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

With fluid management problems
Taking diuretic medication
Living with heart failure
Recovering from a coronary artery disease-related event

Device Description

The ReDS System ("ReDS" or "ReDS System") 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 Sensor Unit connected to a bedside console, as well as a cloud application. The Sensor Unit 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.

AI/ML Overview

The provided document is a 510(k) summary for the ReDS System V2.7, seeking substantial equivalence to a predicate device, the ReDS Wearable System V2.6. As such, the study described focuses on demonstrating that the new device (V2.7) performs equivalently to the existing cleared device (V2.6), rather than establishing de novo performance criteria against a specific medical condition's ground truth.

Therefore, the acceptance criteria and study design are framed around equivalence to a predicate device, not necessarily absolute clinical accuracy or performance based on an independent ground truth outside of this comparison.

Here's an analysis of the document to address your request:

Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by demonstrating "substantial equivalence" to the predicate device (ReDS V2.6). The performance reported is in terms of this equivalence, rather than specific numerical thresholds for diagnostic accuracy against a disease state.

Acceptance Criteria (Implied for Equivalence)	Reported Device Performance (ReDS System V2.7 in comparison to ReDS V2.6)
Functional Equivalence: The ReDS System V2.7 should perform the same intended function as the ReDS V2.6 predicate device (non-invasive monitoring and management of patients with fluid management problems by measuring lung fluid content).	Met: "ReDS System V2.7 has the same intended use and similar indications for use, technological characteristics, and principles of operation as the predicate device, ReDS System V2.6." (Page 6)
Safety and Effectiveness Equivalence: Minor differences between V2.7 and V2.6 should not raise new questions of safety or effectiveness. Performance tests must confirm that these differences do not adversely impact safety or performance.	Met: "Any minor differences between the two generation of devices do not raise any new questions of safety or effectiveness. Performance tests, confirm that these differences do not adversely impact safety or performance." (Page 6). This was supported by non-clinical (biocompatibility, software, electrical safety, bench) and clinical testing.
Biocompatibility: Device materials must be biocompatible for intended use.	Met: ISO 10993 testing (cytotoxicity, skin irritation, sensitization) demonstrated "all passing results, supporting the biocompatibility of the device for its intended use." (Page 5)
Software Validation: Software must be validated and verified as appropriate for release, with hazard analysis performed.	Met: "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." (Page 5)
Electrical Safety and EMC: Device must comply with applicable electrical safety and electromagnetic compatibility standards.	Met: "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)." (Page 5)
Bench Testing Performance: Demonstrate substantial equivalence to the predicate for mechanical durability, packaging, transportation, quality feedback, cleaning, disinfection, and usability. All performance testing passed according to defined acceptance criteria.	Met: "Bench testing, demonstrating substantial equivalence to the predicate device, provided verification and validation of mechanical durability, packaging and transportation, quality feedback mechanisms, and cleaning and disinfection. Usability testing was also conducted... All performance testing passed according to defined acceptance criteria, demonstrating that the device performs as expected." (Page 5)
Clinical Performance Equivalence: Clinical data must show equivalent performance between ReDS System V2.7 and ReDS System V2.6, and consistency with non-clinical findings. No device-related adverse events reported.	Met: "Clinical data was provided to further assess the ReDS System V2.7 equivalency to ReDS System V2.6. Results showed equivalent performance of the two ReDS System generations. The equivalency presented in the clinical setting was consistent with the findings of the nonclinical studies. No device-related adverse events were reported." (Page 5)
Expanded Patient Anatomy Range (Specific to V2.7 improvement): The system should be suitable for a slightly expanded height range and for patients with higher BMI within certain chest size ruler values.	Met: Changed from "height of between 155 cm (5' 1'') to 190 cm (6' 3'')" (V2.6) to "155 cm (5' 1'') to 195 cm (6' 5''). Patients within the height range having a BMI of 36 to 38 can use the system if their chest size ruler value (as measured by the unit) is 39 or less." (V2.7) (Page 7). This is an improvement, not a criterion to be met by a study.
Sensor Attachment Configuration Change (Specific to V2.7 change): The new clip-like sensor unit must not negatively impact performance.	Met: The change from "2 non-touch sensors embedded in a wearable vest" (V2.6) to "2 non-touch sensors embedded in a clip-like sensor unit" (V2.7) was assessed and deemed not to raise new safety/effectiveness questions (Page 5). This would have been covered by the clinical equivalence study.
Algorithm Change (Specific to V2.7 change): The "stricter signal quality assessment mechanism" in V2.7 should not negatively impact overall performance or safety.	Met: This algorithm change was part of the overall device and covered by the clinical equivalence study and software validation. The document states "Algorithm: Same with a stricter signal quality assessment mechanism" (Page 7), implying it's an enhancement that doesn't hinder performance.

Study Details:

The document describes a comparison study to demonstrate substantial equivalence, rather than a de novo clinical trial establishing absolute accuracy against a gold standard for a specific disease or outcome.

