(72 days)
Not Found
No
The description focuses on a mechanical suture anchor and its intended use, with no mention of AI, ML, or related concepts like image processing or data analysis.
No
The device is described as an anchor for soft tissue to bone suture fixation, which is a surgical tool, not a therapeutic device that provides a treatment or therapy itself.
No
The device is described as an anchor for soft tissue to bone suture fixation, which is a surgical tool for repair, not for diagnosis.
No
The device description clearly describes a physical anchor and an introduction device, which are hardware components used for surgical procedures. There is no mention of software as the primary or sole component of the device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical device used for soft tissue to bone suture fixation in various anatomical locations. This is a therapeutic and surgical application, not a diagnostic one.
- Device Description: The description details a physical anchor and suture system used to physically attach tissue to bone. This is a mechanical device for surgical repair.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's condition.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The devices are intended for soft tissue to bone suture fixation for the following indications:
Shoulder
- Rotator cuff tear repairs -
- Biceps tenodesis -
Foot and Ankle
-
Lateral instability repairs/reconstructions -
Elbow, Wrist and Hand -
Ulnar or radial collateral ligament reconstructions -
-
Tennis elbow repair -
-
Biceps tendon reattachment -
Knee
- Extra-capsular repairs: -Medial collateral ligament Lateral collateral ligament
Product codes
Not Found
Device Description
The anchor is tubular in shape and is preassembled threaded with USP size 2-0 through 2 braided polyester suture. An Introduction Device holds the anchor and delivers it into the bone through a predrilled hole. The sutures can then be used to secure the soft tissue to the bone.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Shoulder, Foot and Ankle, Elbow, Wrist and Hand, 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)
The nature of device changes do not necessitate performance data testing.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K934183, K953877, K930892, K904436
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
NUTTI RESEARCH, INC
vergreen avenue, effingham, illinois 6240 "
Summary of Safety and Effectiveness Multitak Suture System™
JAN 1 0 1997
Submitted by
Bonutti Research 1303 Evergreen Ave. Effingham, IL 62401
Prepared by
Lynnette Whitaker Director Regulatory Affairs/Quality Assurance
Date .
.
.
October 28, 1996
Trade Name .
Multitak Suture System
Common Name .
Soft Tissue Anchor
Classification Name
21 CFR 888.3040, Smooth or Threaded Metallic Bone Fixation Fastener
Predicate Devices
- Multitak SS Suture System, manufactured by Bonutti Research, K934183. .
- GII Anchor System, manufactured by Mitek Surgical Products, Inc., . K953877.
- Mini QuickAnchor, manufactured by Mitek Surgical Products, Inc., . K930892 and K904436.
1
Device Description
The anchor is tubular in shape and is preassembled threaded with USP size 2-0 through 2 braided polyester suture. An Introduction Device holds the anchor and delivers it into the bone through a predrilled hole. The sutures can then be used to secure the soft tissue to the bone.
Intended Use
The devices are intended for soft tissue to bone suture fixation for the following indications:
Shoulder
- Rotator cuff tear repairs -
- Biceps tenodesis -
Foot and Ankle
-
Lateral instability repairs/reconstructions -
Elbow, Wrist and Hand -
Ulnar or radial collateral ligament reconstructions -
-
Tennis elbow repair -
-
Biceps tendon reattachment -
Knee
- Extra-capsular repairs: -Medial collateral ligament Lateral collateral ligament
Performance Data
The nature of device changes do not necessitate performance data testing.