(153 days)
The ASSURE Wearable ECG is indicated for adult patients who have been prescribed this device by a medical professional, who were previously prescribed the ASSURE WCD system, and who may be asymptomatic or who may suffer from transient symptoms such as palpitations, shortness of breath, dizziness, light-headedness, presyncope, syncope, fatigue, or anxiety. The signal acquired by the ASSURE Wearable ECG is not intended and should not be used for automated or semi-automated analysis. The device does not deliver any therapy, administer any drugs, provide interpretive or diagnostic statements or provide for any life support.
The ASSURE Wearable ECG is contraindicated for use in patients with an active implantable pacemaker or defibrillator.
The ASSURE Wearable ECG is a reusable, ambulatory electrocardiography-based, cardiac- and physiologicmonitoring, medical-electrical system whose intended purpose is to inform clinical management of options for diagnosing, monitoring and/or mitigating cardiac conditions after patient's improvement following ASSURE® Wearable Cardioverter Defibrillator (WCD) prescriptive use. The system utilizes the same five-electrode SensorFit™ Garment worn previously with the WCD prescription. The system continuously records ECG data and upon detection, it identifies and records episodes as high and low heart rate, as well as patient-triggered events. The system utilizes the same algorithm detection and episode reporting software marketed in the ASSURE WCD with high (Tachy) and low (Brady) capture for later transmission to the medical professional for interpretation. The system captures and stores ECG episodes, and non-ECG patient activity and wear information to be displayed and reported in counters and trends. Recorded events include ECG waveforms and reports identifying high and low heart rates, as well as patient-triggered events. The system uses a 3axis accelerometer to monitor non-ECG patient activity (steps and wear time).
The ASSURE Wearable ECG event reports do not contain diagnostic interpretation. The reported events are provided for review by the prescriber to assist in diagnosis of the recently transitioned WCD patient and to assess care options based on the healthcare professional's judgment and experience.
The ASSURE Wearable Cardiac ECG is a prescription use device. The ASSURE Wearable ECG is intended for use by a patient during their normal daily activities primarily in the home or community setting, but also hospitals, medical clinics, healthcare facilities and transport. The device is non-invasive, and intended to be used on one patient at a time.
The Wearable Cardiac ECG System is comprised of the following reusable patient-worn components:
- Monitor Cable Assembly
- Hub
- Alert Button
- Battery Pack
- SensorFit™ Garment
- Charger
The Kestra Medical Technologies, Inc. ASSURE Wearable ECG (K233864) does not appear to have an artificial intelligence/machine learning component that offers diagnostic interpretation. The provided text states, "The signal acquired by the ASSURE Wearable ECG is not intended and should not be used for automated or semi-automated analysis. The device does not deliver any therapy, administer any drugs, provide interpretive or diagnostic statements, or provide for any life support." and "The ASSURE Wearable ECG event reports do not contain diagnostic interpretation." Therefore, the typical acceptance criteria and study designs for AI/ML devices might not be applicable in the usual sense.
However, based on the information provided, here's a breakdown regarding the device's technical performance and regulatory compliance, reinterpreting "acceptance criteria" through the lens of general medical device performance and safety standards:
1. Table of Acceptance Criteria and Reported Device Performance
Since the device explicitly states it does not perform automated or semi-automated analysis or provide diagnostic statements, traditional AI/ML performance metrics like sensitivity, specificity, or AUC against a ground truth would not be applicable here. Instead, the acceptance criteria are focused on the device's ability to reliably act as a continuous ECG monitor, data recorder, and transmitter, and its compliance with relevant safety and performance standards.
