K113771 · Neurovision Medical Products, Inc. · FAP · Dec 13, 2012 · Gastroenterology, Urology
Device Facts
Record ID
K113771
Device Name
SIGNAL GEAR URETHRAL CATHETER ELECTRODE
Applicant
Neurovision Medical Products, Inc.
Product Code
FAP · Gastroenterology, Urology
Decision Date
Dec 13, 2012
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 876.1620
Device Class
Class 2
Attributes
Pediatric
Indications for Use
The Signal Gear Urethral Catheter Electrode is intended for mucosal surface stimulation/recording from the external urinary sphincter for use in conjunction with urodynamic evaluation of the patient.
Device Story
Signal Gear Urethral Catheter Electrode is a single-use, disposable, sterile accessory for urethral (Foley) catheters. Device consists of a flexible polyurethane film substrate with printed silver conductive traces and gold-ink contact surfaces. It wraps around a standard urethral catheter; when inserted, the two electrical contacts interface with the mucosal lining of the external urinary sphincter. Lead wires terminate in a safety connector for attachment to external electrodiagnostic equipment. Operated by clinicians during urodynamic evaluations to facilitate nerve stimulation and muscle signal recording. Provides diagnostic data to healthcare providers to assist in assessing sphincter function. Benefits include localized, non-invasive surface monitoring/stimulation during urological procedures.
Clinical Evidence
No clinical data. Evidence is based on bench testing, including manufacturing/packaging inspection, electrical continuity, lead wire pull testing, biocompatibility (ISO 10993-5, ISO 10993-10), accelerated aging (ASTM F1980-07), packaging validation (ISO 868-5, 11607-1, DIN 58953-6), and sterility/bioburden testing (ISO 11737-1, 11737-2).
Technological Characteristics
Flexible polyurethane film substrate; silver conductive ink traces with gold-ink contact surfaces. Attaches via adhesive wrap to urethral (Foley) catheter. Single-use, disposable. Biocompatibility per ISO 10993-5/10; accelerated aging per ASTM F1980-07; sterility per ISO 11737-1/2. Passive electrode; no internal energy source; connects to external electrodiagnostic equipment via safety connector.
Indications for Use
Indicated for adults and pediatric patients ages 2 and older undergoing urodynamic evaluation requiring mucosal surface stimulation or recording from the external urinary sphincter.
Regulatory Classification
Identification
A urodynamics measurement system is a device used to measure volume and pressure in the urinary bladder when it is filled through a catheter with carbon dioxide or water. The device controls the supply of carbon dioxide or water and may also record the electrical activity of the muscles associated with urination. The device system may include transducers, electronic signal conditioning and display equipment, a catheter withdrawal device to enable a urethral pressure profile to be obtained, and special catheters for urethral profilometry and electrodes for electromyography. This generic type of device includes the cystometric gas (carbon dioxide) device, the cystometric hydrualic device, and the electrical recording cystometer, but excludes any device that uses air to fill the bladder.
Special Controls
*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 876.9.
Predicate Devices
Dantec Electronic, Inc. St. Mark's Pudendal Electrode (K874758)
Submission Summary (Full Text)
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K113771
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Image /page/0/Picture/1 description: The image shows the logo for Neurovision Medical. The word "neurovision" is in large, bold, black letters. Below it, there are two horizontal lines with a small EKG waveform in between, followed by the word "MEDICAL" in smaller, bold, black letters.
Traditional 510k -Signal gear Signal Gear Urethral Catheter Electrode
#### 5. 510(k) Summary
In accordance with Title 21 of the Code of Federal Regulations, Part 807 and in particular 21 CFR §807.92, the following summary of information is provided:
#### Applicant Information
Christine Vergely Neurovision Medical Products Inc. 2225 Sperry Ave., Suite 1000 Ventura, CA 93003 Telephone Number: 866-815-6999 Fax: 413-410-4579 Email Address: christie@neurovisionmedical.com
#### Device Identification
Trade or Proprietary Name: Signal Gear Urethral Catheter Electrode Device classification: 21 CFR 876.1620, Urodynamics Measurement System Device class: Class II Product code: FAP
#### Predicate Devices
The Signal Gear Urethral Catheter Electrode is substantially equivalent to the following predicate device previously distributed commercially in the U. S .:
- K874758 Dantec Electronic, Inc. St. Mark's Pudendal Electrode .
