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

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Premarket Notification - ZOE Fluid Status Monitor

K112830

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 89118Tel: (888) 906-0413Fax: (702) 614-4170
OFFICIAL CORRESPONDENT	Dr. Marc O Griofa, M.D. (MB BCh BAO), Ph.D., F.A.W.M.Chief Technology/Medical OfficerTel: (888) 906-0413Fax: (702) 614-4170mogriofa@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 MedicalTechnologies, Inc.	ZOE Fluid Status Monitor	K042113	Sept. 14, 2004

Device Description:

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 .

Page 1 of 2

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<112830

Recovering from Coronary Artery Disease related event .
. Suffering from Recurrent Dehydration

Predicate Device Discussion:

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)

Performance Characteristics:

There is no performance standards published for Product Code DSB Impedance Plethysmograph (870.2770)

Quality and Safety Testing:

Noninvasive Medical Technology is presently certified to ISO13485 2003 as of 9/27/09 by IQ Net and NEMKO AS (Registration Number 908132). All products are designed under Quality Management System. The following quality assurance measures were applied to the Zoe Fluid Status Monitor: Risk Analysis Requirements Review Design reviews Code Inspections Verification and Validation H/W and S/W Implementation Verification Testing

The ZOE Fluid Status Monitor underwent testing to assess the overall electrical safety by an independent testing house. The ZOE Fluid Status Monitor complies with the electrical standards of the Underwriters Laboratories UL 2601-1 / CSA C22.2 No. 60601 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/EM1 requirements for Medical Devices EN 60601-1-2 which reasonably assures the device is safe when used as directed for its prescribed intended use.

Conclusion:

The ZOE Fluid Status Monitor has the same method of operation and is functionally equivalent to the predicate device. 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 does not raise any new issues of safety, effectiveness or performance of the device when compared to the existing predicate device ZOE Fluid Status Monitor K042113 (September 14, 2004),

Page 2 of 2

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

NOV 13 2002

DEPARTMENT OF HEALTH & HUMAN SERVICES

Noninvasive Medical Technologies, Inc. c/o Marc O Griofa, M.D., Ph.D., F.A.W.M. Chief Medical/Technology Officer 6412 S. Arville Street Las Vegas, NV 89118

Re: K112830

Trade/Device Name: ZOE Fluid Status Monitor Regulation Number: 21 CFR 870.2770 Regulation Name: Impedance Plethysmograph Regulatory Class: Class II (two) Product Code: DSB Dated: October 24, 2012 Received: October 26, 2012

Dear Dr. O Griofa:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Image /page/2/Picture/11 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. The bottom half of the circle contains a stylized image of an eagle with its wings spread.

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Page 2 - Mr. Leo Wang

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Flease oe advised allat I DA s losaanse or wor device complies with other requirements of the Act that IDA has made a decemmation administered by other Federal agencies. You must. of any reactal statures and regulations and limited to: registration and listing (21 Comply will an the 11ct 3 requirements) ; medical device reporting (reporting of medical CI'N I all 607); labeling (21 CFR 803); good manufacturing practice requirements as set device-related daverse evento) (21 CFR Part 820); and if applicable, the electronic form in the quality by bloms (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please 11 you desire specific advice to: your derntersOffices/CDRH/CDRHOffices/ucm115809.html for go to mep. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . the Center Devices and reading by reference to premarket notification" (21CFR Part note the regulations regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Tou may obtain other getting to thernational and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

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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Premarket Notification - ZOE Fluid Status Monitor

Image /page/4/Picture/1 description: The image shows a sequence of alphanumeric characters. The sequence starts with the letters 'KI', followed by the numbers '112'. After that, there is an '8', a '3', and a '0'. The characters are written in a simple, handwritten style.

Indications for Use Statement

510(k) Number K112830

Previously Cleared as: K042113

Device Name: ZOE Fluid Status Monitor Model Number : ZOE2b

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 .

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH office of Device Evaluation (ODE)
and the control controlled of the production of end of the control of the control of the contribution of the contribution of the contribution of the contribution of the contr

sion Sign-t ion of Cardiovascular Devices

510(k) Number K112838

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Noninvasive Medical Technologies, Inc.

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.