(263 days)
No
The summary describes data processing and analysis but does not explicitly mention the use of AI or ML algorithms. The performance studies focus on traditional statistical measures and comparisons to predicate/comparator devices and standards, not on AI/ML specific metrics or training/test set details indicative of such technologies.
No
The device is described as a "Management System" explicitly intended to "record, store, and transmit" various physiological parameters to "aid medical professionals as they diagnose and identify various clinical conditions, events, and/or trends." Its function is diagnostic and monitoring, not therapeutic.
Yes
The "Intended Use / Indications for Use" states that "The data provided will aid medical professionals as they diagnose and identify various clinical conditions, events, and/or trends." This directly indicates a diagnostic purpose.
No
The device description explicitly lists hardware components such as a Sensor, Patch, Charger, and Gateway, in addition to the Server hardware and software.
Based on the provided information, the uCor Heart Failure and Arrhythmia Management System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
- uCor System Function: The uCor system noninvasively monitors physiological parameters (Thoracic Fluid Index, ECG, Heart Rate, Respiration Rate, Activity, and Posture) directly from the patient's body using sensors and electrodes. It does not analyze samples taken from the body.
- Intended Use: The intended use describes the device as recording, storing, and transmitting physiological data to aid medical professionals in diagnosing and identifying clinical conditions. This is consistent with a patient monitoring device, not an IVD.
- Device Description: The description details the components (sensor, patch, charger, gateway, server) and how they acquire and process signals from the patient's body. There is no mention of handling or analyzing biological samples.
Therefore, the uCor Heart Failure and Arrhythmia Management System falls under the category of a patient monitoring device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The uCor Heart Failure and Arrhythmia Management System is intended to periodically record, store, and transmit Thoracic Fluid Index. The uCor Heart Failure and Arrhythmia Management System is also intended to continuously record and store, and periodically transmit ECG, Heart Rate, Respiration Rate, Activity and Posture. The data provided will aid medical professionals as they diagnose and identify various clinical conditions, events, and/or trends.
The uCor Heart Failure and Arrhythmia Management System is intended for use in clinical and home settings and is indicated for patients who are 21 years of age or older:
- i) Who require monitoring for the detection of non-lethal cardiac arrhythmias, such as, but not limited to, atrial fibrillation, atrial flutter, ventricular ectopy, and bradyarrhythmias; or
- ii) requiring fluid management.
Product codes
MHX, DSI, DSB
Device Description
The µCor Heart Failure and Arrhythmia Management System noninvasively monitors patients' clinical parameters (Thoracic Fluid Index, ECG, Heart Rate, Respiration Rate, Activity, and Posture). It acquires radiofrequency, ECG and accelerometer signals via the patient-worn device; these raw date are transmitted wirelessly to a remote Server for processing into the clinical parameters. The uCor Heart Failure and Arrhythmia Management System is for prescription use only. It is intended for use in outpatient clinic and home settings, with a monitoring period for up to 30 days.
The µCor Heart Failure and Arrhythmia Management System consists of the following components:
- . Sensor - a patient worn device for signal acquisition.
- . Patch – a single use, disposable adhesive piece adhered to the patient's body and allow for Sensor attachment.
- . Charger – the Charger recharges the Sensor and the Gateway. The Sensor typically requires recharging after 5 days. The Gateway typically requires recharging every day.
- Gateway – An off-the-shelf item, the Gateway is essentially a cellphone that relays data and passes commands between the Sensor and the Server.
- Server – Server refers to the hardware and the processing software, and resides in a cyber-secure location. The software analyzes the raw data received from the Sensor and processes the data into clinical values for eventual presentation to the physicians via an independent monitoring center (IDTF) that is regulated under 42 CFR 410.33.
Raw data from the Sensor to the Gateway is transmitted via Bluetooth; the Gateway then transmits this data to the Server via TCP/IP over WiFi or cellular network for data processing and analysis.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
chest wall
Indicated Patient Age Range
21 years of age or older
Intended User / Care Setting
Medical professionals, clinical and home settings.
