ZOE FLUID STATUS MONITOR

K131509 · Noninvasive Medical Technologies, Inc. · DSB · Jun 28, 2013 · Cardiovascular

Device Facts

• Record ID: K131509
• Device Name: ZOE FLUID STATUS MONITOR
• Applicant: Noninvasive Medical Technologies, Inc.
• Product Code: DSB · Cardiovascular
• Decision Date: Jun 28, 2013
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.2770
• Device Class: Class 2

Intended 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. 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 Story

ZOE Fluid Status Monitor (Model ZOE 2b-5K) is a battery-powered, non-invasive impedance plethysmograph. It applies low-amplitude, high-frequency electrical current to the patient's body via disposable silver/silver chloride electrodes. The device measures electrical impedance (Zo); base impedance decreases as fluid increases and increases as fluid decreases. Used by healthcare professionals to monitor fluid status in patients with fluid management issues (e.g., heart failure, renal disease, dehydration). Output provides clinicians with objective data on fluid changes to assist in clinical management and decision-making. Device is intended for use under physician direction.

Clinical Evidence

No clinical data provided. Evidence consists of bench testing, including electrical safety (UL 2601-1 / CSA C22.2 No. 60601), electromagnetic compatibility (EN 60601-1-2), and verification/validation of hardware and software implementation.

Technological Characteristics

Battery-powered impedance plethysmograph. Uses disposable silver/silver chloride electrodes. Sensing principle: application of low-amplitude, high-frequency electrical current to measure base impedance (Zo). Complies with UL 2601-1, CSA C22.2 No. 60601, and EN 60601-1 standards. Certified to ISO 13485:2003.

Indications for Use

Indicated for patients with fluid management problems, including those on diuretics, living with heart failure or end-stage renal disease, recovering from coronary artery disease events, or suffering from recurrent dehydration. Intended for physician-directed non-invasive monitoring.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• ZOE Fluid Status Monitor (K112830)

Submission Summary (Full Text)

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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: [phone] |
| | Fax: [phone] |
| OFFICIAL CORRESPONDENT | Dr. Marc O'Griofa.MD (MB BCH BAO) |
| | Chief Technology/Medical Officer |
| | Tel: [phone] |
| | Fax: [phone] |
| | [e-mail] |
| 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 Medical<br>Technologies, Inc. | ZOE Fluid Status Monitor | K112830 | 11/13/2012 |

#### 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!

#### 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 [phone] or [phone] 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 .

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.

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.