(140 days)
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 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 Nanowear SimpleSENSE device is the next generation diagnostic monitoring technology that captures electrocardiographic (ECG) signals, respiration rate though thoracic impedance, heart sounds, activity including posture with sensors embedded on a wearable textile garment. The signals are stored and wirelessly transmitted to a smartphone, and forwarded to a medical professional for review. The garment is designed to be unobtrusive to everyday activity and provide an easy and efficient means of capturing ECG, respiration rate, heart sounds and activity data from patients. The garment is designed to be unobtrusive to everyday activity and provide an easy and efficient means of capturing ECG data from patients. The device consists of three (3) components:
- The SimpleSENSE Garment: an integrated network of nanosensor electrodes for measuring ECG and respiratory rate from thoracic impedance, and incorporating a MEMS microphone for measuring heart sounds.
- The SimpleSENSE Signal Acquisition Unit (SAU): data acquisition, storage, and transmission to an iPhone 7 using iOS 13.4. Incorporates an accelerometer to measure activity.
- The SimpleSENSE Mobile Application: mobile application for to start/stop a recording and to forward the test report to the medical professional.
Here's a breakdown of the acceptance criteria and study information for the Nanowear SimpleSENSE device, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The FDA 510(k) summary provided does not explicitly list acceptance criteria in a quantitative table format with corresponding reported performance values for clinical metrics. Instead, it describes various performance evaluations against design specifications and equivalence to predicate devices.
However, based on the Performance testing section, we can infer some key areas of evaluation:
| Acceptance Criteria (Inferred from Performance Testing) | Reported Device Performance |
|---|---|
| Verification of multiparametric data capture (ECG, Respiration Rate, Heart Sounds) | Performance demonstrated to design specifications. (Specific quantitative results not provided in this summary). |
| Verification of Bluetooth and iPhone connectivity | Performance demonstrated to design specifications. |
| Verification of encryption of acquired data | Performance demonstrated to design specifications. |
| Respiration Rate detection range and accuracy | "Respiration Rate detection range 6 - 22 breaths per minute (BPM) with accuracy ± 2 BPM" (This is explicitly stated as a characteristic, implying it was an acceptance criterion for this parameter). Performance demonstrated to design specifications (for respiration rate overall). |
| Battery safety and charging status indication | Performance demonstrated to design specifications. |
| Signal Acquisition Unit (SAU) performance and durability | Performance demonstrated to design specifications. |
| MicroSD card durability, capacity, and data storage testing | Performance demonstrated to design specifications. |
| Battery charger verification | Performance demonstrated to design specifications. |
| Biocompatibility of the garment | Performance demonstrated to design specifications. |
| Electrocardiograph sensor performance | Performance demonstrated to design specifications. |
| Electrical current requirements for transthoracic impedance sensor | Performance demonstrated to design specifications. |
| MEMS microphone testing | Performance demonstrated to design specifications. |
| Garment conductive inlays testing for flexibility and electrical performance | Performance demonstrated to design specifications. |
| Garment compression requirements | Performance demonstrated to design specifications. |
| Garment fastening mechanisms | Performance demonstrated to design specifications. |
| Use cycles for the base garment | Performance demonstrated to design specifications. |
| Shelf life | Performance demonstrated to design specifications. |
| Equivalency to predicate/reference devices for specific signal acquisition and display | "The performance data provided demonstrate that the SimpleSENSE device is substantially equivalent to the indicated predicate device." (Implied acceptance criterion for equivalence across all measured parameters compared to predicates). Specific objective measurements for equivalence are not detailed in this summary. |
2. Sample Size Used for the Test Set and Data Provenance
The summary states that "Equivalency testing against predicate/reference devices" was performed as part of the performance testing. However, it does not provide any details regarding the sample size used for clinical testing or the data provenance (e.g., country of origin, retrospective or prospective) for this equivalency testing.
