The Heart Seat is a replacement for a standard toilet seat that is indicated for use in a home environment. The Heart Seat is intended to be used for measuring, reviewing and storing non-invasive functional oxygen saturation of arterial hemoglobin (SpO2) and heart rate (HR) in adults of at least 22 years of age with weight ranging from 90 to 350 pounds. Data from the Heart Seat are collected whenever the seat is used and are automatically uploaded to the Casana Cloud where they can be viewed by the healthcare provider. The Heart Seat is not intended for continuous monitoring.

Device Description

The Heart Seat™ is a prescription use remote monitoring system built into a toilet seat. It is intended for physiological monitoring in the home setting. The device and platform are tools intended to support clinicians by providing them with data to help them better manage patients. Monitored users (or Patients) sit on the seat for their data to be captured and sent to the cloud. Clinical users interact with the clinical cloud-based application that provides the patient measurements.

AI/ML Overview

Here's a summary of the acceptance criteria and the studies that prove the device meets those criteria, based on the provided text:

Acceptance Criteria and Device Performance

Acceptance Criteria	Reported Device Performance
SpO2 Measurement Accuracy (ARMS)	Acceptance Criteria: Not explicitly stated as a numerical value in the "Performance Data" section, but the predicate device had: ±2% (90-100%) ±4% (70-89%). However, the comparison table states that the proposed device is ±3.5% (70-100%) and that "clinical data demonstrates equivalent performance" to the predicate. This implies the device aims to meet or be comparable to the predicate's accuracy.
Heart Rate Measurement Accuracy	Acceptance Criteria: Absolute Accuracy < 5 bpm or 10% (whichever is greater).
BioID False Match Rate (FMR)	Acceptance Criteria: Not explicitly stated as a numerical value, but implied to be "sufficiently high accuracy." The reported performance includes a 95% CI upper bound.
BioID False Negative Match Rate (FNMR)	Acceptance Criteria: Not explicitly stated as a numerical value, but implied to be "sufficiently high accuracy." The reported performance includes a 95% CI upper bound.
Electrical Safety and EMC	Compliance with ANSI AAMI ES60601-1, IEC 60601-1-11, ISO 80601-2-61, IEC 60601-1-2, IEEE/ANSI C63.27, IEC 60086-4, UN 38.3.
Software Verification and Validation	Compliance with FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."
Mechanical Testing	Integrity of mounted seat assembly, hinge, side-to-side stability, cyclical load, slow-close seat endurance. Compliance with ISO 80601-2-61 and ANSI AAMI EC57.
Biocompatibility	Evaluation in accordance with ISO 10993-1:2018 and FDA Guidance "Use of International Standard ISO 10993-1, Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process" and FDA's draft guidance "Select Updates for Biocompatibility of Certain Devices in Contact with Intact Skin.".

Study Details

2. Sample sizes for the test set and data provenance:

Heart Rate Validation Study:
- Sample Size: 117 healthy subjects.
- Data Provenance: Not explicitly stated (e.g., country of origin), but it was a clinical study conducted by Casana. Given the FDA submission, it's likely US-based, and it was prospective.
SpO2 Clinical Validation Study:
- Sample Size: 13 subjects.
- Data Provenance: Not explicitly stated (e.g., country of origin), but it was a clinical study conducted by Casana. Given the FDA submission, it's likely US-based, and it was prospective.
BioID Validation Study:
- Sample Size: 125 subjects.
- Data Provenance: Not explicitly stated (e.g., country of origin), but it was a clinical study conducted by Casana. Given the FDA submission, it's likely US-based, and it was prospective.

3. Number of experts used to establish the ground truth for the test set and their qualifications:

Heart Rate Validation Study: The ground truth was established by a 3-lead ECG device. No human experts are mentioned for establishing ground truth from this reference device.
SpO2 Clinical Validation Study: The ground truth would typically be established by a co-oximeter for fractional oxygen saturation (as per ISO 80601-2-61), which is a reference medical device. While human experts (e.g., clinicians) would operate the equipment and monitor the subjects, the ground truth itself is derived from the reference device, not expert consensus.
BioID Validation Study: The ground truth for subject identity would be established by the actual identity of the user as confirmed during the study setup, not by experts adjudicating data.

