(137 days)
No
The description focuses on electrical stimulation and muscle contraction assistance, with no mention of AI or ML terms, data analysis, or learning capabilities.
Yes
The device is used for the treatment of urinary incontinence and neuromuscular reeducation through muscle stimulation, which are therapeutic applications.
No
Explanation: The device is described as an electrical stimulator used for treatment (muscle stimulation and reeducation), not for diagnosis. While it uses an EMG/Stim sensor, its described function is to deliver stimulation, not to measure or diagnose.
No
The device description explicitly states that the Pathway STM-10 is a device that connects to a sensor and provides electrical stimulation, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Pathway STM-10 is a device that provides electrical stimulation to the pelvic floor muscles in vivo (within the living body) to treat urinary incontinence and for neuromuscular reeducation. It does not analyze samples taken from the body.
- Mechanism of Action: The device directly interacts with the patient's muscles through a sensor inserted into the vagina or rectum. This is a therapeutic and rehabilitative function, not a diagnostic one based on analyzing biological samples.
Therefore, the Pathway STM-10 falls under the category of a therapeutic or rehabilitative medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
-
- Urinary Incontinence : Stress, Urge and Mixed Incontinence
-
- Neuromuscular Reeducation
Product codes
78 KPI
Device Description
The Pathway STM-10 is used to stimulate the pelvic floor muscles for the treatment of incontinence. The Pathway Vaginal or Anal EMG/Stim perineometer sensor is connected to the Pathway STM-10 device to provide stimulation to the patient. This assists the patient with muscle contractions.
The Pathway STM-10 uses Pathway EMG/Stim Perineometer Sensors which are single-user sensors. The patient inserts the sensor into the vagina or rectum and uses the Pathway STM-10 to electrically stimulate the pelvic floor muscles to assist the contraction. 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
pelvic floor muscles, vagina or rectum
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 series of bench tests were performed using the Pathway STM-10 to show the device accurately applies stimulation and is substantially equivalent to the predicate device. The Pathway STM-10 was used to apply programmed stimulation outputs and the resulting waveforms were measured and compared to the intended signals.
The bench tests show the Pathway STM-10 accurately applies muscle stimulation.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
| K030039 | |
|---|---|
| Page 1 of 4 |
The Prometheus Group
One Washington Street, #303 Dover, NH 03801
Phone: 603-749-0733 Fax: 603-749-0511
MAY 2 3 2003
510(k) SUMMARY Safety and Effectiveness Summary
Pathway STM-10 Pelvic Floor Stimulator
Submitted by:
Peter A Sullivan One Washington Street Suite 303 Dover, NH 03820 Phone: 603-749-0733 Fax: 603-749-0511
Contact Person:
Peter Sullivan 781-582-2328
Date Submitted: April 7, 2002
1
K030039
Page 2 of 4
NAME OF DEVICE
Pathway STM-10 Pelvic Floor Stimulator Trade name: Common name: Non-implanted Electrical Continence Device Classification name: 78 KPI, ClassII, (876.5320)
IDENTIFICATION OF PREDICATE DEVICE
The device to which we claim substantial equivalence is the Pathway CTS 2000 K023906 manufactured by The Prometheus Group.
DESCRIPTION OF DEVICE
The Pathway STM-10 is used to stimulate the pelvic floor muscles for the treatment of incontinence. The Pathway Vaginal or Anal EMG/Stim perineometer sensor is connected to the Pathway STM-10 device to provide stimulation to the patient. This assists the patient with muscle contractions.
The Pathway STM-10 uses Pathway EMG/Stim Perineometer Sensors which are single-user sensors. The patient inserts the sensor into the vagina or rectum and uses the Pathway STM-10 to electrically stimulate the pelvic floor muscles to assist the contraction. The aim is to improve the strength and control of the pelvic floor muscles.