3. Number of Experts and Qualifications for Ground Truth
The document does not specify the number of experts or their qualifications used to establish ground truth for any clinical test sets. The indications for use mention evaluation by a "licensed medical professional" and "physician who is skilled in rhythm interpretation" for the ECG data, but this pertains to the intended clinical use of the device, not necessarily how the ground truth for regulatory testing was established.
4. Adjudication Method
The document does not mention any adjudication method (e.g., 2+1, 3+1) for establishing ground truth in clinical test sets.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The document does not mention a Multi-Reader Multi-Case (MRMC) comparative effectiveness study comparing human readers with AI assistance versus without AI assistance. The SimpleSENSE system is a data acquisition and display device intended for manual assessment, not an AI-driven interpretive device.
6. Standalone (Algorithm Only) Performance
The SimpleSENSE system itself is described as a device that records, displays, and stores physiological data for manual assessment by a clinician. It does not appear to have an inherent AI algorithm that provides interpretations or diagnoses. Therefore, a standalone (algorithm only) performance study as typically understood for AI devices would not be applicable or described for this device. The phrase "manual assessment of cardiac rhythm disturbances" reinforces this.
7. Type of Ground Truth Used
The document does not explicitly state the type of ground truth used for any clinical testing (e.g., expert consensus, pathology, outcomes data). Given the nature of the device as a data recorder for manual assessment, it is implied that the "ground truth" for equivalency would come from comparisons to the outputs of the predicate devices or conventionally accepted methods for measuring parameters like ECG, respiration rate, and heart sounds.
8. Sample Size for the Training Set
The document does not mention a training set or its sample size. As the device is for data acquisition and display rather than AI interpretation, a separate training set for an algorithm is not discussed.
9. How Ground Truth for the Training Set Was Established
Since no training set for an AI algorithm is mentioned, the method for establishing ground truth for such a set is also not applicable or described in this summary.
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November 6, 2020
Nanowear Inc. % Melissa Walker President & CTO Graematter, Inc. 1324 Clarkson Clayton Ctr, #332 St Louis, Missouri 63011
Re: K201669
Trade/Device Name: SimpleSENSE Regulation Number: 21 CFR 870.2920 Regulation Name: Telephone Electrocardiograph Transmitter And Receiver Regulatory Class: Class II Product Code: DXH, DSB, BZQ, DPS, DQD Dated: October 4, 2020 Received: October 6, 2020
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. 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.
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
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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 (OS) 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 mediation-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,
Jennifer Shih 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) K201669
Device Name Simple SENSE
Indications for Use (Describe)
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 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.
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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K201669 510(k) Summary
Submitter's information
Nanowear, Inc. 53 Boerum Pl, Suite 3F Brooklyn, NY 11201 United States 718-637-4815
Contact: Venk Varadan 53 Boerum Pl, Suite 3F Brooklyn, NY 11201 United States Phone: 718-637-4815 Date: June 15 2020
Classification The classification for the new device is shown in the table below.
| 21 CFRReference | ProductCode | Class | Trade Name | Classification Name |
|---|---|---|---|---|
| §870.2920 | DXH | 2 | Transmitters and Receivers,Electrocardiograph, Telephone | |
| §870.2770 | DSB | 2 | SimpleSENSE | Plethysmograph, Impedance |
| §868.2375 | BZQ | 2 | SimpleSENSE | Monitor, Breathing Frequency |
| §870.2340 | DPS | 2 | SimpleSENSE | Electrocardiograph |
| §870.1875 | DQD | 2 | SimpleSENSE | Stethoscope, Electronic |
Predicate The predicate device is: devices · K161431 SimplECG cleared on 11/30/2016 from Nanowear, Inc. The following devices are considered as reference devices: • K160981 Patient Monitor, models elite V5, elite V6 and elite V8 cleared on 12/22/2016 from Edan Instruments, Inc. • K151319 Eko Electronic Stethoscope System cleared on 5/18/2015 from Eko Devices, Inc. The SimpleSENSE System is intended for use at home, or at a healthcare facility, under Indications for use 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.