| Acceptance Criteria Category | Specific Criteria/Standard | Reported Device Performance |
|---|---|---|
| Basic Safety & Essential Performance | IEC 60601-1:2005+A1:2012+A2:2020 (General requirements for basic safety and essential performance) | Passed successfully |
| Electromagnetic Compatibility (EMC) | IEC 60601-1-2:2014+A1:2020 (EMC - Requirements and tests) | Passed successfully |
| Home Healthcare Environment | IEC 60601-1-11:2015+A1:2021 (Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment) | Passed successfully |
| Ambulatory ECG Systems (Specific Performance) | IEC 60601-2-47:2015 (Particular requirements for the basic safety and essential performance of ambulatory electrocardiographic systems) | Noted that it intentionally does not meet all performance clauses associated with diagnostic ECG, due to its low-risk patient monitoring design and use of proprietary algorithm detection software developed for a WCD (which is not diagnostic in this context). The implication is that the relevant clauses for its intended function as a monitoring and recording device were met. |
| Biocompatibility | ISO 10993-1:2018 (Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process) | Passed successfully |
| Battery Safety | UL 2054:2004(R2011) (Standard for Household and Commercial Batteries, 2nd Edition) | Passed successfully |
| Lithium Battery Safety | IEC 62133-2:2017 (Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications, Part 2: Lithium systems) | Passed successfully |
| Electromagnetic Immunity (RFID) | AIM 7351731:2017 (Medical Electrical Equipment and System Electromagnetic Immunity Test for Exposure to Radio Frequency Identification Readers - An AIM Standard) | Passed successfully |
| ECG Monitoring & Data Handling | Continuously monitor ECG signal, store ECG event data (high/low heart rate, patient-triggered events), and transmit recorded data to a Kestra display server for clinician review. | Bench test results verify the system's ability to perform these functions. |
2. Sample Size Used for the Test Set and Data Provenance
The provided text does not explicitly state the sample size for any clinical or technical test sets involving patient data. The performance section focuses on bench testing against recognized standards. There is no mention of a separate "test set" in the context of diagnostic accuracy from patient data, as the device doesn't provide diagnostic interpretation.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable as the device explicitly states it does not perform automated or semi-automated analysis or provide diagnostic statements. The "ground truth" here is primarily established by adherence to engineering and safety standards, and functional verification through bench testing. Clinical interpretation of the recorded ECG data is left to medical professionals.
4. Adjudication Method for the Test Set
This information is not applicable given the device's stated function and the type of performance testing described (bench testing against engineering standards, not diagnostic accuracy studies requiring expert adjudication).
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a MRMC comparative effectiveness study was not conducted or described. The device's function is to record ECG data, not to interpret it or assist human readers in interpretation. There is no AI component in this device that provides diagnostic assistance to a human reader.
6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)
While the device uses an "embedded arrhythmia detection algorithm" for auto-triggering events (high and low heart rates), the submission explicitly states that the signal "is not intended and should not be used for automated or semi-automated analysis" and "does not deliver...interpretive or diagnostic statements." Therefore, a standalone performance study in the sense of evaluating the diagnostic accuracy of an AI algorithm was not performed because the device does not claim diagnostic capabilities. Its "algorithm detection and episode reporting software" is for capture and storage of events for later clinician review, not for automated diagnosis.
7. Type of Ground Truth Used
For the functional aspects (ECG monitoring, event triggering, data storage/transmission), the "ground truth" would have been established through instrumentation calibration, controlled simulated signals, and direct measurement during bench testing, verifying that the device accurately records ECG, identifies specified rate thresholds, and transfers data as intended. For the safety and performance standards (e.g., IEC 60601 series), the ground truth is adherence to the requirements and test methods outlined in those international standards.
8. Sample Size for the Training Set
This information is not applicable. The device, as described, does not utilize machine learning/AI for diagnostic purposes, and therefore would not have a "training set" in the context of developing a diagnostic algorithm. The "proprietary algorithm detection software" for event triggering, while an algorithm, is not presented as a machine learning model requiring a training set for diagnostic output.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable. As no machine learning-based diagnostic algorithm is described, there is no "training set" or corresponding ground truth establishment process mentioned.
