(101 days)
No
The device description focuses on mechanical components and physical mechanisms for soft tissue fixation. There is no mention of AI, ML, image processing, or data-driven analysis.
Yes
The device is used for soft tissue to bone fixation in the repair of natural ligament or tendon disruption, which is a therapeutic intervention.
No
Explanation: The device description states its purpose is for "soft tissue to bone fixation in the repair of the natural ligament or tendon disruption or to assist in reconstruction surgeries." It is a surgical anchor system, not a device used to identify, measure, or monitor a medical condition.
No
The device description clearly outlines physical components: an inserter, a UHMWPE non-absorbable loop suture anchor, and threaded sutures. The performance studies also focus on nonclinical testing of these physical components (biocompatibility, sterilization, mechanical testing). There is no mention of software as a component or function of the device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states "soft tissue to bone fixation in the repair of the natural ligament or tendon disruption or to assist in reconstruction surgeries." This describes a surgical procedure performed directly on the patient's body.
- Device Description: The device description details a physical implant (suture anchor) and an inserter used to place it within the body.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This device does not involve testing samples outside the body.
The VersaLoop™ Anchor System is a surgical implant used for musculoskeletal repair.
N/A
Intended Use / Indications for Use
The VersaLoop™ Anchor System is intended for use in soft tissue to bone fixation in the repair of the natural ligament or tendon disruption or to assist in reconstruction surgeries.
Specific indications are: foot, ankle, knee, hip, hand, wrist, elbow and shoulder.
Product codes
MBI
Device Description
The VersaLoop™ Anchor System consists of an inserter and Ultra High Molecular Weight Polyethylene (UHMWPE) non-absorbable loop suture anchor and threaded sutures.
The inserter shaft ends with a "fork" tip which holds the suture anchor. There are 3 narrow slots on the handle which holds the suture, which can be press-locked and released. The handle is designed for hammering the inserter into the pilot hole to deploy the anchor.
When the suture anchor is inserted into bone and the inserter is removed, the main sutures are pulled, and the all-suture anchor (loop) creates a "bunching" effect using targeted compression zones within the implant sheath for optimal fixation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
foot, ankle, knee, hip, hand, wrist, elbow and shoulder.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Nonclinical testing was completed to demonstrate that the VersaLoop™ Anchor System devices meets the established performance characteristics, and to verify that design requirements are satisfied. Testing included biocompatibility evaluation per ISO 10993-1, ethylene oxide sterilization validation, and Bacterial Endotoxin (BET).
Device testing included dimensional, mechanical (fatigue testing, pullout testing, torque testing, applied forces testing) and functional testing.
FDA Guidance that was used for testing: "Bone Anchors - Premarket Notification (510(k)) Submissions Guidance for Industry and Food and Drug Administration Staff" It was concluded from the nonclinical tests that the device is as safe, as effective, and performs as well as or better than the legally marketed device predicate (21 CFR 807.92(b)(3)).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
November 13, 2020
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T.A.G. Medical Products Corporation, Ltd Anat Rozen RA Manager Gaaton, Israel 2513000
Re: K202178 Trade/Device Name: Versaloop™ Anchor System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: MBI Dated: October 8, 2020 Received: October 13, 2020
Dear Anat Rozen:
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 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-reporting
1
combination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
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/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,
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
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Indications for Use
510(k) Number (if known) K202178
Device Name VersaLoop™ Anchor System
Indications for Use (Describe)
The VersaLoop™ Anchor System is intended for use in soft tissue to bone fixation in the repair of the natural ligament or tendon disruption or to assist in reconstruction surgeries.
Specific indications are: foot, ankle, knee, hip, hand, wrist, elbow and shoulder.
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ---------------------------------------------------------------------------------------------------------------------------- | ------------------------------------------------------------------------- |
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Type of Use (Select one or both, as applicable)
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510(k) Summary
Pursuant to CFR 807.92, the following 510(k) Summary is provided:
| 1. | Submitter Address: | Shlomi Dines
T.A.G. Medical Products Corporation, Ltd.
