(65 days)
The CrossFT™ Knotless Suture Anchor with Disposable Driver is intended to reattach soft tissue to bone in orthopedic surgical procedures. 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 appropriate postoperative immobilization, throughout the healing period.
The CrossFT™ Knotless Suture Anchors with Disposable Driver are sterile, single use devices. The CrossFT™ Knotless Suture Anchors are manufactured from PolyEtherEtherKetone (PEEK™). The anchors are provided sterile, single use and preloaded on a disposable driver. The anchors are available in three sizes and nine configurations.
The provided document describes the "CrossFT™ Knotless Suture Anchor with Disposable Driver" and its substantial equivalence to a predicate device (K091549). This is a medical device, not an AI/ML device, and therefore the concepts of acceptance criteria related to algorithmic performance (like sensitivity, specificity, MRMC studies, standalone performance, ground truth establishment by experts, training/test set sizes, and data provenance) are not applicable in this context.
The document focuses on demonstrating substantial equivalence for a medical device through engineering and biological performance testing.
Here's an interpretation of the relevant information provided, focusing on what is available:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly state quantitative acceptance criteria in a table format with corresponding reported performance values for each criterion. It broadly mentions completed performance testing to demonstrate the device performs as intended and is substantially equivalent.
However, based on the types of testing listed, we can infer general areas of acceptance. The "Reported Device Performance" is stated generally as having "met the endotoxin limits" and that the testing "demonstrates that the CrossFT™ Knotless Suture Anchor with Disposable Driver performs as intended and is substantially equivalent to the predicate device."
| Acceptance Criteria (Inferred from testing types) | Reported Device Performance |
|---|---|
| Reliability | Performed as intended |
| Packaging Integrity | Performed as intended |
| Ultimate Fixation Strength | Performed as intended |
| Cyclic Loading Performance | Performed as intended |
| Sterilization Efficacy | Performed as intended |
| Pyrogenicity (Bacterial Endotoxin) | Met endotoxin limits |
| Verification Testing (General Device Function) | Performed as intended |
| Transportation Stability | Performed as intended |
| Biocompatibility | Performed as intended |
| User Validation (Usability) | Performed as intended |
| Shelf-life | Performed as intended |
2. Sample Size for Test Set and Data Provenance
This information is not provided in the document. For a physical medical device, "test set" typically refers to the number of units or samples subjected to each performance test. The document also does not specify the country of origin of data or whether tests were retrospective/prospective.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This information is not applicable for this type of medical device submission. "Ground truth" established by experts is a concept central to evaluating diagnostic or AI/ML device performance. For this physical device, "ground truth" relates to engineering specifications, material properties, and biological safety standards.
4. Adjudication Method for the Test Set
This information is not applicable for this type of medical device submission. Adjudication methods (like 2+1, 3+1) are used to resolve disagreements among human readers/experts when establishing ground truth for diagnostic or AI/ML performance.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
This is not applicable. MRMC studies are used to evaluate the comparative effectiveness of diagnostic methods (e.g., human readers with and without AI assistance) on a set of cases. This document describes a physical surgical implant.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done
This is not applicable. This refers to algorithmic performance without human intervention, which is relevant for AI/ML devices.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance would be defined by engineering specifications, material science standards, and established biological safety standards. For example, the "ultimate fixation strength" would have a specific quantifiable standard that the device must meet, derived from biomechanical requirements. The "met the endotoxin limits" is an example of meeting a specific biological safety standard, which acts as a "ground truth" for endotoxin levels.
8. The Sample Size for the Training Set
This is not applicable. "Training set" refers to data used to train an AI/ML algorithm. This document describes a physical medical device.
9. How the Ground Truth for the Training Set Was Established
This is not applicable for the reasons stated above.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 25, 2017
ConMed Corporation Ms. Nyrobia Freeman Regulatory Affairs Specialist 525 French Road Utica, New York 13502
Re: K163258
Trade/Device Name: CrossFT10 Knotless Suture Anchor with Disposable Driver Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI Dated: December 29, 2016 Received: January 5, 2017
Dear Ms. Freeman:
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 (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.
