Bodyport Cardiac Scale

K211585 · Bodyport, Inc. · DSB · Jul 29, 2022 · Cardiovascular

Device Facts

• Record ID: K211585
• Device Name: Bodyport Cardiac Scale
• Applicant: Bodyport, Inc.
• Product Code: DSB · Cardiovascular
• Decision Date: Jul 29, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2770
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

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.

Device Story

Bodyport Cardiac Scale is a non-invasive cardiovascular monitor and weight scale; measures body weight, peripheral impedance, pulse rate, and center of pressure. User stands barefoot on platform; four electrodes apply safe current (<500uA) at 8kHz and 64kHz to measure foot-to-foot impedance; load cells measure weight and center of pressure. Device provides haptic feedback upon completion; displays results on integrated LED screen. Data automatically transmitted via cellular (LTE-M) to Bodyport cloud for clinician access via web browser, dashboard, or API. Used in home or clinic; operated by patient. No real-time alarms generated. Clinicians use longitudinal data to monitor fluid status and manage patients with fluid-related conditions; supports clinical decision-making by providing objective metrics alongside other clinical data.

Clinical Evidence

Clinical testing validated pulse rate accuracy against single-lead ECG reference in adult subjects. Peripheral impedance clinical utility demonstrated in heart failure patients vs. healthy controls. Correlation established between hand-to-foot and foot-to-foot impedance measurements. No specific sensitivity/specificity metrics provided in summary.

Technological Characteristics

Platform-based scale with four dry electrodes and four load cells. Powered by 4 AA alkaline batteries. Impedance sensing via <500uA current at 8kHz and 64kHz. Connectivity: Cellular (LTE-M). Biocompatibility per ISO 10993-1:2018. Electrical safety per IEC 60601-1:2005, IEC 60601-1-11:2015, and IEC 60601-1-2:2014. Software lifecycle per IEC 62304:2006+A1:2015.

Indications for Use

Indicated for patients with fluid management related health conditions (e.g., heart failure, end-stage renal disease, dehydration, or those taking diuretics). Intended for users over 21 years of age who can stand for measurement and weigh less than 180 kg (397 lbs).

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

• Noninvasive Medical Technologies, Inc.'s ZOE Fluid Status Monitor Model ZOE3 (K133301)

Reference Devices

• N.I. Medical, Ltd.'s NICaS 2001 Noninvasive Cardio-Respiratory System (K942227)
• ImpediMed Limited's SOZO (K172507)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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)

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 vears 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.

| 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.<br>970 Folsom Street<br>San Francisco, California 94107 (USA)<br>P: [phone] |
|----------------------------|--------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Corey Centen<br>P: [phone]<br>E: [e-mail] |
| 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 Status<br>Monitor Model ZOE3 (K133301) |
| Reference Device(s): | N.I. Medical, Ltd.'s NICaS 2001 Noninvasive Cardio-Respiratory<br>System (K942227)<br>ImpediMed Limited's SOZO (K172507) |

# 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

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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.

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.

#### 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:

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.