4. Adjudication method for the test set:

Heart Rate Validation Study: Not applicable in the traditional sense of expert adjudication. The device's measurements were quantitatively compared against a 3-lead ECG device (the reference standard).
SpO2 Clinical Validation Study: Not applicable in the traditional sense of expert adjudication. The device's measurements were quantitatively compared against a reference co-oximeter or similar device as per the ISO standard.
BioID Validation Study: Not applicable. The determination of "true match" or "true non-match" is based on the enrolled individual's identity, not expert adjudication of the algorithm's output.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

No, an MRMC comparative effectiveness study was not done. The studies described focus on the standalone performance of the device against a reference standard or its ability to correctly identify users. These are not studies evaluating human reader performance with or without AI assistance.

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

Yes, standalone performance studies were done.
- The Heart Rate Validation study evaluated the Heart Seat's HR measurements directly against a 3-lead ECG.
- The SpO2 Clinical Validation study evaluated the Heart Seat's SpO2 measurements against a reference standard.
- The BioID Validation study assessed the algorithm's ability to identify users without human intervention in the identification process itself.

7. The type of ground truth used:

Heart Rate Validation Study: The ground truth was established using an independent reference medical device (3-lead ECG device).
SpO2 Clinical Validation Study: The ground truth was established using an independent reference medical device (e.g., co-oximeter), as required by ISO 80601-2-61:2017 for pulse oximeter equipment.
BioID Validation Study: The ground truth was based on the confirmed identity of the actual subject using the seat.

8. The sample size for the training set:

The document does not provide information on the sample size used for the training set for any of the algorithms (SpO2, HR, or BioID). The described studies are all validation studies.

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

The document does not provide information on how the ground truth for the training set was established, as it only details the validation studies, not the development or training phases.

Summary

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April 24, 2023

Casana Care, Inc. % Donna-Bea Tillman Senior Consultant Biologics Consulting 1555 King Street, Suite 300 Alexandria, Virginia 22314

Re: K222330

Trade/Device Name: The Heart Seat Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (Including Cardiotachometer And Rate Alarm) Regulatory Class: Class II Product Code: MWI, DQA Dated: March 27, 2023 Received: March 27, 2023

Dear Donna-Bea Tillman:

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 mediation-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.

Shruti N. Mistry -S

for

Jennifer Shih Kozen Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K222330

Device Name The Heart Seat

Indications for Use (Describe)

The Heart Seat is a replacement for a standard toilet seat that is indicated for use in a home environment. The Heatt Seat is intended to be used for measuring, reviewing and storing non-invasive functional oxygen saturation of arterial hemoglobin (SpO2) and heart rate (HR) in adults of at least 22 years of age with weight ranging from 90 to 350 pounds. Data from the Heart Seat are collected whenever the seat is used and are automatically uploaded to the Casana Cloud where they can be viewed by the healthcare provider. The Heart Seat is not intended for continuous monitoring.

Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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In accordance with 21 CFR 807.87(h) and 21 CFR 807.92 the 510(k) Summary for The Heart Seat is provided below.

1. SUBMITTER

Applicant:	Casana Care, Inc.150 Metro Park Suite ARochester, NY 14623
Contact:	Kara JohnsonVice President Regulatory Affairs and QualityAssuranceCasana Care, Inc.150 Metro Park Suite ARochester, NY 14623kjohnson@casanacare.com
Submission Correspondent:	Donna-Bea Tillman, Ph.D.Senior ConsultantBiologics Consulting1555 King St, Suite 300Alexandria, VA 22314410-531-6542dtillman@biologicsconsulting.com
Date Prepared:	April 18, 2023

2. DEVICE

Device Trade Name:	The Heart Seat
Device Common Name:	Multi-Parameter Patient Monitor
Classification Name	21 CFR 870.2300 Cardiac monitor (including cardiotachometer and rate alarm)
Regulatory Class:	II
Product Code:	Primary: MWISecondary: DQA

PREDICATE DEVICE 3.

Predicate Device: K210086 Vitals360® Multi-Vitals Mobile Monitor

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DEVICE DESCRIPTION 4.

