(102 days)
No
The device description and performance studies focus on the mechanical properties and sterilization of a physical suture anchor, with no mention of software, algorithms, or data processing related to AI/ML.
No.
The device is a non-absorbable suture anchor used to reattach soft tissue to bone, which is a structural or mechanical support rather than a therapeutic treatment in itself. Its purpose is to stabilize tissue during the healing period, not to directly treat a disease or condition.
No
This device is a non-absorbable suture anchor intended to reattach soft tissue to bone, which is a therapeutic intervention, not a diagnostic one.
No
The device description clearly states the device is a physical suture anchor made of PEEK, preloaded on a driver, and includes a suture. It is a hardware device used in surgical procedures.
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 intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is a physical implant (suture anchor) made of PEEK, used to physically connect tissues. IVDs are typically reagents, instruments, or systems used to examine specimens from the human body.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples, detecting markers, or providing diagnostic information about a patient's condition.
- Surgical Procedure: The device is used during a surgical procedure to repair damaged tissue, not to diagnose a disease or condition.
In summary, this device is a surgical implant used for tissue repair, which falls outside the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The non-absorbable suture anchors are 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 suture anchor systems thereby stabilize the damaged soft tissue, in conjunction with appropriate postoperative immobilization, throughout the healing period.
Product codes
MBI
Device Description
The CONMED CrossFT™ Knotless Deep Thread Suture Anchors are manufactured from stable PolyEtherEtherKetone (PEEK). The CrossFT Knotless Deep Thread Anchors are a threaded screw-in suture anchor design. The CrossFT™ Knotless Deep Thread Suture Anchors are provided sterile, preloaded on a single-use driver and some include a preloaded sliding #2 (5 metric) Hi-Fi® Suture. The device is EO sterilized.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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 Deep Thread Suture Anchor performs as intended and is substantially equivalent to the predicate device. Bacterial endotoxin testing was conducted and met the endotoxin limits.
Completed testing includes the following:
Verification Testing
- Reliability
- Ultimate Fixation Strength
- Cyclic
- Sterilization
- Pyrogen
- Biocompatibility
- Shelf-life
- Post Aging Functional Testing
- MR Safety Testing
Validation Testing
- User Validation
- Packaging
- Transportation
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
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA). The HHS logo is on the left, and the FDA logo is on the right. The FDA logo includes the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue.
January 4, 2019
ConMed Corporation Diana Nader-Martone Regulatory Affairs Specialist 525 French Road Utica, New York 13502
Re: K182621
Trade/Device Name: CrossFT™ Knotless Deep Thread 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: November 30, 2018 Received: December 6, 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrl/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, 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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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,
Laurence D. Coyne -S
For Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
K182621
Device Name
CrossFTM Knotless Deep Thread Suture Anchor with Disposable Driver
Indications for Use (Describe)
Intended Use
The non-absorbable suture anchors are 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 suture anchor systems thereby stabilize 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)
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Image /page/3/Picture/0 description: The image shows the logo for CONMED Corporation. The logo features a blue square on the left side with a white curved shape inside. To the right of the square, the word "CONMED" is written in a bold, black font, with a horizontal line underneath. Below the line, the word "CORPORATION" is written in a smaller, lighter font.
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 K182621
I. SUBMITTER
CONMED Corporation 11311 Concept Blvd Largo, Florida 33773
Phone: 727-399-5425 Fax: 727-399-5264
Contact Person: Diana L. Nader-Martone Date Prepared: September 21, 2018
II. DEVICE NAME
| Device Name: | CrossFT™ Knotless Deep Thread Suture Anchor with
Disposable Driver |
|----------------------|-----------------------------------------------------------------------|
| Common Name: | Nonabsorbable Suture Anchor System |
| Classification Name: | Fastener, fixation, nondegradable, soft tissue |
| Regulatory Class: | Class II, per 21 CFR Part 888. 3040 |
| Product Codes: | MBI |
III. PREDICATE/ LEGALLY MARKET DEVICE
| Device Name: | CrossFT™ Knotless Suture Anchor with Disposable Driver |
|---|---|
| Company Name: | ConMed |
| 510(k)#: | K163258 |
IV. REFERENCE/ LEGALLY MARKET DEVICE
| Device Name: | ConMed Linvatec Soft Tissue to Bone System |
|---|---|
| Company Name: | ConMed Linvatec |
| 510(k) #: | K091549 |
V. DEVICE DESCRIPTION
The CONMED CrossFT™ Knotless Deep Thread Suture Anchors are manufactured from stable PolyEtherEtherKetone (PEEK). The CrossFT Knotless Deep Thread Anchors are a threaded screw-in suture anchor design. The CrossFT™ Knotless Deep Thread Suture Anchors are provided sterile, preloaded on a single-use driver and some include a preloaded sliding #2 (5 metric) Hi-Fi® Suture. The device is EO sterilized.
