(123 days)
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.
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.
The provided document is a 510(k) Summary for a medical device (TruShot™ with Y-Knot® Shallow All-Suture Anchor) and describes performance data to demonstrate substantial equivalence to a predicate device, rather than defining acceptance criteria and a study to prove a device meets those acceptance criteria.
Therefore, many of the requested details about acceptance criteria, study design for proving it, and specifics related to AI/algorithm performance (like effect size with AI assistance, standalone performance, training set details) are not applicable or extractable from this type of regulatory submission.
However, I can extract information about the types of performance testing conducted to support the device's clearance.
Here's what can be extracted:
1. A table of acceptance criteria and the reported device performance
The document does not provide specific quantitative acceptance criteria or detailed reported device performance values. It states that "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." It also mentions "met the endotoxin limits" without specifying the limit itself.
| Acceptance Criterion (Implicit) | Reported Device Performance (Summary) |
|---|---|
| Sterilization | Met requirements |
| Pyrogen (Bacterial Endotoxin) | Met the endotoxin limits |
| Reliability (e.g., Ultimate Fixation Strength) | Performs as intended, substantially equivalent to predicate |
| Cyclic Testing | Performed side-by-side with predicate, results support SE |
| User Validation | Met requirements |
| Packaging | Met requirements |
| Transportation | Met requirements |
| Biocompatibility | Met requirements |
| Shelf-life | Met requirements |
| Post Aging Functional Testing | Met requirements |
| MR Safety Testing | Met requirements |
2. Sample size used for the test set and the data provenance
The document does not specify sample sizes for any of the tests. It also does not discuss data provenance in terms of country of origin or retrospective/prospective nature, as these tests are typically bench or lab-based for medical devices like suture anchors.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable. The device is a physical medical implant, not an AI or diagnostic tool requiring expert interpretation for ground truth.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not applicable for this type of device testing.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No such study was done or is relevant to this physical medical device. This is typically applicable to diagnostic AI devices.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No standalone algorithm performance was done. This is not an AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For mechanical and material properties (e.g., Ultimate Fixation Strength, Cyclic testing), the "ground truth" would be established by validated test methods and physical measurements, compared against established standards or performance of the predicate device. For biological tests (e.g., pyrogen, biocompatibility, sterilization), it would be against regulatory limits and specified testing standards.
8. The sample size for the training set
This information is not applicable as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
This information is not applicable as this is not an AI/machine learning device.
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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
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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
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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."
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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-SutureAnchorProposed Device | Mitek MiniQuickAnchor® PlusPredicate Device | ConMed Linvatec Y-Knot® All-SutureAnchor1st Reference Device | Y-Knot Flex All-SutureAnchor, w/Two #2 (5Metric) Hi-Fi Sutures,1.8mm2nd Reference Device | ||
|---|---|---|---|---|---|
| DeviceDescription | The non-absorbablesuture anchors areintended to reattach softtissue to bone inorthopedic surgicalprocedures. | Mitek MiniQuickAnchor® Plus is asterile, disposable boneanchor suppliedpreloaded on an inserterwith a polyester suture. | Same as proposed | Same as proposed | |
| Intended Use | The non-absorbablesuture anchors areintended to reattach softtissue to bone inorthopedic surgicalprocedures. | N/A - Incorporated intotheir indicationsstatement | Same as proposed | Same as proposed | |
| Indication for Use | The system may be usedin either arthroscopic oropen surgicalprocedures. After thesuture is anchored to thebone, it may be used toreattach soft tissue, suchas ligaments, tendons, orjoint capsules to the | Mitek MiniQuickAnchor® Plusindications:Shoulder: Bankart repairAnkle: MidfootReconstructionsFoot: Hallux ValgusReconstruction | Same as proposed | Same as proposed | |
