(56 days)
No
The description focuses on a physical probe for electrical stimulation and EMG feedback, and explicitly states that the only difference from the predicate device is the size. There is no mention of AI, ML, or any software-based analysis that would suggest the use of these technologies.
Yes
The device is intended to provide electromyographic feedback or electrical stimulation for the rehabilitation of weak pelvic floor muscles and restoration of neuromuscular control during the treatment of urinary incontinence, which are therapeutic purposes.
No
The device is used for electromyographic feedback (EMG) or electrical stimulation for rehabilitation purposes, specifically for treating urinary incontinence by strengthening pelvic floor muscles and restoring neuromuscular control. It is a therapeutic device, not a diagnostic one.
No
The device description explicitly states it is a "vaginal 2-electrode stimulation/EMG probe - small," which is a physical hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "electromyographic feedback from pelvic musculature or electrical stimulation to pelvic musculature for the purpose of rehabilitation of weak pelvic floor muscles and restoration of neuromuscular control during the treatment of urinary incontinence." This describes a therapeutic and diagnostic device used directly on the patient's body, not a test performed on a sample taken from the body (which is the definition of an in vitro diagnostic).
- Device Description: The description details a probe inserted into the vagina for direct interaction with the pelvic muscles. This is consistent with an in vivo device, not an in vitro one.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or laboratory procedures, which are hallmarks of IVD devices.
Therefore, this device falls under the category of a therapeutic and diagnostic medical device used in vivo, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
The Vaginal Stimulation/EMG Probe - Small is intended to provide electromyographic feedback from pelvic musculature or electrical stimulation to pelvic musculature for the purpose of rehabilitation of weak pelvic floor muscles and restoration of neuromuscular control during the treatment of urinary incontinence.
Product codes
Not Found
Device Description
Hollister Incorporated through it's InCare Division currently markets a vaginal 2-electrode stimulation/EMG probe (K891773) as an accessory to it's Pelvic Floor Therapy System product line. Requests and comments from physicians and caregivers has indicated the need for a smaller diameter vaginal probe that would be used by patients that have a smaller vaginal anatomy and who cannot use the currently marketed vaginal probe. In response to these comments, Hollister has developed the vaginal 2-electrode stimulation/EMG probe - small. This probe uses the same identical raw material components and manufacturing process as the currently marketed device. The only difference is that the proposed probe has a smaller diameter to accommodate smaller vaginal anatomies.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Vaginal
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
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Summary of Performance Studies
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Key Metrics
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Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.5320 Nonimplanted electrical continence device.
(a)
Identification. A nonimplanted electrical continence device is a device that consists of a pair of electrodes on a plug or a pessary that are connected by an electrical cable to a battery-powered pulse source. The plug or pessary is inserted into the rectum or into the vagina and used to stimulate the muscles of the pelvic floor to maintain urinary or fecal continence. When necessary, the plug or pessary may be removed by the user. This device excludes an AC-powered nonimplanted electrical continence device and the powered vaginal muscle stimulator for therapeutic use (§ 884.5940).(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image shows the Hollister logo. The logo consists of a black geometric shape resembling a stylized cross or asterisk on the left, followed by the word "Hollister" in a bold, sans-serif font. The text is also in black, creating a strong contrast against the white background.
APR 1 5 1997
Hollister Incorporated 2000 Hollister Drive Libertyville, Illinois 60048-3781 PIO3
1970602
Hollister Incorporated Vaginal Stimulation/EMG Probe - Small
510(k) Summary
1. Submitter's name, Address and Contact Person
Submitter Hollister Incorporated 2000 Hollister Drive Libertyville, IL 60048
Contact Person Joseph S. Tokarz Manager, Regulatory Affairs (847)680-2849 Ph (847)918-3860 Fax
Date Summary Prepared - February 13, 1997
2. Name of Device:
Vaginal Stimulation/EMG Probe - Small
3. Name of Predicate Device(s)
Vaginal Stimulation/EMG Probe, K891773
4. Description of Device
Hollister Incorporated through it's InCare Division currently markets a vaginal 2-electrode stimulation/EMG probe (K891773) as an accessory to it's Pelvic Floor Therapy System product line. Requests and comments from physicians and caregivers has indicated the need for a smaller diameter vaginal probe that would be used by patients that have a smaller vaginal anatomy and who cannot use the currently marketed vaginal probe. In response to these comments, Hollister has developed the vaginal 2-electrode stimulation/EMG probe - small. This probe uses the same identical raw material components and manufacturing process as the currently marketed device. The only difference is that the proposed probe has a smaller diameter to accommodate smaller vaginal anatomies.
5. Statement of Intended Use
The Vaginal Stimulation/EMG Probe - Small is intended to provide electromyographic feedback from pelvic musculature or electrical stimulation to pelvic musculature for the purpose of rehabilitation of weak pelvic floor muscles and restoration of neuromuscular control during the treatment of urinary incontinence.
6. Statement of Technological Characteristics of the Device
The proposed device is substantially equivalent to the predicate device. The following is a chart comparing the two devices.
1
K970102 820)
Image /page/1/Picture/1 description: The image shows the Hollister brand logo. On the left is a geometric design that resembles a stylized snowflake or asterisk. To the right of the design is the word "Hollister" in a serif typeface, with a trademark symbol to the right of the word.
Hollister Incorporated Vaginal Stimulation/EMG Probe - Small
Comparison of the Vaginal Stimulation/EMG Probe-Small and Predicate device
| Electrode | Vaginal Stimulation/EMG Probe- | Vaginal Stimulation/EMG Probe - |
|---|---|---|
| Characteristics | Small | Standard |
| Number of Electrode | 2-Stimulation/EMG | 2-Stimulation/EMG |
| Usage Conditions | Reusable - single patient use | Reusable - single patient use |
| Electrode Orientation | Circular | Circular |
| Body Material | Acrylonitrile-Butadiene-Styrene | |
| copolymer (ABS) | Acrylonitrile-Butadiene-Styrene | |
| copolymer (ABS) | ||
| Probe Length | 4.8 inches nominal | 4.8 inches nominal |
| Probe Diameter | 0.750 inch nominal | 1.0 inch nominal |
| Electrode Material | Stainless steel | Stainless steel |
| Electrode Placement | Vaginal | Vaginal |
| Device Connector | Attached cord with 3.5 mm stereo | |
| phono plug | Attached cord with 3.5 mm stereo | |
| phono plug | ||
| Contact Duration | Intermittent mucosal contact |