INTENDED USE
Indications For Use:
-
- Urinary Incontinence : Stress, Urge and Mixed Incontinence
-
- Neuromuscular Reeducation
2
K'030039
Page 394
SUMMARY OF TECHNICAL CHARACTERISTIC COMPARISON TO PREDICATE DEVICE
| Parameter | Pathway STM-10 | Pathway CTS 2000 |
|---|---|---|
| Intended Use | Treatment of Urinary | |
| Incontinence; Neuromuscular | ||
| Reeducation | Treatment of Urinary | |
| Incontinence; Neuromuscular | ||
| Reeducation | ||
| Stimulator Output | 0-60 mA | 0-100 mA |
| Waveform | Asymmetrical Balanced Pulsed | |
| Current | Asymmetrical Balanced Pulsed | |
| Current | ||
| Charge/pulse at 500 ohms | 17uC | 28uC |
| Frequency | 12.5, 50 100, 200Hz | 12.5, 50, 100, 200 Hz |
| Peak pulse intensity | 60 mA | 100 mA |
| Pulse width | .3 ms fixed | .3 ms fixed |
| Ramps | 2 sec on ramp, one sec off ramp | 2 sec on ramp, one sec off ramp |
| Duty Cycle | Work/Rest of 5 seconds on, 5 | |
| seconds off (5/5), 5/10, 10/10, | ||
| 10/20. | Work Time: 1 - 60 Seconds | |
| Rest Time: 0 - 60 Seconds | ||
| Session Duration (min) | 5, 10, 15, 20, 25, or 30. | 0-60 |
| Programmable features | None by Patient; Frequency, Duty | |
| cycle, Session length by physician | None by Patient; Frequency, Duty | |
| cycle, Session length by physician | ||
| Vaginal EMG/Stim Probe Used | Pathway Vaginal | |
| EMG/Stimulation Sensor | ||
| K993976 | Pathway Vaginal | |
| EMG/Stimulation Sensor | ||
| K993976 | ||
| Anal EMG/Stim Probe Used | Pathway Anal EMG/Stimulation | |
| Sensor K993976 | Pathway Anal EMG/Stimulation | |
| Sensor K993976 | ||
| Vaginal EMG/Stim probe | ||
| electrode surface area: | 2.31 cm2 | 2.31 cm2 |
| Anal EMG/Stim probe electrode | ||
| surface area: | 2.12 cm2 | 2.12 cm2 |
| Current Density | ||
| (full output @ 500 ohms) | Pathway Vaginal EMG/Stim | |
| Sensor: 26.0 mA/cm2 | ||
| Pathway Anal EMG/Stim Sensor: | ||
| 28.3 mA/cm2 | ||
| (Max. Instantaneous) | Pathway Vaginal EMG/Stim | |
| Sensor: 43.3 mA/cm2 | ||
| Pathway Anal EMG/Stim Sensor: | ||
| 47.2 mA/cm2 | ||
| (Max. Instantaneous) | ||
| Power Density | ||
| (full output @ 500 ohms) | Pathway Vaginal EMG/Stim | |
| Sensor: 5.6 mW/cm2 | ||
| Pathway Anal EMG/Stim Sensor: | ||
| 6.1 mW/cm2 | ||
| (maximum intensity, .3ms pulse | ||
| width 200Hz) | Pathway Vaginal EMG/Stim | |
| Sensor: 15.6 mW/cm2 | ||
| Pathway Anal EMG/Stim Sensor: | ||
| 17.0 mW/cm2 | ||
| (maximum intensity, .3ms pulse | ||
| width 200Hz) |
3
KO30039
Page 4 of 4
BENCH TEST DATA
A series of bench tests were performed using the Pathway STM-10 to show the device accurately applies stimulation and is substantially equivalent to the predicate device. The Pathway STM-10 was used to apply programmed stimulation outputs and the resulting waveforms were measured and compared to the intended signals.
The bench tests show the Pathway STM-10 accurately applies muscle stimulation.
BIOCOMPATIBILITY TESTING
The Pathway Vaginal EMG/Stimulation Perineometer Sensor and the Pathway Anal EMG/Stimulation Perineometer Sensor have been laboratory tested for the safety of the materials. The Pathway Perineometer Sensors were found to be safe under the standards required for each test.
CONCLUSION
The Pathway STM-10 is safe and effective for its intended use. The Pathway STM-10 is substantially equivalent to the predicate device.
END OF 510(k) SUMMARY
4
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol of three human profiles facing right, with flowing lines representing movement or connection.
{
"markdown": ""
}
Food and Drug Administration 9200 Corporate Boulevald Rockville MD 20850
Mr. Peter A. Sullivan Engineer The Prometheus Group 2 Mallards Cove
DUXBURY MA 02332
Re: K030039
MAY 2 3 2003
Trade/Device Name: Pathway STM-10 Pelvic Floor Stimulator Regulation Number: 21 CFR 876.5320 Regulation Name: Nonimplanted electrical continence device Regulatory Class: II Product Code: 78 KPI Dated: April 7, 2003 Received: April 9, 2003 .
Dear Mr. Sullivan:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean ' that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.
5
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of the letter:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
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" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
.
6
KO30039
SECTION 2 - STATEMENT OF INDICATIONS FOR USE
2.1 STATEMENT OF INDICATIONS FOR USE
510(k) Number:_K030039 Device Name:__Pathway STM-10 pelvic floor stimulator
Indications for Use:
Indications For Use
-
- Urinary Incontinence : Stress, Urge and Mixed Incontinence
-
- Neuromuscular Reeducation
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use:
| (Per 21 CFR 801.109) | X | OR | Over-the-Counter Use: | |
|---|---|---|---|---|
| ------------------------------------------- | --- | ---- | ----------------------- | -- |
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
| 510(k) Number | X030039 |
|---|---|
| --------------- | --------- |