K Number

Device Name

NEVA SYSTEM

Manufacturer

UROMETRICS, INC.

Date Cleared

1998-04-07

(48 days)

Product Code

LIL

Regulation Number

N/A

Intended Use

The NEVA™ System is an device to measure and record penile erectile events nocturnally.

Device Description

The UroMetrics NEVA system consists of three disposable electrodes sets, a portable battery powered recorder, a host interface, cables and a computer program. Two of the three electrode sets are placed on the penis so that one electrode set is on the glans terminating just proximal to the glans, one set is at the base of the penis terminating a fixed distance from the base of the penis. The third electrode is attached to the patient's hip. The wires from the electrodes terminate in a phone connector which plugs into the portable NEVA recorder. The electrodes and the recorder are used by the patient to monitor nocturnal tumescence for up to three nights. The host interface and the computer program are used to prepare (initialize) the recorder for use and to download the data from the recorder for display and analysis on a physician's computer. The NEVA system indicates penile tumescence by monitoring changes in volume, length and area. Due to a variety of factors (patient position, etc.) the size of the penis can change its shape. An increase in length, by itself, may not indicate tumescence. Tumescence is generally indicated by an increase in volume, length and area. This is the primary reason the NEVA system displays volume, length and area throughout the test. Impedance values which are used to determine penile volume, length and area are continuously recorded at one second intervals. The one second time base and the change in volume data allow a physician to determine the fill rate once periods of tumescence are identified. The NEVA system determines changes in volume by measuring the impedance within the penis. A low powered alternating current is sent from the electrode on the glans to the ground electrode on the hip. The remaining electrodes are used to measure the impedance. The electrode set at the base of the penis includes electrodes which are separated by a fixed distance. As the cross-sectional area of the blood volume in the penis increases, there is a decrease in measured impedance in the base electrode set. These impedance changes are then converted to a volume reading by the host computer. With an increase in distance between the base electrode and the electrode posterior to the glans (penis length) there is an increase in the impedance between these electrodes. This change in impedance is converted to a length reading. To begin a test, the NEVA recorder is plugged into a computer through the host interface to a host computer running the NEVA software. The computer and software will recognize the recorder and will display a menu which allows the physician to download previously recorded data or initialize the recorder for a new test. To begin a new test, the physician enters the patient's name and other information and initializes the recorder. All previous data are cleared and the patient information is saved to the recorder. The NEVA software allows the physician the option of real time measurements while connected to the computer. This capability is useful to demonstrate the proper placement of the electrodes and to check for proper operation. Once the NEVA recorder is initialized and the patient is instructed in its use, the recorder and electrodes are sent home with the patient. The electrodes are designed for single use so a separate set of electrodes is needed for each night (sleep period) of the test. The NEVA recorder is normally in standby mode until the electrodes are placed on the patient and the connector is plugged into the recorder. When the connector is removed the recorder returns to the standby mode. Patients should be instructed to plug in the electrodes at the beginning of the test and unplug the electrodes at the end of the test. The recorder can store data for a maximum of 36 hours, typically three sleep periods. At the end of the test period, the NEVA recorder is plugged into a computer through the host interface to a host computer running the NEVA software. The computer and software will recognize the recorder and will display a menu which allows the physician to download the data. The data are then downloaded to the computer and stored on the computer's hard drive. The impedance data are converted to volume, length and crosssectional area plots which are displayed graphically on the computer screen. The software incorporates a number of features which facilitate the analysis and interpretation of the data by the physician.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K941781

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on impedance measurements and data conversion to volume, length, and area, with software for display and analysis by a physician. There is no mention of AI or ML algorithms for data interpretation or decision support.

Therapeutic

No.
Explanation: The device is designed to measure and record penile erectile events; it does not provide any treatment or therapy.

Diagnostic

Yes

Explanation: The NEVA System "measure[s] and record[s] penile erectile events nocturnally" and the collected data are analyzed by a physician to "determine the fill rate once periods of tumescence are identified." The "software incorporates a number of features which facilitate the analysis and interpretation of the data by the physician," enabling the physician to use the data for diagnostic purposes related to erectile function.

