(30 days)
No
The device description and performance studies focus on mechanical and material properties of a manual surgical device, with no mention of AI/ML or related concepts.
Yes.
The device is intended for soft tissue to bone fixation in the repair of natural ligament or tendon disruption or to assist in reconstruction surgeries, which clearly falls under therapeutic use.
No
The device is described as a surgical anchor system for soft tissue to bone fixation, used in repair and reconstruction surgeries. Its function is mechanical fixation, not diagnosis.
No
The device description clearly states it consists of a physical inserter and a PEEK anchor, which are hardware components. The performance studies also focus on mechanical and functional testing of these physical parts.
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 on the patient's body, not a test performed on a sample taken from the patient's body.
- Device Description: The device is described as a "manual surgical device" consisting of an inserter and an anchor. This is consistent with a surgical implant and its delivery system, not a diagnostic test kit or instrument.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in those samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions.
The Betta Link™ Knotless Anchor System is a surgical implant used for mechanical fixation within the body.
N/A
Intended Use / Indications for Use
The Betta Link™ Knotless 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 (comma separated list FDA assigned to the subject device)
MBI
Device Description
The Betta Link™ Knotless Anchor System consists of an inserter and PEEK (Polyether-ether-ketone) non-absorbable anchor. The device is a manual surgical device and is comprised of a handle and PEEK anchor on a proximal (to user) edge of the inserter shaft.
The inserter shaft ends with a dedicated "fork" tip which holds the anchor. The handle is designed for hammering the inserter into the pilot hole to deploy the anchor. When the anchor is inserted into bone and the inserter is removed the fixation is achieved.
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 Betta Link™ Knotless 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.
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): 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.
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March 24, 2021
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square, the words "U.S. FOOD & DRUG ADMINISTRATION" are written in blue.
T.A.G. Medical Products Corporation, Ltd Anat Rozen RA Manager Gaaton 2513000 Israel
Re: K210498
Trade/Device Name: Betta Link™ Knotless Implant System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: MBI Dated: February 16, 2021 Received: February 22, 2021
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
1
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 (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 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.
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
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Indications for Use
510(k) Number (if known) K210498
Device Name Betta Link™ Knotless Anchor System
Indications for Use (Describe)
The Betta Link™ Knotless 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.
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) | ☐ |
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Image /page/3/Picture/0 description: The image shows the logo for a medical products company, followed by the text "510(k) Summary". The logo is a gray circle with the letters "tag" in white. The text "MEDICAL PRODUCTS" is below the logo in a smaller font. The text "510(k) Summary" is in a large, bold font.
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: | Mar 24th, 2021 |
| 2. | Device & Classification | Class II, 21 CFR 888.3040 Fastener, Fixation, Nondegradable, Soft Tissue, product
code MBI |
| | Name: | Betta Link™ Knotless Anchor System:
Betta Link SR Knotless Implant Only
Betta Link LG Knotless Implant Only |
| 3. | Predicate Devices: | K113297 - KNOTILUS ANCHOR SYSTEM
K122314 - Quattro™ Link Knotless Anchor |
| 4. | Reference Devices: | K190125 - FiberStitch Implant, Curved With Two Polyester Implants And 2-0
FiberWire, FiberStitch Implant, Straight With Two Polyester Implants And 2-0
FiberWire |
| 5. | Description: | The Betta Link™ Knotless Anchor System consists of an inserter and PEEK (Polyether-
ether-ketone) non-absorbable anchor. The device is a manual surgical device and is
comprised of a handle and PEEK anchor on a proximal (to user) edge of the inserter
shaft.
The inserter shaft ends with a dedicated "fork" tip which holds the anchor. The
handle is designed for hammering the inserter into the pilot hole to deploy the
anchor. When the anchor is inserted into bone and the inserter is removed the
fixation is achieved. |
| 6. | Intended Use: | The Betta Link™ Knotless 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. |
| 7. | Comparison of
Technological
Characteristics: | The Betta Link™ Knotless Anchor System is substantially equivalent to the TAG
Knotilus Anchor System (K113297) in that it has the same intended use, same
anchor material and features similar technology.
Both the Knotilus Anchor System (K113297) and the proposed Betta Link™ Knotless
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. |
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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 letters are stacked on top of each other, with 't' on top, 'a' in the middle, and 'c' on the bottom. The letters are all lowercase.
MEDICAL PRODUCTS
The difference in the technological characteristics; inserter handle design, do not raise different questions of safety and effectiveness as demonstrated by performance test data. The indications for use are identical and the subject device, the Betta Link™ Knotless Anchor System, is as safe and effective as the predicate device, the Knotilus Anchor System (K113297).
The proposed Betta Link™ Knotless Anchor System is substantially equivalent to the legally marketed Knotilus Anchor System (K113297).
Nonclinical test discussion:
Nonclinical testing was completed to demonstrate that the Betta Link™ Knotless 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)).