The Zone Specific AIM™ Device is an implantable suture retention device which facilitates percutaneous or endoscopic soft tissue repairs, including repair of meniscal tears.

Device Description

The Zone Specific AIM™ is an all-inside meniscal repair device that sequentially deploys implants and suture. The device is composed of peek implants and ultra-high molecular weight polyethylene (UHMWPE) suture (Hi-Fi). The handheld, disposable device, provided sterile for single use, is removed at the end of the repair leaving behind a suture/implant construct. The anchor, suture, and disposable handheld device are EO Sterilized.

AI/ML Overview

This is a 510(k) premarket notification for the Zone Specific AIM™ Device, a meniscal repair device. The document primarily focuses on establishing substantial equivalence to a predicate device (ConMed Linvatec Sequent™ Meniscal Repair Device).

Since this is a 510(k) submission for a medical device that performs a mechanical repair, the acceptance criteria and performance data are primarily focused on physical and mechanical properties, not on a diagnostic algorithm. There is no AI component described in this document. Therefore, many of the requested fields related to AI algorithm performance (like sample sizes for test/training sets, expert ground truth, MRMC studies, or standalone algorithm performance) are not applicable or cannot be extracted from this type of regulatory document.

However, I can extract the general acceptance criteria and the types of studies performed to demonstrate the device's performance relative to its intended use and substantial equivalence.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative "acceptance criteria" and "reported device performance" in a direct numerical comparison for each test. Instead, it states that "Testing has been completed to demonstrate that the Zone Specific AIM™ performs as intended and is substantially equivalent to the predicate device" and "met the endotoxin limits." This implies that the device met the acceptance criteria for each test, but the specific numerical targets and results are not detailed in this summary.

Acceptance Criteria Category (Implied)	Reported Device Performance (Implied)
Mechanical Performance	Performs as intended and is substantially equivalent to the predicate device in terms of:
Ultimate Fixation Strength	Successfully demonstrated (implied to meet predicate performance/safety standards)
Cyclic Performance	Successfully demonstrated (implied to meet predicate performance/safety standards)
Material/Biological Safety	Performed as intended and is substantially equivalent to the predicate device in terms of:
Pyrogenicity (Bacterial Endotoxin)	Met the endotoxin limits
Biocompatibility	Successfully demonstrated (implied to meet safety standards)
MR Safety	Successfully demonstrated (implied to be safe for MR environments)
Device Integrity/Reliability	Performed as intended and is substantially equivalent to the predicate device in terms of:
Reliability	Successfully demonstrated
Transportation	Successfully demonstrated
Packaging	Successfully demonstrated
Labeling	Successfully demonstrated
Sterilization	Successfully demonstrated
Shelf-life	Successfully demonstrated
Usability	Performs as intended:
User Validation	Successfully demonstrated

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

Sample Size for Test Set: Not specified in the provided text.
Data Provenance: Not specified in the provided text (e.g., country of origin, retrospective/prospective). This type of information is typically not included in a 510(k) summary for mechanical device testing.

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

Not applicable. This is a mechanical device, not an AI diagnostic algorithm. "Ground truth" in this context would refer to established engineering standards or validated test methods, not expert consensus on anatomical findings.

4. Adjudication Method for the Test Set

Not applicable. This is a mechanical device. Adjudication methods like 2+1, 3+1 are used for human review of data, typically in diagnostic studies.

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 does not describe an AI-powered device or an MRMC study.

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

Not applicable. This document does not describe an AI algorithm.

7. The Type of Ground Truth Used

For mechanical and material tests, the "ground truth" implicitly refers to:

Established engineering standards (e.g., ASTM, ISO standards for strength, cyclic loading, sterilization effectiveness, biocompatibility).
Predicate device performance data, used as a benchmark for substantial equivalence.
Regulatory limits (e.g., for endotoxin levels).

8. The Sample Size for the Training Set

Not applicable. There is no AI training set described.

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

Not applicable. There is no AI training set described.

Summary

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May 13, 2022

Image /page/0/Picture/1 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, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath in a smaller font.

CONMED Corporation Orjada Dervishleri Regulatory Affairs Specialist 11311 Concept Boulevard Largo, Florida 33773-4908

Re: K220186

Trade/Device Name: Zone Specific AIM™ Device Regulation Number: 21 CFR 878.5000 Regulation Name: Nonabsorbable poly(ethylene terephthalate) surgical suture Regulatory Class: Class II Product Code: GAT, MBI Dated: February 12, 2022 Received: February 14, 2022

Dear Orjada Dervishleri:

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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for

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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.

