(263 days)
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.
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.
Here's an analysis of the acceptance criteria and study details for the µCor Heart Failure and Arrhythmia Management System, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria | Reported Device Performance | Study |
|---|---|---|---|
| Thoracic Fluid Index (TFI) | Lower CI for µCor 3.0 > 0.88 (non-inferiority margin) | 0.95 (95% CI: [0.92, 0.99]) | MaTcH Clinical Study |
| Respiration Rate (metronome-guided) | ± 2.2 breaths per minute | Mean Difference: 0.188 | VIVUS Clinical Study |
| Respiration Rate (spontaneous) | ± 2.2 breaths per minute | Mean Difference: -0.481 | VIVUS Clinical Study |
| Heart Rate | ± 3.16 bpm | Mean Difference: -0.474 | VIVUS Clinical Study |
| Activity Classification | > 0.9 (kappa coefficient) | 0.9908 | VIVUS Clinical Study |
| Posture Classification | > 0.9 (kappa coefficient) | 0.9908 | VIVUS Clinical Study |
| Respiration Rate Measurement Accuracy (bench test) | Standard Deviation < 1, Max < 2 | Standard Deviation: 0.12, Max: 0.294 | Respiration Rate Measurement Accuracy test |
| Impedance Measurement Accuracy | ≤ 0.5% deviation | Worst case: 0.4%, Average: 0.02% | Impedance Measurement Accuracy test |
| Arrhythmia Detection and HR Estimation | Meets clinical requirements per AAMI/ANSI EC 57:2012 | Performance meets requirements | Arrhythmia Detection Algorithm test |
2. Sample Sizes and Data Provenance
- MaTcH Clinical Study (Thoracic Fluid Index):
- Sample Size (Test Set): 20 hemodialysis patients.
- Data Provenance: Prospective, non-significant risk, randomized 2-arm study. The country of origin is not explicitly stated, but the context implies it was conducted in a clinical setting related to device development, likely in the US where FDA clearance is sought.
- VIVUS Clinical Study (ECG, Heart Rate, Respiration Rate, Posture, Activity):
- Sample Size (Test Set): 15 healthy human volunteer subjects.
- Data Provenance: Prospective, non-significant risk, non-randomized premarket study. Country of origin not explicitly stated.
- Arrhythmia Detection Algorithm Test:
- Sample Size (Test Set): ECG databases required by the AAMI/ANSI EC 57:2012 standard. The specific number of cases in these databases is not provided in the text.
- Data Provenance: Standardized ECG databases. Retrospective, as these are pre-existing datasets. Country of origin not specified for the databases themselves.
3. Number of Experts and Qualifications for Ground Truth Establishment
- MaTcH Clinical Study (Thoracic Fluid Index): The ground truth for thoracic fluid index was based on ultrafiltration volume (UFV) extracted during dialysis sessions. This is an objective clinical measurement. No explicit mention of human experts defining this ground truth is made, as it's a direct physiological measurement used as a reference.
- VIVUS Clinical Study (ECG, Heart Rate, Respiration Rate, Posture, Activity): The ground truth for Respiration Rate, ECG, and Heart Rate was established using a comparator device, the ZOLL X-Series (FDA cleared device under K142915). For Activity and Posture, it's implied that the ground truth was derived from the performed activities (breathing, walking, resting) and potentially observed positions, but no explicit mention of human experts setting this ground truth is made.
- Arrhythmia Detection Algorithm Test: The ground truth was provided as reference results available as part of the ECG databases (per AAMI/ANSI EC 57:2012). These reference results are typically established by expert cardiologists or technicians, often through meticulous manual annotation and consensus, but the specifics of who and how many experts, along with their qualifications, are not detailed in this document.
4. Adjudication Method for the Test Set
- MaTcH Clinical Study: Not explicitly described. The comparison is between the device's measurement, a predicate device's measurement, and the objective UFV, focusing on correlation. No human adjudication is indicated for interpreting the primary outcome.
