(412 days)
Not Found
No
The summary describes a device that measures electrical impedance to monitor fluid status. There is no mention of AI, ML, or any related technologies in the intended use, device description, or the specific sections for AI/ML mentions. The predicate device is the same device, suggesting no significant technological change incorporating AI/ML.
No.
The device is described as a "monitor" and is intended for "monitoring and management," indicating it assesses fluid status rather than directly treating a condition.
Yes
The device is intended for "monitoring and management of patients with fluid management problems" and described as an "early warning" monitor for "determining changes in the fluid status." This indicates its role in assessing a patient's condition, which aligns with the definition of a diagnostic device.
No
The device description explicitly states it is a "non-invasive, battery powered impedance monitor" and works by "applying a low amplitude high frequency electrical current to the body and measuring the electrical impedance." This indicates the device includes hardware components for electrical measurement, not just software.
Based on the provided information, the ZOE Fluid Status Monitor is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze specimens taken from the human body. The ZOE Fluid Status Monitor is described as a non-invasive device that applies an electrical current to the body and measures impedance. It does not analyze blood, urine, tissue, or any other biological specimen.
- The device description focuses on measuring electrical impedance directly on the patient's body. This is a direct physiological measurement, not an analysis of a sample.
Therefore, the ZOE Fluid Status Monitor falls under the category of a non-invasive medical device used for monitoring physiological parameters, not an IVD.
N/A
Intended Use / Indications for Use
The ZOE Fluid Status Monitor is intended for patients:
- With fluid management problems ●
- Taking diuretic medication .
- Living with Heart Failure ●
- Living with End-stage Renal Disease .
- Recovering from Coronary Artery Disease related event ●
- Suffering from Recurrent Dehydration .
This device is intended for use under the direction of a physician, for the non-invasive monitoring and management of patients with fluid management problems in a variety of medically accepted clinical applications.
Product codes (comma separated list FDA assigned to the subject device)
DSB
Device Description
The ZOE Fluid Status Monitor is a non-invasive, battery powered impedance monitor designed as an 'early warning' monitor for determining changes in the fluid status of patients with fluid management problems.
The ZOE Fluid Status Monitor works by applying a low amplitude high frequency electrical current to the body and measuring the electrical impedance. Base Impedance also known as Zo, decreases when fluid increases and increases when fluid decreases.
The ZOE Fluid Status Monitor is designed for use with disposable, self-adhesive silver chloride electrodes that are readly available / commercially approved within the United States for other approved cardiovascular monitoring systems.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
under the direction of a physician, for the non-invasive monitoring and management of patients with fluid management problems in a variety of medically accepted clinical applications.
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)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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
§ 870.2770 Impedance plethysmograph.
(a)
Identification. An impedance plethysmograph is a device used to estimate peripheral blood flow by measuring electrical impedance changes in a region of the body such as the arms and legs.(b)
Classification. Class II (special controls). The device, when it is a body composition analyzer which is not intended to diagnose or treat any medical condition, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.
0
Premarket Notification - ZOE Fluid Status Monitor
Image /page/0/Picture/2 description: The image shows the logo for Noninvasive Medical Technologies, Inc. The logo consists of the letters "NMT" in bold, sans-serif font, with three curved lines to the left of the letters. To the right of "NMT" is the text "Noninvasive Medical Technologies, Inc." in a smaller, sans-serif font. The logo is black and white.
NOV 1 3 2012
This summary of safety and effectiveness is provided as part of this Premarket Notification in compliance with 21 CFR, Part 807, Subpart E, Section 807.92.
| APPLICANT | Noninvasive Medical Technologies, Inc.
6412 S. Arville St.
Las Vegas, NV 89118
Tel: (888) 906-0413
Fax: (702) 614-4170 |
|-------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| OFFICIAL CORRESPONDENT | Dr. Marc O Griofa, M.D. (MB BCh BAO), Ph.D., F.A.W.M.
Chief Technology/Medical Officer
Tel: (888) 906-0413
Fax: (702) 614-4170
mogriofa@nmtinc.org |
| DATE PREPAIRED | October 24,2012 |
| TRADE NAME | ZOE Fluid Status Monitor |
| MODEL | ZOE2B |
| COMMON OR CLASSIFICATION NAME | Impedance Plethysmograph |
| DEVICE CLASSIFICATION | Class II per 21CFR §870.2770 |
| PRODUCT CODE | DSB |
| PREDICATE DEVICE NAMES | ZOE Fluid Status Monitor |
The ZOE Fluid Status Monitor is substantially equivalent to the following currently marketed Predicate Device.
| Manufacturer | Device Name | 510-K Number | Decision Date |
|---|---|---|---|
| Noninvasive Medical | |||
| Technologies, Inc. | ZOE Fluid Status Monitor | K042113 | Sept. 14, 2004 |
Device Description:
The ZOE Fluid Status Monitor is a non-invasive, battery powered impedance monitor designed as an 'early warning' monitor for determining changes in the fluid status of patients with fluid management problems.
The ZOE Fluid Status Monitor works by applying a low amplitude high frequency electrical current to the body and measuring the electrical impedance. Base Impedance also known as Zo, decreases when fluid increases and increases when fluid decreases.
The ZOE Fluid Status Monitor is designed for use with disposable, self-adhesive silver chloride electrodes that are readly available / commercially approved within the United States for other approved cardiovascular monitoring systems.
Labeling:
Federal (United States) Law restricts this device to sale by or on the order of a physician or licensed healthcare professional.
Indications For Use:
The ZOE Fluid Status Monitor is intended for patients: With fluid management problems
- Taking diuretic medication �
- Living with Heart Failure .
- Living with End-stage Renal Disease .
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