(41 days)
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No
The summary describes a probe accessory for a pelvic floor therapy system, focusing on its materials and manufacturing process being identical to predicate devices. There is no mention of AI, ML, or any related concepts.
Yes
The device is described as providing electromyographic feedback and electrical stimulation for the rehabilitation of weak pelvic floor muscles and restoration of neuromuscular control in the treatment of urinary incontinence, which are therapeutic purposes.
Yes
The device "is intended to provide electromyographic feedback from pelvic musculature", which is a form of diagnostic information.
No
The device description explicitly states it is a "probe" and uses "raw material components and manufacturing process," indicating it is a physical hardware device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for providing electromyographic feedback and electrical stimulation to pelvic musculature for the purpose of rehabilitation and treatment of urinary incontinence. This involves interacting directly with the patient's body for therapeutic and diagnostic purposes related to muscle function.
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens derived from the human body (like blood, urine, tissue) to provide information about a physiological state, health, disease, or congenital abnormality. This device does not analyze such specimens.
- Device Description: The description confirms it's a probe used for stimulation and EMG, which are procedures performed directly on the patient.
Therefore, this device falls under the category of a therapeutic and diagnostic medical device used in vivo (on the living body), not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Anal Stimulation/EMG Probe - w/Stop, 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 an Anal 2-electrode Stimulation/EMG Probe (K891773 and K930530) as an accessories to it's Pelvic Floor Therapy System product line. The proposed probe uses the same identical raw material components and manufacturing process as the currently marketed predicate devices.
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
pelvic musculature, pelvic floor muscles, Anal (for electrode placement)
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)
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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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§ 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
3/25/99
riomster Incorporated 2000 Hollister Drive Libertyville, illinois 60048-3781 Telephone, 847,680,1000 Facsmile: 347.918 3860
Hollister Incorporated Anal Stimulation/EMG Probe - w/Stop
K990456
PG. 1 OF 3
Image /page/0/Picture/6 description: The image contains the Hollister brand logo. The logo consists of a graphic element on the left and the word "Hollister" on the right. The graphic element is a black, geometric design resembling a woven pattern or a stylized cross.
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 9, 1999
2. Name of Device:
Anal Stimulation/EMG Probe - w/Stop
3. Name of Predicate Device(s)
Anal Stimulation/EMG Probe, K891773 and K930530
4. Description of Device
Hollister Incorporated through it's InCare Division currently markets an Anal 2-electrode Stimulation/EMG Probe (K891773 and K930530) as an accessories to it's Pelvic Floor Therapy System product line. The proposed probe uses the same identical raw material components and manufacturing process as the currently marketed predicate devices.
5. Statement of Intended Use
The Anal Stimulation/EMG Probe - w/Stop, 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
Hollister Incorporated Anal Stimulation/EMG Probe - w/Stop
Image /page/1/Picture/3 description: The image shows the Hollister company logo. The logo consists of a geometric symbol to the left of the word "Hollister". The geometric symbol is a square shape made up of intersecting lines, with a smaller square shape in the center.
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 | Anal Stimulation/EMG
Probe - w/Stop | Anal Stimulation/EMG
Probe - 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 | 2.349 inches nominal | 3.45 inches nominal |
| Probe Diameter (between
electrode) | 0.453 inch nominal | 0.394 inch nominal |
| Electrode Material | Stainless Steel | Stainless Steel |
| Electrode Placement | Anal | Anal |
| 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