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Device The Nanowear SimpleSENSE device is the next generation diagnostic description monitoring technology that captures electrocardiographic (ECG) signals, respiration rate though thoracic impedance, heart sounds, activity including posture with sensors embedded on a wearable textile garment. The signals are stored and wirelessly transmitted to a smartphone, and forwarded to a medical professional for review.
The garment is designed to be unobtrusive to everyday activity and provide an easy and efficient means of capturing ECG, respiration rate, heart sounds and activity data from patients.
The garment is designed to be unobtrusive to everyday activity and provide an easy and efficient means of capturing ECG data from patients. The device consists of three (3) components:
- The SimpleSENSE Garment: an integrated network of nanosensor electrodes for measuring ECG and respiratory rate from thoracic impedance, and incorporating a MEMS microphone for measuring heart sounds.
- The SimpleSENSE Signal Acquisition Unit (SAU): data acquisition, storage, and transmission to an iPhone 7 using iOS 13.4. Incorporates an accelerometer to measure activity.
- The SimpleSENSE Mobile Application: mobile application for to start/stop a recording and to forward the test report to the medical professional.
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| Characteristics | The table below provides a comparison of the New Device with the predicate and reference devices. | ||||
|---|---|---|---|---|---|
| Characteristic | Nanowear Inc.SimpleSENSE - NewDeviceCurrent Submission | Nanowear Inc. SimplECGK161431 | Edan Instruments, PatientMonitor, models elite V5,elite V6 and elite V8K160981 | Eko Devices Inc. EkoElectronicStethoscope SystemK151319 | Comparison |
| Indications forUse Statement | The SimpleSENSE system isintended for use at home,or healthcare facility, underthe direction of a licensedmedical professional, torecord, display and storethe following physiologicaldata: a) 2 leads ofElectrocardiogram b)Respiration rate measuredthrough thoracicimpedance; c) HeartSounds; and d) Activityincluding posture. Thedevice is intended for usewhen the clinician decidesto evaluate the physiologicsignals of adult patients asan aid to diagnosis andtreatment. TheSimpleSENSE System isintended to be used bypatients at rest and notperforming any activities ormovements. ECG | The SimplECG is intendedto aid in the diagnosticevaluation of patients, 21years of age and above, onthe order of a physician,who experience transientsymptoms which maysuggest the need formonitoring to manuallyassess their cardiac rhythmdisturbance. ECG data isrecorded, stored,transferred and displayedwirelessly for review by aphysician who is skilled inrhythm interpretation. | The monitors are intendedto be used for monitoring,storing, and reviewing of,and to generate alarms for,multiple physiologicalparameters of adults,pediatrics and neonates.The monitors are intendedfor use by trainedhealthcare professionals inhospital environments. Themonitored physiologicalparameters include: ECG,respiration (RESP),temperature (TEMP),oxygen saturation ofarterial blood (SpO2), pulserate (PR), non-invasiveblood pressure (NIBP),invasive blood pressure(IBP), carbon dioxide(CO2), cardiac output(C.O.), anesthetic gas (AG),bispectral index (BIS),respiration mechanics (RM) | The Eko ElectronicStethoscope System isintended to be used asa part of a physicalassessment of apatient by healthcareprofessionals fordiagnostic decisionsupport in clinicalsettings. Eko isintended for use onpediatric and adultpatients. It canelectronically amplify,filter and transfersounds to theaccompanying mobileapplication for storageand sharing. It canused to record heartsounds and cardiacmurmurs, bruits,respiratory sounds andabdominal soundsduring physical | The SimpleSENSE offersthe same ECG measuresas the SimplECG; heartsounds as in the Ekodevice, and a subset ofthe measures included inthe Edan Patient Monitordevice.The absence of themeasures does not affectthe substantialequivalence of the NewDevice. |
