The Bodyport Cardiac Scale is intended for use, under the direction of a physician, for the non-invasive monitoring and management of patients with fluid management related health conditions. The device is intended to be used to measure and track body weight, peripheral impedance, pulse rate, and center of pressure. The device is intended to be used in the home or clinic environment.

Intended users are people over 21 years of age who can stand for the measurement and weigh less than 180 kg (397 lbs).

The device does not generate any real-time alarms for consideration by the user at home or by a healthcare professional. Data from the device should be used in the context of all clinical data to make determinations of a patient's status.

Device Description

The Bodyport Cardiac Scale is a non-invasive cardiovascular monitor and body weight scale that measures body weight, peripheral impedance, pulse rate, and center of pressure through the feet of a user standing on its surface. The device is powered by four (4) AA alkaline batteries.

The device is comprised of a physical platform on which the user stands with bare feet. Four electrodes located on the top surface of the platform are used to measure of the user's lower body (foot-to-foot). The impedance signal is obtained by applying a small, safe battery-generated current (<500uA) between the feet of the user and measuring the resulting electrical potential. The impedance signal reflects the electrical resistance of the lower body and is modulated by changes in fluid levels and blood flow in the lower part of the body, enabling the calculation of parameters such as pulse rate and peripheral impedance. The impedance signal is captured at two frequencies (8kHz) to enable the calculation of peripheral impedance values that reflect intra- and extra-cellular fluid levels. The 64kHz signal is used to calculate impedance magnitude and phase angle to measure pulse rate.

Additionally, load cells in each of the four corners of the device measure the static and dynamic loads being applied to the device by the user's body. The load cells are used to measure the user's body weight and center of pressure. The device may show body weight, peripheral impedance, and pulse rate information on a display integrated into the platform.

A user is instructed to stand on the Bodyport Cardiac Scale with bare feet. The measurement starts automatically when the user steps on the scale. The device acquires the data and notifies the user that the measurement is complete through a gentle haptic vibration and displays the results on the device screen. Data collected by the Bodyport Cardiac Scale is automatically transmitted via cellular communication to the Bodyport cloud where it can be accessed through a supported web-based browser, dashboard or API.

AI/ML Overview

The provided text is a 510(k) summary for the Bodyport Cardiac Scale. It outlines the device's intended use, technological characteristics, and performance data used to demonstrate substantial equivalence to a predicate device. However, it does not provide explicit acceptance criteria in a table format or detailed results from a study proving that the device meets specific performance criteria for AI/algorithm-driven features.

The document states:

"Performance Bench Testing: Measurement accuracy and linearity of the Bodyport Cardiac Scale were compared to the predicate device to determine substantial equivalence."
"Clinical Data: Pulse Rate: Clinical testing demonstrated the accuracy of the pulse rate measurement from the Bodyport Cardiac Scale compared to a reference single lead ECG heart rate measurement. For this study, adult subjects, with a range of peripheral impedances and pulse rates, were analyzed. Peripheral Impedance: Analysis of clinical data demonstrated the clinical utility of peripheral impedance in the monitoring of patients with fluid management conditions. This analysis included clinical data from patients with heart failure, as an example patient population with fluid management related health conditions, and healthy subjects, as a control population. Additional testing demonstrated the correlation between impedances measured through hand-to-foot and foot-to-foot body segments. For this study, adult subjects, with a range of peripheral impedances, were analyzed."

Without access to the specific study reports referenced, it's not possible to populate all the requested information about acceptance criteria and study details. The document provides a high-level summary of the types of tests performed but lacks the granular data required.

Here's an attempt to answer the questions based only on the provided text, highlighting what is not available:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly present acceptance criteria in a table or precise reported performance metrics for the device's measurements (body weight, peripheral impedance, pulse rate, center of pressure) against specific numerical targets. It generally states that "Measurement accuracy and linearity... were compared to the predicate device to determine substantial equivalence." and "Clinical testing demonstrated the accuracy of the pulse rate measurement...".

