(88 days)
The CuffLink Implant System is intended to reattach soft tissue to bone in orthopedic surgical procedures.
The Implant System may be used in either arthroscopic or open surgical procedures. After the 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 appropriative immobilization, throughout the healing period.
The CuffLink™ Implant System consists of six kits that will be provided sterile, for singleuse only. Each kit will contain four suture anchors, one disposable broaching punch, and one suture passing loop assembled in a single PETG tray, and sealed in a Tyvek pouch. The tray is subsequently placed in a folding carton.
The provided document is a 510(k) premarket notification from the FDA to CONMED Corporation regarding their CuffLink Implant System. It primarily focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed clinical study data with acceptance criteria for device performance.
Therefore, many of the requested details about acceptance criteria, study design, expert involvement, and ground truth establishment cannot be found in this document. The document focuses on showing the new device is as safe and effective as a previously approved one, often through non-clinical testing.
Here's what can be extracted from the document:
1. A table of acceptance criteria and the reported device performance
The document does not provide specific quantitative acceptance criteria or detailed reported performance data for the CuffLink Implant System in the way one would expect for a clinical study evaluating diagnostic accuracy or a specific functional outcome. It states that "Testing has been completed to demonstrate that the Cufflink Implant System performs as intended and is substantially equivalent to the predicate device."
It lists categories of completed test data:
| Acceptance Criteria Category (Implied) | Reported Device Performance |
|---|---|
| Biocompatibility | Met requirements (in accordance with ISO 10993-1 and FDA# G95-1) |
| Packaging | Testing completed (details not provided) |
| User Validation | Testing completed (details not provided) |
| Shelf-life | 18 months shelf-life established through testing (details not provided) |
| Sterilization | Testing completed (details not provided) |
| Transportation | Testing completed (details not provided) |
| Pyrogenicity (Bacterial Endotoxin) | Conducted and met the limits |
2. Sample size used for the test set and the data provenance
The document does not specify sample sizes for any of the performance testing categories. It also does not mention clinical test sets or data provenance (e.g., country of origin, retrospective/prospective) because the submission focuses on non-clinical performance and a comparison to a predicate device for substantial equivalence, not a clinical outcomes study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This type of submission relies on engineering and laboratory testing for device performance characteristics, not expert consensus on clinical data.
4. Adjudication method for the test set
Not applicable. There is no mention of a test set requiring adjudication in the context of this submission.
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 is a medical device for reattaching soft tissue to bone (suture anchors), not an AI-powered diagnostic or assistive tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithmic device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical tests mentioned (biocompatibility, pyrogenicity, shelf-life, etc.), the "ground truth" would be established by validated test methods and industry standards (e.g., ISO standards for biocompatibility, specific microbial limits for pyrogenicity). No clinical or expert consensus ground truth is described in this document.
8. The sample size for the training set
Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
Not applicable.
{0}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/2 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of three human profiles facing to the right, with three lines above them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
CONMED Corporation Ms. Dionne Sanders Manager, Regulatory Affairs, Orthopedic Division 525 French Road Utica, New York 13502
September 8, 2017
Re: K171725
Trade/Device Name: CuffLink Implant System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI Dated: June 9, 2017 Received: June 12, 2017
Dear Ms. Sanders:
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. 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
{1}------------------------------------------------
Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely.
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
Indications for Use
510(k) Number (if known) K171725
Device Name CuffLink Implant System
Indications for Use (Describe)
The CuffLink Implant System is intended to reattach soft tissue to bone in orthopedic surgical procedures.
The Implant System may be used in either arthroscopic or open surgical procedures. After the 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 appropriative immobilization, throughout the healing period.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 201 Subpart D) | Over-The-Counter Use (21 CFR 201 Subpart C) |
|---|---|
| ---------------------------------------------- | --------------------------------------------- |
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}------------------------------------------------
Image /page/3/Picture/1 description: The image shows the logo for CONMED Corporation. The logo features a blue abstract shape on the left, followed by the word "CONMED" in black, sans-serif font. Below "CONMED" is a thin blue line, and below that is the word "CORPORATION" in smaller, sans-serif font.
