(72 days)
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 patients such as critical care patients. The SimpleSENSE Platform is not intended for use in the presence of a pacemaker.
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.
The provided text describes Nanowear Inc.'s K212160 submission for the SimpleSENSE Platform, an upgraded version of their previously cleared SimpleSENSE System (K201669). The submission is a Special 510(k), which means it primarily focuses on changes to an already cleared device, and thus omits much of the original performance data. Therefore, the information regarding acceptance criteria and performance testing is limited to what was specifically re-evaluated or added for the new device.
Here's an analysis based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly provide a table of acceptance criteria and reported device performance in the format requested. As this is a Special 510(k), the focus is on demonstrating that changes made to the device do not negatively affect safety or efficacy. The "Performance Testing" section (Section 11) lists the tests conducted for the new SimpleSENSE Platform.
However, based on the type of tests performed, we can infer general acceptance criteria for the new or modified components.
| Acceptance Criteria Category (Inferred) | Reported Device Performance (Summary from Performance Testing) |
|---|---|
| Software compatibility and functionality (Android OS App) | Software verification for Android OS App demonstrated. |
| Software compatibility and functionality (SimpleSENSE Web Server) | Software verification for SimpleSENSE Web Server demonstrated. |
| Firmware compatibility and functionality (Android OS) | Firmware requirements verification for Android OS compatibility demonstrated. |
Note: The document explicitly states that performance data and verification/validation activities for aspects not affected by product changes were omitted from this Special 510(k). These include core functionalities like multiparametric data capture, ECG sensor performance, electrical current requirements for thoracic impedance, MEMS microphone testing, etc. For those, it relies on the predicate device's clearance (K201669).
2. Sample size used for the test set and the data provenance
The document does not specify a sample size for the test set used for the software and firmware verification activities. It also does not specify the data provenance (e.g., country of origin, retrospective/prospective) for these tests. This information would typically be found in detailed test reports, which are not included in this summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document does not provide any information about the number or qualifications of experts used to establish ground truth for the test set, as the performance testing primarily focuses on software and firmware verification rather than clinical outcomes or diagnostic accuracy requiring expert interpretation.
4. Adjudication method for the test set
The document does not describe any adjudication method for the test set. Given the nature of the tests (software and firmware verification), a formal adjudication process involving multiple experts is unlikely to have been part of these specific engineering tests.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study. The SimpleSENSE Platform's indications for use state that "ECG recordings are indicated for the manual assessment of cardiac rhythm disturbances" and that the device "does not produce alarms and is not intended for active patient monitoring (real-time)." There is no indication that AI or automated interpretation is part of the device's functionality that would necessitate such a study. The device provides raw physiological data for a medical professional to review.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The document does not describe any standalone (algorithm-only) performance testing. The device is intended to record and transfer physiological data for medical professionals to review; it does not explicitly claim automated diagnostic algorithms that would undergo standalone performance evaluation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the software and firmware verification tests, the "ground truth" would be the expected functional behavior of the software and firmware as per design specifications and requirements. This is not medical ground truth (like pathology or expert consensus) but rather engineering ground truth.
8. The sample size for the training set
The document does not mention a training set sample size. Since the described performance testing is for software/firmware verification and not for machine learning model development, a training set as typically understood in AI/ML contexts would not be relevant here.
9. How the ground truth for the training set was established
Not applicable, as no training set for a machine learning model is mentioned or implied by the described performance testing.
