(58 days)
Not Found
No
The device description focuses on physical design modifications for improved patient mobility and explicitly states it uses the same raw materials and manufacturing process as predicate devices, with no mention of AI/ML.
Yes
The device is intended for "rehabilitation of weak pelvic floor muscles and restoration of neuromuscular control during the treatment of urinary incontinence," which are therapeutic purposes.
Yes
The device is intended to provide "electromyographic feedback from pelvic musculature" which is a diagnostic function to assess the activity of the pelvic floor muscles.
No
The device description explicitly describes a physical probe made of raw material components and manufactured through a process, indicating it is a hardware device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Function: The described device is a probe used for electrical stimulation and electromyographic feedback directly on the pelvic muscles. It is used for therapy and rehabilitation, not for analyzing bodily specimens to diagnose a condition.
- Intended Use: The intended use clearly states "rehabilitation of weak pelvic floor muscles and restoration of neuromuscular control during the treatment of urinary incontinence." This is a therapeutic application, not a diagnostic one.
The device is a therapeutic device used for physical therapy and rehabilitation, not an IVD.
N/A
Intended Use / Indications for Use
The Vaginal Stimulation/EMG Probe - Tampon, 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 (comma separated list FDA assigned to the subject device)
78 KPI, 85 HIR
Device Description
Hollister Incorporated through it's InCare Division currently markets a vaginal 2-electrode Stimulation/EMG probe (K891773 and K930530) and a Small Vaginal Stimulation/EMG probe (K970602) as accessories to it's Pelvic Floor Therapy System product line. Therapy with these currently marketed probes, is normally performed with the patient in the supine position. Requests and comments from physicians and caregivers has indicated the need for a probe that will remain in place and allow the patient to perform normal activities, such as standing or bending during therapy. In response to these comments, Hollister has developed the vaginal 2-electrode stimulation/EMG probe - Tampon. The proposed probe uses the same identical raw material components and manufacturing process as the currently marketed devices. The proposed probe has a shorter overall length to help it remain in place while a patient is standing, bending, stooping or squatting during therapy.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Vaginal (pelvic musculature)
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
Not Found
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).
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 geometric symbol to the left of the word "Hollister". The geometric symbol is a stylized cross or asterisk shape, formed by intersecting bars. The word "Hollister" is written in a bold, sans-serif font.
Hollister Incorporated 2000 Ho!lister Drive Libertyville, Illinois 60048-3781
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Hollister Incorporated Vaginal Stimulation/EMG Probe - Tampon
510(k) Summary
JUN 2 5 1997
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 Ph (847)680-2849 (847)918-3860 Fax -
Date Summary Prepared - April 24, 1997
2. Name of Device:
Vaginal Stimulation/EMG Probe - Tampon
3. Name of Predicate Device(s)
Vaginal Stimulation/EMG Probe, K891773 and K930530 Vaginal Stimulation/EMG Probe - Small K970602
4. Description of Device
Hollister Incorporated through it's InCare Division currently markets a vaginal 2-electrode Stimulation/EMG probe (K891773 and K930530) and a Small Vaginal Stimulation/EMG probe (K970602) as accessories to it's Pelvic Floor Therapy System product line. Therapy with these currently marketed probes, is normally performed with the patient in the supine position. Requests and comments from physicians and caregivers has indicated the need for a probe that will remain in place and allow the patient to perform normal activities, such as standing or bending during therapy. In response to these comments, Hollister has developed the vaginal 2-electrode stimulation/EMG probe - Tampon. The proposed probe uses the same identical raw material components and manufacturing process as the currently marketed devices. The proposed probe has a shorter overall length to help it remain in place while a patient is standing, bending, stooping or squatting during therapy.
5. Statement of Intended Use
The Vaginal Stimulation/EMG Probe - Tampon, 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.
1
Image /page/1/Picture/1 description: The image shows the Hollister logo. On the left is a black geometric shape that resembles a plus sign with additional arms. To the right of the shape is the word "Hollister" in a serif font.
Hollister Incorporated Vaginal Stimulation/EMG Probe - Tampon
6. Statement of Technological Characteristics of the Device
The proposed device is substantially equivalent to the predicate devices. The following is a chart comparing the devices.
| Electrode
Characteristics | Vaginal Stimulation/
EMG Probe - Tampon | Vaginal Stimulation/
EMG Probe-Small | Vaginal Stimulation/
EMG Probe - Standard |
|------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|
| Number of Electrode | 2-Stimulation/EMG | 2-Stimulation/EMG | 2-Stimulation/EMG |
| Usage Conditions | Reusable - single patient
use | Reusable - single patient
use | Reusable - single patient
use |
| Electrode
Orientation | Circular | Circular | Circular |
| Body Material | Acrylonitrile-Butadiene-
Styrene copolymer
(ABS) | Acrylonitrile-Butadiene-
Styrene copolymer
(ABS) | Acrylonitrile-Butadiene-
Styrene copolymer
(ABS) |
| Probe Length | 2.3 inches nominal | 4.8 inches nominal | 4.8 inches nominal |
| Probe Diameter | 0.841 inch nominal | 0.750 inch nominal | 1.0 inch nominal |
| Electrode Material | Stainless steel | Stainless steel | Stainless steel |
| Electrode Placement | Vaginal | Vaginal | Vaginal |
| Device Connector | Attached cord with 3.5
mm stereo phono plug | Attached cord with 3.5
mm stereo phono plug | Attached cord with 3.5
mm stereo phono plug |
| Contact Duration | Intermittent mucosal
contact