SaMD (Software as a Medical Device)

The device description explicitly details hardware components including disposable electrode sets, a portable battery-powered recorder, a host interface, and cables, in addition to the computer program (software).

IVD (In Vitro Diagnostic)

Based on the provided information, the NEVA™ System is not an In Vitro Diagnostic (IVD) device.

Here's why:

IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
NEVA System Function: The NEVA System directly measures physiological parameters (impedance changes related to volume, length, and area) on the patient's body to assess penile erectile events. It does not analyze specimens taken from the body.

Therefore, the NEVA System falls under the category of a non-IVD medical device that performs physiological measurements.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The NEVA™ System is an device to measure and record penile erectile events nocturnally.
Measure and record penile erectile events nocturnally.

Product codes

78 LIL

Device Description

The electrodes and the recorder are used by the patient to monitor nocturnal tumescence for up to three nights. The host interface and the computer program are used to prepare (initialize) the recorder for use and to download the data from the recorder for display and analysis on a physician's computer.

The NEVA system indicates penile tumescence by monitoring changes in volume, length and area. Due to a variety of factors (patient position, etc.) the size of the penis can change its shape. An increase in length, by itself, may not indicate tumescence. Tumescence is generally indicated by an increase in volume, length and area. This is the primary reason the NEVA system displays volume, length and area throughout the test.

Impedance values which are used to determine penile volume, length and area are continuously recorded at one second intervals. The one second time base and the change in volume data allow a physician to determine the fill rate once periods of tumescence are identified.

The NEVA system determines changes in volume by measuring the impedance within the penis. A low powered alternating current is sent from the electrode on the glans to the ground electrode on the hip. The remaining electrodes are used to measure the impedance. The electrode set at the base of the penis includes electrodes which are separated by a fixed distance. As the cross-sectional area of the blood volume in the penis increases, there is a decrease in measured impedance in the base electrode set. These impedance changes are then converted to a volume reading by the host computer. With an increase in distance between the base electrode and the electrode posterior to the glans (penis length) there is an increase in the impedance between these electrodes. This change in impedance is converted to a length reading.

To begin a test, the NEVA recorder is plugged into a computer through the host interface to a host computer running the NEVA software. The computer and software will recognize the recorder and will display a menu which allows the physician to download previously recorded data or initialize the recorder for a new test. To begin a new test, the physician enters the patient's name and other information and initializes the recorder. All previous data are cleared and the patient information is saved to the recorder.

The NEVA software allows the physician the option of real time measurements while connected to the computer. This capability is useful to demonstrate the proper placement of the electrodes and to check for proper operation. Once the NEVA recorder is initialized and the patient is instructed in its use, the recorder and electrodes are sent home with the patient. The electrodes are designed for single use so a separate set of electrodes is needed for each night (sleep period) of the test.

The NEVA recorder is normally in standby mode until the electrodes are placed on the patient and the connector is plugged into the recorder. When the connector is removed the recorder returns to the standby mode. Patients should be instructed to plug in the electrodes at the beginning of the test and unplug the electrodes at the end of the test. The recorder can store data for a maximum of 36 hours, typically three sleep periods.

At the end of the test period, the NEVA recorder is plugged into a computer through the host interface to a host computer running the NEVA software. The computer and software will recognize the recorder and will display a menu which allows the physician to download the data.

The data are then downloaded to the computer and stored on the computer's hard drive. The impedance data are converted to volume, length and crosssectional area plots which are displayed graphically on the computer screen.

The software incorporates a number of features which facilitate the analysis and interpretation of the data by the physician.

The NEVA™ System has many components and accessories. Components are pieces of the NEVA™ System unit which are necessary to perform any reading of nocturnal tumescence. Accessories are additional equipment that allow for more efficient recordings.

NEVA™ System Components

Recorder .
Electrode Sets .

NEVA™ System Accessories

Cables .
Computer Program .
Carrying Cases (Physician and Patient) .
Electrode Harness .
Isolation Box .
. Leg Strap and Bag
Power Adapter .
9-Volt Batteries .
. Patient Manual
Physician's Operator Manual .

