INCARE PELVIC FLOOR THERAPY SYSTEM WITH DESKTOP COMPUTER
K961872 · Hollister, Inc. · KPI · Aug 9, 1996 · Gastroenterology, Urology
Device Facts
Record ID
K961872
Device Name
INCARE PELVIC FLOOR THERAPY SYSTEM WITH DESKTOP COMPUTER
Applicant
Hollister, Inc.
Product Code
KPI · Gastroenterology, Urology
Decision Date
Aug 9, 1996
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 876.5320
Device Class
Class 2
Attributes
Therapeutic
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.
Device Story
Office-based system for pelvic floor rehabilitation; utilizes instrumentation unit linked to desktop computer. Inputs: electromyographic (EMG) signals or pressure measurements from pelvic musculature. Transformation: instrumentation unit manages patient treatment (electrical stimulation/biofeedback); desktop computer handles data manipulation and presentation. Outputs: visual biofeedback and electrical stimulation (square, symmetrical, balanced, biphasic waveforms). Used in physician offices, clinics, or hospitals by physicians, nurses, or physiotherapists. Healthcare providers use output to monitor muscle activity and guide therapy sessions; electrical stimulation aids muscle rehabilitation. Benefits: restoration of neuromuscular control and treatment of female urinary incontinence.
Clinical Evidence
No clinical data provided; substantial equivalence is based on technological characteristics and bench testing comparisons to the predicate device.
Technological Characteristics
System consists of an instrumentation unit and a desktop computer. Stimulation: 0-30 VDC, square/symmetrical/balanced/biphasic waveforms, 12.5-100 Hz frequency. Biofeedback: 2-channel EMG (100-500 Hz bandwidth, RMS processing) or pressure sensing. Connectivity: communication pathway between instrumentation unit and desktop PC. Compliance: IEC 601-1, IEC 601-1-1, IEC 601-2-10, EN 60601-1-2, CISPR 11, IEC 801-2/3/4/5.
Indications for Use
Indicated for female patients with weak pelvic floor muscles requiring rehabilitation and restoration of neuromuscular control for the treatment of urinary incontinence.
Regulatory Classification
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).
Predicate Devices
Hollister PRS9300 Pelvic Floor Therapy System (K930530/C)
Submission Summary (Full Text)
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K961872
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
2000 Hollister Drive
Libertyville, IL 60048
Ph | Joseph S. Tokarz
Manager, Regulatory Affairs
(847)680-2849
Fax (847)918-3860 |
| 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, nurses, nurse clinicians, and physiotherapists in a physician's 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.
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K961872
# 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:
1. Intended Use of the two devices are identical.
2. 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.
4. 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:
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K961872
# InCare Pelvic Floor Therapy System with Desktop Computer
Comparison of the Technological Characteristics of the InCare Pelvic Floor 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 | Treatment of Urinary Incontinence | Treatment of Urinary Incontinence |
| Computer Type (see Exhibit I, Section VI, page 29) | Laptop 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 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, Frequency, Duty Cycle, Session length | 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 |
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K961872
# InCare Pelvic Floor Therapy System with Desktop Computer
| 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 |
**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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Two short videos show you everything — or skip straight to the written tutorial if you'd rather read. You can reopen this any time from the Tutorial button in the top bar.
Part 1 — Search, results, and everyday workflows 16 min
Part 2 — Embeddings: the galaxy map 3 min
1. Search: exact and fuzzy
Type a phrase like "coronary artery calcification" into the search box. You get two kinds of results. Exact results match the literal phrase — prefix searches work ("coronary artery calcificati") but suffix searches do not. Fuzzy results match on the meaning and intent of your phrase rather than the exact words, and are sorted by relevance score. Hover over the Exact or Fuzzy badge on any row to see exactly why it matched.
Use the checkboxes above the results to narrow: SaMD keeps only software-only devices, AI / ML keeps only devices with AI.
Exact vs. fuzzy search: what's the difference?
Exact matches on the literal phrase (prefix search works, suffix does not). Fuzzy matches on the meaning and intent of the phrase rather than the exact words. Hover over the badge on any row to see why it matched.
You search "coronary artery calcification" and want only software devices with AI. What two filters do you apply?
Narrow by SaMD (software-only devices), then narrow by AI/ML (devices with AI).
2. The results table
Scroll right in the results table. The intended use is extracted for you — no need to open the PDF. The device story gives a high-level snapshot of what the device does and how it's used. The AI Performance sub-table shows each output name, acceptance criteria, observed values, and development/test dataset descriptions — the same format Innolitics uses for regulatory strategy outputs, and the fastest high-level fingerprint of an AI device. It is AI-generated but has been very reliable in practice.
Where do you find a device's intended use without opening the PDF?
Scroll right in the search results table. The intended use column is extracted for you; no need to dig into the 510(k) summary PDF.