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
MaTcH Clinical Study:
- Sample Size: 20 hemodialysis patients
- Data Source: Patients wearing the µCor 3.0 and the predicate device ZOE simultaneously.
- Annotation Protocol: Not explicitly stated, but data included readings from both devices and ultra-filtration volume extracted, recorded simultaneously. The study used a non-inferiority design to compare correlation between µCor 3.0 measurements and ultrafiltration volume (UFV) with the correlation between ZOE measurements and UFV.
VIVUS Clinical Study:
- Sample Size: 15 healthy human volunteer subjects
- Data Source: Subjects wore the µCor 3.0 and performed activities (breathing, walking, resting). The ZOLL X-Series (K142915) was used as a comparator device.
- Annotation Protocol: Respiration rates, ECG, Heart Rates, Activity and Postures were collected during these activities.
Respiration Rate Measurement Accuracy:
- Sample Size: Not explicitly stated, but refers to the µCor Heart Failure and Arrhythmia Management System Sensor.
- Data Source: A mechanical fixture simulating respiration movement.
- Annotation Protocol: Accelerometer readings were acquired by the sensor and fed to an algorithm for respiration rate estimation.
Impedance Measurement Accuracy:
- Sample Size: Not explicitly stated, but refers to the µCor Heart Failure and Arrhythmia Management System.
- Data Source: Comparison against a Virtual Network Analyzer (VNA).
- Annotation Protocol: Not explicitly stated, but measured deviation between the µCor Heart Failure and Arrhythmia Management System and the VNA measurement.
Arrhythmia Detection Algorithm:
- Sample Size: Not explicitly stated, but refers to standard ECG databases.
- Data Source: ECG databases required by AAMI/ANSI EC 57:2012.
- Annotation Protocol: The test algorithm generated an attribute file with analysis results, which were then compared to reference results available as part of the database, using comparison applications provided by PhysioNet.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
MaTcH Clinical Study:
- Study Type: Prospective, non-significant risk, randomized, 2-arm study, premarket validation study. Non-inferiority design.
- Sample Size: 20 hemodialysis patients.
- Key Results:
- µCor 3.0 Mean Correlation with UFV: 0.95
- ZOE Mean Correlation with UFV: 0.211
- µCor 3.0 95% CI: [0.92, 0.99]
- The lower confidence interval for the µCor 3.0 (0.92) was greater than the pre-specified acceptance criteria of 0.88 (derived from CoVa's mean correlation of r=0.93 with UFV and a non-inferiority margin of -0.05).
- The study demonstrates that the µCor 3.0 (and by extension the µCor Heart Failure and Arrhythmia Management System) is substantially equivalent to the ZOE (secondary predicate) and CoVa (reference).
VIVUS Clinical Study:
- Study Type: Prospective, non-significant risk, non-randomized, premarket study to validate the capability of the µCor 3.0 to monitor ECG, Heart Rate, Respiration Rate, Posture and Activity.
- Sample Size: 15 healthy human volunteer subjects.
- Key Results:
- RR (metronome-guided) Mean Difference: 0.188 (Acceptance Criteria: ± 2.2 breaths per minute) - Pass
- RR (spontaneous) Mean Difference: -0.481 (Acceptance Criteria: ± 2.2 breaths per minute) - Pass
- HR Mean Difference: -0.474 (Acceptance Criteria: ± 3.16 bpm) - Pass
- Activity (kappa coefficient): 0.9908 (Acceptance Criteria: > 0.9) - Pass
- Posture (kappa coefficient): 0.9908 (Acceptance Criteria: > 0.9) - Pass
- The results show the ability of the µCor 3.0 (and by extension the µCor Heart Failure and Arrhythmia Management System) to collect ECG data, measure Heart Rate and Respiration Rate, and classify Posture and Activity, within the accuracy defined in the endpoints.
