The biofeedback components of the InCare Pelvic Floor Therapy System with Desktop Computer are intended to provide electromyographic or pressure biofeedback from pelvic musculature for the purpose of rehabilitation of weak pelvic floor muscles and restoration of neuromuscular control for the treatment of urinary incontinence.

The electrical stimulation component of the InCare Pelvic Floor Therapy System with Desktop Computer provides stimulation capabilities for the purpose of rehabilitation of weak pelvic floor muscles for the treatment of urinary incontinence.

Device Description

The InCare Pelvic Floor Therapy System with Desktop Computer is an office based instrument that is intended to be used by physicians, nurses, nurse clinicians, and physiotherapists in a physicians office, clinic, or hospital for the purpose of providing electromyographic or pressure biofeedback from pelvic musculature for the purpose of rehabilitation of weak pelvic floor muscles and restoration of neuromuscular control for the treatment of urinary incontinence. The InCare Pelvic Floor Therapy System also provides electrical stimulation capabilities for the purpose of rehabilitation of weak pelvic floor muscles for the treatment of urinary incontinence.

The premarket notification is being submitted to the Agency to include the electrical stimulation parameter of 200 Hz to the existing InCare Pelvic Floor Therapy System with Desktop Computer, K961872.

AI/ML Overview

The provided text is a 510(k) premarket notification for the InCare Pelvic Floor Therapy System with Desktop Computer. It focuses on demonstrating substantial equivalence to a predicate device (Hollister PRS9300 Pelvic Floor Therapy System, K961872), primarily due to the addition of a 200 Hz electrical stimulation parameter.

This type of submission does not typically include detailed acceptance criteria in the sense of performance metrics (like sensitivity, specificity, accuracy) derived from a clinical study, nor does it present the results of such a study with sample sizes, ground truth establishment, or expert adjudication. Instead, the acceptance criteria are met by demonstrating that the new device's technological characteristics are substantially equivalent to a legally marketed predicate device, and that this new parameter does not raise new questions of safety or effectiveness.

Therefore, many of the requested fields cannot be directly extracted from this document as the safety and effectiveness summary relies on substantial equivalence to a predicate device rather than a new clinical performance study with specific acceptance criteria that would be typical for a novel device or a device with new indications.

However, I can extract information related to the device characteristics that are presented to support the claim of substantial equivalence.

1. A table of acceptance criteria and the reported device performance

Since this is a substantial equivalence claim, the "acceptance criteria" are implicitly that the proposed device's characteristics must be comparable to the predicate device, or any differences must not raise new questions of safety or effectiveness. The "reported device performance" is essentially the detailed specifications of the proposed device, shown in comparison to the predicate device.

Characteristic	Acceptance Criteria (Predicate Device K961872)	Reported Device Performance (Proposed Device)
Stimulation Characteristics
Intended Use	Treatment of Urinary Incontinence	Treatment of Urinary Incontinence
Computer Type	Desktop Computer	Desktop Computer
Output (nominal)	0-30 VDC	0-30 VDC
Waveform	Square, Symmetrical, Balanced, Biphasic	Square, Symmetrical, Balanced, Biphasic
Charge/pulse at 500Ω	60 µC/phase; net charge/pulse = 0	60 µC/phase; net charge/pulse = 0
Frequency	12.5, 20, 50, 100 Hz	12.5, 20, 50, 100, 200 Hz (This is the difference)
Peak Pulse Intensity	30 VDC	30 VDC
Pulse width	0.3, 1 ms	0.3, 1 ms
Ramps	20%, 40%, 60%, 80%, 100% of “ON” time (no down ramping)	20%, 40%, 60%, 80%, 100% of “ON” time (no down ramping)
Duty Cycle	On (sec): 1-80 in 1 sec increments; Off (sec): 0 - 80 in 1 sec increments	On (sec): 1-80 in 1 sec increments; Off (sec): 0 - 80 in 1 sec increments
Session Duration (min)	0-30, 1 minute increments	0-30, 1 minute increments
Programmable Features	By physician: Pulse width, Frequency, Duty cycle, Session length (none by patient)	By physician: Pulse width, Frequency, Duty cycle, Session length (none by patient)
Current Density (Probe 9595)	0.003 amperes/cm²	0.003 amperes/cm²
Current Density (Probe 9596)	0.018 amperes/cm²	0.018 amperes/cm²
Power Density (Probe 9595)	0.047 watts/cm²	0.047 watts/cm²
Power Density (Probe 9596)	0.239 watts/cm²	0.239 watts/cm²
EMI	Meets IEC 601-1, IEC 601-1-1, IEC 601-2-10 (except Para 36), EN 60601-1-2/IEC 601-1-2, EN 55011/CISPR 11, EN60801-2/IEC 801-2, IEC 801-3, IEC 801-4, IEC 801-5	Meets IEC 601-1, IEC 601-1-1, IEC 601-2-10 (except Para 36), EN 60601-1-2/IEC 601-1-2, EN 55011/CISPR 11, EN60801-2/IEC 801-2, IEC 801-3, IEC 801-4, IEC 801-5
Biofeedback Characteristics
Intended Use	Treatment of Urinary Incontinence	Treatment of Urinary Incontinence
Measurement Channels	Adjustable, 2 channels EMG, 2 channels pressure, or combination	Adjustable, 2 channels EMG, 2 channels pressure, or combination
EMG Sensitivity (microvolts)	0-5, 0-10, 0-25, 0-50, 0-100, 0-250, 0-500	0-5, 0-10, 0-25, 0-50, 0-100, 0-250, 0-500
EMG Bandwidth	100-500 Hz	100-500 Hz
EMG Signal Processing	Root Mean Squared (RMS)	Root Mean Squared (RMS)
EMG Detection	Bipolar	Bipolar
Pressure Sensitivity (cm-H2O)	0-10, 0-25, 0-50, 0-100	0-10, 0-25, 0-50, 0-100
Work Period (sec)	1-80 in 1 second increments	1-80 in 1 second increments
Rest Period (sec)	0-80 in 1 second increments	0-80 in 1 second increments
Session Duration (min)	1-60 in 1 minute increments	1-60 in 1 minute increments

