(118 days)
INTENDED USE
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 tissue, in conjunction with appropriate postoperative immobilization, throughout the healing period.
INDICATIONS FOR USE
The CuffLinkTM Implant System Biocomposite is indicated to reattach soft tissue to bone in the following orthopedic surgical procedures.
Procedure: Rotator cuff repair, Achilles Repair
Joint: Shoulder, Ankle
The CuffLink™ Implant System Biocomposite consists of six kits that are provided sterile, for single-use only. Each kit contains four (4) suture anchors in various combinations of the CrossFT Knotless Biocomposite Suture Anchor with Disposable Driver (K171592) and Y-Knot RC All-Suture Anchor (K133224). Two (2) of the anchors are meant to be used as the primary/medial row and two (2) anchors are meant to be used for the knotless/lateral row. Each kit also contains one (1) disposable broaching punch, and one (1) suture passing loop assembled in a single PETG tray, and sealed in a Tyvek pouch.
The provided text describes a 510(k) premarket notification for a medical device called the "CuffLink Implant System Biocomposite". The purpose of a 510(k) submission is to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device. This process primarily focuses on comparing the new device to existing ones in terms of intended use, technological characteristics, and safety and effectiveness, rather than establishing acceptance criteria for an AI algorithm or presenting a detailed study proving its performance against such criteria.
Therefore, the provided document does not contain the information requested regarding acceptance criteria and a study proving a device meets these criteria in the context of an Artificial Intelligence (AI) or machine learning algorithm. The document is for a physical medical implant (suture anchor system) and focuses on demonstrating substantial equivalence through comparison to predicate devices and general performance testing (e.g., biocompatibility, packaging, sterilization).
Specifically, the following detailed information is not available in the provided text:
- A table of acceptance criteria and reported device performance (for an AI/ML algorithm): The document lists "performance data" which refers to general engineering and biological testing of the physical implant, not algorithmic performance metrics.
- Sample size used for the test set and data provenance (for an AI/ML algorithm): No mention of test datasets for an algorithm.
- Number of experts used to establish ground truth and qualifications: Not applicable, as there's no AI algorithm being evaluated for diagnostic accuracy.
- Adjudication method: Not applicable.
- Multi-Reader Multi-Case (MRMC) comparative effectiveness study: Not applicable.
- Standalone (algorithm-only) performance: Not applicable.
- Type of ground truth used: Not applicable.
- Sample size for the training set: Not applicable.
- How ground truth for the training set was established: Not applicable.
The document's "Performance Data" section states: "Testing has been completed to demonstrate that the Cufflink™ Implant System Biocomposite performs as intended and is substantially equivalent to the predicate device. The bacterial endotoxin testing was conducted and met the endotoxin limits. Completed testing includes biocompatibility, packaging, user validation, shelf life, sterilization, transportation, and pyrogenicity." This refers to standard engineering and biological tests for a physical implant, not the kind of AI/ML performance evaluation you've asked about.
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Image /page/0/Picture/0 description: The image shows 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 is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
CONMED Corporation Diana L. Nader-Martone Regulatory Affairs Specialist 525 French Road Utica, New York 13502
July 19, 2018
Re: K180763
Trade/Device Name: CuffLink Implant System Biocomposite Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: MAI, MBI Dated: June 15, 2018 Received: June 18, 2018
Dear Ms. Nader-Martone:
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 Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
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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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2020 See PRA Statement below.
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
1
510(k) Number (if known)
Device Name CuffLink Implant System Biocomposite
Indications for Use (Describe)
INTENDED USE
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 tissue, in conjunction with appropriate postoperative immobilization, throughout the healing period.
INDICATIONS FOR USE
The CuffLinkTM Implant System Biocomposite is indicated to reattach soft tissue to bone in the following orthopedic surgical procedures.
| Procedure | Joint |
|---|---|
| Rotator cuff repair | Shoulder |
| Achilles Repair | Ankle |
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.
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*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."
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Image /page/3/Picture/0 description: The image shows the logo for CONMED Corporation. The logo features a stylized blue and white graphic on the left, followed by the word "CONMED" in black, bold letters. Below "CONMED" is the word "CORPORATION" in smaller, lighter letters, also in black.
