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 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 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.

AI/ML Overview

The provided text describes the IMED-Z Fluid Status Monitor and its substantial equivalence to a predicate device, the ZOE Fluid Status Monitor. However, it does not contain a detailed study proving the device meets specific acceptance criteria in the way a clinical performance study would typically be presented. Instead, it focuses on bench testing and comparisons to the predicate device's performance.

Based on the information provided, here's a breakdown:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding performance metrics for a clinical study. Instead, it describes various types of testing and their outcomes aimed at demonstrating substantial equivalence. The core performance "acceptance criteria" appear to be related to matching the measurement linearity and accuracy of the predicate device for impedance measurements in a bench setting.

Acceptance Criteria (Inferred from Performance Bench Testing)	Reported Device Performance
Measurement linearity of impedance on simulated thoracic impedances	IMED-Z device demonstrated linearity matching the predicate ZOE device.
Measurement accuracy of impedance on simulated thoracic impedances	IMED-Z device demonstrated accuracy matching the predicate ZOE device.
Biocompatibility (cytotoxicity, sensitization, irritation)	Fulfilled, in accordance with ISO-10993.
Electrical Safety (IEC 60601-1 Ed 3.1)	Fulfilled requirements (Report Number: 101945161LAX-001).
Electromagnetic Compatibility (IEC 60601-1-2 Ed 3.0)	Complies with requirements (Report Number: 101754547BOX-001).
Design Specification Requirements	All design requirements, including impedance measurement accuracy, were met (via Design Verification and Validation Activities).
Shelf-life	Validated for up to 24 months (via accelerated shelf-life testing).
Usability	Healthcare workers validated human interface design and instructions for use, ensuring safe and effective device interactions.

2. Sample Size Used for the Test Set and Data Provenance

The document describes performance bench testing using a "calibrated precision resistor array." This means the "test set" was not human physiological data, but rather a set of known electrical impedances.

Sample size for test set: Not explicitly stated as a number of "cases" but implies a range of impedance loads from the precision resistor array.
Data provenance: Bench simulated data, not from human subjects or specific countries.
Retrospective/Prospective: Not applicable, as it's bench testing.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Number of experts: Not applicable. The "ground truth" for the bench testing was the known values of the "calibrated precision resistor array."
Qualifications of experts: Not applicable.

4. Adjudication Method for the Test Set

Adjudication method: Not applicable. The "ground truth" was instrumental (calibrated resistor values), not based on expert opinion.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. The document describes a "head-to-head performance bench test" comparing the IMED-Z device to the predicate ZOE device using a resistor array. It does not involve human readers interpreting output or measuring their improvement with or without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, a standalone performance assessment was done in the context of the bench testing. The device (algorithm and hardware) was tested on its own to measure impedance values against known resistor values, demonstrating its function without a human interpreter in the loop for that specific measurement. However, this is for the technical performance of measuring impedance, not a clinical diagnostic performance in a standalone AI context.

7. The Type of Ground Truth Used

Bench Testing: The ground truth for the performance bench testing was the known, calibrated electrical impedance values presented by the precision resistor array.
Other Testing:
- Biocompatibility: Established through standardized laboratory tests.
- Electrical Safety and EMC: Established through compliance with international standards (IEC 60601-1, IEC 60601-1-2).
- Design Verification/Validation: Established against internal design specifications.
- Usability: Established through observation and feedback from healthcare workers.

8. The Sample Size for the Training Set

Not applicable / Not explicitly mentioned. This document describes premarket notification for a medical device (Impedance Plethysmograph), not an AI/ML algorithm that typically requires a large training set of labeled data. The IMED-Z device functions by directly measuring electrical impedance, not by pattern recognition or learning from a dataset in the way a modern AI would. It is a measurement device.

9. How the Ground Truth for the Training Set Was Established

Not applicable / Not explicitly mentioned. As there's no indication of an AI/ML component requiring a "training set" in the conventional sense, the establishment of ground truth for such a set is not discussed.

Summary

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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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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

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: (760) 571-3861 FAX: (760)683-6508

Contact Person:

Warren Craycroft Vice President, Regulatory and Quality Phone: (760) 571-3861 Ext 211 Fax: (760) 683-6509 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 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

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.

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.