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

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.

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.

AI/ML Overview

The provided document does not contain information about specific acceptance criteria, a study proving device performance against such criteria, sample sizes, ground truth establishment, or multi-reader multi-case studies.

The document is a 510(k) Premarket Notification summary for the ZOE Fluid Status Monitor. It asserts substantial equivalence to a previously cleared device (K042113), stating that the hardware is identical and the indications for use are the same. This type of submission typically relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device, rather than requiring new clinical studies with defined acceptance criteria and performance metrics against a de novo ground truth.

Here's what can be extracted from the document regarding a "study":

Study Information Pertaining to K112830 (ZOE Fluid Status Monitor):

A table of acceptance criteria and the reported device performance:
- N/A. The document does not specify performance acceptance criteria or report specific device performance metrics from a new study. Instead, it relies on substantial equivalence to the predicate device.
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- N/A. No new clinical data (test set) is mentioned or presented for K112830. The submission is based on the device being identical to the predicate.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- N/A. No new clinical data or ground truth establishment process is described for K112830.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- N/A. Not applicable as no new test set is described.
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:
- N/A. This device is an impedance plethysmograph, not an AI-assisted diagnostic imaging device for human readers. No MRMC study was conducted or is relevant.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- N/A. While the device works independently to measure impedance, the filing does not discuss performance of a standalone algorithm in the context of a new study. Its performance is considered equivalent to the predicate device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- N/A. No new ground truth is established or discussed for K112830 as its substantial equivalence is based on being identical to a previously cleared device.
The sample size for the training set:
- N/A. There is no mention of a training set as this is not an AI/machine learning device undergoing a new performance study.
How the ground truth for the training set was established:
- N/A. Not applicable.

Summary from the Document:

The basis for clearance of ZOE Fluid Status Monitor (K112830) is substantial equivalence to a predicate device (ZOE Fluid Status Monitor K042113). The document explicitly states:

"The hardware utilized in the ZOE Fluid Status Monitor is identical to the hardware utilized in the currently marketed approved device the ZOE Fluid Status Monitor K042113 (September 14, 2004)."
"The ZOE Fluid Status Monitor has the identical indications for use as the predicate devices the ZOE Fluid Status Monitor K042113 (September 14, 2004)"
"The ZOE Fluid Status Monitor has the same method of operation and is functionally equivalent to the predicate device."
"There is no performance standards published for Product Code DSB Impedance Plethysmograph (870.2770)"

Therefore, the "study that proves the device meets the acceptance criteria" is implicitly the prior regulatory clearance of the predicate device (K042113), which established its safety and effectiveness. This new submission asserts that because the device is identical in hardware, function, and intended use, it inherently meets the same safety and effectiveness profile as the predicate without requiring new performance data. The quality and safety testing mentioned (ISO13485 certification, UL 2601-1, CSA C22.2 No. 60601, EN 60601-1 2003, EN 60601-1-2) are primarily related to manufacturing quality systems and electrical safety/EMC standards, not clinical performance studies with specific patient cohorts or ground truths.

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.