(153 days)
Not Found
No
The summary explicitly states that the signal acquired is "not intended and should not be used for automated or semi-automated analysis" and that the device "does not provide interpretive or diagnostic statements." While it uses algorithms for detection and reporting, these are described as the "same algorithm detection and episode reporting software marketed in the ASSURE WCD," suggesting a more traditional algorithmic approach rather than AI/ML. There is no mention of AI, ML, DNN, or any training/test data sets typically associated with AI/ML development.
No
The 'Intended Use / Indications for Use' section explicitly states, "The device does not deliver any therapy, administer any drugs, provide interpretive or diagnostic statements or provide for any life support." This indicates it is a diagnostic/monitoring device, not a therapeutic one.
Yes
The "Intended Use / Indications for Use" section states: "The ASSURE Wearable ECG is indicated for adult patients...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 "Device Description" also clarifies that the device's purpose is to "inform clinical management of options for diagnosing, monitoring and/or mitigating cardiac conditions" and that "The reported events are provided for review by the prescriber to assist in diagnosis of the recently transitioned WCD patient". These statements indicate that the device provides information used to aid in the diagnosis of cardiac conditions.
No
The device description explicitly lists multiple hardware components that are part of the system, including a Monitor Cable Assembly, Hub, Alert Button, Battery Pack, SensorFit™ Garment, and Charger. This indicates it is a hardware-based medical device with accompanying software.
Based on the provided text, the ASSURE Wearable ECG is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This testing is performed outside of the body (in vitro).
- ASSURE Wearable ECG Function: The ASSURE Wearable ECG is a device that monitors and records electrical activity of the heart (ECG) directly from the patient's body. It does not analyze specimens taken from the body.
- Intended Use: The intended use describes monitoring and recording ECG data for review by a medical professional to assist in diagnosis and assess care options. This is a direct physiological measurement, not an in vitro test.
- Device Description: The description details a wearable system that captures and stores ECG data and patient activity. It does not mention any analysis of biological specimens.
Therefore, the ASSURE Wearable ECG falls under the category of a medical device that performs physiological monitoring, not an In Vitro Diagnostic device.
N/A
Intended Use / 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, 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 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.
Product codes (comma separated list FDA assigned to the subject device)
MWJ, DXH
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. Systems 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-Ion 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. ●
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
adult patients
Intended User / Care Setting
medical professional / primarily in the home or community setting, but also hospitals, medical clinics, healthcare facilities and transport.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
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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).
1
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
2
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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4
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 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, | |||
| light-headedness, presyncope, | |||
| syncope, fatigue, or anxiety. The | |||
| signal acquired by the 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 Biotres is indicated for | ||
| use on adult patients 18 years | |||
| or older who may be | |||
| asymptomatic or who suffer | |||
| from transient symptoms such | |||
| as palpitations, shortness of | |||
| breath, dizziness, light | |||
| headedness, pre-syncope, | |||
| syncope, fatigue, chest pain | |||
| and/or anxiety and may | |||
