"DemeSTEEL" is a stainless steel suture composed of 316L stainless steel with or without needles attached, and is intended for use in abdominal wound closure, intestinal anastomosis, hernia repair, sternal closure and certain orthopedic procedures, including cerclage and tendon repair.

Device Description

Demetech's DemeSTEEL is a Monofilament and/or Multifilament Non-absorbable surgical suture composed of 316L Stainless Steel and supplied with and without needles affixed to the sutures. Demetech's DemeSTEEL Surgical Suture meets the requirements established by the United States Pharmacopeia (U.S.P.) for nonabsorbable surgical sutures. DemeSTEEL Stainless Steel sutures are composed of 316L stainless steel conforming to the FDA recognized ASTM Standard F138 Grade 2 "Stainless steel bar and wire for surgical implants".

AI/ML Overview

This document describes the Demetech Non-Absorbable Stainless Steel Surgical Suture (DemeSTEEL) and its equivalency to predicate devices, primarily through non-clinical testing.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document leverages the United States Pharmacopeia (USP) standards as its primary acceptance criteria. The device is reported to meet or exceed these standards.

Acceptance Criteria (USP Standard)	Reported Device Performance (DemeSTEEL)
Performance requirements for "Non-Absorbable Surgical Suture" (Official Monograph of USP)	Meets or exceeds performance requirements
Performance requirements for "Diameter", Section <661> (USP)	Meets performance requirements
Performance requirements for "Tensile Strength" <881> (USP)	Meets or exceeds performance requirements
Performance requirements for "Needle Attachment" <871> (USP)	Meets or exceeds performance requirements
Performance requirements for "Suture Length Requirement" (95% of stated label length) (USP)	Meets performance requirements
Performance requirements for Sterility (USP and ISO-11137)	Meets performance requirements
Requirements of ASTM F138-13a -- Standard Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for Surgical Implants UNS S31673	Meets requirements
Classification requirements in 21CFR section 878.4495, Identification A stainless steel suture	Meets classification requirements
Biocompatibility: Cytotoxicity, Acute Toxicity, Skin Sensitization, Mutagenicity, Carcinogenicity and Reproductive Toxicity	Performed on 316L stainless steel sutures and considered acceptable due to material's established history

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

The document does not explicitly state the specific sample sizes for each non-clinical test. It generally states that "Non-clinical testing was conducted on the device to prove conformance to the requirements of USP standards." The data provenance is laboratory testing conducted by Demetech, likely in the US, given the company's address and the FDA submission. The data is prospective, generated specifically for this submission.

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

Not applicable. This is a medical device submission primarily based on objective physical and chemical testing against established standards (USP, ASTM). There were no experts involved in establishing a "ground truth" in the way it is typically understood for interpretative tasks (e.g., medical image analysis). The "ground truth" here is adherence to specified material and performance parameters.

4. Adjudication Method for the Test Set:

Not applicable. No adjudications were performed as this primarily involves objective measurements of physical and chemical properties 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:

Not applicable. This is a submission for a surgical suture, not an AI-powered diagnostic or assistive device. Therefore, no MRMC study was conducted or is relevant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

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

7. The Type of Ground Truth Used:

The "ground truth" used is defined by:

Established Industry Standards: United States Pharmacopeia (USP) for non-absorbable surgical sutures, including specific sections for diameter, tensile strength, needle attachment, suture length, and sterility.
Material Specifications: ASTM Standard F138 Grade 2 for 316L stainless steel.
Biocompatibility Standards: Implicitly, common standards for biocompatibility testing for implantable devices, with the 316L material having an "established history of use."

8. The Sample Size for the Training Set:

Not applicable. There is no "training set" as this is not a machine learning or AI-based device.