510(k) SUMMARY
- l. SUBMITTER
CONMED Corporation 525 French Road Utica, NY 13502
| Phone: | 727.399.5425 |
|---|---|
| Fax: | 727.399.5264 |
Diana L. Nader-Martone Contact Person: Date Prepared: June 15, 2018
- II. DEVICE
| Device Name: | CuffLinkTM Implant System Biocomposite |
|---|---|
| Trade Name/Common Name: | Bioabsorbable Suture Anchor |
| Classification Name: | Fastener, fixation, biodegradable, soft tissue |
| Regulatory Class: | Class II, per 21 CFR Part 888.3030 |
| Product Code: | MAI, MBI |
III. PREDICATE DEVICE
CrossFT™ Knotless Biocomposite Suture Anchor with Disposable Driver Device Name: Manufacturer: CONMED Corporation 510(k) Number: K171592
- IV. REFERENCE DEVICE
| Device Name: | CuffLink™ Implant System |
|---|---|
| Manufacturer: | CONMED Corporation |
| 510(k) Number: | K171725 |
V. DEVICE DESCRIPTION
The CuffLink™ Implant System Biocomposite consists of six kits that are provided sterile, for single-use only. Each kit contains four (4) suture anchors in various combinations of the CrossFT Knotless Biocomposite Suture Anchor with Disposable Driver (K171592) and Y-Knot RC All-Suture Anchor (K133224). Two (2) of the anchors are meant to be used as the primary/medial row and two (2) anchors are meant to be used for the knotless/lateral row. Each kit also contains one (1) disposable broaching punch, and one (1) suture passing loop assembled in a single PETG tray, and sealed in a Tyvek pouch.
- VI. INTENDED USE/INDICATIONS FOR USE STATEMENT
INTENDED USE
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
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Image /page/4/Picture/0 description: The image shows the logo for Conmed Corporation. The logo consists of a blue abstract shape on the left, followed by the word "CONMED" in black, bold letters. Below the word "CONMED" is the word "CORPORATION" in smaller, gray letters. There is a blue line separating the two words.
damaged soft tissue, in conjunction with appropriate postoperative immobilization, throughout the healing period.
INDICATIONS FOR USE
The CuffLink™ Implant System Biocomposite is indicated to reattach soft tissue to bone in the following orthopedic surgical procedures.
| Procedure | Joint |
|---|---|
| Rotator Cuff Repair | Shoulder |
| Achilles Repair | Ankle |
- VII. COMPARISION OF THE TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
CONMED's CuffLink Implant System Biocomposite is substantially equivalent in design, manufacturing materials, intended use, principles of operation, and technical characteristics to the CONMED CrossFT Knotless Biocomposite Suture Anchor (predicate device (K171592)) with Disposable Driver and CuffLink™ Implant System (reference device (K171725)) and raises no new issues of safety or effectiveness.
The similarities and differences between the proposed, predicate, and reference devices are summarized in the table below.
| Proposed Device | Predicate Device | Reference Device | |
|---|---|---|---|
| Device | CuffLink™ Implant SystemBiocomposite | CrossFT™ KnotlessBiocomposite SutureAnchor with DisposableDriver | CuffLink™ ImplantSystem |
| 510(k) Number | K171592 | K171725 | |
| Manufacturer | CONMED Corporation | ||
| Intended Use | The Implant System maybe used in eitherarthroscopic or opensurgical procedures. Afterthe suture is anchored tothe bone, it may be usedto reattach soft tissue,such as ligaments,tendons, or joint capsulesto the bone. The sutureanchor system therebystabilizes the damagedsoft tissue, in conjunctionwith appropriatepostoperativeimmobilization, | The biocomposite sutureanchor is intended toreattach soft tissue to bonein the following orthopedicsurgical procedures:Procedure JointRotator cuff repair ShoulderAchilles Repair AnkleBiceps Tenodesis ShoulderGluteus Medius Repair HipMedial Patellofemoral KneeLigament (MPFL) | The CuffLink™ ImplantSystem is intended toreattach soft tissue tobone in orthopedicsurgical procedures. |
| throughout the healingperiod. | |||
| Indications for Use | The CuffLink™ ImplantSystem Biocomposite isindicated to reattach softtissue to bone in thefollowing orthopedicsurgical procedures.ProcedureJointRotator Cuff Repair ShoulderAchilles Repair Ankle | 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 appropriatepostoperativeimmobilization, throughoutthe healing period. | The Implant System maybe used in eitherarthroscopic or opensurgical procedures. Afterthe suture is anchored tothe bone, it may be usedto reattach soft tissue,such as ligaments,tendons, or joint capsulesto the bone. The sutureanchor system therebystabilizes the damagedsoft tissue, in conjunctionwith appropriatepostoperativeimmobilization,throughout the healingperiod. |
| Proposed Device | Predicate Device | Reference Device | |
| Device | CuffLink™ Implant SystemBiocomposite | CrossFT™ KnotlessBiocomposite SutureAnchor with DisposableDriver | CuffLink™ ImplantSystem |
