(103 days)
No
The document describes a mechanical suture anchor system and does not mention any AI or ML components or functionalities.
Yes
Explanation: The device is intended to reattach soft tissue to bone and stabilize damaged soft tissue, which constitutes a therapeutic intervention addressing a medical condition.
No
The 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 outlines physical components (suture anchors, inserter, drill bit, guide handle) and mentions sterilization and mechanical testing, indicating it is a hardware medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The device is intended for reattaching 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) with associated tools for insertion. It does not involve the analysis of biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing blood, urine, tissue, or any other biological specimen. The device's function is mechanical and surgical.
IVD devices are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening. This device does not fit that description.
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 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.
Product codes (comma separated list FDA assigned to the subject device)
MBI
Device Description
The CONMED TruShot™ with Y-Knot® All-Suture Anchor is manufactured from High Strength Flat Braided Suture threaded with either one or two #2 (5 metric) Hi-Fi® suture strands with needles. Each All-Suture Anchor is preloaded on a disposable inserter, and pre-assembled with a disposable drill bit and guide handle. The anchor, suture(s) with needles, inserter, drill bit, and guide handle are pre-assembled and provided sterile, intended for single-use. The device is EO Sterilized.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bone (for reattaching soft tissue)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
orthopedic 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 TruShot™ with Y-Knot® All-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): 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.
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
§ 888.3040 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.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
December 19, 2018
CONMED Corporation Diana L. Nader-Martone, M.S. Regulatory Affairs Specialist 525 French Road Utica, New York 13502
Re: K182446
Trade/Device Name: TruShot™ with Y-Knot® All-Suture Anchor Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI Dated: November 16, 2018 Received: November 20, 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/cdrh/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
1
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) 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 (QS) 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
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Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
See PRA Statement below.
Indications for Use
510(k) Number (if known)
K182446
Device Name TruShot™ with Y-Knot® All-Suture Anchor
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) |
|---|
| ------------------------------------------------- |
X 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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Image /page/3/Picture/1 description: The image shows the logo for Conmed Corporation. The logo features a blue square with a white abstract design on the left. To the right of the square, the word "CONMED" is written in bold, black letters. Below "CONMED", the word "CORPORATION" is written in smaller, black letters.
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 K182446.
I. SUBMITTER
CONMED Corporation 11311 Concept Blvd Largo, Florida 33773
Phone: 727-399-5425 Fax: 727-399-5264
Contact Persons: Diana L. Nader-Martone or Kathy Reddig Date Prepared: September 6, 2018
II. DEVICE NAME
| Device Name: | TruShot™ with Y-Knot® All-Suture Anchors |
|---|---|
| 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: | ConMed Linvatec Y-Knot™ All-Suture Anchor |
|---|---|
| Company Name: | ConMed Linvatec |
| 510(k) #: | K111779 |
IV. REFERENCE DEVICE
| Device Name: | Y-Knot Flex All-Suture Anchor, w/Two #2 (5 Metric) Hi-Fi |
|---|---|
| Sutures, 1.8mm | |
| Company Name: | ConMed Linvatec |
| 510(k) #: | K131035 |
V. DEVICE DESCRIPTION
The CONMED TruShot™ with Y-Knot® All-Suture Anchor is manufactured from High Strength Flat Braided Suture threaded with either one or two #2 (5 metric) Hi-Fi® suture strands with needles. Each All-Suture Anchor is preloaded on a disposable inserter, and pre-assembled with a disposable drill bit and guide handle. The anchor, suture(s) with
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Image /page/4/Picture/1 description: The image shows the logo for Conmed Corporation. The logo features a blue square with a white abstract shape inside, resembling a stylized "C". To the right of the square is the word "CONMED" in bold, black letters. Below "CONMED" is the word "CORPORATION" in smaller, lighter letters, underlined with a blue line.
needles, inserter, drill bit, and guide handle are pre-assembled and provided sterile, intended for single-use. The device is EO Sterilized.
VI. INTENDED USE/ INDICATIONS FOR USE
The non-absorbable suture anchors are intended to reattach soft tissue to bone in orthopedic surgical procedures.
The 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.
VII. COMPARISON OF THE TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
The following table represents a summary of the technological characteristics between the proposed and the predicate device.
| | TruShotTM with Y-Knot® All-
Suture Anchor
Proposed Device | ConMed Linvatec Y-Knot® All-
Suture Anchor
Predicate Device | Y-Knot Flex All-Suture Anchor,
w/Two #2 (5 Metric) Hi-Fi
Sutures, 1.8mm
Reference Device |
|-----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|
| Device
Description | The non-absorbable suture anchors
are intended to reattach soft tissue
to bone in orthopedic surgical
procedures. | Same | Same |
| 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 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. | Same | Same |
| Contraindications | 1. Pathological conditions of bone
which would adversely affect
the Y-Knot 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, | Same | Same |
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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, the word "CONMED" is written in a bold, black font. Below the word "CONMED", the word "CORPORATION" is written in a smaller, black font.
| | TruShot™ with Y-Knot® All-
Suture Anchor
Proposed Device | ConMed Linvatec Y-Knot® All-
Suture Anchor
Predicate Device | Y-Knot Flex All-Suture Anchor,
w/Two #2 (5 Metric) Hi-Fi
Sutures, 1.8mm
Reference Device |
|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|
| | 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. | | |
| Components | All-Suture Anchor
Disposable Guide Handle
Suture | All-Suture Anchor
Disposable Driver
Suture | All-Suture Anchor
Disposable Driver
Suture |
| Technological
Characteristics | Flat-braid suture anchor | Flat-braid suture anchor | Flat-braid suture anchor |
| | One or two #2 sutures
Drilled pilot hole | One #2 suture
Drilled pilot hole | Two #2 sutures
Drilled pilot hole |
| | Press-fit insertion | Press-fit insertion | Press-fit insertion |
| | Expandable design | Expandable design | Expandable design |
VIII. PERFORMANCE DATA
Testing has been completed to demonstrate that the TruShot™ with Y-Knot® All-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 .
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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 curved shape inside on the left. To the right of the square is the word "CONMED" in a bold, sans-serif font, with a horizontal line underneath. Below the line is the word "CORPORATION" in a smaller, sans-serif font.
IX. CONCLUSION
The TruShot™ with Y-Knot® All-Suture Anchor is either substantially equivalent or identical in design, materials, intended use, principles of operation, and technical characteristics to the predicate ConMed Linvatec Y-Knot™ All-Suture Anchor. Based upon the findings of our performance testing, the differences present no new issues of safety and efficacy, and the TruShot™ with Y-Knot® All-Suture Anchor is substantially equivalent to the ConMed Linvatec Y-Knot™ All-Suture Anchor (K111779).