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. This is a substantial equivalence submission based on device specifications comparison, not a clinical study with a test set of data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. No ground truth was established by experts for a test set in this submission.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No test set adjudication method described as no clinical performance study was conducted.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is not an AI-assisted device, and no MRMC study was conducted or described.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a medical device for treatment/biofeedback, not an algorithm being evaluated for standalone performance.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable. As noted, this submission is driven by substantial equivalence to a predicate device based on technical specifications rather than a clinical study requiring ground truth derived from expert consensus, pathology, or outcomes data. The "ground truth" for this application is the established safety and effectiveness of the predicate device and the demonstration that the new device remains within those bounds.

8. The sample size for the training set

Not applicable. This submission doesn't involve machine learning or a training set.

9. How the ground truth for the training set was established

Not applicable. This submission doesn't involve machine learning or a training set.

Summary

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Image /page/0/Picture/0 description: The image shows the Hollister logo. The logo consists of a geometric symbol resembling a stylized cross or asterisk, followed by the word "Hollister" in a serif typeface. The symbol is composed of intersecting bars, creating a symmetrical design with a central void. The text is positioned to the right of the symbol, with the letters evenly spaced and clearly legible.

DFC 2 3 1997

Hollister Incorporated 2000 Hollister Drive Libertyville, Illinois 60048-3781

P1073

InCare Pelvic Floor Therapy System with Desktop Computer

Safety and Effectiveness 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 - October 21, 1997

2. Name of Device:

InCare Pelvic Floor Therapy System with Desktop Computer

3. Name of Predicate Device(s)

Hollister PRS9300 Pelvic Floor Therapy System, K961872

4. Description of Device

5. Statement of Intended Use

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K974048
P293

Image /page/1/Picture/1 description: The image shows a black geometric symbol. The symbol is composed of four thick, rectangular bars arranged in a cross-like formation. The bars intersect at their midpoints, creating a square-shaped void in the center of the symbol. The overall design is symmetrical and bold, with a small imperfection visible on the upper left corner of the symbol.

Hollister.

InCare Pelvic Floor Therapy System with Desktop Computer

6. Statement of Technological Characteristics of the Device

· The proposed device and the predicate device, K961872 are substantially equivalent based upon the following:

1. Intended Use of the two devices are identical.

The proposed device and the predicate device, K961872 utilizes the exact same instrumentation unit. The Instrumentation Unit controls features and functions that are "patient treatment actions."
The proposed device and the predicate device, K961872 utilizes the same software for the "data manipulation and presentation" activities associated with the personal computer and the "patient therapy" actions associated with the Instrumentation Unit.
The proposed device differs from the predicate device, K961872 in one aspect only. The proposed device has the additional stimulation parameter of 200 Hz.

