(224 days)
Not Found
No
The description focuses on electrical stimulation parameters and clinical study results, with no mention of AI/ML terms or functionalities.
No
The device is used to locate and identify nerves during surgery and test their excitability, but it does not provide therapy itself.
Yes
The device is used to locate and identify nerves and test their excitability, and to stimulate cavernosal nerves to elicit a measurable response. These are diagnostic functions in a surgical setting.
No
The device description explicitly states it is an "electrical Nerve Stimulator" and provides details about the electrical output (current, pulse width, frequency), indicating it is a hardware device that delivers electrical stimulation.
Based on the provided information, the Urovations Nerve Stimulator is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body ("in vitro").
- Urovations Nerve Stimulator Function: The Urovations Nerve Stimulator is used directly on the body during surgery to locate and stimulate nerves. It does not analyze samples taken from the body.
Therefore, the Urovations Nerve Stimulator falls under the category of a medical device used for direct intervention and assessment in vivo, not an IVD.
N/A
Intended Use / Indications for Use
The Urovations Nerve Stimulator is intended to provide electrical stimulation to the body to locate and identify nerves and to test their excitability.
The Urovations Nerve Stimulator is indicated for use in the stimulation of the cavernosal nerves during open prostatectomy (surgical) procedures, aiding the surgeon in locating these nerves. The device is designed as an adjunct to current open prostatectomy procedures in which a nerve sparing technique is used. The Nerve Stimulator is not designed to replace the surgeon's expertise in mapping out the vascular bundles. Each surgeon's skill determines whether these nerves are spared regardless of any aid.
Product codes (comma separated list FDA assigned to the subject device)
77 ETN, 78 FGM
Device Description
The Urovations Nerve Stimulator is a electrical Nerve Stimulator designed for use during open prostatectomy (surgical) procedures. The stimulator provides a biphasic current pulse with variable amplitude between 1 - 20mA, a constant pulse width of 800usec/phase, and a constant frequency of 16Hz. The stimulation is applied to the body by the surgeon in order to locate and test the excitability of the cavernosal nerves.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cavernosal nerves
Indicated Patient Age Range
Not Found
Intended User / Care Setting
surgeon / open prostatectomy (surgical) procedures
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)
Pre-clinical and Clinical Testing:
A variety of physical tests were conducted on the Urovations Nerve Stimulator to characterize its physical properties, safety margins, and failure modes, as part of a failure modes and effects analysis. In addition, extensive biocompatibility testing was conducted on the materials which will have human contact to demonstrate that the materials are biocompatible, suitable and safe for their intended use.
A clinical study was conducted to determine if the Urovations Nerve Stimulator provides electrical stimulation to the cavernosal nerves during radical prostatectomy procedures. The results of the study indicate the Urovations Nerve Stimulator provides an electrical charge to stimulate the cavernosal nerves and elicits a visible and measurable response in tumescence. No reported adverse events were associated with device use.
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.
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
§ 874.1820 Surgical nerve stimulator/locator.
(a)
Identification. A surgical nerve stimulator/locator is a device that is intended to provide electrical stimulation to the body to locate and identify nerves and to test their excitability.(b)
Classification. Class II.
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A o T
142
510(k) Summary of Safety and Effectiveness Urovations Nerve Stimulator
OCT 27 1997
Company Name
Urovations Inc. 64 A Street Needham, MA 02194
Official Contact
Frederick Tobia Director, Clinical and Regulatory Affairs
Device Name
| Proprietary Name: | Urovations Nerve Stimulator |
|---|---|
| Common Name: | Nerve Stimulator/Locator |
| Classification Name(s): | 21 CFR § 874.1820 Surgical Nerve Stimulator/Locator |
Predicate Devices used for Substantial Equivalence
Grass Nerve Stimulator K844216 Brown Nocturnal Penile Tumescence Monitor K830221
Intended Use
The Urovations Nerve Stimulator is intended to provide electrical stimulation to the body to locate and identify nerves and to test their excitability.
Indications for Use
The Urovations Nerve Stimulator is indicated for use in the stimulation of the cavernosal nerves during open prostatectomy (surgical) procedures, aiding the surgeon in locating these nerves. The device is designed as an adjunct to current open prostatectomy procedures in which a nerve sparing technique is used. The Nerve Stimulator is not designed to replace the surgeon's expertise in mapping out the vascular bundles. Each surgeon's skill determines whether these nerves are spared regardless of any aid.
1
Description
The Urovations Nerve Stimulator is a electrical Nerve Stimulator designed for use during open prostatectomy (surgical) procedures. The stimulator provides a biphasic current pulse with variable amplitude between 1 - 20mA, a constant pulse width of 800usec/phase, and a constant frequency of 16Hz. The stimulation is applied to the body by the surgeon in order to locate and test the excitability of the cavernosal nerves.
Summary of Standards Achieved
The Urovations Nerve Stimulator meets UL-544 specifications for electronic medical devices, conforms to AAMI ES1-1993 Safe Current Limits, and meets IEC-601 standards for electronic medical devices.
Pre-clinical and Clinical Testing
A variety of physical tests were conducted on the Urovations Nerve Stimulator to characterize its physical properties, safety margins, and failure modes, as part of a failure modes and effects analysis. In addition, extensive biocompatibility testing was conducted on the materials which will have human contact to demonstrate that the materials are biocompatible, suitable and safe for their intended use.
A clinical study was conducted to determine if the Urovations Nerve Stimulator provides electrical stimulation to the cavernosal nerves during radical prostatectomy procedures. The results of the study indicate the Urovations Nerve Stimulator provides an electrical charge to stimulate the cavernosal nerves and elicits a visible and measurable response in tumescence. No reported adverse events were associated with device use.
Summary
In summary, the Urovations Nerve Stimulator is substantially equivalent to legally marketed devices. Furthermore, based on the results of preclinical and clinical testing, the nerve stimulator is substantially equivalent to these devices with respect to its performance, safety and effectiveness.
2
Image /page/2/Picture/0 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, with the profiles overlapping each other. The profiles are arranged in a way that they also resemble a bird in flight. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" is arranged in a circular pattern around the image.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Nancy C. MacDonald Manager, Clinical & Regulatory Affairs UroMed Corporation 64 A Street Needham, Massachusetts 02194
Dear Ms. MacDonald:
Re: K970971
Urovations Nerve Stimulator Dated: September 22, 1997 Received: September 23, 1997 Regulatory class: II 21 CFR §874.1820/Product code: 77 ETN 21 CFR §876.4730/Product code: 78 FGM OCT 27 1997
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 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 probibitions 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 (QS) 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 yitro 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 of titled, "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,
William 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
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510(k) Number (if known): K970971
Device Name: Urovations Nerve Stimulator
Indications for Use:
The Urovations Nerve Stimulator is indicated for use in the stimulation of the cavernosal nerves during open prostatectomy (surgical) procedures, aiding the surgeon in locating these nerves. The device is designed as an adjunct to current open prostatectomy procedures in which a nerve sparing technique is used. The Nerve Stimulator is not designed to replace the surgeon's expertise in mapping out the vascular bundles. Each surgeon's skill determines whether these nerves are spared regardless of any aid.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use: レ (Per 21 CFR 801.109)
OR
Over-The-Counter Use
Peter D. Rathbun
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number K970921