SimpleSENSE Platform

K212160 · Nanowear, Inc. · DXH · Sep 22, 2021 · Cardiovascular

Device Facts

• Record ID: K212160
• Device Name: SimpleSENSE Platform
• Applicant: Nanowear, Inc.
• Product Code: DXH · Cardiovascular
• Decision Date: Sep 22, 2021
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.2920
• Device Class: Class 2

Indications for Use

The SimpleSENSE Platform is intended for use at home, or at a healthcare facility, under the direction of a licensed medical professional, to record, display and store the following physiological data: a) 2 leads of Electrocardiogram; b) Respiration rate measured through thoracic impedance; c) Heart Sounds; d) Activity including posture; and e) other validated data sources. The SimpleSENSE Platform is intended for use when the licensed medical professional decides to evaluate the physiologic signals of adult patients as an aid to diagnosis and treatment. The SimpleSENSE Platform is intended to be used by patients at rest and not performing any activities or movements. ECG recordings are indicated for the manual assessment of cardiac rhythm disturbances. The SimpleSENSE Platform does not is not intended for active patient monitoring (real-time). The SimpleSENSE Platform is not intended for use as life supporting equipment on high-risk patients such as critical care patients. The SimpleSENSE Platform is not intended for use in the presence of a pacemaker.

Device Story

SimpleSENSE Platform captures 2-lead ECG, respiration (thoracic impedance), heart sounds (MEMS microphone), and activity/posture (accelerometer) via sensors embedded in a wearable textile garment. Signal Acquisition Unit (SAU) stores data on microSD and transmits wirelessly via Bluetooth to a mobile app (iOS/Android). Data is forwarded to a web server for physician review. Used at home or healthcare facilities; operated by patients at rest. Physicians access data via web portal to evaluate cardiac rhythm and physiologic signals as an aid to diagnosis. Benefits include unobtrusive, efficient data capture for clinical assessment.

Clinical Evidence

No clinical data. Bench testing only. Verification focused on software/firmware updates for Android OS compatibility and web server integration.

Technological Characteristics

Wearable textile garment with integrated nanosensor electrodes (ECG, thoracic impedance) and MEMS microphone. SAU uses 24-bit resolution for ECG/impedance/heart sounds and 16-bit for accelerometer. Connectivity via Bluetooth, cellular, and Wi-Fi. Power: rechargeable Li-Ion battery. Data storage: removable 16GB microSD. Software: iOS/Android mobile apps and web server interface.

Indications for Use

Indicated for adult patients requiring evaluation of physiologic signals (ECG, respiration, heart sounds, activity/posture) as an aid to diagnosis and treatment. Intended for use at rest. Contraindicated for high-risk/critical care patients, life-support applications, and patients with pacemakers.

Regulatory Classification

Identification

A telephone electrocardiograph transmitter and receiver is a device used to condition an electrocardiograph signal so that it can be transmitted via a telephone line to another location. This device also includes a receiver that reconditions the received signal into its original format so that it can be displayed. The device includes devices used to transmit and receive pacemaker signals.

Predicate Devices

• SimpleSENSE (K201669)

Submission Summary (Full Text)

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September 22, 2021

Nanowear Inc. Venkatesh Varadan CEO 53 Boerum Place, Suite 3F Brooklyn, New York 11201

Re: K212160

Trade/Device Name: SimpleSENSE Platform Regulation Number: 21 CFR 870.2920 Regulation Name: Telephone Electrocardiograph Transmitter and Receiver Regulatory Class: Class II Product Code: DXH, DQD, DSB, BZQ, DPS Dated: August 19, 2021 Received: August 23, 2021

Dear Venkatesh Varadan:

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

Jennifer Shih Kozen 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) K212160

Device Name SimpleSENSE Platform

#### Indications for Use (Describe)

The SimpleSENSE Platform is intended for use at home, or at a healthcare facility, under the direction of a licensed medical professional, to record, display and store the following physiological data: a) 2 leads of Electrocardiogram; b) Respiration rate measured through thoracic impedance; c) Heart Sounds; d) Activity including posture; and e) other validated data sources. The SimpleSENSE Platform is intended for use when the licensed medical professional decides to evaluate the physiologic signals of adult patients as an aid to diagnosis and treatment. The SimpleSENSE Platform is intended to be used by patients at rest and not performing any activities or movements. ECG recordings are indicated for the manual assessment of cardiac rhythm disturbances. The SimpleSENSE Platform does not is not intended for active patient monitoring (real-time). The SimpleSENSE Platform is not intended for use as life supporting equipment on high-risk patients such as critical care patients. The SimpleSENSE Platform is not intended for use in the presence of a pacemaker.

| Type of Use ( <i>Select one or both, as applicable</i> ) | |
|-------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|
| <div style="display:flex; align-items:center;"><span style="margin-right:5px;"> </span>Prescription Use (Part 21 CFR 801 Subpart D)</div> | <div style="display:flex; align-items:center;"><span style="margin-right:5px;"> </span>Over-The-Counter Use (21 CFR 801 Subpart C)</div> |

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# 510(K) SUMMARY PER 21 CFR §807.92

## 1. SUBMITTER'S INFORMATION

Nanowear Inc.

