(150 days)
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.
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. 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.
The provided text describes the acceptance criteria and study proving the performance of the SimpleSense-BP software application for blood pressure estimation.
Here's an organized breakdown of the requested information:
Acceptance Criteria and Device Performance
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the SimpleSense-BP algorithm are based on the ISO 81060-2 standard for non-invasive sphygmomanometers. The reported performance refers to the accuracy of the device's blood pressure estimations compared to reference measurements.
| Measured Parameter | Acceptance Criteria (ISO 81060-2) | Reported Device Performance (Mean Difference (MD) ± Standard Deviation (SD)) |
|---|---|---|
| Blood Pressure | ||
| Overall Performance (All Protocol Timepoints) | ||
| Systolic (SBP) | MD ≤ ±5 mmHg; SD ≤ 8 mmHg | 0.09 ± 4.08 mmHg (N=147 subjects) |
| Diastolic (DBP) | MD ≤ ±5 mmHg; SD ≤ 8 mmHg | 0.35 ± 3.32 mmHg (N=147 subjects) |
| Performance with Nominal Changes (SBP Change ≤ ±15 mmHg; DBP Change ≤ ±10 mmHg) | ||
| Systolic (SBP) | MD ≤ ±5 mmHg; SD ≤ 8 mmHg | 0.10 ± 3.88 mmHg (N=147 subjects) |
| Diastolic (DBP) | MD ≤ ±5 mmHg; SD ≤ 8 mmHg | 0.46 ± 3.17 mmHg (N=147 subjects) |
| Performance with Significant Induced Changes | ||
| SBP Increase ≥ 15 mmHg | MD ≤ ±5 mmHg; SD ≤ 8 mmHg | -4.65 ± 2.62 mmHg (N=77 subjects) |
| SBP Decrease ≤ -15 mmHg | MD ≤ ±5 mmHg; SD ≤ 8 mmHg | 4.20 ± 2.87 mmHg (N=72 subjects) |
| DBP Increase ≥ 10 mmHg | MD ≤ ±5 mmHg; SD ≤ 8 mmHg | -2.54 ± 2.98 mmHg (N=73 subjects) |
| DBP Decrease ≤ -10 mmHg | MD ≤ ±5 mmHg; SD ≤ 8 mmHg | 3.36 ± 3.36 mmHg (N=25 subjects) |
| Accuracy over Calibration Period (Weekly Performance against ISO 81060-2) | ||
| Systolic | MD ≤ ±5 mmHg; SD ≤ 8 mmHg | |
| Week-1 | -1.7 ± 5.13 mmHg (N=91 subjects) | |
| Week-2 | -1.71 ± 5.05 mmHg (N=91 subjects) | |
| Week-3 | -0.88 ± 4.94 mmHg (N=91 subjects) | |
| Week-4 | -2.94 ± 4.82 mmHg (N=91 subjects) | |
| Diastolic | MD ≤ ±5 mmHg; SD ≤ 8 mmHg | |
| Week-1 | -0.41 ± 4.19 mmHg (N=91 subjects) | |
| Week-2 | -0.23 ± 4.12 mmHg (N=91 subjects) | |
| Week-3 | 0.22 ± 4.05 mmHg (N=91 subjects) | |
| Week-4 | -0.77 ± 3.75 mmHg (N=91 subjects) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Induced Change Test: 149 subjects in total were identified, with 147 subjects having usable data. The study ensured at least 10 subjects had a change in BP of at least 15 mmHg systolic or 10 mmHg diastolic for each of the 4 models used by the device.
- Sample Size for Accuracy over Calibration Period Test: 91 subjects. The study enrolled subjects until at least 85 subjects were included and at least 21 subjects in each clinical stratification (Normal, Prehypertension, Stage 1 hypertension, and Stage 2 hypertension) were represented.
- Data Provenance: The document does not explicitly state the country of origin. It indicates that blood pressure variations were induced using physical activity and thermal stimuli, and auscultatory reference measurements were used for validation, suggesting a prospective study design.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document states that "auscultatory reference measurements were used to validate the SimpleSense-BP algorithm." This implies a clinical setting where blood pressure is manually measured by trained personnel, typically healthcare professionals, using a cuff. However, the exact number of experts, their specific qualifications (e.g., "radiologist with 10 years of experience"), or the method of their involvement (e.g., individual readings, consensus) are not specified in the provided text.
