K Number

Device Name

The Heart Seat

Manufacturer

Casana Care, Inc.

Date Cleared

2023-04-24

(265 days)

Product Code

MWI DQA

Regulation Number

870.2300

Intended Use

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.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K210086

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

Yes
The summary mentions a "biometric identification algorithm" used for user identification, which is a common application of machine learning.

Therapeutic

No
The device is used for measuring, reviewing, and storing physiological data (SpO2 and heart rate) for monitoring purposes, and is not intended to provide therapy or treatment.

Diagnostic

The device is marketed as a monitoring system that collects physiological data (SpO2 and heart rate) for healthcare providers to review, rather than providing a diagnosis itself. The "Intended Use" states it is for "measuring, reviewing and storing" data, and the "Device Description" clarifies it is a "remote monitoring system" and a "tool intended to support clinicians by providing them with data to help them better manage patients." This indicates its role is in data collection and presentation, not diagnostic interpretation.

SaMD (Software as a Medical Device)

The device description explicitly states it is "built into a toilet seat" and involves "physiological monitoring in the home setting," indicating a physical hardware component is integral to its function. The performance studies also validate the accuracy of measurements taken by the physical seat.

IVD (In Vitro Diagnostic)

Based on the provided information, the Heart Seat is not an In Vitro Diagnostic (IVD) device.

Here's why:

IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This testing is done outside of the body (in vitro).
Heart Seat Function: The Heart Seat measures physiological parameters (SpO2 and heart rate) directly from the user's body while they are sitting on the seat. This is a non-invasive, in vivo measurement.
Intended Use: The intended use describes measuring, reviewing, and storing SpO2 and heart rate. It does not involve the analysis of bodily specimens.

Therefore, the Heart Seat falls under the category of a medical device that performs physiological monitoring, but it does not meet the definition of an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

No
The letter does not state that the FDA has reviewed and approved or cleared a PCCP for this specific device.

Overview

Intended Use / Indications for Use

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.

Product codes (comma separated list FDA assigned to the subject device)

MWI, DQA

Device Description

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Thigh (for SpO2 and HR measurement)
Fingertip (for predicate device SpO2 and HR measurement)

Indicated Patient Age Range

adults of at least 22 years of age

Intended User / Care Setting

Home environment; healthcare provider (for viewing data)

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Heart Rate Validation study:

Sample size: 117 healthy subjects
Data source: Heart rate measurements reported by the Heart Seat compared to those obtained from a 3-lead ECG device.
Annotation protocol: A total of 349 heart rate measurement pairs were collected.

SpO2 Clinical Validation study:

Sample size: Thirteen subjects, three of whom had Fitzpatrick VI skin tone.
Data source: Not explicitly stated beyond "under steady state no-motion conditions."
Annotation protocol: In accordance with the FDA Pulse Oximeter Guidance Document and the FDA recognized standard ISO 80601-2-61:2017.

BioID Validation study:

Sample size: 125 subjects with a range of ages, BMI, and skin tone.
Data source: Not explicitly stated beyond "demonstrate that the biometric identification algorithm used by the Heart Seat is capable of identifying someone using the seat as the desired/designated user."
Annotation protocol: Not explicitly stated.

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Heart Rate Validation study:

Study type: Validation study
Sample size: 117 healthy subjects
Key results: 348/349 data points over the range of 40 to 103 bpm meet the Pass/Fail criteria of an Absolute Accuracy

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).

Summary

Image /page/0/Picture/0 description: The image contains 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 in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" stacked on top of each other.

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.

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

Indications for Use

510(k) Number (if known) K222330

Device Name The Heart Seat

Indications for Use (Describe)

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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

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

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

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

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

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 A
Rochester, NY 14623 |
|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Kara Johnson
Vice President Regulatory Affairs and Quality
Assurance
Casana Care, Inc.
150 Metro Park Suite A
Rochester, NY 14623
kjohnson@casanacare.com |
| Submission Correspondent: | Donna-Bea Tillman, Ph.D.
Senior Consultant
Biologics Consulting
1555 King St, Suite 300
Alexandria, VA 22314
410-531-6542
dtillman@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: MWI
Secondary: DQA

PREDICATE DEVICE 3.

Predicate Device: K210086 Vitals360® Multi-Vitals Mobile Monitor

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 of
Differences
Classification
Regulation	21 CFR 870.2300	21 CFR 870.2300	N/A
Product Code	MWI, DQA	MWI, DQA, DSH,
DXN, FLL	Heart Seat provides a
subset of the predicate
features
Prescription/OTC	Prescription	Prescription	Same
Use environment	Home	Home, clinic	Heart Seat can be used in
a subset of the predicate
use environments
Intended
Population	18 years and older	18 years and older	Same
Modes	Remote monitoring	Point of Care
Remote monitoring	Heart Seat provides a
subset of the predicate
features
Parameters
measured	SpO2, HR	SpO2, HR, NIBP,
Temp, Height, Weight	Heart Seat provides a
subset of the predicate
features
Data upload	Automatically - WiFi	Automatically - WiFi
or Cellular	Heart Seat provides a
subset of the predicate
features
Data storage
location	Casana Cloud	Third party MDDS	Both provide options for
remote storage of data
Patient
Identification	Uses BioID software
algorithm	None	Clinical testing
demonstrates that device
meets specifications, user
needs and intended uses
SpO2 Functionality
Principle of
operation	PPG	PPG	Same
Measurement site	Thigh	Fingertip	Different locations;
clinical data
demonstrates equivalent
performance
Measurement range	70% - 100%	70% - 100%	Same
	Proposed Device	Predicate Device	Discussion of
Differences
Measurement
accuracy
performance
(Arms)	±3.5% (70-100%)	±2% (90~100%),
±4% (70~89%)	Clinical data
demonstrates equivalent
performance
Heart Rate
Source	Single lead ECG	Single lead ECG (two
embedded metal
electrodes)	Same
Measurement site	Thigh	Fingertip	Different locations;
clinical data
demonstrates equivalent
performance
Measurement range	40-200 bpm	30 - 240 bpm	Heart Seat provides a
subset of the predicate
range. Outside of the
Heart Seat range, no
value is reported.
Resolution	1 bpm	1 bpm	Same
Measurement
accuracy	Specification: ±5bpm
or ±10%, whichever is
greater

Actual Performance:
Mean error 0.8bpm | Specification: ±2bpm
or ±2%, whichever is
greater | Clinical data
demonstrates equivalent
performance |

Table 1: Technological Comparison

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 (