Parameter	Acceptance Criteria	Reported Device Performance
Pulse Rate	Not explicitly stated (e.g., within X bpm of reference)	"Clinical testing demonstrated the accuracy of the pulse rate measurement from the Bodyport Cardiac Scale compared to a reference single lead ECG heart rate measurement." (Specific accuracy values e.g., mean absolute error, correlation, are not provided in this summary.)
Peripheral Impedance	Not explicitly stated (e.g., within X ohms of reference)	"Analysis of clinical data demonstrated the clinical utility of peripheral impedance in the monitoring of patients with fluid management conditions." and "Additional testing demonstrated the correlation between impedances measured through hand-to-foot and foot-to-foot body segments." (Specific utility or correlation metrics are not provided in this summary.)
Body Weight	Not explicitly stated	"Measurement accuracy and linearity... were compared to the predicate device to determine substantial equivalence." (Specific accuracy values are not provided in this summary.)
Center of Pressure	Not explicitly stated	"Measurement accuracy and linearity... were compared to the predicate device to determine substantial equivalence." (Specific accuracy values are not provided in this summary.)

2. Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size for Pulse Rate Study: "adult subjects, with a range of peripheral impedances and pulse rates, were analyzed." (Specific number of subjects not provided).
Sample Size for Peripheral Impedance Utility Study: "patients with heart failure, as an example patient population with fluid management related health conditions, and healthy subjects, as a control population." (Specific numbers not provided).
Sample Size for Peripheral Impedance Correlation Study: "adult subjects, with a range of peripheral impedances, were analyzed." (Specific number not provided).
Data Provenance: Not specified (e.g., country of origin, retrospective or prospective). The context of a 510(k) submission for a US device often implies US-based studies, but it is not explicitly stated.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

The document mentions "reference single lead ECG heart rate measurement" for pulse rate, implying a gold standard measurement, not subjective expert opinion.
For peripheral impedance, "clinical utility" and "correlation" were analyzed. It does not mention experts establishing ground truth or their qualifications.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This concept is not relevant as the "ground truth" for the measured parameters (pulse rate, impedance, weight, center of pressure) would typically be established by validated reference instruments or objective clinical data, not expert consensus or adjudication in this context.

5. 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 involving human readers with and without AI assistance was not performed or described. The device is a "Cardiac Scale" that measures physiological parameters; it is not an AI-driven diagnostic imaging interpretation tool where human-in-the-loop performance would typically be evaluated in an MRMC study. The device's role is to provide data for physicians to use in context.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Yes, the performance data presented (accuracy of pulse rate, utility/correlation of impedance, accuracy/linearity of weight/center of pressure) would represent the standalone performance of the device's measurement algorithms. It measures the parameters directly.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

Pulse Rate: "reference single lead ECG heart rate measurement." This is an objective, instrumental ground truth.
Peripheral Impedance: For utility, it involved "patients with heart failure... and healthy subjects" which implies clinical diagnoses/outcomes as context for utility. For correlation, it involved comparison between "hand-to-foot and foot-to-foot body segments," likely referring to an instrumental comparison.
Body Weight & Center of Pressure: Not specified beyond "compared to the predicate device to determine substantial equivalence," which implies a reference standard or validated measurement.

8. The sample size for the training set

The document does not describe any specific training set for an AI/ML model. It describes "clinical testing" and "analysis of clinical data" but does not differentiate between training and test sets in the context of a machine learning pipeline. The device's function appears to be direct measurement and calculation, not an AI model trained on a large dataset to make a diagnosis or prediction.

9. How the ground truth for the training set was established

Not applicable, as no explicit training set for an AI/ML model is described. The device's functionalities (measuring impedance, pulse rate, weight, center of pressure) are based on established physiological principles and signal processing, not explicitly a supervised machine learning model requiring a ground-truthed training set in the typical AI/ML sense.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

July 29, 2022

Bodyport Inc. % Prithul Bom Most Responsible Person Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k Saint Paul, Minnesota 55114

Re: K211585

Trade/Device Name: Bodyport Cardiac Scale Regulation Number: 21 CFR 870.2770 Regulation Name: Impedance Plethysmograph Regulatory Class: Class II Product Code: DSB Dated: May 31, 2022 Received: June 1, 2022

Dear Prithul Bom:

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.

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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 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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

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/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

for

LCDR Stephen Browning Assistant Director Division of Cardiac Electrophysiology, Diagnostics, and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K211585

Device Name Bodyport Cardiac Scale

Indications for Use (Describe)

Intended users are people over 21 vears of age who can stand for the measurement and weigh less than 180 kg (397 lbs).