| Characteristic | Nanowear Inc.SimpleSENSE - NewDeviceCurrent Submission | Nanowear Inc. SimplECGK161431 | Edan Instruments, PatientMonitor, models elite V5,elite V6 and elite V8K160981 | Eko Devices Inc. EkoElectronicStethoscope SystemK151319 | Comparison |
| recordings are indicated forthe manual assessment ofcardiac rhythmdisturbances. The devicedoes not produce alarmsand is not intended foractive patientmonitoring(real-time). Thedevice is not intended foruse as life supportingequipment on high-riskpatients such as critical carepatients. The device is notintended for use in thepresence of a pacemaker. | and impedancecardiography (ICG). BIS isintended for use on adultand pediatric patients.ICG monitoring is intendedfor use on adults only. Thearrhythmia detection andST Segment analysis areintended for adult patients.The monitors areadditionally intended foruse during patienttransport inside hospitals.The monitors are notintended for MRIenvironments. | examination in normalpatients or those withsuspected diseases ofthe cardiac, vascular,pulmonary orabdominal organsystems. | |||
| Product Code(s) | DXH, DPS, DQD, DSB, BZQ | DXH | MHX, DSI, DRT, CBQ, DXN,DSK, CBR, DQA, NHO, CBS,NHQ, NHP, CCK, DSB, CCL,BZQ, BZK, DPS, FLL, DRG,MLD | DQD | Similar |
| Characteristic | Nanowear Inc.SimpleSENSE - NewDeviceCurrent Submission | Nanowear Inc. SimplECGK161431 | Edan Instruments, PatientMonitor, models elite V5,elite V6 and elite V8K160981 | Eko Devices Inc. EkoElectronicStethoscope SystemK151319 | Comparison |
| Acquired Data | Electrocardiogram(EKG/ECG)Respiration Rate derivedfrom thoracic impedanceHeart Sounds | Electrocardiogram(EKG/ECG) | ECG, Respiration Rate,Temperature SpO2, pulserate non-invasive bloodpressure (NIBP), invasiveblood pressure (IBP),carbon dioxide (CO2),cardiac output (C.O.),anesthetic gas (AG),Bispectral Index (BIS),respiration mechanics (RM)Impedance Cardiography(ICG). | Heart Sounds | Same measures as thosefound in the predicate &reference devices. TheNew Device captures theECG signal in the sameway as the SimplECGpredicate. The NewDevice captures some ofthe measures in the Edanreference and the heartsounds as in the Ekoreference. The absence ofsome measures does notaffect the substantialequivalence of theSimpleSENSE device. |
| Electrocardiogram(EKG/ECG): Textile-basedNanosensors | Electrocardiogram(EKG/ECG): Textile-basedNanosensors | Not Applicable | Not Applicable | Same sensors as in theSimplECG device are usedto capture signals | |
| SensorTechnology | Respiration Rate: Textile-based Nanosensorsmeasure thoracicimpedance andrespiration is derivedfrom thoracic impedance | Not Applicable | ThoracicImpedance/ImpedanceCardiogram (ICG), ECG:Disposable Silver orSilver/Silver Chlorideelectrode.Respiration Rate: derivedfrom thoracic impedance | Not Applicable | Both the New Device andthe Edan referencemeasure and deriverespiration rate usingthoracic impedancecaptured via a sensor.The sensors in the twodevices are different,however both types ofsensors are used for |
| Characteristic | Nanowear Inc.SimpleSENSE - NewDeviceCurrent Submission | Nanowear Inc. SimplECGK161431 | Edan Instruments, PatientMonitor, models elite V5,elite V6 and elite V8K160981 | Eko Devices Inc. EkoElectronicStethoscope SystemK151319 | Comparison |
| physiologic signal capturein other cleared devices. | |||||
| Heart Sound:Microelectromechanical(MEMS) microphone | Not Applicable | Not Applicable | Heart Sound: Uses astandard stethoscopediaphragm. Method oftransduction anddigitization of soundwaves is not Available | The SimpleSENSE deviceuses a different sensorthan the Eko reference.However, the signalacquisition and locationused in both theSimpleSENSE device andthe Eko reference aresimilar. | |
| Electrocardiogram(EKG/ECG): StandardBipolar leadinstrumentation amplifierand Sigma-Delta Analogto Digital Converter. | Electrocardiogram(EKG/ECG): StandardBipolar leadinstrumentation amplifierand Sigma-Delta Analog toDigital Converter | Not Applicable | Not Applicable | The signal acquisitionmethod in the New Devicefor capturing ECG signal isthe same as the SimplECGpredicate. | |