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May 7, 2024
Kestra Medical Technologies, Inc. Jay Wiese Sr. Regulatory Affairs Specialist 3933 Lake Washington Boulevard NE Suite 200 Kirkland, Washington 98033
Re: K233864
Trade/Device Name: ASSURE Wearable ECG Regulation Number: 21 CFR 870.2800 Regulation Name: Medical Magnetic Tape Recorder Regulatory Class: Class II Product Code: MWJ, DXH Dated: April 9, 2024 Received: April 9, 2024
Dear Jay Wiese:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 W. Shih -S
Jennifer Shih Kozen Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
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Indications for Use
Submission Number (if known)
Device Name
ASSURE Wearable ECG (80553-001)
Indications for Use (Describe)
The ASSURE Wearable ECG is indicated for adult patients who have been prescribed this device by a medical professional, who were previously prescribed the ASSURE WCD system, and who may be asymptomatic or who may suffer from transient symptoms such as palpitations, shortness of breath, dizziness, light-headedness, presyncope, fatigue, or anxiety. The signal acquired by the ASSURE Wearable ECG is not intended and should not be used for automated or semiautomated analysis. The device does not deliver any therapy, administer any drugs, provide interpretive or diagnostic statements, or provide for any life support.
The ASSURE Wearable ECG is contraindicated for use in patients with an active implantable pacemaker or defibrillator.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
ver-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary (K233864)
Date Prepared: April 9, 2024
I. General Information
Applicant:
Kestra Medical Technologies, Inc. 3933 Lake Washington Blvd NE Ste 200 Kirkland, WA 98033 USA Phone: 425-526-4927 Fax: 415-632-5701
Contact Person:
Bev Magrane VP, Quality and Requlatory Affairs Email: beverly.magrane@kestramedical.com
II. Device Information
Trade Name:
| ASSURE Wearable ECG | |
|---|---|
| Generic/Common Name: | |
| Classification Regulation: | 21 CFR 870.2800 |
| Classification Name: | Medical Magnetic Tape Recorder |
| Regulatory Class: | Class II |
| Product Codes: | MWJ Electrocardiograph, Ambulatory (Without Analysis)DXH Transmitters and Receivers, Electrocardiograph, Telephone |
III. Predicate Devices
The following predicate devices have been selected:
| Primary Predicate Device: | Biotricity Biotres system |
|---|---|
| Predicate Clearance | K211709 (19 Jan 2022) |
| Classification Regulation: | 21 CFR 870.2800 |
| Classification Name: | Medical Magnetic Tape Recorder |
| Regulatory Class: | Class II |
| Product Code: | MWJ Electrocardiograph, Ambulatory (Without Analysis) |
| Secondary Predicate Device: | Biotricity Bioflux system |
| Predicate Clearance | K172311 (15 Dec 2017) |
| Classification Regulation: | 21 CFR 870.2920 |
| Classification Name: | Telephone Electrocardiograph Transmitter and Receiver |
| Regulatory Class: | Class II |
| Product Code: | DXH Transmitters and Receivers, Electrocardiograph, Telephone |
IV. Indications for Use
The ASSURE Wearable ECG is indicated for adult patients who have been prescribed this device by a medical professional, who were previously prescribed the ASSURE WCD system, and who may be asymptomatic or who may suffer from transient symptoms such as palpitations, shortness of breath, dizziness, lightheadedness, presyncope, syncope, fatigue, or anxiety. The signal acquired by the ASSURE Wearable ECG is
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not intended and should not be used for automated or semi-automated analysis. The device does not deliver any therapy, administer any drugs, provide interpretive or diagnostic statements or provide for any life support.
The ASSURE Wearable ECG is contraindicated for use in patients with an active implantable pacemaker or defibrillator.
V. Intended Use
The ASSURE Wearable ECG continuously monitors heart rate information. Event data, which is automatically stored for low and high heart rates and patient-triggered events, is intended to aid medical professionals as they monitor various clinical conditions, events, and trends. The ASSURE Wearable ECG is intended for use by a patient during their normal daily activities primarily in the home or community setting, but also hospitals, medical clinics, healthcare facilities and transport.