Animal Safety Study:
- Study Type: GLP study.
- Sample Size: Porcine model (number not specified).
- Key Results: Demonstrated that the µCor 3.0 is safe through macroscopic and microscopic evaluations of major visceral organs and tissues subjacent to the test devices.
Mechanical Force:
- Study Type: Bench testing.
- Sample Size: Not specified, but involved Sensors and Patches.
- Key Results: Showed no degradation in electrical connection or spring-loaded latch after cycles of insertion and removal.
Respiration Rate Measurement Accuracy:
- Study Type: Bench testing.
- Sample Size: Not specified.
- Key Results:
- Standard Deviation: 0.12 (Acceptance Criteria:
§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).
(a)
Identification. The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.
0
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May 11, 2018
ZOLL Manufacturing Corporation Dawn Chang Sr. Regulatory Affairs Manager 2000 Ringwood Avenue San Jose, California 95131
Re: K172510
Trade/Device Name: uCor Heart Failure and Arrhythmia Management System Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia Detector and Alarm (Including ST-Segment Measurement and Alarm) Regulatory Class: Class II Product Code: MHX, DSI, DSB Dated: April 18, 2018 Received: April 20, 2018
Dear Dawn Chang:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
1
Page 2 - Dawn Chang
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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
M.A. Wilhelm
for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K172510
Device Name
µCor Heart Failure and Arrhythmia Management System
Indications for Use (Describe)
The uCor Heart Failure and Arrhythmia Management System is intended to periodically record, store, and transmit Thoracic Fluid Index. The uCor Heart Failure and Arrhythmia Management System is also intended to continuously record and store, and periodically transmit ECG, Heart Rate, Respiration Rate, Activity and Posture. The data provided will aid medical professionals as they diagnose and identify various clinical conditions, events, and/or trends.
The uCor Heart Failure and Arrhythmia Management System is intended for use in clinical and home settings and is indicated for patients who are 21 years of age or older:
- i) Who require monitoring for the detection of non-lethal cardiac arrhythmias, such as, but not limited to, atrial fibrillation, atrial flutter, ventricular ectopy, and bradyarrhythmias; or
- ii) requiring fluid management.
| 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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5. 510(k) Summary
| 510(k) Owner: | ZOLL Manufacturing Corporation
121 Gamma Drive
Pittsburgh, PA 15238
USA |
|--------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Zachary Nelson
Sr. Regulatory Affairs Engineer
Phone: 412-968-3333 x14814
Fax: 412-592-0953
Email: znelson@zoll.com |
| Date Summary Prepared: | May 11, 2018 |
| Trade Name: | µCor Heart Failure and Arrhythmia Management System |
| Common Name: | Management and Monitoring System |
| Device Classification
Name: | Monitor, Physiological, Patient
(with arrhythmia detection or alarms)
Arrhythmia Detector and Alarm
Plethysmograph, Impedance |
| Product Code: | MHX, DSI, DSB |
| Classification Regulation: | 870.1025, 870.2770 |
| Device Classification: | II |
| Classification Panel: | Circulatory System Devices Panel (74) |
| Predicate Device: | AVIVO Mobile Patient Management System (K113187)
- Primary Predicate
ZOE Fluid Status Monitor (K133301) - Secondary Predicate
(used for the comparison of thoracic impedance measurement only) |
| Reference Device: | CoVa™ Monitoring System (K142087) |
| Comparator Device: | ZOLL X-Series (K142915)
(used in validation testing) |
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Device Description
The µCor Heart Failure and Arrhythmia Management System noninvasively monitors patients' clinical parameters (Thoracic Fluid Index, ECG, Heart Rate, Respiration Rate, Activity, and Posture). It acquires radiofrequency, ECG and accelerometer signals via the patient-worn device; these raw date are transmitted wirelessly to a remote Server for processing into the clinical parameters. The uCor Heart Failure and Arrhythmia Management System is for prescription use only. It is intended for use in outpatient clinic and home settings, with a monitoring period for up to 30 days.
