(269 days)
No
The summary describes arrhythmia detection algorithms but does not explicitly mention the use of AI or ML. The performance studies compare the algorithm to a predicate device's algorithm, not an AI/ML model.
No
The device is indicated for monitoring and detecting arrhythmias, not for treating any condition.
Yes
The Nuubo System continuously records and stores ECG and activity data for up to 30 days and detects arrhythmias, which are conditions indicative of disease. It processes and analyzes this data to provide information for diagnosis, as evidenced by its use in evaluating symptoms like palpitations, shortness of breath, and syncope, and its comparison to other ECG analysis software.
No
The device description clearly states that the system is composed of three main components: a wearable textile chest-belt with electrodes (Nuubo30), a physical recorder (NuuboREC), and software (Nuubo Leonardo). This indicates the system includes hardware components in addition to software.
Based on the provided information, the Nuubo System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
- Nuubo System Function: The Nuubo System directly records and analyzes electrical signals from the patient's heart (ECG data) through electrodes placed on the skin. It does not analyze specimens taken from the body.
- Intended Use: The intended use describes the device's purpose as continuously recording and storing ECG and activity data to detect arrhythmias. This is a physiological measurement and analysis, not an in vitro test.
Therefore, the Nuubo System falls under the category of a medical device that performs physiological monitoring and analysis, rather than an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Nuubo System is indicated for use on 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 Nuubo system continuously records and stores ECG and activity data for up to 30 days at a time. The Nuubo System detects arrhythmias at the end of the monitoring period upon download of the ECG data. The Nuubo System is Rx use device.
Product codes
DSH, DQK
Device Description
The Nuubo System, developed by Smart Solutions Technologies (SST), is a wearable device designed for ambulatory recording electrocardiogram (ECG) up to 30 days. The system is composed of 3 main components:
- Nuubo30 – The Nuubo30 wearable is a single patient textile like a chest-belt that contains 4 textile electrodes in the inner side that are used for sensing patient 's ECG. The patient places the inner side of the textile in direct contact to the skin in the chest region, and an electroconductive media is placed in between the electrodes and the skin to sense the patient's ECG. The textile has an electrical and mechanical snap connector to plug the Recorder.
- NuuboREC - The Nuubo recorder is a small, lightweight device that records ECG continuously. The device records 2 Leads of ECG data up to 30 days. The device also records data from a 3-axis accelerometer located inside the device. The patient can activate the button while wearing the product to mark a symptom. To start and stop the recording the user will press the on/off button. The data is stored into a micro SD memory card.
- Nuubo Leonardo - The Leonardo Software is installed on a computer where the patient´s ECG data stored in the recorder will be downloaded for subsequent analysis and report. The Leonardo software also prepares the recorder for new patients, enabling the user to erase the data from previous patients and synchronizing time and data.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Chest region
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Clinician or trained technician in the Clinician's office; patient and caregiver.
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
The Nuubo Arrhythmia detection algorithm was tested per requirements of AAMI/IEC60601-2-47. To validate the arrhythmia detection algorithms were used three public databases and one private database. The public databases were MIT-BIH, AHA and MITAF. The Private Database comprised of 90 ECG registries of 58 patients. Registries were selected to contain all the arrhythmias detected by our algorithm. All the data used from the study was anonymized, keeping only the ECG raw data recorded on the device, age and sex of the patient. The database was annotated using experienced medical professionals, using prospectively defined guidelines, consistent with US medical practice.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Preclinical software/algorithm testing, biocompatibility, shipping/packaging and usability study results validate Nuubo System towards its proposed intended use, and supports substantial equivalence to the predicate.
The Nuubo Arrhythmia detection algorithm was tested per requirements of AAMI/IEC60601-2-47 using three public databases (MIT-BIH, AHA, MITAF) and one private database (90 ECG registries from 58 patients). The private database was anonymized and annotated by experienced medical professionals. The results obtained validate the Nuubo Arrhythmia Algorithms and prove equivalence to Monebo Automated ECG Analysis And Interpretation Software Library, version 3.0 (K062282). All results are comparable to the results claimed by Monebo.
Summative usability testing was completed, demonstrating that 98.4% participants did not encounter any difficulties associated with a risk for potential of serious harm (critical tasks). The results show that the Nuubo System can be used by the patient, caregiver and healthcare professional per the labeled instructions for use.
