(86 days)
K930530/C
Not Found
No
The summary describes a system for biofeedback and electrical stimulation for pelvic floor therapy. It mentions data manipulation and presentation on a computer but does not include any terms or descriptions indicative of AI or ML algorithms being used for analysis, diagnosis, or treatment planning.
Yes.
The device is used for rehabilitation and treatment of medical conditions, specifically weak pelvic floor muscles and female urinary incontinence, which falls under the definition of a therapeutic device.
No
The device is described as providing biofeedback and electrical stimulation for rehabilitation and treatment, not for diagnosis. While biofeedback involves measuring physiological signals, its purpose here is therapeutic (rehabilitation and restoration of neuromuscular control), not to identify or characterize a disease.
No
The device description explicitly states the system includes an "instrumentation unit" which controls "patient treatment" actions, in addition to the desktop computer. This indicates the presence of hardware beyond just the computer.
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 intended to be used in vitro for the examination of specimens, including blood and tissue samples, derived from the human body, solely or principally for the purpose of providing information concerning a physiological or pathological state, or a congenital abnormality, or to determine the safety and compatibility with potential recipients, or to monitor therapeutic measures.
- Device Function: The InCare Pelvic Floor Therapy System with Desktop Computer is described as an office-based instrument that provides biofeedback (electromyographic or pressure) and electrical stimulation directly to the patient's pelvic musculature. It is used for rehabilitation and treatment of a physical condition (female urinary incontinence).
- No Specimen Examination: The device does not examine any specimens (blood, tissue, etc.) derived from the human body in vitro. It interacts directly with the patient's body.
Therefore, the function and intended use of this device clearly fall outside the scope of an In Vitro Diagnostic.
N/A
Intended Use / Indications for 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 female 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 female urinary incontinence.
Product codes (comma separated list FDA assigned to the subject device)
Not Found
Device Description
The InCare Pelvic Floor Therapy System with Desktop Computer is an office based instrument that is intended to be used by physicians, 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 female 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 female urinary incontinence.
The "nucleus" of the system is the combination of an instrumentation unit and a desktop computer. Other peripheral devices such as monitors and printers can be added for convenience or ease of use. There is a clear separation of functional control between the two elements of the system. Features or functions that are "data manipulation and presentation" activities are properly associated with the personal computer. Features and functions that are "patient treatment" actions are controlled by the Instrumentation Unit.
The desktop computer and Instrumentation Unit are physically separate devices "linked" to each other by a communication pathway.
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, 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.
K930530/C
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
AUG - 9 1996
InCare Pelvic Floor Therapy System with Desktop Computer
Safety and Effectiveness Summary
1. Submitter's name, Address and Contact Person
| Submitter | Contact Person |
|---|---|
| Hollister Incorporated | Joseph S. Tokarz |
| 2000 Hollister Drive | Manager, Regulatory Affairs |
| Libertyville, IL 60048 | Ph (847)680-2849 |
| Fax (847)918-3860 |
Fax --------------------------------------------------------------------------------------------------------------------------------------------------------------------------Date Summary Prepared - May 13, 1996
2. Name of Device:
InCare Pelvic Floor Therapy System with Desktop Computer
3. Name of Predicate Device(s)
Hollister PRS9300 Pelvic Floor Therapy System, K930530/C
4. Description of Device
The InCare Pelvic Floor Therapy System with Desktop Computer is an office based instrument that is intended to be used by physicians, 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 female 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 female urinary incontinence.
The "nucleus" of the system is the combination of an instrumentation unit and a desktop computer. Other peripheral devices such as monitors and printers can be added for convenience or ease of use. There is a clear separation of functional control between the two elements of the system. Features or functions that are "data manipulation and presentation" activities are properly associated with the personal computer. Features and functions that are "patient treatment" actions are controlled by the Instrumentation Unit.
The desktop computer and Instrumentation Unit are physically separate devices "linked" to each other by a communication pathway.
1
InCare Pelvic Floor Therapy System with Desktop Computer
5. Statement of 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 female 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 female urinary incontinence.
6. Statement of Technological Characteristics of the Device
· The InCare Pelvic Floor Therapy System with Desktop Computer and the InCare PRS9300 (K930530)C) are substantially equivalent based upon the following:
-
Intended Use of the two devices are identical.
-
The InCare Pelvic Floor Therapy System with Desktop Computer utilizes the exact same instrumentation unit as the predicate device (InCare PRS9300). The
Instrumentation Unit controls features and functions that are patient treatment actions. 3. The InCare Pelvic Floor Therapy System with Desktop Computer utilizes the same software that is used in the predicate device (InCare PRS9300) for the data manipulation and presentation activities associated with the personal computer and the patient therapy actions associated with the Instrumentation Unit.
- The InCare Pelvic Floor Therapy System with Desktop Computer differs from the predicate device (InCare PRS9300) in one aspect only. The proposed device utilizes a desktop personal computer whereas the predicate device utilizes a laptop personal computer. Because of this difference the communication pathway between the respective computers and the Instrumentation Unit is different.
A chart showing the differences and similarities of the InCare Pelvic Floor Therapy System with Desktop Computer and the predicate device follows on the next page:
2
InCare Pelvic Floor Therapy System with Desktop Computer
Comparison of the Technological Characteristics of the InCare Pelvic Floor Therapy of System with Desktop Computer and the Predicate Device Include Predicate Province of therapy
System with Desktop Computer and the Predicate Device InCare PRS9300 (K930530/c)
| Stimulation
Characteristics | Predicate device
PRS9300 - K930530/C | Proposed device
InCare Pelvic Floor Therapy
System w/ Desktop Computer |
|-----------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|
| Intended Use
Computer Type (see
Exhibit I, Section VI, page
29) | Treatment of Urinary Incontinence
Laptop Computer | Treatment of Urinary Incontinence
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 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
By Physician:
Pulse width, Frequency, Duty Cycle,
Session length | NONE BY PATIENT
By Physician:
Pulse width, Frequency, Duty Cycle,
Session length |
| Current Density
Conditions: Full output
setting, 100Hz, 1ms 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 |
| 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 | Engineering models of PRS9300 have
been tested and shown to comply with
EN 55011 and IEC 801-3 emissions
and immunity, respectively. | **See note on following page |
| Biofeedback
Characteristics | Predicate device
PRS9300 - K930530/C | Proposed device
InCare Pelvic Floor Therapy
System w/ Desktop Computer |
| 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 (seconds) | 1-80 in 1 second increments | 1-80 in 1 second increments |
| Rest Period (seconds) | 0-80 in 1 second increments | 0-80 in 1 second increments |
| Session Duration
(minutes) | 1-60 in 1 minute increments | 1-60 in 1 minute increments |
3
InCare Pelvic Floor Therapy System with Desktop Computer
**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.