- VIVUS Clinical Study: Not explicitly described. The comparison is with a comparator device (ZOLL X-Series) for physiological parameters, and for activity/posture, it's against the performed activities. No human adjudication for interpreting these measurements is indicated.
- Arrhythmia Detection Algorithm Test: The test results were compared to reference results available as part of the database. This implies the ground truth in the reference results was already adjudicated or established with high confidence within those standardized databases. The comparison itself was done using "comparison applications provided by PhysioNet," suggesting an automated comparison against the established ground truth.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No MRMC comparative effectiveness study is described in this document. The studies primarily focus on the standalone performance of the device or its comparison against predicate/reference devices using objective physiological measurements or standardized databases, not on human reader improvement with AI assistance.
6. Standalone (Algorithm Only) Performance Study
- Yes, standalone performance was done for several aspects:
- The Arrhythmia Detection Algorithm was tested in a standalone manner by applying the algorithm to ECG databases and comparing its output to reference results.
- Respiration Rate Measurement Accuracy (bench testing) directly assessed the algorithm's estimation from accelerometer readings against simulated respiration movement.
- Impedance Measurement Accuracy (bench testing) assessed the device's ability to detect impedance change against a Virtual Network Analyzer, focusing on the core measurement capability.
- The VIVUS Clinical Study evaluated the µCor 3.0's capability to monitor ECG, Heart Rate, Respiration Rate, Posture, and Activity, comparing its measurements to a comparator device or observed activities. While it involved human subjects, the assessment was of the device's automated measurement and classification capabilities.
7. Type of Ground Truth Used
- Objective Clinical Measurements:
- Ultrafiltration Volume (UFV) for Thoracic Fluid Index (MaTcH Clinical Study).
- Measurements from an FDA-cleared comparator device (ZOLL X-Series) for Respiration Rate, ECG, and Heart Rate (VIVUS Clinical Study).
- Metronome-guided breathing and spontaneous activities for Respiration Rate, Activity, and Posture (VIVUS Clinical Study).
- Virtual Network Analyzer (VNA) for Impedance Measurement Accuracy (bench test).
- Simulated respiration movement for Respiration Rate Measurement Accuracy (bench test).
- Expert-Established Reference Results from Standardized Databases:
- Reference results from AAMI/ANSI EC 57:2012 compliant ECG databases for Arrhythmia Detection Algorithm and Heart Rate estimation. While not explicitly detailed here, such databases rely on expert annotations.
8. Sample Size for the Training Set
- The document describes validation studies and does not provide specific details on the training set size for the AI algorithms used within the device. This information is typically found in the design and development sections of regulatory submissions, not usually in the summary or performance data presented here.
9. How Ground Truth for Training Set was Established
- Similar to the previous point, the document does not specify how the ground truth for any potential training set was established. The studies listed are primarily for validation of the finalized device/algorithms. If machine learning was used, the training set ground truth would have been established separately, likely through expert annotation of various physiological signals to teach the algorithm patterns for arrhythmia, posture, activity, etc.