VI. Device Description
The ASSURE Wearable ECG is a reusable, ambulatory electrocardiography-based, cardiac- and physiologicmonitoring, medical-electrical system whose intended purpose is to inform clinical management of options for diagnosing, monitoring and/or mitigating cardiac conditions after patient's improvement following ASSURE® Wearable Cardioverter Defibrillator (WCD) prescriptive use. The system utilizes the same five-electrode SensorFit™ Garment worn previously with the WCD prescription. The system continuously records ECG data and upon detection, it identifies and records episodes as high and low heart rate, as well as patient-triggered events. The system utilizes the same algorithm detection and episode reporting software marketed in the ASSURE WCD with high (Tachy) and low (Brady) capture for later transmission to the medical professional for interpretation. The system captures and stores ECG episodes, and non-ECG patient activity and wear information to be displayed and reported in counters and trends. Recorded events include ECG waveforms and reports identifying high and low heart rates, as well as patient-triggered events. The system uses a 3axis accelerometer to monitor non-ECG patient activity (steps and wear time).
The ASSURE Wearable ECG event reports do not contain diagnostic interpretation. The reported events are provided for review by the prescriber to assist in diagnosis of the recently transitioned WCD patient and to assess care options based on the healthcare professional's judgment and experience.
The ASSURE Wearable Cardiac ECG is a prescription use device. The ASSURE Wearable ECG is intended for use by a patient during their normal daily activities primarily in the home or community setting, but also hospitals, medical clinics, healthcare facilities and transport. The device is non-invasive, and intended to be used on one patient at a time.
The Wearable Cardiac ECG System is comprised of the following reusable patient-worn components:
- Monitor Cable Assembly Houses the primary electronics, embedded application software, . communication modules, and ECG signal acquisition hardware. It includes a Hub, Alert Button and Battery Connector.
- Hub Physical housing for the primary Wearable ECG electronics and 3-axis accelerometer. The Hub ● provides a means for connecting the Monitor Cable to the Garment.
- Alert Button Provides audio, tones and voice prompts as well as vibratory alerts and a button for the ● user to provide input.
- Battery Pack - Rechargeable Lithium-lon battery.
- SensorFit™ Garment This is the same PMA-approved (P200037) garment previously worn with the . WCD and fitted according to body size and body style. The Garment includes built-in ECG electrodes and provides a method of affixing the Hub, Alert Button, and Battery Pack for proper placement during operation.
- Charger Medical-grade AC-DC power adaptor and USB-C power cable. ●
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VII. Comparison of Technological Characteristics with Predicate Device
The subject ASSURE Wearable ECG has the same intended use as the predicate devices. The differences in the technological characteristics between the subject and predicate devices do not raise any issues of safety or effectiveness as the fundamental scientific technology and intended use is unchanged.
The ASSURE Wearable ECG is considered substantially equivalent to the predicate devices. A comparison table outlining the similarities and differences between the subject device and the predicate devices is provided in the Summary Table below.
