DemeDIOX Absorbable Surgical Suture is indicated for use in general soft tissue approximation including pediatric cardiovascular tisue where growth is expected to occur and ophthalmic surgery, but not for use in adult cardiovascular, microsurgery and neural tissue. These sutures are useful where absorbable suture with extended wound support (up to six weeks) is desirable.

Device Description

DemeDIOX Absorbable Surgical Suture is an absorbable, sterile surgical monofilament suture composed of polyester, poly (p-dioxanone). The DemeTECH Suture meets all requirements in the latest edition of the USP monograph for absorbable surgical sutures and the modification from the existence 510k K082097 is that thread is winded around the needle, a foam needle park is applied to the needle to securely hold the needle in place with the thread. One to four needles will be placed in a suture size 6-0, 5cm length, no thread attached to the needle. The material is dyed violet or un-dyed and contains no additives.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device, the DemeDIOX Absorbable Surgical Suture. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study for an AI/algorithm-based medical device. Therefore, much of the requested information regarding AI study details (like sample size for test/training sets, experts for ground truth, MRMC studies, standalone performance, etc.) is not applicable or cannot be extracted from this document, as it pertains to a physical surgical suture.

However, I can extract the acceptance criteria and the "device performance" in terms of compliance with standards and equivalence to the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

For DemeDIOX Absorbable Surgical Suture, the "acceptance criteria" are compliance with established regulatory and pharmacopeial standards, and "device performance" is demonstrated by meeting or exceeding these requirements and showing substantial equivalence to a predicate device.

Acceptance Criteria (Standard/Requirement)	Reported Device Performance (Compliance/Equivalence)
USP Monograph for Absorbable Surgical Sutures (latest edition/USP 40/41)	DemeTECH Suture meets all requirements in the latest edition of the USP monograph for absorbable surgical sutures.
Suture Diameter and Suture Length	Physical properties and functionality testing assured that the device conformed with suture diameter and suture length (methods outlined in USP 41). Suture Material meets or exceeds the performance requirements defined in USP for "Suture Length Requirement" (95% of stated label length).
Extractable Color	Physical properties and functionality testing assured that the device conformed with extractable color (methods outlined in USP 41).
Sterility	Physical properties and functionality testing assured that the device conformed with sterility (methods outlined in USP 41). Labeling specifies "Sterile, Single Use". Sterilization method is Ethylene Oxide (EO).
Biocompatibility (ISO 10993-1)	Biocompatibility testing was conducted in accordance with ISO 10993-1. DemeTECH's material used was selected based on known biocompatibility (per ISO 10993) and established history of use in the surgical suture industry. Biocompatibility data demonstrated substantial equivalence.
In-vitro and In-vivo Resorption	In-vitro and in-vivo resorption testing was conducted to further demonstrate substantial equivalence to the predicate devices.
Predicate Device Equivalence (K082097)	DemeDIOX Absorbable Surgical Suture is composed of the same material (Polydioxanone) and has the same design (sterile, flexible, monofilament absorbable thread) as the predicate device. It shares the same product code (NEW), common name (Polydioxanone Absorbable Suture), suture characteristic (absorbable Polydioxanone surgical suture), labeling (Sterile, Single Use), intended use (soft tissue approximation), technical characteristics (monofilament, synthetic absorbable suture prepared from polyester, poly-(p-dioxanone)), material (prepared from polyester, poly-(p-dioxanone)), and sterilization method (Ethylene Oxide (EO)). Most USP performance requirements for "Absorbable Surgical Suture" in USP 40 are met or exceeded, with exceptions for Tensile Strength and Needle Attachment due to specific product configuration (see below).
Tensile Strength Requirements (USP 40 for "Tensile Strength" <881>)	Exception: Length of the thread is too short to perform the knot pull (for the specific configuration tested: suture size 6-0, 5cm length, no thread attached to the needle).
Needle Attachment Requirements (USP 40 for "Needle Attachment" <871>)	Exception: Thread is not attached to the needle (for the specific configuration tested: suture size 6-0, 5cm length, no thread attached to the needle).
Suture Packaging	Suture Material is packaged in the same or equivalent manner with sterile single or double package having labeling conforming to 21 CFR and USP 40.

Regarding the study that proves the device meets the acceptance criteria:

The "study" in this context refers to a series of non-clinical tests and demonstrations of equivalence to a legally marketed predicate device.

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

Sample Size for Test Set: Not explicitly stated as a number of "samples" in the traditional sense of a clinical trial or AI dataset. The testing was done on the DemeDIOX Absorbable Surgical Suture itself, likely using batches or representatives of the manufactured suture according to standard test methods for medical devices (e.g., USP monographs).
Data Provenance: Not specified. Being a US FDA submission, the tests were presumably conducted in facilities adhering to relevant good laboratory practices (GLP), but the country of origin of the specific data is not mentioned.
Retrospective or Prospective: Not applicable in the conventional sense for non-clinical device testing. These were pre-market, non-clinical performance and equivalence tests conducted specifically for this submission.

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. This device is a physical surgical suture, not an AI/algorithm-based diagnostic device where expert ground truth establishment for a test set would be relevant. Compliance was assessed against established pharmacopeial and ISO standards.

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

Not applicable. This is not an AI/algorithm study involving human interpretation or adjudication.

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 physical medical device (surgical suture), not an AI-assisted diagnostic tool.

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

Not applicable. This is a physical medical device.

