K Number

Device Name

INCARE PELVIC FLOOR THERAPY SYSTEM WITH DESKTOP COMPUTER

Manufacturer

HOLLISTER, INC.

Date Cleared

1997-12-23

(60 days)

Product Code

KPI

Regulation Number

876.5320

Intended Use

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.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K961872

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a biofeedback and electrical stimulation device for pelvic floor therapy. There is no mention of AI, ML, or any related technologies in the intended use, device description, or other sections. The submission is focused on adding an electrical stimulation parameter.

Therapeutic

Yes
The device is described as providing biofeedback and electrical stimulation for the rehabilitation of weak pelvic floor muscles and the treatment of urinary incontinence, which are therapeutic purposes.

Diagnostic

The device is intended for rehabilitation and treatment (biofeedback and electrical stimulation) of weak pelvic floor muscles, not for diagnosing a condition.

SaMD (Software as a Medical Device)

The device description explicitly states it is an "office based instrument" and provides both biofeedback and electrical stimulation capabilities, indicating the presence of hardware components beyond just software.

IVD (In Vitro Diagnostic)

Based on the provided text, 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 InCare Pelvic Floor Therapy System with Desktop Computer is described as providing biofeedback (electromyographic or pressure) and electrical stimulation directly to the pelvic musculature. It is used for rehabilitation and treatment of urinary incontinence.
Lack of Sample Analysis: The description does not mention the analysis of any samples taken from the body. The device interacts directly with the patient's body.

Therefore, the device falls under the category of a therapeutic or rehabilitative medical device, not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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.

Product codes (comma separated list FDA assigned to the subject device)

78 KPI, 85 HIR

Device Description

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

pelvic musculature, pelvic floor muscles

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Physicians, nurses, nurse clinicians, and physiotherapists in a physicians office, clinic, or hospital.

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)

Not Found

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.

K961872

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

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).

Summary

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

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 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	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 Density
Conditions: Full output setting, 100Hz,
Ims pulse width at 500 ohms (nominal)	Probe 9595 - 0.003 amperes/cm²
Probe 9596 - 0.018 amperes/cm²	Probe 9595 - 0.003 amperes/cm²
Probe 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:

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 Density
Conditions: Full output setting, 100Hz,
1ms pulse width at 500 ohms (nominal)	Probe 9595 - 0.047 watts/cm²
Probe 9596 - 0.239 watts/cm²	Probe 9595 - 0.047 watts/cm²
Probe 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, 2
channels pressure, or combination
EMG and pressure	Adjustable, 2 channels EMG, 2
channels pressure, or combination
EMG 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.

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

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

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