SimpleSense-BP, SimpleSense-BP Software Application

K232053 · Nanowear, Inc. · DXN · Dec 8, 2023 · Cardiovascular

Device Facts

• Record ID: K232053
• Device Name: SimpleSense-BP, SimpleSense-BP Software Application
• Applicant: Nanowear, Inc.
• Product Code: DXN · Cardiovascular
• Decision Date: Dec 8, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1130
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

The SimpleSense Platform is intended for use at home, a healthcare facility, or medical research organization 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; e) Systolic and Diastolic Blood Pressure and f) 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 with a stationary torso. 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. 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. The SimpleSense-BP software application is intended to estimate, display and store blood pressure data on adult patients who are twenty two (22) years and older. The SimpleSense-BP can be used after a clinician determines the user's hypertension classification via an auscultatory blood pressure cuff measurement. The Blood Pressure algorithm uses patient specific information (age, gender, height and weight) and the blood pressure measurement as inputs. SimpleSense-BP is used to provide blood pressure estimations derived from physiological sensors to qualified medical personnel as a complimentary physiological feature for the purposes of assessing a patient's cardiac health and variance.

Device Story

SimpleSense-BP is a software module for the existing SimpleSense wearable garment/electronics system. It processes ECG, heart sounds, and thoracic impedance data captured by textile nanosensors and MEMS microphones. Inputs include patient demographics (age, gender, height, weight) and a clinician-provided baseline blood pressure measurement (required every 21 days). The system operates at home or in clinical settings; data is transmitted via Bluetooth to a mobile app and then to a web server for physician review. The device provides retrospective blood pressure estimations to assist in assessing cardiac health. It does not provide real-time monitoring or alarms. The system rejects data if motion is detected, ensuring measurements occur only at rest.

Clinical Evidence

Clinical validation study (n=149) evaluated performance against auscultatory reference measurements across four hypertension categories (Normal, Prehypertensive, Stage 1, Stage 2). Results met ISO 81060-2 criteria (MD ≤ ±5 mmHg, SD ≤ 8 mmHg). Accuracy maintained over a 21-day calibration period (n=91) with no evidence of drift. Subgroup analysis confirmed performance across diverse demographics and blood pressure ranges.

Technological Characteristics

Wearable chest-worn garment with textile-based nanosensors for ECG and thoracic impedance; MEMS microphone for heart sounds. Materials: Polyester, ABS, Neoprene, Spandex, Silver, Polyurethane. Connectivity: Bluetooth to mobile app, Wi-Fi/cellular to cloud. Software: Fixed computational algorithm for BP estimation. Non-sterile. Standards: AAMI ES 60601-1, IEC 60601-1-6, IEC 60601-1-2, IEC 60601-2-47, ISO 10993-1, ISO 14971.

Indications for Use

Indicated for adult patients (22+ years) requiring evaluation of physiologic signals (ECG, respiration, heart sounds, activity, blood pressure) as an aid to diagnosis and treatment. Contraindicated for high-risk/critical care patients and patients with pacemakers. Requires stationary torso at rest.

Regulatory Classification

Identification

A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.

Predicate Devices

• Nanowear Inc. – SimpleSense Platform (K212160)

Reference Devices

• Biobeat Technologies Ltd. – BB-613 WP (K190792)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

December 8, 2023

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

Re: K232053

Trade/Device Name: SimpleSense-BP, SimpleSense-BP Software Application Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive blood pressure measurement system Regulatory Class: Class II Product Code: DXN, DXH, DSB, BZQ, DPS, DQD Dated: July 10, 2023 Received: July 11, 2023

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

{1}------------------------------------------------

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# Robert T. Kazmierski -S

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

{2}------------------------------------------------

# Indications for Use

510(k) Number (if known) K232053

Device Name SimpleSense-BP

#### Indications for Use (Describe)

The SimpleSense Platform is intended for use at home, a healthcare facility, or medical research organization 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; e) Systolic and Diastolic Blood Pressure and f) 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 with a stationary torso. 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. 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.

The SimpleSense-BP software application is intended to estimate, display and store blood pressure data on adult patients who are twenty two (22) years and older. The SimpleSense-BP can be used after a clinician determines the user's hypertension classification via an auscultatory blood pressure cuff measurement. The Blood Pressure algorithm uses patient specific information (age, gender, height and weight) and the blood pressure measurement as inputs. SimpleSense-BP is used to provide blood pressure estimations derived from physiological sensors to qualified medical personnel as a complimentary physiological feature for the purposes of assessing a patient's cardiac health and variance.

| Type of Use (Select one or both, as applicable) | |
|-----------------------------------------------------------------------------|----------------------------------------------------------------------------|
| <div> <span> </span> Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> <span> </span> Over-The-Counter Use (21 CFR 801 Subpart C) </div> |

### 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 [e-mail]

"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."