Gaaton 2513000, ISRAEL
www.tag-med.com |
|----|----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Mfg. Phone: | Tel.: 972-4-9858400 |
| | Contact Person: | Anat Rozen |
| | Date: | November 13th, 2020 |
| 2. | Device & Classification
Name: | Suture Anchor, class II, 21 CFR 888.3040 Fastener, Fixation, Nondegradable, Soft
Tissue, product code MBI
VersaLoop™ Anchor System:
VersaLoop™ 1.5MM - SINGLE LOADED SUTURE
VersaLoop™ 1.5MM - SINGLE LOADED TAPE
VersaLoop™ 1.8MM - DOUBLE LOADED SUTURE
VersaLoop™ 1.8MM - DOUBLE LOADED TAPE
VersaLoop™ 2.5MM - DOUBLE LOADED SUTURE
VersaLoop™ 2.5MM - DOUBLE LOADED TAPE
VersaLoop™ 2.5MM - TRIPLE LOADED SUTURE |
| 3. | Predicate Devices: | K113297 - KNOTILUS ANCHOR SYSTEM (primary predicate)
K181769 - Arthrex FiberTak Suture Anchor |
| 4. | Reference Devices: | K132043 - Arthrex SpeedCinch
K193575 - Arthrex SutureTape |
| 5. | Description: | The VersaLoop™ Anchor System consists of an inserter and Ultra High Molecular
Weight Polyethylene (UHMWPE) non-absorbable loop suture anchor and threaded
sutures.
The inserter shaft ends with a "fork" tip which holds the suture anchor. There are 3
narrow slots on the handle which holds the suture, which can be press-locked and
released. The handle is designed for hammering the inserter into the pilot hole to
deploy the anchor.
When the suture anchor is inserted into bone and the inserter is removed, the main
sutures are pulled, and the all-suture anchor (loop) creates a "bunching" effect
using targeted compression zones within the implant sheath for optimal fixation. |
| 6. | Intended Use: | The VersaLoop™ Anchor System is intended for use in soft tissue to bone fixation in
the repair of the natural ligament or tendon disruption or to assist in reconstruction
surgeries.
Specific indications are: foot, ankle, knee, hip, hand, wrist, elbow and shoulder. |
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Image /page/4/Picture/1 description: The image shows a gray circle with the letters 'tac' in white. The letters are stylized and appear to be a logo. The 't' is lowercase, while the 'a' and 'c' are uppercase. The logo is simple and modern.
7. Comparison of Technological Characteristics:
The VersaLoop™ Anchor System is substantially equivalent to the TAG Knotilus Anchor System (K113297) and to the Arthrex FiberTak Suture Anchor (K181769) in that it has the same intended use and features similar technology.
The Knotilus Anchor System (K113297), Arthrex FiberTak Suture Anchor (K181769) and the proposed VersaLoop™ Anchor System are intended for use in soft tissue to bone fixation in the repair of the natural ligament or tendon disruption or to assist in reconstruction surgeries. The clinical use is identical; both are anchor system devices. Additionally, both devices' designs allow for the devices to be endoscopically delivered from a single access point.
The differences in the technological characteristics; anchor material and dimensions, and inserter handle design, do not raise different questions of safety and effectiveness as demonstrated by performance and biocompatibility test data. The indications for use are identical and the subject device, the VersaLoop™ Anchor System, is as safe and effective as the predicate devices, the Knotilus Anchor System (K113297) and Arthrex FiberTak Suture Anchor (K181769).
The proposed VersaLoop™ Anchor System is substantially equivalent to the legally marketed Knotilus Anchor System(K113297) and the Arthrex FiberTak Suture Anchor (K181769).
Nonclinical test discussion:
Nonclinical testing was completed to demonstrate that the VersaLoop™ Anchor System devices meets the established performance characteristics, and to verify that design requirements are satisfied. Testing included biocompatibility evaluation per ISO 10993-1, ethylene oxide sterilization validation, and Bacterial Endotoxin (BET).
Device testing included dimensional, mechanical (fatigue testing, pullout testing, torque testing, applied forces testing) and functional testing.
FDA Guidance that was used for testing: "Bone Anchors - Premarket Notification (510(k)) Submissions Guidance for Industry and Food and Drug Administration Staff" It was concluded from the nonclinical tests that the device is as safe, as effective, and performs as well as or better than the legally marketed device predicate (21 CFR 807.92(b)(3)).