| Contraindications | 1. Pathological conditionsof bone which wouldadversely affect theCuffLink™ ImplantSystem Biocomposite.2. Pathological conditionsin the soft tissue to berepaired or reconstructedwhich would adverselyaffect suture fixation.3. Physical conditionsthat would eliminate, ortend to eliminate,adequate implant supportor retard healing. | 1. Pathological conditionsof bone which wouldadversely affect theCrossFT™ KnotlessBiocomposite SutureAnchor.2. Pathological conditionsin the soft tissue to berepaired or reconstructedwhich would adverselyaffect suture fixation.3. Physical conditions thatwould eliminate, or tend toeliminate, adequateimplant support or retardhealing. | 1. Pathologicalconditions of bone whichwould adversely affectthe CuffLink™ ImplantSystem.2. Pathologicalconditions in the softtissue to be repaired orreconstructed whichwould adversely affectsuture fixation.3. Physical conditionsthat would eliminate, ortend to eliminate,adequate implantsupport or retardhealing. |
| 4. Conditions which tendto limit the patient'sability or willingness torestrict activities or followdirections during the | 4. Conditions which tendto limit the patient's abilityor willingness to restrictactivities or follow | 4. Conditions which tendto limit the patient'sability or willingness to | |
| healing period. | directions during the | restrict activities or follow | |
| 5. Attachment of artificial | healing period. | directions during thehealing period. | |
| ligaments or otherimplants.6. Foreign body | 5. Attachment of artificialligaments or otherimplants. | 5. Attachment of artificialligaments or otherimplants. | |
| sensitivity, known orsuspected allergies toimplant and/or instrumentmaterials. | 6. Foreign body sensitivity,known or suspectedallergies to implant and/orinstrument materials. | 6. Foreign bodysensitivity, known orsuspected allergies toimplant and/or | |
| 7. This device is notapproved for screw | 7. This device is notapproved for screw | instrument materials. | |
| attachment or fixation tothe posterior elements(pedicles) of the cervical,thoracic or lumbar spine. | attachment or fixation tothe posterior elements(pedicles) of the cervical,thoracic or lumbar spine. | 7. This device is notapproved for screwattachment or fixation tothe posterior elements(pedicles) of the cervical,thoracic or lumbar spine. | |
| Proposed Device | Predicate Device | Reference Device | |
| Device | CuffLink™ Implant SystemBiocomposite | CrossFT™ KnotlessBiocomposite SutureAnchor with DisposableDriver | CuffLink™ ImplantSystem |
| Reuse/Sterilization | Single-Use | ||
| Principle ofOperation | Soft tissue to bone fixation | ||
| Biocompatibility | In accordance with ISO 10993-1 and FDA # G95-1 | ||
| Packaging | Multiple implants in tray | Single device unit inpackage | Multiple implants in tray |
| Materials | UHMWPE, polyester, nylon suture, stainless steel,polycarbonate, 96L/4D co-polymer and β-TCP | UHMWPE, polyester,nylon suture, stainlesssteel, polycarbonate,PEEK Optima® |
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Image /page/5/Picture/0 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, with a horizontal line underneath. Below the line, the word "CORPORATION" is written in smaller, black letters.
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Image /page/6/Picture/0 description: The image shows the logo for Conmed Corporation. The logo features a blue square with a white "C" shape inside on the left. To the right of the square is the word "CONMED" in a bold, sans-serif font. Below the word "CONMED" is the word "CORPORATION" in a smaller, sans-serif font.
PERFORMANCE DATA VIII.
Testing has been completed to demonstrate that the Cufflink™ Implant System Biocomposite performs as intended and is substantially equivalent to the predicate device. The bacterial endotoxin testing was conducted and met the endotoxin limits.
Completed testing includes biocompatibility, packaging, user validation, shelf life, sterilization, transportation, and pyrogenicity.
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Image /page/7/Picture/0 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, sans-serif font. Below the word "CONMED", the word "CORPORATION" is written in a smaller, sans-serif font.
CONCLUSION IX.
CONMED's Cufflink™ Implant System Biocomposite is either substantially equivalent or identical in design, manufacturing materials, intended use, principles of operation, and technical characteristics to the predicate and reference devices. Based upon the findings of performance testing, the differences do not present any novel issues of safety and efficacy, and is substantially equivalent to the predicate device.
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.