| require cardiac recording on a | |||
| continuous basis for up to 30 | |||
| days. The signal acquired by | |||
| the Biotres is not intended | |||
| and should not be used for | |||
| automated or semi-automated | |||
| analysis. | The bioflux Device is intended for | ||
| use by patients who either have or | |||
| are at risk of having cardiac disease | |||
| and those that demonstrate | |||
| intermittent symptoms indicative of | |||
| cardiac disease and require cardiac | |||
| monitoring on a continuing basis for | |||
| up to 30 days. The device | |||
| continuously records ECG data and | |||
| upon detection by an ECG analysis | |||
| algorithm or manually initiated by the | |||
| patient, automatically delivers the | |||
| recorded cardiac activity to the | |||
| server where it is presented and can | |||
| be reviewed by a medical | |||
| professional. | |||
| The data received from the bioflux | |||
| device can be used by another | |||
| device for arrhythmia analysis, | |||
| reporting and signal measurements. | |||
| The Bioflux device is not intended to | |||
| sound any alarms. The device does | |||
| not deliver any therapy, administer | |||
| any drugs, provide interpretive or | |||
| diagnostic statements or provide for | |||
| any life support. | |||
| bioflux is for prescription use only. | |||
| Classification | |||
| Name | Recorder, Magnetic Tape, | ||
| Medical | Recorder, Magnetic Tape, | ||
| Medical | Telephone electrocardiograph | ||
| transmitter and receiver | |||
| Product Code | MWJ, DXH | MWJ | DXH |
| Category | Wearable ECG (subject) | Biotres (predicate) K211709 | Bioflux (secondary) K172311 |
| Defibrillator | |||
| Protection | The ECG Electrodes in the | ||
| WCD-approved Garment are | |||
| classified as defibrillation-proof | |||
| applied parts. | Not Defibrillator Proof, 8.5.5.2 | ||
| of IEC 60601-1 passed | |||
| Wear Time | Up to 30 Days | Up to 30 Days | Up to 30 Days |
| Recording Format | Continuously monitors ECG and | ||
| activity data. Data is auto- | |||
| triggered for events such as | |||
| Bradycardia and Tachycardia, as | |||
| identified by an embedded | |||
| arrhythmia detection algorithm; | |||
| and stored as low and high heart | |||
| rate episodes and patient- | |||
| triggered events | Continuous | Captures patient-activated and auto- | |
| triggered events such as | |||
| Bradycardia, Tachycardia, pause and | |||
| Atrial Fibrillation as identified by an | |||
| embedded arrhythmia detection | |||
| algorithm | |||
| Delivered device | |||
| includes | ECG monitor with 5-electrode | ||
| WCD-supplied garment | |||
| Internal rechargeable battery | |||
| Wall Battery charger | -3 lead ECG monitor | ||
| -internal rechargeable battery | |||
| -Wall Battery charger | Device has at least 2 ECG channels | ||
| and 3-lead electrodes | |||
| Monitor functional | |||
| blocks | Analog ECG front end, | ||
| accelerometer, MCU, eMMC | |||
| data storage, BLE modem for | |||
| data transmission, LED | |||
| indicator, and event record | |||
| button | Analog ECG front end, MCU, | ||
| Flash data storage, BLE | |||
| modem for data transmission, | |||
| LED indicator, and Record | |||
| button | Analog ECG front end, MCU, Flash | ||
| data storage, RF modem for data | |||
| transmission, LCD screen, and | |||
| Record button | |||
| Data transfer | Bluetooth for transfer of patient | ||
| data by mobile data client to a | |||
| Wi-Fi-connected server | Mobile App, iOS, Android | Data can be delivered to the server | |
| wirelessly via mobile network | |||
| Server | Subsequent access to ECG | ||
| display and episode report | |||
| viewer for evaluation by | |||
| prescribing medical professional | Facilitate data communication | ||
| with the Biotres device, | |||
| provide data storage, and | |||
| present the data for | |||
| evaluation by a medical | |||
| professional | Facilitate data communication with | ||
| the Bioflux device, provide data | |||
| storage, and present the data for | |||
| evaluation by a medical professional | |||
| Device form factor | Utilizes Kestra PMA-approved | ||
| WCD garment electrodes | Small, lightweight body worn | ||
| ambulatory cardiac monitors | Small, lightweight body worn | ||
| ambulatory cardiac monitors | |||
| Category | Wearable ECG (subject) | Biotres (predicate) K211709 | Bioflux (secondary) K172311 |