{1}------------------------------------------------
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 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 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
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K163258
Device Name
CrossFTTM Knotless Suture Anchor with Disposable Driver
Indications for Use (Describe)
The CrossFT™ Knotless Anchor with Disposable Driver is intended to reattach soft tissue to bone in orthopedic surgical procedures. The device may be used in either arthroscopic or open surgical procedures. After the sutured 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 appropriative immobilization, throughout the healing period.
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}------------------------------------------------
Image /page/3/Picture/0 description: The image shows the logo for Conmed Corporation. The logo features a blue square with a white curved shape inside on the left. To the right of the square is the word "CONMED" in black, with the word "CORPORATION" in smaller, blue letters underneath.
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 K163258.
I. SUBMITTER
CONMED Corporation 11311 Concept Blvd Largo, Florida 33773
Phone: 727-399-5416 Fax: 727-399-5264
Contact Person: Nyrobia Freeman Date Prepared: November 18, 2016
II. DEVICE NAME
| Device Name: | CrossFT™ Knotless Suture Anchor with Disposable Driver |
|---|---|
| Common Name: | Nonabsorbable Suture Anchor |
| Classification Name: | Fastener, Fixation, Non-degradable, Soft-Tissue |
| Regulatory Class: | Class II, per 21 CFR Part 888. 3040 |
| Product Codes: | MBI |
III. PREDICATE/ LEGALLY MARKET DEVICE
| Device Name: | CrossFTTM Suture Anchor with Disposable Drive |
|---|---|
| Company Name: | CONMED Linvatec |
| 510(k) #: | K091549 |
IV. DEVICE DESCRIPTION
The CrossFT™ Knotless Suture Anchors with Disposable Driver are sterile, single use devices. The CrossFT™ Knotless Suture Anchors are manufactured from PolyEtherEtherKetone (PEEK™). The anchors are provided sterile, single use and preloaded on a disposable driver. The anchors are available in three sizes and nine configurations. (See table 1)
| Catalog Number | Description |
|---|---|
| CFK-40 | CrossFTTM Knotless 4.0 mm Suture Anchor |
| CFK-40TA | CrossFTTM Knotless 4.0 mm Suture Anchor with one 2 mm Hi-Fi ® Tape (Blue) |
Table 1: CrossFT™ Knotless Suture Anchors with Disposable Driver sizes and configurations
{4}------------------------------------------------
Image /page/4/Picture/0 description: The image shows the logo for CONMED Corporation. The logo consists of a blue square with a white abstract shape on the left, and the word "CONMED" in black capital letters on the right. Below the word "CONMED" is the word "CORPORATION" in smaller black capital letters, underlined by a thin blue line. The logo is clean and professional, and the colors are simple and effective.
| CFK-40TB | CrossFTTM Knotless 4.0 mm Suture Anchor with one 2 mm Hi-Fi® Tape (White/Black) |
|---|---|
| CFK-475S | CrossFTTM Knotless 4.75 mm Suture Anchor |
| CFK-475STA | CrossFTTM Knotless 4.75 mm Suture Anchor with one 2 mm Hi-Fi Tape (Blue) |
| CFK-475STB | CrossFTTM Knotless 4.75 mm Suture Anchor with one 2 mm Hi-Fi Tape (White/Black) |
| CFK-55S | CrossFTTM Knotless 5.5 mm Suture Anchor |
| CFK-55STA | CrossFTTM Knotless 5.5 mm Suture Anchor with one 2 mm Hi-Fi® Tape (Blue) |
| CFK-55STB | CrossFTTM Knotless 5.5 mm Suture Anchor with one 2 mm Hi-Fi® Tape (White/Black) |
V. INTENDED USE/ INDICATIONS FOR USE
The CrossFT™ Knotless Suture Anchor with Disposable Driver is intended to reattach soft tissue to bone in orthopedic surgical procedures.
