(82 days)
The Mitek 5 mm Ligament Anchor
Not Found
No
The device description and performance studies focus on the mechanical properties and surgical application of a physical implant and instrumentation, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is intended for ligament to bone reattachment of Anterior and Posterior Cruciate Ligaments in patients with recurrent instability of the knee, which is a therapeutic purpose.
No
The device, an 8mm Ligament Fastener, is an implantable tendon fixation device used for ligament to bone reattachment, which is a therapeutic function, not diagnostic.
No
The device description clearly outlines physical, implantable hardware (ligament fastener, sleeve, pin) and associated instrumentation (hex driver, inserter, drill). There is no mention of any software component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Function: The Innovasive Devices 8mm Ligament Fastener is an implantable device used for the surgical repair of ligaments within the knee. It is a physical device used inside the body to reattach tissue to bone.
The description clearly indicates a surgical implant and associated instrumentation, not a device used for laboratory testing of biological samples.
N/A
Intended Use / Indications for Use
The Innovasive Devices 8mm Ligament Fastener is intended for ligament to bone reattachment of Anterior and Posterior Cruciate Ligaments in patients with recurrent instability of the knee.
Product codes
Not Found
Device Description
The Innovasive 8mm Ligament Fastener is an implantable tendon fixation device complete with the instrumentation needed to effect ligament to bone repair. The devices consist of a high density polyethylene sleeve with an acetal drive pin which is deployed into a pre-drilled hole in the bone. The Fastener is deployed through the use of a hex driver, for screwing in the sleeve, and an inserter which drives the pin into the sleeve.
In addition to the Fastener, a stainless steel drill is available to establish the proper hole in the bone for the Fastener. All of the instrumentation except the Fastener will be offered as reusable devices and be autoclaved in the sterilization tray provided for this purpose.
The Fastener will be available as a sterile, single use device for use in both an open and arthroscopic procedures.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
knee
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)
Cadaver study: Comparison of the ultimate holding strength in the bone indicated, compared to the predicate device. The Innovasive Fastener holding strength was found to be equivalent to the strength of the predicate device at a .01 significance level.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
The Mitek 5 mm Ligament Anchor
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
K970316 510(K) SUMMARY
1. SUBMITTER:
Innovasive Devices, Inc. 734 Forest Street Marlboro, MA 01752 Telephone: 508-460-8229
APR 1 6 1997
Contact: Eric Bannon, V.P. of Quality Assurance and Regulatory Affairs
Date Prepared: April 14, 1997
2. DEVICE:
Innovasive 8 mm Ligament Fastener Classification Name: Single/multiple component bone fixation appliances and accessories. Trade Name: Innovasive Devices Ligament Fastener
3. PREDICATE DEVICE:
The predicate device used to determine substantial equivalence for the Innovasive Devices 8 mm Ligament Fastener was the Mitek 5 mm Ligament Anchor, marketed by Mitek Surgical, Norwood, MA.
4. DEVICE DESCRIPTIONS:
The Innovasive 8mm Ligament Fastener is an implantable tendon fixation device complete with the instrumentation needed to effect ligament to bone repair. The devices consist of a high density polyethylene sleeve with an acetal drive pin which is deployed into a pre-drilled hole in the bone. The Fastener is deployed through the use of a hex driver, for screwing in the sleeve, and an inserter which drives the pin into the sleeve.
In addition to the Fastener, a stainless steel drill is available to establish the proper hole in the bone for the Fastener. All of the instrumentation except the Fastener will be offered as reusable devices and be autoclaved in the sterilization tray provided for this purpose.
The Fastener will be available as a sterile, single use device for use in both an open and arthroscopic procedures.
1
The Innovasive Devices 8mm Ligament Fastener is intended for ligament to bone reattachment of Anterior and Posterior Cruciate Ligaments in patients with recurrent instability of the knee.
6. COMPARISON OF CHARACTERISTICS:
The Innovasive Devices 8mm Ligament Fastener is comprised of two polymer components; high density polyethylene and acetal plastic. This device is used to secure a ligament in a predrilled hole in bone. It remains fixed in the bone by the screw threads and also radial compression as the device is deployed.
The Mitek Ligament Anchor is comprised of titanium with nitinol arcs. The arcs are imbedded in the bone when placed in the predrilled hole. The intended use of the Mitek Ligament Anchor and the Innovasive Ligament Fastener are identical.
7. PERFORMANCE DATA:
The following performance data was provided in support of the substantial equivalence determination:
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- Cadaver study: Comparison of the ultimate holding strength in the bone indicated, compared to the predicate device. The Innovasive Fastener holding strength was found to be equivalent to the strength of the predicate device at a .01 significance level.