DemeDIOX Barbed 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 with the exception of diameter. DemeDIOX Barbed Suture consists of an absorbable monofilament strand thread with spiral unidirectional barbs and is available with or without needles in a suture size 5-0 to 2. The material is dyed with D&C Violet No.2. and contains no additives. The barbing allows for tissue approximation without the use of surgical knots.

AI/ML Overview

The provided text describes the submission of a 510(k) premarket notification for a medical device: DemeDIOX Barbed Absorbable Surgical Suture. This type of submission relies on demonstrating substantial equivalence to a previously legally marketed device (predicate device) rather than proving de novo safety and effectiveness through extensive clinical trials.

Therefore, the study design described is focused on non-clinical testing to demonstrate conformance to established standards and comparison to predicate devices, rather than a clinical study measuring human-in-the-loop performance or outcomes in a clinical setting.

Based on the provided information, here's an analysis of the acceptance criteria and the "study" (non-clinical testing) that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are largely derived from established standards for absorbable surgical sutures, primarily the United States Pharmacopeia (USP) and ISO 10993. The reported device performance demonstrates adherence to these standards and equivalence to predicate devices.

Acceptance Criteria (Derived from USP 42, ISO 10993, and predicate equivalence)	Reported Device Performance (as stated in the 510(k) Summary)
Material Composition	Composed of polyester, poly (p-dioxanone), same as predicate devices.
Sterility	Sterile. Achieved via Ethylene Oxide (EO) sterilization.
Biocompatibility	Conforms to ISO 10993-1. Material (polydioxanone) has
"known biocompatibility" and "established history of use" in surgical sutures.
In-vitro Resorption	Testing conducted to further demonstrate substantial equivalence to predicate devices. (No specific numerical results provided, but stated to support equivalence).
USP 42 Requirements for "Absorbable Surgical Suture"	Suture Material meets or exceeds requirements, with the exception of diameter (due to barbs). This includes:
a. Suture Diameter	Meets USP 42 requirements except for diameter. This deviation is explicitly acknowledged and attributed to the presence of barbs on the suture.
b. Suture Length	Meets or exceeds the performance requirements defined in USP for "Suture Length Requirement" (95% of stated length).
c. Tensile Strength (<881> USP)	Meets or exceeds the performance requirements defined in USP 42 for "Tensile Strength."
d. Needle Attachment (<871> USP)	For sutures supplied with needles, meets or exceeds the performance requirements defined in USP 42 for "Needle Attachment."
Extractable Color	Assured conformance to methods outlined in USP 42. (The device is dyed with D&C Violet No.2).
Physical Properties & Functionality	Assured conformance to suture diameter and length. (Reiterates USP conformance with the noted diameter exception due to barbs). The barbing allows for tissue approximation without knots.
Labeling	Sterile, Single Use. Packaging and labeling conform to 21 CFR standards.
Substantial Equivalence	Demonstrated to be substantially equivalent to the predicate devices (Ethicon PDS Barbed Suture K113004 and DemeTECH Polydioxanone Synthetic Monofilament K082097) in terms of intended use, technical characteristics, material, sterilization, and performance (with the acknowledged exception for diameter due to barbs).

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

Sample Size: The document does not specify the exact sample sizes (e.g., number of sutures tested) for each non-clinical test (tensile strength, diameter, length, etc.). It generally states that "Non-clinical testing was conducted... to prove conformance to the requirements of USP for synthetic absorbable suture, biocompatibility testing in accordance to ISO 10993-1 and in-vitro resorption." and "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 42." These tests typically involve a statistically relevant number of samples to ensure robust results, as outlined in the respective standards (USP, ISO).
Data Provenance: The data is generated from non-clinical laboratory testing performed specifically for this 510(k) submission. No information on the country of origin of the data or whether it was retrospective or prospective is given, but non-clinical tests would inherently be prospective for the purpose of demonstrating conformance.

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

This information is not applicable to this type of submission. Ground truth, in the context of diagnostic AI or image analysis, typically involves expert human annotation or clinical outcomes. For a medical device like a surgical suture, the "ground truth" and acceptance criteria are defined by established performance standards (USP, ISO) and comparison to predicate device characteristics as detailed in their respective 510(k) clearances. The performance is measured against these objective standards through physical and chemical testing, not through expert consensus on a test set.

4. Adjudication Method for the Test Set

This information is not applicable. Adjudication methods (e.g., 2+1, 3+1) are used in studies where human experts are making subjective assessments, often in diagnostic accuracy studies. For testing a physical device like a suture, the "adjudication" is inherent in the standardized testing process where results are objectively measured against defined criteria.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a MRMC comparative effectiveness study was not done.

This type of study is relevant for diagnostic devices, particularly those involving human interpretation (e.g., AI-assisted radiology).
The device in question, DemeDIOX Barbed Absorbable Surgical Suture, is a physical surgical suture, not a diagnostic or AI-powered device that assists human readers.
The submission explicitly states: "No clinical trials were conducted."

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

No, a standalone study (in the context of an algorithm or AI) was not done.

This is not an AI/algorithm-based device.
The performance assessment for this device is based on its physical properties, material characteristics, and biological compatibility as measured directly through laboratory tests and comparisons to predicate devices, not through an algorithm.

7. Type of Ground Truth Used

The "ground truth" used for this device's acceptance is based on:

Established Industry Standards: Primarily the United States Pharmacopeia (USP 42) monographs for absorbable surgical sutures, which define physical and chemical performance requirements (tensile strength, diameter, length, etc.).
International Standards: ISO 10993-1 for biocompatibility.
Predicate Device Characteristics: Demonstrating that the new device is "substantially equivalent" to legally marketed predicate devices (Ethicon PDS Barbed Suture and DemeTECH Polydioxanone Synthetic Monofilament Suture) in terms of intended use, technology, and safety/performance profile.

