DemeTECH DemeFORCE Suture is a nonabsorbable, sterile surgical monofilament suture composed of Ultra-high-molecular-weight polyethylene. The DemeTECH UHMWPE 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 available in different colors and may be provided with or without an attached needle(s).

AI/ML Overview

This document is a 510(k) summary for the DemeTECH DemeFORCE Nonabsorbable Surgical Suture. It describes non-clinical testing performed to establish substantial equivalence to predicate devices, rather than a study proving the device meets an acceptance criterion for an AI/ML algorithm or diagnostic tool. Therefore, much of the requested information regarding AI/ML studies is not applicable.

Here's the information that can be extracted or inferred from the provided text, focused on the non-clinical tests performed:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Set by USP and FDA Guidance)	Reported Device Performance (Summary)
Conformance to USP for nonabsorbable surgical suture	Meets or exceeds all requirements in the latest edition of the USP monograph for nonabsorbable surgical sutures and USP 41.
Biocompatibility	Meets requirements in accordance with ISO 10993-1.
In-vitro and in-vivo resorption	Demonstrated substantial equivalence to predicate devices.
Suture diameter	Conforms to methods outlined in USP 41.
Suture length (95% of stated label length)	Meets or exceeds the performance requirements defined in USP for "Suture Length Requirement".
Knot pull tensile strength	Meets or exceeds the performance requirements defined in USP for "Tensile Strength" < 881 >.
Needle attachment strength	Meets or exceeds the performance requirements defined in USP for "Needle Attachment" < 871 >.
Extractable color	Conforms to methods outlined in USP 41.
Sterility	Conforms to methods outlined in USP 41.

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

The document does not specify exact sample sizes for each non-clinical test. It states "Non-clinical testing was conducted on the device... to prove conformance to the requirements of USP." The provenance of the data is from in-house non-clinical testing performed by DemeTECH Corporation, as described in the "Non-Clinical Tests Performed" section. It is not retrospective or prospective patient data from a specific country, but rather laboratory testing of the device itself.

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

This information is not applicable to this type of submission. Ground truth in this context refers to established standards (USP monographs, ISO 10993) and the results of laboratory tests. There is no mention of human experts establishing ground truth for a "test set" in the context of imaging or diagnostic evaluations.

4. Adjudication method for the test set

Not applicable. This is not a study requiring adjudication of expert interpretations. The "test set" is the physical device being tested against predefined technical 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

Not applicable. This document is for a surgical suture and does not involve AI, human readers, or diagnostic interpretation.

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

Not applicable. This document is for a physical medical device (suture), not an algorithm.

7. The type of ground truth used

The ground truth used for the non-clinical tests were:

Established standards: United States Pharmacopeia (USP) monographs for nonabsorbable surgical sutures (specifically USP 41), and FDA's Special Control Guidance Document: Surgical Sutures.
International standards: ISO 10993-1 for biocompatibility.
Predicate device characteristics: For demonstrating substantial equivalence in areas like in-vitro and in-vivo resorption.

8. The sample size for the training set

Not applicable. This is a 510(k) submission for a physical medical device, not an AI/ML algorithm that requires a training set.

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

Not applicable, as there is no training set for an AI/ML algorithm in this submission.

Summary

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July 31, 2019

DemeTECH Corporation Tracy Chadwrick Director of Quality 14175 NW 60th Ave Miami Lakes, Florida 33014

Re: K190777

Trade/Device Name: DemeTECH DemeFORCE Nonabsorbable Surgical Suture Regulation Number: 21 CFR 878.5000 Regulation Name: Nonabsorbable poly(ethylene terephthalate) surgical suture Regulatory Class: Class II Product Code: GAT Dated: April 29, 2019 Received: April 29, 2019

Dear Tracy Chadwrick:

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

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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) for devices or postmarketing safety reporting (21 CFR 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 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

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/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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-device-advice-comprehensive-regulatoryassistance/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,

For Nina Mezu-Nwaba, PharmD., MPH., MSc, CAPT., United States Public Health Service Assistant Director (Acting), Plastic Surgery Implant Devices Team Division of Infection Control and Plastic Surgery Devices 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) K190777

Device Name

DemeTECH DemeFORCE Nonabsorbable Surgical Suture

Indications for Use (Describe)

DemeFORCE Suture is indicated for use in approximation and/or ligation of soft tissues, including use of 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)

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005 – 510K 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:	Tracy ChadwrickPhone: 305-824-1048tracy.chadwrick@demetech.us
C. Date Summary Prepared:	February 07, 2019
Trade Name:	DemeTECH DemeFORCE Surgical Suture
Common Name:	Ultra-high-molecular-weight polyethylene (UHMWPE)Nonabsorbable Surgical Suture
Classification Name:	Non-absorbable poly(ethylene terephthalate)surgical suture
Product Code:	GAT21 CFR 878.5000Class II

