(129 days)
Not Found
No
The summary describes a device that measures and displays physiological signals (pressures, flow, EMG) and stores data. There is no mention of AI, ML, or any form of automated analysis or interpretation of the data beyond basic parameter measurement.
No.
The device is intended to assist in the diagnosis of incontinence and voiding disorders by performing various urodynamic tests, not to treat them.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states, "The Ellipse 4™ is intended to assist in the diagnosis of incontinence and/or voiding disorders."
No
The device description explicitly states it is a "small, compact device" that registers pressures, uroflow, and EMG, and includes hardware components like an LCD screen, thermal printer, and memory. It also uses physical components like microp catheters and surface electrodes.
Based on the provided information, the Ellipse 4™ is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood, tissue, and urine, derived from the human body, solely or principally for the purpose of providing information concerning a physiological or pathological state, or a congenital abnormality, or to determine the safety and compatibility with potential recipients, or to monitor therapeutic measures.
- Ellipse 4™ Function: The Ellipse 4™ is a Urodynamic System that directly measures physiological parameters within the patient's body (pressures, uroflow, EMG) using catheters and surface electrodes. It does not examine specimens in vitro.
- Intended Use: Its intended use is to assist in the diagnosis of incontinence and/or voiding disorders by directly measuring these physiological responses.
Therefore, the Ellipse 4™ falls under the category of a medical device used for direct physiological measurement, not an IVD.
N/A
Intended Use / Indications for Use
The Ellipse 4™ is intended to assist in the diagnosis of incontinence and/or voiding disorders. The Ellipse 4™ is a Urodynamic System. It can perform the following tests: Flowmetry, Cystometry, Pressure Flow, Urethral Pressure Profile and EMG.
Product codes
FAP
Device Description
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 microp catheters (MTC's) for recording the pressures, and surface electrodes.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
Bench testing was performed to confirm accuracy of the basic parameters measured by the Ellipse 4M . 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 4M has confirmed its safety and effectiveness. Over 10,000 Urodynamic investigations have been performed using the Ellipse 4TM with excellent results and an absence of complications.
Key Metrics
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Predicate Device(s)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.
0
MAR 2 1 1997
Image /page/0/Picture/1 description: The image shows a logo with a black triangle at the top. Below the triangle is the word "ANDROMEDA" in capital letters. Underneath the word is the alphanumeric code "K964522" in a handwritten style font. The logo appears to be for a company or organization named Andromeda.
SUMMARY OF SAFETY AND EFFECTIVENESS
MANUFACTURER IDENTIFICATION:
ANDROMBIDA medizinische Systeme GmbH Wallbergstrassc 5 D-22024 Taufkirchen / Potzham Germany
SPONSOR IDENTIFICATION:
KSTABLISHMENT KEGISTRATION NUMBER:
OFFICIAL CONTACT PERSON:
DATE OF PREPARATION OF THIS SUMMARY:
TRADE NAME:
COMMON NAME:
CLASSIFICATION NAME:
REFERENCE:
PROPOSED REGULATORY CLASS:
|DEVICE PRODUCT CODE:
PANEL CODE:
. .
In process (Submitted Nov. 5, 1996)
Norman F. Estrin, Ph.D., RAC President Estrin Consulting Group, Inc. 9109 Copenhaver Drive Potomac , MD 20854
Tcl. : (301) 279 -2899 Fax : (301) 294-0126
March 21, 1997
Ellipse AM
Same
Urodynamic System
Urodynamic Measuring System
(2) CPR Section 876.1620)
Class II
FAP
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1
| 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 microp catheters
(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 TM 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 4M . 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 4M has confirmed its safety and effectiveness. Over 10,000 Urodynamic investigations have been performed using the Ellipse 4TM with excellent results and an absence of complications.
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