8. Sample Size for the Training Set

This information is not applicable. This submission is for a physical medical device (surgical suture), not a machine learning model or an AI algorithm. Therefore, there is no "training set" in the sense of data used to train an algorithm. The development of the suture material and manufacturing process would involve internal R&D and quality control, but not a formally defined "training set" for an AI.

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

This information is not applicable as there is no "training set" for an AI algorithm in this context. The "ground truth" for the development and testing of the suture is established by the well-defined and often long-standing scientific and engineering principles of material science, biomaterials, and surgical product design, all guided by regulatory standards like USP and ISO.

Summary

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November 7, 2019

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

Re: K191361

Trade/Device Name: DemeDIOX Barbed Absorbable Surgical Suture Regulation Number: 21 CFR 878.4840 Regulation Name: Absorbable Polydioxanone Surgical Suture Regulatory Class: Class II Product Code: NEW Dated: May 10, 2019 Received: May 21, 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 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

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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 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). 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,

Cindy Chowdhury, Ph.D., M.B.A. Acting Assistant Director DHT4B: Division of Infection Control and Plastic 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) K191361

Device Name

DemeDIOX Barbed Absorbable Surgical Suture

Indications for Use (Describe)

DemeDIOX Barbed polydioxanone suture is indicated for use in soft tissue approximation where use of absorbable sutures is appropriate.

Type of Use (Select one or both, as applicable)
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☒ Registration Use (Part 31 CFR 901.3, Subpart B)	☐ One-Time Contact Use (31 CFR 901.3, Subpart C)
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Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(K) Summary

Submission Date:	11/07/2019
K191361
SUBMITTER INFORMATION:
Company Name:	DemeTECH Corporation
Company Address:	14175 NW 60th Avenue, Miami Lakes, FL 33014
Contact Person:	Tracy ChadwrickPhone: 305-824-1048 Ext 131Tracy.Chadwrick@demetech.us
Device Trade Name:	DemeDIOX Barbed Absorbable Surgical Suture
Device Common Name:	POLYDIOXANONE monofilament synthetic absorbable sutures
Class:	Class II
Classification:	21 CFR 878.4840Absorbable Barbed Polydioxanone Surgical Suture
Product Code:	NEW

Predicate Devices:

The predicate is Ethicon PDS Barbed Suture, 510(k) - K113004 (The primary predicate), and the original DemeTECH Polydioxanone Synthetic Monofilament (PDO) Absorbable Suture, 510(k) -K082097 (Additional predicate).

Device Description:

Intended Use:

DemeDIOX Barbed polydioxanone suture is indicated for use in soft tissue approximation where use of absorbable sutures is appropriate.

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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 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 42.

Substantial Equivalence:

Comparison Items	DemeTECHDemeDIOX BarbedAbsorbable Suture	DemeTECHDemeDIOX AbsorbableSuture	EthiconPDS Barbed Suture(Primary Predicate>
FDA ID#	K191361	K082097	K113004
Product Code	NEW	Same	Same
Common Name	Polydioxanone BarbedAbsorbable Suture	Same	Same
Suture Characteristic	Barbed AbsorbablePolydioxanone surgicalsuture	AbsorbablePolydioxanone surgicalsuture	Same
Labeling	Sterile, Single Use	Same	Same
Intended Use	Soft tissue approximation	Same	Same
Technical Characteristics	Monofilament, syntheticspiral unidirectionalBarbed absorbablesuture is prepared frompolyester, poly-(p-dioxanone)	Monofilament, syntheticnon-Barbed absorbablesuture is prepared frompolyester, poly-(p-dioxanone)	Same
Material	Prepared from polyester,poly-(p-dioxanone)	Same	Same
Sizes	5-0, 4-0, 3-0, 2-0, 1-0, 0, 1, 2	7-0, 6-0, 5-0, 4-0, 3-0, 2-0, 1-0, 0, 1, 2	3-0, 2-0, 1-0, 0, 1
Sterilization	Ethylene Oxide (EO)	Same	Same
USP Requirements	Suture Material meets orexceeds requirements for"Absorbable SurgicalSuture" in USP 42 exceptdiameter.	Suture Material meets orexceeds requirements for"Absorbable SurgicalSuture" in USP 42	Suture Material meets orexceeds requirements for"Absorbable SurgicalSuture" in USP 42 exceptdiameter

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Comparison Items	DemeTECHDemeDIOX BarbedAbsorbable Suture	DemeTECHDemeDIOX AbsorbableSuture	EthiconPDS Barbed Suture(Primary Predicate>
Tensile StrengthRequirements	Suture Material meets orexceeds the performancerequirements defined inthe USP 42 for "TensileStrength" <881>	Same	Same
Needle AttachmentRequirements	Suture Material meets orexceeds the performancerequirements defined inthe USP 42 for "NeedleAttachment" <871>	Same	Same
Suture LengthRequirements	Suture Material meets orexceeds the performancerequirements defined inUSP for "Suture LengthRequirement" (95% of	Same	Same
Suture Packaging	Suture Material ispackaged in a same orequivalent manner withsterile single or doublepackage having labelingconforming to 21 CFR	Same	Same

Clinical Tests Performed:

No clinical trials were conducted

Conclusion:

DemeDIOX Barbed Absorbable Surgical Suture is composed of the same material as the predicated devices DemeTECH DemeDIOX Polydioxanone Absorbable Suture and the Ethicon PDS Barbed Suture. It also has the same design being a sterile, flexible, monofilament absorbable thread meeting all the requirements of the United States Pharmacopeia with the exception diameter due to the small barbs created on the suture. 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 Barbed 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).

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.