The µCor Heart Failure and Arrhythmia Management System consists of the following components:
- . Sensor - a patient worn device for signal acquisition.
- . Patch – a single use, disposable adhesive piece adhered to the patient's body and allow for Sensor attachment.
- . Charger – the Charger recharges the Sensor and the Gateway. The Sensor typically requires recharging after 5 days. The Gateway typically requires recharging every day.
- Gateway – An off-the-shelf item, the Gateway is essentially a cellphone that relays data and passes commands between the Sensor and the Server.
- Server – Server refers to the hardware and the processing software, and resides in a cyber-secure location. The software analyzes the raw data received from the Sensor and processes the data into clinical values for eventual presentation to the physicians via an independent monitoring center (IDTF) that is regulated under 42 CFR 410.33.
Raw data from the Sensor to the Gateway is transmitted via Bluetooth; the Gateway then transmits this data to the Server via TCP/IP over WiFi or cellular network for data processing and analysis.
Indications for Use Statement
The μCor Heart Failure and Arrhythmia Management System is intended to periodically record, store, and transmit Thoracic Fluid Index. The μCor Heart Failure and Arrhythmia Management System is also intended to continuously record and store, and periodically transmit ECG, Heart Rate, Respiration Rate, Activity and Posture. The data provided will aid medical professionals as they diaqnose and identify various clinical conditions, events, and/or trends.
The µCor Heart Failure and Arrhythmia Management System is intended for use in clinic and home settings and is indicated for patients who are 21 years of age or older:
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- i) Who require monitoring for the detection of non-lethal cardiac arrhythmias, such as, but not limited to, atrial fibrillation, atrial flutter, ventricular ectopy, and bradyarrhythmias; or ii) Requiring fluid management.
Technological Characteristics and Substantial Equivalence Discussion
The μCor Heart Failure and Arrhythmia Management System's technological characteristics are substantially equivalent to those of its predicate devices. All of the devices are noninvasive, prescription use, and indicated for home setting. Same as both predicates, the µCor Heart Failure and Arrhythmia Management System is intended for the monitoring of patient's physiological data, and indicated for patients with fluid management problems. Both the uCor Heart Failure and Arrhythmia Management System and the AVIVO (primary predicate device) use a body-worn sensor to acquire the physiological data of interest, with the Gateway to relay the physiological data, and a remote server to process the data. Both the uCor Heart Failure and Arrhythmia Management System and the AVIVO use a singlelead ECG recorder to obtain ECG signal and to derive Heart Rate. Both the μCor Heart Failure and Arrhythmia Management System and the AVIVO derive data collected by a triaxis accelerometer to derive activity and posture. The μCor Heart Failure and Arrhythmia Management System Respiration Rate is derived from data collected by the tri-axis accelerometer while the AVIVO Respiration Rate is derived from impedance. Both the uCor Heart Failure and Arrhythmia Management System and the AVIVO monitor thoracic fluid based on thoracic impedance measurements. The μCor Heart Failure and Arrhythmia Management System obtains its impedance measurement, i.e. Thoracic Fluid Index, from radiofrequency signal while the AVIVO and the ZOE obtain their impedance measurements using electrical current. The AVIVO's output is called Body Fluid Status and is provided in ohms, while the ZOE's output is Thoracic Impedance (aka Thoracic Z¿), also provided in ohms. The minor differences in technology between the μCor Heart Failure and Arrhythmia Management System and the predicate devices used to measure thoracic fluid index/thoracic impedance and respiration rate do not raise new type of safety and effectiveness questions. These differences have been assessed in bench, preclinical, and clinical testing. Results established that the μCor Heart Failure and Arrhythmia Management System performs as intended and is substantially equivalent to its predicate devices. Table 1 provides a comparison chart between the subject and predicate devices.
