ReDs Wearable System

K150095 · Sensible Medical Innovations , Ltd. · DSB · Aug 6, 2015 · Cardiovascular

Device Facts

• Record ID: K150095
• Device Name: ReDs Wearable System
• Applicant: Sensible Medical Innovations , Ltd.
• Product Code: DSB · Cardiovascular
• Decision Date: Aug 6, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2770
• Device Class: Class 2

Intended Use

ReDS is intended for use by qualified health care practitioners and by patients, under the direction of a physician, in hospitals, hospital-type facilities and home environment, for the non-invasive monitoring and management of patients with fluid management problems in a variety of medically accepted clinical applications.

Device Story

ReDS Wearable System is a non-invasive thoracic impedance monitor measuring lung fluid content. System comprises a wearable vest with embedded sensors, a bedside console with touch-screen display, and a cloud application. Principle of operation: emission of low-power electromagnetic (EM) signals into the body; sensors intercept signals; wave impedance calculated as function of tissue conductivity and capacitance, representing fluid content. Used in hospitals, hospital-type facilities, and home environments by healthcare providers or patients (self-use). Console processes signals, displays readings, and enables remote monitoring. Output assists clinicians in managing fluid status, potentially improving outcomes for heart failure and CAD patients.

Clinical Evidence

Evaluated via non-clinical bench testing, porcine animal model, and clinical studies. Clinical studies assessed pulmonary fluid quantification across a range of congestion levels (normal to highly congested). Results were consistent with non-clinical findings; no device-related adverse events reported. Bench testing verified accuracy, reproducibility, mechanical durability, and EM signal specifications. Biocompatibility confirmed per ISO 10993-5 and ISO 10993-10.

Technological Characteristics

Non-invasive thoracic impedance plethysmograph. Components: wearable vest with embedded sensors, bedside console with embedded computer. Energy source: low-power electromagnetic signals. Connectivity: bedside console with cloud application for remote monitoring. Standards: IEC 60601-1, IEC 60601-1-11, IEC 60601-1-2, IEC 60601-1-6, IEC 62366, ISO 10993, ISO 14971.

Indications for Use

Indicated for patients with fluid management problems, those taking diuretic medication, patients living with Heart Failure, and patients recovering from a Coronary Artery Disease related event.

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 (NMT Medical) (K131509, K112830, K042113, K133301)
• Aesculon (Osypka Medical) (K070985, K081035)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird in flight, composed of three overlapping profiles facing to the right. The profiles are arranged in a way that creates the impression of movement or flight. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.

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

August 6, 2015

Sensible Medical Innovations Ltd. % Janice Hogan Partner Hogan Lovells US LLP 1835 Market St Suite 2920 Philadelphia, Pennsylvania 19103

Re: K150095

Trade/Device Name: ReDSTM Wearable System Regulation Number: 21 CFR 870.2770 Regulation Name: Impedance Plethysmograph Regulatory Class: Class II Product Code: DSB Dated: July 8, 2015 Received: July 8, 2015

Dear Janice Hogan:

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 Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

{1}------------------------------------------------

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,

# Bram D. Zuckerman -S

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

# Indications for Use

510(k) Number (if known)

K150095

Device Name

ReDS™ Wearable System

Indications for Use (Describe)

ReDS is intended for use by qualified health care practitioners and by patients, under the direction of a physician, in hospitals, hospital-type facilities and home environment, for the non-invasive monitoring and management of patients with fluid management problems in a variety of medically accepted clinical applications.

ReDS is indicated for patients:

- · With fluid management problems
- · Taking diuretic medication
- · Living with Heart Failure
- Recovering from Coronary Artery Disease related event .

Type of Use (Select one or both, as applicable)

区 Prescription Use (Part 21 CFR 801 Subpart D)

_ Over-The-Counter Use (21 CFR 801 Subpart C)

#### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

#### FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Druq Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page

{3}------------------------------------------------

# 510(K) Summary DATE PREPARED: July 24, 2015 ReDS Wearable System 510(k) Number: K150095

# Applicant's Name:

Sensible Medical Innovations HaAlon 4 Kfar Neter, 4059300 POB 8702, Netanya Israel Tel: [phone], Fax: [phone]

# Contact Person:

Name: Inbal Ben-Tzvi Title: VP Requlatory Affairs Tel: Office ([phone] (x 103), Mobile [phone] Fax: [phone] Email: [e-mail]

#### Device Trade Name:

ReDS Wearable System

# Common/Classification Name:

Impedance plethysmograph

## Classification:

FDA has classified impedance plethysmographs as Class II devices (product code DSB, 21 CFR 870.2770), and they are reviewed by the Cardiovascular panel.