INTENDED USE/INDICATIONS FOR USE 5.

The Heart Seat is a replacement for a standard toilet seat that is indicated for use in a home environment. The Heart Seat is intended to be used for measuring, displaying, reviewing and storing non-invasive functional oxygen saturation of arterial hemoglobin (SpO2) and heart rate (HR) in adults of at least 22 years of age with weight ranging from 90 to 350 pounds. Data from the Heart Seat are collected whenever the seat is used and are automatically uploaded to the Casana Cloud where they can be viewed by the healthcare provider. The Heart Seat is not intended for continuous monitoring.

6. SUBSTANTIAL EQUIVALENCE

Comparison of Indications

The Vitals360 and the Heart Seat are both prescription-use devices intended to be used in the home environment to collect physiological data from users 18 years and older. The physiological data collected by the Heart Seat is a subset of that collected by the Vitals360. While there are differences in the form factors of the devices, they have the same intended use, which is to provide for the measurement, display, review, and storage of physiological data.

Technological Comparisons

The table below compares the key technological feature of the subject devices to the predicate device (Vitals360® Multi-Vitals Mobile Monitor, K210086).

	Proposed Device	Predicate Device	Discussion of Differences
510(k) Number	TBD	K210086	N/A
Applicant	Casana Care, Inc.	VoCare, Inc.	N/A
Device Name	Heart Seat	Vitals360® Multi-Vitals Mobile Monitor	N/A
	Proposed Device	Predicate Device	Discussion ofDifferences
ClassificationRegulation	21 CFR 870.2300	21 CFR 870.2300	N/A
Product Code	MWI, DQA	MWI, DQA, DSH,DXN, FLL	Heart Seat provides asubset of the predicatefeatures
Prescription/OTC	Prescription	Prescription	Same
Use environment	Home	Home, clinic	Heart Seat can be used ina subset of the predicateuse environments
IntendedPopulation	18 years and older	18 years and older	Same
Modes	Remote monitoring	Point of CareRemote monitoring	Heart Seat provides asubset of the predicatefeatures
Parametersmeasured	SpO2, HR	SpO2, HR, NIBP,Temp, Height, Weight	Heart Seat provides asubset of the predicatefeatures
Data upload	Automatically - WiFi	Automatically - WiFior Cellular	Heart Seat provides asubset of the predicatefeatures
Data storagelocation	Casana Cloud	Third party MDDS	Both provide options forremote storage of data
PatientIdentification	Uses BioID softwarealgorithm	None	Clinical testingdemonstrates that devicemeets specifications, userneeds and intended uses
SpO2 Functionality
Principle ofoperation	PPG	PPG	Same
Measurement site	Thigh	Fingertip	Different locations;clinical datademonstrates equivalentperformance
Measurement range	70% - 100%	70% - 100%	Same
	Proposed Device	Predicate Device	Discussion ofDifferences
Measurementaccuracyperformance(Arms)	±3.5% (70-100%)	±2% (90~~100%),±4% (70~~89%)	Clinical datademonstrates equivalentperformance
Heart Rate
Source	Single lead ECG	Single lead ECG (twoembedded metalelectrodes)	Same
Measurement site	Thigh	Fingertip	Different locations;clinical datademonstrates equivalentperformance
Measurement range	40-200 bpm	30 - 240 bpm	Heart Seat provides asubset of the predicaterange. Outside of theHeart Seat range, novalue is reported.
Resolution	1 bpm	1 bpm	Same
Measurementaccuracy	Specification: ±5bpmor ±10%, whichever isgreaterActual Performance:Mean error 0.8bpm	Specification: ±2bpmor ±2%, whichever isgreater	Clinical datademonstrates equivalentperformance

Table 1: Technological Comparison

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In conclusion, the differences in technological characteristics do not raise new questions of safety and effectiveness.

PERFORMANCE DATA 7.

Biocompatibility Testing

The subject device is considered surface contacting for a or a limited duration (<24 hours). A biocompatibility evaluation was performed in accordance with ISO 10993-1:2018 and FDA Guidance "Use of International Standard ISO 10993-1, Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process" and FDA's draft guidance

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"Select Updates for Biocompatibility of Certain Devices in Contact with Intact Skin.". Based on the evaluation biocompatibility testing is not required.

