IMED-Z FLUID STATUS MONITOR

K142503 · Intersection Medical, Inc. · DSB · Jun 5, 2015 · Cardiovascular

Device Facts

• Record ID: K142503
• Device Name: IMED-Z FLUID STATUS MONITOR
• Applicant: Intersection Medical, Inc.
• Product Code: DSB · Cardiovascular
• Decision Date: Jun 5, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2770
• Device Class: Class 2

Intended Use

The IMED-Z 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 ● - o Suffering from Recurrent Dehydration This device is intended for use, under the direction of a physician, for the noninvasive monitoring and management of patients with fluid management problems in a variety of medically accepted clinical applications.

Device Story

Non-invasive, battery-powered impedance monitor; determines fluid status changes in patients with fluid management issues. Device applies low-amplitude, high-frequency (2.0 mA at 100 kHz) electrical current to thorax via four-point measurement technique using Ag/AgCl hydrogel electrodes. Base impedance (Zo) decreases with fluid increase, increases with fluid decrease. Used in clinical settings under physician direction. Hardware-controlled measurement timing; mounted on patient strap with short cable to electrode sensor. Provides clinicians with objective impedance data to assist in fluid management and monitoring decisions; aids in early warning of fluid status changes.

Clinical Evidence

Bench testing only. No clinical data. Performance characterized via head-to-head bench testing against predicate ZOE monitor using calibrated precision resistor array to simulate thoracic impedance loads. Results demonstrated matching measurement linearity and accuracy. Biocompatibility (ISO 10993), electrical safety (IEC 60601-1), and EMC (IEC 60601-1-2) testing performed. Usability testing validated human interface design.

Technological Characteristics

Bioimpedance measurement device; 4-point thoracic measurement. Energy: battery-powered, 2.0 mA at 100 kHz output. Materials: Ag/AgCl hydrogel electrodes, patient strap. Form factor: strap-mounted acquisition module. Connectivity: standalone. Sterilization: N/A (disposable electrodes). Hardware-based timing control. Safety: Type BF protection, IEC 60601-1 compliant.

Indications for Use

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

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 (K133301)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure.

Public Health Service

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

June 5, 2015

Intersection Medical, Inc. c/o Mr. Warren Craycroft Vice President of Regulatory and Quality 1808 Aston Ave Suite 120 Carlsbad, California 92008-7364

Re: K142503

> Trade/Device Name: IMED-Z Fluid Status Monitor Regulation Number: 21 CFR 870.2770 Regulation Name: Impedance Plethysmograph Regulatory Class: Class II Product Code: DSB Dated: April 30, 2015 Received: May 4, 2015

Dear Mr. Warren Craycroft,

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

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Part 807); labeling (21 CFR Part 801); medical device reporting of medical devicerelated 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 Industry and Consumer Education at its toll-free number [phone] or [phone] 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Mitchell Stein

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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# K142503

# Indications for Use Statement

510(k) Number K142503

Device Name: IMED-Z Fluid Status Monitor

Indications for Use:

The IMED-Z 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 ●
- o Suffering from Recurrent Dehydration

This device is intended for use, under the direction of a physician, for the noninvasive monitoring and management of patients with fluid management problems in a variety of medically accepted clinical applications.

Prescription Use YES Over-The-Counter Use NO AND/OR (Part 21 CFR 801 Subpart D) (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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## 5. 510(K) SUMMARY

#### SUBMITTER I.

Intersection Medical, Inc. 1808 Aston Avenue, Suite 120 Carlsbad, CA 92008-7364 Tel: [phone] FAX: [phone]

Contact Person:

Warren Craycroft Vice President, Regulatory and Quality Phone: [phone] Ext 211 Fax: [phone] E-mail: wcraycroft(@intersectionmedical.com

Date Prepared: April 28, 2015

## II. DEVICE

| Name of Device: | IMED-Z Fluid Status Monitor |
|-----------------------|--------------------------------------------|
| Common or Usual Name: | Fluid status monitor |
| Classification Name: | Impedance Plethysmograph (21CFR §870.2770) |
| Regulatory Class: | II |
| Product Code: | DSB |

## III. PREDICATE DEVICE

ZOE Fluid Status Monitor, K133301 (January 22, 2014) This predicate has not been subject to a design-related recall.

No reference devices were used in this submission.

## IV. DEVICE DESCRIPTION

The IMED-Z 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 IMED-Z Fluid Status Monitor works by applying a low-amplitude, high frequency electrical current to the body and measuring the electrical impedance using

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a four-point measurement technique through hydrogel (ECG style) electrode contacts. Base Impedance, also known as Zo, decreases when fluid increases and increases when fluid decreases.

