(190 days)
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.
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.
The provided text describes the SimplECG, a wearable garment with integrated nanosensors for collecting ECG data. This device is intended to aid in the diagnostic evaluation of patients experiencing transient symptoms that may suggest cardiac rhythm disturbance. The 510(k) summary provides details about the device, its comparison to predicate devices, and a list of performance standards it claims conformance to, as well as pre-clinical performance data.
However, the document does not contain specific acceptance criteria, a detailed study description, or reported device performance metrics in a format that would allow for the direct creation of the requested table. The text primarily focuses on demonstrating substantial equivalence to predicate devices based on intended use, technological characteristics, and conformance to general medical device standards.
Here's an analysis of the provided information relative to your request:
1. A table of acceptance criteria and the reported device performance
This table cannot be fully generated from the provided text. The document lists several performance standards (e.g., AAMI / ANSI 60601-1, IEC 60601-2-47) that the device claims conformance to. Conformance to these standards implies meeting their respective requirements, which would serve as acceptance criteria. However, the specific metrics and values that define "acceptance" and the *actual measured performance *of the SimplECG against these metrics are not explicitly stated in the summary. For example, while it states "The ECG acquisition performance of the SimplECG is comparable to the predicate devices," it doesn't provide numerical data to support this.
2. Sample size used for the test set and the data provenance
The document mentions "Pre-clinical testing included... Performance Testing – Bench" and "Equivalency Testing of SimplECG to Standard of Care Device." However, it does not specify the sample size used for these tests (e.g., number of ECG recordings, number of subjects/garments). The data provenance (e.g., country of origin, retrospective or prospective) is also not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document states that ECG data is reviewed by "a physician who is skilled in rhythm interpretation." This refers to the clinical use case of the device, where a physician interprets the collected data. However, for the pre-clinical performance testing aimed at establishing "equivaleency" or "comparability" to a standard of care device, the number of experts and their qualifications used to establish ground truth for the test set are not specified.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
The document does not mention any adjudication method used for establishing ground truth during its pre-clinical testing.
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 SimplECG device "does not perform any automatic beat or rhythm classification on the acquired ECG data" and "does not perform any ECG analysis." Therefore, it is a data acquisition and display device, not an AI-assisted interpretation tool. As such, a multi-reader multi-case (MRMC) comparative effectiveness study with AI assistance was not performed nor is it relevant to this device's functionality.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device is designed for review by a medical professional. Its function is to collect, store, transfer, and display ECG data. It does not have a standalone algorithm for diagnosis or interpretation, so "standalone (algorithm only)" performance without human-in-the-loop is not applicable to the stated functionality of the SimplECG.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The document implies that "Equivalency Testing of SimplECG to Standard of Care Device" was performed. This suggests that the "ground truth" for the SimplECG's performance would be the data acquired by the "Standard of Care Device." However, the exact nature of this ground truth (e.g., whether the standard of care data itself was validated by expert consensus on arrhythmias) is not explicitly detailed.
8. The sample size for the training set
The document does not mention any "training set." As the SimplECG device does not perform automated classification or analysis, it is unlikely to involve machine learning models that require a training set in the typical sense.
9. How the ground truth for the training set was established
As no training set is mentioned or implied for an AI/ML model, this question is not applicable.
Summary of Missing Information:
The provided 510(k) summary focuses on demonstrating substantial equivalence by comparing the SimplECG's intended use and technical characteristics to predicate devices and by claiming conformance to general medical device standards. It does not provide the granular detail typically found in a clinical or performance study report regarding specific acceptance criteria, measured performance metrics, sample sizes, ground truth establishment, or expert involvement for the pre-clinical performance testing.
