ZOEFLUID STATUS MONITOR (MODEL ZOE 2B)

K112830 · Noninvasive Medical Technologies, Inc. · DSB · Nov 13, 2012 · Cardiovascular

Device Facts

• Record ID: K112830
• Device Name: ZOEFLUID STATUS MONITOR (MODEL ZOE 2B)
• Applicant: Noninvasive Medical Technologies, Inc.
• Product Code: DSB · Cardiovascular
• Decision Date: Nov 13, 2012
• Decision: SESE
• Submission Type: Traditional
• 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 is a battery-powered, non-invasive impedance plethysmograph. Device applies low-amplitude, high-frequency electrical current to patient body via disposable, self-adhesive silver chloride electrodes. System measures electrical impedance (Zo); base impedance decreases with fluid increase and increases with fluid decrease. Used under physician direction for monitoring/managing fluid status in patients with fluid management issues (e.g., heart failure, renal disease, dehydration). Healthcare providers use output to assess fluid status changes, aiding clinical decision-making for fluid management. Device provides early warning of fluid status shifts.

Clinical Evidence

No clinical data provided. Safety and effectiveness supported by bench testing, including electrical safety (UL 2601-1/CSA C22.2 No. 60601) and electromagnetic compatibility (EN 60601-1, EN 60601-1-2).

Technological Characteristics

Impedance plethysmograph; battery-powered. Uses disposable silver chloride electrodes. Sensing principle: electrical impedance measurement via low-amplitude, high-frequency current. Complies with UL 2601-1, CSA C22.2 No. 60601, EN 60601-1, and EN 60601-1-2. Quality management system certified to ISO 13485:2003.

Indications for Use

Indicated for patients with fluid management problems, including those taking 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 use.

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 (K042113)

Submission Summary (Full Text)

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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.<br>6412 S. Arville St.<br>Las Vegas, NV 89118<br>Tel: [phone]<br>Fax: [phone] |
|-------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| OFFICIAL CORRESPONDENT | Dr. Marc O Griofa, M.D. (MB BCh BAO), Ph.D., F.A.W.M.<br>Chief Technology/Medical Officer<br>Tel: [phone]<br>Fax: [phone]<br>[e-mail] |
| 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 Medical<br>Technologies, Inc. | ZOE Fluid Status Monitor | K042113 | Sept. 14, 2004 |

#### 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.

#### 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 .

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<112830

- 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 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),

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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 [phone] or [phone] 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

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# 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 .

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) |
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| 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.