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.

Device Description

The ZOE Fluid Status Monitor Model ZOE3 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 Model ZOE3 works by applying a low amplitude high frequency electrical current to the body and measuring the electrical impedance also known as Zo, decreases when fluid increases and increases when fluid decreases. The ZOE Fluid Status Monitor Model ZOE3 is designed for use with disposable, self-adhesive silver i silver chloride electrodes that are readliy available from Noninvasive Medical Technologies, Inc. NMT approved electrodes must be used with the ZOE Fluid Status Monitor. Zo readings obtained from unapproved electrodes may not be accurate!

AI/ML Overview

This 510(k) premarket notification for the ZOE Fluid Status Monitor Model ZOE3 does not contain the detailed performance study information requested.

The document states: "The ZOE Fluid Status Monitor Model ZOE3 has the same method of operation and is functionally equivalent to the predicate devices K112830 (November 13, 2012) & K131509 (June 28, 2013). The ZOE Fluid Status Monitor has the identical indications for use as the ZOE Fluid Status Monitor K112830 (November 13, 2012) & K131509 (June 28, 2013)." and "The ZOE3 Fluid Status Monitor does not raise any new issues of safety, effectiveness or performance of the device when compared to the existing predicate devices ZOE Fluid Status Monitor K112830 (November 13, 2012) & K131509 (June 28, 2013)."

This indicates that the device's acceptance is based on its substantial equivalence to previously cleared predicate devices, rather than new performance studies detailed in this specific submission. The submission focuses on general quality and safety testing relevant to device manufacturing and electrical standards, not clinical performance metrics.

Therefore, many of the requested details about a specific performance study are not available in this document.

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

1. Table of acceptance criteria and the reported device performance:

Acceptance Criteria: Not explicitly stated as quantifiable performance metrics for this specific submission, beyond meeting the general safety and functional equivalence of the predicate devices.
Reported Device Performance: No specific performance metrics (e.g., accuracy, sensitivity, specificity) for fluid status monitoring are reported in this document for the ZOE3. The document only confirms functional equivalence to predicate devices.

2. Sample size used for the test set and the data provenance:

Sample Size: Not specified.
Data Provenance: Not specified, as no new clinical performance study is detailed here.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Number of Experts: Not applicable, as no new clinical performance study is detailed here.
Qualifications of Experts: Not applicable.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not applicable, as no new clinical performance study is detailed here.

5. 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 an impedance monitor for fluid status, not an AI-assisted diagnostic imaging device with human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

A standalone performance in the context of clinical metrics is not detailed. The device itself is "standalone" in its measurement, but the document does not present a standalone clinical performance study to establish new efficacy.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Not applicable, as no new clinical performance study is detailed here.

8. The sample size for the training set:

Not applicable, as the document doesn't describe an AI/ML algorithm or a training set for clinical performance.

9. How the ground truth for the training set was established:

Not applicable.

Summary of available information:

This 510(k) submission for the ZOE Fluid Status Monitor Model ZOE3 relies on substantial equivalence to predicate devices (K112830 and K131509) for its acceptance. It emphasizes that the new model has the "same method of operation" and is "functionally equivalent" with "identical indications for use." The only specific "testing" mentioned relates to quality assurance measures (Risk Analysis, Requirements Review, Design reviews, Code Inspections, Verification and Validation, H/W and S/W Implementation Verification Testing) and electrical safety and EMI safety standards (CAN/CSA C22.2 No. 60601-1:08, IEC 60601-1, IEC 60601-1-2). No new clinical performance studies are presented in this document.

Summary

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Special 510(k) Premarket Notification - ZOE Fluid Status Monitor Model: ZOE3

Image /page/0/Picture/1 description: The image shows the logo for Noninvasive Medical Technologies, Inc. The logo consists of three concentric arcs on the left, followed by the letters "NMT". To the right of "NMT" is the text "Noninvasive Medical Technologies, Inc.". The text is in a simple, sans-serif font.