4. Adjudication Method for the Test Set
The document does not describe a formal adjudication method (e.g., 2+1, 3+1, none) for the test set. The ground truth was established by "auscultatory reference measurements," which usually implies direct clinical measurement rather than adjudicated review of digital data.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. The provided text describes a standalone performance study comparing the device's output to a gold standard (auscultatory measurements), not a comparative effectiveness study involving human readers with and without AI assistance. Therefore, there is no mention of an effect size for human reader improvement with AI assistance.
6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done
Yes. The entire performance testing section (Section 11) is dedicated to evaluating the "SimpleSense-BP algorithm" against auscultatory reference measurements. This represents a standalone (algorithm only) performance evaluation.
7. The Type of Ground Truth Used
The type of ground truth used is auscultatory blood pressure cuff measurements, which is considered the gold standard for non-invasive blood pressure measurement.
8. The Sample Size for the Training Set
The sample size for the training set is not specified. The document explicitly states, "There was no overlap of subjects between the training and test data sets i.e., none of the measurements from subjects in the training data set were included in the test data set and vice versa," confirming that a training set was used but not detailing its size.
9. How the Ground Truth for the Training Set Was Established
The document does not explicitly state how the ground truth for the training set was established. However, given that the validation uses "auscultatory reference measurements" as the gold standard, it is highly probable that the training data's ground truth was established using the same (or a similar and equally robust) method of auscultatory blood pressure measurements.
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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).
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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
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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) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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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: 718-637-4815
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:
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- 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.
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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.
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Table 1: Predicate Comparison: System Design
| Nanowear Inc.SimpleSense Platform | Nanowear Inc.SimpleSense-BP (on SimpleSense Platform) | BioBeat Technologies LTDBB-613 | ||
|---|---|---|---|---|
| 510(k)Number | K212160 | New Device - K214069 | K190792 | |
| Indicationsfor UseStatement | The SimpleSense Platform isintended for use at home, or at ahealthcare facility, under thedirection of a licensed medicalprofessional, to record, display andstore the following physiologicaldata: a) 2 leads ofElectrocardiogram; b) Respirationrate measured through thoracicimpedance; c) Heart Sounds; d)Activity including posture; and e)other validated data sources. TheSimpleSense Platform is intendedfor use when the licensed medicalprofessional decides to evaluatethe physiologic signals of adultpatients as an aid to diagnosis andtreatment. The SimpleSensePlatform is intended to be used bypatients at rest and not performingany activities or movements. ECGrecordings are indicated for themanual assessment of cardiacrhythm disturbances. TheSimpleSense Platform does notproduce alarms and is not intendedfor active patient monitoring (real-time).The SimpleSense Platform is notintended for use as life supportingequipment on high-risk patientssuch as critical care patients. TheSimpleSense Platform is notintended for use in the presence ofa pacemaker. | The SimpleSense Platform is intended for use at home,a healthcare facility, or medical research organizationunder the direction of a licensed medical professionalto record, display, and store the following physiologicaldata: a) 2 leads of Electrocardiogram; b) Respirationrate measured through thoracic impedance; c) HeartSounds; d) Activity including posture; e) Systolic andDiastolic Blood Pressure and f) other validated datasources. The SimpleSense Platform is intended for usewhen the licensed medical professional decides toevaluate the physiologic signals of adult patients