What does the AI Performance sub-table show, and why is it useful?
Output name, acceptance criteria, observed values, development dataset description, and test dataset description. It's the same format we use for regulatory strategy output and Fast 510(k) input, and the fastest high-level fingerprint of an AI device. AI-generated but reliable in practice.
3. Judging fuzzy relevance
Fuzzy results trail off in relevance as you scroll. Use three signals to decide how far down to go: the fuzzy badge explanations, the intended use column, and whether your target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, you're past the relevant zone. A top hit with a low score (~0.4) and a stretched explanation is a hint the closest predicates are far away — the project may be headed for De Novo. Note the fuzzy search is a pattern match: it doesn't handle negation ("not") well, and hardware devices can appear — filter by SaMD/AI ML to cut them.
How do you judge how far down fuzzy search results to go?
Use the relevancy signals: the fuzzy badge explanations, the intended use column, and whether the target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, results are trailing off in relevancy.
4. Device detail page: chat and citations
Click a device name to open its detail page: device facts on the left, a chat window on the right. Ask something like "Describe the training data". The answer carries little citation bubbles — click one to jump to the highlighted passage in the source PDF, so you can verify every AI answer against the document. There's also a Download PDF button for sharing.
How do you verify an AI chat answer on the device detail page?
Click the citation bubbles to jump to the relevant highlight in the source document.
Reading rule for every project: how many summaries do you read in full?
At least the three most relevant 510(k) or De Novo summaries, in full. After that, use targeted chat questions to confirm your memory quickly. The tool supports this professional habit — it doesn't replace it.
5. Side-by-side comparison
Select multiple rows in the results table (aim for under ~10), then open the PDF Viewer tab. Ask one question — it goes to all selected devices in parallel, each with citations. This is the fastest way to compare and contrast devices: training data, PCCP scope, how they handled adding new scanners, and so on.
What does the side-by-side PDF viewer mode do?
Select multiple devices, open the PDF viewer tab, and ask one question (e.g., "Describe the training data"). It queries all selected devices simultaneously with citations, so you can compare and contrast quickly.
6. Collections
With rows selected, go to the Collections tab and create a labeled collection (e.g., "Cobb Angle Project"). Reload that selection any time — before a client call, pull up the collection and ask questions across all of its devices at once.
How do you save a set of selected devices for later use?
Select the rows, go to the Collections tab, and create a labeled collection (e.g., "Cobb Angle Project"). You can reload the selection anytime and carry it into the PDF viewer and other tabs that support selections.
7. Product codes and the regulations tree
Click a product code in the results to jump to it in the regulations tree — identification text, sibling product codes, and devices you can open in a PDF viewer on the right. Click a regulation number to see its identification, special controls, and related product codes. You can also search by product code or regulation number at the top of the tree. Always read the special controls if any exist for your device — it broadens your search and sharpens pre-kickoff research.
What can you do from the regulations tree view?
Browse product codes and regulation numbers, read the identification text and special controls, browse sibling product codes, open device PDFs on the right, and search by product code or regulation number at the top of the tree.
8. Chart view
Click Show Chart and segment by regulation number (or product code) to see which regulations dominate your result set. Clicking a regulation takes you into the regulations tree. Great for spotting that most matches are, say, hardware laparoscopic devices — a cue to go back and filter.
How do you see which regulations dominate a search result set?
Click "Show Chart" and segment by Regulation Number. Clicking a regulation takes you to the regulations tree.
9. The predicate graph
Open the Predicates tab for a family-tree view of predicate relationships. Click a node to trace its parents and children; selections from search carry over pre-selected. Commonly predicated devices are worth reading — a lot of people predicated them for a reason. The visual lineage is also handy on client calls, e.g. to show how a predicate family evolved and justify why your predicate still holds.
In the predicate graph, why are commonly predicated devices worth reading?
A lot of people predicated them for a reason. Clicking a node traces parents and children, and selections from search carry over pre-selected.
10. Embeddings: the galaxy map
The Embeddings tab plots every matching document in a 2-D "galaxy map" where semantically similar devices cluster together. Hover or click clusters to explore, and let AI label the clusters for you. Embeddings beat product codes for grouping: two devices can carry different product codes (LLZ vs. QIH) yet do the same thing — the embedding captures the meaning of the intended use and device story. This is also exactly how retrieval-augmented generation (RAG) works under the hood, and it makes a great visual on client calls.
Try it yourself
Head to the search page and work through a few of these AI/ML fuzzy searches to build intuition: perivascular fat on CT · aortic valve calcification opportunistic screening on noncontrast CT · breast cancer prediction on digital pathology slides · autism detection · gestational age prediction · a hearing aid that can also detect a pulse · foundation model based analysis of ECG · large language models · penetration test. Watch how the relevance scores, intended use, and AI Performance tables tell you when results stop being meaningful.
