(59 days)
K911190/A
Not Found
No
The device description and performance studies focus on basic EMG signal measurement and biofeedback, with no mention of AI/ML algorithms for analysis or interpretation.
Yes
The device is described as an EMG perineometer probe used for the treatment of incontinence and neuromuscular reeducation, and it aims to improve the strength and control of pelvic floor muscles, which are therapeutic goals.
No
The device is used to monitor pelvic floor muscle activity and provide bio-feedback for the treatment of incontinence. While it measures physiological signals, its primary purpose is therapeutic monitoring and neuromuscular reeducation, not diagnosis of a disease or condition.
No
The device description explicitly states it is a "plastic probe with three metal electrode contacts" and is a "single-user plastic probe". This indicates a physical hardware component is the primary device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Function: The Pathway Vaginal/Rectal Perineometer Probe is an EMG (Electromyography) probe. It measures the electrical activity of muscles (specifically the pelvic floor muscles) in vivo (within the living body). It does not analyze samples taken from the body.
- Intended Use: The intended use is for monitoring pelvic floor muscle activity for the treatment of incontinence and neuromuscular reeducation, which are therapeutic and biofeedback applications, not diagnostic testing of bodily fluids or tissues.
Therefore, this device falls under the category of a therapeutic or biofeedback device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
-
- Urinary Incontinence : Stress, Urge and Mixed Incontinence
-
- Fecal Incontinence
-
- Neuromuscular Reeducation
Product codes
85 HIR
Device Description
The Pathway Vaginal/Rectal Perineometer Probe is an EMG perineometer probe used to monitor the pelvic floor muscles for the treatment of incontinence. This probe is connected to a surface EMG device to provide Bio-feedback to the patient. This allows the patient to monitor their pelvic muscle activity which is otherwise difficult due to the anatomical location of the pelvic floor muscles.
The Pathway Vaginal/Rectal Perineometer Probe is a single-user plastic probe with three metal electrode contacts. The patient inserts the probe into the vagina or rectum and uses a surface EMG instrument to monitor the muscle activity during contraction and relaxation of the pelvic floor muscles. The aim is to improve the strength and control of the pelvic floor muscles.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vagina or rectum
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Clinic, Hospital & Home Use
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
Non-Clinical Performance Data: Bench tests were performed using the Pathway Vaginal/Rectal Perineometer Probe to show the probe accurately measured EMG signals and was substantially equivalent to the predicate device. A matrix of different frequencies and amplitudes was measured by the probe. The readings obtained using the Pathway Vaginal/Rectal Perineometer Probe were generally within 5% of the readings obtained using the predicate device.
Clinical Performance Data: The Pathway Vaginal/Rectal Perineometer Probe was used in a series of simple clinical tests to show the probe accurately measured EMG signals and was equivalent to the predicate device. A number of Male and Female subjects were instructed to perform a series of contractions and relaxations using the Pathway Vaginal/Rectal Perineometer Probe and also using the predicate device. These sessions were recorded using a personal computer. The Pathway Vaginal/Rectal Perineometer Probe had an overall ratio between EMG contraction levels and EMG relaxation levels of 5.4:1 and the predicate device had an overall ratio between EMG contraction levels and EMG relaxation levels of 5.1:1.
Biocompatibility Testing: Laboratory testing was performed for the safety of the materials. Tests performed include Skin Sensitization Kligman Maximization Test (0% Sensitization; Weak allergenic potential), Systemic Injection Test (Negative; No significant biological reaction), L929 MEM Elution Test (Non-cytotoxic), Pyrogen Test (Material Mediated) (Non-pyrogenic), Primary Vaginal Test - Repeated Exposure (Minimal irritant), and Rectal Irritation Test - Repeated Exposure (Non-irritant).
Key Metrics
Not Found
Predicate Device(s)
K911190/A
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 884.1425 Perineometer.
(a)
Identification. A perineometer is a device consisting of a fluid-filled sack for intravaginal use that is attached to an external manometer. The devices measure the strength of the perineal muscles by offering resistence to a patient's voluntary contractions of these muscles and is used to diagnose and to correct, through exercise, uninary incontinence or sexual dysfunction.(b)
Classification. Class II (performance standards).