Sample size used for the test set and the data provenance:
- Test Set (Clinical Data): The document states "Clinical data was provided to further assess the ReDS System V2.7 equivalency to ReDS System V2.6." However, it does not specify the sample size for this clinical test set.
- Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective for the clinical testing.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Given that this is an equivalence study between two versions of the same device, and not a study validating the device's accuracy against a specific physiological ground truth (e.g., direct measurement of lung fluid volume), the concept of "experts establishing ground truth for the test set" in the traditional sense (e.g., radiologists annotating images) is not directly applicable here.
- The "ground truth" for this study is essentially the performance of the predicate device (ReDS V2.6). The clinical study aimed to show that V2.7's performance was equivalent to V2.6's.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable in the context of this equivalence study. There is no mention of independent reviewers or an adjudication process for clinical "ground truth" labels, as the study's goal was to compare the two device versions.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, an MRMC comparative effectiveness study was not conducted or described. The ReDS System measures lung fluid content; it is not described as an AI-assisted diagnostic imaging tool where human readers "improve with AI assistance." The device is a direct measurement system.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The ReDS System itself is a standalone device that measures lung fluid content algorithmically. It's described as a "non-invasive thoracic base wave impedance monitor that provides measurement of patient lung fluid content." The "clinical data" section (Page 5) effectively serves as a standalone performance assessment in comparison to the predicate device. The performance of the algorithm within V2.7 was assessed as part of the overall device performance against V2.6.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the clinical study's "ground truth," the performance of the predicate device (ReDS V2.6) was implicitly used as the reference point for comparison. The study aimed to show that the new device (V2.7) did not significantly differ in its measurements or clinical utility from the established V2.6.
- The document does not detail a separate, independent "gold standard" for fluid assessment (e.g., invasive measurements, specific clinical outcomes data) against which both devices were tested. The core claim is equivalence to the predicate.
The sample size for the training set:
- Not applicable / Not explicitly stated. This document describes the validation of a medical device hardware and software system, not the training of a machine learning model. While an internal algorithm exists (which was updated with a "stricter signal quality assessment mechanism" in V2.7), the summary does not suggest a discrete "training set" in the common machine learning sense. The development of the algorithm would have involved internal data sets, but these are not reported as a "training set" in the context of this 510(k) summary.
How the ground truth for the training set was established:
- Not applicable. As above, the summary does not detail a machine learning training process or corresponding ground truth establishment.

Summary

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February 28, 2019

Sensible Medical Innovations Ltd. % Janice Hogan Partner Hogan Lovells US LLP 1735 Market Street, Floor 23 Philadelphia, Pennsylvania 19103

Re: K180479

Trade/Device Name: ReDS System Regulation Number: 21 CFR 870.2770 Regulation Name: Impedance Plethysmograph Regulatory Class: Class II Product Code: DSB Dated: February 25, 2019 Received: February 25, 2019

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Stephen C. Browning -S5

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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Indications for Use

510(k) Number (if known) K180479

Device Name ReDS System

Indications for Use (Describe)

With fluid management problems
Taking diuretic medication
· Living with heart failure
· Recovering from a coronary artery disease-related event

Type of Use (Select one or both, as applicable)X Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(K) Summary

Update date : February 9, 2019

ReDS System V2.7

510(k) Number K180479

Applicant's Name:

Sensible Medical Innovations Meir Ariel 6, Netanya, 4059300 POB 8702 Israel Tel: 972-9-8654402, Fax: 972-9-8654472

Contact Person:

Name: Shlomi Bergida Title: VP Product Tel: Office (+972) 9-8654402, Mobile (+972) 52-6584101 Fax: (+972) 9-8654472 Email: shlomi.b@sensible-medical.com

Device Trade Name:

ReDS 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.

Predicate Devices:

ReDS Wearable System V2.6 (K150095)

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Indications for Use:

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

The ReDS System is indicated for patients:

With fluid management problems ●
. Taking diuretic medication
Living with heart failure .
. Recovering from a coronary artery disease-related event

Device Description:

Technological Characteristics:

The ReDS System's technological characteristics are substantially equivalent to those of its predicate device, i.e., the first generation ReDS System V2.6. Both devices are non-invasive, prescription use, transportable bedside devices indicated for use in hospital and hospital-like environments by healthcare providers. Same as the predicate, ReDS V2.7 uses non-invasive measurements of impedance characteristics to assess the amount of fluid in tissue. Both devices use sensors placed on the user's body and measurement initiation through a graphical user interface. ReDS V2.7 sensors are located in a clip-like sensor unit, whereas the predicate device use sensors embedded in the wearable vest. The minor differences noted above between ReDS V2.7 and the ReDs V2.6 predicate device

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do not raise new types of safety and effectiveness questions. These differences have been assessed in bench, human factors, and clinical testing. Results established that the ReDS System V2.7 performs as intended and is substantially equivalent to its predicate device.

Performance Data:

ReDS System V2.7 was evaluated in non-clinical and clinical testing. Results demonstrated that the device meets specifications and supported substantial equivalence to the predicate device. 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), skin irritation (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 device, provided verification and validation of mechanical durability, packaging and transportation, quality feedback mechanisms, and cleaning and disinfection. Usability testing was also conducted to validate use of the system by the intended professional users. All performance testing passed according to defined acceptance criteria, demonstrating that the device performs as expected.

