(123 days)
No
The device description and performance studies focus on mechanical properties and sterilization, with no mention of AI or ML.
Yes
The device is intended to reattach soft tissue to bone in orthopedic surgical procedures to stabilize damaged soft tissue throughout the healing period, which is a therapeutic function.
No
The device is a non-absorbable suture anchor used to reattach soft tissue to bone during orthopedic surgical procedures. Its function is to stabilize damaged soft tissue for healing, not to diagnose a condition or disease.
No
The device description clearly outlines physical components like suture anchors, sutures, needles, inserter, drill bit, and guide handle, indicating it is a hardware medical device.
Based on the provided text, 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 procedure performed directly on the patient's body.
- Device Description: The device is a "non-absorbable suture anchor" and associated surgical tools. These are physical implants and instruments used during surgery.
- Lack of Diagnostic Activity: There is no mention of the device being used to test samples (like blood, urine, or tissue) in vitro (outside the body) to diagnose a condition, monitor treatment, or screen for diseases.
IVD devices are specifically designed for testing biological samples in vitro to provide diagnostic information. This device is a surgical tool used for repair in vivo.
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 bone. The suture anchor systems thereby stabilize 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® Shallow All-Suture Anchor is manufactured from High Strength Flat Braided Suture threaded with either one #0 (3.5 metric) or one #2-0 (3 metric) Hi-Fi® suture strand 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
soft tissue to bone
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 TruShot™ with Y-Knot® Shallow All-Suture Anchor performs as intended and is substantially equivalent to the predicate device. Performance testing was addressed by side-by-side testing comparing the subject device to predicate K992487. Bacterial endotoxin testing was conducted and met the endotoxin limits.
Completed testing includes the following:
Verification Testing
- Sterilization
- Pyrogen
- Reliability
- Ultimate Fixation Strength
Side-by-Side Testing
- Cyclic
Validation Testing
- User Validation
- Packaging
- Transportation
- Biocompatibility
- Shelf-life
- Post Aging Functional Testing
- MR Safety Testing
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.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG" in blue, and below that, the word "ADMINISTRATION" in blue.
January 8, 2019
CONMED Corporation Diana L. Nader-Martone, M.S. Regulatory Affairs Specialist 525 French Road Utica, New York 13502
Re: K182439
Trade/Device Name: TruShot™ with Y-Knot® Shallow 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 19, 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, 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
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.htm); 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 mediation-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
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) K182439
Device Name
TruShot™ with Y-Knot® Shallow 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 bone. 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)
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/1 description: The image shows the logo for CONMED Corporation. The logo features a stylized blue "C" shape on the left side. To the right of the "C" is the word "CONMED" in black, sans-serif font, with a horizontal blue line underneath. Below the line is the word "CORPORATION" in a smaller, sans-serif 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
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 18, 2018
DEVICE NAME II.
| Device Name: | TruShot™ with Y-Knot® Shallow 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 MARKETED DEVICE
| Device Name: | Mitek Mini QuickAnchor® Plus |
|---|---|
| Company Name: | Mitek |
| 510(k) #: | K992487 |
IV. REFERENCE DEVICE
| Device Name: | ConMed Linvatec Y-Knot™ All-Suture Anchor |
|---|---|
| Company Name: | ConMed Linvatec |
| 510(k) #: | K111779 |
V. ADDITIONAL 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 |
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Image /page/4/Picture/0 description: The image shows the logo for Conmed Corporation. The logo consists of a blue square on the left with a white, stylized "C" shape inside. To the right of the square is the word "CONMED" in a bold, sans-serif font, with the word "CORPORATION" in a smaller font underneath.
VI. DEVICE DESCRIPTION
The CONMED TruShot™ with Y-Knot® Shallow All-Suture Anchor is manufactured from High Strength Flat Braided Suture threaded with either one #0 (3.5 metric) or one #2-0 (3 metric) Hi-Fi® suture strand 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.
VII. 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 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 VIII. PREDICATE DEVICE
The following table represents a summary of the technological characteristics between the proposed and the predicate device.
| | TruShot™ with Y-Knot®
Shallow All-Suture
Anchor
Proposed Device | Mitek Mini
QuickAnchor® Plus
Predicate Device | ConMed Linvatec Y-Knot® All-Suture
Anchor
1st Reference Device | Y-Knot Flex All-Suture
Anchor, w/Two #2 (5
Metric) Hi-Fi Sutures,
1.8mm
2nd Reference Device | |
|-----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------|
| Device
Description | The non-absorbable
suture anchors are
intended to reattach soft
tissue to bone in
orthopedic surgical
procedures. | Mitek Mini
QuickAnchor® Plus is a
sterile, disposable bone
anchor supplied
preloaded on an inserter
with a polyester suture. | Same as proposed | Same as proposed | |
| Intended Use | The non-absorbable
suture anchors are
intended to reattach soft
tissue to bone in
orthopedic surgical
procedures. | N/A - Incorporated into
their indications
statement | Same as proposed | Same as proposed | |
| 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 | Mitek Mini
QuickAnchor® Plus
indications:
Shoulder: Bankart repair
Ankle: Midfoot
Reconstructions
Foot: Hallux Valgus
Reconstruction | Same as proposed | Same as proposed | |
| | TruShot™ with Y-Knot®
Shallow All-Suture
Anchor
Proposed Device | Mitek Mini
QuickAnchor® Plus
Predicate Device | ConMed Linvatec Y-
Knot® All-Suture
Anchor
1st Reference Device | Y-Knot Flex All-Suture
Anchor, w/Two #2 (5
Metric) Hi-Fi Sutures,
1.8mm
2nd Reference Device | |
| Contraindications | bone. The suture anchor
system thereby stabilizes
the damaged soft tissue,
in conjunction with
appropriate
postoperative
immobilization,
throughout the healing
period.
