FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

With allergies to electrode hydrogel O
Skin sensitivities to electrode hydrogel o
Skin breakdown in areas on the chest where ZOE electrode placement is o required.

This device is intended for use by qualified health care practitioners, 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.

Device Description

The ZOE™ Fluid Status Monitor is a non-invasive, battery powered thoracic base impedance monitor designed as an 'early warning' monitor for determining changes in the fluid status of patients with fluid management problems.

The ZOE works by applying a minimal current to the patient. measuring electrical impedance changes throughout the thorax as aortic blood flow increases and decreases in response to each heartbeat. Base Impedance also known as Zo, decreases when fluid increases and rises when less fluid exists in the chest. This device incorporates a proprietary algorithm to calculate the Zo value.

The ZOE is designed for use with disposable, self-adhesive silver / silver chloride electrodes that are readily available / commercially approved within the United States for other approved cardiovascular monitoring systems.

AI/ML Overview

This 510(k) submission for the ZOE™ Fluid Status Monitor does not provide specific acceptance criteria in terms of quantitative performance metrics (e.g., accuracy, sensitivity, specificity, or agreement rates) that were evaluated in a study to "prove the device meets the acceptance criteria."

Instead, the submission focuses on demonstrating substantial equivalence to a predicate device (the Renaissance Technology, Inc. IQ System™) based on:

Similar patient interface design.
Same intended uses and operating principles (effectiveness) for the Zo measurement function.
Same or similar operational features.
Same or similar safety features.

The document explicitly states: "The ZOE does not raise any new issues of safety, effectiveness or performance of the device when compared to the existing predicate device."

Therefore, it implicitly relies on the established safety and effectiveness of the predicate device. The information provided heavily emphasizes compliance with electrical and safety standards rather than clinical performance metrics for the ZOE device itself.

Given this, I cannot fill out all requested sections as the information is not present in the provided text.

Here's a breakdown of what can be extracted and what is missing:

Acceptance Criteria and Device Performance (Based on Provided Document)

Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Substantial Equivalence to Predicate Device (Renaissance IQ System™) for Zo measurement function:
a. Patient interface design similarities.	Verified to be "very similar."
b. Identical intended uses and operating principles (effectiveness) for Zo measurement.	Verified as "the SAME."
c. Same or similar operational features.	Verified as "the SAME or SIMILAR."
d. Same or similar safety features.	Verified as "the SAME or very SIMILAR."
Compliance with Electrical and Safety Standards:
a. UL 2601-1 / CSA C22.2 No. 60601	Device complies and "has passed an inspection to these standards by an independent testing house."
b. EN 60601-1:2003 (LVD Low Voltage Directive)	Device "met all electrical and electromagnetic compatibility (EMI) safety requirements."
c. EN 60601-1-2 (EMC testing for Emissions/Immunity)	Device "met all electrical and electromagnetic compatibility (EMI) safety requirements."
Does not raise new issues of safety, effectiveness, or performance compared to predicate.	Confirmed: "The ZOE does not raise any new issues of safety, effectiveness or performance of the device when compared to the existing predicate device."
Reasonable assurance of safety and effectiveness for intended use.	Confirmed: "With the information provided, the safety and effectiveness of the product can be reasonably assured."

Missing Information (Not provided in the document for the ZOE™ Fluid Status Monitor):

The document explicitly states: "Clinical performance data has been submitted." However, the summary does not elaborate on the specific acceptance criteria for this clinical data, nor does it present the results of such a study. The primary argument for substantial equivalence is based on the Zo measurement function being the same as the predicate and compliance with electrical safety standards, implying that extensive stand-alone clinical performance studies with specific metrics for the ZOE device were not the main basis of this 510(k) summary.

Therefore, the following points cannot be answered from the provided text:

Sample size used for the test set and the data provenance: Not specified.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no specific performance study with a test set and ground truth is detailed.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable; this device is a monitor, not an AI-assisted diagnostic tool for human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The document implies that the "operating principles" and "Zo measurement function" are the same as the predicate, which involved a proprietary algorithm. However, specific performance metrics for this algorithm in a standalone clinical evaluation are not presented.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not specified for any clinical performance data.
The sample size for the training set: Not applicable; the document does not describe a training set in the context of device development or machine learning.
How the ground truth for the training set was established: Not applicable.

Summary

Regulation Number and Section

§ 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.