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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(5) 510(k) Summary

510(k) Owner/ Submitter:	Bodyport Inc.970 Folsom StreetSan Francisco, California 94107 (USA)P: (650) 200-1557
Contact Person:	Corey CentenP: (415) 990-5415E: corey@bodyport.com
Date Prepared:	July 21, 2022
Trade Name:	Bodyport Cardiac Scale (or Bodyport Scale)
Device Type/ Common Name:	Plethysmograph, Impedance
Classification Name:	Impedance plethysmograph
Classification Regulation:	870.2770
Class:	II
Panel:	Cardiovascular
Product Code:	DSB
Predicate Device(s):	Noninvasive Medical Technologies, Inc.'s ZOE Fluid StatusMonitor Model ZOE3 (K133301)
Reference Device(s):	N.I. Medical, Ltd.'s NICaS 2001 Noninvasive Cardio-RespiratorySystem (K942227)ImpediMed Limited's SOZO (K172507)

Device Description:

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peripheral impedance. The impedance signal is captured at two frequencies (8kHz) to enable the calculation of peripheral impedance values that reflect intra- and extra-cellular fluid levels. The 64kHz signal is used to calculate impedance magnitude and phase angle to measure pulse rate.

Intended Use/ Indications for Use:

The Bodyport Cardiac Scale has the same intended use as the predicate device; it raises neither new nor different questions of safety and effectiveness compared to the predicate device.

Indications for Use:

Intended users are people over 21 years of age who can stand for the measurement and weigh less than 180 kg (397 lbs).

Technological Characteristics:

The Bodyport Cardiac Scale has the same or similar technological characteristics – materials, design, and energy source – as the predicate device; it raises neither new nor different questions of safety and effectiveness compared to the predicate device.

A summary table is included for reference:

