SimplECG

K161431 · Nanowear, Inc. · DXH · Nov 30, 2016 · Cardiovascular

Device Facts

• Record ID: K161431
• Device Name: SimplECG
• Applicant: Nanowear, Inc.
• Product Code: DXH · Cardiovascular
• Decision Date: Nov 30, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2920
• Device Class: Class 2

Intended 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. ECC data is recorded, stored, transferred and displayed wirelessly for review by a physician who is skilled in rhythm interpretation.

Device Story

SimplECG is a wearable garment (shirt or brassiere) with integrated nanosensors for continuous ECG signal acquisition. A magnetically attached communication module (Nylon/PA2200 enclosure) collects, stores, and wirelessly transmits ECG data to a patient-supplied iOS mobile application. The mobile app allows symptom logging and uploads data to a secure Nanowear server. A web application enables physicians, nurses, or technicians to initiate tests and review ECG data. Used in clinical or home environments for up to 24 hours. The device does not perform automatic beat or rhythm classification; it provides raw ECG data for manual interpretation by a skilled physician. Benefits include patient comfort, ease of use, and reliable clinical-quality ECG monitoring without requiring skin preparation.

Clinical Evidence

No clinical data was required for this submission. Evidence consists of bench testing, including usability assessments, performance testing of the nanosensor garment, communication module, and firmware, and equivalency testing against a standard-of-care device.

Technological Characteristics

Wearable garment with integrated nanosensors; 3-channel (male) or 1-channel (female) ECG; 24-bit resolution; 250 Hz sample rate; 0.05-65 Hz frequency response. Communication module uses Bluetooth/cellular/Wi-Fi for data transfer. Powered by 1 AA Lithium battery. Enclosure material: Nylon/PA2200. Standards: AAMI/ANSI 60601-1, AAMI/ANSI 60601-1-2, IEC 60601-2-47, ISO 10993, ISO 14971, ASTM D4169.

Indications for Use

Indicated for patients 21 years and older experiencing transient symptoms suggesting a need for cardiac rhythm monitoring. Contraindications not specified.

Regulatory Classification

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.

Predicate Devices

• eMotion Faros ECG Mobile (K143032)
• Master Caution Device (K142476)

Submission Summary (Full Text)

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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

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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 [phone] or [phone] 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 [phone] or [phone] 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

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#### 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) | |
|-------------------------------------------------------------------------------|------------------------------------------------------------------------------|
| <div> <span> </span> Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> <span> </span> Over-The-Counter Use (21 CFR 801 Subpart C) </div> |

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

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### k161431

## K161431 510(k) Summary

# SimpIECG Summary

| Submitter's<br>information | Nanowear Inc<br>53 Boerum Place, Suite 3F<br>Brooklyn, NY 11201<br>United States<br>Phone: [phone] | Contact: Venk Varadan<br>53 Boerum Place, Suite 3F<br>Brooklyn, NY 11201<br>United States<br>[phone]<br>Date: October 20, 2016 |
|-----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|
| Device/<br>classification<br>name | The device trade name(s) and classification name(s) for the New Device are:<br>• Trade Name: SimplECG<br>• Regulation Name: Telephone Electrocardiograph Transmitter and Receiver<br>• Classification Name: 21CFR §870.2920<br>• Class II<br>• Product Code DXH | |
| Predicate<br>device(s) | The predicate devices are:<br>• K143032 eMotion Faros ECG Mobile cleared on March 29, 2015 from<br>Mega Electronics Ltd.<br>• K142476 Master Caution Device cleared on February 17, 2015 from<br>Healthwatch, Ltd.<br>Based on a review of the FDA's Recalls database, the predicate devices have<br>not been the subject of a design-related recall. | |
| | No reference devices were used in this submission. | |
| Device<br>description | The Nanowear SimplECG (“SimplECG”) device is a wearable garment (either<br>a shirt or brassiere) that is magnetically attached to a communication module<br>which is secured in place by an elastic pouch. The SimplECG is designed for<br>reliability, patient comfort and ease of use in clinical-quality<br>electrocardiogram (“ECG”) applications. The SimplECG device does not<br>perform any automatic beat or rhythm classification on the acquired ECG<br>data. The intended duration of use of the SimplECG device is up to 24 hours.<br><br>The SimplECG Communication Module can collect continuous ECG data<br>from the garment, securely stores it and transfers to a compatible mobile<br>device (iOS), which then uploads the recorded ECG data to a secure<br>Nanowear Inc. (“Nanowear”) server for review by a medical professional<br>(inclusive of a physician, nurse or technician). The device consists of four (4)<br>components:<br>• The SimplECG Garment: a shirt or brassiere, consisting of a network of<br>nanosensors integrated directly into the garment, that collects ECG signals<br>directly from the skin which are then captured by the communication<br>module.<br>• The SimplECG Communication Module*: collects, stores and wirelessly<br>transmits ECG signals from the garment to the patient mobile device.<br>• The SimplECG Mobile Application: allows for patient logging of symptoms<br>and transmission of ECG recordings to a secure, remote server through a<br>patient-supplied mobile device operating on Apple iOS.<br>• The Nanowear Web Application: allows initiation of a test, and storage and<br>review of patient ECG data sent from the Mobile Application to the server.<br><br>*The electronic enclosure for the SimplECG Communication Module is made of<br>Nylon/PA2200. | |
| Indications for<br>use | The SimplECG is intended to aid in the diagnostic evaluation of patients, 21<br>years of age and above, on the order of a physician, who experience transient<br>symptoms which may suggest the need for monitoring to manually assess<br>their cardiac rhythm disturbance. ECG data is recorded, stored, transferred<br>and displayed wirelessly for review by a physician who is skilled in rhythm<br>interpretation.<br><br>The Indications for Use statement for the predicate devices are not identical.<br>However, the differences do not alter the intended use of the device, nor do<br>they affect the safety and effectiveness of the SimplECG relative to the<br>predicate. Both the SimplECG device and the predicate devices have the<br>same intended use for capturing and displaying electrocardiogram signals. | |