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Table 1: Comparison Chart between μCor Heart Failure and Arrhythmia Management System, AVIVO and ZOE
| | µCor Heart Failure
and Arrhythmia
Management
System
(Subject Device) | AVIVO
(Primary
Predicate) | ZOE
(Secondary
Predicate) | Comparison |
|----------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Ambulatory
recording and
monitoring of
physiological
parameters | Ambulatory
recording and
monitoring of
physiological
parameters | Recording and
monitoring of
physiological
parameters in home
and clinical settings | Same |
| Intended Use
Environment | Home, clinic | Home, clinic | Home, clinic | Same |
| Parameters
Monitored | Thoracic Fluid
Index | Body Fluid Status | Thoracic Impedance
(Thoracic Z₀) | Similar
The µCor Heart Failure
and Arrhythmia
Management System
Thoracic Fluid Index is
obtained by comparing
the patient's current
Thoracic Impedance
(T2) to his/her baseline
(T1) and is presented in
index format (T2/T1),
e.g. 1.5. AVIVO Body
Fluid Status and the
ZOE Thoracic Z₀ are
both presented in
ohms and are not
relative to the patient's
baseline.
The µCor Heart Failure
and Arrhythmia
Management System,
the AVIVO and the ZOE
monitor patient's
thoracic fluid by
trending the Thoracic
Impedance
measurements taken
periodically. The µCor
Heart Failure and
Arrhythmia
Management System |
| | µCor Heart Failure
and Arrhythmia
Management
System
(Subject Device) | AVIVO
(Primary
Predicate) | ZOE
(Secondary
Predicate) | Comparison |
| | | | | and the AVIVO are
substantially
equivalent. |
| | ECG | ECG | NA | Same |
| | Heart Rate | Heart Rate
(including HR
variability) | NA | Same. Both µCor Heart
Failure and Arrhythmia
Management System
and AVIVO measure
Heart Rate. |
| | Respiration Rate | Respiration Rate
(including RR
variability) | NA | Same. Both µCor Heart
Failure and Arrhythmia
Management System
and AVIVO measure
Respiration Rate. |
| | Activity | Activity | NA | Same. |
| | Posture | Posture | NA | Same. |
| System
Components | - Sensor
- Patch
- Charger
- Gateway
- Server | - PiiX (aka
Adherent
Device) - zLink (aka
Gateway) - Server | NA | Same.
The µCor Heart Failure
and Arrhythmia
Management System
and AVIVO both have
the following
components serving
the same purpose: (1)
a body-worn sensor to
acquire the
physiological data of
interest; (2) Gateway to
relay the physiological
data; (3) a remote
server to process data. |
| Arrhythmia
Detection | Detect non-lethal
cardiac
arrhythmias, such
as, but not limited
to, atrial
fibrillation, atrial
flutter, ventricular
ectopy, and
bradyarrythmias. | Detect non-lethal
cardiac arrhythmias
such as, but not
limited to,
supraventricular
tachycardias (e.g.
atrial fibrillation,
atrial flutter,
paroxysmal SVTs) | NA | Similar. Testing of the
µCor Heart Failure and
Arrhythmia
Management System
did not include testing
of paroxysmal SVT or
conduction disorders. |
| | µCor Heart Failure
and Arrhythmia
Management
System
(Subject Device) | AVIVO
(Primary
Predicate) | ZOE
(Secondary
Predicate) | Comparison |
| | | bradyarrhythmias
and conductions
disorders | | |
| Date Transmission | - Sensor to
Gateway:
Bluetooth - Gateway to
Server: WiFi or
Cellular | - PiiX to Gateway:
Bluetooth - Gateway to
Server: Cellular | NA | Both µCor Heart Failure
and Arrhythmia
Management System
and AVIVO transmit
data using Bluetooth
technology and a
cellular network. The
µCor Heart Failure and
Arrhythmia
Management System
additionally uses WiFi,
a standard networking
technology covered
under IEEE 802.11. The
Gateway of the µCor
Heart Failure and
Arrhythmia
Management System is
essentially an off-the-
shelf standard
cellphone approved by
FCC and PTCRB and is
certified to work in the
cellular network
licensed frequencies
and designed to co-
exist with other users
of the cellular
frequency band,
ensuring data
transmission.