9. How the Ground Truth for the Training Set Was Established:

Not applicable. As noted above, there is no "training set." The performance of the suture is assessed against predefined, universally accepted physical and chemical standards.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract image of three human profiles facing to the right, stacked on top of each other.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

September 25, 2014

Demetech Corporation Mr. Anthony J. Dimercurio Vice President of Regulatory Affairs/Quality Assurance 14175 Northwest 60th Avenue Miami Lakes, Florida 33014

Re: K141007

Trade/Device Name: Demetech Non-Absorbable Stainless Steel Surgical Suture Regulation Number: 21 CFR 878.4495 Regulation Name: Stainless steel suture Regulatory Class: Class II Product Code: GAQ Dated: August 29, 2014 Received: September 4, 2014

Dear Mr. Dimercurio:

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 (reporting of medical

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device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

David Krause -S

Binita S. Ashar, M.D., M.B.A., F.A.C.S. for Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure

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Image /page/2/Picture/0 description: The image shows the logo for "DemeTECH". To the left of the company name is a blue circle with a white triangle inside. The company name is in bold, black font. To the right of the company name is a registered trademark symbol.

Section 6 Indications for Use Statement

Indication for use

Device Name: Demetech Non-Absorbable Stainless Steel Surgical Suture.

Indication for Use:

Prescription Use Star "X" -And / Or Over the-Counter Use (Part 21 CFR 801; Subpart D) (21 CFR 801; Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Image /page/3/Picture/0 description: The image shows the logo for "DemeTECH". The logo consists of a blue circle with a white triangle inside on the left side. To the right of the circle is the company name "DemeTECH" in bold, black letters. There is a registered trademark symbol next to the "H" in "DemeTECH".

Section 7 - 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 predicate devices listed.

A. Applicant:	Demetech Corporation,14175 NW 60th Ave.Miami Lakes FL. 33014 USA
B. Contact Person	Anthony. J. DimercurioE-mail: tony@demetech.usPhone # 305-824-1048 Ext 115
C. Date Prepared:	April 17th, 2014
Trade Name:	DemeSTEEL Stainless Steel Non-Absorbable Suture
Common Name:	Stainless Steel Suture
Classification Name:	Suture, non-absorbable, steel,monofilament and multifilament,sterile
D. Device Classification:
FDA Class:	Class II
Regulation Number:	878.4495 Stainless steel suture
Code:	GAQ

E. Predicate Devices: Demetech's Stainless Steel Non-absorbable Suture (DemeSTEEL) is substantially equivalent to these predicate devices:
. Look Inc., 316L Stainless Steel surgical sutures reference 510K number K933686, Look Inc. Lonnie Abbott Ind. Blvd. Ada OK 74820
Lukens Medical Corp. Stainless Steel Suture, reference 510K number K930940 via the Lahr Group Mahwah, NJ.
Ethicon's, Stainless Steel Suture reference 510K number, K931271, Ethicon 0 Inc. Somerville NJ.

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F. Device Description:

G. Intended Use:

DemeSTEEL is a stainless steel suture composed of 316L stainless steel, with or without needles attached, and is intended for use in abdominal wound closure, intestinal anastomosis, hernia repair, sternal closure and certain orthopedic procedures, including cerclage and tendon repair.

H. Non-Clinical Tests Performed:

Non-clinical testing was conducted on the device to prove conformance to the requirements of USP standards and to demonstrate substantial equivalence to the predicate devices. Physical properties and functionality testing assures the device conforms with suture diameter, suture length, knot pull and/or straight pull tensile strength, needle attachment strength, and sterility, methods outlined in USP 36. Demetech's DemeSTEEL Sutures meets all In-house and United States Pharmacopeia specifications and is equivalent to the above mentioned predicate devices.

DemeSTEEL is manufactured with 316L Stainless Steel, selected based on known biocompatibility and established history of use in the medical device industry for implantable devices, and is identical and equivalent to the Stainless Steel 316L used in the predicate devices listed above. Biocompatibility testing performed on 316L stainless steel sutures included within this submission, the following: Cytotoxicity. Acute Toxicity, Skin Sensitization, Mutagenicity, Carcinogenicity and Reproductive Toxicity.

