K Number
K961555
Device Name
ACUFEX TAG BIOABSORBABLE ANCHORS
Date Cleared
1996-07-10

(79 days)

Product Code
Regulation Number
888.3030
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The TAG® Bioabsorbable Anchors are intended to be used to secure suture to bone, thereby facilitating the reattachment of soft tissue. Indications The TAG® Bioabsorbable 3.7mm Rod, 3.7mm and 3.0mm Wedge Anchors statement are indicated for use in soft tissue to bone fixation in the surgical repair of injuries in the foot, ankle and elbow.
Device Description
The Acufex TAG Bioabsorbable Anchors are wedge-and rod shaped, sterile suture anchors, with a hole through which suture is threaded. the tag anchors are implanted into bone, burying and anchoring the implant and attached suture, which can be used to reattach and secure soft tissue, such as ligaments and tendons. Three sizes of the devices will be used in the foot, ankle and elbow applications, the Tag 3.7mm Wedge and Rod II and 3.0mm and 2.0mm Wedge Anchors.
More Information

No
The summary describes a purely mechanical device (suture anchors) and makes no mention of AI, ML, image processing, or any data-driven analytical capabilities.

Yes
The device is described as facilitating the reattachment of soft tissue and being used in the surgical repair of injuries, which are therapeutic actions.

No

Explanation: The device is a bioabsorbable anchor used for surgical repair and fixation of soft tissue to bone. It is an implantable medical device used in treatment, not for diagnosing conditions.

No

The device description clearly states it is a physical, sterile suture anchor made of bioabsorbable material, which is implanted into bone. This is a hardware device, not software.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use is to "secure suture to bone, thereby facilitating the reattachment of soft tissue." This is a surgical procedure performed directly on the patient's body.
  • Device Description: The device is a "sterile suture anchor" implanted "into bone." This is a physical implant used in surgery.
  • Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples, etc.) to provide information for diagnosis, monitoring, or compatibility testing.

IVD devices are used outside the body to analyze samples and provide diagnostic information. This device is a surgical implant used inside the body for mechanical support.

N/A

Intended Use / Indications for Use

The TAG® Bioabsorbable Anchors are intended to be used to secure suture to bone, thereby facilitating the reattachment of soft tissue.

The TAG® Bioabsorbable 3.7mm Rod, 3.7mm and 3.0mm Wedge Anchors statement are indicated for use in soft tissue to bone fixation in the surgical repair of injuries in the foot, ankle and elbow.

The Acufex® Mini-TAG and TAG Bioabsorbable Anchors are intended for use as a suture anchor in repairs of soft tissue of the foot, ankle and elbow.

Product codes

Not Found

Device Description

The Acufex TAG Bioabsorbable Anchors are wedge-and rod shaped, sterile suture anchors, with a hole through which suture is threaded. the tag anchors are implanted into bone, burying and anchoring the implant and attached suture, which can be used to reattach and secure soft tissue, such as ligaments and tendons.

Three sizes of the devices will be used in the foot, ankle and elbow applications, the Tag 3.7mm Wedge and Rod II and 3.0mm and 2.0mm Wedge Anchors.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

foot, ankle, elbow

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)

Extensive performance testing was conducted to ensure the material and design parameters of the TAG Bioabsorbable Anchor are adequate for their intended use and environment: performance testing is described in detail in Section 5 of this submission. Performance testing of the TAG Bioabsorbable Anchors demonstrated the following:

  • Pull-out strength of the TAG Bioabsorbable Anchors is equivalent to that of the commercially available TAG Anchors when directly compared in cadaveric bones of the tibia, a worst case model.
  • Pull-out strength of the TAG Bioabsorbable Anchors is greater than t or equivalent to the "worst-case" clinical loads encountered by the anchors in the specified surgical indications.
  • Bridge strength of the TAG Bioabsorbable Anchors is significantly greater than the largest size sutures intended for use with the anchors.
  • Pull-out strength of the smallest size sutures intended for use with the TAG Bioabsorbable Anchors is greater than or equivalent to the "worst-case" clinical loads encountered by the anchors in the specified surgical indications
  • The "worst-case" clinical loads encountered by the anchors in the specified indications are lower than those encountered in the treatment of shoulder instability, one of the currently cleared indications for use (K946346).

Given the equivalent pull-out strength of the TAG Bioabsorbable Suture Anchors and TAG (non-absorbable) Suture Anchors, the performance testing conducted on the TAG Suture Anchors supports the following conclusions:

  • Pull-out strength of the TAG Bioabsorbable Anchors is equivalent to that of the commercially available Mitek Mini-GII Anchors and TAG Anchors. The Mitek Mini-GII Anchors and the TAG Anchors were directly compared in cadaveric bones of the tibia (worst case), foot, ankle, and elbow.
  • Repair strengths using the TAG Bioabsorbable Anchors in the foot and ankle are equivalent to standard suture repair techniques for the same soft tissue repairs.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K946346

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.

(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.

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