ELLIPSE 4

K964522 · Andromeda Medizinische Systeme GmbH · FEN · Mar 21, 1997 · Gastroenterology, Urology

Device Facts

• Record ID: K964522
• Device Name: ELLIPSE 4
• Applicant: Andromeda Medizinische Systeme GmbH
• Product Code: FEN · Gastroenterology, Urology
• Decision Date: Mar 21, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1620
• Device Class: Class 2

Intended Use

The Ellipse 4™ is intended to assist in the diagnosis of incontinence and/or voiding disorders.

Device Story

Ellipse 4™ is a compact urodynamic system for clinical use; registers pressure, uroflow, and EMG signals. Inputs: microtip catheters (MTCs) for pressure; surface electrodes for EMG. Signals undergo A/D conversion; displayed on LCD; printed via thermal printer; stored in memory. Data transferable to PC via network. Assists clinicians in diagnosing incontinence and voiding disorders by providing objective physiological measurements; enables comprehensive urodynamic investigations.

Clinical Evidence

Bench testing confirmed accuracy of transducers, pump, EMG, pressure, pressure flow, and urethral pressure profile. Clinical experience includes over 10,000 urodynamic investigations with no reported complications.

Technological Characteristics

Coated aluminum housing; microtip catheters (MTCs) for pressure sensing; surface electrodes for EMG; A/D signal conversion; LCD display; thermal printer; network connectivity for PC download; non-energy delivering.

Indications for Use

Indicated for patients requiring urodynamic evaluation, including flowmetry, cystometry, pressure flow, urethral pressure profile, and EMG testing for incontinence or voiding disorders.

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

• MERKUR™ 4000 (K920575)
• SPACE™ 7500 (K912071)

Submission Summary (Full Text)

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MAR 21 1997
ANDROMEDA
K964522

# SUMMARY OF SAFETY AND EFFECTIVENESS

## MANUFACTURER IDENTIFICATION:
ANDROMHDA medizinische Systeme GmbH
Wallbergstrasse 5
D-82024 Taufkirchen / Potzham
Germany

## SPONSOR IDENTIFICATION:
Same

## ESTABLISHMENT REGISTRATION NUMBER:
In process (Submitted Nov. 5, 1996)

## OFFICIAL CONTACT PERSON:
Norman F. Estrin, Ph.D., RAC
President
Estrin Consulting Group, Inc.
9109 Copenhagen Drive
Potomac, MD 20854
Tel.: [phone]
Fax: [phone]

## DATE OF PREPARATION OF THIS SUMMARY:
March 21, 1997

## TRADE NAME:
Ellipse 4™

## COMMON NAME:
Urodynamic System

## CLASSIFICATION NAME:
Urodynamic Measuring System

## REFERENCE:
(21 CFR Section 876.1620)

## PROPOSED REGULATORY CLASS:
Class II

## DEVICE PRODUCT CODE:
FAP

## PANEL CODE:
GU

ANDROMHDA
medizinische Systeme GmbH
Wallbergstraße 5
D-82024 Taufkirchen/Potzham
Tel: [phone]
Fax: [phone]

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p 2072

## DESCRIPTION OF DEVICE:

The *Ellipse 4™* is a small, compact device that can register pressures, uroflow and EMG from the patient. The signals are AD converted and displayed on a LCD screen, printed on a thermal printer and stored in memory. After the recording, the data can be copied on a printer or downloaded to a PC using a network. The *Ellipse 4™* uses microup cadieters (MTC’s) for recording the pressures, and surface electrodes.

## INTENDED USE:

The *Ellipse 4™* is intended to assist in the diagnosis of incontinence and/or voiding disorders.

## INDICATIONS FOR USE:

The *Ellipse 4™* is a Urodynamic System. It can perform the following tests: Flowmetry, Cystometry, Pressure Flow, Urethral Pressure Profile and EMG.

## PREDICATE DEVICE:

The *Ellipse 4™* is substantially equivalent to the **MERKUR™ 4000**, manufactured by F. M. Wiest Medizintechnik (K920575) and to the **SPACE™ 7500** manufactured by F. M. Wiest (K 912071).

## COMPARISON OF TECHNOLOGICAL CHARACTERISTICS:

Both the *Ellipse 4™* and the **MERKUR™ 4000** have the same intended use and are of very similar design. They both have a coated aluminum housing and are powered similarly. Neither deliver energy to the patient. The *Ellipse 4™* is also capable of carrying out CC-EMG investigations.

## SUMMARY OF STUDIES:

Bench testing was performed to confirm accuracy of the basic parameters measured by the *Ellipse 4™*. Tests were performed in the following areas: transducer, pump, EMG, pressure, pressure flow and urethral pressure profile. Satisfactory results were achieved.

Clinical experience in use of the *Ellipse 4™* has confirmed its safety and effectiveness. Over 10,000 Urodynamic investigations have been performed using the *Ellipse 4™* with excellent results and an absence of complications.

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