as anaid to diagnosis and treatment. The SimpleSensePlatform is intended to be used by patients at rest witha stationary torso. ECG recordings are indicated for themanual assessment of cardiac rhythm disturbances.The SimpleSense Platform does not produce alarmsand is not intended for active patient monitoring.The SimpleSense Platform is not intended for use as lifesupporting equipment on high-risk patients such ascritical care patients. The SimpleSense Platform is notintended for use in the presence of a pacemaker.The SimpleSense-BP software application is intended toestimate, display and store blood pressure data onadult patients who are twenty two (22) years andolder. The SimpleSense-BP can be used after a cliniciandetermines the user's hypertension classification via aFDA cleared blood pressure cuff and enters patientspecific information (age, gender, height and weight).SimpleSense-BP is used to provide blood pressurecalculations derived from physiological sensors toqualified medical personnel as a complimentaryphysiological feature for the purposes of assessing apatient's cardiac health and variance. | The BB-613 WP is awrist-worn or skinattached deviceindicated for use inmeasuring anddisplaying functionaloxygen saturation ofarterial hemoglobin(%SpO2) and pulse rate.The BB-613WP can alsotrack changes in bloodpressure based on PulseWave Transit Time(PWTT) which isobtained utilizing pulsemeasurements from theintegrated SpO2 sensor,following a calibrationprocess usingoscillometric bloodpressure monitor.The BB-613WP isintended for spot-checking of adultpatients in hospitals,clinics, long-term care,and home use. | |
| Product Code | DXH, DSB, BZQ, DPS, DQD | DXH, DSB, BZQ, DPS, DQD, DXN | DXN, DQA, DRG | |
| AcquiredData | • Electrocardiogram• Respiration Rate fromthoracic impedance• Heart Sounds• Activity | • Electrocardiogram• Respiration Rate from thoracic impedance• Heart Sounds• Activity• Systolic and Diastolic Blood Pressure from acombination of above data and patientinformation | • Oxygen Saturation(SpO2)• Pulse Rate (PR)• Blood Pressure (BP) | |
| TargetPopulation | Adult patients requiringevaluation of physiologic signals | No change - Same | Adults | |
| Nanowear Inc.SimpleSense Platform | Nanowear Inc.SimpleSense-BP (on SimpleSense Platform) | BioBeat TechnologiesLTDBB-613 | ||
| 510(k)Number | K212160 | New Device - K214069 | K190792 | |
| MonitoringType | • Intermittent, Spot-checking | No change - Same | Spot-checking | |
| SensorTechnology | • Electrocardiogram: Textile-basednanosensors• Respiration Rate: Textile-basednanosensors measure thoracicimpedance and respiration isderived from thoracic impedance• Heart Sound:Microelectromechanical (MEMs)microphone | No change - Same | Pulse reflectancetechnology, Four LED(red + IR) and photodiode absorbs reflectedlight.[Photoplethysmography PPG sensor] | |
| AnatomicalSites | Chest worn sash with multipleembedded sensors | No change - Same | Wrist worn device oradhesive patch onchest | |
| Materials | Polyester, ABS Hook and Loop,Neoprene, Spandex, Silver andPolyurethane | No change - SameThe materials used in Nanowear hardware have beenconsistent across all Nanowear products, including this 510(k)for the SimpleSense-BP. The SimpleSense system hardware(K201669) was used for validating the SimpleSense-BPsoftware and is the exclusive hardware to be used withSimpleSense-BP software. | Polycarbonate,Photodiode window,SiliconeAdhesive patch | |
| SignalAcquisitionMethod | • Electrocardiogram (EKG/ECG):Standard Bipolar leadinstrumentation amplifier andSigma-Delta Analog to DigitalConverter.• Respiration rate: ThoracicImpedance is measured usingfour-point probe using lowamplitude current applied to thebody and impedance measuredfrom voltage drop derived fromthoracic impedance.• Heart Sound: solid stateMicroelectromechanical (MEMs)microphone embedded ingarment and located near Apexof heart. | • Electrocardiogram (EKG/ECG): Standard Bipolar leadinstrumentation amplifier and Sigma-Delta Analog toDigital Converter.• Respiration rate: Thoracic Impedance is measuredusing four-point probe using low amplitude currentapplied to the body and impedance measured fromvoltage drop derived from thoracic impedance.• Heart Sound: solid state Microelectromechanical(MEMs) microphone embedded in garment andlocated near Apex of heart.• Blood Pressure: software algorithm model forestimating systolic and diastolic blood pressurebased on SimpleSense device data. | • Pulse Wave TransitTime (PWTT)calculation based onmeasurement offunctional oxygensaturation | |
| Display Type | No on-device displaySoftware application for iOS andAndroid | No change - Same | LCD on device orhandheld display unit | |