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Predicate Device Comparison
Description:	Predicate Device - ZOE Fluid Status MonitorModel ZOE3	Subject Device - Bodyport Cardiac Scale	Discussion of Differences
Device Name:	ZOE Fluid Status Monitor Model ZOE3	Bodyport Cardiac Scale	N/A
510(k) Number:	K133301	-	N/A
Device Classificationand Product Code:	Class II/DSB	Class II/DSB	No differences
Prescription Device:	Yes	Yes	No differences
Device Description:	The ZOE Fluid Status Monitor Model ZOE3 isa non-invasive, battery powered impedancemonitor designed as an 'early warning'monitor for determining changes in the fluidstatus of patients with fluid managementproblems.The ZOE Fluid Status Monitor Model ZOE3works by applying a low amplitude highfrequency electrical current to the body andmeasuring the electrical impedance. BaseImpedance also known as Z0, decreaseswhen fluid increases and increases whenfluid decreases.The ZOE Fluid Status Monitor Model ZOE3 isdesigned for use with disposable, self-adhesive silver/ silver chloride electrodesthat are readily available from NoninvasiveMedical Technologies, Inc. NMT approvedelectrodes must be used with the ZOE FluidStatus Monitor. Z0 readings obtained fromunapproved electrodes may not be accurate!	The Bodyport Cardiac Scale is a non-invasivecardiovascular monitor and body weightscale that measures body weight, peripheralimpedance, pulse rate, and center ofpressure through the feet of a user standingon its surface. The device is powered by four(4) AA alkaline batteries.The device is comprised of a physicalplatform on which the user stands with barefeet. Four electrodes located on the topsurface of the platform are used to measurethe impedance of the user's lower body(foot-to-foot). The impedance signal isobtained by applying a small, safe battery-generated current (<500uA) between thefeet of the user and measuring the resultingelectrical potential. The impedance signalreflects the electrical resistance of the lowerbody and is modulated by changes in fluidlevels and blood flow in the lower part of thebody, enabling the calculation of parameterssuch as pulse rate and peripheralimpedance. The impedance signal iscaptured at two frequencies (8kHz and64kHz) to enable the calculation ofperipheral impedance values that reflectintra- and extra-cellular fluid levels. The64kHz signal is used to calculate impedancemagnitude and phase angle to measurepulse rate.Additionally, load cells in each of the fourcorners of the device measure the static anddynamic loads being applied to the device bythe user's body. The load cells are used tomeasure the user's body weight and centerof pressure. The device may show bodyweight, peripheral impedance, and pulserate information on a display integrated intothe platform.A user is instructed to stand on the BodyportCardiac Scale with bare feet. Themeasurement starts automatically when theuser steps on the scale. The device acquires	The Bodyport Cardiac Scalemeasures body weight,peripheral impedance, pulserate, and center of pressure,and has cellular connectivity.
		the data and notifies the user that themeasurement is complete through a gentlehaptic vibration and displays the results onthe device screen. Data collected by theBodyport Cardiac Scale is automaticallytransmitted via cellular communication tothe Bodyport cloud where it can be accessedthrough a supported web-based browser,dashboard or API.
Indications for Use:	The ZOE Fluid Status Monitor is intended forpatients:• With fluid management problems• Taking diuretic medication• Living with Heart Failure• Living with End-stage RenalDisease• Recovering from Coronary ArteryDisease related event• Suffering from RecurrentDehydrationThis device is intended for use under thedirection of a physician, for the non-invasivemonitoring and management of patientswith fluid management problems in a varietyof medically accepted clinical applications.	The Bodyport Cardiac Scale is intended foruse, under the direction of a physician, forthe non-invasive monitoring andmanagement of patients with fluidmanagement related health conditions. Thedevice is intended to be used to measureand track body weight, peripheralimpedance, pulse rate, and center ofpressure. The device is intended to be usedin the home or clinic environment.Intended users are people over 21 years ofage who can stand for the duration of themeasurement and weigh less than 180 kg(397 lbs).The device does not generate any real-timealarms for consideration by the user at homeor by a healthcare professional. Data fromthe device should be used in the context ofall clinical data to make determinations of apatient's status.	No clinical differences:The Bodyport Cardiac Scalemeasures impedance, thesame as the predicate device.Additionally, the BodyportCardiac Scale measures pulserate, weight, and center ofpressure.Pulse rate is measured fromthe same impedance signalused to measure peripheralimpedance.Stand-on patient scales -product code FRI - are 510(k)exempted devices perregulation number 880.2700,as are force-measuringplatforms - product code KHX- per FDA regulations number890.1575.These additional metricsprovide clinicians greatercontext when interpretatingchanges in the fluid status ofpatients, without alteringstandard of care. Thesefeatures are therefore notcritical to the intended use ofthe device and do not affect itssafety and effectiveness.
Technical Method:	2.0mA current at 100kHz	<500 μA current at 8kHz and 64kHz	No functional differences:The Bodyport Cardiac Scaleperforms in the same mannerwith lower applied currents,modulated at two frequenciesinstead of one. The differencesin frequency have minimalimpact on measurementaccuracy. The use of twofrequencies enablescalculation of impedancevalues that represent extra-and intra-cellular fluid levels.This does not raise new
			questions of safety andeffectiveness.
			No functional differences:
Operating Principle:	A small current of 2.0mA is applied acrossthe chest of the patient to measureimpedance. The current is modulated at100kHz.	A small, battery-generated current of<500uA is applied to the feet of the patientto measure impedance. The current ismodulated at two frequencies, 8kHz and64kHz.	The Bodyport Cardiac Scaleperforms in the same manner- through the lower bodyversus across the chest – withlower applied current,modulated at two frequencies.
ElectrodeConfiguration:	Tetrapolar; wet electrodes	Tetrapolar; dry electrodes	No functional differences:The current source design andelectrode configuration enablethe use of dry electrodes withminimal impact onmeasurement accuracy.
ImpedanceMeasurementRange:	15-45 ohms	150-1250 ohms	No functional differences:The ranges vary due to use ofdifferent segments of thebody.
Connectivity:	None	Cellular (LTE-M)	The Bodyport Cardiac Scale hascellular connectivity forlongitudinal data collectionand review.
Display:	7-segment LCD display	White LED display: 43 x 17 pixels	No functional differences:The Bodyport Cardiac Scaleuses an LED-matrix displayintegrated into the device.
Measurement Time:	30 seconds	30 seconds	No differences
Batteries and Power:	Four (4) AA alkaline batteries, userreplaceable, or 5V DC Power adapter(GTM31060-1505)	Four (4) AA Alkaline, user replaceable	No functional differences:The Bodyport Cardiac Scaledoes not use a DC poweradapter.
Performance Data/Standards:	CAN/CSA 22.2 No 60601-1:08	ISO 10993-1:2018	No functional differences:The Bodyport Cardiac Scale hasundergone additional testing.
	60601-1, 3rd Edition	IEC 60601-1:2005, A1:2012
	60601-1-2	IEC 60601-1-2:2014
		IEC 60601-1-6:2010+A1:2013
		IEC 62366-1:2015
		IEC 60601-1-11:2015
		ASTM D4169-16
		ASTM D4332-14
		IEC 62304:2006+A1:2015

