The devices may be used in either arthroscopic or open surgical procedures. After suture is anchored to the bone, it may be used to reattach soft tissue, such as ligaments, tendons, or joint capsules to the suture anchor system thereby stabilizes the damaged soft tissue, in conjunction with appropriate immobilizations, throughout the healing period.

Device Description

The CONMED Y-Knot® OneStep™ Anchors are manufactured from High Strength Flat Braided Suture and threaded with either one or two #2 (5 metric) Hi-Fi® suture strands or suture ribbon. Y-Knot® OneStep anchors are provided single-use, sterile, and preloaded onto a disposable inserter. The anchors, sutures and disposable inserter are EO Sterilized.

AI/ML Overview

This is a 510(k) premarket notification for a medical device called the Y-Knot® OneStep™ Anchor, which is intended for reattaching soft tissue to bone in orthopedic surgical procedures. The document establishes substantial equivalence to a predicate device, the Y-Knot® Flex All-Suture Anchor.

Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly present a table of acceptance criteria with specific quantitative thresholds. Instead, it describes a series of tests conducted to demonstrate that the proposed device performs as intended and is substantially equivalent to the predicate device. The performance is assessed by comparing the device's characteristics and the results of various verification and validation tests to those of the predicate.

Acceptance Criterion (Implicit)	Reported Device Performance
Similarity in Design, Materials, Intended Use, Principles of Operation, and Technical Characteristics to Predicate Device	The Y-Knot® OneStep™ Anchor is manufactured from High Strength Flat Braided Suture and threaded with either one or two #2 (5 metric) Hi-Fi® suture strands or suture ribbon. It is provided single-use, sterile, and preloaded onto a disposable inserter. The anchors, sutures, and disposable inserter are EO Sterilized. The intended use and indications for use are nearly identical to the predicate device, focusing on reattaching soft tissue to bone in orthopedic surgical procedures (arthroscopic or open) to stabilize damaged soft tissue during healing. The contraindications and components (All-Suture Anchor, Disposable Inserter, Suture) are also the same. Technologically, both are flat-braid suture anchors, with expandable design, and flexible inserters. Both are single-use and sterilized by EtO to a Sterility Assurance Level (SAL) of 10-6. Biocompatibility materials met ISO 10993-1 and FDA Guidance requirements. The primary difference noted is the inclusion of "suture ribbon" option for the proposed device and "one or two #2 sutures or ribbon" compared to "two #2 sutures" for the predicate, and a longer shelf life for the predicate (5 years) vs. the proposed device (18 months); however, the overall conclusion states these differences present no new issues of safety and efficacy.
Performance as Intended	Testing has been completed to demonstrate that the Y-Knot® OneStep™ Anchor performs as intended. Specific tests conducted include: - Verification Testing: Reliability, Fixation/Pull Out, Displacement, Cyclic, Sterilization, Pyrogen, Biocompatibility, Shelf-life, Transportation, Post Aging Functional Testing, MR Safety Testing. - Validation Testing: User Validation, Packaging And Labeling. Bacterial endotoxin testing was conducted and met endotoxin limits. The document concludes that based on the performance testing findings, the device is substantially equivalent to the predicate.
Safety and Efficacy (Implicit through Substantial Equivalence)	The document explicitly states: "Based upon the findings of our performance testing, the differences present no new issues of safety and efficacy, and the Y-Knot® OneStep™ Anchor is substantially equivalent to the Y-Knot® Flex All-Suture Anchor (K131035)." This implies that the device achieved performance levels comparable to a legally marketed device known to be safe and effective for its indicated use.

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

The document does not provide details on the sample sizes used for the various tests (e.g., Reliability, Fixation/Pull Out, Displacement, Cyclic, etc.) nor does it specify the data provenance (e.g., country of origin, retrospective or prospective). These tests are typically conducted in a laboratory setting on device prototypes or manufactured units rather than on patient data.

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

This information is not provided in the document. For a physical device like a suture anchor, "ground truth" is typically established through adherence to engineering specifications, validated test methods, and comparison against established performance benchmarks (often derived from predicate devices or industry standards), rather than expert medical opinion on a specific "test set" of cases in the way it would be for an AI diagnostic device. The "User Validation" mentioned under validation testing might involve experts, but no details are given.