Nuubo30 was tested to the ISO10993 standards, including cytotoxicity, irritation, sensitization and material characterization per ISO 10993-18.
The Transport Simulation test according to ASTM D 4169 DC 13 of
- Nuubo shipping box, containing products Nuubo30, NuuboREC and Nuubo (i) Leonardo
- of a shipping bag containing the Nuubo Patient box (ii)
and subsequent visual inspection (ASTM F 1886/F 1886M: Standard Test Method for Determining Integrity of Seals for Flexible Packaging by Visual Inspection; 2016) were successfully completed.
The Nuubo System was subject to, and successfully completed the EMI/EMC/Electrical safety test requirements per IEC60601.
The Nuubo system was also subject to the following preclinical tests: - System safety testing
- Software verification and validation
- ECG Performance testing
- Wireless transmission data quality and wireless coexistence testing
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
ZioPatch (K143513)
Reference Device(s)
Monebo (K062282), my Patch sl (K163535), Cardiobelt (K063044), Accuheart (K043361), Preventice (K151188)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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).
0
Image /page/0/Picture/0 description: The image contains the logos of the U.S. Department of Health & Human Services and the U.S. Food & 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 is a blue square with the letters "FDA" in white, followed by the words "U.S. Food & Drug Administration" in blue.
August 3, 2018
Smart Solutions Technologies SL % Nandini Murthy Regulatory Consultant ENEM Consulting, LLC 556 Lowell Street Lexington, Massachusetts 02420
Re: K173461
Trade/Device Name: Nuubo System Regulation Number: 21 CFR 870.2800 Regulation Name: Medical magnetic tape recorder Regulatory Class: Class II Product Code: DSH, DQK Dated: July 31, 2018 Received: August 1, 2018
Dear Nandini Murthy:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
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. Hillemann
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
510(k) Number (if known)
K173461
Device Name
Nuubo System™
Indications for Use (Describe)
The Nuubo System is indicated for use on 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 Nuubo system continuously records and stores ECG and activity data for up to 30 days at a time. The Nuubo System detects arrhythmias at the end of the monitoring period upon download of the ECG data. The Nuubo System is Rx use device
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D) Subpart C)
□ Over-The-Counter Use (21 CFR 801
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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3
Traditional 510(k) Premarket Notification Submission – Nuubo System
SECTION 5
510(k) SUMMARY - K173461
| Submitter Name: | Smart Solutions Technologies SL |
|---|---|
| Submitter Address: | Calle Toronga 21, Local 1, Madrid 28015, Spain |
| Contact Person: | Daniel Llorca |
| Phone Number: | (+34) 609 882 563 |
| Submission Correspondent: | Nandini Murthy |
| Phone Number: | (781) 710-5378 |
| Date Prepared: | August 3, 2018 |
| Device Trade Name: | Nuubo System |
| Device Common Name: | ECG Recorder, Arrhythmia Detection |
| Classification Name: | Medical Magnetic Tape Recorder |
| Classification regulation: | 21 CFR 870.2800, Product Code DSH, DQK |
| Predicate Device: | ZioPatch (K143513) |
| Reference devices: | Monebo (K062282) |
| my Patch sl (K163535) | |
| Cardiobelt (K063044) | |
| Accuheart (K043361) | |
| Preventice (K151188) | |
| Classification Name: | Medical Magnetic Tape Recorder |
| Classification regulation: | 21 CFR 870.2800, Product Code DSH, DQK |
Device Description:
The Nuubo System, developed by Smart Solutions Technologies (SST), is a wearable device designed for ambulatory recording electrocardiogram (ECG) up to 30 days. The system is composed of 3 main components:
- . Nuubo30 – The Nuubo30 wearable is a single patient textile like a chest-belt that contains 4 textile electrodes in the inner side that are used for sensing patient 's ECG. The patient places the inner side of the textile in direct contact to the skin in
4
Traditional 510(k) Premarket Notification Submission – Nuubo System
the chest region, and an electroconductive media is placed in between the electrodes and the skin to sense the patient's ECG. The textile has an electrical and mechanical snap connector to plug the Recorder.
- NuuboREC - The Nuubo recorder is a small, lightweight device that records ECG continuously. The device records 2 Leads of ECG data up to 30 days. The device also records data from a 3-axis accelerometer located inside the device. The patient can activate the button while wearing the product to mark a symptom. To start and stop the recording the user will press the on/off button. The data is stored into a micro SD memory card.