Contact: Venkatesh Varadan

53 Boerum Pl, Suite 3F

Brooklyn, NY 11201

United States

Phone: [phone]

Date: June 30, 2021

# 2. CLASSIFICATION

The classification for the new device is shown in the table below:

| 21 CFR<br>Reference | Product<br>Code | Class | Trade Name | Classification Name |
|---------------------|-----------------|-------|-------------------------|--------------------------------------------------------------|
| §870.2920 | DXH | 2 | | Transmitters and Receivers,<br>Electrocardiograph, Telephone |
| §870.2770 | DSB | 2 | SimpleSENSE<br>Platform | Plethysmograph, Impedance |
| §868.2375 | BZQ | 2 | | Monitor, Breathing Frequency |
| §870.2340 | DPS | 2 | | Electrocardiograph |
| §870.1875 | DQD | 2 | | Stethoscope, Electronic |

### 3. PREDICATE DEVICE

The predicate device is:

- K201669 SimpleSENSE cleared on November 6, 2020, from Nanowear Inc. ●
# 4. INDICATIONS FOR USE

The SimpleSENSE Platform is intended for use at home, or at a healthcare facility, under the direction of a licensed medical professional, to record, display and store the following physiological data: a) 2 leads of Electrocardiogram; b) Respiration rate measured through thoracic impedance; c) Heart Sounds; d) Activity including posture; and e) other validated data sources. The SimpleSENSE Platform is intended for use when the licensed medical professional decides to evaluate the physiologic signals of adult patients as an aid to diagnosis and treatment. The SimpleSENSE Platform is intended to be used by patients at rest and not performing any activities or movements. ECG recordings are indicated for the manual assessment of cardiac rhythm disturbances. The SimpleSENSE Platform does not produce alarms and is not intended for active patient monitoring (real-time). The SimpleSENSE Platform is not intended for use as life supporting equipment on high-risk

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patients such as critical care patients. The SimpleSENSE Platform is not intended for use in the presence of a pacemaker.

### 5. DEVICE DESCRIPTION

The Nanowear SimpleSENSE Platform is the next generation diagnostic monitoring technology that captures electrocardiographic (ECG) signals, respiration rate though thoracic impedance, heart sounds, activity including posture and movement with sensors embedded on a wearable textile garment. The signals are stored and wirelessly transmitted to a smartphone, which is then forwarded to a medical professional for review.

The garment is designed to be unobtrusive to everyday activity and provide an easier and more efficient means of capturing ECG data from patients. The device consists of a combination of:

- The SimpleSENSE Garment: an integrated network of nanosensor electrodes for measuring ECG and respiratory rate from thoracic impedance. A MEMS microphone for measuring heart sounds.
- The SimpleSENSE Signal Acquisition Unit (SAU): data acquisition, storage, and transmission to a phone running iOS or Android. An accelerometer to measure activity.
- The SimpleSENSE Mobile Application: mobile application to start/stop a recording, logging symptoms, and data transmission.
- . SimpleSENSE Web Server: allows initiation of a test, storage, and review of prescribed test data by a medical professional.

Image /page/4/Picture/11 description: The image shows a diagram of a medical monitoring system. The diagram shows a person wearing a chest strap, which is connected to a smartphone app. The smartphone app then sends data to a doctor who is monitoring the patient's health. The arrows indicate the flow of information between the different components of the system.

FIGURE 1: SIMPLESENSE PLATFORM CLINICAL MODEL OF DATA COLLECTION, TRANSMISSION AND REVIEW

#### 6. INTENDED USE

The Nanowear SimpleSENSE Platform is intended for use by licensed medical professionals or patients to record, store, and transfer electrocardiogram (ECG), respiratory rate, heart sounds, and activity including posture and movement.