0
| KY14036 | |
|---|---|
| page 1 of 6 |
The Prometheus Group
| 80 Bow Street | Portsmouth, NH 03801 |
|---|---|
| Phone: 603-431-5121 | Fax: 603-431-0650 |
DEC 2 2 1997
510(k) SUMMARY Safety and Effectiveness Summary
Pathway Vaginal/Rectal Perineometer Probe
Submitted by:
Peter A Sullivan 80 Bow Street Portsmouth, NH 03801 Phone: 603-431-5121 Fax: 603-431-0650
Contact Person:
Peter A Sullivan
Date Submitted:
October 23, 1997
1
NAME OF DEVICE
Trade name: Pathway Vaginal/Rectal Perineometer Probe Common name: Perineometer Probe Classification name: Perineometer (per 21 CFR section 884.1425)
IDENTIFICATION OF PREDICATE DEVICE
The device to which we claim substantial equivalence is the Perrymeter Vaginal Perineometer Probe and Perrymeter Anal Perincometer Probe 510(k) number K911190/A. The Perrymeter probes are also single-user plastic probes with three metal electrode contacts.
DESCRIPTION OF DEVICE
The Pathway Vaginal/Rectal Perineometer Probe is an EMG perineometer probe used to monitor the pelvic floor muscles for the treatment of incontinence. This probe is connected to a surface EMG device to provide Bio-feedback to the patient. This allows the patient to monitor their pelvic muscle activity which is otherwise difficult due to the anatomical location of the pelvic floor muscles.
The Pathway Vaginal/Rectal Perineometer Probe is a single-user plastic probe with three metal electrode contacts. The patient inserts the probe into the vagina or rectum and uses a surface EMG instrument to monitor the muscle activity during contraction and relaxation of the pelvic floor muscles. The aim is to improve the strength and control of the pelvic floor muscles.
Pathway Vaginal/Rectal Perineometer Probe
Image /page/1/Picture/9 description: The image shows a thermometer. The thermometer is white and has a digital display. The thermometer is lying on a dark surface. The thermometer is used to measure temperature.
INTENDED USE
Indications For Use:
-
- Urinary Incontinence : Stress, Urge and Mixed Incontinence
-
- Fecal Incontinence
-
- Neuromuscular Reeducation
2
SUMMARY OF TECHNICAL CHARACTERISTIC COMPARISON TO PREDICATE DEVICE
| Pathway Probe | Perrymeter Probe | |
|---|---|---|
| Single-User Perineometer Probe | Yes | Yes |
| Plastic Probe with Metal Contacts | Yes | Yes |
| Three Electrode Contacts | Yes | Yes |
| Two Active, One Ground Contact | Yes | Yes |
| Shielded Cable | Yes | Yes |
| 1/8" Stereo Plug Connector | Yes | Yes |
| Proper Orientation for Best Use | Yes | Yes |
| Urinary or Fecal Incontinence | Yes | Yes |
| Vaginal Use | Yes | Yes (Perry Vaginal) |
| Rectal Use | Yes | Yes (Perry Anal) |
| Clinic, Hospital & Home Use | Yes | Yes |
| Bulb at Tip of Probe to Assist | ||
| Retention of Probe During Use | No | Yes |
| Light Weight to Assist Retention | ||
| of Probe During Use | Yes | No |
| Bulb at Base of Probe | ||
| for Insertion/Removal | ||
| and Control Insertion Depth | No | Yes |
| Tab at Base of Probe | ||
| for Insertion/Removal | ||
| and Control Insertion Depth | Yes | No |
| Arrow on Bottom of Probe | ||
| for Orientation | No | Yes |
| Tab at Base of Probe | ||
| for Orientation | Yes | No |
3
1714056 page 4 of 6
NON-CLINICAL PERFORMANCE DATA
A series of bench tests were performed using the Pathway Vaginal/Rectal Perineometer Probe to show the probe accurately measured EMG signals and was substantially equivalent to the predicate device. The Pathway Vaginal/Rectal Perineometer Probe was used to measure signals spanning the input range of the EMG device. A matrix of different frequencies and amplitudes was measured by the probe and the resulting readings compared to the input signals. The same bench tests were performed on the predicate device.