| Nanowear Inc.SimpleSense Platform | Nanowear Inc.SimpleSense-BP (on SimpleSense Platform) | BioBeat TechnologiesLTDBB-613 | ||
| 510(k)Number | K212160 | New Device - K214069 | K190792 | |
| DisplayRequirement | User provided display hardwarefor a healthcare professional toview the recorded data. Ageneral-purposePC/Laptop/Desktop may beused. | No change - Same | N/A | |
| Power Source | Internally powered using Li-Ionrechargeable battery | No change - Same | Internally poweredbattery | |
| EnergyDelivered | No energy delivered | No change - Same | Unknown | |
| InternalMemory | Removeable MicroSD card | No change - Same | On-device storage | |
| Comm.Interface | Wireless transceiver usingBluetooth | No change - Same | Wireless | |
| Access toRecordedData | Data is transferred to the smartphone,which is then shared with thehealthcare professional via theSimpleSense Web Server.For redundancy, encrypted datais also stored in the removeablestorage medium. | No change - Same | Unknown | |
| UseEnvironment | Home healthcare | No change - Same | Hospitals, clinics,long-term care, andhome use | |
| StandardsUsed | • AAMI ES 60601-1:2005 /(R)2012• IEC 60601-1-6:2010 +A1:2013• IEC 60601-1-2:2014• IEC 60601-2-47:2012• ISO 10993-1:2009• ASTM D4169-09• ISO 14971:2007 | No change - Same | ISO 80601-2-56:2018IEC 60601-1-2:2014IEC 60601-1:2012 (3.1Edition)ANSI C63.27-2017 | |
| Sterility | Non-sterile | No change - Same | Supplied and usednon-sterile | |
| PhotoplethysmographySensorAttributes | N/A | N/A | Emitted light peakwavelength: 880nm(IR), 650nm (Red)Measurement RangeSpO2: 40% to 100%Arms, SpO2: ±2% | |
| FrequencyResponse | ECGThoracicImpedanceHeart SoundAccelerometer | 0.05 Hz - 65 Hz0.05 Hz - 65 Hz0.05 Hz - 236 Hz0-25 Hz | No change - Same | N/AUnknownN/AN/A |
| Channels | ECG | 2 channels | No change - Same | N/A |
| Nanowear Inc.SimpleSense Platform | Nanowear Inc.SimpleSense-BP (on SimpleSense Platform) | BioBeat TechnologiesLTDBB-613 | ||
| 510(k)Number | K212160 | New Device - K214069 | K190792 | |
| ThoracicImpedance | 2 channels | No change - Same | Unknown | |
| Heart Sound | 1 channel | No change - Same | N/A | |
| Accelerometer | 1 channel | No change - Same | N/A | |
| Resolution | ECG | 24-bit | No change - Same | N/A |
| ThoracicImpedance | 24-bit | No change - Same | Unknown | |
| Heart Sound | 24-bit | No change - Same | N/A | |
| Accelerometer | 16-bit | No change - Same | N/A | |
| Sampling Rate | ECG | 200 Hz | No change - Same | N/A |
| ThoracicImpedance | 200 Hz | No change - Same | Unknown | |
| Heart Sound | 500 Hz | No change - Same | N/A | |
| Accelerometer | 50 Hz | No change - Same | N/A | |
| Range | Heart Rateor(Pulse Rate)(Heart Rate fromECG) | No change - Same | 40 to 250 bpm, Arms,±3% (Pulse rate fromPPG) | |
| BloodPressure | N/A | SBP: 80-230 mmHgDBP: 40-130 mmHg | 0 mmHg - 299 mmHg | |
| RespirationRate | 6-22 breathes perminute (BPM) withaccuracy ± 2 BPM | No change - Same | N/A | |
| BloodPressureAccuracy | Not Available | ± 5 mmHg (Mean Difference); ± 8 mmHg(Standard Deviation) | ±5 mmHg (Meanerror) | |
| Memory | microSD card/16GB | No change - Same | Unknown | |
| Power Supply– BatteryType | Rechargeable Lithium-Ion | No change - Same | Unknown | |
| OperationalTime | Up to 15 hours total recordingtime using a single garment. | No change - Same | 72 hours | |
| Data Transfer | Bluetooth, Cellular, Wi-Fi | No change - Same | Bluetooth, Cellular,Wi-Fi | |
| SoftwareInterface | iOS or Android OS MobileApplication and web browser | No change - Same | iOS or Android OSMobile Application | |
| PhysicalSpecification:Dimensions | 3.3" x 2.40" x 1.03" | No change - Same | Unknown and variesbased on wrist wornor chest worn device | |
| PhysicalSpecification:Weight | 3.3 (ounces) | No change - Same | Unknown and variesbased on wrist wornor chest worn device | |
| Electrodes | Integrated into the device | No change - Same | Unknown | |
| UsageEnvironment | Healthcare facility or homeenvironment | No change - Same | Healthcare facility orhome environment | |
| Environmental OperatingTemperature | 5°C to 45°C | No change - Same | Unknown | |
| StorageTemperature | -20°C to 60°C | No change - Same | Unknown |
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10. Discussion of Key System Differences
10.1. Indications for Use, Product Code
The legally marketed predicate SimpleSense Platform (K212160) records, displays and stores ECG, Respiration Rate, and Heart Sounds. With the addition of the SimpleSense-BP software, the SimpleSense Platform can display systolic and diastolic blood pressure. There are approximately 500 FDA cleared medical blood pressure monitors in the DXN product code (noninvasive blood pressure measurement system), proving it a well-accepted physiologic parameter for 510(k) clearance.