| Wireless | |||
| technology used | |||
| to transmit data to | |||
| server | Yes | Yes | Data is delivered to the server |
| wirelessly via mobile cellular | |||
| dedicated network connection | |||
| Power | Device is battery powered by a | ||
| rechargeable Li-Ion battery | Device is battery powered by | ||
| a rechargeable Li-Ion battery | Device is battery powered by a | ||
| rechargeable Li-Ion battery | |||
| Device Program | |||
| Parameters | ASSURE Wearable ECG has no | ||
| user-programmable functions or | |||
| features | Using an Android or IOS | ||
| based app, clinician can | |||
| adjust device programming | |||
| parameters such as pre-post | |||
| recording times and auto- | |||
| triggering configuration | A medical professional, using the | ||
| server, can adjust and program the | |||
| device configuration and auto- | |||
| triggering parameters | |||
| Monitor Multiple | |||
| Parameters | ECG signal, high and low heart | ||
| rate and accelerometer-based | |||
| patient data (steps and wear | |||
| time) | No (ECG only) | Captures patient activated and auto- | |
| triggered events such as | |||
| Bradycardia, Tachycardia, pause and | |||
| Atrial Fibrillation as identified by an | |||
| embedded arrhythmia detection | |||
| algorithm | |||
| Manual Event | |||
| Recording | Alert button for patient-triggered | ||
| event recordings and visual, | |||
| audio and haptic modes of | |||
| alerting patient to device status | Devices have Record button | ||
| for manual event recordings | |||
| and a user LED to indicate | |||
| device status and mode of | |||
| operation. | Devices have Record button for | ||
| manual event recordings and a user | |||
| LED to indicate device status and | |||
| mode of operation. | |||
| Prescriber Review | The ECG recorded data from | ||
| the ASSURE Wearable ECG is | |||
| transferred to the clinician from | |||
| the Kestra Secure Server when | |||
| the device is connected to the | |||
| server at the end of a patient | |||
| study | The ECG recorded data from | ||
| the Biotres Recorder can be | |||
| transferred, by the clinician, | |||
| from the Biotres Configured | |||
| Secure Server when the | |||
| recorder is connected to the | |||
| Biotres Gateway App at the | |||
| end of a patient study. | Automatically delivers the recorded | ||
| cardiac activity to the server where it | |||
| is presented and can be reviewed by | |||
| a 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:
8
| Recognition
| Number | Number | Document Description (Title) |
|---|---|---|
| 19-49 | IEC 60601- | |
| 1:2005+A1:2012+A2:2020 | Medical electrical equipment - Part 1: General requirements | |
| for basic safety and essential performance (Edition 3.2) | ||
| 19-36 | IEC 60601-1-2:2014+A1:2020 | Medical electrical equipment - Part 1-2: General requirements |
| for basic safety and essential performance - Collateral | ||
| standard: Electromagnetic compatibility - Requirements and | ||
| tests | ||
| 19-38 | IEC 60601-1-11:2015+A1:2021 | Medical electrical equipment - Part 1-11: General |
| requirements for basic safety and essential performance - | ||
| Collateral Standard: Requirements for medical electrical | ||
| equipment and medical electrical systems used in the home | ||
| healthcare environment | ||
| 3-155 | IEC 60601-2-47:2015 | Medical electrical equipment - Part 2-47: Particular |
| requirements for the basic safety and essential performance | ||
| of ambulatory electrocardiographic systems | ||
| 2-258 | ISO 10993-1:2018 | Biological evaluation of medical devices Part 1: Evaluation |
| and testing within a risk management process | ||
| 19-11 | UL 2054:2004(R2011) | Standard for Household and Commercial Batteries, 2nd |
| Edition | ||
| 19-33 | IEC 62133-2:2017 | Secondary cells and batteries containing alkaline or other |
| non-acid electrolytes - Safety requirements for portable | ||
| sealed secondary cells, and for batteries made from them, for | ||
| use in portable applications, Part 2: Lithium systems (IEC | ||
| 62133-2:2017) | ||
| 19-30 | AIM 7351731:2017 | Medical Electrical Equipment and System Electromagnetic |
| Immunity Test for Exposure to Radio Frequency Identification | ||
| Readers - 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.