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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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 ( 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: June 30, 2021
2. CLASSIFICATION
The classification for the new device is shown in the table below:
| 21 CFRReference | ProductCode | Class | Trade Name | Classification Name |
|---|---|---|---|---|
| §870.2920 | DXH | 2 | Transmitters and Receivers,Electrocardiograph, Telephone | |
| §870.2770 | DSB | 2 | SimpleSENSEPlatform | 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.SimpleSENSE System | Nanowear Inc.SimpleSENSE Platform | ||
|---|---|---|---|
| 510(k) Number | K201669 | To be assigned | |
| IndicationStatement | The SimpleSENSE System is intended foruse at home, or at a healthcare facility,under the direction of a licensed medicalprofessional, to record, display and storethe following physiological data: a) 2leads of Electrocardiogram; b)Respiration rate measured throughthoracic impedance; c) Heart Sounds;and d) Activity including posture.The device isintended for use when theclinician decides to evaluatethe physiologic signals of adult patientsas an aid to diagnosis and treatment.The SimpleSENSE System is intended tobe used by patients at rest and notperforming any activities or movements.ECG recordings are indicated for themanual assessment of cardiac rhythmdisturbances. The devicedoes not produce alarms and is notintended for active patient monitoring(real-time). The device isnot intended for use as life supportingequipment on high-risk patients such ascritical care patients. Thedevice is not intended for use in thepresence of a pacemaker. | The SimpleSENSE Platform is intendedfor use at home, or at a healthcarefacility, under the direction of a licensedmedical professional, to record, displayand store the following physiologicaldata: a) 2 leads of Electrocardiogram; b)Respiration rate measured throughthoracic impedance; c) Heart Sounds; d)Activity including posture; and e) othervalidated data sources. TheSimpleSENSE Platform is intended foruse when the licensed medicalprofessional decides to evaluate thephysiologic signals of adult patients asan aid to diagnosis and treatment. TheSimpleSENSE Platform is intended to beused by patients at rest and notperforming any activities or movements.ECG recordings are indicated for themanual assessment of cardiac rhythmdisturbances. The SimpleSENSE Platformdoes not produce alarms and is notintended for active patient monitoring(real-time). The SimpleSENSE Platform isnot intended for use as life supportingequipment on high-risk patients such ascritical care patients. The SimpleSENSEPlatform is not intended for use in thepresence of a pacemaker. | |
| Product Code | DXH, DSB, BZQ, DPS, DQD | Same | |
| Acquired Data | • Electrocardiogram (EKG/ECG)• Respiration Rate derived from thoracicimpedance• Heart Sounds | Same | |
| SensorTechnology | • Electrocardiogram (EKG/ECG): Textile-based Nanosensors• Respiration Rate: Textile-basedNanosensors measure thoracicimpedance and respiration is derivedfrom thoracic impedance• Heart Sound: Microelectromechanical(MEMs) microphone | Same | |
| Signalacquisitionmethod | • Electrocardiogram (EKG/ECG):Standard Bipolar lead instrumentationamplifier and Sigma-Delta Analog toDigital Converter.• Respiration rate: Thoracic Impedanceis measured using four-point probeusing low amplitude current applied tothe body and impedance measuredfrom voltage drop derived fromthoracic impedance.• Heart Sound: solid stateMicroelectromechanical (MEMs)microphone embedded in garmentand located near Apex of heart. | Same | |
| Display Type | No on-device display. | Same | |
| DisplayRequirement | User provided display hardware for ahealthcare professional to view therecorded data. A general-purposePC/Laptop/Desktop may be used. | Same | |
| Power Source | Internally powered using Li-Ionrechargeable battery | Same | |
| InternalMemory/data | Removeable MicroSD card | Same | |
| CommunicationInterface | Wireless transceiver using Bluetooth | Same | |
| Access torecorded data | Data is transferred to the iPhone,which is then shared with the healthcareprofessional via email.For redundancy, encrypted data is alsostored in the removeable storagemedium. | Data is transferred to the smart phone,which is then shared with the healthcareprofessional via the SimpleSENSE WebServer.For redundancy, encrypted data is alsostored in the removeable storagemedium. | |
| Characteristic | Category | New DeviceSimpleSENSE Platform | PredicateSimpleSENSE System |
| Frequencyresponse | 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 | Same | |
| Heart Sound | 500 Hz | Same | |
| Accelerometer | 50 Hz | Same | |
| Memory | Device | microSD card/16GB | Same |
| Power supply –battery type | Device | Rechargeable Lithium-Ion | Same |
| Data Transfer | Device | Bluetooth, Cellular, Wi-Fi | Same |
| SoftwareInterface | Device | iOS Mobile Application | iOS or Android OS MobileApplication and web browser |
Table 1: Predicate Comparison: System Design
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8. DISCUSSION OF KEY SYSTEM DIFFERENCES
8.1. Indications for Use
The primary change to the Indications for Use is the ability for SimpleSENSE Platform to record, display and store additional data sources. New data sources are validated for
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compatibility with the SimpleSENSE Web Server to ensure proper display and synchronicity of the new data with existing data.