Generally the addition of blood pressure to a multi-parameter monitor does not introduce additional risks. It is common to view vital signs such as ECG, Heart Rate, Respiratory Rate and Blood Pressure within the same device/user-interface. Analogous to all other parameters measured by the SimpleSense device, blood pressure data is reviewed retrospectively so there are no physiologic alarm functions, no automated diagnosis, and no real-time clinical response as a result of monitoring. There are no additional concerns of safe and effective use of the SimpleSense Platform running the SimpleSense-BP software for display of blood pressure alongside existing parameters.
10.2. Acquired Data
The primary difference between SimpleSense-BP software and primary predicate device is the inclusion of blood pressure estimation. The secondary predicate Biobeat BB-613-WP (K190792) is included to provide an example of a cleared medical device with a similar use of software-based analysis to obtain blood pressure in a multi-parameter system (as opposed to the traditionally more common oscillometric method). Biobeat uses Pulse Wave Transit Time (PWTT) which is based on an oxygen saturation sensor data, but there are other similar software-based analysis methods such as Pulse Decomposition Analysis (PDA) which uses ECG and tonometry.
Generally, software-based blood pressure measurements have been proven substantially equivalent to a predicate device by adherence to compliance standards and comparison in non-inferiority studies to a legally marketed medical device. Nanowear has followed that same path to prove substantial equivalence. The performance study was performed to compare the SimpleSense-BP to the gold standard.
10.3. Signal Acquisition Method
Blood Pressure reported by the SimpleSense-BP software is derived from existing (unchanged) sensor data obtained by the SimpleSense Platform. The SimpleSense-BP software is an algorithm model for estimating systolic and diastolic blood pressure based on SimpleSense device data. SimpleSense-BP is a fixed algorithm.
The method of signal acquisition from the nanosensors on the SimpleSense garment, does not raise any new questions regarding patient safety compared to the legally marketed SimpleSense Platform (K212160). This change does not introduce new hazards that result in unacceptable risk for the patient or medical professional. Further evaluation of performance is necessary to ensure the SimpleSense-BP software algorithm analysis is as effective as previously cleared medical device (see §10 below).
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10.4. Monitoring Type
The conditions described in the labeling for the required period of rest and the posture to be assumed by the user are identical to the instructions provided to patients who might use cuff-based blood pressure cuff at home following the standard of care for at-home self-reported blood pressure estimation. The users are instructed and are aware that blood pressure will be estimated after the stipulated period of rest following an initiation of a recording on the SimpleSense device. Due to the manner of operation of many cuffbased devices, the inflation of the cuff informs the user that a blood pressure is being estimated. However, the SimpleSense device does not provide a physical stimulus of that nature. Instead, the SimpleSense mobile App provides indication that a recording is ongoing. In either condition, the user is aware that a estimation will be taken by the device and are instructed to remain still. In case of device use outside of intended conditions, the SimpleSense-BP software actively rejects data captured if movements are detected by the SimpleSense activity monitoring function. Given this condition of use, instructions provided to the user, and the presence of software mitigations to detect use outside specified intended use, the difference in monitoring type raises no new questions of safety and efficacy.
11. Performance Testing
The ensemble models estimate systolic and diastolic pressures based on features extracted from the input SimpleSense data, and demographics data inclusive of the clinical stratification, an initial blood pressure measurement, age, gender, height, and weight. These inputs need to be updated every 21 days.