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Technology comparison The table below shows a comparison of technical characteristics between the SimplECG (new device) and the predicate devices.

| Characteristic | SimplECG<br>New Device | eMotion Faros ECG<br>Mobile | MasterCaution<br>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<br>moisture / perspiration | Yes | No | No |
| Patient symptom logging<br>on smartphone | Yes | No | No |
| ECG analysis | No | No | No |
| Collects other health<br>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)/<br>1 channel (female) | Online: 1-channel<br>Offline: 3-channels | NA |
| Resolution | 24 bit | 24 bit | 12 bit |
| Sample rate | 250 Samples/second | Selectable: 100, 125,<br>250, 500, 1000 Hz | 1 kHz |
| Memory | microSD card | Internal | NA |
| Memory type/capacity | 2 GB | 1GB or more | NA |
| Power Supply- Battery<br>type | 1 AA Lithium battery<br>(Energizer Ultimate<br>Lithium AA) | 3.7 V Li-ion battery | Type unknown<br>3.7 V @ 2450 mAh |
| Data Transfer | Bluetooth, Cellular<br>network / Wi-Fi | Bluetooth, Cellular<br>network / Wi-Fi | Bluetooth, Cellular<br>network / Wi-Fi |
| Software Interface | iOS-based (9 or later),<br>web-based software | Web-based software | Android 4.2 / iOS 6+,<br>web-based software |
| Communication Module<br>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<br>Weight | 3.43 ounces | 0.45 ounces | 3.17 ounces |
| Electrodes | Integrated in device | NA | Integrated in device |
| Usage Environment | Healthcare facility or<br>Home environment | Healthcare facility or<br>Home environment | Healthcare facility or<br>Home environment |
| Environmental<br>Operating Temp | 5°C to 45°C | Unknown | Unknown |
| Storage Temp | -25°C to 60°C | Unknown | Unknown |

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Performance Conformance for the SimplECG device is claimed to the standards listed in testing the table below.

| Standard Number | Title |
|----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| AAMI / ANSI 60601-<br>1:2005 /(R) 2012 | Medical Electrical Equipment – Part 1: General Requirements for Basic<br>Safety and Essential Performance |
| AAMI / ANSI 60601-1-<br>2:2014 | Medical Electrical Equipment – Part 1-2: General Requirements for Basic<br>Safety and Essential Performance – Collateral Standard: Electromagnetic<br>Disturbances – Requirements and Tests |
| IEC 60601-2-47:2012 | Medical Electrical Equipment – Part 2-47: Particular requirements for Basic<br>Safety and Essential Performance of Ambulatory Electrocardiographic<br>Systems |
| ISO 10993:2009 | Biological Evaluation of Medical Devices –<br>Part 1: Evaluation and Testing within a Risk Management Process;<br>Part 5: Tests for Cytotoxicity;<br>Part 10: Tests for Irritation and Skin Sensitization |
| ASTM D4169-09 | Standard Practice for Performing Testing of Shipping Containers and<br>Systems Distribution Cycle II |
| ISO 14971:2007 | Medical devices - Application of risk management to medical devices |

| Pre-clinical<br>performance<br>data to support<br>substantial<br>equivalence | In addition to testing required to support conformance to the above listed<br>standards, pre-clinical testing included the following:<br>• Usability Assessment<br>• Performance Testing – Bench<br>o Equivalency Testing of SimplECG to Standard of Care Device<br>o Performance Testing of SimplECG under typical use conditions<br>• Performance Testing - Communication Module<br>• Performance Testing - Nanosensor Garment<br>• Performance Testing - Firmware |
|------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Clinical<br>performance<br>data | Clinical data was not required for this submission |
| | Continued on next page |

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| Summary -<br>substantial<br>equivalence to<br>predicate. | Results of the Performance testing for Communication Module, Nanosensor<br>garment and the Firmware show that - |
|----------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | SimplECG device uses the same standard wireless transmission<br>protocols as the predicate devices. The ECG acquisition performance of the SimplECG is comparable to<br>the predicate devices and does not raise any new concerns over safety<br>or effectiveness. |
| | Results of the Usability Assessment presented show that - |
| | SimplECG device's user interfaces were evaluated to ensure that any<br>minor differences from the predicates do not raise any safety or<br>effectiveness concerns. |
| | Results of the Performance Testing - Bench presented show that |
| | The differences in the technological characteristics do not raise any<br>new issues affecting the safety and effectiveness of the SimplECG<br>device as compared to the predicate devices. |
| Conclusions | Based on the comparability of the intended use, the technological<br>characteristics, and the performance data, the SimplECG device is<br>substantially equivalent to the predicate devices. |