# 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 Monitor<br>Model 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 Classification<br>and 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 is<br>a non-invasive, battery powered impedance<br>monitor designed as an 'early warning'<br>monitor for determining changes in the fluid<br>status of patients with fluid management<br>problems.<br>The ZOE Fluid Status Monitor Model ZOE3<br>works by applying a low amplitude high<br>frequency electrical current to the body and<br>measuring the electrical impedance. Base<br>Impedance also known as Z0, decreases<br>when fluid increases and increases when<br>fluid decreases.<br>The ZOE Fluid Status Monitor Model ZOE3 is<br>designed for use with disposable, self-<br>adhesive silver/ silver chloride electrodes<br>that are readily available from Noninvasive<br>Medical Technologies, Inc. NMT approved<br>electrodes must be used with the ZOE Fluid<br>Status Monitor. Z0 readings obtained from<br>unapproved electrodes may not be accurate! | The Bodyport Cardiac Scale is a non-invasive<br>cardiovascular monitor and body weight<br>scale that measures body weight, peripheral<br>impedance, pulse rate, and center of<br>pressure through the feet of a user standing<br>on its surface. The device is powered by four<br>(4) AA alkaline batteries.<br>The device is comprised of a physical<br>platform on which the user stands with bare<br>feet. Four electrodes located on the top<br>surface of the platform are used to measure<br>the impedance of the user's lower body<br>(foot-to-foot). The impedance signal is<br>obtained by applying a small, safe battery-<br>generated current (<500uA) between the<br>feet of the user and measuring the resulting<br>electrical potential. The impedance signal<br>reflects the electrical resistance of the lower<br>body and is modulated by changes in fluid<br>levels and blood flow in the lower part of the<br>body, enabling the calculation of parameters<br>such as pulse rate and peripheral<br>impedance. The impedance signal is<br>captured at two frequencies (8kHz and<br>64kHz) to enable the calculation of<br>peripheral impedance values that reflect<br>intra- and extra-cellular fluid levels. The<br>64kHz signal is used to calculate impedance<br>magnitude and phase angle to measure<br>pulse rate.<br>Additionally, load cells in each of the four<br>corners of the device measure the static and<br>dynamic loads being applied to the device by<br>the user's body. The load cells are used to<br>measure the user's body weight and center<br>of pressure. The device may show body<br>weight, peripheral impedance, and pulse<br>rate information on a display integrated into<br>the platform.<br>A user is instructed to stand on the Bodyport<br>Cardiac Scale with bare feet. The<br>measurement starts automatically when the<br>user steps on the scale. The device acquires | The Bodyport Cardiac Scale<br>measures body weight,<br>peripheral impedance, pulse<br>rate, and center of pressure,<br>and has cellular connectivity. |
| | | the data and notifies the user that the<br>measurement is complete through a gentle<br>haptic vibration and displays the results on<br>the device screen. Data collected by the<br>Bodyport Cardiac Scale is automatically<br>transmitted via cellular communication to<br>the Bodyport cloud where it can be accessed<br>through a supported web-based browser,<br>dashboard or API. | |
| Indications for Use: | The ZOE Fluid Status Monitor is intended for<br>patients:<br>• With fluid management problems<br>• Taking diuretic medication<br>• Living with Heart Failure<br>• Living with End-stage Renal<br>Disease<br>• Recovering from Coronary Artery<br>Disease related event<br>• Suffering from Recurrent<br>Dehydration<br>This device is intended for use under the<br>direction of a physician, for the non-invasive<br>monitoring and management of patients<br>with fluid management problems in a variety<br>of medically accepted clinical applications. | The Bodyport Cardiac Scale is intended for<br>use, under the direction of a physician, for<br>the non-invasive monitoring and<br>management of patients with fluid<br>management related health conditions. The<br>device is intended to be used to measure<br>and track body weight, peripheral<br>impedance, pulse rate, and center of<br>pressure. The device is intended to be used<br>in the home or clinic environment.<br>Intended users are people over 21 years of<br>age who can stand for the duration of the<br>measurement and weigh less than 180 kg<br>(397 lbs).<br>The device does not generate any real-time<br>alarms for consideration by the user at home<br>or by a healthcare professional. Data from<br>the device should be used in the context of<br>all clinical data to make determinations of a<br>patient's status. | No clinical differences:<br>The Bodyport Cardiac Scale<br>measures impedance, the<br>same as the predicate device.<br>Additionally, the Bodyport<br>Cardiac Scale measures pulse<br>rate, weight, and center of<br>pressure.<br>Pulse rate is measured from<br>the same impedance signal<br>used to measure peripheral<br>impedance.<br>Stand-on patient scales -<br>product code FRI - are 510(k)<br>exempted devices per<br>regulation number 880.2700,<br>as are force-measuring<br>platforms - product code KHX<br>- per FDA regulations number<br>890.1575.<br>These additional metrics<br>provide clinicians greater<br>context when interpretating<br>changes in the fluid status of<br>patients, without altering<br>standard of care. These<br>features are therefore not<br>critical to the intended use of<br>the device and do not affect its<br>safety and effectiveness. |
| Technical Method: | 2.0mA current at 100kHz | <500 μA current at 8kHz and 64kHz | No functional differences:<br>The Bodyport Cardiac Scale<br>performs in the same manner<br>with lower applied currents,<br>modulated at two frequencies<br>instead of one. The differences<br>in frequency have minimal<br>impact on measurement<br>accuracy. The use of two<br>frequencies enables<br>calculation of impedance<br>values that represent extra-<br>and intra-cellular fluid levels.<br>This does not raise new |
| | | | questions of safety and<br>effectiveness. |
| | | | No functional differences: |
| Operating Principle: | A small current of 2.0mA is applied across<br>the chest of the patient to measure<br>impedance. The current is modulated at<br>100kHz. | A small, battery-generated current of<br><500uA is applied to the feet of the patient<br>to measure impedance. The current is<br>modulated at two frequencies, 8kHz and<br>64kHz. | The Bodyport Cardiac Scale<br>performs in the same manner<br>- through the lower body<br>versus across the chest – with<br>lower applied current,<br>modulated at two frequencies. |
| Electrode<br>Configuration: | Tetrapolar; wet electrodes | Tetrapolar; dry electrodes | No functional differences:<br>The current source design and<br>electrode configuration enable<br>the use of dry electrodes with<br>minimal impact on<br>measurement accuracy. |
| Impedance<br>Measurement<br>Range: | 15-45 ohms | 150-1250 ohms | No functional differences:<br>The ranges vary due to use of<br>different segments of the<br>body. |
| Connectivity: | None | Cellular (LTE-M) | The Bodyport Cardiac Scale has<br>cellular connectivity for<br>longitudinal data collection<br>and review. |
| Display: | 7-segment LCD display | White LED display: 43 x 17 pixels | No functional differences:<br>The Bodyport Cardiac Scale<br>uses an LED-matrix display<br>integrated into the device. |
| Measurement Time: | 30 seconds | 30 seconds…