgicalSuture" in USP 39.	Same	Same
Tensile Strength Requirements	Suture Material meets orexceeds the performancerequirements defined inUSP for "Tensile Strength" <881 >	Same	Same
Needle Attachment Requirements	Suture Material meets orexceeds the performancerequirements defined inUSP for "NeedleAttachment" < 871 >	Same	Same
Suture Length Requirements	Suture Material meets orexceeds the performancerequirements defined inUSP for "Suture LengthRequirement" (95% ofstated label length)	Same	Same
Suture Packaging	Device wound onto innersupport card, within a Tyvek/ Poly pouch	Device woundonto inner supportcard, within aTyvek/Poly PrimaryPouch; inside aTyvek / Polysecondary pouch	Device woundonto inner supportcard, within aTyvek / Poly pouch

H. Clinical Tests Performed:

No clinical trials were conducted

l. Conclusion:

DemeTECH PTFE Nonabsorbable Surgical Suture is composed of the same material as the predicated devices and has the same design being a sterile, monofilament nonabsorbable thread meeting all the requirements of the United States Pharmacopeia. DemeTECH's material used was selected based on known biocompatibility (per ISO 10993) and established history of use in the surgical suture industry.

The biocompatibility data and the results of performance testing presented, demonstrate the substantial equivalence of DemeTECH PTFE Nonabsorbable Surgical Suture to that of the predicate devices. It further demonstrates conformance with the USP, ISO 10993 and FDA Guidance for Surgical Suture 510(k).

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Image /page/6/Picture/1 description: The image contains the logo for DemeTECH. The logo consists of a blue circle with a white triangular shape inside, followed by the company name "DemeTECH" in bold, black letters. The registered trademark symbol is located to the right of the company name.

Based on the 510(k) summaries and the information provided herein we conclude that DemeTECH PTFE Nonabsorbable Surgical Suture is substantially equivalent for its intended purpose.

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.