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K211585

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Non-Clinical Performance Data:

Biocompatibility Testing:

A biocompatibility evaluation for the Bodyport Cardiac Scale – considered tissue contacting for a duration of less than 24 hours – was conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Use of International Standard ISO 10993-1, 'Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process'", September 4, 2020 and International Standard ISO 10993-1:2018, "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process", as recognized by FDA. The battery of testing included:

Cytotoxicity
Sensitization
Irritation

Electrical Safety and Electromagnetic Compatibility (EMC) Testing:

Electrical safety and electromagnetic compatibility (EMC) testing were conducted on the Bodyport Cardiac Scale. The device complies with IEC 60601-1:2005, "Medical electrical equipment -Part 1: General requirements for basic safety and essential performance" and its relevant collateral standards, including IEC 60601-1-11:2015, "Medical electrical equipment – Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment" and IEC 60601-1-2:2014, "Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests", as recognized by FDA.

Additionally, a coexistence evaluation was performed per AAMI TIR69:2017, "Risk management of radiofrequency wireless coexistence for medical devices and systems", identifying the Bodyport Cardiac Scale as "Category D" – negligible wireless risk, no significant risk – and requiring no coexistence testing.

As a device that operates on the licensed radio spectrum, Bodyport conducted PTCRB testing to ensure proper LTE-M transmission reliability.

Software Verification and Validation Testing:

The Bodyport Cardiac Scale complies with IEC 62304:2006+AMD1:2015 CSV, "Medical device software – Software life cycle processes", as recognized by FDA.

Software verification and validation testing were conducted, and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices", May 11, 2005. The software for this device was considered as a "moderate" level of concern since a failure or latent flaw in the software could directly result in minor injury to the patient.

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Human Factors Validation Testing:

The Bodyport Cardiac Scale complies with IEC 60601-1-6:2010+A1:2013, "Medical electrical equipment -Part 1-6: General requirements for basic safety and essential performance - Collateral Standard: Usability" / IEC 62366-1:2015, "Medical devices – Part 1: Application of usability engineering to medical devices", as recognized by FDA.

Additionally, human factors and usability engineering testing for the Bodyport Cardiac Scale was conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Applying Human Factors and Usability Engineering to Medical Devices", February 3, 2016.

Performance Bench Testing:

Measurement accuracy and linearity of the Bodyport Cardiac Scale were compared to the predicate device to determine substantial equivalence.

Implantable Electronic Cardiac Device (IECD) Compatibility Testing:

Bench testing of the Bodyport Cardiac Scale with implantable electronic cardiac devices was performed using the torso simulator described in ANSI/AAMI/ISO 14117:2012 EMC Test Protocol and IECD test specimens.

Clinical Data:

Pulse Rate:

Clinical testing demonstrated the accuracy of the pulse rate measurement from the Bodyport Cardiac Scale compared to a reference single lead ECG heart rate measurement. For this study, adult subjects, with a range of peripheral impedances and pulse rates, were analyzed.

Peripheral Impedance:

Analysis of clinical data demonstrated the clinical utility of peripheral impedance in the monitoring of patients with fluid management conditions. This analysis included clinical data from patients with heart failure, as an example patient population with fluid management related health conditions, and healthy subjects, as a control population.

Additional testing demonstrated the correlation between impedances measured through hand-to-foot and foot-to-foot body segments. For this study, adult subjects, with a range of peripheral impedances, were analyzed.

Conclusions:

The non-clinical and clinical data support the safety of the Bodyport Cardiac Scale and the hardware and software verification and validation demonstrate that the device should perform as intended in the specified use conditions.

The Bodyport Cardiac Scale is substantially equivalent to the predicate 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.