The bench tests show the Pathway Vaginal/Rectal Perineometer Probe accurately measures EMG signals. The bench tests also show that the Pathway Vaginal/Rectal Perineometer Probe performs similarly to the predicate device. The readings obtained using the Pathway Vaginal/Rectal Perineometer Probe were generally within 5% of the readings obtained using the predicate device.
CLINICAL PERFORMANCE DATA
)
The Pathway Vaginal/Rectal Perineometer Probe was used in a series of simple clinical tests to show the probe accurately measured EMG signals and was equivalent to the predicate device. A number of Male and Female subjects were instructed to perform a series of contractions and relaxations using the Pathway Vaginal/Rectal Perineometer Probe and also using the predicate device. These sessions were recorded using a personal computer.
The clinical tests show the Pathway Vaginal/Rectal Perineometer Probe accurately monitors the pelvic floor muscles. The clinical tests also show the Pathway Vaginal/Rectal Perineometer Probe performs similarly to the predicate device. The Pathway Vaginal/Rectal Perineometer Probe had an overall ratio between EMG contraction levels and EMG relaxation levels of 5.4:1 and the predicate device had an overall ratio between EMG contraction levels and EMG relaxation levels of 5.1:1.
4
K974036 page 5 € f 6
BIOCOMPATIBILITY TESTING
The Pathway Vaginal/Rectal Perineometer Probe has been laboratory tested for the safety of the materials. The Pathway Vaginal/Rectal Perineometer Probes were found to be safe under the standards required for each test. A listing of each performed test and the result:
| Test | Result |
|---|---|
| SKIN SENSITIZATION KLIGMAN MAXIMIZATION TEST | |
| Date of Test: 9/25/97 | 0% Sensitization; |
| Weak allergenic potential | |
| SYSTEMIC INJECTION TEST | |
| Date of Test: 9/9/97 | Negative: |
| No significant biological | |
| reaction | |
| L929 MEM ELUTION TEST | |
| Date of Test: 8/21/97 | Non-cytotoxic |
| PYROGEN TEST (Material Mediated) | |
| Date of Test: 9/3/97 | Non-pyrogenic |
| PRIMARY VAGINAL TEST - REPEATED EXPOSURE | |
| Date of Test: 10/14/97 | Minimal irritant |
| RECTAL IRRITATION TEST - REPEATED EXPOSURE | |
| Date of Test: 9/26/97 | Non-irritant |
5
CONCLUSION
The Pathway Vaginal/Rectal Perineometer Probe is safe and effective for its intended use. The Pathway Vaginal/Rectal Perineometer Probe is substantially equivalent to the predicate device.
END OF 510(k) SUMMARY
6
Image /page/6/Picture/2 description: The image is a simple, minimalist composition consisting of a single, dark, horizontal line against a white background. The line is positioned near the top of the frame, creating a sense of division within the image. The stark contrast between the line and the background emphasizes the line's presence and form. The image is simple and lacks any other elements.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 2 2 1997
Mr. Richard Horton Vice President of Engineering The Prometheus Group 2 Mallards Cove Duxbury, Massachusetts 02332
Re: K974036
Pathway Vaginal/Rectal Perineometer Probe Dated: October 23, 1997 Received: October 24, 1997 Regulatory class: II 21 CFR §884.1425/Product code: 85 HIR
Dear Mr. Horton:
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 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 III (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 requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that through periodic OS inspections the Food and Drue 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 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 marked 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 question 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/cdrh/dsmamain.html".
Sincerely vours.
William Yu, Ph.D.
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
7
SECTION 2 STATEMENT of INDICATIONS for USE
510(k) Number (if known): Pathway Vaginal/Rectal Perineometer Probe Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications for Use:
ﻪﺳﺮ
Indications For Use
-
- Urinary Incontinence : Stress, Urge and Mixed Incontinence
-
- Fecal Incontinence
-
- Neuromuscular Reeducation
Concurrence of CDRH, Office of Device Evaluation (ODE)
Robert R. Sather /
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices K974036 510(k) Number
OR
Prescription Use:_ X (Per 21 CFR 801.109)
Over-the-Counter Use: _________________
(1