DYNATAPE™ Suture is a sterile non-absorbable orthopedic suture. DYNATAPE™ Suture has a double sheath and core design, composed of Ultra High Molecular Weight Polyethylene and Polyester, with or without colorants, as well as a Silicone/NaCl core. DYNATAPE™ Suture's outer sheath is braided flat, with rounded tips.

AI/ML Overview

The provided text does not describe acceptance criteria for a medical device's performance in the context of clinical or diagnostic accuracy studies. Instead, it refers to the DYNATAPETM Suture, a non-absorbable orthopedic suture, and its substantial equivalence to a predicate device.

The "acceptance criteria" mentioned relate to non-clinical testing for material properties and regulatory compliance, not performance in a diagnostic or clinical accuracy sense. Specifically, the text states:

USP Knot Tensile Strength: The DYNATAPE™ Suture "meets USP knot tensile strength for size 2 non-absorbable sutures."
In-vitro approximation force over time: This testing was conducted to demonstrate the laxity resistance of the suture.
Sterility testing: Testing was conducted.
Biocompatibility, stability, in-vivo testing of the predicate device: These were included by reference (K181182).
Bacterial endotoxin testing: Completed as part of another submission (K200949), meeting endotoxin limits.

The study presented is a 510(k) Premarket Notification, which aims to demonstrate that a device is "substantially equivalent" to a legally marketed predicate device. This is a regulatory pathway, not a clinical trial to establish device performance in terms of diagnostic accuracy or comparative clinical effectiveness.

Therefore, most of your specific questions regarding sample size, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set information are not applicable to the information provided in this document, as it focuses on non-clinical testing and substantial equivalence.

Here's a breakdown of what can be extracted and why other parts are not applicable:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (Non-clinical)	Reported Device Performance
USP knot tensile strength for size 2 non-absorbable sutures	DYNATAPE™ Suture "meets USP knot tensile strength for size 2 non-absorbable sutures."
Laxity resistance (in-vitro approximation force)	DYNATAPE™ and DYNACORE™ sutures are "laxity resistant, as shown by approximation force testing."
Sterility	Sterility testing conducted.
Biocompatibility	Included by reference to predicate device (K181182).
Stability	Included by reference to predicate device (K181182).
In-vivo performance	Included by reference to predicate device (K181182).
Bacterial endotoxin limits	Testing completed (as part of K200949), meeting limits.

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

The document describes non-clinical laboratory testing (e.g., mechanical property tests, sterility tests). It does not provide details on specific sample sizes for these tests, nor does it refer to a "test set" in the context of patient data or clinical studies. Data provenance (country, retrospective/prospective) is not applicable or provided for these types of non-clinical tests.

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. "Ground truth" in this context refers to clinical outcomes or expert diagnoses, which are not part of this 510(k) summary for a surgical suture based on non-clinical testing.

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

Not applicable. This pertains to clinical studies involving multiple readers or evaluators, not non-clinical laboratory testing of a device's material properties.

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 about a surgical suture, not a diagnostic imaging device or an AI-assisted system.

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

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

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

For the non-clinical tests described, the "ground truth" would be established by standardized testing methods and specifications (e.g., USP standards for tensile strength) rather than expert clinical consensus or pathology.

8. The sample size for the training set

Not applicable. There is no mention of a "training set" as this document is not about an algorithm or machine learning model.

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

Not applicable. See point 8.

Summary

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March 18, 2021

Medos International SARL % Tatyana Korsunsky Regulatory Affairs Technical Manager DePuy Mitek, a Johnson and Johnson company 325 Paramount Drive Raynham, Massachusetts 02767

Re: K203186

Trade/Device Name: DYNATAPE Suture Regulation Number: 21 CFR 878.5000 Regulation Name: Nonabsorbable Poly(Ethylene Terephthalate) Surgical Suture Regulatory Class: Class II Product Code: GAT Dated: October 25, 2020 Received: October 27, 2020

Dear Tatyana Korsunsky:

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

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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 (OS) 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. 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) K203186

Device Name DYNATAPETM Suture

Indications for Use (Describe)

DYNATAPE suture is indicated for orthopedic procedural use in soft-tissue approximation, and or ligation, including use with allograft tissue.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k) SUMMARY