D. Predicate Devices: The DemeTECH UHMWPE Suture is substantially equivalent to the predicates Arthrex (UHMWPE) and Force Fiber OrthoTape Nonabsorbable Suture in which the basic features and intended uses are the same. Any differences between the DemeTECH UHMWPE Suture and the predicates are considered minor and do not raise questions concerning safety and effectiveness.
Teleflex Medical Incorporated, Force Fiber® OrthoTape™ reference 510k number K150438
Arthrex Incorporation, Arthrex (UHMWPE) reference 510k number K122374
E. Device Description:

F. Intended Use:

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DemeFORCE Suture is indicated for use in approximation and/or ligation of soft tissues, including use of allograft tissue for orthopedic surgeries

G. Non-Clinical Tests Performed:
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 41.

COMPARISON TABLE
Comparison Items	Demetech DemeFORCENonabsorbable Suture	Force Fiber®OrthoTape™Nonabsorbable Suture	Arthrex (UHMWPE)Nonabsorbable Suture
Product Code	GAT	GAT	GAT
Common Name	UHMWPE and PolyesterNonabsorbable suture	UHMWPE and PolyesterNonabsorbable suture	UHMWPE and PolyesterNonabsorbable suture
Suture Characteristic	Nonabsorbable multicolorco-braid of UHMWPE andPolyester surgical suture	Nonabsorbable multicolorco-braid of UHMWPE andother materials surgicalsuture	Nonabsorbablemulticolor co-braid ofUHMWPE and othermaterials surgical suture
Labeling	Sterile, Single Use	Sterile, Single Use	Sterile, Single Use
Intended Use	Approximation or ligationof soft tissues	Same, does not includeexclusions in indicationsstatement.	Same, also includescardiovascular as well asrepair of the dura mater.
Technical Characteristics	USP Nonabsorbable suture	USP Nonabsorbablesuture	USP Nonabsorbablesuture
Material	UHMWPE and Polyester(UHMWPE)	UHMWPE alone or withPolyester, nylon 6,6 orpolypropylene (UHMWPE)	UHMWPE and Polyester(UHMWPE)
Sizes	7, 6, 5, 4, 3, 2, 1, 0, 1-0, 2-0	6, 5, 4, 3, 2, 1, 0, 1-0, 2-0	6, 5, 4, 3, 2, 1, 0, 1-0, 2-0
Sterilization	Ethylene Oxide (EO)	Ethylene Oxide (EO)	Ethylene Oxide (EO)

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USP PerformanceRequirements	Suture Material meets or exceedsperformance requirements for"Nonabsorbable Surgical Suture"in USP 41.	Suture Material meets orexceeds performancerequirements for"Nonabsorbable SurgicalSuture" in USP 41.	Suture Material meets orexceeds performancerequirements for"Nonabsorbable SurgicalSuture" in USP 41.
Tensile StrengthRequirements	Suture Material meets or exceedsthe performance requirementsdefined in USP for "TensileStrength" < 881 >	Suture Material meets orexceeds the performancerequirements defined inUSP for "Tensile Strength"< 881 >	Suture Material meets orexceeds the performancerequirements defined inUSP for "Tensile Strength"< 881 >
Needle AttachmentRequirements	Suture Material meets or exceedsthe performance requirementsdefined in USP for "NeedleAttachment" < 871 >	Suture Material meets orexceeds the performancerequirements defined inUSP for "NeedleAttachment" < 871 >	Suture Material meets orexceeds the performancerequirements defined inUSP for "NeedleAttachment" < 871 >
Suture LengthRequirements	Suture Material meets or exceedsthe performance requirementsdefined in USP for "Suture LengthRequirement" (95% of stated labellength)	Suture Material meets orexceeds the performancerequirements defined inUSP for "Suture LengthRequirement" (95% ofstated label length)	Suture Material meets orexceeds the performancerequirements defined inUSP for "Suture LengthRequirement" (95% ofstated label length)
Suture Packaging	Device wound onto inner supportcard, within a Tyvek / Poly pouch	Device wound onto innersupport card, within aTyvek/Poly PrimaryPouch; inside a Tyvek /Poly secondary pouch	Device wound onto innersupport card, within aTyvek / Poly pouch

H. Clinical Tests Performed:

No clinical trials were conducted

l. Conclusion:

DemeTECH DemeFORCE Nonabsorbable Surgical Suture is composed of the same material as are the predicated devices and the same design' being a sterile, flexible, threads meeting the requirements of the United States Pharmacopeia. DemeTECH DemeFORCE Surgical Suture is manufactured in the same manner as the predicate devices in operations considered standard in the fiber industry forming the finished suture fiber in bulk. The manufacturer supplies these bulk fibers to DemeTECH with the same materials as it sells to other suture manufacturers including those with cleared 510K submissions.

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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Based on the 510(k) summaries and the information provided herein we conclude that DemeTECH DemeFORCE Nonabsorbable Surgical Suture is substantially equivalent and as safe and effective as the predicate device.

Regulation Number and Section

§ 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.