(61 days)
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No
The summary describes a mechanical bone anchor system and its insertion instrument. There is no mention of software, algorithms, image processing, or any terms related to AI/ML. The performance studies focus on mechanical strength, not algorithmic performance.
Yes
The device is intended for the treatment of stress type (female) urinary incontinence, which is a medical condition, making it a therapeutic device.
No
The device, UroTac Bone Anchor System, is intended for soft tissue fixation to the pubic bone to treat stress urinary incontinence, which is a therapeutic function rather than a diagnostic one.
No
The device description explicitly states it consists of a bone anchor device and an inserter instrument, which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for soft tissue fixation to the pubic bone for the treatment of stress urinary incontinence. This is a surgical procedure performed on the patient's body.
- Device Description: The device consists of a bone anchor and an inserter instrument, which are physical tools used in a surgical setting.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information about a physiological state, health, or disease.
IVD devices are used to perform tests on samples taken from the body, not to directly treat a condition within the body. The UroTac Bone Anchor System is a surgical implant and instrument.
N/A
Intended Use / Indications for Use
The UroTac Bone Anchor System is intended for soft tissue fixation to the pubic bone by means of bone anchors threaded with suture. The UroTac Bone Anchor System is indicated for the treatment of stress type (female) urinary incontinence resulting from urethral hypermobility.
Product codes
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Device Description
Fixation of non-absorbable suture below bone surface for soft tissue fixation.
Suture anchor constructed of Nitinol designed to lock into medulla of the pubic bone when pull force is applied to the suture attached to the anchor.
Anchor - Nitinol Inserter - Stainless Steel (ASTM F899-94).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
pubic bone
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)
The mean failure load of the UroTac Bone Anchor, when pulled from pubic bone, has been tested in a manner consistent with the Guidance Document for Testing Bone Anchor Devices (Draft November 1, 1993). The mean fixation strength of the device was demonstrated to be substantially equivalent to that of the Mitek predicate device. The tests did not yield any data suggesting safety or effectiveness issues which are other than those presented by the Mitek predicate device or the Microvasive bladder neck suspension procedure using the Vesica Bone Anchor.
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
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§ 888.4540 Orthopedic manual surgical instrument.
(a)
Identification. An orthopedic manual surgical instrument is a nonpowered hand-held device intended for medical purposes to manipulate tissue, or for use with other devices in orthopedic surgery. This generic type of device includes the cerclage applier, awl, bender, drill brace, broach, burr, corkscrew, countersink, pin crimper, wire cutter, prosthesis driver, extractor, file, fork, needle holder, impactor, bending or contouring instrument, compression instrument, passer, socket positioner, probe, femoral neck punch, socket pusher, reamer, rongeur, scissors, screwdriver, bone skid, staple driver, bone screw starter, surgical stripper, tamp, bone tap, trephine, wire twister, and wrench.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 888.9.
0
Influence, Inc.
637 Steiner Street San Francisco, California 94117 Tel. 415-552-4303/Fax. 415-552-4309
510(k) SUMMAR Y
Prepared: June 18, 1996.
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR Section 807.92.
SUBMITTER
| NAME | Influence, Inc. |
|---|---|
| ADDRESS | 637 Steiner Street |
| San Francisco, California 94117 | |
| TEL.#/FAX# | 415-552-4303 / 415-552-4309 |
| CONTACT | Peter A. Bick, MD |
| President |
- UroTac Bone Anchor System NAME OF DEVICE Consisting of:
UroTac Bone Anchor TRADE NAME Device for soft tissue to bone attachment. COMMON NAME CLASSIFICATION NAME Staple, Fixation, Bone
TRADE NAME UroTac Bone Anchor Inserter Instrument used to insert bone anchor in desired situs. COMMON NAME CLASSIFICATION NAME Surgical Instrument - Staple Driver
PREDICATE DEVICE
MITEK GII Bone Anchor (and accessories) (K920213) MICROVASIVE (VESICA) Bone Anchor (K932925)
DESCRIPTION OF THE DEVICE
FUNCTION
Fixation of non-absorbable suture below bone surface for soft tissue fixation.
UroTac Bone Anchor System WDC - 65853/2 - 0292817 02
1
DEVICE DESIGN
Suture anchor constructed of Nitinol designed to lock into medulla of the pubic bone when pull force is applied to the suture attached to the anchor.
MATERIAL
Anchor - Nitinol Inserter - Stainless Steel (ASTM F899-94).
INTENDED USE
The UroTac Bone Anchor System is intended for soft tissue fixation to the pubic bone by means of bone anchors threaded with suture. The UroTac Bone Anchor System is indicated for the treatment of stress type (female) urinary incontinence resulting from urethral hypermobility.
COMPARISON TO PREDICATE DEVICES
The predicate device is the Mitek GII Anchor. Equivalent features include: use in connection with bladder neck suspension procedure to accomplish soft tissue fixation to the pubic bone; insertion of anchor into pubic bone; use of an inserter to set the anchor into the pubic bone; use of Nitinol as an essential material; use of USP Class I suture; and initial fixation strengths that are substantially equivalent. Microvasive's Vesica Bone Anchor is a predicate device by virtue of the similarity of certain aspects of the bladder neck suspension procedure.
DESCRIPTION OF NON CLINICAL TESTS
The mean failure load of the UroTac Bone Anchor, when pulled from pubic bone, has been tested in a manner consistent with the Guidance Document for Testing Bone Anchor Devices (Draft November 1, 1993).
CONCLUSIONS FROM TESTS
The mean fixation strength of the device was demonstrated to be substantially equivalent to that of the Mitek predicate device. The tests did not yield any data suggesting safety or effectiveness issues which are other than those presented by the Mitek predicate device or the Microvasive bladder neck suspension procedure using the Vesica Bone Anchor.
UroTac Bone Anchor System \DC - 65853/2 - 0292817 02