(190 days)
No reference devices were used in this submission.
No
The device description explicitly states, "The SimplECG device does not perform any automatic beat or rhythm classification on the acquired ECG data." This indicates that the device does not utilize AI/ML for interpretation.
No.
The device is intended to aid in diagnostic evaluation by recording and displaying ECG data for review by a physician; it does not provide any therapy or treatment.
Yes
The "Intended Use / Indications for Use" states that the device is "intended to aid in the diagnostic evaluation of patients" to "assess their cardiac rhythm disturbance." Although the device itself does not perform automatic classification, it records, stores, transfers, and displays ECG data for review by a physician skilled in rhythm interpretation, which is a key step in diagnosis.
No
The device description explicitly lists and describes hardware components: a wearable garment with nanosensors and a communication module made of Nylon/PA2200. Performance studies also include testing of the Communication Module, Nanosensor Garment, and Firmware, indicating hardware components are integral to the device.
Based on the provided information, the SimplECG device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the body (like blood, urine, tissue). The SimplECG device is a wearable garment that collects electrical signals from the skin (ECG data). It does not analyze biological samples.
- The intended use is to aid in the diagnostic evaluation of cardiac rhythm disturbances by recording and displaying ECG data. This is a physiological measurement, not an in vitro analysis of a sample.
- The device description clearly outlines the components and how they collect and transmit ECG signals. There is no mention of any component or process that involves the analysis of a biological sample.
Therefore, the SimplECG falls under the category of a medical device that measures physiological parameters, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The SimplECG is intended to aid in the diagnostic evaluation of patients, 21 years of age and above, on the order of a physician, who experience transient symptoms which may suggest the need for monitoring to manually assess their cardiac rhythm disturbance. ECG data is recorded, stored, transferred and displayed wirelessly for review by a physician who is skilled in rhythm interpretation.
Product codes
DXH
Device Description
The Nanowear SimplECG (“SimplECG”) device is a wearable garment (either a shirt or brassiere) that is magnetically attached to a communication module which is secured in place by an elastic pouch. The SimplECG is designed for reliability, patient comfort and ease of use in clinical-quality electrocardiogram (“ECG”) applications. The SimplECG device does not perform any automatic beat or rhythm classification on the acquired ECG data. The intended duration of use of the SimplECG device is up to 24 hours.
The SimplECG Communication Module can collect continuous ECG data from the garment, securely stores it and transfers to a compatible mobile device (iOS), which then uploads the recorded ECG data to a secure Nanowear Inc. (“Nanowear”) server for review by a medical professional (inclusive of a physician, nurse or technician). The device consists of four (4) components:
• The SimplECG Garment: a shirt or brassiere, consisting of a network of nanosensors integrated directly into the garment, that collects ECG signals directly from the skin which are then captured by the communication module.
• The SimplECG Communication Module*: collects, stores and wirelessly transmits ECG signals from the garment to the patient mobile device.
• The SimplECG Mobile Application: allows for patient logging of symptoms and transmission of ECG recordings to a secure, remote server through a patient-supplied mobile device operating on Apple iOS.
• The Nanowear Web Application: allows initiation of a test, and storage and review of patient ECG data sent from the Mobile Application to the server.
*The electronic enclosure for the SimplECG Communication Module is made of Nylon/PA2200.
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
21 years of age and above
Intended User / Care Setting
Healthcare facility or Home environment
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)
Pre-clinical performance data to support substantial equivalence included:
- Usability Assessment
- Performance Testing – Bench
- Equivalency Testing of SimplECG to Standard of Care Device
- Performance Testing of SimplECG under typical use conditions
- Performance Testing - Communication Module
- Performance Testing - Nanosensor Garment
- Performance Testing - Firmware
Key results:
- SimplECG device uses the same standard wireless transmission protocols as the predicate devices. The ECG acquisition performance of the SimplECG is comparable to the predicate devices and does not raise any new concerns over safety or effectiveness.
- SimplECG device's user interfaces were evaluated to ensure that any minor differences from the predicates do not raise any safety or effectiveness concerns.
- The differences in the technological characteristics do not raise any new issues affecting the safety and effectiveness of the SimplECG device as compared to the predicate devices.
Clinical data was not required for this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
No reference devices were used in this submission.
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
Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized image of three human profiles facing right, stacked on top of each other. The profiles are connected and appear to be part of a single, flowing design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 30, 2016
Nanowear Inc. % Melissa Walker President and CTO Graematter, Inc. 1324 Clarkson Clayton Center St Louis. Missouri 63011
Re: K161431
Trade/Device Name: SimplECG Regulation Number: 21 CFR 870.2920 Regulation Name: Telephone Electrocardiograph Transmitter and Receiver Regulatory Class: Class II Product Code: DXH Dated: October 21, 2016 Received: October 25, 2016
Dear Melissa Walker:
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. 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.