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 appropriate postoperative immobilization, throughout the healing period.
COMPARISON OF THE TECHNOLOGICAL CHARACTERISTICS WITH THE VI. PREDICATE DEVICE
The CrossFTTM Knotless Suture Anchor with Disposable Driver is substantially equivalent in design, materials, intended use, principles of operation, and technical characteristics to the predicate CrossFT™ Suture Anchors with Disposable Driver and raises no new issues of safety or effectiveness.
The similarities and difference between the predicate and proposed Nonabsorbable Suture Anchors are the following-
| CrossFT TM Knotless Suture Anchor withDisposable DriverProposed | ConMed Linvatec Soft Tissue to Bone System(CrossFT TM Suture Anchor with Disposable Driver)Predicate | |
|---|---|---|
| Manufacturer | CONMED Corporation | ConMed Linvatec |
| 510k | Pending | K091549 |
| Product Code | MBI | MBI |
| Classification | II | II |
| Intended Use | The CrossFT TM Knotless Suture Anchor isintended to reattach soft tissue to bone inorthopedic surgical procedures. | The CrossFT TM Suture Anchor is intended toreattach soft tissue to bone in orthopedic surgicalprocedures. |
| Indication for Use | The device may be used in either arthroscopicor open surgical procedures. After the suture isanchored to the bone, it may be used to reattachsoft tissue, such as ligaments, tendons, or jointcapsules to the bone. The suture anchor system | The device may be used in either arthroscopic oropen surgical procedures. After the suture isanchored to the bone, it may be used to reattachsoft tissue, such as ligaments, tendons, or jointcapsules to the bone. The suture anchor system |
| CrossFTTM Knotless Suture Anchor withDisposable DriverProposed | ConMed Linvatec Soft Tissue to Bone System(CrossFTTM Suture Anchor with Disposable Driver)Predicate | |
| Contraindications | thereby stabilizes the damaged soft tissue, inconjunction with appropriate postoperativeimmobilization, throughout the healing period.*Pathological conditions of bone which wouldadversely affect the CrossFT Knotless SutureAnchor.*Pathological conditions in soft tissue to berepaired or reconstructed which wouldadversely affect suture fixation.*Physical conditions that would eliminate, ortend to eliminate adequate implant support orretard healing.*Conditions which tend to limit the patient'sability or willingness to restrict activities orfollow directions during the healing period.*Attachment of artificial ligaments or otherimplants.*Foreign body sensitivity, known or suspectedallergies to implant and/or instrument materials.*This device is not cleared for screwattachment or fixation to the posterior elements(pedicles) of the cervical, thoracic or lumbarspine. | thereby stabilizes the damaged soft tissue, inconjunction with appropriate postoperativeimmobilization, throughout the healing period.*Pathological conditions of bone which wouldadversely affect the CrossFT Knotless SutureAnchor.*Pathological conditions in soft tissue to berepaired or reconstructed which would adverselyaffect suture fixation.*Physical conditions that would eliminate, or tendto eliminate adequate implant support or retardhealing.*Conditions which tend to limit the patient's abilityor willingness to restrict activities or followdirections during the healing period.*Attachment of artificial ligaments or otherimplants.*Foreign body sensitivity, known or suspectedallergies to implant and/or instrument materials.*This device is not cleared for screw attachment orfixation to the posterior elements (pedicles) of thecervical, thoracic or lumbar spine. |
| Handle | Two pieces that consist of a handle and grip | One piece handle |
| AnchorDimensions | 4.0 mm, 4.75 mm and 5.5 mm in width14.5" inches in length | 4.5mm, 5.5mm and 6.5mm in width9.5" inches in length |