| TruShot™ with Y-Knot®Shallow All-SutureAnchorProposed Device | Mitek MiniQuickAnchor® PlusPredicate Device | ConMed Linvatec Y-Knot® All-SutureAnchor1st Reference Device | Y-Knot Flex All-SutureAnchor, w/Two #2 (5Metric) Hi-Fi Sutures,1.8mm2nd Reference Device | ||
| Contraindications | bone. The suture anchorsystem thereby stabilizesthe damaged soft tissue,in conjunction withappropriatepostoperativeimmobilization,throughout the healingperiod.1. Reattachment ofintracapsular kneeligaments (ACL &PCL).2. Pathologicalconditions of bonewhich wouldadversely affect the Y-Knot anchor.3. Pathologicalconditions in the softtissue to be repairedor reconstructedwhich wouldadversely affect suturefixation.4. Physical conditionsthat would eliminate,or tend to eliminate,adequate implantsupport or retardhealing.5. Conditions which tendto limit the patient'sability or willingnessto restrict activities orfollow directionsduring the healingperiod.6. Attachment ofartificial ligaments orother implants.7. Foreign bodysensitivity, known orsuspected allergies toimplant and/orinstrument materials.8. This device is notapproved for screwattachment or fixationto the posteriorelements (pedicles) ofthe cervical, thoracicor lumbar spine. | Wrist: ScapholunateligamentReconstructionHand: Ulnar or LateralCollateral LigamentReconstructionPubis: Fixation in thepubis for bladder necksuspicion to resolvestress urinaryincontinence1. Reattachment ofintracapsular kneeligaments (ACL &PCL).2. Surgical proceduresother than those listedin the INDICATIONSsection.3. Pathologic conditionsof bone, such ascystic changes orsevere osteopenia,which would impairits ability to securelyfix the Depuy MitekAnchor, arecontraindicated.4. Pathological changesin the soft tissuessutured to the bonewhich would preventits secure fixation bythe suture arecontraindicated.5. Comminuted bonesurface, which wouldmilitate against securefixation of the DepuyMitek Anchor, iscontraindicated.6. Physical conditionsthat would eliminateor tend to eliminateadequate implantsupport or retardhealing, i.e., bloodsupply limitation,previous infections,etc. arecontraindicated.7. Conditions which tendto preempt thepatient's ability or thehealing period, such | 1. Pathologicalconditions of bonewhich wouldadversely affect theY-Knot anchor.2. Pathologicalconditions in the softtissue to be repairedor reconstructedwhich wouldadversely affect suturefixation.3. Physical conditionsthat would eliminate,or tend to eliminate,adequate implantsupport or retardhealing.4. Conditions which tendto limit the patient'sability or willingnessto restrict activities orfollow directionsduring the healingperiod.5. Attachment ofartificial ligaments orother implants.6. Foreign bodysensitivity, known orsuspected allergies toimplant and/orinstrument materials.7. This device is notapproved for screwattachment or fixationto the posteriorelements (pedicles) ofthe cervical, thoracicor lumbar spine.8. Patients with activesepsis or infection. | 1. Pathologicalconditions of bonewhich wouldadversely affect theY-Knot anchor.2. Pathologicalconditions in the softtissue to be repairedor reconstructedwhich wouldadversely affect suturefixation.3. Physical conditionsthat would eliminate,or tend to eliminate,adequate implantsupport or retardhealing.4. Conditions which tendto limit the patient'sability or willingnessto restrict activities orfollow directionsduring the healingperiod.5. Attachment ofartificial ligaments orother implants.6. Foreign bodysensitivity, known orsuspected allergies toimplant and/orinstrument materials.7. This device is notapproved for screwattachment or fixationto the posteriorelements (pedicles) ofthe cervical, thoracicor lumbar spine.8. Patients with activesepsis or infection. | |
| TruShot™ with Y-Knot®Shallow All-SutureAnchorProposed Device | Mitek MiniQuickAnchor® PlusPredicate Device | ConMed Linvatec Y-Knot® All-SutureAnchor1st Reference Device | Y-Knot Flex All-SutureAnchor, w/Two #2 (5Metric) Hi-Fi Sutures, 1.8mm2nd Reference Device | ||
| 9. Patients with activesepsis or infection. | illness or alcoholismare contraindicated.8. The Depuy MitekAnchor is notdesigned for andshould never be usedto attach artificialligaments or otherimplants. | ||||
| Components | All-Suture AnchorDisposable GuideHandleSuture | HandleShaftAnchorSutureNeedles | All-Suture AnchorDisposable DriverSuture | All-Suture AnchorDisposable DriverSuture | |
| TechnologicalCharacteristics | Soft-body suture anchorOne #0 or #2-0 sutureDrilled pilot holePress-fit insertionExpandable design | Hard-body suture anchorOne #2/0 sutureDrilled pilot holePress-fit insertionExpandable design | Soft-body suture anchorOne #2 sutureDrilled pilot holePress-fit insertionExpandable design | Soft-body suture anchorTwo #2 suturesDrilled pilot holePress-fit insertionExpandable 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.
N/A