Additionally, co-
existence testing has
been conducted on the
µCor HFAMS.
Therefore, the µCor
Heart Failure and
Arrhythmia |
| µCor Heart Failure
and Arrhythmia
Management
System
(Subject Device) | AVIVO
(Primary
Predicate) | ZOE
(Secondary
Predicate) | Comparison | |
| | | | Management System is
at least as safe and
effective as the AVIVO. | |
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Performance Data
The µCor Heart Failure and Arrhythmia Management System was evaluated in non-clinical, and clinical testing, which are summarized in Table 2 below.
| Title | Description | ||||||
|---|---|---|---|---|---|---|---|
| MaTcH Clinical Study | This is a prospective, non-significant risk, randomized, 2-arm study, premarket validation study. A non-inferiority design was used to test substantial equivalence between the µCor 3.0 (which uses identical RF technology to monitor thoracic impedance) and the ZOE in the ability to measure thoracic impedance. This was done by comparing the correlation between µCor 3.0 measurements and ultrafiltration volume (UFV) with the correlation between ZOE measurements and UFV. |
In this study, 20 hemodialysis patients were enrolled wearing the µCor 3.0. All patients had the predicate device ZOE applied in the sternum location. During the patient's dialysis session, readings from both the µCor 3.0 and the ZOE, as well as the ultra-filtration volume extracted were recorded simultaneously. The results are summarized below:
µCor 3.0 Mean Correlation ZOE Mean Correlation µCor 3.0 95% CI 0.95 0.211 [0.92, 0.99]
The reference device (CoVa) also measures thoracic impedance in an ambulatory setting. The CoVa device has a mean correlation of r=0.93 with UFV. To test for substantial equivalence, a non-inferiority design was used. Using a non-inferiority margin, δ, or -0.05, the lower confidence interval for the µCor 3.0 is greater than the pre-specified acceptance criteria of 0.093-0.05 = 0.88. Therefore the alternate hypothesis that the µCor 3.0 was non-inferior to CoVa was accepted.
The study demonstrates that the µCor 3.0 (and by extension the µCor Heart Failure and Arrhythmia Management System) is substantially equivalent to the ZOE (secondary predicate) and CoVa (reference). | | | | | | |
Table 2: µCor Heart Failure and Arrhythmia Management System V&V Activities Summary
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| VIVUS Clinical Study | This is a prospective, non-significant risk, non-randomized, premarket study to validate the capability of the µCor 3.0 (which uses identical accelerometers, ECG acquisition circuitry, and algorithms as the µCor Heart Failure and Arrhythmia Management System) to monitor ECG, Heart Rate, Respiration Rate, Posture and Activity. | |||
|---|---|---|---|---|
| In this study, 15 healthy human volunteer subjects wore the µCor 3.0. Each subject was asked to perform the following activities during the study: breathing, walking and resting. Respiration rates, ECG, Heart Rates, Activity and Postures were collected during these activities. For comparison, the ZOLL X-Series (an FDA cleared device under K142915) was used as the comparator device for Respiration Rate, ECG and Heart Rate. Results are summarized below: | ||||
| Parameter | Mean Difference | Acceptance Criteria | Results | |
| RR (metronome-guided) | 0.188 | ± 2.2 breaths per minute | Pass | |
| RR (spontaneous) | -0.481 | ± 2.2 breaths per minute | Pass | |
| HR | -0.474 | ± 3.16 bpm | Pass | |
| Activity | 0.9908 | > 0.9 (kappa coefficient) | Pass | |
| Posture | 0.9908 | > 0.9 (kappa coefficient) | Pass | |
| The results show the ability of the µCor 3.0 (and by extension the µCor Heart Failure and Arrhythmia Management System) to collect ECG data, measure Heart Rate and Respiration Rate, and classify Posture and Activity, within the accuracy defined in the endpoints. | ||||
| Animal Safety Study | This GLP study was conducted to assess adverse effects resulting from the µCor 3.0 (which uses the same Patch and RF technology) following application on the chest wall and activation in the porcine model. Results of the study demonstrate that the µCor 3.0 (and by extension the µCor Heart Failure and Arrhythmia Management System) is safe through macroscopic and microscopic evaluations of the major visceral organs tissues subjacent to the test devices with a RF measurement paradigm equivalent to an average of 42 days. | |||