- . Nuubo Leonardo - The Leonardo Software is installed on a computer where the patient´s ECG data stored in the recorder will be downloaded for subsequent analysis and report. The Leonardo software also prepares the recorder for new patients, enabling the user to erase the data from previous patients and synchronizing time and data.
Indications for Use:
The Nuubo System is indicated for use on 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 Nuubo system continuously records and stores ECG and activity data for up to 30 days at a time. The Nuubo System detects arrhythmias at the end of the monitoring period upon download of the ECG data. The Nuubo System is Rx use device.
Rationale for Substantial Equivalence:
The table below is a comparison of the Indications for use of the Nuubo against the predicate device.
5
Traditional 510(k) Premarket Notification Submission – Nuubo System
| Indications | Nuubo
K173461 | ZioPatch
K143513 |
|------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for
use | The Nuubo System is indicated
for use on patients who may be
asymptomatic or who may suffer
from transient symptoms such as
palpitations, shortness of breath,
dizziness, light-headedness, pre-
syncope, syncope, fatigue, or
anxiety.
The Nuubo system continuously
records and stores ECG and
activity data for upto 30 days at
a time. The Nuubo System
detects arrhythmias at the end of
the monitoring period upon
download of the ECG data.
The Nuubo System is a Rx use
device. | Prescription-only, single-patient-use,
continuously recording ECG monitor that
can be worn up to 14 days. It is indicated
for use on patients who may be
asymptomatic or who may suffer from
transient symptoms such as palpitations,
shortness of breath, dizziness, light-
headedness, pre-syncope,
syncope, fatigue, or anxiety. |
Substantial Equivalence Comparison: Indications for use
Substantial Equivalence: Indications for use
The Indications for Use is the same as the predicate device.
Indications for Use Comparison:
Nuubo and the predicate device are both prescription devices, intended for use in recording ECG in the ambulatory environment. The Nuubo includes a proprietary algorithm (Leonardo) that can be used to download and analyze for arrhythmias following the recording. This application is similar to the ZioPatch (K143513), which has a similar post-recording ECG analysis feature. The workflow of the Nuubo intended use and system features is equivalent to that of the predicate, in that both systems include a sensor, a recorder that are used to record ECG signals in the ambulatory environment. At the end of the monitoring period, the recorded data is analyzed via a proprietary arrhythmia detection algorithm. In the case of the ZIO, a technician reviews it before it goes to a Clinician for review/editing/reporting. In the case of the Nuubo system, the recorded data is analyzed via the Leonardo in the Clinician's office by the QHP (there is no interim technician review service), then a Clinician or trained technician should review the events detected prior to generating a report. The two systems are substantially equivalent by indications for use, workflow/intended use and technology/components.
6
Traditional 510(k) Premarket Notification Submission – Nuubo System
Substantial Equivalence: Technology
| Characteristics | Nuubo | ZioPatch |
|---|---|---|
| Product Code | DQK, DSH | DXH, DQK, DSH |
| Number of leads | Two leads | One lead |
| Monitor Multiple | ||
| Parameters | Yes (ECG and motion) | Yes (ECG, HR) |
| Event detection | Patient triggered, during 30 day | |
| use | Patient triggered, during14 day | |
| use | ||
| Data | ||
| Transmission | Bluetooth only to verify | |
| connection (onboarding) | ||
| Data transmission at the end of | ||
| the monitoring period | Data transmission at the end of | |
| the monitoring period | ||
| Arrhythmia | ||
| detection | Yes, at end of monitoring period | Yes, at end of monitoring period |
Comparison of Nuubo Features to Predicate Device
The Nuubo and the predicate device:
- Include an ECG recording feature
- Monitor multiple parameters
- Include 1-2 leads
- Allow patients to record events
- Are used in the ambulatory environment for ECG recording
- Store recorded parameters on the local hardware (recorder) ●
- Include proprietary arrhythmia detection capability in a standalone software package
Differences:
The Nuubo has minor differences from the predicate.
The Nuubo System is intended for use up to 30 days, while the ZIO monitors for up to 14 days. Further the Nuubo monitors for motion (ZIO monitors for HR) and has 2 leads (versus one lead for ZIO). However, there are other cardiovascular ECG monitors that are used in the same intended use environment and include the same features as Nuubo system.