{3}------------------------------------------------

# 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: October 11, 2022

# 2. New Device

- Trade Name: SimpleSense-BP
- Common Name: Blood pressure monitor
- Classification Name: ●
- System, Measurement, Blood-Pressure, Non-Invasive (21 CFR §870.1130 Product O Code DXN)

# 3. PRIMARY PREDICATE DEVICE - K212160

Provided all sensors and the majority of functionality has not changed since the prior clearance (no physical changes and 5 of 6 product codes remain the same), Nanowear's prior clearance was selected as the predicate device.

- Trade Name: Nanowear Inc. – SimpleSense Platform
- Common Name: Vital signs monitoring system
- Classification Names:
- O Transmitters and Receivers, Electrocardiograph, Telephone (21 CFR §870.2920 -Product Code: DXH)
- Plethysmograph, Impedance (21 CFR §870.2770 Product Code: DSB) O
- Monitor, Breathing Frequency (21 CFR §868.2375 Product Code: BZQ) O
- Electrocardiograph (21 CFR §870.2340 Product Code: DPS) O
- Stethoscope, Electronic (21 CFR §870.1875 Product Code: DQD) O

# 4. SECONDARY PREDICATE DEVICE - K190792

Since the predicate device does not include product code DXN, the following reference device is provided to establish equivalence to a previously cleared medical device for the additional product code. This device is used to establish similar use of software-based analysis to obtain blood pressure in a multi-parameter system.

- Trade Name: Biobeat Technologies Ltd. – BB-613 WP
- Common Name: Vital signs monitoring system ●
- Classification Names:

{4}------------------------------------------------

- Oximeter (21 CFR §870.2920 Product Code: DQA) о
- System, Measurement, Blood-Pressure, Non-Invasive (21 CFR §870.1130 Product o Code DXN)
- Transmitters And Receivers, Physiological Signal, Radiofrequency (21 CFR §868.2910 o - Product Code: DRG)

# 5. Indications for Use

The SimpleSense Platform is intended for use at home, a healthcare facility, or medical research organization 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; e) Systolic and Diastolic Blood Pressure and f) 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 with a stationary torso. 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. 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.

The SimpleSense-BP software application is intended to estimate, display and store blood pressure data on adult patients who are twenty two (22) years and older. The SimpleSense-BP can be used after a clinician determines the user's hypertension classification via an auscultatory blood pressure cuff measurement. The Blood Pressure algorithm uses patient specific information (age, gender, height and weight) and the blood pressure measurement as inputs. SimpleSense-BP is used to provide blood pressure estimations derived from physiological sensors to qualified medical personnel as a complimentary physiological feature for the purposes of assessing a patient's cardiac health and variance.

# 6. Device Description

The SimpleSense-BP Software Application accesses the physiological parameters like ECG, heart sounds, and thoracic impedance captured by the SimpleSense Device for processing into the vital sign outputs of the product which includes estimation of Systolic and Diastolic blood pressure. The software uses recorded data from the SimpleSense electronics module as inputs into a validated computational model for estimating blood pressure over the period of wear. The system samples blood pressure while the user is at rest. In addition, SimpleSense-BP Software utilizes inputs such as demographic information (age, weight, height, and gender) and a blood pressure measurement for clinical stratification to the algorithm. The blood pressure outputs are returned to the SimpleSense Mobile Application and/or SimpleSense webserver for display, review and interpretation by a physician.

The Nanowear SimpleSense system is a non-invasive, wearable, and portable medical device for the evaluation and monitoring of patients. It utilizes physiologic and biometric sensors embedded in a garment and an electronics module to gather the heart health data.

{5}------------------------------------------------

The specific physiological parameters recorded by the device include: two vectors of Electrocardiogram (ECG), respiratory rate though thoracic impedance, heart sounds, and activity including posture. The signals are recorded by the electronics module on a removable data storage card and are periodically transferred to a smartphone mobile application that connects to the electronics module over a wireless Bluetooth connection. The mobile application provides the functionality of transferring the data collected by the electronics module then relaying the data to the Nanowear web server for display of the data by a physician.

