(50 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description and performance studies do not mention any AI/ML components or methodologies.
Yes
The device is indicated for pelvic floor stimulation in the treatment of urinary incontinence, which is a therapeutic application.
Yes
The device "monitors and allows assessment of EMG activity of the pelvic floor muscles," which is a diagnostic function to evaluate muscle activity.
No
The device description explicitly states it is an "electrode," which is a hardware component. The summary also discusses the physical design and reuse instructions for this electrode.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside the body.
- Device Function: The described device is an electrode used for pelvic floor stimulation and monitoring EMG activity. This involves applying electrical stimulation to the body and measuring electrical signals from the body. This is an in vivo (within the living body) process, not an in vitro process.
- Intended Use: The intended use clearly states "pelvic floor stimulation use in the treatment of urinary incontinence and monitors and allows assessment of EMG activity of the pelvic floor muscles." This is a therapeutic and diagnostic function performed directly on the patient.
Therefore, the device's function and intended use fall outside the scope of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The electrode is indicated for pelvic floor stimulation use in the treatment of urinary incontinence and monitors and allows assessment of EMG activity of the pelvic floor muscles. The electrode can be used either vaginally and rectally; it should not be interchanged between the two positions. The electrode is reusable between patients if reuse instructions are followed.
Product codes (comma separated list FDA assigned to the subject device)
78 KPI
Device Description
The Small Vaginal and Rectal Stimulation Electrode is identical in design to the predicate rectal electrode device except for the addition of vaginal use for stimulation. There were no design changes required or made to allow for this change.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
pelvic floor
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)
A Clinical study was performed to establish equivalence between this electrode used vaginally and the currently marketed stimulation electrodes. This study confirmed the suitability of performance of this electrode.
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.
K952688, K954272, K964577, K940091
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
1983206
Cost Effective Health Care Solutions
SUMMARY OF SAFETY AND EFFECTIVENESS Innova Small Vaginal and Rectal Stimulation Electrode
Date of Summary: September 11, 1998 Page 1 of 1
Empi. Inc. 599 Cardigan Road St. Paul, Minnesota 55126-4099 USA
612-415-9000 FAX 612-415-7305
| General Provisions | FAX |
|---|---|
| Submitter's Name: | Empi, Inc. |
| Submitter's Address: | 599 Cardigan Road |
| St. Paul, Minnesota 55126-3965 | |
| Contact Person: | Carolyn M. Steele Husten |
| Regulatory Affairs Manager | |
| Classification Name: | Non-Implanted Electrical Continence Device |
| 21 CFR Part 876.5320 | |
| Proprietary Name: | Innova® Small Vaginal and Rectal Stimulation |
| Electrode | |
| Common Name: | Pelvic Floor Stimulation Device |
B. Name of Predicate Devices
| • | Empi, Inc. Innova Rectal or Small Vaginal EMG Sensing Electrode | K952688 |
|---|---|---|
| • | Empi, Inc. Innova Rectal Stimulation Electrode | K954272 |
| • | Innova® ComfortPulse™ Vaginal Electrodes (Small and Std.) | K964577 |
| • | Innova® Vaginal Electrode | K940091 |
C. Device Description
The Small Vaginal and Rectal Stimulation Electrode is identical in design to the predicate rectal electrode device except for the addition of vaginal use for stimulation. There were no design changes required or made to allow for this change.
D. Intended Use
The electrode is indicated for pelvic floor stimulation use in the treatment of urinary incontinence and monitors and allows assessment of EMG activity of the pelvic floor muscles. The electrode can be used either vaginally and rectally; it should not be interchanged between the two positions. The electrode is reusable between patients if reuse instructions are followed.
E. Non-Clinical and Clinical Test Summary
A Clinical study was performed to establish equivalence between this electrode used vaginally and the currently marketed stimulation electrodes. This study confirmed the suitability of performance of this electrode.
3 1998 NOV
A.
NOV 3
1
Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare, with three wavy lines representing the twin snakes intertwined around a staff. The text "DEPARTMENT OF HEALTH & HUMAN" is arranged in a semi-circular fashion around the left side of the caduceus.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
3 1998 NOVI
Ms. Carolyn M. Steele Husten Regulatory Affairs Manager Empi, Incorporated 599 Cardigan Road St. Paul, Minnesota 55126-4099 Re: K983206 Empi Small Vaginal and Rectal Stimulation Electrode Dated: September 11, 1998 Received: September 14, 1998 Regulatory Class: II 21 CFR §876.5320/Product Code: 78 KPI
Dear Ms. Steele Husten:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include - requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdr/dsmaldsmamain.html".
Sincerely yours
Lillian Yin, Ph.D.
Director, Division of Reproductive, Abdominal, Ear, Nose and Throat and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Empi, Inc. 510(k) Submission Small Vaginal/Rectal Stimulation Electrode Page 3
510(k) Number: (if known): Unknown at time of submission Device Name: Small Vaginal and Rectal Electrode Indications for Use:
The electrode is indicated for pelvic floor stimulation use in the treatment of urinary incontinence and monitors and allows assessment of EMG activity of the pelvic floor muscles. The electrode can be used either vaginally and rectally; it should not be interchanged between the two positions. The electrode is reusable between patients if reuse instructions are followed.
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Vinid G. Logom
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devic 510(k) Number
OR
Prescription Use
(Per 21 CFR 801.109)
Over-The Counter Use _________________________________________________________________________________________________________________________________________________________
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