7
Traditional 510(k) Premarket Notification Submission – Nuubo System
Reference device Preventice (K151188) includes features like monitoring up to 30 days, monitoring for motion, has two leads, requires that the patient charge the device every 12 hours and that electrodes be replaced every 3 days. Note that the intended use of the Preventice is also ECG monitoring with arrhythmia detection.
Another difference between the Nuubo and the predicate devices is the battery used to power the device. Nuubo uses a rechargeable Lithium ion polymer battery using a micro-USB plug to connect the power adapter, instead the predicate devices use a non rechargeable battery. Ziopatch uses a 2 connected disposable batteries of 3V 225 mAh. However there is another cardiac monitor reference device (my Patch sl, K163535) with similar feature of using a micro-USB to charge the battery.
Another difference between the Nuubo and the predicate devices is the form factor of the ECG electrodes/leads as worn on the body. However, there are other cardiac monitoring reference devices with similar features. Both the Cardiobelt (K063044) and Accuheart (K043361) have electrodes in a wearable belt.
Performance Data:
Preclinical software/algorithm testing, biocompatibility, shipping/packaging and usability study results validate Nuubo System towards its proposed intended use, and supports substantial equivalence to the predicate.
The following are the referenced standards during design and development of Nuubo:
- · ISO 15223-1:2016, Medical devices Symbols to be used with medical device labels, labeling and information to be supplied
- · ISO 14971:2007, Medical Devices Risk Management Part 1: Application of Risk Analysis to Medical Devices
- · IEC 62304:2006, Medical Device Software Software Life Cycle Process
- ANSI/AAMI EC12 "Disposable ECG Electrodes" ●
- ANSI/AAMI/ISO 10993-1 "Biological evaluation of medical devices -- Part 1: Evaluation and testing"
- IEC 62366-1:2015, titled Medical devices Part 1: Application of usability . engineering to medical devices, published by the International Electrotechnical Commission.
- AAMI HE 75:2009, titled Human Factors Engineering Design of Medical Devices, . Section 9 - Usability Testing, published by the Association for the Advancement of Medical Instrumentation.
- · IEC 60601-1-2 4th edition Medical Electrical Equipment -- Part 1: General Requirements for Safety; Electromagnetic Compatibility -- Requirements and Tests.
8
Traditional 510(k) Premarket Notification Submission – Nuubo System
- · Recognition Number 19-4: AAMI / ANSI ES60601-1:2005/(R)2012 and A1:2012, c1:2009/(r)2012 and a2:2010/(r)2012 (consolidated text) medical electrical equipment - part 1: general requirements for basic safety and essential performance (IEC 60601-1:2005, mod). (General II (ES/EMC))
- . IEC 60601-1-11: 2015 Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
- . ANSI/ AAMI/ IEC 60601-2-47: 2012 Medical Electrical Equipment -- Part 2-47: Particular requirements for the basic safety and essential performance of ambulatory electrocardiographic systems
- IEC 60601-1:2012 (Edition 3.1): Test of defibrillation protection .
Nuubo30 was tested to the ISO10993 standards, including cytotoxicity, irritation, sensitization and material characterization per ISO 10993-18.
The Transport Simulation test according to ASTM D 4169 DC 13 of
- Nuubo shipping box, containing products Nuubo30, NuuboREC and Nuubo (i) Leonardo
- of a shipping bag containing the Nuubo Patient box (ii)
and subsequent visual inspection (ASTM F 1886/F 1886M: Standard Test Method for Determining Integrity of Seals for Flexible Packaging by Visual Inspection; 2016) were successfully completed.
The Nuubo System was subject to, and successfully completed the EMI/EMC/Electrical safety test requirements per IEC60601. Although Nuubo System labeling contraindicates use during cardiac defibrillation. In a likely emergency situation, if a responder attempts to defibrillate a patient without removing the Nuubo System, the Nuubo System design mitigates potential thermal risk.
The Nuubo system was also subject to the following preclinical tests:
- . System safety testing
- 0 Software verification and validation
- ECG Performance testing ●
- Wireless transmission data quality and wireless coexistence testing ●
Summative usability testing was completed, demonstrating that 98.4% participants did not encounter any difficulties associated with a risk for potential of serious harm (critical tasks). The results show that the Nuubo System can be used by the patient, caregiver and healthcare professional per the labeled instructions for use.
The Nuubo Arrhythmia detection algorithm was tested per requirements of AAMI/IEC60601-2-47. To validate the arrhythmia detection algorithms were used three public databases and one private database. The public databases were MIT-BIH, AHA and MITAF. The Private Database comprised of 90 ECG registries of 58 patients.