| Mechanical Force | This bench testing was conducted to validate the ability of the µCor Heart Failure and Arrhythmia Management System Sensor and Patch snap-in mechanism to resist mechanical force anticipated under normal use throughout its expected lifetime. In this testing, the Sensors and Patches went through cycles of insertion and removal. Results showed that there was no degradation in the electrical connection in the Patch wires or in the spring-loaded latch in the Sensor. |
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Image /page/11/Picture/1 description: The image shows the word "ZOLL" in a bold, sans-serif font. The letters are all capitalized and colored in a bright blue. A registered trademark symbol is located to the right of the second "L".
| Respiration Rate Measurement
Accuracy | This bench testing was conducted to verify the accuracy of the µCor Heart
Failure and Arrhythmia Management System respiration rate estimation.
In this testing, the µCor Heart Failure and Arrhythmia Management
System Sensor was attached to a mechanical fixture which simulated the
respiration movement; accelerometer readings were acquired by the
Sensor, and then fed to the algorithm for respiration rate estimation.
Results are summarized below: | | | |
|-------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------|------------------------|---------|
| | | µCor Heart
Failure and
Arrhythmia
Management
System -
reference | Acceptance
Criteria | Results |
| | Standard
Deviation | 0.12 | in vitro cytotoxicity
• ISO 10993-10 3rd Ed (2010) Biological evaluation of medical devices –
Part 10: Tests for irritation and skin sensitization
Results demonstrate that the System Patch meets the biocompatibility
requirements set forth in the standards. |
| Shelf-life Testing | Accelerated aging test was conducted with the System Patch. Data
collected to date supports the claimed shelf life. |
| Shipping & Packaging Testing | Shipping tests were conducted on µCor Heart Failure and Arrhythmia
Management System packaging. The testing followed ASTM D4169-16.
Results demonstrated that the function of µCor Heart Failure and
Arrhythmia Management System is not adversely affected during
transportation. |
| Software | Following FDA guidance document "Guidance for the Content of
Premarket Submissions for Software Contained in Medical Devices,"
issued on May 11, 2005, The following items are included in the 510(k):
• µCor Heart Failure and System Level of Concern
• Software Description
• Device Hazard Analysis
• Software Requirements Specification (SRS)
• Architecture Design Chart
• Software Design Specification (SDS)
• Traceability Analysis
• Software Development Environment Description
• Verification and Validation Documentation
• Revision Level History
• Unresolved Anomalies |
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Image /page/13/Picture/0 description: The image shows the word "ZOLL" in a bold, sans-serif font. The letters are all capitalized and in a bright blue color. A registered trademark symbol is located to the right of the second "L".
Conclusion
The µCor Heart Failure and Arrhythmia Management System has the same intended use and similar technological characteristics as the predicate devices. Any minor differences in the μCor Heart Failure and Arrhythmia Management System as compared to the predicate devices do not raise any new questions of safety or effectiveness. As summarized in the Performance Data section above, non-clinical and clinical tests demonstrate that the μCor Heart Failure and Arrhythmia Management System performs similarly to the legally marketed predicate devices. Test results confirm that the μCor Heart Failure and Arrhythmia Management System is as least as safe and effective as the predicate devices; therefore, the μCor Heart Failure and Arrhythmia Management System is substantially equivalent to its predicate devices.