(79 days)
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No
The document describes a mechanical soft tissue anchor and does not mention any AI or ML components or functionalities.
No
Explanation: A therapeutic device is one that treats or manages a disease or condition. This device, a soft tissue anchor, is used to hold soft tissue to bone to aid in the healing process, which is part of a surgical repair rather than a therapeutic treatment in itself. Its function is mechanical support.
No
The device description states its purpose is to "hold, with sutures, the soft tissue against the bone for a prescribed healing period," indicating it is a surgical implant for tissue fixation, not a diagnostic tool.
No
The device description clearly states it is a "titanium alloy self-drilling, selftapping cancellous screw threaded device," indicating it is a physical hardware implant, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The description clearly states the device is a "titanium alloy self-drilling, self-tapping cancellous screw threaded device" used to "hold, with sutures, the soft tissue against the bone." This is a surgical implant used directly within the body for mechanical support and tissue attachment.
- Lack of Diagnostic Activity: There is no mention of the device analyzing biological samples or providing diagnostic information. Its function is purely mechanical and structural.
Therefore, this device falls under the category of a surgical implant or medical device, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
The Howmedica Mainstay™ Soft Tissue Anchor is a titanium alloy self-drilling, selftapping cancellous screw threaded device for the attachment of soft tissue to bone. The device is available in three sizes and has a proximal thru-hole for the attachment of the desired suture material. The purpose of the device is to hold, with sutures, the soft tissue against the bone for a prescribed healing period. This device is to be used for soft tissue attachment in the shoulder, ankle, foot, wrist, hand, elbow, knee and pelvis. This present submission is being made to introduce an additional indication for use in soft tissue reconstruction following total hip arthroplasty.
Product codes (comma separated list FDA assigned to the subject device)
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Device Description
The Howmedica Mainstay™ Soft Tissue Anchor is a titanium alloy self-drilling, selftapping cancellous screw threaded device for the attachment of soft tissue to bone. The device is available in three sizes and has a proximal thru-hole for the attachment of the desired suture material.
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
shoulder, ankle, foot, wrist, hand, elbow, knee, pelvis, hip
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Testing was performed in accordance with that described in the FDA "Bone Anchor Devices: Guidance for Testing - April 20, 1996." Results of this testing indicated that the initial fixation strength of the Mainstay™ Soft Tissue Anchor did not differ significantly from that of the Mitek SuperAnchor when used in the same anatomic site.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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.
0
510(k) Summary
MAR 1 3 1997
Howmedica Mainstav ™ Soft Tissue Anchor Device:
The Howmedica Mainstay™ Soft Tissue Anchor is a titanium alloy self-drilling, selftapping cancellous screw threaded device for the attachment of soft tissue to bone. The device is available in three sizes and has a proximal thru-hole for the attachment of the desired suture material. The purpose of the device is to hold, with sutures, the soft tissue against the bone for a prescribed healing period. This device is to be used for soft tissue attachment in the shoulder, ankle, foot, wrist, hand, elbow, knee and pelvis.
The 510(k) for this device K953531 was determined to be substantially equivalent on September 26, 1995. This present submission is being made to introduce an additional indication for use in soft tissue reconstruction following total hip arthroplasty. Testing was performed in accordance with that described in the FDA "Bone Anchor Devices: Guidance for Testing - April 20, 1996." Results of this testing indicated that the initial fixation strength of the Mainstay™ Soft Tissue Anchor did not differ significantly from that of the Mitek SuperAnchor when used in the same anatomic site.
For information contact:
John Dichiara Manager, Regulatory Affairs Howmedica Inc. 359 Veterans Boulevard Rutherford, NJ 07070 (201) 507-7386 Fax: (201) 507-6870