| Category | Wearable ECG (subject) | Biotres (predicate) K211709 | Bioflux (secondary) K172311 |
|---|---|---|---|
| Indications forUse | The ASSURE Wearable ECG isindicated for adult patients whohave been prescribed thisdevice by a medicalprofessional, who werepreviously prescribed theASSURE WCD system, andwho may be asymptomatic orwho may suffer from transientsymptoms such as palpitations,shortness of breath, dizziness,light-headedness, presyncope,syncope, fatigue, or anxiety. Thesignal acquired by the WearableECG is not intended and shouldnot be used for automated orsemi-automated analysis. Thedevice does not deliver anytherapy, administer any drugs,provide interpretive or diagnosticstatements or provide for any lifesupport. | The Biotres is indicated foruse on adult patients 18 yearsor older who may beasymptomatic or who sufferfrom transient symptoms suchas palpitations, shortness ofbreath, dizziness, lightheadedness, pre-syncope,syncope, fatigue, chest painand/or anxiety and mayrequire cardiac recording on acontinuous basis for up to 30days. The signal acquired bythe Biotres is not intendedand should not be used forautomated or semi-automatedanalysis. | The bioflux Device is intended foruse by patients who either have orare at risk of having cardiac diseaseand those that demonstrateintermittent symptoms indicative ofcardiac disease and require cardiacmonitoring on a continuing basis forup to 30 days. The devicecontinuously records ECG data andupon detection by an ECG analysisalgorithm or manually initiated by thepatient, automatically delivers therecorded cardiac activity to theserver where it is presented and canbe reviewed by a medicalprofessional.The data received from the biofluxdevice can be used by anotherdevice for arrhythmia analysis,reporting and signal measurements.The Bioflux device is not intended tosound any alarms. The device doesnot deliver any therapy, administerany drugs, provide interpretive ordiagnostic statements or provide forany life support.bioflux is for prescription use only. |
| ClassificationName | Recorder, Magnetic Tape,Medical | Recorder, Magnetic Tape,Medical | Telephone electrocardiographtransmitter and receiver |
| Product Code | MWJ, DXH | MWJ | DXH |
| Category | Wearable ECG (subject) | Biotres (predicate) K211709 | Bioflux (secondary) K172311 |
| DefibrillatorProtection | The ECG Electrodes in theWCD-approved Garment areclassified as defibrillation-proofapplied parts. | Not Defibrillator Proof, 8.5.5.2of IEC 60601-1 passed | |
| Wear Time | Up to 30 Days | Up to 30 Days | Up to 30 Days |
| Recording Format | Continuously monitors ECG andactivity data. Data is auto-triggered for events such asBradycardia and Tachycardia, asidentified by an embeddedarrhythmia detection algorithm;and stored as low and high heartrate episodes and patient-triggered events | Continuous | Captures patient-activated and auto-triggered events such asBradycardia, Tachycardia, pause andAtrial Fibrillation as identified by anembedded arrhythmia detectionalgorithm |
| Delivered deviceincludes | ECG monitor with 5-electrodeWCD-supplied garmentInternal rechargeable batteryWall Battery charger | -3 lead ECG monitor-internal rechargeable battery-Wall Battery charger | Device has at least 2 ECG channelsand 3-lead electrodes |
| Monitor functionalblocks | Analog ECG front end,accelerometer, MCU, eMMCdata storage, BLE modem fordata transmission, LEDindicator, and event recordbutton | Analog ECG front end, MCU,Flash data storage, BLEmodem for data transmission,LED indicator, and Recordbutton | Analog ECG front end, MCU, Flashdata storage, RF modem for datatransmission, LCD screen, andRecord button |
| Data transfer | Bluetooth for transfer of patientdata by mobile data client to aWi-Fi-connected server | Mobile App, iOS, Android | Data can be delivered to the serverwirelessly via mobile network |
| Server | Subsequent access to ECGdisplay and episode reportviewer for evaluation byprescribing medical professional | Facilitate data communicationwith the Biotres device,provide data storage, andpresent the data forevaluation by a medicalprofessional | Facilitate data communication withthe Bioflux device, provide datastorage, and present the data forevaluation by a medical professional |
| Device form factor | Utilizes Kestra PMA-approvedWCD garment electrodes | Small, lightweight body wornambulatory cardiac monitors | Small, lightweight body wornambulatory cardiac monitors |
| Category | Wearable ECG (subject) | Biotres (predicate) K211709 | Bioflux (secondary) K172311 |
| Wirelesstechnology usedto transmit data toserver | Yes | Yes | Data is delivered to the serverwirelessly via mobile cellulardedicated network connection |