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

The "ground truth" for the device's performance is established by its compliance with:

The United States Pharmacopeia (USP) monographs for absorbable surgical sutures (e.g., USP 40, USP 41).
ISO 10993-1 for biocompatibility.
General device requirements and FDA Guidance for Surgical Sutures 510(k).
These are objective, quantitative standards for material properties, sterility, and biological safety.

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI algorithm requiring a training set.

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

Not applicable. This is a physical medical device.

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 & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

August 27, 2018

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

Re: K181582

Trade/Device Name: DemeTECH DemeDIOX absorbable surgical suture Regulation Number: 21 CFR 878.4840 Regulation Name: Absorbable Polydioxanone Surgical Suture Regulatory Class: Class II Product Code: NEW Dated: June 12, 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. 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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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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 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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Indications for Use

510(k) Number (if known) K181582

Device Name DemeDIOX Absorbable Surgical Suture

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)

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Image /page/3/Picture/0 description: The image contains the logo for "DemeTECH". To the left of the company name is a circular logo with a triangle in the center. The triangle is light blue and the circle is a gradient of light blue. The company name is in bold, black font, and the registered trademark symbol is to the right of the company name.

006 - 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:	June 12, 2018
Trade Name:	DemeDIOX Absorbable Surgical Suture
Common Name:	POLYDIOXANONE monofilament syntheticabsorbable sutures Suture
Classification Name:	Absorbable expanded Polydioxanonesurgical suture
Product Code:	NEW21 CFR 878.4840Class II

D. Predicate Device:

The predicate is the original DEMETECH POLYDIOXANONE SYNTHETIC MONOFILAMENT (PDO) ABSORBABLE SUTURE, 510K K082097.

E. Device Description:

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Image /page/4/Picture/0 description: The image contains the logo for DemeTECH. On the left side of the logo is a blue circle with a white triangle inside. To the right of the circle is the company name, "DemeTECH", in bold, black letters. A registered trademark symbol is located to the right of the company name.

F. Intended Use:

DemeDIOX Absorbable Surgical Suture is indicated for use in general soft tissue approximation including pediatric cardiovascular tissue where growth is expected to occur and ophthalmic surgery, but not for use in adult cardiovascular, microsurgery and neural tissue. These sutures are useful where absorbable suture with extended wound support (up to six weeks) is desirable.

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 and suture length, extractable color and sterility to methods outlined in USP 41.

Comparison Items	DemeDIOX DemetechAbsorbable Suture	Demetech PolydioxanoneAbsorbable Suture
Product Code	NEW	Same
Common Name	Polydioxanone Absorbable Suture	Same
Suture Characteristic	Absorbable Polydioxanone surgicalsuture	Same
Labeling	Sterile, Single Use	Same
Intended Use	Soft tissue approximation	Same
Technical Characteristics	Monofilament, synthetic absorbablesuture is prepared from polyester, poly-(p-dioxanone)	Same
Material	Prepared from polyester,poly-(p-dioxanone)	Same
Sizes	6-0	2-0, 3-0, 4-0, 5-0, 6-0
Sterilization	Ethylene Oxide (EO)	Same
USP PerformanceRequirements	Suture Material meets or exceedsperformance requirements for"Absorbable Surgical Suture" in USP 40.	Same

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Comparison Items	DemeDIOX DemetechAbsorbable Suture	Demetech PolydioxanoneAbsorbable Suture
Tensile StrengthRequirements	Length of the thread is too short toperform the knot pull	Suture Material meets orexceeds the performancerequirements defined in the USP40 for "Tensile Strength" <881>
Needle AttachmentRequirements	Thread is not attached to the needle	Suture Material meets orexceeds the performancerequirements defined in the USP40 for "Needle Attachment"<871>
Suture LengthRequirements	Suture Material meets or exceeds theperformance requirements defined inUSP for "Suture Length Requirement"(95% of stated label length)	Same
Suture Packaging	Suture Material is packaged in a same orequivalent manner with sterile single ordouble package having labelingconforming to 21 CFR and USP 40.	Same

H. Clinical Tests Performed:

No clinical trials were conducted

l. Conclusion:

DemeDIOX Absorbable Surgical Suture is composed of the same material as the predicated device Demetech Polydioxanone Absorbable Suture and has the same design being a sterile, flexible, monofilament absorbable thread meeting all the requirements of the United States Pharmacopeia with the exception of the needle attachment and knot pull. 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 DemeDIOX Absorbable 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 shows the DemeTECH logo. The logo consists of a light blue triangle on the left and the word "DemeTECH" in black on the right. The triangle is a three-dimensional shape with a light blue color and a white outline. The word "DemeTECH" is in a bold, sans-serif font.

Based on the 510(k) summaries and the information provided herein we conclude that DemeTECH DemeDIOX Absorbable Surgical Suture is substantially equivalent and are safe and effective for its intended purpose.

Regulation Number and Section

§ 878.4840 Absorbable polydioxanone surgical suture.

(a)
Identification. An absorbable polydioxanone surgical suture is an absorbable, flexible, sterile, monofilament thread prepared from polyester polymer poly (p-dioxanone) and is intended for use in soft tissue approximation, including pediatric cardiovascular tissue where growth is expected to occur, and ophthalmic surgery. It may be coated or uncoated, undyed or dyed, and with or without a standard needle attached.(b)
Classification. Class II (special controls). The special control for the 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.