(144 days)
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Not Found
No
The provided text describes a physical implantable device made of silicone and dacron mesh for tendon reconstruction. There is no mention of software, algorithms, data processing, or any terms related to AI or ML. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
Yes
The device is implanted to aid in the growth of a new tendon sheath and prepare the tendon bed for a graft, indicating a therapeutic purpose.
No
The device is a temporary implant used for the surgical reconstruction of tendons and is not involved in diagnosing a condition.
No
The device description explicitly states it is an implantable device made of silicone elastomer, dacron polyester mesh, and suture, which are physical materials, not software.
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 Description: The Avanta Orthopaedics Tendon Spacer is a device that is implanted into the body during surgery. It is used to aid in the reconstruction of tendons.
- Intended Use: The intended use is for surgical reconstruction of tendons, which is a procedure performed on the body, not on specimens taken from the body.
The device description and intended use clearly indicate that this is a surgically implanted medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Surgical indications for the Avanta Orthopaedics Tendon Spacer include: Reconstruction of the flexor or extensor tendons of the fingers, thumb and wrist. Scared or adherent tendons following trauma or failed primary repair. Absence of tendon sheath. Scarred or adherent non-functional tendon pulleys. Ruptured tendon. The device is a single-use, temporary implantation for 2-6 months.
Product codes
Not Found
Device Description
The Avanta Orthopaedics Tendon Spacer is a device intended to be implanted made of silicone elastomer which is reinforced with dacron polyester mesh and suture. The device is intended to be used in the surgical reconstruction of a flexor or extensor tendon of the hand. The device may be implanted long enough to permit maturation of the tendon bed to the point at which it can nourish and lubricate the gliding tendon graft. The device may be implanted for a period of time from 2 to 6 months to aid growth of a new tendon sheath. The device is not intended as a permanent implant nor to function as a replacement for the ligament or tendon or to function as a scaffold for soft tissue ingrowth.
The tendon spacer will be available in four sizes, 3,4,5 and 6 mm diameter and 24 cm in length:
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
fingers, thumb and wrist
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Wright Silastic Tendon Spacer
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3025 Passive tendon prosthesis.
(a)
Identification. A passive tendon prosthesis is a device intended to be implanted made of silicon elastomer or a polyester reinforced medical grade silicone elastomer intended for use in the surgical reconstruction of a flexor tendon of the hand. The device is implanted for a period of 2 to 6 months to aid growth of a new tendon sheath. The device is not intended as a permanent implant nor to function as a replacement for the ligament or tendon nor to function as a scaffold for soft tissue ingrowth.(b)
Classification. Class II.
0
MAR 2 5 1997
510(k) SUMMARY
Submitter's Name:
Contact: Date of Preparation: Device Name: Common Name: Predicate Device:
Avanta Orthopaedics 9369 Carroll Park Drive, Suite A San Diego, CA 92121 619-452-8580
Louise Focht September 24, 1996 Avanta Orthopaedics Tendon Spacer Tendon Spacer Wright Silastic Tendon Spacer
Device Description:
The Avanta Orthopaedics Tendon Spacer is a device intended to be implanted made of silicone elastomer which is reinforced with dacron polyester mesh and suture. The device is intended to be used in the surgical reconstruction of a flexor or extensor tendon of the hand. The device may be implanted long enough to permit maturation of the tendon bed to the point at which it can nourish and lubricate the gliding tendon graft. The device may be implanted for a period of time from 2 to 6 months to aid growth of a new tendon sheath. The device is not intended as a permanent implant nor to function as a replacement for the ligament or tendon or to function as a scaffold for soft tissue ingrowth.
The tendon spacer will be available in four sizes, 3,4,5 and 6 mm diameter and 24 cm in length:
Device Intended Use:
Surgical indications for the Avanta Orthopaedics Tendon Spacer include: Reconstruction of the flexor or extensor tendons of the fingers, thumb and wrist. Scared or adherent tendons following trauma or failed primary repair. Absence of tendon sheath. Scarred or adherent non-functional tendon pulleys. Ruptured tendon. The device is a single-use, temporary implantation for 2-6 months.