9
Traditional 510(k) Premarket Notification Submission – Nuubo System
Registries were selected to contain all the arrhythmias detected by our algorithm. All the data used from the study was anonymized, keeping only the ECG raw data recorded on the device, age and sex of the patient. The database was annotated using experienced medical professionals, using prospectively defined guidelines, consistent with US medical practice.
| Algorithm functionality | Detection criteria |
|---|---|
| Beat detection | Nuubo Arrhythmia Algorithm beat detector relies on the |
| amplitude of the signal. It is a modified Tompkins detector that | |
| has an adaptive threshold of beat detection above 0.2mV, | |
| which is the minimum value to detect a beat. | |
| Heart rate measurement | Heart rate is calculated by averaging the RR of the beats |
| contained in non-overlapped windows of 10 seconds. | |
| Normal beats classification | A beat with a morphology similar to the predominant normal |
| morphologic family or contained in it that is considered to be | |
| not premature. | |
| Supraventricular beats | |
| classification | A beat with a morphology similar to the predominant normal |
| morphologic family, or contained in it that is considered to be | |
| premature. Prematurity is defined as having a RR interval 80% | |
| shorter than the RR average of the 4 preceding beats. | |
| Ventricular beats classification | A beat with morphology different than the predominant normal |
| morphologic family that fits with ventricular criteria of width, | |
| premature ratio or dissimilarity. | |
| Atrial Fibrillation | Irregular rhythm longer than 30 seconds |
| Isolated Ventricular beat | One Ventricular beat [V] isolated surrounded by non-ventricular |
| beats not contained in a bigeminy or trigeminy sequence. | |
| Ventricular Pair | Two consecutive Ventricular beats [VV] surrounded by non- |
| ventricular beats. | |
| Ventricular Run | Three or more consecutive Ventricular beats [VVV]. |
| Ventricular Bigeminy | At least one sequence of [Ventricular / Normal or Non |
| Classified / Ventricular] beats [VNV]. | |
| Ventricular Trigeminy | At least one sequence of [Ventricular / Normal or Non- |
| Classified / Normal or Non-Classified / Ventricular] beats | |
| [VNNV]. | |
| Algorithm functionality | Detection criteria |
| Isolated Supraventricular beat | One Supraventricular beat [S] isolated surrounded by non- |
| supraventricular beats. | |
| Supraventricular Pair | Two consecutive Supraventricular beats [SS] surrounded by |
| non-supraventricular beats. | |
| Supraventricular Run | Three or more consecutive Supraventricular beats [SSS]. |
| Pauses | A RR Interval longer than 2000ms. |
| Tachycardia | A rhythm faster than 100 bpm longer than 10 beats of any type. |
| Bradycardia | A rhythm slower than 50 bpm longer than 10 seconds with |
| beats of any type. |
The next list shows the arrhythmias detected by the Nuubo arrhythmia algorithms.
10
Traditional 510(k) Premarket Notification Submission – Nuubo System
The results obtained validate the Nuubo Arrhythmia Algorithms and prove equivalence to Monebo Automated ECG Analysis And Interpretation Software Library, version 3.0 [manufacturer Monebo Technologies, 510(k) number K062282]. The predicate ZioPatch 510(k) K091075 referenced the Monebo for purposes of comparison, therefore, the Monebo was chosen for this arrhythmia performance. All results are comparable to the results claimed by Monebo.
The Nuubo Arrhythmia Detection Algorithm is not intended to replace the Clinician review of signals. The software menu prompts the Clinician or trained technician to review events prior to generating a report
Conclusion:
Nuubo System has similar indications statements as the predicate device. Both devices are used for ECG monitoring by patients in the ambulatory environment.
Preclinical software/algorithm testing, biocompatibility, shipping/packaging, usability, EMI/EMC/Electrical safety and ECG electrode test results validate Nuubo System towards its proposed intended use. These above-referenced study results, along with a comparison of the indications for use and technological features between the Nuubo and the predicate device, supports a finding of substantial equivalence. Based on arrhythmia validation testing and the AAMI/ IEC 60601-2-47 report, the arrhythmia detection algorithm used by the Nuubo Leonardo software application complies with the standard requirements as well as the performance requirements established for it.
Therefore, Nuubo System is substantially equivalent to the predicate device.