| Signalacquisitionmethod | Respiration rate: ThoracicImpedance is measuredusing four-point probeusing low amplitudecurrent applied to thebody and impedancemeasured from voltagedrop derived fromthoracic impedance.(Respiration Ratedetection range 6 - 22 | Not Applicable | ThoracicImpedance/ImpedanceCardiograph: four-pointprobe using low amplitudecurrent applied to the bodyand impedance measuredfrom voltage drop.Respiration Rate: derivedfrom thoracic impedance | Not Applicable | The signal acquisitionmethod for capturingthoracic impedance is thesame as the Edanreference. |
| Characteristic | Nanowear Inc.SimpleSENSE - NewDeviceCurrent Submission | Nanowear Inc. SimplECGK161431 | Edan Instruments, PatientMonitor, models elite V5,elite V6 and elite V8K160981 | Eko Devices Inc. EkoElectronicStethoscope SystemK151319 | Comparison |
| breaths per minute (BPM)with accuracy ± 2 BPM) | |||||
| Heart Sound: solid stateMicroelectromechanical(MEMS) microphoneembedded in garmentand located near Apex ofheart. | Not Applicable | Not Applicable | Heart Sound: sensorembedded in astandard stethoscopeattachment that canamplify, digitize andtransmit data. | The signal acquisitionmethod for detectingheart sounds is similar tothe Eko reference. Bothdevices are placed insimilar locations to detectand capture heartsounds. | |
| Display Type | No on-device display. | No on-device display. | On Device Display ofwaveforms acquired andderived parameters isavailable. Data can bedownloaded from thedevice through an Ethernetconnection or a USBconnection. | No on-device display.Display of data isavailable on asmartphone through asmartphone app or onthe web using webservices. | Data display for the NewDevice is the same as theSimplECG predicate andthe Eko reference thatrely on wirelesstransmission and displayon a smartphone or web-based display. |
| DisplayRequirement | User provided displayhardware for ahealthcare professionalto view the recordeddata. A general-purposePC/Laptop/Desktop ormobile device may beused. | User provided displayhardware for a healthcareprofessional to view therecorded data. A general-purposePC/Laptop/Desktop may beused. | No requirement foradditional user providedhardware for display | Display availablethrough User providedsmartphone or tablet.Display also availablethrough Web browseron anyLaptop/PC/Desktop. | The Edan referenceincludes a display(hardware) while the NewDevice, the SimplECG, andthe Eko reference alldisplay the data on theuser's hardware and viaweb based display. |
| Power Source | Internally powered usingLi-Ion rechargeablebattery | Single Use Lithium AA typebatteries | Rechargeable Lithium-IonBattery and AC Mainssupported. | Internally poweredusing Li-Ionrechargeable battery | All of the devices are ableto operate on batterypower. The Edanreference has an option |
| Characteristic | Nanowear Inc.SimpleSENSE - NewDeviceCurrent Submission | Nanowear Inc. SimplECGK161431 | Edan Instruments, PatientMonitor, models elite V5,elite V6 and elite V8K160981 | Eko Devices Inc. EkoElectronicStethoscope SystemK151319 | Comparison |
| InternalMemory/data | Removeable MicroSDcard | Removeable MicroSD card | Solid state memory non-removeable. | Solid state memorynon-removeable | All devices use memorydevices to store the datacollected. The NewDevice and the SimplECGpredicate use removeablecards while the Edan andEko references use non-removable memorydevices. |
| CommunicationInterface | Wireless transceiverusing Bluetooth | Wireless transceiver usingBluetooth | USB connection or Ethernetconnection | Wireless transceiverusing Bluetooth | The New Device uses thesame communicationinterface as the SimplECGpredicate and Ekoreference. The Edanreference uses a non-wireless interface. |
| Access torecorded data | Data is transferred to theiPhone, which is thenshared with thehealthcare professional.For redundancy,encrypted data is alsostored in the removeablestorage medium. | Data is transferred to theiPhone, which is thenshared with the healthcareprofessional. Forredundancy, encrypteddata is also stored in theremoveable storagemedium. Data istransferred from the deviceto a web server and a Webinterface is used to accessthe data. | Trends data can bedownloaded usingproprietary clinicalmanagement software. | Data is transferredand stored in .wavformat and can beretrieved from a webinterface | Access to the data outputfor the New Device is thesame as the SimplECG andsimilar to the Ekoreference. The Edanreference uses proprietarysoftware to manage theirdownloadable data. |