Subjects in four categories of hypertension - Normal, Prehypertensive, Stage 1, and Stage 2 hypertension were recruited with at least 21 subjects in each category as per IEEE 1708-2019a standard requirements reflecting the true breadth of the intended population. Blood pressure variations were induced using physical activity and thermal stimulus and the performance was achieved by the SimpleSense-BP algorithm. The auscultatory reference measurements were used to validate the SimpleSense-BP algorithm. Table 2 includes the results of the testing of the validation set. The range of BP tested was 80-230 mmHg for Systolic Blood Pressure and 40-130 mmHg for Diastolic Blood Pressure.
11.1. Induced blood pressure change test
To ensure models operate accurately over a broad range of blood pressures, both within the specified range of the original model chosen by baseline calibration and outside the range of the baseline model, enrollment was done until at least 10 subjects have a change in BP of at least 15 mmHg systolic or 10 mmHg diastolic for each of the 4 models used by the device.
The analysis results in the tables below show performance on all protocol timepoints, protocol timepoints with nominal changes only, and protocol timepoints with significant changes only.
All tables demonstrate that for each type of significant change in systolic and diastolic pressure and for each clinical stratification, there were at least 10 subjects identified. The
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performance Mean Difference (MD) and Standard Deviation of Difference (SD) meets the acceptance criteria of ISO 81060-2 in all 16 categories supporting generalizability across the intended population, safely and efficaciously supporting SimpleSense-BP's indications for use. 149 subjects in total were identified. Due to software risk mitigations within SimpleSense-BP that rejects unusable data, 147 subjects had usable data at any protocol time point of change. The accuracy after an induced change has met the acceptance criteria specified in ISO 81060-2 (mean difference no greater than ±5 mmHg with a standard deviation no greater than 8 mmHg).
| MeasurementType | All Protocol time points (Overall)included | Only protocol time points with nominalchanges(SBP Change ≤ ±15 mmHg; DBP Change ≤±10 mmHg) | ||||
|---|---|---|---|---|---|---|
| Number ofSubjects | Results | Number ofSubjects | Results | |||
| MD | SD | MD | SD | |||
| Systolic | 147 | 0.09 | 4.08 | 147 | 0.10 | 3.88 |
| Diastolic | 147 | 0.35 | 3.32 | 147 | 0.46 | 3.17 |
TABLE 2 PERFORMANCE OF MEASURED CHANGES IN BLOOD PRESSURE
| Significant Blood Pressure Changes | |||||
|---|---|---|---|---|---|
| Systolic | Diastolic | ||||
| Description of Change | Number of Subjects | AveragedMD SD | Description of Change | Number of Subjects | AveragedMD SD |
| SBP Increase ≥ 15 mmHg | 77 | -4.65 2.62 | DBP Increase ≥ 10 mmHg | 73 | -2.54 2.98 |
| SBP Decrease ≤ -15 mmHg | 72 | 4.20 2.87 | DBP Decrease ≤ - 10 mmHg | 25 | 3.36 3.36 |
11.2. Accuracy over calibration period test
To ensure the device maintains its accuracy for the labeled period of calibration, performance evaluation was performed with measurements at baseline, at the end, and at intermediate time points. Subjects were enrolled following IEEE 1708 specifications of at least 85 subjects and at least 21 subjects in each clinical stratification of Normal, Prehypertension, Stage 1 hypertension, and stage 2 hypertension. 4 measurements after the initial calibration measurement are made for each enrolled subject separated by 7 days to cover an evaluation period of 21 days.
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The table below provides a weekly time point performance for SBP And DBP for weeks 1,2,3, and 4 with device calibrated at week 1. The performance Mean Difference (MD) and Standard Deviation of Difference (SD) meets the acceptance criteria of ISO 81060-2 in all 4 categories and in each of the 7-day timepoints. As originally postulated, there is no evidence of drift or divergence irrespective of test condition. For each change type, the performance meets acceptance criteria established by FDA supporting generalizability across the intended population, safely and efficaciously supporting SimpleSense-BP's indication for use. (Total Number of Subjects = 91). The majority of the subjects are hypertensive, mirroring the focus of the validation study's patient population (~74% hypertensive; 67 out of 91
| BPmeasurementtype | Recording | Number ofSubjects | MD(mmHg) | SD (mmHg) |
|---|---|---|---|---|
| Systolic | Week-1 | 91 | -1.7 | 5.13 |
| Week-2 | 91 | -1.71 | 5.05 | |
| Week-3 | 91 | -0.88 | 4.94 | |
| Week-4 | 91 | -2.94 | 4.82 | |
| Diastolic | Week-1 | 91 | -0.41 | 4.19 |
| Week-2 | 91 | -0.23 | 4.12 | |
| Week-3 | 91 | 0.22 | 4.05 | |
| Week-4 | 91 | -0.77 | 3.75 |
| TABLE 3 PERFORMANCE RESULTS FOR BLOOD PRESSURE MEASUREMENTS OVER THE CALIBRATION PERIOD. |
|---|
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The device accuracy has met the acceptance criteria specified in ISO 81060-2 (mean difference no greater than ± 5 mmHg with standard deviation no greater than 8 mmHg) for 21 days.
