(32 days)
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.
The CONMED Paradigm™ All-Suture Anchor manufactured from High Strength Flat Braided Suture, co-braided with a nylon monofilament, and threaded with one #2 (5 metric) Hi-Fi® suture strand. The ParadigmTM All-Suture Anchor is provided single-use, sterile, and preloaded on disposable driver. The anchor, suture, and disposable driver are EO Sterilized.
The provided text is a 510(k) summary for the CONMED Paradigm™ All-Suture Anchor. This document is a premarket notification to the FDA to demonstrate that the new device is substantially equivalent to a legally marketed predicate device.
It does not contain information related to an AI/ML-based medical device or a study proving its performance against specific acceptance criteria for diagnostic/prognostic tasks. Instead, it describes a medical device (a surgical anchor) and its equivalence to existing predicate devices based on material, design, intended use, and performance data relevant to its mechanical and biological properties.
Therefore, I cannot extract the information required to answer your prompt, such as:
- Acceptance Criteria Table and Reported Performance: The document lists "Verification Testing" and "Validation Testing" categories for the physical device, such as Reliability, Ultimate Fixation Strength, Biocompatibility, and Shelf-life. It states "Testing has been completed to demonstrate that the Paradigm™ All-Suture Anchor performs as intended and is substantially equivalent to the predicate device" and that "Bacterial endotoxin testing was conducted and met the endotoxin limits." However, it does not provide specific numerical acceptance criteria or performance numbers (e.g., a required tensile strength in N and the achieved tensile strength for the device).
- Sample size for test set and data provenance: Not applicable to this type of device.
- Number of experts and qualifications for ground truth: Not applicable.
- Adjudication method for test set: Not applicable.
- Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable.
- Standalone (algorithm only) performance: Not applicable.
- Type of ground truth used: Not applicable in the context of diagnostic performance. The "ground truth" for this device would relate to its structural integrity, biocompatibility, and similar physical/chemical properties, which are confirmed through engineering and biological testing.
- Sample size for training set: Not applicable.
- How ground truth for training set was established: Not applicable.
In summary, the document describes the substantial equivalence of a physical medical device (a surgical suture anchor) to a predicate device, focusing on material, mechanical, and biological properties, not on an AI/ML algorithm's diagnostic performance. Therefore, the requested information elements related to AI/ML study design are not present in this text.
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Image /page/0/Picture/0 description: The image contains 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, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font below.
March 18, 2019
ConMed Corporation Orjada Dervishleri Regulatory Affairs Specialist 525 French Road Utica, New York 13502
Re: K190333
Trade/Device Name: Paradigm™ All-Suture Anchor 1.8mm. White/Black #2 Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI Dated: February 13, 2019 Received: February 14, 2019
Dear Orjada Dervishleri:
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
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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.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
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| DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration | K190333Page 1 of 1Form Approved: OMB No. 0910-0120Expiration Date: 06/30/2020See PRA Statement below. |
|---|---|
| 510(k) Number (if known) | K190333 |
| Device Name | Paradigm™ All-Suture Anchor 1.8mm, White/Black #2 |
| 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.
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FORM FDA 3881 (7/17) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF
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Image /page/3/Picture/0 description: The image shows the Conmed Corporation logo. The logo consists of a blue square with a white curved shape inside, followed by the word "Conmed" in black, with a blue line underneath. Below the line, 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 __K190333
I. SUBMITTER
CONMED Corporation 11311 Concept Blvd Largo, Florida 33773
Phone: 727-399-5491 Fax: 727-399-5264
Contact Person: Orjada Dervishleri Date Prepared: February 13th, 2019
II. DEVICE NAME
| Device Name: | Paradigm™ All-Suture Anchor |
|---|---|
| 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 ConMed Linvatec Company Name: 510(k) #: K131035
V. DEVICE DESCRIPTION
The CONMED Paradigm™ All-Suture Anchor manufactured from High Strength Flat Braided Suture, co-braided with a nylon monofilament, and threaded with one #2 (5 metric) Hi-Fi® suture strand. The ParadigmTM All-Suture Anchor is provided single-use, sterile, and preloaded on disposable driver. The anchor, suture, and disposable driver are EO Sterilized.
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Image /page/4/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 is the word "CONMED" in black, with a horizontal blue line underneath. Below the line is the word "CORPORATION" in smaller, black letters.
VI. INTENDED USE/ INDICATIONS FOR USE
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.
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.
| Paradigm™ All-Suture AnchorProposed Device | ConMed Linvatec Y-Knot®All-Suture AnchorPredicate Device | Y-Knot Flex All-SutureAnchor, w/Two #2 (5 Metric)Hi-Fi Sutures, 1.8mmReference Device | |
|---|---|---|---|
| Device Description | The CONMED Paradigm™ All-SutureAnchor manufactured from High StrengthFlat Braided Suture, co-braided with a nylonmonofilament, and threaded with one #2 (5metric) Hi-Fi® suture strand. TheParadigm™ All-Suture Anchor is providedsingle-use, sterile, and preloaded ondisposable driver. The anchor, suture, anddisposable driver are EO Sterilized. | Same | Same |
| Intended Use | The non-absorbable suture anchors areintended to reattach soft tissue to bone inorthopedic surgical procedures. | Same | Same |
| Indication for Use | The device may be used in eitherarthroscopic or open surgical procedures.After the suture is anchored to the bone, itmay be used to reattach soft tissue, such asligaments, tendons, or joint capsules to thebone. The suture anchor system therebystabilizes the damaged soft tissue, inconjunction with appropriate postoperativeimmobilization, throughout the healingperiod. | Same | Same |
| Contraindications | 1. Pathological conditions of bone whichwould adversely affect the Paradigm™All-Suture Anchor.2. Pathological conditions in the soft tissue tobe repaired or reconstructed which wouldadversely affect suture fixation.3. Physical conditions that would eliminate,or tend to eliminate, adequate implantsupport or retard healing.4. Conditions which tend to limit the patient'sability or willingness to restrict activities | Same | Same |
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Image /page/5/Picture/1 description: The image shows the logo for Conmed Corporation. The logo consists of a blue square with a white curved shape inside, followed by the word "Conmed" in black, with a blue line underneath. Below the line is the word "Corporation" in smaller, black letters.
| or follow directions during the healingperiod.5. Attachment of artificial ligaments or otherimplants.6. Foreign body sensitivity, known orsuspected allergies to implant and/orinstrument materials.7. This device is not approved for screwattachment or fixation to the posteriorelements (pedicles) of the cervical,thoracic or lumbar spine.8. Patients with active sepsis or infection. | |||
|---|---|---|---|
| Components | All-Suture AnchorDisposable DriverSutureHandle | Same | Same |
| TechnologicalCharacteristics | Flat-braid suture anchorOne #2 sutureDrilled pilot holePress-fit insertionExpandable design | Same | Flat-braid suture anchorTwo #2 suturesDrilled pilot holePress-fit insertionExpandable design |
VIII. PERFORMANCE DATA
Testing has been completed to demonstrate that the Paradigm™ 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 ●
- Transportation ●
- Cyclic ●
- Pyrogen ●
- Biocompatibility
- Shelf-life
- Post Aging Functional Testing
- MR Safety Testing ●
Validation Testing
- User Validation
- Packaging ●
- Labeling ●
- Sterilization ●
IX. CONCLUSION
The Paradigm™ 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 Paradigm™ All-Suture Anchor is substantially equivalent to the ConMed Linvatec Y-Knot™ All-Suture Anchor (K111779).
N/A