(90 days)
Not Found
No
The 510(k) summary describes a mechanical suture anchor and driver system made of biocomposite materials. There is no mention of software, algorithms, or any features that would suggest the use of AI or ML. The testing described focuses on mechanical properties, sterilization, and biocompatibility.
Yes
The device is intended to reattach soft tissue to bone, stabilizing damaged soft tissue during the healing period, which is a therapeutic function.
No
Explanation: The device is a suture anchor used in orthopedic surgical procedures to reattach soft tissue to bone. Its function is to provide mechanical stabilization during the healing period, not to diagnose a condition.
No
The device description explicitly states it is a physical suture anchor made from polylactide copolymer and ß-Tricalcium Phosphate, preloaded on a disposable driver. This is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "reattach[ing] soft tissue to bone in the following orthopedic surgical procedures." This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is a "Suture Anchor with Disposable Driver" made of biomaterials. This is a physical implant and delivery system used during surgery.
- 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 compatibility testing.
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 CrossFT™ Knotless Biocomposite Suture Anchor with Disposable Driver is intended to reattach soft tissue to bone in the following orthopedic surgical procedures:
| Procedure | Joint |
|---|---|
| Rotator Cuff Repair | Shoulder |
| Achilles Repair | Ankle |
| Bicep Tenodesis | Shoulder |
| Gluteus Medius Repair | Hip |
| Medial Patellofemoral Ligament (MPFL) | Knee |
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, 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.
Product codes (comma separated list FDA assigned to the subject device)
MAI
Device Description
The CrossFT™ Knotless Biocomposite Suture Anchors with Disposable Driver are sterile, single use devices. The CrossFTTM Knotless Biocomposite Suture Anchors with Disposable Driver are manufactured from polylactide copolymer (96L/4D PLA) and ß-Tricalcium Phosphate (8-TCP). The anchors are provided sterile, single use and preloaded on a disposable driver. The anchors are available in three sizes and nine configurations.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Shoulder, Ankle, Hip, Knee
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Testing has been completed to demonstrate that the CrossFT™ Knotless Biocomposite 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. The test parameters utilized were supported by clinical data in the literature to support the specific indications and corresponding anatomic locations in this submission.
Completed testing includes the following:
Verification Testing
- Reliability
- Ultimate Fixation Strength
- Cyclic
- Sterilization
- Pyrogenicity
- Biocompatibility
- Shelf-life
Validation Testing
- User Validation
- Packaging
- Transportation
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
August 29, 2017
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
ConMed Corporation Ms. Diana L. Nader-Martone Regulatory Affairs Specialist 525 French Road Utica. New York 13502
Re: K171592
Trade/Device Name: CrossFT™ Knotless Biocomposite Suture Anchor with Disposable Driver Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: MAI Dated: May 30, 2017 Received: May 31, 2017
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
Image /page/0/Picture/10 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.
1
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.
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
Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
See PRA Statement below.
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
K171592
Device Name
CrossFTM Knotless Biocomposite Suture Anchor with Disposable Driver
Indications for Use (Describe)
The CrossFT™ Knotless Biocomposite Suture Anchor with Disposable Driver is intended to reattach soft tissue to bone in the following orthopedic surgical procedures:
| Procedure | Joint |
|---|---|
| Rotator Cuff Repair | Shoulder |
| Achilles Repair | Ankle |
| Bicep Tenodesis | Shoulder |
| Gluteus Medius Repair | Hip |
| Medial Patellofemoral Ligament (MPFL) | Knee |
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, 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.
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 K171592
I. SUBMITTER
CONMED Corporation 525 French Road Utica, New York 13502
Phone: 727-399-5425 Fax: 727-399-5264
Contact Person: Diana L. Nader-Martone Date Prepared: May 30, 2017
II. DEVICE NAME
| Device Name: | CrossFTTM Knotless Biocomposite Suture Anchor with |
|---|---|
| Disposable Driver | |
| Common Name: | Bioabsorbable Suture Anchor |
| Classification Name: | Fastener, fixation, biodegradable, soft tissue |
| Regulatory Class: | Class II, per 21 CFR Part 888. 3030 |
| Product Codes: | MAI |
III. PREDICATE DEVICE
| Device Name: | CrossFT™ Knotless Biocomposite Suture Anchor with |
|---|---|
| Disposable Driver | |
| Company Name: | ConMed Corporation |
| 510(k) #: | K170501 |
IV. DEVICE DESCRIPTION
The CrossFT™ Knotless Biocomposite Suture Anchors with Disposable Driver are sterile, single use devices. The CrossFTTM Knotless Biocomposite Suture Anchors with Disposable Driver are manufactured from polylactide copolymer (96L/4D PLA) and ß-Tricalcium Phosphate (8-TCP). The anchors are provided sterile, single use and preloaded on a disposable driver. The anchors are available in three sizes and nine configurations.
