(72 days)
No
The summary describes a device for recording, displaying, and storing physiological data. It explicitly states that the device does not produce alarms and is not intended for active patient monitoring (real-time). There is no mention of AI, ML, or any form of automated analysis or interpretation of the data beyond manual assessment by a medical professional.
No.
The device is intended for recording, displaying, and storing physiological data to aid in diagnosis and treatment, but it does not produce alarms, is not intended for active patient monitoring, and is not life-supporting, indicating it's a diagnostic tool, not a therapeutic device.
Yes.
The "Intended Use / Indications for Use" section states that the platform is "intended for use... as an aid to diagnosis," and the "Device Description" explicitly calls it "the next generation diagnostic monitoring technology."
No
The device description explicitly states that the device consists of a combination of hardware components, including a wearable textile garment with embedded sensors, a Signal Acquisition Unit (SAU), and a mobile application. It is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- SimpleSENSE Platform Function: The SimpleSENSE Platform records, displays, and stores physiological data directly from the patient's body (ECG, respiration, heart sounds, activity) using sensors embedded in a garment. It does not analyze samples taken from the body.
- Intended Use: The intended use clearly states it's for evaluating physiological signals as an aid to diagnosis and treatment, not for performing tests on biological samples.
Therefore, the SimpleSENSE Platform falls under the category of a non-IVD medical device that measures physiological parameters directly from the patient.
N/A
Intended Use / 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 patients such as critical care patients. The SimpleSENSE Platform is not intended for use in the presence of a pacemaker.
Product codes
DXH, DQD, DSB, BZQ, DPS
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
adult patients
Intended User / Care Setting
licensed medical professional / at home, or at a healthcare facility
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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
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
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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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.
1
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 CFR
Reference | Product
Code | Class | Trade Name | Classification Name |
|---------------------|-----------------|-------|-------------------------|--------------------------------------------------------------|
| §870.2920 | DXH | 2 | | Transmitters and Receivers,
Electrocardiograph, Telephone |
| §870.2770 | DSB | 2 | SimpleSENSE
Platform | Plethysmograph, Impedance |
| §868.2375 | BZQ | 2 | | Monitor, Breathing Frequency |
| §870.2340 | DPS | 2 | | Electrocardiograph |
| §870.1875 | DQD | 2 | | Stethoscope, Electronic |
3. PREDICATE DEVICE
The predicate device is:
- K201669 SimpleSENSE cleared on November 6, 2020, from Nanowear Inc. ●
4. INDICATIONS FOR USE
The SimpleSENSE Platform is intended for use at home, or at a healthcare facility, under the direction of a licensed medical professional, to record, display and store the following physiological data: a) 2 leads of Electrocardiogram; b) Respiration rate measured through thoracic impedance; c) Heart Sounds; d) Activity including posture; and e) other validated data sources. The SimpleSENSE Platform is intended for use when the licensed medical professional decides to evaluate the physiologic signals of adult patients as an aid to diagnosis and treatment. The SimpleSENSE Platform is intended to be used by patients at rest and not performing any activities or movements. ECG recordings are indicated for the manual assessment of cardiac rhythm disturbances. The SimpleSENSE Platform does not produce alarms and is not intended for active patient monitoring (real-time). The SimpleSENSE Platform is not intended for use as life supporting equipment on high-risk
4
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.
5
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 | |
| Indication
Statement | The SimpleSENSE System 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;
and d) Activity including posture.
The device is
intended for use when the
clinician decides to evaluate
the physiologic signals of adult patients
as an aid to diagnosis and treatment.
The SimpleSENSE System 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 device
does not produce alarms and is not
intended for active patient monitoring
(real-time). The device is
not intended for use as life supporting
equipment on high-risk patients such as
critical care patients. The
device is not intended for use in the
presence of a pacemaker. | 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. | |
| Product Code | DXH, DSB, BZQ, DPS, DQD | Same | |
| Acquired Data | • Electrocardiogram (EKG/ECG)
• Respiration Rate derived from thoracic
impedance
• Heart Sounds | Same | |
| Sensor
Technology | • Electrocardiogram (EKG/ECG): Textile-
based Nanosensors
• Respiration Rate: Textile-based
Nanosensors measure thoracic
impedance and respiration is derived
from thoracic impedance
• Heart Sound: Microelectromechanical
(MEMs) microphone | Same | |
| Signal
acquisition
method | • Electrocardiogram (EKG/ECG):
Standard Bipolar lead instrumentation
amplifier and Sigma-Delta Analog to
Digital Converter.
• Respiration rate: Thoracic Impedance
is measured using four-point probe
using low amplitude current applied to
the body and impedance measured
from voltage drop derived from
thoracic impedance.
• Heart Sound: solid state
Microelectromechanical (MEMs)
microphone embedded in garment
and located near Apex of heart. | Same | |
| Display Type | No on-device display. | Same | |
| Display
Requirement | User provided display hardware for a
healthcare professional to view the
recorded data. A general-purpose
PC/Laptop/Desktop may be used. | Same | |
| Power Source | Internally powered using Li-Ion
rechargeable battery | Same | |
| Internal
Memory/data | Removeable MicroSD card | Same | |
| Communication
Interface | Wireless transceiver using Bluetooth | Same | |
| Access to
recorded data | Data is transferred to the iPhone,
which is then shared with the healthcare
professional via email.
For redundancy, encrypted data is also
stored in the removeable storage
medium. | Data is transferred to the smart phone,
which is then shared with the healthcare
professional via the SimpleSENSE Web
Server.
For redundancy, encrypted data is also
stored in the removeable storage
medium. | |
| Characteristic | Category | New Device
SimpleSENSE Platform | Predicate
SimpleSENSE System |
| Frequency
response | ECG | 0.05 Hz - 65 Hz | Same |
| | Thoracic Impedance | 0.05 Hz - 65 Hz | Same |
| | Heart Sound | 0.05 Hz - 236 Hz | Same |
| | Accelerometer | 0-25 Hz | Same |
| Channels | ECG | 2 channels | Same |
| | Thoracic Impedance | 2 channels | Same |
| | Heart Sound | 1 channel | Same |
| | Accelerometer | 1 channel | Same |
| Resolution | ECG | 24-bit | Same |
| | Thoracic Impedance | 24-bit | Same |
| | Heart Sound | 24-bit | Same |
| | Accelerometer | 16-bit | Same |
| Sampling Rate | ECG | 200 Hz | Same |
| | Thoracic Impedance | 200 Hz | 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 |
| Software
Interface | Device | iOS Mobile Application | iOS or Android OS Mobile
Application and web browser |
Table 1: Predicate Comparison: System Design
6
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
7
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
8
| Physical SAU
Specification:
| dimensions | Device | 3.3" x 2.40" x 1.03" | Same |
|---|---|---|---|
| Physical SAU | |||
| Specification: | |||
| weight | Device | 3.3 (ounces) | Same |
| Electrodes | Device | Integrated into the device | Same |
| Usage | |||
| Environment | Device | Healthcare facility or | |
| Home environment | Same | ||
| Environmental | |||
| Operating | |||
| Temperature | Device | 5ºC to 45ºC | Same |
| Storage | |||
| Temperature | 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
9
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.