510(k) SUMMARY
SUBMITTER I.
CONMED Corporation 525 French Road Utica, NY 13502
Phone: 727-399-5564 Fax: 727-399-5264
Contact Person: Dionne Sanders, RAC Date Prepared: June 9, 2017
II. DEVICE
| Name of Device: | CuffLink Implant System |
|---|---|
| Trade Name/Common Name: | Non-absorbable Suture Anchors |
| Classification Name: | Smooth or threaded metallic bone fixation fastener |
| Regulatory Class: | Class II, per 21 CFR Part 888.3040 |
| Product Code: | MBI |
III. PREDICATE DEVICE
| Device Name: | CrossFT Knotless Suture Anchor w/Disposable Driver |
|---|---|
| Manufacturer: | CONMED Corporation |
| 510(k) #: | K163258 |
IV. DEVICE DESCRIPTION
The CuffLink™ Implant System consists of six kits that will be provided sterile, for singleuse only. Each kit will contain four suture anchors, one disposable broaching punch, and one suture passing loop assembled in a single PETG tray, and sealed in a Tyvek pouch. The tray is subsequently placed in a folding carton.
INTENDED USE / INDICATIONS FOR USE
The CuffLink Implant System is intended to reattach soft tissue to bone in orthopedic surgical procedures.
The Implant System may be used in either arthroscopic or open surgical procedures. After the 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
{4}------------------------------------------------
Image /page/4/Picture/1 description: The image shows the logo for CONMED Corporation. The logo features a blue abstract shape on the left, followed by the word "CONMED" in a bold, sans-serif font. Below the word "CONMED" is the word "CORPORATION" in a smaller, sans-serif font, underlined by a thin blue line. The logo is clean and professional, suggesting a company in the medical or technology field.
tissue, in conjunction with appropriate postoperative immobilization, throughout the healing period.
COMPARISION OF THE TECHNOLOGICAL CHARACTERISTICS WITH THE V. PREDICATE DEVICE
CONMED's CuffLink Implant System is substantially equivalent in design, manufacturing materials, intended use, principles of operation, and technical characteristics to the CONMED CrossFT Knotless and Y-Knot RC Suture Anchors and raises no new issues of safety or effectiveness.
The similarities and differences between the predicate and proposed sterilization trays are the following-
| Proposed Device | Predicate Device | Reference Device | |
|---|---|---|---|
| CuffLink Implant System | CrossFT Knotless SutureAnchor | Y-Knot RC Suture Anchor | |
| 510k Number | TBD | K163258 | K133224 |
| Manufacturer | CONMED Corporation | ||
| Intended Use | Intended to reattach soft tissue to bone in orthopedic surgical procedures. | ||
| Indications for Use | The device may be used ineither arthroscopic or opensurgical procedures. Afterthe suture is anchored tothe bone, it may be used toreattach soft tissue, such asligaments, tendons, or jointcapsules to the bone. Thesuture anchor systemthereby stabilizes thedamaged soft tissue, inconjunction with theappropriate postoperativeimmobilization,throughout the healing | The device may be used ineither arthroscopic or openprocedures. After thesuture is anchored to thebone, it may be used toreattach soft tissue, such asligaments, tendons, or jointcapsules to the bone. Thesuture anchor systemthereby stabilizes thedamaged soft tissue, inconjunction withappropriate postoperativeimmobilization,throughout the healing | The device may be used ineither arthroscopic or opensurgical procedures. Afterthe suture strands areanchored to the bone, theymay be used to reattachsoft tissue, such asligaments, tendons or jointcapsules to the bone. Inconjunction withappropriate post-operativeimmobilization throughoutthe healing period, thesuture anchor systemsstabilize the damaged soft |
| period. | period. | tissue | |
| Contraindications | 1. Pathologicalconditions ofbone whichwould adverselyaffect theCuffLink ImplantSystem.2. Pathologicalconditions inthe soft tissueto be repaired | 1. Pathologicalconditions ofbone whichwould adverselyaffect theCrossFT KnotlessSuture Anchor.2. Pathologicalconditions inthe soft tissueto be repaired | 1. Pathologicalconditions ofbone whichwould adverselyaffect the Y-KnotAnchors.2. Pathologicalconditions inthe soft tissueto be repairedor |
