(153 days)
Not Found
No
The device description and performance studies focus on mechanical properties and surgical technique, with no mention of AI or ML.
Yes
The FSSA is intended to reattach soft tissue to bone and stabilize damaged soft tissue during the healing period, which are therapeutic actions.
No
Explanation: The device is a surgical system intended to reattach soft tissue to bone, serving a therapeutic purpose rather than a diagnostic one.
No
The device description clearly outlines physical components (anchors, sutures, delivery instrument) and performance testing related to these physical components (insertion, pullout, fatigue, slippage), indicating it is a hardware device, not software-only.
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 procedure performed directly on the patient's body.
- Device Description: The device is a "Flexible Suturing System with Anchors" used to physically connect tissue to bone. This is a surgical implant/device.
- IVD Definition: In Vitro Diagnostics (IVDs) are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
This device is clearly designed for surgical intervention within the body, not for testing samples outside the body.
N/A
Intended Use / Indications for Use
The Flexible Suturing System with Anchors (FSSA) is 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 suture anchor system thereby stabilizes the damaged soft tissue, in conjunction with appropriate postoperative immobilization, throughout the healing period.
Product codes
MBI
Device Description
The Flexible Suturing System with Anchors (FSSA) includes anchors, a pre-strung single common repair suture serially connecting the anchors in an array and an individual locking suture associated with each anchor (except the first anchor in the array) for selectively locking the repair suture relative to each anchor after tensioning the repair suture to form a tensioned stitch with a just prior implanted anchor in the array. The implanted array of anchors with a continuous set of anchor-to-anchor single suture stitches creates a seam-like attachment akin to a sewing machine construct. Each anchor of the FSSA is a monolithic injection molded body. An ancillary delivery instrument is utilized to create a bone hole and insert each anchor.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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 FSSA performs as intended and is substantially equivalent to the predicate device. The completed tests include standard verification and validation testing. Additionally, the following specific bench testing was completed for device comparisons: Suture Characterization, Insertion Testing, Pullout Testing, Fatigue Testing and Repair Suture Slippage Testing, as well as sterility assurance.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 USA seal. To the right of the seal is the FDA logo in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION".
January 26, 2023
Integrity Orthopaedics, Inc. Jeff Sims Vice President, Regulatory Affairs 5565 Pioneer Creek Drive Maple Plain, Minnesota 55359
Re: K222589
Trade/Device Name: Flexible Suturing System with Anchors (FSSA) Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: MBI Dated: December 26, 2022 Received: December 27, 2022
Dear Jeff Sims:
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
1
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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Sara S. Thompson -S
For
Laura C. Rose, Ph.D. Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2023
See PRA Statement below.
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name
Flexible Suturing System with Anchors (FSSA)
Indications for Use (Describe)
The Flexible Suturing System with Anchors (FSSA) is 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 suture anchor system thereby stabilizes 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/2 description: The image shows the logo for Integrity Orthopaedics. The logo consists of a square made up of smaller squares with horizontal and vertical lines. Below the logo is the text "INTEGRITY ORTHOPAEDICS" in a sans-serif font, and below that is the text "FASTER BETTER STRONGER" in a smaller font.
510(k) Summary Flexible Suturing System with Anchors (FSSA)
Applicant Information
| Applicant Name: | Integrity Orthopaedics, Inc. |
|---|---|
| Applicant Address: | 5565 Pioneer Creek Drive |
| Maple Plain, MN 55359 | |
| Contact Person: | Jeff Sims |
| Vice President, Regulatory Affairs | |
| Telephone: | 952-594-2795 |
| e-mail: | jsims@integrity-ortho.com |
| Date Prepared: | January 26, 2023 |
Name of Device
| Trade Name: | Flexible Suturing System with Anchors (FSSA) |
|---|---|
| Common Name: | Suture Anchors |
| Classification Name: | Fastener, Fixation, Nondegradable, Soft Tissue |
| Proposed Class: | Class II |
| Product Code: | MBI |
| Regulation: | 21 CFR Part 888.3040 |
| Legally Marketed Devices to Which Substantial Equivalence is Claimed | |
|---|---|
| Predicate Device: | ConMed Linvatec Soft Tissue to Bone System |
| K091549 | |
| Company Name: | ConMed Linvatec |
Description of the Device
The Flexible Suturing System with Anchors (FSSA) includes anchors, a pre-strung single common repair suture serially connecting the anchors in an array and an individual locking suture associated with each anchor (except the first anchor in the array) for selectively locking the repair suture relative to each anchor after tensioning the repair suture to form a tensioned stitch with a just prior implanted anchor in the array. The implanted array of anchors with a continuous set of anchor-to-anchor single suture stitches creates a seam-like attachment akin to a sewing machine construct. Each anchor of the FSSA is a monolithic injection molded body. An ancillary delivery instrument is utilized to create a bone hole and insert each anchor.
Indications for Use
The Flexible Suturing System with Anchors (FSSA) is 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.
4
Image /page/4/Picture/2 description: The image shows the logo for Integrity Orthopaedics. The logo consists of a square made up of horizontal and vertical lines, with the words "INTEGRITY ORTHOPAEDICS" below it. Below that, the words "FASTER BETTER STRONGER" are written in a smaller font. The logo is simple and modern, and the use of the square suggests stability and strength.
The suture anchor system thereby stabilizes the damaged soft tissue, in conjunction with appropriate postoperative immobilization, throughout the healing period.
Summary Comparison of Technical Characteristics
The components of the FSSA and counterpart components of the predicate device perform the exact same functions. However, the way each function is accomplished (exact structure) varies slightly. The FSSA anchor has a monolithic generally cylindrical body that is inserted lengthwise below the cortical shell, then rotated to provide a retention surface in contact with the inner surface of the cortical shell and/or cancellous bone. In contrast, the predicate device includes expandable wings that extend from the anchor body when activated to provide a retention surface. However, each perform the same function with minor variation in structure. A lateral surface below the cortical shell provides retention of the anchor in both devices. Additionally, there is a difference in the structure of the mechanism for locking the repair suture relative to anchor. The FSSA locks the repair suture between anchors utilizing a locking suture. The predicate device includes an inner anchor member that can be moved to a locked position that pinches or locks the repair suture between the inner and outer anchor bodies to prevent relative movement.
Performance Data
Testing has been completed to demonstrate that the FSSA performs as intended and is substantially equivalent to the predicate device. The completed tests include standard verification and validation testing. Additionally, the following specific bench testing was completed for device comparisons: Suture Characterization, Insertion Testing, Pullout Testing, Fatigue Testing and Repair Suture Slippage Testing, as well as sterility assurance.
Conclusion
The substantial equivalence between the FSSA and the predicate device is confirmed by the results of extensive performance bench testing where it was shown that the varied features of the FSSA anchors perform as well or better as the corresponding features in the predicate device and therefore did not raise any safety and effectiveness concerns. Further. biocompatibility and sterility assurance results confirm all elements used in the flexible suturing system are safe, including permanent implantation materials of the anchor, repair suture and locking suture components. Therefore, the FSSA is substantially equivalent to the named predicate device.