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

penis

Indicated Patient Age Range

Not Found

Intended User / Care Setting

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)

Performance testing raised no issues, and the 510(k) included Comparative Testing and Function and Beta Testing.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K941781

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

N/A

Summary

Image /page/0/Picture/17 description: The image shows the logo for UroMetrics. The logo consists of a stylized letter 'U' inside a circle above the word 'UroMetrics'. The letter 'U' is formed by two curved lines that converge at the bottom, and the circle is filled with a textured pattern. The word 'UroMetrics' is written in a simple sans-serif font.

K980627

1 of 5

APR - 7 1998

510(k) SUMMARY of SAFETY and EFFECTIVENESS

445 Etna Street, #56

St. Paul, MN 55106

2134152

A. General Information

UroMetrics, Inc. 1. Submitter's Name:
1. Address:
612-774-1552 3. Telephone:
Philip A. Messina 4. Contact Person:
February 16, 1998 5. Date Prepared:
1. Registration Number:

B. Device

1. Name:	NEVA™ System
2. Trade Name:	NEVA™ System
3. Common Name:	Penile Tumescence Monitor
4. Classification Name:	Penile Tumescence Monitor
5. Product Code:	78 LIL
6. Class:	II
7. Regulation Number:	None

UroMetrics, Inc.
445 Etna Street Suite 56
Saint Paul, MN 55106

612•774•1552
612•774•1882 fax

C. Identification of Legally Marketed Device

1. Name:	RigiScan® Plus System
2. K Number:	K941781

August 25, 1994 3. Date Cleared:

D. Description of the Device

base of the penis includes electrodes which are separated by a fixed distance. As the cross-sectional area of the blood volume in the penis increases, there is a decrease in measured impedance in the base electrode set. These impedance changes are then converted to a volume reading by the host computer. With an increase in distance between the base electrode and the electrode posterior to the glans (penis length) there is an increase in the impedance between these electrodes. This change in impedance is converted to a length reading.

The software incorporates a number of features which facilitate the analysis and interpretation of the data by the physician.

NEVA™ System Components

Recorder .
Electrode Sets .

NEVA™ System Accessories

Cables .
Computer Program .
Carrying Cases (Physician and Patient) .
Electrode Harness .
Isolation Box .
. Leg Strap and Bag
Power Adapter .
9-Volt Batteries .
. Patient Manual
Physician's Operator Manual .

E. Intended Use Statement

The NEVA™ System is an device to measure and record penile erectile events nocturnally.

F. Technological Characteristics Summary

The NEVA™ System is substantially equivalent to the RigiScan® Plus System in terms of technology and uses.

Differences that exist between these devices, relating to technical specifications, physical appearance and design, do not affect the relative safety and effectiveness of the NEVA™ System.

8067 (

G. Performance Data

11:50 C

ﺗﺮﺣﻴﺔ ﺗ

Performance testing raised no issues, and the 510(k) included Comparative Testing and Function and Beta Testing.

Image /page/5/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of a bird-like figure.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR - 7 1998

Mr. Philip.A. Messina President and COO UroMetrics, Inc. 445 Etna Street, Suite 56 Saint Paul, Minnesota 55106 Re: K980627

UroMetrics NEVA™ System Dated: February 16, 1998 Received: February 18, 1998 Regulatory Class: Unclassified Product Code: 78 LIL

Dear Mr. Messina:

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 to 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). 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.

If your device is classified (see above) into either class III (Premarket Aporoval), 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 (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS 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 not affect any obligation you might have under sections 531 through 542 of the Electronic Product 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 vitro 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 entitled, "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,

Kilian Yh

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

510(k) Number:

Device Name: NEVA™ System

Indications for Use:

Measure and record penile erectile events nocturnally .
PLEASE DO NOT WRITE BELOW THIS LINE -CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use /

ﻌﺴﺴﻪ

over-The-Counter use ________________________________________________________________________________________________________________________________________________________ (optional Form 1-2-96)

Robert P. Rathing
(Division Sign Off)

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices

510(k) Number K980627