The Fluid Status Monitor is designed for use with disposable, self-adhesive silver / silver chloride electrodes that are readily available from Intersection Medical, Inc. IMED-approved electrodes must be used with the IMED-Z Fluid Status Monitor. Zo reading obtained from unapproved electrodes may not be accurate.

The associated components and accessories include the following:

- IMED-Z acquisition module
- Battery pack and cable .
- Battery charger
- Single-use electrode sensor ●
- Single-use electrode interface cables .
- Single-use patient strap

# V. INDICATIONS FOR USE

The IMED-Z Fluid Status Monitor has the identical indications for use as the predicate device ZOE Fluid Status Monitor K133301 (January 22, 2014 ):

The IMED-Z 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 Dehvdration

This device is intended for use, under the direction of a physician, for the noninvasive monitoring and management of patients with fluid management problems in a variety of medically accepted clinical applications.

# VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

Both the subject and predicate devices are bioimpedance measurement devices that measure thoracic base impedance to assess fluid status. At a high level, the subject and predicate devices are based on the following same technological elements:

- 4-point impedance measurement of the patient's thorax
- Identical electric current output: 2.0 mA at 100 kHz .
- Ag / AgCl hydrogel electrodes ●
- . Type BF degree of protection
- Low-voltage monitor electronics; no mains voltage on-board either monitor ●

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The following technological differences exist between the subject and predicate devices:

- . Placement of electrodes: IMED-Z on back; predicate ZOE on chest
- The IMED-Z uses hardware to control measurement timing. The predicate ● ZOE uses a microprocessor and software.
- The IMED-Z is mounted on a patient strap with a short cable connection to ● the electrode sensor. The predicate ZOE is connected to the electrode by a 68 inch cable.

#### VII. PERFORMANCE TESTING:

The following performance data were provided in support of the substantial equivalence determination.

## Biocompatibility testing

The biocompatibility evaluation for the IMED-Z device was conducted in accordance with the FDA Blue Book Memorandum #G95-1 "Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing, "" May 1, 1995, and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. The battery of testing included the following tests:

- Cytotoxicity .
- Sensitization ●
- Irritation .

The electrode sensor and patient strap are classified as intact skin contact for a duration of less than 24 hours.

# Electrical safety

Electrical safety testing in compliance with IEC 60601-1 Ed 3.1 was completed on April 27, 2015 by Intertek Testing Services NA Inc. The IMED-Z fulfils the requirements of IEC 60601-1. The Report Number is 101945161LAX-001.

# Electromagnetic compatibility (EMC) testing

EMC testing to the IEC 60601-1-2 Ed 3.0 (2007-03) standard was completed on the IMED-Z device on July 28, 2014 by Intertek Testing Services NA Inc. The IMED-Z complies with the requirements of the standard indicated. The Report Number is 101754547BOX-001.

# Design Verification and Validation Activities

Design Verification and validation activities have been performed on the IMED-Z. The IMED-Z meets its design specification requirements, including impedance measurement accuracy.

## Shelf-life testing

Accelerated shelf-life testing has been completed, validating a shelf life of up to 24

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### months.

## Usability testing

Usability testing was performed with healthcare workers to validate the human interface design and instructions for use to ensure safe and effective device interactions.

## Performance bench testing

A head-to-head performance bench test with the predicate device was performed to characterize and compare the impedance measurement performance of the IMED-Z Fluid Status Monitor and the predicate ZOE Fluid Status Monitor (K133301). A calibrated precision resistor array was used to present a range of impedance loads to both devices. The IMED-Z device demonstrated substantial equivalence to the predicate ZOE device by matching measurement linearity and measurement accuracy of the ZOE device.

# VIII. CONCLUSIONS

The biocompatibility testing, electrical safety evaluation, and EMC testing demonstrate that the IMED-Z device is as safe as the predicate ZOE Fluid Status Monitor. The hardware verification and validation demonstrate that design requirements, including measurement accuracy requirements, are met. The usability testing ensures that intended users can operate the device safely and effectively. The head-to-head performance bench testing demonstrates that the IMED-Z performs impedance measurements on simulated thoracic impedances as well as the predicate ZOE Fluid Status Monitor that is currently marketed for the same intended use.

Conclusions drawn from performance testing demonstrate that the IMED-Z device is as safe, as effective, and performs as well as the ZOE Fluid Status Monitor K133301, a legally marketed device.