4
Image /page/4/Picture/0 description: The image shows the logo for CONMED Corporation. The logo features a stylized blue graphic on the left, resembling a curved shape. To the right of the graphic is the company name, "CONMED," in bold, black letters. Below the company name is the word "CORPORATION" in smaller, black letters.
INTENDED USE/ INDICATIONS FOR USE VI.
The non-absorbable suture anchor 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 following table represents a summary of the technological characteristics between the proposed and the predicate device.
| | CrossFT™ Knotless Deep Thread
Suture Anchor with Disposable
Driver
Proposed Device | CrossFT™ Knotless Suture
Anchor with Disposable
Driver
Predicate Device | ConMed Linvatec Soft Tissue
to Bone System
(CrossFT™ Suture Anchor
with Disposable Driver)
Reference |
|----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------|
| Device Description | The CONMED CrossFT™
Knotless Deep Thread Suture
Anchors are manufactured from
stable PolyEtherEtherKetone
(PEEK). The CrossFT Knotless
Deep Thread Anchors are a
threaded screw-in suture anchor
design. The CrossFT™ Knotless
Deep Thread Suture Anchors are
provided sterile, preloaded on a
single-use driver and some
include a preloaded sliding #2 (5
metric) Hi-Fi® Suture. The
device is EO sterilized. | The CONMED CrossFT™
Knotless Deep Thread Suture
Anchors are manufactured
from stable
PolyEtherEtherKetone
(PEEK). The CrossFT
Knotless Deep Thread
Anchors are a threaded screw-
in suture anchor design. The
CrossFT™ Knotless Deep
Thread Suture Anchors are
provided sterile, preloaded on
a single-use driver and some
include a preloaded sliding #2
(5 metric) Hi-Fi® Suture. The
device is EO sterilized. | Reference |
| Intended Use | The non-absorbable suture anchors
are intended to reattach soft tissue
to bone in orthopedic surgical
procedures. | Same | Same |
| Indication 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 appropriate
postoperative immobilization,
throughout the healing period. | Same | Same |
| | CrossFT™ Knotless Deep Thread
Suture Anchor with Disposable
Driver
Proposed Device | CrossFT™ Knotless Suture
Anchor with Disposable
Driver
Predicate Device | ConMed Linvatec Soft Tissue
to Bone System
(CrossFT™ Suture Anchor
with Disposable Driver)
Reference |
| Contraindications | 1. Pathological conditions of bone
which would adversely affect
the CrossFT™ Knotless Deep
Thread Suture Anchor.
2. Pathological conditions in the
soft tissue to be repaired or
reconstructed which would
adversely affect suture fixation.
3. Physical conditions that would
eliminate, or tend to eliminate,
adequate implant support or
retard healing.
4. Conditions which tend to limit
the patient's ability or
willingness to restrict activities
or follow directions during the
healing period.
5. Attachment of artificial
ligaments or other implants.
6. Foreign body sensitivity,
known or suspected allergies to
implant and/or instrument
materials.
7. This device is not approved for
screw attachment or fixation to
the posterior elements
(pedicles) of the cervical,
thoracic or lumbar spine.
8. Patients with active sepsis or
infection. | Same | Same |
| Components | Non-absorbable Anchor
Disposable Driver
Threader
Suture (some catalog numbers) | Non-absorbable Anchor
Disposable Driver
Threader
Suture (some catalog
numbers)
Suture Tape (some catalog
numbers) | Non-absorbable Anchor
Disposable Driver
Suture |
| Technological
Characteristics | Non-absorbable,
PolyEtherEtherKetone (PEEK)
Anchor
Screw-in, Knotless Anchor
Design
Threader
Disposable Driver | Same | Non-absorbable,
PolyEtherEtherKetone
(PEEK) Anchor
Screw-in Anchor Design
Disposable Driver |
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Image /page/5/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 is the word "CONMED" in black, sans-serif font, with a horizontal line underneath. Below the line is the word "CORPORATION" in smaller, sans-serif font.
PERFORMANCE DATA
Testing has been completed to demonstrate that the CrossFT™ Knotless Deep Thread Suture Anchor performs as intended and is substantially equivalent to the predicate device. Bacterial endotoxin testing was conducted and met the endotoxin limits.
Completed testing includes the following:
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Image /page/6/Picture/0 description: The image shows the Conmed Corporation logo. 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.
K182621 Page 4 of 4
Verification Testing
- Reliability ●
- Ultimate Fixation Strength ●
- Cyclic ●
- Sterilization ●
- Pyrogen ●
- Biocompatibility
- Shelf-life
- Post Aging Functional Testing ●
- MR Safety Testing ●
VIII. CONCLUSION
The CrossFTTM Knotless Deep Thread 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 ConMed CrossFT™ Knotless 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 CrossFTM Knotless Deep Thread Suture Anchor with Disposable Driver is substantially equivalent to the ConMed CrossFT™ Knotless Suture Anchor with Disposable Driver (K163258).
Validation Testing
- User Validation ●
- Packaging ●
- Transportation ●