(88 days)
No
The summary describes a mechanical implant system for reattaching soft tissue to bone and does not mention any AI or ML components or functionalities.
Yes
The device is intended to reattach soft tissue to bone and stabilize damaged soft tissue, facilitating healing, which aligns with the definition of a therapeutic device.
No
The device is an implant system used to reattach soft tissue to bone during surgical procedures, which is a therapeutic function, not a diagnostic one.
No
The device description clearly outlines physical components like suture anchors, a broaching punch, a suture passing loop, a PETG tray, and a Tyvek pouch, indicating it is a hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to reattach soft tissue to bone in orthopedic surgical procedures. This is a surgical implant used directly on the patient's body.
- Device Description: The device consists of suture anchors, a broaching punch, and a suture passing loop. These are all physical components used in a surgical procedure.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) during surgery.
N/A
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 suture anchor system thereby stabilizes the damaged soft tissue, in conjunction with appropriative immobilization, throughout the healing period.
Product codes
MBI
Device Description
The CuffLink™ Implant System consists of six kits that will be provided sterile, for single-use 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bone, ligaments, tendons, or joint capsules
Indicated Patient Age Range
Not Found
Intended User / Care Setting
orthopedic surgical procedures; arthroscopic or open surgical procedures.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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 -
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
DEPARTMENT OF HEALTH & HUMAN SERVICES
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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
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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.
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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
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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 Suture | ||
Anchor | 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 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 the | |||
appropriate postoperative | |||
immobilization, | |||
throughout the healing | The device may be used in | ||
either arthroscopic or open | |||
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 | The device may be used in | ||
either arthroscopic or open | |||
surgical procedures. After | |||
the suture strands are | |||
anchored to the bone, they | |||
may be used to reattach | |||
soft tissue, such as | |||
ligaments, tendons or joint | |||
capsules to the bone. In | |||
conjunction with | |||
appropriate post-operative | |||
immobilization throughout | |||
the healing period, the | |||
suture anchor systems | |||
stabilize the damaged soft | |||
period. | period. | tissue | |
Contraindications | 1. Pathological | ||
conditions of | |||
bone which | |||
would adversely | |||
affect the | |||
CuffLink Implant | |||
System. |
- Pathological
conditions in
the soft tissue
to be repaired | 1. Pathological
conditions of
bone which
would adversely
affect the
CrossFT Knotless
Suture Anchor. - Pathological
conditions in
the soft tissue
to be repaired | 1. Pathological
conditions of
bone which
would adversely
affect the Y-Knot
Anchors. - Pathological
conditions in
the soft tissue
to be repaired
or |
| | or
reconstructed
which would
adversely
affect suture
fixation. - Physical conditions
that would eliminate,
or tend to eliminate,
adequate implant
support or retard
healing. - Conditions which
tend to limit the
patient's ability or
willingness to
restrict activities
or follow
directions during
the healing period. - Attachment of artificial
ligaments or other
implants. - Foreign body
sensitivity, known or
suspected allergies to
implant and/or
instrument materials. - This device is not
approved for screw
attachment or
fixation to the
posterior elements
(pedicles) of the
cervical, thoracic or
lumbar spine. | or
reconstructed
which would
adversely
affect suture
fixation. - Physical conditions
that would eliminate,
or tend to eliminate,
adequate implant
support or retard
healing. - Conditions which
tend to limit the
patient's ability or
willingness to
restrict activities
or follow
directions during
the healing period. - Attachment of artificial
ligaments or other
implants. - Foreign body
sensitivity, known or
suspected allergies to
implant and/or
instrument materials. - This device is not
approved for screw
attachment or
fixation to the
posterior elements
(pedicles) of the
cervical, thoracic or
lumbar spine. | reconstructed
which would
adversely
affect suture
fixation. - Physical conditions
that would eliminate,
or tend to eliminate,
adequate implant
support or retard
healing. - Conditions which
tend to limit the
patient's ability or
willingness to
restrict activities
or follow
directions during
the healing period. - Attachment of artificial
ligaments or other
implants. - Foreign body
sensitivity, known or
suspected allergies to
implant and/or
instrument materials. - This device is not
approved for screw
attachment or
fixation to the
posterior elements
(pedicles) of the
cervical, thoracic or
lumbar spine. - Patients with active
sepsis or infection. |
| How Supplied | Sterile, Kit (anchor
implants, instrumentation,
suture) | | Sterile anchor with delivery system |
| Reuse/Sterilization | Single-Use | | |
| Shelf-Life | 18 month | | 5-years |
| Principle of
Operation | | For soft tissue to bone fixation | |
| Biocompatibility | In accordance with ISO 10993-1 and FDA# G95-1 | | |
| Packaging | Multiple implants
packaged in a tray to | Packaged as a single device | |
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| | include a broaching punch
and Hi-Fi Suture | | |
|-----------|-------------------------------------------------------------------------------------------|---------------------------------------------------------------------------|-----------------------------------------------------------------|
| Materials | PEEK Optima, UHMWPE,
polyester, and nylon
suture, stainless steel,
polycarbonate | PEEK Optima, UHMWPE
suture, stainless steel,
polycarbonate, nitinol | UHMWPE, polyester, and
nylon suture tape, stainless
steel |
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.