ZOE FLUID STATUS MONITOR

K042113 · Noninvasive Medical Technologies, LLC · DSB · Sep 14, 2004 · Cardiovascular

Device Facts

• Record ID: K042113
• Device Name: ZOE FLUID STATUS MONITOR
• Applicant: Noninvasive Medical Technologies, LLC
• Product Code: DSB · Cardiovascular
• Decision Date: Sep 14, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.2770
• Device Class: Class 2

Intended Use

The ZOE™ Fluid Status Monitor is intended for use by qualified health care practitioners, 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 (Per 21 CFR 801.109)

Device Story

ZOE™ Fluid Status Monitor is a non-invasive, battery-powered thoracic base impedance monitor. It applies minimal current to the patient to measure electrical impedance changes in the thorax corresponding to aortic blood flow and heartbeat. Base impedance (Zo) decreases with increased fluid and rises with decreased fluid. The device uses a proprietary algorithm to calculate Zo values. It is intended for use by qualified healthcare practitioners under physician direction in clinical settings. Output provides fluid status data to assist clinicians in managing patients with fluid-related conditions, potentially aiding in early warning of fluid status changes.

Clinical Evidence

Clinical performance data was submitted; however, specific study results, sample sizes, or statistical metrics were not detailed in the provided documentation. The device relies on substantial equivalence to predicate devices and compliance with electrical safety standards (UL 2601-1/CSA C22.2 No. 60601, EN 60601-1:2003, EN 60601-1-2).

Technological Characteristics

Thoracic base impedance monitor; battery-powered. Uses disposable silver/silver chloride electrodes. Complies with UL 2601-1, CSA C22.2 No. 60601, EN 60601-1:2003, and EN 60601-1-2 standards. Proprietary algorithm for Zo calculation.

Indications for Use

Indicated for patients with fluid management problems, those taking diuretic medication, living with heart failure, living with end-stage renal disease, recovering from coronary artery disease-related events, or suffering from recurrent dehydration. Contraindicated for patients with hydrogel allergies, skin sensitivities to hydrogel, or skin breakdown at chest electrode sites.

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

• IQ System™ (K922218)
• IQ System™ (K981720)

Submission Summary (Full Text)

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K042113
page 1 of 3

SEP 1 4 2004

# ZOE™ Fluid Status Monitor

## 510(k) SPECIAL PREMARKET NOTIFICATION SUMMARY

- ZOE™ Fluid Status Monitor · Device Trade or Proprietary Name:
- · Common / Classification Name: Impedance Plethysmograph
- · Class: Class II Regulation Number: 870.2770 .
- Product Code: DSB

#### · Labeling:

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

#### · Predicate Device for Substantial Equivalence Comparison:

The ZOE™ Fluid Status Monitor, also referred to as ZOE or Zoe in the rest of this document, is claimed to be substantially equivalent to the following currently marketed Predicate Device and currently being marketed by NMT, LLC:

| Manufacturer | Device Name | 510-K Number | Decision Date |
|---------------------------------|-------------|--------------|-------------------|
| Renaissance<br>Technology, Inc. | IQ System™ | K922218 | December 08, 1992 |
| Renaissance<br>Technology, Inc. | IQ System™ | K981720 | February 08, 1998 |

### • Device Description:

The ZOE™ Fluid Status Monitor is a non-invasive, battery powered thoracic base impedance monitor designed as an 'early warning' monitor for determining changes in the fluid status of patients with fluid management problems.

The ZOE works by applying a minimal current to the patient. measuring electrical impedance changes throughout the thorax as aortic blood flow increases and decreases in response to each heartbeat. Base Impedance also known as Zo, decreases when fluid increases and rises when less fluid exists in the chest. This device incorporates a proprietary algorithm to calculate the Zo value.

The ZOE is designed for use with disposable, self-adhesive silver / silver chloride electrodes that are readily available / commercially approved within the United States for other approved cardiovascular monitoring systems.

- · Indications for Use Statement:

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K042113
page 2 of 3

#### The ZOE™ Fluid Status Monitor is indicated for patients:

- With fluid management problems o
- Taking diuretic medication o
- Living with Heart Failure o
- Living with End-stage Renal Disease o
- Recovering from Coronary Artery Disease related event o
- Suffering from Recurrent Dehydration o

#### Contraindications for Use .

The ZOE™ Fluid Status Monitor is contraindicated for use with patients:

- With allergies to electrode hydrogel O
- Skin sensitivities to electrode hydrogel o
- Skin breakdown in areas on the chest where ZOE electrode placement is o required.