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### 7. CHARACTERISTICS

The table below delineates the similarities and differences between the cleared SimpleSENSE System, and the proposed SimpleSENSE Platform. The table includes comparisons of the system features of the devices. Any differences between the two designs have been marked with bold font which are further discussed below the table.

| | Nanowear Inc.<br>SimpleSENSE System | Nanowear Inc.<br>SimpleSENSE Platform | |
|---------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------|
| 510(k) Number | K201669 | To be assigned | |
| Indication<br>Statement | The SimpleSENSE System is intended for<br>use at home, or at a healthcare facility,<br>under the direction of a licensed medical<br>professional, to record, display and store<br>the following physiological data: a) 2<br>leads of Electrocardiogram; b)<br>Respiration rate measured through<br>thoracic impedance; c) Heart Sounds;<br>and d) Activity including posture.<br>The device is<br>intended for use when the<br>clinician decides to evaluate<br>the physiologic signals of adult patients<br>as an aid to diagnosis and treatment.<br>The SimpleSENSE System is intended to<br>be used by patients at rest and not<br>performing any activities or movements.<br>ECG recordings are indicated for the<br>manual assessment of cardiac rhythm<br>disturbances. The device<br>does not produce alarms and is not<br>intended for active patient monitoring<br>(real-time). The device is<br>not intended for use as life supporting<br>equipment on high-risk patients such as<br>critical care patients. The<br>device is not intended for use in the<br>presence of a pacemaker. | The SimpleSENSE Platform is intended<br>for use at home, or at a healthcare<br>facility, under the direction of a licensed<br>medical professional, to record, display<br>and store the following physiological<br>data: a) 2 leads of Electrocardiogram; b)<br>Respiration rate measured through<br>thoracic impedance; c) Heart Sounds; d)<br>Activity including posture; and e) other<br>validated data sources. The<br>SimpleSENSE Platform is intended for<br>use when the licensed medical<br>professional decides to evaluate the<br>physiologic signals of adult patients as<br>an aid to diagnosis and treatment. The<br>SimpleSENSE Platform is intended to be<br>used by patients at rest and not<br>performing any activities or movements.<br>ECG recordings are indicated for the<br>manual assessment of cardiac rhythm<br>disturbances. The SimpleSENSE Platform<br>does not produce alarms and is not<br>intended for active patient monitoring<br>(real-time). The SimpleSENSE Platform is<br>not intended for use as life supporting<br>equipment on high-risk patients such as<br>critical care patients. The SimpleSENSE<br>Platform is not intended for use in the<br>presence of a pacemaker. | |
| Product Code | DXH, DSB, BZQ, DPS, DQD | Same | |
| Acquired Data | • Electrocardiogram (EKG/ECG)<br>• Respiration Rate derived from thoracic<br>impedance<br>• Heart Sounds | Same | |
| Sensor<br>Technology | • Electrocardiogram (EKG/ECG): Textile-<br>based Nanosensors<br>• Respiration Rate: Textile-based<br>Nanosensors measure thoracic<br>impedance and respiration is derived<br>from thoracic impedance<br>• Heart Sound: Microelectromechanical<br>(MEMs) microphone | Same | |
| Signal<br>acquisition<br>method | • Electrocardiogram (EKG/ECG):<br>Standard Bipolar lead instrumentation<br>amplifier and Sigma-Delta Analog to<br>Digital Converter.<br>• Respiration rate: Thoracic Impedance<br>is measured using four-point probe<br>using low amplitude current applied to<br>the body and impedance measured<br>from voltage drop derived from<br>thoracic impedance.<br>• Heart Sound: solid state<br>Microelectromechanical (MEMs)<br>microphone embedded in garment<br>and located near Apex of heart. | Same | |
| Display Type | No on-device display. | Same | |
| Display<br>Requirement | User provided display hardware for a<br>healthcare professional to view the<br>recorded data. A general-purpose<br>PC/Laptop/Desktop may be used. | Same | |
| Power Source | Internally powered using Li-Ion<br>rechargeable battery | Same | |
| Internal<br>Memory/data | Removeable MicroSD card | Same | |
| Communication<br>Interface | Wireless transceiver using Bluetooth | Same | |
| Access to<br>recorded data | Data is transferred to the iPhone,<br>which is then shared with the healthcare<br>professional via email.<br><br>For redundancy, encrypted data is also<br>stored in the removeable storage<br>medium. | Data is transferred to the smart phone,<br>which is then shared with the healthcare<br>professional via the SimpleSENSE Web<br>Server.<br><br>For redundancy, encrypted data is also<br>stored in the removeable storage<br>medium. | |
| Characteristic | Category | New Device<br>SimpleSENSE Platform | Predicate<br>SimpleSENSE System |
| Frequency<br>response | ECG | 0.05 Hz - 65 Hz | Same |
| | Thoracic Impedance | 0.05 Hz - 65 Hz | Same |
| | Heart Sound | 0.05 Hz - 236 Hz | Same |
| | Accelerometer | 0-25 Hz | Same |
| Channels | ECG | 2 channels | Same |
| | Thoracic Impedance | 2 channels | Same |
| | Heart Sound | 1 channel | Same |
| | Accelerometer | 1 channel | Same |
| Resolution | ECG | 24-bit | Same |
| | Thoracic Impedance | 24-bit | Same |
| | Heart Sound | 24-bit | Same |
| | Accelerometer | 16-bit | Same |
| Sampling Rate | ECG | 200 Hz | Same |
| | Thoracic Impedance | 200 Hz…