- Reattachment of
intracapsular knee
ligaments (ACL &
PCL). - Pathological
conditions of bone
which would
adversely affect the Y-Knot anchor. - 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. | Wrist: Scapholunate
ligament
Reconstruction
Hand: Ulnar or Lateral
Collateral Ligament
Reconstruction
Pubis: Fixation in the
pubis for bladder neck
suspicion to resolve
stress urinary
incontinence - Reattachment of
intracapsular knee
ligaments (ACL &
PCL). - Surgical procedures
other than those listed
in the INDICATIONS
section. - Pathologic conditions
of bone, such as
cystic changes or
severe osteopenia,
which would impair
its ability to securely
fix the Depuy Mitek
Anchor, are
contraindicated. - Pathological changes
in the soft tissues
sutured to the bone
which would prevent
its secure fixation by
the suture are
contraindicated. - Comminuted bone
surface, which would
militate against secure
fixation of the Depuy
Mitek Anchor, is
contraindicated. - Physical conditions
that would eliminate
or tend to eliminate
adequate implant
support or retard
healing, i.e., blood
supply limitation,
previous infections,
etc. are
contraindicated. - Conditions which tend
to preempt the
patient's ability or the
healing period, such | 1. Pathological
conditions of bone
which would
adversely affect the
Y-Knot anchor. - 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. - Patients with active
sepsis or infection. | 1. Pathological
conditions of bone
which would
adversely affect the
Y-Knot anchor. - 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. - Patients with active
sepsis or infection. | |
| | TruShot™ with Y-Knot®
Shallow All-Suture
Anchor
Proposed Device | Mitek Mini
QuickAnchor® Plus
Predicate Device | ConMed Linvatec Y-Knot® All-Suture
Anchor
1st Reference Device | Y-Knot Flex All-Suture
Anchor, w/Two #2 (5
Metric) Hi-Fi Sutures, 1.8mm
2nd Reference Device | |
| | 9. Patients with active
sepsis or infection. | illness or alcoholism
are contraindicated. - The Depuy Mitek
Anchor is not
designed for and
should never be used
to attach artificial
ligaments or other
implants. | | | |
| Components | All-Suture Anchor
Disposable Guide
Handle
Suture | Handle
Shaft
Anchor
Suture
Needles | All-Suture Anchor
Disposable Driver
Suture | All-Suture Anchor
Disposable Driver
Suture | |
| | Technological
Characteristics | Soft-body suture anchor
One #0 or #2-0 suture
Drilled pilot hole
Press-fit insertion
Expandable design | Hard-body suture anchor
One #2/0 suture
Drilled pilot hole
Press-fit insertion
Expandable design | Soft-body suture anchor
One #2 suture
Drilled pilot hole
Press-fit insertion
Expandable design | Soft-body suture anchor
Two #2 sutures
Drilled pilot hole
Press-fit insertion
Expandable design |
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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 abstract shape inside, resembling a stylized "C". To the right of the square is the word "CONMED" in bold, sans-serif font. Below "CONMED" is the word "CORPORATION" in a smaller, sans-serif font.
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Image /page/6/Picture/0 description: The image shows the logo for CONMED Corporation. The logo consists of a blue square with a white, stylized "C" inside, followed by the word "CONMED" in black, sans-serif font. Below the word "CONMED" is a thin blue line, and below that is the word "CORPORATION" in a smaller, sans-serif font.
IX. PERFORMANCE DATA
Testing has been completed to demonstrate that the TruShot™ with Y-Knot® Shallow All-Suture Anchor performs as intended and is substantially equivalent to the predicate device. Performance testing was addressed by side-by-side testing comparing the subject device to predicate K992487. Bacterial endotoxin testing was conducted and met the endotoxin limits.
Completed testing includes the following:
Verification Testing
- Sterilization ●
- Pyrogen ●
- Reliability
- o Ultimate Fixation Strength
Side-by-Side Testing
- Cyclic .
- Validation Testing
- User Validation ●
- Packaging ●
- o Transportation
- Biocompatibility ●
- Shelf-life ●
- Post Aging Functional Testing
- MR Safety Testing
X. CONCLUSION
The TruShot™ with Y-Knot® Shallow All-Suture Anchor is either substantially equivalent or identical in design, materials, intended use, principles of operation, and technical characteristics to the predicate Mitek QuickAnchor Plus device. Based upon the findings
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Image /page/7/Picture/1 description: The image shows the logo for CONMED Corporation. The logo features a stylized blue graphic on the left, followed by the word "CONMED" in bold, black letters. Below the word "CONMED" is the word "CORPORATION" in smaller, gray letters.
of our performance testing, the differences present no new issues of safety and efficacy, and the TruShot™ with Y-Knot® Shallow All-Suture Anchor is substantially equivalent to the Mini QuickAnchor Plus (K992487) devices.