8.2. Access to Recorded Data
The Android OS App is included in the SimpleSENSE Platform to accommodate users that do not have access to an Apple iPhone running iOS. The Android OS App is essentially identical to the iOS App, with minor differences to accommodate user interface differences associated with Android OS compared to iOS.
The SimpleSENSE Web Server automates report/data delivery from patient to physician and provides the physician a single location (web application) to service their patient's data. The SimpleSENSE Web Server is a means of accessing patient data instead of requiring patient user intervention to email a report to their physician.
9. COMPARISON OF TECHNICAL CHARACTERISTICS
The table below delineates the differences between the cleared SimpleSENSE System, and the proposed SimpleSENSE Platform. The table includes comparisons of technical characteristics. Any differences between the two designs have been marked with bold font which are further discussed below the table.
Table 2: Predicate Comparison: Technical Characteristics
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| Physical SAUSpecification:dimensions | Device | 3.3" x 2.40" x 1.03" | Same |
|---|---|---|---|
| Physical SAUSpecification:weight | Device | 3.3 (ounces) | Same |
| Electrodes | Device | Integrated into the device | Same |
| UsageEnvironment | Device | Healthcare facility orHome environment | Same |
| EnvironmentalOperatingTemperature | Device | 5ºC to 45ºC | Same |
| StorageTemperature | Device | -20°C to 60°C | Same |
10. DISCUSSION OF KEY TECHNICAL DIFFERENCES
10.1. Software Interface
See §8.2 above.
11. PERFORMANCE TESTING
This Special 510(k) omits performance data and verification and validation activities that have not been affected by the product changes to the previously cleared SimpleSENSE System (K201699). Testing for the SimpleSENSE Platform not included in this submission:
- Verification of multiparametric data capture
- Verification of Bluetooth and iPhone connectivity
- Verification of encryption of acquired data
- Battery safety and charging status indication
- Signal Acquisition Unit (SAU) performance and durability
- Durability, capacity, and data storage testing of the microSD card
- . Battery charger verification
- Biocompatibility of the garment
- Electrocardiograph sensor performance
- Electrical current requirements for transthoracic impedance sensor
- MEMS microphone testing
- Garment conductive inlays testing for flexibility and electrical performance
- Garment compression requirements
- Garment fastening mechanisms
- Use cycles for the base garment
- Shelf life
- Equivalency testing against predicate/reference devices
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Additional testing referenced in this Special 510(k) was conducted to establish evidence of safe and effective use of the changed device and to demonstrate performance to design specifications. Testing for the SimpleSENSE Platform referenced in this submission:
- Software verification - addition of Android OS App
- . Software verification – addition of SimpleSENSE Web Server
- . Firmware requirements verification – new requirements for Android OS compatibility
12. CONCLUSION
Based on the qualitative and quantitative comparative analysis provided here, there are no design specification or technical differences between the SimpleSENSE System (predicate) and the SimpleSENSE Platform (new device) that negatively affect the safety or efficacy of the medical device.
§ 870.2920 Telephone electrocardiograph transmitter and receiver.
(a)
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.(b)
Classification. Class II (performance standards).