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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Mude Yellm
for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K161431
Device Name SimplECG
Indications for Use (Describe)
The SimplECG is intended to aid in the diagnostic evaluation of patients, 21 years of age and above, on the order of a physician, who experience transient symptoms which may suggest the nead ly assess their cardiac rhythm disturbance. ECC data is recorded, stored, transferred and displayed wirelessly for review by a physician who is skilled in rhythm interpretation.
| 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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3
K161431
K161431 510(k) Summary
SimpIECG Summary
| Submitter's
information | Nanowear Inc
53 Boerum Place, Suite 3F
Brooklyn, NY 11201
United States
Phone: (718) 637-4815 | Contact: Venk Varadan
53 Boerum Place, Suite 3F
Brooklyn, NY 11201
United States
(718) 637-4815
Date: October 20, 2016 |
|-----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|
| Device/
classification
name | The device trade name(s) and classification name(s) for the New Device are:
• Trade Name: SimplECG
• Regulation Name: Telephone Electrocardiograph Transmitter and Receiver
• Classification Name: 21CFR §870.2920
• Class II
• Product Code DXH | |
| Predicate
device(s) | The predicate devices are:
• K143032 eMotion Faros ECG Mobile cleared on March 29, 2015 from
Mega Electronics Ltd.
• K142476 Master Caution Device cleared on February 17, 2015 from
Healthwatch, Ltd.
Based on a review of the FDA's Recalls database, the predicate devices have
not been the subject of a design-related recall. | |
| | No reference devices were used in this submission. | |
| Device
description | The Nanowear SimplECG (“SimplECG”) device is a wearable garment (either
a shirt or brassiere) that is magnetically attached to a communication module
which is secured in place by an elastic pouch. The SimplECG is designed for
reliability, patient comfort and ease of use in clinical-quality
electrocardiogram (“ECG”) applications. The SimplECG device does not
perform any automatic beat or rhythm classification on the acquired ECG
data. The intended duration of use of the SimplECG device is up to 24 hours.
The SimplECG Communication Module can collect continuous ECG data
from the garment, securely stores it and transfers to a compatible mobile
device (iOS), which then uploads the recorded ECG data to a secure
Nanowear Inc. (“Nanowear”) server for review by a medical professional
(inclusive of a physician, nurse or technician). The device consists of four (4)
components:
• The SimplECG Garment: a shirt or brassiere, consisting of a network of
nanosensors integrated directly into the garment, that collects ECG signals
directly from the skin which are then captured by the communication
module.
• The SimplECG Communication Module*: collects, stores and wirelessly
transmits ECG signals from the garment to the patient mobile device.
• The SimplECG Mobile Application: allows for patient logging of symptoms
and transmission of ECG recordings to a secure, remote server through a
patient-supplied mobile device operating on Apple iOS.
• The Nanowear Web Application: allows initiation of a test, and storage and
review of patient ECG data sent from the Mobile Application to the server.
*The electronic enclosure for the SimplECG Communication Module is made of
Nylon/PA2200. | |
| Indications for
use | The SimplECG is intended to aid in the diagnostic evaluation of patients, 21
years of age and above, on the order of a physician, who experience transient
symptoms which may suggest the need for monitoring to manually assess
their cardiac rhythm disturbance. ECG data is recorded, stored, transferred
and displayed wirelessly for review by a physician who is skilled in rhythm
interpretation.
The Indications for Use statement for the predicate devices are not identical.
However, the differences do not alter the intended use of the device, nor do
they affect the safety and effectiveness of the SimplECG relative to the
predicate. Both the SimplECG device and the predicate devices have the
same intended use for capturing and displaying electrocardiogram signals. | |
Continued on next page
4
Continued on next page
5
Technology comparison The table below shows a comparison of technical characteristics between the SimplECG (new device) and the predicate devices.