K133301 Page 1 of 2

JAN 222 2014

510(k) Summary

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 922614
	Tel: (888) 906-0413
	Fax: (702) 614-4170
OFFICIAL CORRESPONDENT	Dr. Marc O'Griofa MD (MB BCh BAO)
	Chief Technology/Medical Officer
	Tel: (888) 906-0413
	Fax: (702) 614-4170
	mogriofa@nmtinc.org
DATE PREPAIRED	October 19.2012
TRADE NAME	ZOE Fluid Status Monitor
MODEL	ZOE3
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 Model ZOE3 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	K112830	11/13/2012
	ZOE Fluid Status Monitor	K131509	06/28/2013.

Device Description:

The ZOE Fluid Status Monitor Model ZOE3 works by applying a low amplitude high frequency electrical current to the body and measuring the electrical impedance also known as Zo, decreases when fluid increases and increases when fluid decreases.

The ZOE Fluid Status Monitor Model ZOE3 is designed for use with disposable, self-adhesive silver i silver chloride electrodes that are readliy available from Noninvasive Medical Technologies, Inc. NMT approved electrodes must be used with the ZOE Fluid Status Monitor. Zo readings obtained from unapproved electrodes may not be accurate!

Labeling:

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

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Special 510(k) Premarket Notification – ZOE Fluid Status Monitor Model: ZOE3

Indications for Use:

The ZOE Fluid Status Monitor is intended for patients: With fluid management problems

K133301 Page 2 of 2

. 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.

Predicate Device Discussion:

The ZOE Fluid Status Monitor Model ZOE3 has the same method of operation and is functionally equivalent to the predicate devices K112830 (November 13, 2012) & K131509 (June 28, 2013). The ZOE Fluid Status Monitor has the identical indications for use as the ZOE Fluid Status Monitor K112830 (November 13, 2012) & K131509 (June 28, 2013)

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 and manufactured 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 ZQE Fluid Status Monitor Model ZOE3 will undergo testing to assess the overall electrical safety and EMI safety by an independent testing house. The ZOE Fluid Status Monitor with the electrical standards of the CAN/CSA C22.2 No. 60601-1:08 standard The ZOE will meet 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 IEC 60601-1, 3rd edition, EMC testing to Emissions / Immunity Requirements for EMC/EMI requirements for Medical Devices IEC 60601-1-2 which reasonably assures the device is safe when used as directed for its prescribed intended use.

Conclusion:

The ZOE3 Fluid Status Monitor Model has the same method of operation and is functionally equivalent to the predicate devices. The ZOE3 Fluid Status Monitor has the identical indications for use as the predicate devices the ZOE Fluid Status Monitors K112830 (November 13, 2012) & K131509 (June 28, 2013) The ZOE3 Fluid Status Monitor does not raise any new issues of safety, effectiveness or performance of the device when compared to the existing predicate devices ZOE Fluid Status Monitor K112830 (November 13, 2012) & K131509 (June 28, 2013)

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of two main elements: a circular text element and an abstract symbol. The text element reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion. The abstract symbol is a stylized representation of an eagle or bird-like figure, with three curved lines forming the body and wings.

Public Health Service

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

January 22, 2014

Noninvasive Medical Technologies, Inc. Marc O'Griofa MD 6412 S. Arville St. Las Vegas, NV 89118

K133301 Re:

Trade/Device Name: ZOE3 Fluid Content Monitor Regulation Number: 21 CFR 870.2770 Regulation Name: Impedance Plethysmograph Regulatory Class: Class II Product Code: DSB Dated: December 20, 2013 Received: December 23, 2013

Dear Marc 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.

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); medical device reporting (reporting of medical device

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Page 2 - Marc O'Griofa

related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions 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 Division of Small Manufacturers, International 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/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Owen P. Faris -S

for

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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Special 510(k) Premarket Notification - ZOE Fluid Status Monitor Model: ZOE3

Indications for Use Statement

510(k) Number

K133301 Page 1 of 1

Previously Cleared as: K112830 (11/13/2012) & K131509 (06/28/1013)

Device Name: ZOE Fluid Status Monitor Model: ZOE3

Indications for Use:

The ZOE Fluid Status Monitor is intended for patients:

With fluid management problems o
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 X (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)

Digitally signed by
Owen P. Faris -S
Date: 2014.01.22
05:48:01-05'00'

October 24, 2013 : 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.