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Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue box, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
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);
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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
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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 Corporation121 Gamma DrivePittsburgh, PA 15238USA |
|---|---|
| Contact: | Zachary NelsonSr. Regulatory Affairs EngineerPhone: 412-968-3333 x14814Fax: 412-592-0953Email: 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 ClassificationName: | Monitor, Physiological, Patient(with arrhythmia detection or alarms)Arrhythmia Detector and AlarmPlethysmograph, 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 PredicateZOE 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 Failureand ArrhythmiaManagementSystem(Subject Device) | AVIVO(PrimaryPredicate) | ZOE(SecondaryPredicate) | Comparison | |
|---|---|---|---|---|
| Intended Use | Ambulatoryrecording andmonitoring ofphysiologicalparameters | Ambulatoryrecording andmonitoring ofphysiologicalparameters | Recording andmonitoring ofphysiologicalparameters in homeand clinical settings | Same |
| Intended UseEnvironment | Home, clinic | Home, clinic | Home, clinic | Same |
| ParametersMonitored | Thoracic FluidIndex | Body Fluid Status | Thoracic Impedance(Thoracic Z₀) | SimilarThe µCor Heart Failureand ArrhythmiaManagement SystemThoracic Fluid Index isobtained by comparingthe patient's currentThoracic Impedance(T2) to his/her baseline(T1) and is presented inindex format (T2/T1),e.g. 1.5. AVIVO BodyFluid Status and theZOE Thoracic Z₀ areboth presented inohms and are notrelative to the patient'sbaseline.The µCor Heart Failureand ArrhythmiaManagement System,the AVIVO and the ZOEmonitor patient'sthoracic fluid bytrending the ThoracicImpedancemeasurements takenperiodically. The µCorHeart Failure andArrhythmiaManagement System |
| µCor Heart Failureand ArrhythmiaManagementSystem(Subject Device) | AVIVO(PrimaryPredicate) | ZOE(SecondaryPredicate) | Comparison | |
| and the AVIVO aresubstantiallyequivalent. | ||||
| ECG | ECG | NA | Same | |
| Heart Rate | Heart Rate(including HRvariability) | NA | Same. Both µCor HeartFailure and ArrhythmiaManagement Systemand AVIVO measureHeart Rate. | |
| Respiration Rate | Respiration Rate(including RRvariability) | NA | Same. Both µCor HeartFailure and ArrhythmiaManagement Systemand AVIVO measureRespiration Rate. | |
| Activity | Activity | NA | Same. | |
| Posture | Posture | NA | Same. | |
| SystemComponents | - Sensor- Patch- Charger- Gateway- Server | - PiiX (akaAdherentDevice)- zLink (akaGateway)- Server | NA | Same.The µCor Heart Failureand ArrhythmiaManagement Systemand AVIVO both havethe followingcomponents servingthe same purpose: (1)a body-worn sensor toacquire thephysiological data ofinterest; (2) Gateway torelay the physiologicaldata; (3) a remoteserver to process data. |
| ArrhythmiaDetection | Detect non-lethalcardiacarrhythmias, suchas, but not limitedto, atrialfibrillation, atrialflutter, ventricularectopy, andbradyarrythmias. | Detect non-lethalcardiac arrhythmiassuch as, but notlimited to,supraventriculartachycardias (e.g.atrial fibrillation,atrial flutter,paroxysmal SVTs) | NA | Similar. Testing of theµCor Heart Failure andArrhythmiaManagement Systemdid not include testingof paroxysmal SVT orconduction disorders. |
| µCor Heart Failureand ArrhythmiaManagementSystem(Subject Device) | AVIVO(PrimaryPredicate) | ZOE(SecondaryPredicate) | Comparison | |
| bradyarrhythmiasand conductionsdisorders | ||||
| Date Transmission | - Sensor toGateway:Bluetooth- Gateway toServer: WiFi orCellular | - PiiX to Gateway:Bluetooth- Gateway toServer: Cellular | NA | Both µCor Heart Failureand ArrhythmiaManagement Systemand AVIVO transmitdata using Bluetoothtechnology and acellular network. TheµCor Heart Failure andArrhythmiaManagement Systemadditionally uses WiFi,a standard networkingtechnology coveredunder IEEE 802.11. TheGateway of the µCorHeart Failure andArrhythmiaManagement System isessentially an off-the-shelf standardcellphone approved byFCC and PTCRB and iscertified to work in thecellular networklicensed frequenciesand designed to co-exist with other usersof the cellularfrequency band,ensuring datatransmission.Additionally, co-existence testing hasbeen conducted on theµCor HFAMS.Therefore, the µCorHeart Failure andArrhythmia |
