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 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 / silver chloride electrodes that are readily 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 document is a 510(k) premarket notification for the ZOE Fluid Status Monitor (Model ZOE 2b-5k). It addresses the safety and effectiveness of the device by establishing its substantial equivalence to a predicate device.

Acceptance Criteria and Device Performance:

The document does not detail specific quantitative acceptance criteria or a dedicated study showing the device meets such criteria in terms of accuracy, sensitivity, or specificity for diagnosing fluid status. Instead, the primary "acceptance criterion" for this 510(k) submission is substantial equivalence to a previously cleared predicate device.

The reported "device performance" is based on the claim of functional equivalence and identical indications for use as the predicate device.

Acceptance Criteria Category	Specific Criteria	Reported Device Performance
Functional Equivalence	Method of operation is the same as the predicate device.	The ZOE Fluid Status Monitor has the same method of operation as the predicate device (K112830).
Indications for Use	Indications for use are identical to the predicate device.	The ZOE Fluid Status Monitor has identical indications for use as the predicate device (K112830).
Safety and Effectiveness Issues	Does not raise any new issues of safety, effectiveness, or performance.	The ZOE Fluid Status Monitor does not raise any new issues of safety, effectiveness, or performance compared to the predicate device.
Electrical Safety	Compliance with UL 2601-1 / CSA C22.2 No. 60601.	The ZOE Fluid Status Monitor complies with UL 2601-1 / CSA C22.2 No. 60601.
EMC/EMI Compliance	Compliance with EN 60601-1-2 and EN 60601-1:2003.	The ZOE met all electrical and electromagnetic compatibility (EMI) safety requirements, including EN 60601-1:2003 and EN 60601-1-2.
Quality Management System	Manufactured under a certified Quality Management System.	Noninvasive Medical Technology is certified to ISO13485 2003.

Study Details:

The document describes a 510(k) premarket notification process, not a clinical study in the traditional sense that generates new performance data to prove efficacy. The "study" here is the comparative analysis against the predicate device to demonstrate substantial equivalence.

Sample size used for the test set and the data provenance: Not applicable. This document does not describe a clinical test set with human subjects for performance evaluation. The "test set" for this 510(k) is the comparison of device characteristics (design, materials, operating principles, indications for use, safety standards) to the predicate device.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth in a clinical sense (e.g., diagnosis of a condition) is not established in this document. The "ground truth" for the substantial equivalence claim is the pre-existing FDA clearance of the predicate device (K112830).
Adjudication method for the test set: Not applicable. There was no clinical test set requiring adjudication.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No. An MRMC study was not described or performed for this 510(k) submission. The document focuses on device characteristics and regulatory compliance, not on human reader performance with or without AI assistance.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: The ZOE Fluid Status Monitor is a hardware device (impedance plethysmograph) that measures electrical impedance. It does not appear to involve an AI algorithm that would have standalone performance in the way a diagnostic imaging algorithm might. Its "performance" revolves around accurate impedance measurement, which is addressed by electrical safety and EMC testing, not standalone algorithmic evaluations.
The type of ground truth used: For the purposes of this 510(k) submission, the "ground truth" is the established safety and effectiveness of the predicate device (ZOE Fluid Status Monitor K112830), as previously cleared by the FDA. The current device is deemed "substantially equivalent" based on direct comparison of its attributes to those of the predicate. Compliance with electrical safety and EMC standards (UL 2601-1 / CSA C22.2 No. 60601, EN 60601-1, EN 60601-1-2) serves as "ground truth" for those specific engineering performance aspects.
The sample size for the training set: Not applicable. This is not an AI/machine learning device that requires a training set in the conventional sense.
How the ground truth for the training set was established: Not applicable, as there is no training set mentioned for this device.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for Noninvasive Medical Technologies, Inc. The logo consists of the letters "NMT" inside of a partial circle on the left, and the words "Noninvasive Medical Technologies, Inc." on the right. The text is in a simple, sans-serif font and is black in color. The logo is clean and professional, and it conveys a sense of innovation and technology.

JUN 2 8 2013

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.

Noninvasive Medical Technologies, Inc.

APPLICANT

	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	ZOE 2b-5k
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	K112830	11/13/2012

Device Description:

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 / silver chloride electrodes that are readily 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.

Indications for Use:

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

Taking diuretic medication き
. Living with Heart Failure

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� 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 has the same method of operation and is functionally equivalent to the predicate device K112830 (November 13, 2012). The ZOE Fluid Status Monitor has the identical indications for use as the predicate devices the ZOE Fluid Status Monitor K112830 (November 13, 2012)

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 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/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.

Conclusion:

The ZOE Fluid Status Monitor has the same method of operation and is functionally equivalent to the predicate device. ). The ZOE Fluid Status Monitor has the identical indications for use as the predicate devices the ZQE Fluid Status Monitor K112830 (November 13, 2012)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 K112830 (November 13, 2012)

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle with its wings spread, with three horizontal lines above the eagle's head.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

June 28, 2013

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: K131509

Trade/Device Name: ZOE Fluid Status Monitor (Model ZOE 2b-5K) Regulation Number: 21 CFR 870.2770 Regulation Name: Impedance Plethysmograph Regulatory Class: Class II (two) Product Code: DSB Dated: May 30, 2013 Received: May 31, 2013

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.

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Page 2 - Dr. Marc O Griofa

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-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Owen P. Earis -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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K131509

pg I of I

Special 510(k) Premarket Notification - ZOE Fluid Status Monitor Model ZOE2b-Sk

Indications for Use Statement

510(k) Number

Previously Cleared as: K112830 (11/13/2012)

Device Name: ZOE Fluid Status Monitor Model Number: ZOE 2b-5K

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)

Owen P. Faris -S
2013.06.28 14:18:47
-04'00'

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.