For:

Laura C. Rose, Ph.D. 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)

K220186

Device Name Zone Specific AIM™

Indications for Use (Describe)

The Zone Specific AIM™ Device is an implantable suture retention device which facilitates percutaneous or endoscopic soft tissue repairs, including repair of meniscal tears.

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 K220186.

I. SUBMITTER

CONMED Corporation 11311 Concept Blvd Largo, Florida 33773

Phone: 727-392-6464

Contact Person: Orjada Dervishleri Date Prepared: May 13th, 2022

II. DEVICE NAME

Device Name:	Zone Specific AIM™ Device
Classification Name:	Suture, Nonabsorbable, Synthetic, Polyethylene
Regulatory Class:	Class II, per 21 CFR Part 878. 5000
Product Codes:	GAT, MBI

III. PREDICATE/ LEGALLY MARKETED DEVICE

Device Name:	ConMed Linvatec Sequent™ Meniscal Repair Device
Company Name:	ConMed Linvatec
510(k) #:	K102339

IV. DEVICE DESCRIPTION

V. INTENDED USE/ INDICATIONS FOR USE The Zone Specific AIM™ Device is an implantable suture retention device which facilitates percutaneous or endoscopic soft tissue repairs, including repair of meniscal tears.

COMPARISON OF THE TECHNOLOGICAL CHARACTERISTICS WITH THE VI. PREDICATE DEVICE

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	Zone Specific AIM™ DeviceProposed Device	Sequent™ Meniscal Repair DevicePredicate Device
DeviceDescription	The Zone Specific AIM™ is an all-insidemeniscal repair device that sequentiallydeploys implants and suture. The device iscomposed of peek implants and ultra-highmolecular weight polyethylene (UHMWPE)suture (Hi-Fi). The handheld, disposabledevice, provided sterile for single use, isremoved at the end of the repair leaving behinda suture/implant construct. The anchor, suture,and disposable handheld device are EOSterilized.	The ConMed Linvatec Sequent™ MeniscalRepair Device is an all-inside meniscalrepair device that sequentially deploysimplants and suture. This device allows thesurgeon to generate multiple stitches inorder to create fixation points along a softtissue tear. The hand held, disposabledevice, provided sterile for single use, isremoved at the end of the repair leavingbehind a suture/implant construct. Theimplant encompasses a cleat which retainsthe suture and allows the knotless feature.
Intended Use /Indications for use	The Zone Specific AIM™ Device is animplantable suture retention device whichfacilitates percutaneous or endoscopic softtissue repairs, including repair of meniscal tears.	The ConMed Linvatec Sequent™ MeniscalRepair Device is an implantable sutureretention device which facilitatespercutaneous or endoscopic soft tissuerepairs, including the repair of meniscaltears.
Contraindications	1. Insufficient quantity or quality of tissue.
	2. Blood supply limitations and/or previous infections, which may tend to retard healing.
	3. Patients with active sepsis or infection.
	4. Conditions which tend to limit the patient's ability or willingness to follow directions duringthe healing period.
	5. Foreign body sensitivity, known or suspected allergies to implant and/or instrumentmaterials.
	6. Soft tissue tears which would not be appropriate to repair.
Components	AnchorSutureShaftHandleProtective sleeve
TechnologicalCharacteristics	All-Inside ImplantPretiedAdjustable SleeveTwo (2) implant configurationsPolyethylene suture / Peek ImplantStitch RepairMultiple needle access/curves (25° Curved; 15°Reverse)Suture management wheelEtO Sterilization	IdenticalNot pretiedManually adjusted depth sheathMultiple Implant configurationIdenticalIdenticalMultiple needle access (straight; curved)IdenticalIdentical

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

VII. PERFORMANCE DATA

Testing has been completed to demonstrate that the Zone Specific AIM™ 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:

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Verification Testing

Reliability
Ultimate Fixation Strength ●
Transportation ●
Cyclic ●
Pyrogen ●
Biocompatibility ●
Shelf-life ●

CONCLUSION

VIII.

MR Safety Testing ●

Validation Testing

. User Validation
Packaging ●
Labeling ●
Sterilization ●

The Zone Specific AIM™ Device is either substantially equivalent or identical in design, materials, intended use, principles of operation, and technical characteristics to the predicate Sequent™ Meniscal Repair Device. Based upon the findings of our performance testing, the differences present no new issues of safety and efficacy, and the Infinity™ Fixation System is substantially equivalent to the Sequent™ Meniscal Repair Device (K102339).

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.