# 7. Intended Use

The Nanowear SimpleSense-BP blood pressure software module is intended to estimate systolic and diastolic blood pressure using the SimpleSense device data and demographic information of the patient inclusive of age, weight, and gender. In addition, an initial blood pressure value for clinical stratification must be determined and entered by a clinician. The blood pressure value is also input into the device as an input to the blood pressure algorithm. A new blood pressure measurement needs to be taken and updated into the system every 21 days.

# 8. CLINICAL USE MODEL

The SimpleSense-BP software application allows medical professionals to remotely obtain, and review blood pressure measurements computed from the SimpleSense device data. Under the care of a physician, a medical professional prescribes the SimpleSense device which captures data via the garment, stores and transmits data from a Signal Acquisition Unit (SAU) to a smartphone device via Bluetooth and wirelessly transmits via Wi-Fi or cellular data for review by a medical professional. The data that is transmitted to the Nanowear servers is used as inputs to the SimpleSense-BP software algorithm. The output of the algorithm is estimated Systolic and Diastolic blood pressure.

### 9. Substantial Equivalence Comparison

See §4 (Indications for Use) above to review bold font that demarks the difference between the predicate device and the SimpleSense-BP software.

The table below delineates the differences between the cleared SimpleSense Platform, and the proposed SimpleSense-BP software algorithm. 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.