| Characteristic | SimplECG
New Device | eMotion Faros ECG
Mobile | MasterCaution
Device |
|-------------------------------------------------|------------------------------------------------------------|--------------------------------------------|---------------------------------------------|
| | | Predicate Device | Predicate Device |
| Bluetooth | Yes | Yes | Yes |
| Remote transmission | Yes | Yes | Yes |
| Shaving / skin prep | No | Yes | N/A |
| Electrode type | Nanosensor | Standard electrode | N/A |
| Works in presence of
moisture / perspiration | Yes | No | No |
| Patient symptom logging
on smartphone | Yes | No | No |
| ECG analysis | No | No | No |
| Collects other health
parameters | No | Yes | Yes |
| Web interface | Yes | Yes | Yes |
| Frequency response | 0.05 Hz to 65 Hz | NA | 0.05 — 120 Hz |
| ECG channels | 3 channel (male)/
1 channel (female) | Online: 1-channel
Offline: 3-channels | NA |
| Resolution | 24 bit | 24 bit | 12 bit |
| Sample rate | 250 Samples/second | Selectable: 100, 125,
250, 500, 1000 Hz | 1 kHz |
| Memory | microSD card | Internal | NA |
| Memory type/capacity | 2 GB | 1GB or more | NA |
| Power Supply- Battery
type | 1 AA Lithium battery
(Energizer Ultimate
Lithium AA) | 3.7 V Li-ion battery | Type unknown
3.7 V @ 2450 mAh |
| Data Transfer | Bluetooth, Cellular
network / Wi-Fi | Bluetooth, Cellular
network / Wi-Fi | Bluetooth, Cellular
network / Wi-Fi |
| Software Interface | iOS-based (9 or later),
web-based software | Web-based software | Android 4.2 / iOS 6+,
web-based software |
| Communication Module
Dimensions | 3.32" x 2.99" x 0.82" | 1.89" x 1.14" x 0.47" | 2.95" x 2.48" x 0.7" |
| Communication Module
Weight | 3.43 ounces | 0.45 ounces | 3.17 ounces |
| Electrodes | Integrated in device | NA | Integrated in device |
| Usage Environment | Healthcare facility or
Home environment | Healthcare facility or
Home environment | Healthcare facility or
Home environment |
| Environmental
Operating Temp | 5°C to 45°C | Unknown | Unknown |
| Storage Temp | -25°C to 60°C | Unknown | Unknown |
Continued on next page
6
Performance Conformance for the SimplECG device is claimed to the standards listed in testing the table below.
| Standard Number | Title |
|---|---|
| AAMI / ANSI 60601- | |
| 1:2005 /(R) 2012 | Medical Electrical Equipment – Part 1: General Requirements for Basic |
| Safety and Essential Performance | |
| AAMI / ANSI 60601-1- | |
| 2:2014 | Medical Electrical Equipment – Part 1-2: General Requirements for Basic |
| Safety and Essential Performance – Collateral Standard: Electromagnetic | |
| Disturbances – Requirements and Tests | |
| IEC 60601-2-47:2012 | Medical Electrical Equipment – Part 2-47: Particular requirements for Basic |
| Safety and Essential Performance of Ambulatory Electrocardiographic | |
| Systems | |
| ISO 10993:2009 | Biological Evaluation of Medical Devices – |
| Part 1: Evaluation and Testing within a Risk Management Process; | |
| Part 5: Tests for Cytotoxicity; | |
| Part 10: Tests for Irritation and Skin Sensitization | |
| ASTM D4169-09 | Standard Practice for Performing Testing of Shipping Containers and |
| Systems Distribution Cycle II | |
| ISO 14971:2007 | Medical devices - Application of risk management to medical devices |
| Pre-clinical
performance
data to support
substantial
equivalence | In addition to testing required to support conformance to the above listed
standards, pre-clinical testing included the following:
• Usability Assessment
• Performance Testing – Bench
o Equivalency Testing of SimplECG to Standard of Care Device
o Performance Testing of SimplECG under typical use conditions
• Performance Testing - Communication Module
• Performance Testing - Nanosensor Garment
• Performance Testing - Firmware |
|------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Clinical
performance
data | Clinical data was not required for this submission |
| | Continued on next page |
7
| Summary -
substantial
equivalence to
predicate. | Results of the Performance testing for Communication Module, Nanosensor
garment and the Firmware show that - |
|----------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | SimplECG device uses the same standard wireless transmission
protocols as the predicate devices. The ECG acquisition performance of the SimplECG is comparable to
the predicate devices and does not raise any new concerns over safety
or effectiveness. |
| | Results of the Usability Assessment presented show that - |
| | SimplECG device's user interfaces were evaluated to ensure that any
minor differences from the predicates do not raise any safety or
effectiveness concerns. |
| | Results of the Performance Testing - Bench presented show that |
| | The differences in the technological characteristics do not raise any
new issues affecting the safety and effectiveness of the SimplECG
device as compared to the predicate devices. |
| Conclusions | Based on the comparability of the intended use, the technological
characteristics, and the performance data, the SimplECG device is
substantially equivalent to the predicate devices. |