Electrical safety and electromagnetic compatibility (EMC)

The Heart Seat was tested in accordance with:

ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012. C1:2009/(R)2012 and . A2:2010/(R)2012 (Consolidated Text) Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD)
IEC 60601-1-11: 2020 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
ISO 80601-2-61:2017 Medical electrical equipment Part 2-61: Particular requirements . for basic safety and essential performance of pulse oximeter equipment
IEC 60601-1-2 Edition 4.0 2014-02 Medical electrical equipment Part 1-2: General . requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
IEEE/ANSI C63.27:2017 American National Standard For Evaluation Of Wireless Coexistence
IEC 60086-4 Edition 5.0 2019-04 Primary batteries Part 4: Safety of lithium batteries ● [Including: Corrigendum 1 (2019) and Corrigendum 2 (2020)]
UN 38.3: Transportation Testing for Lithium Batteries and Cells ●

Software Verification and Validation Testing

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." The software for this device is considered moderate as an erroneous diagnosis or a delay in delivery of appropriate medical care could only lead to a minor injury.

Bench Testing

The following mechanical testing was performed on the Heart Seat

Dynamic rocker testing to test the integrity of the mounted seat assembly including the ● hinge, Side to Side Stability testing, Cyclical load testing, and Slow close seat endurance testing
The Heart Seat was also tested in accordance with:
ISO 80601-2-61 Second edition 2017-12 (Corrected version 2018-02) Medical electrical ● equipment - Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment
ANSI AAMI EC57:2012 Testing and reporting performance results of cardiac rhythm ● and ST-segment measurement algorithms

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IEC 60601-2-27 Edition 3.0 2011-03Medical electrical equipment - Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment

Animal Testing

Not applicable. Animal studies are not necessary to establish the substantial equivalence of this device.

Clinical Data

Casana conducted a Heart Rate Validation study in 117 healthy subjects comparing Heart Rate measurements reported by the Heart Seat to those obtained from a 3-lead ECG device. A total of 349 heart rate measurement pairs were collected, and 348/349 data points over the range of 40 to 103 bpm meet the Pass/Fail criteria of an Absolute Accuracy < 5 bpm or 10% (whichever is greater) when compared to both the reference average and the reference median. Subgroup analyses based on subject sex and aged (the two variables that might impact the results) showed no meaningful difference in performance.

Casana conducted an SpO2 Clinical Validation study in accordance with the FDA Pulse Oximeter Guidance Document and the FDA recognized standard ISO 80601-2-61:2017 under steady state no-motion conditions. Thirteen subjects provided data for the final analysis, three of whom had Fitzpatrick VI skin tone. The study met the acceptance criteria with an ARMS of 2.7 over the range of 70-100%.

Casana conducted a BioID Validation study to demonstrate that the biometric identification algorithm used by the Heart Seat is capable of identifying someone using the seat as the desired/designated user with sufficiently high accuracy without missing too many of that desired/designated user's recordings. The study enrolled 125 subjects with a range of ages, BMI, and skin tone intended to represent the intended users. The study met both primary endpoints:

The overall mean False Match Rate (FMR) was 0.7% with an upper 95% CI of 0.89%. ● The FMR is the % of total number of sit recordings (true nonmatches) where the nondesignated user is incorrectly IDed as the designated user.
. The overall mean FNMR (False Negative Match Rate) was 15.3% with an upper 95% CI of 20.47%. The FNMR is the % of total number of sit recordings where the designated user is incorrectly IDed as a non-designated user.

CONCLUSION 8.

Based on the detailed comparison of the intended use, indications for use, and specifications for the predicate Vitals360® Multi-Vitals Mobile Monitor (K210086), the performance testing, conformance with applicable standards, clinical testing and software verification testing, the Heart Seat can be found substantially equivalent to the predicate device. The differences in technological characteristics do not raise different questions of safety and effectiveness.

Regulation Number and Section

§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).

(a)
Identification. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.(b)
Classification. Class II (performance standards).