#### Device Description
The Signal Gear Urethral Catheter Electrode is a single patient use, disposable sterile device. It consists of an adhesive, highly flexible, polyurethane film substrate that wraps around the urethral (Foley) catheter. The conductive portion of the electrode is printed onto the polyurethane film substrate in a pattern that, when the electrode is wrapped around the catheter, leaves two conductive contact surfaces forming the two electrical contacts of the electrode. The remainder of the conductive pattern is overwrapped by an additional layer of polyurethane film during manufacture in order to insulate the traces. The conductive ink used is silver, with the exception of the two electrical contacts of the electrode, which have an additional printed layer of gold ink.
Lead wires are attached that terminate in a safety connector that cannot be connected to an AC power outlet. The Electrode connects to the user's electrodiagnostic equipment. The electrode is to be used under the supervision of a physician. When the urethral catheter with the applied electrode is inserted in the human urethra, the exposed two electrical contacts of the electrode contact the mucosal lining of the urethra in the location of the external urinary sphincter muscle, and the end of the electrode with leadwire attachments are outside of the urethral meatus.
#### Intended Use
The Signal Gear Urethral Catheter Electrode is intended for mucosal surface stimulation/recording from the external urinary sphincter for use in conjunction with urodynamic evaluation of the patient.
DEC 1 3 2012
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Image /page/1/Picture/1 description: The image shows the logo for Neurovision Medical. The word "neurovision" is in large, bold, black letters. Below the word "neurovision" is a black line with a small EKG waveform in the middle, followed by the word "MEDICAL" in smaller, black letters.
atheter Electrode Traditional 510k -Signal gear Signal Gear Urethral
This device is indicated for use in adults, as well as in pediatric patients ages 2 and older.
#### Technological Characteristics of Device in Relation to Predicate Devices
The Signal Gear Urethral Catheter Electrode is an attachment electrode designed to attach to a urethral (Foley) catheter. It is a printed electrode on a flexible base designed for surface stimulation of and surface recording from physiologic tissue adjacent to the urethra such as the external urinary sphincter muscle. It is self adhesive and is attached during manufacture by wrapping around a urethral (Foley) catheter. It is disposable for single use.
The predicate Dantec 13L40 St Mark's Pudendal Electrode is an attachment electrode, printed on a flexible base designed to stimulate the pudendal nerve and to record from the anal sphincter muscle. It is self adhesive and attaches by wrapping around the finger of a surgical glove. It is disposable for single use.
The technological characteristics of the Signal Gear Urethral Catheter Electrode are substantially equivalent to the predicate device. No new questions of safety or effectiveness are raised.
#### Summary of Non-Clinical Testing in Support of Substantial Equivalence
Nonclinical testing included inspection for defects in manufacturing, workmanship and packaging, electrical continuity testing and lead wire pull testing.
Biocompatibility was tested according to ISO 10993-5:2009 Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicity and ISO 10993-10:2010 Biological evaluation of medical devices Part 10: Tests for irritation and delayed-type Hypersensitivity.
Accelerated aging was conducted according to ASTM F1980-07.
Packaging validation tests were conducted according to the methods described in Standards UNI EN ISO 868-5 and 11607-1 and European Standard DIN 58953-6.
The bioburden and sterility tests were conducted according to the methods described in Standards UNI EN ISO 11737-1 and 11737-2.
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### DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three lines forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular fashion around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 13, 2012
Neurovision Medical Products, Inc. % Ms. Christine Vergély Regulatory Manager 2225 Sperry Avenue, Suite 1000 VENTURA CA 93003
Re: K113771
> Trade/Device Name: Signal Gear Urethral Catheter Electrode Regulation Number: 21 CFR 876.1620 Regulation Name: Urodynamics measurement system Regulatory Class: II Product Code: FAP Dated: November 29, 2012 Received: November 29, 2012
Dear Ms. Vergély:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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
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Page 2 – Ms. Christine Vergély
(21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please i go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
# Herbert R. Lerner
for
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/4/Picture/0 description: The image shows the logo for Neurovision Medical. The word "neurovision" is written in bold, black letters. Below the word, there are two horizontal lines with a small graphic between them, and the word "MEDICAL" is written in smaller, black letters to the right of the graphic.
Traditional 510k -Signal gear Signa r Electrode
## Indications for Use
510(k) Number: K113771 (Urethral Surface Electrode)
Device Name: Signal Gear Urethral Catheter Electrode
Indications for Use:
The Signal Gear Urethral Catheter Electrode is intended for mucosal surface stimulation/recording from the external urinary sphincter for use in conjunction with urodynamic evaluation of the patient.
This device is indicated for use in adults, as well as in pediatric patients ages 2 and older.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
**Herbert P. Lerner**
(Division Sign-On)
Division of Reproductive, Gastro-Renal, and
Urological Devices
510(k) Number K113771
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.