| Power | Device is battery powered by arechargeable Li-Ion battery | Device is battery powered bya rechargeable Li-Ion battery | Device is battery powered by arechargeable Li-Ion battery |
| Device ProgramParameters | ASSURE Wearable ECG has nouser-programmable functions orfeatures | Using an Android or IOSbased app, clinician canadjust device programmingparameters such as pre-postrecording times and auto-triggering configuration | A medical professional, using theserver, can adjust and program thedevice configuration and auto-triggering parameters |
| Monitor MultipleParameters | ECG signal, high and low heartrate and accelerometer-basedpatient data (steps and weartime) | No (ECG only) | Captures patient activated and auto-triggered events such asBradycardia, Tachycardia, pause andAtrial Fibrillation as identified by anembedded arrhythmia detectionalgorithm |
| Manual EventRecording | Alert button for patient-triggeredevent recordings and visual,audio and haptic modes ofalerting patient to device status | Devices have Record buttonfor manual event recordingsand a user LED to indicatedevice status and mode ofoperation. | Devices have Record button formanual event recordings and a userLED to indicate device status andmode of operation. |
| Prescriber Review | The ECG recorded data fromthe ASSURE Wearable ECG istransferred to the clinician fromthe Kestra Secure Server whenthe device is connected to theserver at the end of a patientstudy | The ECG recorded data fromthe Biotres Recorder can betransferred, by the clinician,from the Biotres ConfiguredSecure Server when therecorder is connected to theBiotres Gateway App at theend of a patient study. | Automatically delivers the recordedcardiac activity to the server where itis presented and can be reviewed bya medical professional |
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VIII. Performance Data
Safety and performance of the subject ASSURE Wearable ECG system has been evaluated and verified in accordance with design specifications and to support a determination of substantial equivalence to the predicate device. Because the device is designed and intended to monitor low-risk patients using proprietary algorithm detection software developed for the ASSURE Wearable Cardioverter Defibrillator, it intentionally does not meet all performance clauses of IEC 60601-2-47:2015 that are associated with diagnostic ECG.
The following performance and safety tests have passed successfully:
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| RecognitionNumber | Number | Document Description (Title) |
|---|---|---|
| 19-49 | IEC 60601-1:2005+A1:2012+A2:2020 | Medical electrical equipment - Part 1: General requirementsfor basic safety and essential performance (Edition 3.2) |
| 19-36 | IEC 60601-1-2:2014+A1:2020 | Medical electrical equipment - Part 1-2: General requirementsfor basic safety and essential performance - Collateralstandard: Electromagnetic compatibility - Requirements andtests |
| 19-38 | IEC 60601-1-11:2015+A1:2021 | Medical electrical equipment - Part 1-11: Generalrequirements for basic safety and essential performance -Collateral Standard: Requirements for medical electricalequipment and medical electrical systems used in the homehealthcare environment |
| 3-155 | IEC 60601-2-47:2015 | Medical electrical equipment - Part 2-47: Particularrequirements for the basic safety and essential performanceof ambulatory electrocardiographic systems |
| 2-258 | ISO 10993-1:2018 | Biological evaluation of medical devices Part 1: Evaluationand testing within a risk management process |
| 19-11 | UL 2054:2004(R2011) | Standard for Household and Commercial Batteries, 2ndEdition |
| 19-33 | IEC 62133-2:2017 | Secondary cells and batteries containing alkaline or othernon-acid electrolytes - Safety requirements for portablesealed secondary cells, and for batteries made from them, foruse in portable applications, Part 2: Lithium systems (IEC62133-2:2017) |
| 19-30 | AIM 7351731:2017 | Medical Electrical Equipment and System ElectromagneticImmunity Test for Exposure to Radio Frequency IdentificationReaders - An AIM Standard (Rev. 2.00) |
Bench test results verify that the ASSURE Wearable ECG system can continuously monitor ECG signal, store ECG event data in the device memory, and transmit recorded data to a Kestra display server for clinician review.
IX. Conclusion
Based on a review of the test results and a comparison to the predicate devices characteristics and known specifications, the results show that the ASSURE Wearable ECG is substantially equivalent to the predicate device.
§ 870.2800 Medical magnetic tape recorder.
(a)
Identification. A medical magnetic tape recorder is a device used to record and play back signals from, for example, physiological amplifiers, signal conditioners, or computers.(b)
Classification. Class II (performance standards).