4. Adjudication Method for the Test Set:

This information is not provided and is generally not applicable to the type of performance testing described for a mechanical medical device. Adjudication methods like 2+1 or 3+1 are relevant for clinical studies or studies establishing ground truth for diagnostic devices, particularly with ambiguous cases.

5. If a Multi-Reader, Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:

No MRMC comparative effectiveness study was mentioned or performed. This type of study is relevant for diagnostic devices, particularly those involving interpretation of medical images or data by human readers, and comparing their performance with and without AI assistance. The Y-Knot® OneStep™ Anchor is a surgical implant.

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

This concept is not applicable to the Y-Knot® OneStep™ Anchor, as it is a physical medical device and not an algorithm or AI system.

7. The Type of Ground Truth Used:

For this device, the "ground truth" for the performance tests would be established by:

Engineering Specifications: The device met pre-defined mechanical and material properties.
Validated Test Methods: Performance tests (e.g., pull-out strength, displacement, cyclic loading) were conducted according to established, validated protocols.
Predicate Device Performance: The results from the new device's tests were compared against the known performance characteristics of the legally marketed predicate device to demonstrate substantial equivalence.
Regulatory Standards: Biocompatibility testing met ISO 10993-1 and FDA Guidance, and sterilization achieved a SAL of 10-6.

8. The Sample Size for the Training Set:

This information is not applicable as there is no "training set" in the context of a physical medical device like a suture anchor. Training sets are used in machine learning for AI algorithms.

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

This information is not applicable for the same reason as point 8.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & Drug Administration (FDA). On the left, there is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

January 22, 2020

ConMed Corporation Carrie Engleman Lead Regulatory Affairs Specialist 525 French Road Utica, New York 13502

Re: K193606

Trade/Device Name: Y-Knot® OneStep™ Anchor Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: MBI Dated: December 20, 2019 Received: December 23, 2019

Dear Ms. Engleman:

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,

Laura C. Rose, Ph.D. Acting Assistant Director DHT6C: Division of Restorative, Repair, and Trauma Devices OHT6: Office of Orthopedic 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)

K193606

Device Name Y-Knot® OneStep™ Anchor

Indications for Use (Describe)

The non-absorbable implant is intended to reattach soft tissue to bone in orthopedic surgical procedures.

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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510(k) SUMMARY

In accordance with the requirements of the Safe Medical Device Act of 1990 and 21 CFR 807.92, CONMED Corporation is hereby submitting the 510(k) Summary of Safety and Effectiveness for 510(k) Number

I. SUBMITTER

CONMED Corporation 525 French Road Utica, New York 13502

Phone: 727-399-5574 Fax: 727-399-5264

Contact Person: Carrie Engleman Date Prepared: December 20, 2019

II. DEVICE NAME

Device Name:	Y-Knot® OneStep™ Anchor
Classification Name:	Fastener, fixation, nondegradable, soft tissue
Regulatory Class:	Class II, per 21 CFR Part 888. 3040
Product Codes:	MBI

III. PREDICATE/ LEGALLY MARKETED DEVICE

Device Name:	Y-Knot® Flex All-Suture Anchor
Company Name:	ConMed Linvatec
510(k) #:	K131035

DEVICE DESCRIPTION IV.

V. INTENDED USE/ INDICATIONS FOR USE

The non-absorbable implant is intended to reattach soft tissue to bone in orthopedic surgical procedures.

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The devices may be used in either arthroscopic or open surgical procedures. After suture is anchored to the bone, it may be used to reattach soft tissue, such as ligaments, tendons, or joint capsules to the bone. The suture anchor system thereby stabilizes the damaged soft tissue, in conjunction with appropriate postoperative immobilization, throughout the healing period.

COMPARISON OF THE TECHNOLOGICAL CHARACTERISTICS WITH THE VII. PREDICATE DEVICE

The following table represents a summary of the technological characteristics between the proposed and the predicate device.