V. INTENDED USE/ INDICATIONS FOR USE
4
Image /page/4/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 a bold, sans-serif font. Below the word "CONMED" is the word "CORPORATION" in a smaller, sans-serif font. A blue line underlines the word "CONMED".
The CrossFT™ Knotless Biocomposite Suture Anchor with Disposable Driver is intended to reattach soft tissue to bone in the following orthopedic surgical procedures:
| Procedure | Joint |
|---|---|
| Rotator cuff repair | Shoulder |
| Achilles Repair | Ankle |
| Bicep Tenodesis | Shoulder |
| Gluteus Medius Repair | Hip |
| Medial Patellofemoral Ligament (MPFL) | Knee |
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 following table represents a summary of the technological characteristics between the proposed and the predicate device.
| | CrossFTTM Knotless Biocomposite Suture
Anchor with Disposable Driver
Proposed | CrossFTTM Knotless Biocomposite Suture
Anchor with Disposable Driver
Predicate | | | | | | | | | | | | |
|-----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|--|--|--|--|--|--|--|------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device
Description | Same | The CrossFTTM Knotless Biocomposite Suture
Anchor with Disposable Drivers are sterile, single
use devices. The CrossFTTM Knotless
Biocomposite Suture Anchor with Disposable
Drivers are manufactured from polylactide
copolymer (96L/4D PLA) and β-Tricalcium
Phosphate (β-TCP). The anchors are provided
sterile, single use and preloaded on a disposable
driver. The anchors are available in three sizes
and nine configurations. | | | | | | | | | | | | |
| Intended Use | The CrossFTTM Knotless Biocomposite Suture
Anchor with Disposable Driver is intended to
reattach soft tissue to bone in the following
orthopedic surgical procedures:
Procedure Joint Rotator Cuff Repair Shoulder Achilles Repair Ankle Bicep Tenodesis Shoulder Gluteus Medius Repair Hip Medial Patellofemoral Ligament (MPFL) Knee | | | | | | | | | | | | | The CrossFTTM Knotless Biocomposite Suture
Anchor with Disposable Driver is intended to
reattach soft tissue to bone in orthopedic surgical
procedures. |
| Indication for Use | Same | 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. | | | | | | | | | | | | |
5
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 bold, black letters. Below the word "CONMED" is the word "CORPORATION" in smaller, black letters. A thin blue line separates the two words.
| | CrossFT™ Knotless Biocomposite Suture
Anchor with Disposable Driver
Proposed | CrossFT™ Knotless Biocomposite Suture
Anchor with Disposable Driver
Predicate |
|-------------------|------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contraindications | Same | *Pathological conditions of bone which would
adversely affect the CrossFT™ Knotless
Biocomposite Suture Anchor with Disposable
Driver with Disposable Driver.
- Pathological conditions in the soft tissue to be
repaired 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. |
| Components | Same | Bioabsorbable anchor
Disposable Driver
Suture and/or Suture Tape
Threader |
VII. PERFORMANCE DATA
Testing has been completed to demonstrate that the CrossFT™ Knotless Biocomposite 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. The test parameters utilized were supported by clinical data in the literature to support the specific indications and corresponding anatomic locations in this submission.
Completed testing includes the following:
Verification Testing
- Reliability ●
- Ultimate Fixation Strength ●
- Cvclic ●
- Sterilization ●
- Pyrogenicity ●
- Biocompatibility ●
- Shelf-life
● User Validation
- Packaging .
- Transportation ●
Validation Testing
- VIII. CONCLUSION
The CrossFT™ Knotless Biocomposite Suture Anchor with Disposable Driver is identical in design, materials, principles of operation, and technical characteristics to the predicate, and substantially equivalent in intended use to the predicate. Based upon the findings of our performance testing, the difference regarding intended use presents no new issues of
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 the word "CORPORATION" in smaller blue letters underneath.
safety and efficacy, and the proposed, CrossFT™ Knotless Biocomposite Suture Anchor
with Disposable Driver is substantially equivalent to the CrossFT™ Knotless Biocomposite Suture Anchor with Disposable Driver (K170501).