Zone Specific AIM
Device Facts
| Record ID | K220186 |
|---|---|
| Device Name | Zone Specific AIM |
| Applicant | Conmed Corporation |
| Product Code | GAT · General, Plastic Surgery |
| Decision Date | May 13, 2022 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 878.5000 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
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.
Device Story
Handheld, disposable, single-use device for all-inside meniscal repair; facilitates percutaneous or endoscopic soft tissue fixation. Surgeon operates device to sequentially deploy PEEK implants and UHMWPE (Hi-Fi) suture into soft tissue. Device removed post-deployment, leaving behind suture/implant construct. Enables stitch repair via multiple needle access configurations (25° curved, 15° reverse) and suture management wheel. Provides mechanical fixation for meniscal tears; assists in tissue approximation to promote healing. Used in clinical/OR settings.
Clinical Evidence
Bench testing only. Verification and validation testing included reliability, ultimate fixation strength, cyclic testing, biocompatibility, shelf-life, MR safety, packaging, labeling, and sterilization. Bacterial endotoxin testing met established limits.
Technological Characteristics
Materials: PEEK implants, UHMWPE (Hi-Fi) suture. Components: Anchor, suture, shaft, handle, protective sleeve. Features: All-inside implant, pretied, adjustable sleeve, two implant configurations, multiple needle access (25° curved, 15° reverse), suture management wheel. Sterilization: Ethylene Oxide (EtO).
Indications for Use
Indicated for percutaneous or endoscopic soft tissue repairs, including meniscal tears. Contraindicated in patients with insufficient tissue quality/quantity, poor blood supply, active sepsis/infection, inability to follow post-op directions, foreign body sensitivity/allergies to implant materials, or tears inappropriate for repair.
Regulatory Classification
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.
Special Controls
*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.
Predicate Devices
- ConMed Linvatec Sequent™ Meniscal Repair Device (K102339)
Submission Summary (Full Text)
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May 13, 2022
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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) | |
|--------------------------------------------------------------------------|-------------------------------------------------------------------------|
| <div> <span>☑ Prescription Use (Part 21 CFR 801 Subpart D)</span> </div> | <div> <span>☐ Over-The-Counter Use (21 CFR 801 Subpart C)</span> </div> |
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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
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.
### 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™ Device<br>Proposed Device | Sequent™ Meniscal Repair Device<br>Predicate Device |
|---------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device<br>Description | The Zone Specific AIM™ is an all-inside<br>meniscal repair device that sequentially<br>deploys implants and suture. The device is<br>composed of peek implants and ultra-high<br>molecular weight polyethylene (UHMWPE)<br>suture (Hi-Fi). The handheld, disposable<br>device, provided sterile for single use, is<br>removed at the end of the repair leaving behind<br>a suture/implant construct. The anchor, suture,<br>and disposable handheld device are EO<br>Sterilized. | The ConMed Linvatec Sequent™ Meniscal<br>Repair Device is an all-inside meniscal<br>repair device that sequentially deploys<br>implants and suture. This device allows the<br>surgeon to generate multiple stitches in<br>order to create fixation points along a soft<br>tissue tear. The hand held, disposable<br>device, provided sterile for single use, is<br>removed at the end of the repair leaving<br>behind a suture/implant construct. The<br>implant encompasses a cleat which retains<br>the suture and allows the knotless feature. |
| Intended Use /<br>Indications for use | The Zone Specific AIM™ Device is an<br>implantable suture retention device which<br>facilitates percutaneous or endoscopic soft<br>tissue repairs, including repair of meniscal tears. | The ConMed Linvatec Sequent™ Meniscal<br>Repair Device is an implantable suture<br>retention device which facilitates<br>percutaneous or endoscopic soft tissue<br>repairs, including the repair of meniscal<br>tears. |
| 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 during<br>the healing period. | |
| | 5. Foreign body sensitivity, known or suspected allergies to implant and/or instrument<br>materials. | |
| | 6. Soft tissue tears which would not be appropriate to repair. | |
| Components | Anchor<br>Suture<br>Shaft<br>Handle<br>Protective sleeve | |
| Technological<br>Characteristics | All-Inside Implant<br>Pretied<br>Adjustable Sleeve<br>Two (2) implant configurations<br>Polyethylene suture / Peek Implant<br>Stitch Repair<br>Multiple needle access/curves (25° Curved; 15°<br>Reverse)<br>Suture management wheel<br>EtO Sterilization | Identical<br>Not pretied<br>Manually adjusted depth sheath<br>Multiple Implant configuration<br>Identical<br>Identical<br>Multiple needle access (straight; curved)<br><br>Identical<br>Identical |
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).