{6}------------------------------------------------

# Table 1: Predicate Comparison: System Design

| | Nanowear Inc.<br>SimpleSense Platform | Nanowear Inc.<br>SimpleSense-BP (on SimpleSense Platform) | BioBeat Technologies LTD<br>BB-613 | |
|--------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------|
| 510(k)<br>Number | K212160 | New Device - K214069 | K190792 | |
| Indications<br>for Use<br>Statement | The SimpleSense Platform is<br>intended for use at home, or at a<br>healthcare facility, under the<br>direction of a licensed medical<br>professional, to record, display and<br>store the following physiological<br>data: a) 2 leads of<br>Electrocardiogram; b) Respiration<br>rate measured through thoracic<br>impedance; c) Heart Sounds; d)<br>Activity including posture; and e)<br>other validated data sources. The<br>SimpleSense Platform is intended<br>for use when the licensed medical<br>professional decides to evaluate<br>the physiologic signals of adult<br>patients as an aid to diagnosis and<br>treatment. The SimpleSense<br>Platform is intended to be used by<br>patients at rest and not performing<br>any activities or movements. ECG<br>recordings are indicated for the<br>manual assessment of cardiac<br>rhythm disturbances. The<br>SimpleSense Platform does not<br>produce alarms and is not intended<br>for active patient monitoring (real-<br>time).<br>The SimpleSense Platform is not<br>intended for use as life supporting<br>equipment on high-risk patients<br>such as critical care patients. The<br>SimpleSense Platform is not<br>intended for use in the presence of<br>a pacemaker. | The SimpleSense Platform is intended for use at home,<br>a healthcare facility, or medical research organization<br>under the direction of a licensed medical professional<br>to record, display, and store the following physiological<br>data: a) 2 leads of Electrocardiogram; b) Respiration<br>rate measured through thoracic impedance; c) Heart<br>Sounds; d) Activity including posture; e) Systolic and<br>Diastolic Blood Pressure and f) other validated data<br>sources. The SimpleSense Platform is intended for use<br>when the licensed medical professional decides to<br>evaluate the physiologic signals of adult patients as an<br>aid to diagnosis and treatment. The SimpleSense<br>Platform is intended to be used by patients at rest with<br>a stationary torso. ECG recordings are indicated for the<br>manual assessment of cardiac rhythm disturbances.<br>The SimpleSense Platform does not produce alarms<br>and is not intended for active patient monitoring.<br>The SimpleSense Platform is not intended for use as life<br>supporting equipment on high-risk patients such as<br>critical care patients. The SimpleSense Platform is not<br>intended for use in the presence of a pacemaker.<br>The SimpleSense-BP software application is intended to<br>estimate, display and store blood pressure data on<br>adult patients who are twenty two (22) years and<br>older. The SimpleSense-BP can be used after a clinician<br>determines the user's hypertension classification via a<br>FDA cleared blood pressure cuff and enters patient<br>specific information (age, gender, height and weight).<br>SimpleSense-BP is used to provide blood pressure<br>calculations derived from physiological sensors to<br>qualified medical personnel as a complimentary<br>physiological feature for the purposes of assessing a<br>patient's cardiac health and variance. | The BB-613 WP is a<br>wrist-worn or skin<br>attached device<br>indicated for use in<br>measuring and<br>displaying functional<br>oxygen saturation of<br>arterial hemoglobin<br>(%SpO2) and pulse rate.<br>The BB-613WP can also<br>track changes in blood<br>pressure based on Pulse<br>Wave Transit Time<br>(PWTT) which is<br>obtained utilizing pulse<br>measurements from the<br>integrated SpO2 sensor,<br>following a calibration<br>process using<br>oscillometric blood<br>pressure monitor.<br>The BB-613WP is<br>intended for spot-<br>checking of adult<br>patients in hospitals,<br>clinics, long-term care,<br>and home use. | |
| Product Code | DXH, DSB, BZQ, DPS, DQD | DXH, DSB, BZQ, DPS, DQD, DXN | DXN, DQA, DRG | |
| Acquired<br>Data | • Electrocardiogram<br>• Respiration Rate from<br>thoracic impedance<br>• Heart Sounds<br>• Activity | • Electrocardiogram<br>• Respiration Rate from thoracic impedance<br>• Heart Sounds<br>• Activity<br>• Systolic and Diastolic Blood Pressure from a<br>combination of above data and patient<br>information | • Oxygen Saturation<br>(SpO2)<br>• Pulse Rate (PR)<br>• Blood Pressure (BP) | |
| Target<br>Population | Adult patients requiring<br>evaluation of physiologic signals | No change - Same | Adults | |
| | Nanowear Inc.<br>SimpleSense Platform | Nanowear Inc.<br>SimpleSense-BP (on SimpleSense Platform) | BioBeat Technologies<br>LTD<br>BB-613 | |
| 510(k)<br>Number | K212160 | New Device - K214069 | K190792 | |
| Monitoring<br>Type | • Intermittent, Spot-checking | No change - Same | Spot-checking | |
| Sensor<br>Technology | • Electrocardiogram: Textile-based<br>nanosensors<br>• Respiration Rate: Textile-based<br>nanosensors measure thoracic<br>impedance and respiration is<br>derived from thoracic impedance<br>• Heart Sound:<br>Microelectromechanical (MEMs)<br>microphone | No change - Same | Pulse reflectance<br>technology, Four LED<br>(red + IR) and photo<br>diode absorbs reflected<br>light.<br>[Photoplethysmograp<br>hy PPG sensor] | |
| Anatomical<br>Sites | Chest worn sash with multiple<br>embedded sensors | No change - Same | Wrist worn device or<br>adhesive patch on<br>chest | |
| Materials | Polyester, ABS Hook and Loop,<br>Neoprene, Spandex, Silver and<br>Polyurethane | No change - Same<br>The materials used in Nanowear hardware have been<br>consistent across all Nanowear products, including this 510(k)<br>for the SimpleSense-BP. The SimpleSense system hardware<br>(K201669) was used for validating the SimpleSense-BP<br>software and is the exclusive hardware to be used with<br>SimpleSense-BP software. | Polycarbonate,<br>Photodiode window,<br>Silicone<br>Adhesive patch | |
| Signal<br>Acquisition<br>Method | • Electrocardiogram (EKG/ECG):<br>Standard Bipolar lead<br>instrumentation amplifier and<br>Sigma-Delta Analog to Digital<br>Converter.<br>• Respiration rate: Thoracic<br>Impedance is measured using<br>four-point probe using low<br>amplitude current applied to the<br>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<br>garment and located near Apex<br>of heart. | • Electrocardiogram (EKG/ECG): Standard Bipolar lead<br>instrumentation amplifier and Sigma-Delta Analog to<br>Digital Converter.<br>• Respiration rate: Thoracic Impedance is measured<br>using four-point probe using low amplitude current<br>applied to the body and impedance measured from<br>voltage drop derived from thoracic impedance.<br>• Heart Sound: solid state Microelectromechanical<br>(MEMs) microphone embedded in garment and<br>located near Apex of heart.<br>• Blood Pressure: software algorithm model for<br>estimating systolic and diastolic blood pressure<br>based on SimpleSense device data. | • Pulse Wave Transit<br>Time (PWTT)<br>calculation based on<br>measurement of<br>functional oxygen<br>saturation | |
| Display Type | No on-device display<br>Software application for iOS and<br>Android | No change - Same | LCD on device or<br>handheld display unit | |
| | Nanowear Inc.<br>SimpleSense Platform | Nanowear Inc.<br>SimpleSense-BP (on SimpleSense Platform) | BioBeat Technologies<br>LTD<br>BB-613 | |
| 510(k)<br>Number | K212160 | New Device - K214069…