DYNATAPE™ Suture

Date Prepared: February 09, 2021

Submitter'sName andAddress	DePuy Synthes Mitek Sports Medicinea Johnson & Johnson company325 Paramount DriveRaynham, MA 02767On behalf of:Medos International SARLChemin-Blanc 38, Le Locle NeuchatelCH 2400, Switzerland
Contact Person	Tatyana KorsunskyRegulatory Affairs Technical ManagerDePuy Synthes Mitek Sports Medicinea Johnson & Johnson company325 Paramount DriveRaynham, MA 02767Telephone: 508-828-3122e-mail: tkorsuns@its.jnj.com
Name ofMedical Device	Proprietary Name: DYNATAPE™ SutureClassification Name: Polyethylene, suture, nonabsorbable, synthetic (21 CFR 878.5000)Common Name: Suture
SubstantialEquivalence	The DYNATAPE™ Suture is substantially equivalent to:K181182 DYNACORD™ Suture (MEDOS International SARL) Reference devices: K200949 HEALIX ADVANCE™ Anchor with DYNATAPE™ Suture (MEDOS International SARL) K183506 HEALIX ADVANCE™ Anchor with DYNACORD™ Suture (MEDOS International SARL) K021434, K041553 FiberWire® (Arthrex)
DeviceClassification	DYNATAPETM Suture is classified as:
	Polyethylene, suture, nonabsorbable, synthetic, classified as Class II, product codeGAT, regulated under 21 CFR 878.5000.
DeviceDescription	DYNATAPE™ Suture is a sterile non-absorbable orthopedic suture. DYNATAPE™Suture has a double sheath and core design, composed of Ultra High MolecularWeight Polyethylene and Polyester, with or without colorants, as well as aSilicone/NaCl core. DYNATAPE™ Suture's outer sheath is braided flat, withrounded tips.
TechnologicalCharacteristics	The DYNATAPE™ Suture is a surgical suture, that meets USP knot tensile strengthfor size 2 non-absorbable sutures. As DYNATAPE™ Suture is flat, it does not followUSP suture diameter requirements. DYNATAPE™ Suture's outer sheath is braidedflat to allow for a wider contact area with tissue.
	When DYNATAPE™ Suture is placed in an aqueous environment, the salt particleswithin the silicone core elute out, leaving behind a micro-porous structure within thesilicone core. These small voids are consequently filled with surrounding fluid as thecore hydrates, resulting in a radial expansion of the suture. If laxity is present, thisradial expansion of the braid causes an axial shortening of the total suture length.The self-tensioning property of DYNATAPE™ Suture is designed to resist laxity andminimize gap formation in a repair, by maintaining approximation force(compression) if laxity (looseness) is present.
Comparison tothe PredicateDevices	The DYNATAPE™ Suture, similar to the predicate device DYNACORD®(K181182), meets USP knot tensile requirements for size 2 suture. Both subject andpredicate device have the same indications, intended use and materials. BothDYNATAPE™ and DYNACORE™ sutures are laxity resistant, as shown byapproximation force testing.The sheath of the DYNATAPE™ Suture has been redesigned with a unique braidingpattern of ticker fibers to create the flattened structure specific to DYNATAPE™
	Suture, differentiating from the predicate device.DYNATAPE™ Suture is offered as a suture component of the reference predicateHEALIX ADVANCE™ Anchor with DYNATAPE™ Suture (K200949).
Indications forUse	DYNATAPE suture is indicated for orthopedic procedural use in soft-tissueapproximation, and/ or ligation, including use with allograft tissue.
Non clinicalTesting	USP Knot Tensile Strength, in-vitro approximation force over time, and sterilitytesting have been conducted. Biocompatibility, stability, in-vivo testing of thepredicate device were included by reference (K181182). Bacterial endotoxin testing

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	has been completed as part of the HEALIX ADVANCE™ Anchor with DYNATAPE™ Suture (K200949), meeting the endotoxin limits.
Safety and Performance	Results of non-clinical testing have demonstrated that the proposed devices are suitable for their intended use. Based on similarities in the indications for use, technological characteristics, and performance in comparison to the predicate device, the proposed DYNATAPE™ Suture has shown to be substantially equivalent to the predicate device under the Federal Food, Drug and Cosmetic Act.

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.