Clinical Data

Clinical data was provided to further assess the ReDS System V2.7 equivalency to ReDS System V2.6. Results showed equivalent performance of the two ReDS System generations. The equivalency presented in the clinical setting was consistent with the findings of the nonclinical studies. No device-related adverse events were reported.

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Conclusion:

ReDS System V2.7 has the same intended use and similar indications for use, technological characteristics, and principles of operation as the predicate device, ReDS System V2.6. Any minor differences between the two generation of devices do not raise any new questions of safety or effectiveness. Performance tests, confirm that these differences do not adversely impact safety or performance. In summary, the conclusions from the non-clinical tests demonstrate that ReDS System V2.7 is as safe, as effective, and performs as well as or better than the legally marketed predicate device, ReDS System V2.6.

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Substantial Equivalence Comparison Table

Criteria	ReDS V2.6 (As Cleared In K150095)	ReDS V2.7 (K180479)
Manufacturer	Sensible Medical Innovations Ltd.	Sensible Medical Innovations Ltd.
K Number	K150095	K180479
Product Code	DSB	DSB
Classification	Class II	Class II
ProductClassification/CommonName	Plethysmograph/Fluid Status Monitor	Same
Indications forUse	ReDS is intended for use by qualified health carepractitioners and by patients, under the direction of aphysician, in hospitals, hospital-type facilities and homeenvironment, for the non-invasive monitoring andmanagement of patients with fluid managementproblems in a variety of medically accepted clinicalapplications.ReDS is indicated for patients:◇ With fluid management problems◇ Taking diuretic medication◇ Living with Heart Failure◇ Recovering from Coronary Artery Disease relatedevent	The ReDS System is intended for use by qualifiedhealth care practitioners, under the direction of aphysician, in hospitals, hospital-type facilities andhome environments, for the non-invasive monitoringand management of patients with fluid managementproblems in a variety of medically accepted clinicalapplications.The ReDS System is indicated for patients:◇ With fluid management problems◇ Taking diuretic medication◇ Living with heart failure◇ Recovering from a coronary artery disease-relatedevent
Criteria	ReDS V2.6 (As Cleared In K150095)	ReDS V2.7 (K180479)
Range ofPatientAnatomies(Height, BMI)	◊ The system is suitable for both male and femalepatients with a body mass index of 22 to 36 and aheight of between 155 cm (5' 1'') to 190 cm (6' 3'').	◊ The system is suitable for both male and femalepatients with a body mass index of 22 to 36 and aheight between 155 cm (5' 1'') to 195 cm (6' 5'').◊ Patients within the height range having a BMI of 36to 38 can use the system if their chest size rulervalue (as measured by the unit) is 39 or less.
Rx Device	Yes	Yes
Power Source	AC powered	Same
Technology	Induced electromagnetic fields are used to measurewave impedance of the thorax.	Same
Energy Type	Electromagnetic fields at 1-2 Ghz	Same
Device DisplayParameter(Fluid)	Measurement of fluid status by:◊ Base impedance in Ohm (Ω) units (70–150Ω) or◊ Volume percent (%) units (15-60%)	Measurement of fluid status by:◊ Volume percent (%) units (15-60%) (baseimpedance option no longer presented)
SensorAttachmentConfiguration	◊ 2 non-touch sensors embedded in a wearable vestattached to the patient thorax on the front and backof chest◊ Vest is adjustable for patient dimensions	◊ 2 non-touch sensors embedded in a clip-like sensorunit attached to the patient thorax on the front andback of chest
Criteria	ReDS V2.6 (As Cleared In K150095)	ReDS V2.7 (K180479)
	◊ Bedside console connected to the patient sensor vest via a cable	◊ Unit is adjustable for patient dimensions◊ Bedside console connected to the clip-like sensor unit via a cable
Main System Components - Electronics	RF Signal generator and analyzer	Same with added WiFi connectivity
Software	V2.6 Software	V2.6 Software with the following main additions:◊ User interface providing Sensor Unit use instructions◊ Multi-patient management with anonymized ID option◊ Historical readings screen
Cloud Application	V2.6 SensiCloud application	V2.6 SensiCloud application with the following main additional features:◊ User interface enhancements◊ HCP option to set thresholds range and receive out of range notices.◊ Patient's measurements graph UI improvements (e.g. a green zone was added on the graph marking the center range)◊ Task management indicators for administrative users
User Interface	10" Touch screen graphical user interface and display	Same
Algorithm	◊ Calculation of thorax impedance from measured signals	◊ Same with a stricter signal quality assessment mechanism
Criteria	ReDS V2.6 (As Cleared In K150095)	ReDS V2.7 (K180479)
	◇ Conversion of impedance measurements to presentfluid content in volume percentage units◇ Assessment of signal quality
Mode of Use	◇ Intermittent use	◇ Intermittent use
	◇ Application on a single patient	◇ Application on single and multiple patient

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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.