In conclusion, the error performance was within the acceptable range for all subgroups based on clinical stratification. Several transitions in clinical stratifications relative to the initial stratification from static readings were observed in the test population and the subjects enrolled in the study had blood pressures that were evenly spread across the range of blood pressures in each clinical stratification.
11.3. Subject demography
A minimum of 21 subjects were included in each of the four stratifications (Normal, Prehypertensive, Stage 1, and Stage 2 hypertension) for test sets as shown in Figure 1 of 03CBT01 – SimpleSense-BP Validation Report Rev D Appendix C.
There was no overlap of subjects between the training and test data sets i.e., none of the measurements from subjects in the training data set were included in the test data set and vice versa.
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| InducedChange TestPopulation | CalibrationTestPopulation | ||
|---|---|---|---|
| Demographic Information | Category | Number of Subjects | |
| Ethnicity | Asian | 17 | 16 |
| Black | 45 | 18 | |
| Hispanic | 20 | 11 | |
| White | 67 | 46 | |
| Gender | Female | 68 | 39 |
| Male | 81 | 52 | |
| Age | 20 - 30yrs. | 19 | 10 |
| 30 - 40yrs. | 28 | 14 | |
| 40 - 50yrs. | 38 | 16 | |
| 50 - 60yrs. | 32 | 24 | |
| 60 - 70yrs. | 14 | 13 | |
| 70 - 80yrs. | 18 | 14 |
Table 4 Demographics and subgroup information
In addition to the coverage of categories of hypertension, the requirements of ISO 81060-2 for distribution of blood pressure values were also satisfied as listed in Table 4.
| ISO 81060-2 Clause 5.1.5 Blood Pressure Distribution Requirements | Percentages in test data |
|---|---|
| At least 5 % of the REFERENCE BLOOD PRESSURE readings shall have a SYSTOLICBLOOD PRESSURE ≤100 mmHg (13,33 kPa). | 9.03% |
| At least 5 % of the REFERENCE BLOOD PRESSURE readings shall have a SYSTOLICBLOOD PRESSURE ≥160 mmHg (21,33 kPa). | 10.13% |
| At least 20 % of the REFERENCE BLOOD PRESSURE readings shall have a SYSTOLICBLOOD PRESSURE ≥140 mmHg (18,66 kPa). | 32.15% |
| At least 5 % of the REFERENCE BLOOD PRESSURE readings shall have a DIASTOLICBLOOD PRESSURE ≤60 mmHg (8,0 kPa). | 7.59% |
Table 5 Test set blood pressure distribution satisfying ISO 81060-2 Clause 5.1.5
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| At least 5 % of the REFERENCE BLOOD PRESSURE readings shall have a DIASTOLICBLOOD PRESSURE ≥100 mmHg (13,33 kPa). | 7.26% |
|---|---|
| At least 20 % of the REFERENCE BLOOD PRESSURE readings shall have a DIASTOLICBLOOD PRESSURE ≥85 mmHg (11,33 kPa). | 29.73% |
12. Conclusion
Based on the qualitative and quantitative comparative analysis provided here, there are no design specification or technical differences between the cleared SimpleSense Platform running the SimpleSense-BP software (new device) that negatively affect the safety or efficacy of the medical device. The conclusions drawn from the non- clinical tests demonstrate that the device is as safe, as effective, and performs as well as or better than the legally marketed predicate devices The proposed SimpleSense-BP software running on the SimpleSense Platform is found to be substantially equivalent to the predicate device.
§ 870.1130 Noninvasive blood pressure measurement system.
(a)
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.(b)
Classification. Class II (performance standards).