(109 days)
Not Found
No
The description focuses on the mechanical function and materials of an implantable suture retention device, with no mention of AI or ML capabilities.
Yes
The device is used to repair soft tissues, specifically meniscal tears, which is a therapeutic function.
No
The device description clearly states its purpose is to facilitate soft tissue repairs, specifically meniscal tears, by deploying implants and suture. It is a repair device, not one used for diagnosis.
No
The device description clearly states it is an "implantable suture retention device" and a "handheld, disposable device" composed of physical components (peek implants, UHMWPE suture). It also mentions sterilization and physical testing (fixation strength, cyclic, etc.), indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside the body (in vitro).
- Device Description: The Zone Specific AIM™ Device is an implantable suture retention device used for soft tissue repairs, specifically meniscal tears. It is a surgical tool that is used within the body during a procedure.
- Intended Use: The intended use is to facilitate percutaneous or endoscopic soft tissue repairs, which is a surgical intervention, not a diagnostic test performed on a sample.
The description clearly indicates a device used for surgical repair, not for analyzing biological samples to diagnose or monitor a condition.
N/A
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.
Product codes
GAT, MBI
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
meniscal
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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:
Verification Testing
- Reliability
- Ultimate Fixation Strength
- Transportation
- Cyclic
- Pyrogen
- Biocompatibility
- Shelf-life
- MR Safety Testing
Validation Testing
- User Validation
- Packaging
- Labeling
- Sterilization
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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
1
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
2
Indications for Use
510(k) Number (if known)
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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
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
4
| | Zone Specific AIM™ Device
Proposed Device | Sequent™ Meniscal Repair Device
Predicate Device |
|---------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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. | The ConMed Linvatec Sequent™ Meniscal
Repair Device is an all-inside meniscal
repair device that sequentially deploys
implants and suture. This device allows the
surgeon to generate multiple stitches in
order to create fixation points along a soft
tissue tear. The hand held, disposable
device, provided sterile for single use, is
removed at the end of the repair leaving
behind a suture/implant construct. The
implant encompasses a cleat which retains
the suture and allows the knotless feature. |
| 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. | The ConMed Linvatec Sequent™ Meniscal
Repair Device is an implantable suture
retention device which facilitates
percutaneous or endoscopic soft tissue
repairs, including the repair of meniscal
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
the healing period. | |
| | 5. Foreign body sensitivity, known or suspected allergies to implant and/or instrument
materials. | |
| | 6. Soft tissue tears which would not be appropriate to repair. | |
| Components | Anchor
Suture
Shaft
Handle
Protective sleeve | |
| Technological
Characteristics | All-Inside Implant
Pretied
Adjustable Sleeve
Two (2) implant configurations
Polyethylene suture / Peek Implant
Stitch Repair
Multiple needle access/curves (25° Curved; 15°
Reverse)
Suture management wheel
EtO Sterilization | Identical
Not pretied
Manually adjusted depth sheath
Multiple Implant configuration
Identical
Identical
Multiple needle access (straight; curved)
Identical
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:
5
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).