COMPARISON TABLE DEMETECH DemeSTEEL TO PREDICATE DEVICES
Comparison Items	DemetechStainlessSteelSuture	Look 316LStainlessSteelSuture	LukensMedicalStainlessSteel Suture	EthiconStainlessSteel Suture
DemeSTEEL Stainless Steel suture us a Non-Absorbable surgical suture. It is a sterile flexibleMonofilament or Multifilament thread, composed of316L Steel	≡	Same	Same	Same
DemeSTEEL suture is un-dyed silver metallic andis un-coated.	≡	Same	Same	Same

DemeSTEEL is a stainless steel suture composedof 316L stainless steel, is intended for use inabdominal wound closure, intestinal anastomosis,hernia repair, sternal closure and certainorthopedic procedures, including cerclage andtendon repair	≡	Same	Same	Same
DemeSTEEL suture is supplied for single use only	≡	Same	Same	Same
DemeSTEEL suture is sterilized by GammaIrradiation Sterilization	≡	Same	Same	Same
DemeSTEEL suture is packaged in the same orequivalent manner, and has the same orequivalent labeling claims as that of the predicatedevices including indications, warnings, cautionsand precautions	≡	Same	Same	Same
DemeSTEEL suture meets or exceeds theperformance requirements for "Non-AbsorbableSurgical Suture" as defined in the OfficialMonograph of the United States Pharmacopeia.	≡	Same	Same	Same
DemeSTEEL suture meets the performancerequirements for "Diameter", Section <661> asdefined in the United States Pharmacopeia.	≡	Same	Same	Same
DemeSTEEL suture meets or exceeds theperformance requirements defined in the UnitedStates Pharmacopeia for "Tensile Strength" <881>	≡	Same	Same	Same
DemeSTEEL suture meets or exceeds theperformance requirements defined in the UnitedStates Pharmacopeia and the current edition USPfor "Needle Attachment" < 871 >	≡	Same	Same	Same
DemeSTEEL suture meets the performancerequirements defined in the United StatesPharmacopeia for "Suture Length Requirement"(95% of stated label length)	≡	Same	Same	Same
DemeSTEEL suture meets the performancerequirements defined in the United StatesPharmacopeia current edition U.S.P. for sterilityand per ISO-11137	≡	Same	Same	Same
DemeSTEEL Suture is packaged in a same orequivalent manner with sterile single or doublepackage having labeling conforming to 21 CFRand Current edition of USP.	≡	Same	Same	Same
DemeSTEEL Meets the requirements of ASTMF138-13a-- Standard Specification for Wrought18Chromium-14Nickel-2.5Molybdenum StainlessSteel Bar and Wire for Surgical Implants UNSS31673	≡	Same	Same	Same
DemeSteel Stainless Steel 316L meets theClassification requirements in 21CFR section878.4495, Identification A stainless steel suture,needled or without needles, is a non-absorbablesuture composed of 316L stainless steel.	≡	Same	Same	Same

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Note: "≡"; Signifies the Demetech statement is identical to each of the predicate devices.

l. Clinical Tests Performed:

No clinical trials were conducted or required for this submission

J. Conclusion:
DemeSteel Sutures are composed of the same suture materials, "an implantable surgical grade 316L Stainless Steel suture", as are the predicated devices, having the same design, being a sterile, flexible, Monofilament and/or Multifilament threads meeting all the requirements of the United States Pharmacopeia. Demetech's DemeSteel Sutures are manufactured in the same manner as the predicate devices, being composed of a monofilament or multifilament 316L stainless steel thread or wire, with or without attached needles. Our supplier produces the treads or wire, in operations considered standard in the industry to manufacture and form the stainless steel suture material. Our vendor supplies to Demetech the same stainless steel grade 316L suture materials as it does to other suture manufacturers, including some of those listed as predicates in this submission.

Regulation Number and Section

§ 878.4495 Stainless steel suture.

(a)
Identification. A stainless steel suture is a needled or unneedled nonabsorbable surgical suture composed of 316L stainless steel, in USP sizes 12-0 through 10, or a substantially equivalent stainless steel suture, intended for use in abdominal wound closure, intestinal anastomosis, hernia repair, and sternal closure.(b)
Classification. Class II (special controls). The device, when it is a steel monofilament suture that is uncoated and does not incorporate barbs, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9. 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.