| orreconstructedwhich wouldadverselyaffect suturefixation.3. Physical conditionsthat would eliminate,or tend to eliminate,adequate implantsupport or retardhealing.4. Conditions whichtend to limit thepatient's ability orwillingness torestrict activitiesor followdirections duringthe healing period.5. Attachment of artificialligaments or otherimplants.6. Foreign bodysensitivity, known orsuspected allergies toimplant and/orinstrument materials.7. This device is notapproved for screwattachment orfixation to theposterior elements(pedicles) of thecervical, thoracic orlumbar spine. | orreconstructedwhich wouldadverselyaffect suturefixation.3. Physical conditionsthat would eliminate,or tend to eliminate,adequate implantsupport or retardhealing.4. Conditions whichtend to limit thepatient's ability orwillingness torestrict activitiesor followdirections duringthe healing period.5. Attachment of artificialligaments or otherimplants.6. Foreign bodysensitivity, known orsuspected allergies toimplant and/orinstrument materials.7. This device is notapproved for screwattachment orfixation to theposterior elements(pedicles) of thecervical, thoracic orlumbar spine. | reconstructedwhich wouldadverselyaffect suturefixation.3. Physical conditionsthat would eliminate,or tend to eliminate,adequate implantsupport or retardhealing.4. Conditions whichtend to limit thepatient's ability orwillingness torestrict activitiesor followdirections duringthe healing period.5. Attachment of artificialligaments or otherimplants.6. Foreign bodysensitivity, known orsuspected allergies toimplant and/orinstrument materials.7. This device is notapproved for screwattachment orfixation to theposterior elements(pedicles) of thecervical, thoracic orlumbar spine.8. Patients with activesepsis or infection. | |
| How Supplied | Sterile, Kit (anchorimplants, instrumentation,suture) | Sterile anchor with delivery system | |
| Reuse/Sterilization | Single-Use | ||
| Shelf-Life | 18 month | 5-years | |
| Principle ofOperation | For soft tissue to bone fixation | ||
| Biocompatibility | In accordance with ISO 10993-1 and FDA# G95-1 | ||
| Packaging | Multiple implantspackaged in a tray to | Packaged as a single device |
{5}------------------------------------------------
Image /page/5/Picture/1 description: The image shows the logo for Conmed Corporation. The logo features a blue square with a white, stylized "C" shape inside. To the right of the square, the word "CONMED" is written in a bold, black font. Below the word "CONMED", the word "CORPORATION" is written in a smaller, gray font.
{6}------------------------------------------------
Image /page/6/Picture/1 description: The image shows the logo for Conmed Corporation. The logo features a blue, stylized "C" shape on the left. To the right of the "C" is the word "CONMED" in a bold, sans-serif font, with a horizontal line underneath. Below the line is the word "CORPORATION" in a smaller, sans-serif font.
| include a broaching punchand Hi-Fi Suture | |||
|---|---|---|---|
| Materials | PEEK Optima, UHMWPE,polyester, and nylonsuture, stainless steel,polycarbonate | PEEK Optima, UHMWPEsuture, stainless steel,polycarbonate, nitinol | UHMWPE, polyester, andnylon suture tape, stainlesssteel |
VI. PERFORMANCE DATA
Testing has been completed to demonstrate that the Cufflink Implant System performs as intended and is substantially equivalent to the predicate device. The bacterial endotoxin testing was conducted and met the limits.
Completed test data includes the following:
- Biocompatibility -
- Packaging -
- User Validation -
- Shelf-life —
- -Sterilization
- -Transportation
- Pyrogenicity -
VII. CONCLUSION
CONMED's Cufflink Implant System is either substantially equivalent or identical in design, manufacturing materials, intended use, principles of operation, and technical characteristics to the CrossFT Knotless Suture Anchor w/Disposable Driver. Based upon the findings of our performance testing, the differences present no new issues of safety and is substantially equivalent to the predicate device.
N/A