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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 (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
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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) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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K161431
K161431 510(k) Summary
SimpIECG Summary
| Submitter'sinformation | Nanowear Inc53 Boerum Place, Suite 3FBrooklyn, NY 11201United StatesPhone: (718) 637-4815 | Contact: Venk Varadan53 Boerum Place, Suite 3FBrooklyn, NY 11201United States(718) 637-4815Date: October 20, 2016 |
|---|---|---|
| Device/classificationname | 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 | |
| Predicatedevice(s) | The predicate devices are:• K143032 eMotion Faros ECG Mobile cleared on March 29, 2015 fromMega Electronics Ltd.• K142476 Master Caution Device cleared on February 17, 2015 fromHealthwatch, Ltd.Based on a review of the FDA's Recalls database, the predicate devices havenot been the subject of a design-related recall. | |
| No reference devices were used in this submission. | ||
| Devicedescription | The Nanowear SimplECG (“SimplECG”) device is a wearable garment (eithera shirt or brassiere) that is magnetically attached to a communication modulewhich is secured in place by an elastic pouch. The SimplECG is designed forreliability, patient comfort and ease of use in clinical-qualityelectrocardiogram (“ECG”) applications. The SimplECG device does notperform any automatic beat or rhythm classification on the acquired ECGdata. The intended duration of use of the SimplECG device is up to 24 hours.The SimplECG Communication Module can collect continuous ECG datafrom the garment, securely stores it and transfers to a compatible mobiledevice (iOS), which then uploads the recorded ECG data to a secureNanowear 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 ofnanosensors integrated directly into the garment, that collects ECG signalsdirectly from the skin which are then captured by the communicationmodule.• The SimplECG Communication Module*: collects, stores and wirelesslytransmits ECG signals from the garment to the patient mobile device.• The SimplECG Mobile Application: allows for patient logging of symptomsand transmission of ECG recordings to a secure, remote server through apatient-supplied mobile device operating on Apple iOS.• The Nanowear Web Application: allows initiation of a test, and storage andreview of patient ECG data sent from the Mobile Application to the server.*The electronic enclosure for the SimplECG Communication Module is made ofNylon/PA2200. | |
| Indications foruse | The SimplECG is intended to aid in the diagnostic evaluation of patients, 21years of age and above, on the order of a physician, who experience transientsymptoms which may suggest the need for monitoring to manually assesstheir cardiac rhythm disturbance. ECG data is recorded, stored, transferredand displayed wirelessly for review by a physician who is skilled in rhythminterpretation.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 dothey affect the safety and effectiveness of the SimplECG relative to thepredicate. Both the SimplECG device and the predicate devices have thesame 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 | SimplECGNew Device | eMotion Faros ECGMobile | MasterCautionDevice |
|---|---|---|---|
| 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 ofmoisture / perspiration | Yes | No | No |
| Patient symptom loggingon smartphone | Yes | No | No |
| ECG analysis | No | No | No |
| Collects other healthparameters | 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-channelOffline: 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- Batterytype | 1 AA Lithium battery(Energizer UltimateLithium AA) | 3.7 V Li-ion battery | Type unknown3.7 V @ 2450 mAh |
| Data Transfer | Bluetooth, Cellularnetwork / Wi-Fi | Bluetooth, Cellularnetwork / Wi-Fi | Bluetooth, Cellularnetwork / Wi-Fi |
| Software Interface | iOS-based (9 or later),web-based software | Web-based software | Android 4.2 / iOS 6+,web-based software |
| Communication ModuleDimensions | 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 ModuleWeight | 3.43 ounces | 0.45 ounces | 3.17 ounces |
| Electrodes | Integrated in device | NA | Integrated in device |
| Usage Environment | Healthcare facility orHome environment | Healthcare facility orHome environment | Healthcare facility orHome environment |
| EnvironmentalOperating 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 60601-1:2005 /(R) 2012 | Medical Electrical Equipment – Part 1: General Requirements for BasicSafety and Essential Performance |
| AAMI / ANSI 60601-1-2:2014 | Medical Electrical Equipment – Part 1-2: General Requirements for BasicSafety and Essential Performance – Collateral Standard: ElectromagneticDisturbances – Requirements and Tests |
| IEC 60601-2-47:2012 | Medical Electrical Equipment – Part 2-47: Particular requirements for BasicSafety and Essential Performance of Ambulatory ElectrocardiographicSystems |
| 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 andSystems Distribution Cycle II |
| ISO 14971:2007 | Medical devices - Application of risk management to medical devices |
| Pre-clinicalperformancedata to supportsubstantialequivalence | In addition to testing required to support conformance to the above listedstandards, pre-clinical testing included the following:• Usability Assessment• Performance Testing – Bencho Equivalency Testing of SimplECG to Standard of Care Deviceo Performance Testing of SimplECG under typical use conditions• Performance Testing - Communication Module• Performance Testing - Nanosensor Garment• Performance Testing - Firmware |
|---|---|
| Clinicalperformancedata | Clinical data was not required for this submission |
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| Summary -substantialequivalence topredicate. | Results of the Performance testing for Communication Module, Nanosensorgarment and the Firmware show that - |
|---|---|
| SimplECG device uses the same standard wireless transmissionprotocols as the predicate devices. The ECG acquisition performance of the SimplECG is comparable tothe predicate devices and does not raise any new concerns over safetyor effectiveness. | |
| Results of the Usability Assessment presented show that - | |
| SimplECG device's user interfaces were evaluated to ensure that anyminor differences from the predicates do not raise any safety oreffectiveness concerns. | |
| Results of the Performance Testing - Bench presented show that | |
| The differences in the technological characteristics do not raise anynew issues affecting the safety and effectiveness of the SimplECGdevice as compared to the predicate devices. | |
| Conclusions | Based on the comparability of the intended use, the technologicalcharacteristics, and the performance data, the SimplECG device issubstantially equivalent to the predicate devices. |
§ 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).