(357 days)
No
The device description and performance studies focus on the physical and electrical properties of the electrode, with no mention of data processing, algorithms, or learning capabilities.
No
The device is intended for "mucosal surface stimulation/recording from the external urinary sphincter for use in conjunction with urodynamic evaluation of the patient," which is for diagnostic purposes, not therapeutic.
Yes
The device is intended for "mucosal surface stimulation/recording from the external urinary sphincter for use in conjunction with urodynamic evaluation of the patient," and "Connects to the user's electrodiagnostic equipment." This indicates its role in gathering information for diagnosis.
No
The device description clearly details physical components such as a polyurethane film substrate, conductive ink (silver and gold), lead wires, and a safety connector, indicating it is a hardware device.
Based on the provided information, 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. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The Signal Gear Urethral Catheter Electrode is a device that is inserted into the body (in vivo) to directly stimulate and record electrical signals from the external urinary sphincter. It is used in conjunction with urodynamic evaluation, which is a procedure performed on the patient's body.
- Lack of Sample Analysis: The device does not analyze a sample taken from the patient. It interacts directly with the patient's tissue.
Therefore, the function and intended use of this device clearly fall outside the scope of in vitro diagnostics.
N/A
Intended Use / 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.
Product codes
FAP
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Urethra, external urinary sphincter
Indicated Patient Age Range
adults, as well as in pediatric patients ages 2 and older.
Intended User / Care Setting
used under the supervision of a physician
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.1620 Urodynamics measurement system.
(a)
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.(b)
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.
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PAGE 1 OF 2
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.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
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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
3
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