{4}------------------------------------------------

# Predicate Devices:

- > ZOE Fluid Status Monitor (NMT Medical), product code DSB, cleared for marketing under K131509, K112830, K042113, K133301 (primary predicate)
- > Aesculon (Osypka Medical), product code DSB, cleared for marketing under K070985, K081035

#### Indications for Use:

ReDS is intended for use by qualified health care practitioners and by patients, under the direction of a physician, in hospital-type facilities and home environment, for the non-invasive monitoring and management of patients with fluid management problems in a variety of medically accepted clinical applications.

ReDS is indicated for patients:

- . With fluid management problems
- Taking diuretic medication ●
- Living with Heart Failure
- Recovering from Coronary Artery Disease related event .

# Device Description:

The ReDS Wearable System ("ReDS") is a non-invasive thoracic base wave impedance monitor that provides measurement of patient lung fluid content. ReDS™ technology measures wave impedance of biological tissues. Low power electromagnetic (EM) signals are emitted into the body, and intercepted by sensors on the body. The wave impedance is a function of the distributed tissue conductivity and capacitance properties, and is representative of tissue fluid content.

The system consists of a Wearable Vest connected to a bedside console, as well as a cloud application. The Wearable Vest encases two sensors and an attachment mechanism. The Bedside Console is an enclosure housing the electronic modules, an embedded computer and a touch-screen display. The device software provides the management of the device as well as analysis of the measured signals, graphic display of readings, reporting, and communications functionality to enable remote patient monitoring.

# Technoloqical Characteristics:

The ReDS Wearable System's technological characteristics are substantially equivalent to those of its predicate devices. All of the devices are non-invasive, prescription use, transportable bedside devices indicated for use in hospital and hospital-like environments by healthcare providers, and both the ReDS and the Aesculon are also indicated for use in the home environment by patients for selfmeasuring. Same as both predicates, ReDS uses non-invasive measurements of impedance characteristics to assess the amount of fluid in tissue. All of the devices use sensing elements placed on the user's body and measurement

{5}------------------------------------------------

initiation through a graphical user interface. ReDS sensors are embedded in the wearable vest, whereas the predicate devices use sensors adhered to the body. The minor differences between the ReDS and the predicate devices, e.g., range of parameters, number of sensors, and the sensor placement methods, do not raise new types of safety and effectiveness questions. These differences have been assessed in bench, preclinical, and clinical testing. Results established that the ReDS System performs as intended and is substantially equivalent to its predicate devices.

#### Performance Data:

The ReDS Wearable System was evaluated in non-clinical, and clinical testing. Results demonstrated that the device meets specifications and supported substantial equivalence to the predicate devices. The device is not provided sterile and does not require end user sterilization.

#### Biocompatibility

ISO 10993 testing demonstrated biocompatibility of the device materials. Cytotoxicity (ISO 10993-5), intracutaneous (ISO 10993-10), and sensitization (ISO 10993-10) testing demonstrated all passing results, supporting the biocompatibility of the device for its intended use.

#### Software

Software validation and verification testing was conducted for the ReDS System software. Results demonstrated that the software was appropriate for release. The software hazard analysis was performed in accordance with ISO 14971:2007.

#### Electrical Safety and Electromagnetic Compatibility

Electrical safety and electromagnetic compatibility testing were conducted. Results demonstrated that the system complies with the applicable testing standards (IEC 60601-1, IEC 60601-1-11, IEC 60601-1-2, IEC 60601-1-6, and IEC 62366).

#### Bench Testing

Bench testing, demonstrating substantial equivalence to the predicate display provided devices, reproducibility and accuracy), mechanical durability and EM signal specifications verification. Usability testing was also conducted to validate use of the system by the intended professional and lay users. All performance testing passed according to defined acceptance criteria, demonstrating that the device performs as expected.

#### Animal Study

The ReDS System was also evaluated in a porcine animal model to demonstrate the ReDS accuracy in quantifying lung fluid content.

{6}------------------------------------------------

#### Clinical Data

Clinical studies were conducted to provide preliminary clinical performance data of the ReDS technology for the quantification of pulmonary fluid level in patients presenting various fluid content levels across the operational range (including normal to highly congested patients). No device-related adverse events were reported. The performance of ReDS in the clinical setting was consistent with the findings of the nonclinical studies.

# Conclusion:

The ReDS Wearable System has the same intended use and similar indications for use, technological characteristics and principles of operation as the predicate devices. Any minor differences in the ReDS System compared to the predicate devices do not raise any new questions of safety or effectiveness. Performance tests, including bench studies, animal testing and clinical studies, have been conducted to confirm that these differences do not adversely impact safety or performance. In sum, the conclusions from the non-clinical and clinical tests demonstrate that the ReDS Wearable System performs similarly to the leqally marketed predicate devices.