(48 days)
OUESTUSTM Polyester Suture Soft Tissue Anchor System
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No
The device description and performance studies focus on the mechanical properties and surgical application of a physical anchor and suture system. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is described as a "Soft Tissue Anchor System" used for "repair of instability secondary to tear or separation of" various ligaments and tendons in different anatomical sites, which indicates it is used for therapeutic purposes such as repair and stabilization.
No
The device is a soft tissue anchor system used for repairing tears or separations of ligaments and tendons. It is a surgical implant, not a tool for diagnosing medical conditions.
No
The device description explicitly states it is a "single use, sterile, preassembled kit consisting of a bone anchor, a suture, and a disposable instrument driver," which are all hardware components.
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 to anchor soft tissue to bone for the repair of various injuries in the shoulder, elbow, hand/wrist, knee, and foot/ankle. This is a therapeutic and structural function, not a diagnostic one.
- Device Description: The device is described as a bone anchor, suture, and instrument driver, made of titanium alloy. This is consistent with a surgical implant and its delivery system, not a device used to examine specimens from the human body.
- No mention of in vitro testing: There is no indication that this device is used to test samples like blood, urine, or tissue outside of the body. The performance study mentioned is related to the mechanical strength of the anchor in a simulated environment, not diagnostic performance.
IVD devices are used to perform tests on specimens taken from the human body to provide information for diagnosis, monitoring, or screening. This device does not fit that description.
N/A
Intended Use / Indications for Use
The OUESTUSTM Polyester Suture Soft Tissue Anchor System is indicated for the following:
- ownig. lesion, acromioclavicular separation, biceps tenodesis, deltoid tear/separation, or capsular shift or capsulolabral reconstruction;
- repair of elbow instability secondary to biceps tendon detachment, tennis elbow, of ulnar or radial collateral ligament tear/separation;
- repair of hand/wrist instability secondary to tear or separation of the scapholunate ligament, ulnar collateral ligament, or radial collateral ligament;
- repair of knee instability secondary to tear or separation of the medial collateral ligament, lateral collateral ligament, patellar tendon, or posterior oblique ligament, or secondary to iliotibial band tenodesis;
- repair of foot/ankle instability secondary to tear or separation of the Achilles tendon, lateral stabilization tendons/ligaments, medial stabilization tendons/ligaments, midfoot tendons/ligaments, or metatarsal tendons/ligaments
Product codes
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Device Description
The OUESTUSTM Polyester Suture Soft Tissue Anchor System, size 7.5mm, is a single use, sterile, preassembled kit consisting of a bone anchor, a suture, and a disposable instrument driver, and is an additional size offering to the QUESTUSIM Polyester Suture Soft Tissue Anchor System. The anchor is manufactured from titanium alloy and threaded into bone. Soft tissue is secured to the implant site with suture.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
The 7.5mm QUESTUS™ Polyester Suture Soft Tissue Anchor System was tested according to Draft Guidance Document for Testing Bone Anchor Devices, April 1, 1993 The conclusion from this test is that the 7.5mm anchor can be expected to meet or exceed the in vivo performance of the 5.0mm anchor.
Summary of Performance Studies
The 7.5mm QUESTUS™ Polyester Suture Soft Tissue Anchor System was tested according to Draft Guidance Document for Testing Bone Anchor Devices, April 1, 1993 The conclusion from this test is that the 7.5mm anchor can be expected to meet or exceed the in vivo performance of the 5.0mm anchor.
Key Metrics
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Predicate Device(s)
OUESTUSTM Polyester Suture Soft Tissue Anchor System
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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/2 description: The image shows the text "OCT - 2 1996" on the top line and "K96320" on the second line. The text is black and the background is white. The text appears to be handwritten.
510(k) Summary
RI, INGTON, IN
901 - 867 -
AIRLINE
Contact Person: Date Prepared:
Cristie Manuel September 30, 1996
Trade/Proprietarv Name:
Common Name: Product Classification: Predicate Device:
OUESTUSTM Polyester Suture Soft Tissue Anchor System, Size 7.5mm Fastener, fixation, nondegradable, soft tissue Class II OUESTUSTM Polyester Suture Soft Tissue Anchor System
ROAD
38002
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR $807.92.
Description/Intended Use
The OUESTUSTM Polyester Suture Soft Tissue Anchor System, size 7.5mm, is a single use, sterile, preassembled kit consisting of a bone anchor, a suture, and a disposable instrument driver, and is an additional size offering to the QUESTUSIM Polyester Suture Soft Tissue Anchor System. The anchor is manufactured from titanium alloy and threaded into bone. Soft tissue is secured to the implant site with suture.
The OUESTUSTM Polyester Suture Soft Tissue Anchor System is indicated for the following:
- ownig. lesion, acromioclavicular separation, biceps tenodesis, deltoid tear/separation, or capsular shift or capsulolabral reconstruction;
- repair of elbow instability secondary to biceps tendon detachment, tennis elbow, of ulnar or radial collateral ligament tear/separation;
- repair of hand/wrist instability secondary to tear or separation of the scapholunate ligament, ulnar collateral ligament, or radial collateral ligament;
- repair of knee instability secondary to tear or separation of the medial collateral ligament, lateral collateral ligament, patellar tendon, or posterior oblique ligament, or secondary to iliotibial band tenodesis;
- repair of foot/ankle instability secondary to tear or separation of the Achilles tendon, lateral stabilization tendons/ligaments, medial stabilization tendons/ligaments, midfoot tendons/ligaments, or metatarsal tendons/ligaments
Testing Summary
The 7.5mm QUESTUS™ Polyester Suture Soft Tissue Anchor System was tested according to Draft Guidance Document for Testing Bone Anchor Devices, April 1, 1993 The conclusion from this test is that the 7.5mm anchor can be expected to meet or exceed the in vivo performance of the 5.0mm anchor.