| Suture and/orSuture Tapesconfigurations | CrossFTTM Knotless 4.0 mm Suture AnchorCrossFTTM Knotless 4.0 mm Suture Anchorwith one 2 mm Hi-Fi Tape (White/Black)CrossFTTM Knotless 4.75 mm Suture AnchorCrossFTTM Knotless 4.75 mm Suture Anchorwith one 2 mm Hi-Fi Tape (Blue)CrossFTTM Knotless 4.75 mm Suture Anchorwith one 2 mm Hi-Fi Tape (White/Black)CrossFTTM Knotless 5.5 mm Suture AnchorCrossFTTM Knotless 5.5 mm Suture Anchorwith one 2 mm Hi-Fi Tape (Blue)CrossFTTM Knotless 5.5 mm Suture Anchorwith one 2 mm Hi-Fi Tape (White/Black) | Cross FT Anchor with two #2 Hi-Fi Suture, 4.5mmCross FT Anchor with three #2 Hi-Fi Suture,4.5mmCross FT Anchor with two # 2 Hi-Fi Suture,5.5mmCross FT Anchor with three # 2 Hi-Fi Suture,5.5mmCross FT Anchor with two #2 Hi-Fi Suture,6.5mmCross FT Anchor with two #2 Hi-Fi Suture,6.5mm |
| Threader | Used to thread Hi-Fi® Tape limbs or Hi-Fi® #2suture limbs through the anchor and driverFor the 4.0 mm anchor, a maximum of two (2)Hi-Fi® Tape limbs can be loaded.For the 4.75 mm and 5.5 mm anchors, amaximum of two (2) Hi-Fi® Tape limbs plustwo (2) Hi-Fi® #2 suture limbs, or six (6) Hi-Fi® #2 suture limbs can be loaded. | None |
| Cleat | Available with two (2) suture cleats. The firstcleat is part of the handle design and located ontop of the handle. This cleat is used to wrap thepreloaded suture and/or suture type standsaround for packaging purposes. The second | The suture cleat is used to hold the suturestrands while tensioning the anchor and forpackaging purpose |
| CrossFTTM Knotless Suture Anchor withDisposable DriverProposed | ConMed Linvatec Soft Tissue to Bone System(CrossFTTM Suture Anchor with Disposable Driver)Predicate | |
| cleat is grey in color and has slotted indents oneach side to wrap the suture strands around. Thesecond cleat is also used to maintain tension onthe suture strands while the anchor is driveninto the bone. | ||
| Packaging | PouchTray | PouchPETG retaining clipTyvek and Nylon/PE Film pouch |
| Single Use/Reusable | Sterile, Single-Use | Sterile, Single-Use |
| Sterilization | Eto | Eto |
| Components | Bone PunchBone TapDrill Bit | Bone PunchBone Tap |
| Shelf-Life | 18 months | 5 year |
{5}------------------------------------------------
Image /page/5/Picture/0 description: The image shows the logo for Conmed Corporation. The logo features a blue square with a white curved shape inside, followed by the word "CONMED" in black, bold letters. Below the word "CONMED" is the word "CORPORATION" in smaller, blue letters with a blue line above it.
{6}------------------------------------------------
Image /page/6/Picture/0 description: The image shows the logo for Conmed Corporation. The logo consists of a blue square with a white curved shape inside on the left. To the right of the square is the word "CONMED" in black, with a blue line underneath, and the word "CORPORATION" in black below the line.
PERFORMANCE DATA
Testing has been completed to demonstrate that the CrossFT™ Knotless Suture Anchor with Disposable Driver 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 the following:
- . Reliability
- Packaging .
- Ultimate Fixation Strength ●
- Cyclic ●
- Sterilization ●
- Pyrogenicity
- Verification Testing ●
- . Transportation
- Biocompatibility ●
- User Validation ●
- Shelf-life ●
VIII. CONCLUSION
The CrossFTTM Knotless Suture Anchor with Disposable Driver is either substantially equivalent or identical in design, materials, intended use, principles of operation, and technical characteristics to the predicate CrossFT™ Suture Anchor with Disposable Driver. Based upon the findings of our performance testing, the differences present no new issues of safety and efficacy and the CrossFT™ Knotless Suture Anchor with Disposable Driver is substantially equivalent to the CrossFT™ Suture Anchor with Disposable Driver (K091549).
§ 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.