	Proposed Device	Predicate Device K961872
Stimulation Characteristics
Intended Use	Treatment of Urinary Incontinence	Treatment of Urinary Incontinence
Computer Type	Desktop Computer	Desktop Computer
Output (nominal)	0-30 VDC	0-30 VDC
Waveform	Square, Symmetrical, Balanced,Biphasic	Square, Symmetrical, Balanced,Biphasic
charge/pulse at 500Ω	60 µC/phase; net charge/pulse = 0	60 µC/phase; net charge/pulse = 0
Frequency	12.5, 20, 50, 100, 200 Hz	12.5, 20, 50, 100 Hz
Peak Pulse Intensity	30 VDC	30 VDC
Pulse width	0.3, 1 ms	0.3, 1 ms
Ramps	20%, 40%, 60%, 80%, 100%of “ON” time (no down ramping)	20%, 40%, 60%, 80%, 100%of “ON” time (no down ramping)
Duty Cycle	On (sec): 1-80 in 1 sec incrementsOff (sec): 0 - 80 in 1 secincrements	On (sec): 1-80 in 1 sec incrementsOff (sec): 0 - 80 in 1 secincrements
Session Duration (min)	0-30, 1 minute increments	0-30, 1 minute increments
Programmable Features	NONE BY PATIENT	NONE BY PATIENT
	By physician: Pulse width, Freq-uency, Duty cycle, Session length	By physician: Pulse width, Freq-uency, Duty cycle, Session length
Current DensityConditions: Full output setting, 100Hz,Ims pulse width at 500 ohms (nominal)	Probe 9595 - 0.003 amperes/cm²Probe 9596 - 0.018 amperes/cm²	Probe 9595 - 0.003 amperes/cm²Probe 9596 - 0.018 amperes/cm²

· A chart showing the differences and similarities of the InCare Pelvic Floor Therapy System with Desktop Computer and the predicate device follows:

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Image /page/2/Picture/0 description: The image shows the Hollister brand logo. On the left is a black geometric design that resembles a stylized cross or snowflake. To the right of the design is the word "Hollister" in a serif font, with a trademark symbol next to it.

K974048

f3093

InCare Pelvic Floor Therapy System with Desktop Computer

	Proposed Device	Predicate Device K961872
Power DensityConditions: Full output setting, 100Hz,1ms pulse width at 500 ohms (nominal)	Probe 9595 - 0.047 watts/cm²Probe 9596 - 0.239 watts/cm²	Probe 9595 - 0.047 watts/cm²Probe 9596 - 0.239 watts/cm²
EMI	**See Note below	**See Note below
Biofeedback Characteristics
Intended Use	Treatment of Urinary Incontinence	Treatment of Urinary Incontinence
Measurement Channels	Adjustable, 2 channels EMG, 2channels pressure, or combinationEMG and pressure	Adjustable, 2 channels EMG, 2channels pressure, or combinationEMG and pressure
EMG Sensitivity (microvolts)	0-5, 0-10, 0-25, 0-50, 0-100, 0-250, 0-500	0-5, 0-10, 0-25, 0-50, 0-100, 0-250, 0-500
EMG Bandwidth	100-500 Hz	100-500 Hz
EMG Signal Processing	Root Mean Squared (RMS)	Root Mean Squared (RMS)
EMG Detection	Bipolar	Bipolar
Pressure Sensitivity (cm-H2O)	0-10, 0-25, 0-50, 0-100	0-10, 0-25, 0-50, 0-100
Work Period (sec)	1-80 in 1 second increments	1-80 in 1 second increments
Rest Period (sec)	0-80 in 1 second increments	0-80 in 1 second increments
Session Duration (min)	1-60 in 1 minute increments	1-60 in 1 minute increments

**NOTE

IEC 601-1 (except Amendment 2:1995, new subclause 56.3c) IEC 601-1-1 IEC 601-2-10 (except Paragraph 36) EN 60601-1-2/IEC 601-1-2 EN 55011/CISPR 11 EN60801-2/IEC 801-2, 3kv contact, 8kv air IEC 801-3, 3v/m, 1 khz IEC 801-4, 1kv IEC 801-5, 1kv

7. Conclusion

Based upon the information presented above it is concluded that the proposed InCare Pelvic Floor Therapy System with Desktop Computer is safe and effective for its intended use and is substantially equivalent to the predicate device.

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Image /page/3/Picture/0 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's emblem, which is a stylized representation of a human figure embracing a bird. The emblem is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA". The text is arranged in a circular fashion around the emblem.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 2 3 1997

Mr. Joseph S. Tokarz Manager, Regulatory Affairs Hollister Incorporated 2000 Hollister Drive Libertyville, IL 60048

Re: K974048

InCare Pelvic Floor Therapy System with Desktop Computer Dated: October 21, 1997 Received: October 24, 1997 Regulatory class: II 21 CFR §876.5320/Product code 78 KPI 21 CFR §884.1425/Product code 85 HIR

Dear Mr. Tokarz:

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, 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 (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 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 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 yours,

W.Liau Yu

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

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InCare Pelvic Floor Therapy System with Desktop Computer

Statement of Intended Use

510(k) Number (if Known):
Device Name:	InCare Pelvic Floor Therapy System with Desktop Computer

Indications For Use:

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use	V
(Per 21 CFR 801.109)

Over-

Over-the-Counter-Use _________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number	K974048

Page 5

Regulation Number and Section

§ 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).