(32 days)
No
The summary describes a mechanical suture anchor and does not mention any AI or ML components or functionalities.
No.
A therapeutic device is one that treats a disease or condition. This device is a suture anchor used to reattach soft tissue to bone, acting as a support structure during healing rather than actively treating a disease or condition itself.
No
This device is a suture anchor used in orthopedic surgical procedures to reattach soft tissue to bone, which is a therapeutic rather than a diagnostic function.
No
The device description clearly states it is a physical suture anchor made from braided suture and nylon monofilament, preloaded on a disposable driver. 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 implant used directly on the patient's body.
- Device Description: The device is a suture anchor made of suture material, designed to be implanted into bone.
- Lack of Diagnostic Purpose: There is no mention of the device being used to examine specimens from the human body to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used in vitro (outside the body) to analyze samples like blood, urine, or tissue to provide diagnostic information. This device is used in vivo (inside the body) as a surgical implant.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
MBI
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bone
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 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
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 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
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 | K190333
Page 1 of 1
Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2020
See 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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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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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
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FORM FDA 3881 (7/17) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF
3
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.
4
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 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 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
Paradigm™ All-Suture Anchor is provided
single-use, sterile, and preloaded on
disposable driver. The anchor, suture, and
disposable driver are EO Sterilized. | 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 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 |
| Contraindications | 1. Pathological conditions of bone which
would adversely affect the Paradigm™
All-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 | Same | Same |
5
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 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 Driver
Suture
Handle | Same | Same |
| Technological
Characteristics | Flat-braid suture anchor
One #2 suture
Drilled pilot hole
Press-fit insertion
Expandable design | Same | Flat-braid suture anchor
Two #2 sutures
Drilled pilot hole
Press-fit insertion
Expandable 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).