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| Discussion -similarities | The similarities of the New Device to one or more of the predicate/references are:• Sensor technology is the same as the SimplECG predicate device sensor |
|---|---|
| • Same measures as those found in the predicate and reference devices. | |
| • Same sensors as in the SimplECG device are used to capture signals (except heartsounds) | |
| • Both the New Device and the Edan reference measure and derive respiration rateusing thoracic impedance captured via a sensor. | |
| • The signal acquisition method for capturing ECG signal is the same as theSimplECG predicate. | |
| • The signal acquisition method for capturing thoracic impedance is the same asthe SimplECG predicate. | |
| • The signal acquisition method for detecting heart sounds is similar to the Ekoreference. Both devices are placed in similar locations to detect and captureheart sounds. | |
| • Data display for the New Device is the same as the SimplECG predicate and Ekoreference that rely on wireless transmission and display on a smartphone or web-based display. | |
| • The Edan reference includes a display (hardware) while the New Device, theSimplECG predicate, and the Eko reference displays the data on the user'shardware or via web based display. | |
| • All of the devices are able to operate on battery power. The Edan reference hasan additional option for use with an AC Main. | |
| • All of the devices listed use memory devices to store the data collected. The NewDevice and the SimplECG predicate use removeable cards while the Edan and Ekoreference devices use non-removable memory devices. | |
| • The New Device uses the same communication interface as the SimplECGpredicate and Eko reference device. | |
| • Access to the data output for the New Device is the same as the SimplECG andsimilar to the Eko reference. | |
| Discussion -differences | The differences between the New Device and the predicate/referencedevices are: |
| • The New Device does not capture all of the measures in the Edan reference. | |
| • The sensors in the new device and Edan reference are different, however bothtypes of sensors are used for physiologic signal capture in other cleared devices. | |
| • The SimpleSENSE device uses a different sensor than the Eko reference.However, the signal acquisition and location used in both the SimpleSENSEdevice and the Eko reference are similar types of sensors. | |
| • The Edan reference uses a wired interface. | |
| • The Edan reference uses proprietary software to manage their downloadabledata. |
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| Performancetesting | Performance testing for the SimpleSENSE device included the following:• Verification of multiparametric data capture• Verification of Bluetooth and iPhone connectivity• Verification of encryption of acquired data• Battery safety and charging status indication• 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 devicesPerformance testing demonstrated performance to design specifications. |
|---|---|
| Conclusion | The performance data provided demonstrate that the SimpleSENSE device issubstantially equivalent to the indicated predicate device. |
§ 870.2920 Telephone electrocardiograph transmitter and receiver.
(a)
Identification. A telephone electrocardiograph transmitter and receiver is a device used to condition an electrocardiograph signal so that it can be transmitted via a telephone line to another location. This device also includes a receiver that reconditions the received signal into its original format so that it can be displayed. The device includes devices used to transmit and receive pacemaker signals.(b)
Classification. Class II (performance standards).