	Y-Knot® OneStep™Anchor Proposed Device	Y-Knot® Flex All-SutureAnchor, w/ Two #2 (5metric) Hi-Fi Sutures,1.8mmPredicate Device
Device Description	The CONMED Y-Knot®OneStep™ Anchor Systemare manufactured from HighStrength Flat Braided Sutureand threaded with either oneor two #2 (5 metric) Hi-Fi®suture strands or sutureribbon. Y-Knot OneStepanchors are provided single-use, sterile, and preloadedonto a disposable inserter.The anchors, sutures anddisposable inserter are EOSterilized.	ConMed Linvatec Y-Knot®Flex All-Suture Anchor ismanufactured from HighStrength Flat BraidedSuture and threaded witheither one or two #2 (5metric) Hi-Fi® suturestrands. Y-Knot anchors areprovided single-use, sterile,and preloaded on adisposable inserter. Theanchor, suture anddisposable inserter are EOSterilized.
Intended Use	The non-absorbable implantis intended to reattach softtissue to bone in orthopedicsurgical procedures.	The non-absorbable sutureanchor is intended toreattach soft tissue to bonein orthopedic surgicalprocedures.
Indication for Use	The devices may be used ineither arthroscopic or opensurgical procedures. Aftersuture is anchored to thebone, it may be used toreattach soft tissue, such asligaments, tendons, or jointcapsules to the bone. Thesuture anchor system	The devices may be used ineither arthroscopic or opensurgical procedures. Aftersuture is anchored to thebone, it may beused to reattach soft tissue,such as ligaments, tendons,or joint capsules to the
	thereby stabilizes the	bone. The suture anchor
	damaged soft tissue, in	systems thereby
	conjunction with	stabilize the damaged soft
	appropriate postoperative	tissue, in conjunction with
	immobilization, throughout	appropriate postoperative
	the healing period.	immobilization, throughout
		the healing period.
Contraindications	1. Pathological conditionsof bone which wouldadversely affect Y-Knotanchors.2. Pathological conditions inthe soft tissue to berepaired or reconstructedwhich would adverselyaffect suture fixation.3. Physical conditions thatwould eliminate, or tendto eliminate, adequateimplant support or retardhealing.4. Conditions which tend tolimit the patient's abilityor willingness to restrictactivities or followdirections during thehealing period.5. Attachment of artificialligaments or otherimplants.6. Foreign body sensitivity,known or suspectedallergies to implant and/orinstrument materials.7. This device is notapproved for screwattachment or fixation tothe posterior elements(pedicles) of the cervical,thoracic or lumbar spine.8. Patients with active sepsisor infection.	Same
Components	All-Suture AnchorDisposable InserterSuture	All-Suture AnchorDisposable InserterSuture

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TechnologicalCharacteristics	Flat-braid suture anchorOne or two #2 sutures orribbonPilot hole drilled withinserterPress-fit insertionExpandable designFlexible Inserter	Flat-braid suture anchorTwo #2 suturesPilot hole drilled withdisposable drill bitPress-fit insertionExpandable designFlexible Inserter
Single Use/Reusable	Single-Use	Same
Sterilization	EtOSterility Assurance Level(SAL) of 10-6	Same
Biocompatibility	Materials are Biocompatibleand met the requirements ofan acceptable biologicalevaluation per ISO 10993-1and FDA Guidance	Same
Shelf Life	18-months	5-years

PERFORMANCE DATA

Testing has been completed to demonstrate that the Y-Knot® OneStep™ Anchor performs as intended and is substantially equivalent to the predicate device. Bacterial endotoxin testing was conducted and met the endotoxin limits.

Completed testing includes the following:

Verification Testing

Reliability ●
Fixation/Pull Out ●
Displacement ●
Cyclic ●
Sterilization ●
Pyrogen
Biocompatibility ●
Shelf-life ●
Transportation ●
Post Aging Functional Testing ●
MR Safety Testing ●

Validation Testing

User Validation .
Packaging And Labeling .

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VIII. CONCLUSION

Y-Knot® OneStep™ Anchor is substantially equivalent in design, materials, intended use, principles of operation, and technical characteristics to the predicate Y-Knot® Flex All-Suture Anchor. Based upon the findings of our performance testing, the differences present no new issues of safety and efficacy, and the Y-Knot® OneStep™ Anchor is substantially equivalent to the Y-Knot® Flex All-Suture Anchor (K131035).

Regulation Number and Section

N/A