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

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K042113
page 1 of 3

SEP 1 4 2004

ZOE™ Fluid Status Monitor

510(k) SPECIAL PREMARKET NOTIFICATION SUMMARY

ZOE™ Fluid Status Monitor · Device Trade or Proprietary Name:
· Common / Classification Name: Impedance Plethysmograph
· Class: Class II Regulation Number: 870.2770 .
Product Code: DSB

· Labeling:

Federal (United States) Law restricts this device to sale by or on the order of a physician or licensed healthcare professional.

· Predicate Device for Substantial Equivalence Comparison:

The ZOE™ Fluid Status Monitor, also referred to as ZOE or Zoe in the rest of this document, is claimed to be substantially equivalent to the following currently marketed Predicate Device and currently being marketed by NMT, LLC:

Manufacturer	Device Name	510-K Number	Decision Date
RenaissanceTechnology, Inc.	IQ System™	K922218	December 08, 1992
RenaissanceTechnology, Inc.	IQ System™	K981720	February 08, 1998

• Device Description:

· Indications for Use Statement:

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K042113
page 2 of 3

The ZOE™ Fluid Status Monitor is indicated for patients:

With fluid management problems o
Taking diuretic medication o
Living with Heart Failure o
Living with End-stage Renal Disease o
Recovering from Coronary Artery Disease related event o
Suffering from Recurrent Dehydration o

Contraindications for Use .

The ZOE™ Fluid Status Monitor is contraindicated for use with patients:

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.

• Clinical Performance Data

Clinical performance data has been submitted.

· Rationale for Substantial Equivalence

1. The ZOE™ Fluid Status Monitor patient interface design is very similar to the predicate device [IQ System (Impedance Plethysmograph Monitor {DSB}) already approved by the FDA and currently being marketed by NMT, LLC]
1. The INTENDED USES and the OPERATING PRINCIPLES (i.e. Effectiveness) of the ZOE™ Fluid Status Monitor are the SAME as the Zo measurement function of the predicate device.
1. The OPERATIONAL FEATURES of the ZOE™ Fluid Status Monitor are the SAME or SIMILAR to those offered by the predicate device
1. The SAFETY FEATURES of the ZOE™ Fluid Status Monitor are the SAME or very SIMILAR to those offered by the predicate device.

Therefore, in summary, the ZOE™ Fluid Status Monitor is substantially equivalent to the Zo measurement feature in the identified predicate device that has previously been allowed for commercial distribution in the United States.

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· Safety and Effectiveness

The ZOE™ Fluid Status Monitor complies with the electrical standards of the Underwriters Laboratories UL 2601-1 / CSA C22.2 No. 60601 and has passed an inspection to these standards by an independent testing house. The ZOE underwent independent scrutiny and testing to assess the overall electrical safety and EMI safety. The ZOE met all electrical and electromagnetic compatibility (EMI) safety requirements set forth in the European national Safety Requirements LVD Low voltage Directive testing to Safety of Medical Devices EN 60601-1:2003, EMC testing to Emissions / Immunity Requirements for EMC/EMI requirements for Medical Devices EN 60601-1-2 which reasonably assures the device is safe when used as directed for its prescribed intended use.

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

· Conclusions

The data submitted in this 510(k) Premarket Notification, for the ZOE Fluid Status Monitor demonstrates that this product is substantially equivalent with respect to the indications for use, operating principles, operational features, and safety features to the identified legally marketed predicate device. With the information provided, the safety and effectiveness of the product can be reasonably assured, and we believe that this device clearly meets the requirement for a "Substantial Equivalence" decision in accordance with the 510(k) guidelines.

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Public Health Service

Image /page/3/Picture/2 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular in shape, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle or bird-like figure, with three curved lines representing its wings or body.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 4 2004

Noninvasive Medical Technologies, LLC c/o Mr. Alden Kay Consultant 4367 Tuolumne Place Carlsbad, CA 92008-7924

Re: K042113

Trade Name: ZOE™ Fluid Status Monitor Regulation Number: 21 CFR 870.2770 Regulation Name: Impedance Plethysmograph Regulatory Class: Class II (two) Product Code: DSB Dated: August 3, 2004 Received: August 5, 2004

Dear Mr. Kay:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave teviewed your becally be device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for asc stated in the encreate to togally to togally the Medical Device Amendments, or to commerce prior to May 20, 1978, the excordance with the provisions of the Federal Food, Drug, devices that have been recuire approval of a premarket approval application (PMA). and Cosmetic Act (1101) market the device, subject to the general controls provisions of the Act. The 1 ou may, therefore, mailer are as act include requirements for annual registration, listing of general controls profices of of rectice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (600 a00 ro) als. Existing major regulations affecting your device can may be subject to subli additions, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Mr. Alden Kay

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4646. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

B/Bimmumer for
Prem D. Zuckerman, M.D.

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K042113 510(k) Number (if known):

Previously approved as: K981720

"ZOE™ Fluid Status Monitor" Impedance Plethysmograph Device Name:

Indications For Use:

As with the predicate devices indicated in this submission (cardiac monitors employing impedance plethysmography {DSB}):

The ZOE™ Fluid Status Monitor is intended for:

With fluid management problems 0
Taking diuretic medication ಂ
Living with Heart Failure o
Living with End-stage Renal Disease O
Recovering from Coronary Artery Disease related event 0
Suffering from Recurrent Dehydration O

The ZOE™ Fluid Status Monitor is contraindicated for use with patients:

With allergies to electrode hydrogel 0
Skin sensitivities to electrode hydrogel ্
Skin breakdown in areas on the chest where ZOE clectrode placement is o required.

Prescription Use (Per 21 CFR 801.109)

	OR Over-The-Counter Use
Division Sign-Off)
	Division of Cardiovascular, Respiratory,
and Neurological Devices	(optional form

(4-methyl-1,3-dioxolan-2-one)

format: 1-2-96)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Bhiman

510(k) Number K042113

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.