| µCor Heart Failureand ArrhythmiaManagementSystem(Subject Device) | AVIVO(PrimaryPredicate) | ZOE(SecondaryPredicate) | Comparison | |
| Management System isat least as safe andeffective 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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| Respiration Rate MeasurementAccuracy | This bench testing was conducted to verify the accuracy of the µCor HeartFailure and Arrhythmia Management System respiration rate estimation.In this testing, the µCor Heart Failure and Arrhythmia ManagementSystem Sensor was attached to a mechanical fixture which simulated therespiration movement; accelerometer readings were acquired by theSensor, and then fed to the algorithm for respiration rate estimation.Results are summarized below: | |||
|---|---|---|---|---|
| µCor HeartFailure andArrhythmiaManagementSystem -reference | AcceptanceCriteria | Results | ||
| StandardDeviation | 0.12 | < 1 | Pass | |
| Max | 0.294 | < 2 | Pass | |
| Impedance MeasurementAccuracy | This bench testing was conducted to demonstrate the impedancemeasurement accuracy of the µCor Heart Failure and ArrhythmiaManagement System by comparing its ability to detect impedance changeagainst that of a Virtual Network Analyzer (VNA). Results show that theworst case deviation between the µCor Heart Failure and ArrhythmiaManagement System and the VNA measurement is 0.4%, while theaverage deviation between the µCor Heart Failure and ArrhythmiaManagement System and the VNA measurement is 0.02%, meeting theacceptance criteria of ≤ 0.5%. | |||
| Arrhythmia Detection Algorithm | The µCor Heart Failure and Arrhythmia Management System ECG analysissoftware performance was verified by testing to AAMI/ANSI EC 57:2012.Test methodology included applying the algorithm under test to the ECGdatabases required by the standard. The test algorithm was required togenerate an attribute file with the analysis results. Test results werecompared to reference results, which were available as part of thedatabase, using comparison applications provided by PhysioNet. Resultsdemonstrate that the performance of the µCor Heart Failure andArrhythmia Management System ECG analysis software meets the clinicalrequirements for arrhythmia detection and heart rate estimation. | |||
| Basic Safety and EssentialPerformance for MedicalElectrical Equipment | • AAMI/ANSI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 andA2:2010/(R)2012• IEC 60601-1-11 Ed 2.0 2015-01• AAMI/ANSI/IEC 60601-2-47:2012Results demonstrate that µCor Heart Failure and Arrhythmia ManagementSystem meet the safety and performance requirements set forth in thestandards. | |||
| Electromagnetic Compatibility | • AAMI/ANSI/IEC 60601-1-2: 2014 |
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| Results demonstrate that µCor Heart Failure and Arrhythmia ManagementSystem meet the emissions and immunity requirements set forth in thestandard. | |
|---|---|
| Co-existence | Co-existence testing was conducted to validate the data channel telemetryof µCor Heart Failure and Arrhythmia Management System bydemonstrating the performance of the system's data transmission link isnot affected by the signals from other RF wireless technologies typicallyfound in a home setting. Results demonstrate that the µCor Heart Failureand Arrhythmia Management System transmits measured data withoutinterruption, loss or corruption of data in the presence of otherrepresentative RF wireless devices. |
| Biocompatibility (cytotoxicity,irritation, sensitization) | • AAMI/ANSI/ISO 10993-5:2009/(R)2012 Biological evaluation of medicaldevices - Part 5: Tests for in vitro cytotoxicity• ISO 10993-10 3rd Ed (2010) Biological evaluation of medical devices –Part 10: Tests for irritation and skin sensitizationResults demonstrate that the System Patch meets the biocompatibilityrequirements set forth in the standards. |
| Shelf-life Testing | Accelerated aging test was conducted with the System Patch. Datacollected to date supports the claimed shelf life. |
| Shipping & Packaging Testing | Shipping tests were conducted on µCor Heart Failure and ArrhythmiaManagement System packaging. The testing followed ASTM D4169-16.Results demonstrated that the function of µCor Heart Failure andArrhythmia Management System is not adversely affected duringtransportation. |
| Software | Following FDA guidance document "Guidance for the Content ofPremarket 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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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.
§ 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.