#### • Clinical Performance Data

Clinical performance data has been submitted.

#### · Rationale for Substantial Equivalence

- 1. The ZOE™ Fluid Status Monitor patient interface design is very similar to the predicate device [IQ System (Impedance Plethysmograph Monitor {DSB}) already approved by the FDA and currently being marketed by NMT, LLC]
- 2. The INTENDED USES and the OPERATING PRINCIPLES (i.e. Effectiveness) of the ZOE™ Fluid Status Monitor are the SAME as the Zo measurement function of the predicate device.
- 3. The OPERATIONAL FEATURES of the ZOE™ Fluid Status Monitor are the SAME or SIMILAR to those offered by the predicate device
- 4. The SAFETY FEATURES of the ZOE™ Fluid Status Monitor are the SAME or very SIMILAR to those offered by the predicate device.

Therefore, in summary, the ZOE™ Fluid Status Monitor is substantially equivalent to the Zo measurement feature in the identified predicate device that has previously been allowed for commercial distribution in the United States.

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## · Safety and Effectiveness

The ZOE™ Fluid Status Monitor complies with the electrical standards of the Underwriters Laboratories UL 2601-1 / CSA C22.2 No. 60601 and has passed an inspection to these standards by an independent testing house. The ZOE underwent independent scrutiny and testing to assess the overall electrical safety and EMI safety. 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.

The ZOE does not raise any new issues of safety, effectiveness or performance of the device when compared to the existing predicate device.

#### · Conclusions

The data submitted in this 510(k) Premarket Notification, for the ZOE Fluid Status Monitor demonstrates that this product is substantially equivalent with respect to the indications for use, operating principles, operational features, and safety features to the identified legally marketed predicate device. With the information provided, the safety and effectiveness of the product can be reasonably assured, and we believe that this device clearly meets the requirement for a "Substantial Equivalence" decision in accordance with the 510(k) guidelines.

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Public Health Service

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 4 2004

Noninvasive Medical Technologies, LLC c/o Mr. Alden Kay Consultant 4367 Tuolumne Place Carlsbad, CA 92008-7924

Re: K042113

Trade Name: ZOE™ Fluid Status Monitor Regulation Number: 21 CFR 870.2770 Regulation Name: Impedance Plethysmograph Regulatory Class: Class II (two) Product Code: DSB Dated: August 3, 2004 Received: August 5, 2004

Dear Mr. Kay:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave teviewed your becally be device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for asc stated in the encreate to togally to togally the Medical Device Amendments, or to commerce prior to May 20, 1978, the excordance with the provisions of the Federal Food, Drug, devices that have been recuire approval of a premarket approval application (PMA). and Cosmetic Act (1101) market the device, subject to the general controls provisions of the Act. The 1 ou may, therefore, mailer are as act include requirements for annual registration, listing of general controls profices of of rectice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (600 a00 ro) als. Existing major regulations affecting your device can may be subject to subli additions, 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 - Mr. Alden Kay

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); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrh/dsma/dsmamain.html

Sincerely yours,

B/Bimmumer for
Prem D. Zuckerman, M.D.

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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#### K042113 510(k) Number (if known):

Previously approved as: K981720

"ZOE™ Fluid Status Monitor" Impedance Plethysmograph Device Name:

#### Indications For Use:

As with the predicate devices indicated in this submission (cardiac monitors employing impedance plethysmography {DSB}):

The ZOE™ Fluid Status Monitor is intended for:

- With fluid management problems 0
- Taking diuretic medication ಂ
- Living with Heart Failure o
- Living with End-stage Renal Disease O
- Recovering from Coronary Artery Disease related event 0
- Suffering from Recurrent Dehydration O

The ZOE™ Fluid Status Monitor is contraindicated for use with patients:

- With allergies to electrode hydrogel 0
- Skin sensitivities to electrode hydrogel ্
- Skin breakdown in areas on the chest where ZOE clectrode placement is o required.

This device is intended for use by qualified health care practitioners, 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 (Per 21 CFR 801.109)

| | <b>OR Over-The-Counter Use</b> |
|--------------------------|------------------------------------------|
| Division Sign-Off) | |
| | Division of Cardiovascular, Respiratory, |
| and Neurological Devices | (optional form |

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Bhiman

510(k) Number k042113