(60 days)
The Nuubo Smart 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, fatigue, or anxiety. The Nuubo Smart continuously records and stores ECG and activity data for up to 30 days at a time. The Nuubo Smart detects arrhythmias at the end of each monitoring day upon download of the ECG data. The Nuubo Smart is Rx use device.
Nuubo Smart is composed of the following main components:
Nuubo30 (wearable) - The Nuubo30 is the wearable box that contains one Nuubo30 textile unit, ECG conductive cream, patient instructions and washing bag. Each textile can be used for 30 days.
NuuboREC (recorder). 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 Dock - The Nuubo Dock is the element for downloading the data from the NuuboREC and uploads that data to the Nuubo Cloud. It consists of a plastic stand with a smartphone attached to it and a microUSB port where the NuuboREC is connected for recharge and data download. The smartphone is a single-purpose device that is intended to be always connected to the dock. The dock is intended to be connected to an outlet in the patient's home with the charger provided. The dock allows to charge the NuuboREC device, and during this charging, it downloads the data from the NuuboREC device into the smartphone. The smartphone is software restricted and can only run the Nuubo Dock App that transmits and receives data from the Nuubo Cloud.
Leonardo Smart - Is used for downloading, analysis, visualization and report of the ECG-data stored by the recorder device and for managing the recorder device. The new version Leonardo Smart allows a clinical professional previously authenticated in the platform, to download and review signals recorded by the NuuboREC device which have been uploaded using Nuubo Dock.
Here's a breakdown of the acceptance criteria and study information for the Nuubo Smart device, based on the provided text:
1. Acceptance Criteria and Reported Device Performance
The document primarily focuses on demonstrating substantial equivalence to predicate devices and compliance with harmonized standards. Direct, quantifiable acceptance criteria for arrhythmia detection performance are not explicitly stated for the new Nuubo Smart device in a separate table, but the performance of its underlying algorithm (inherited from Nuubo System K173461) is provided:
| Acceptance Criteria Category | Specific Criteria (from referenced standards/previous device) | Reported Device Performance (Nuubo Smart, or its inherited algorithm) |
|---|---|---|
| Arrhythmia Detection (QRS) | QRS Sensitivity and QRS Positive Predictivity per IEC60601-2-47. | Over 99% QRS Sensitivity and QRS Positive Predictivity against the MIT-BIH database. Over 97% QRS Sensitivity and QRS Positive Predictivity against the AHA database. |
| Software | Met all requirements (Unit Testing, System Verification and Validation Testing). | Passed all Unit Testing and System Verification and Validation Testing. |
| Biocompatibility | Compliance with ISO10993 standards (cytotoxicity, irritation, sensitization, material characterization per ISO 10993-18), as demonstrated for Nuubo System (K173461). | The Nuubo Smart uses the same textile belt technology as Nuubo System (K173461), which was previously shown to comply with these standards. |
| EMI/EMC/Electrical Safety | Compliance with IEC60601 requirements. | Successfully completed the EMI/EMC/Electrical safety test requirements per IEC60601. |
| Bench Studies (Wearable/Recorder) | Met all requirements (design input), including battery performance for up to 30 days of use. | Verification and validation testing for wearable and recorder confirmed it met all requirements, including battery performance for the proposed up to 30 days of use. |
| Shipping and Packaging | Successful completion of Transport Simulation tests (ASTM D 7386 TS-4, ASTM D 4169 DC 13) and visual inspection (ASTM F 1886/F 1886M). | The Transport Simulation test according to ASTM D 7386 TS-4 of Nuubo Smart box, the Transport Simulation test according to ASTM D 4169 DC 13 of 4 Nuubo Smart units and subsequent visual inspection (ASTM F 1886/F 1886M) were successfully completed. |
| Usability | Summative usability testing demonstrating patients and caregivers did not encounter difficulties associated with a risk for potential of serious harm (critical tasks). | Summative usability testing was completed demonstrating that patients and caregivers did not encounter any difficulties associated with a risk for potential of serious harm (critical tasks). |
2. Sample Size Used for the Test Set and Data Provenance
The document mentions that the Nuubo Leonardo Arrhythmia detection algorithm (same as Nuubo System K173461) was tested against standard databases:
- MIT-BIH database: A widely recognized standard for arrhythmia analysis.
- AHA database: Another standard for arrhythmia analysis.
The exact sample sizes (number of recordings or patients) from these databases used for testing are not explicitly stated in this document. These databases are generally retrospective collections of ECG data. The country of origin of the data is not specified for these public databases, but they are international benchmarks.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not provide information on the number of experts or their qualifications used to establish the ground truth for the MIT-BIH and AHA databases. These databases typically have expert-annotated ground truth established by cardiologists or electrophysiologists as part of their creation.
4. Adjudication Method for the Test Set
The document does not specify the adjudication method (e.g., 2+1, 3+1) used for the ground truth in the MIT-BIH and AHA databases. This information is usually part of the detailed documentation for those databases.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with AI assistance vs. without AI assistance was not mentioned or described in the provided text. The evaluation focused on the standalone performance of the algorithm against standard ECG databases.
6. Standalone (Algorithm Only) Performance
Yes, a standalone (algorithm only without human-in-the-loop performance) evaluation was done for the arrhythmia detection algorithm. As stated: "The Nuubo Leonardo Arrhythmia detection algorithm (same as Nuubo System K173461) was tested per requirements of IEC60601-2-47, and showed a QRS Sensitivity and QRS Positive predictivity of over 99% against the MIT-BIH database, and over 97% against the AHA database."
7. Type of Ground Truth Used
The ground truth used for the standalone algorithm testing was based on expert-annotated arrhythmias within the MIT-BIH and AHA databases. These are widely used standard databases with established annotations.
8. Sample Size for the Training Set
The document does not provide information on the sample size used for the training set of the Nuubo Leonardo Arrhythmia detection algorithm.
9. How the Ground Truth for the Training Set Was Established
The document does not provide information on how the ground truth for the training set was established. It only discusses the testing of the algorithm against public databases.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text.
August 1, 2023
Smart Solutions Technologies SL % Nandini Murthy Regulatory Consultant ENEM Consulting LLC 556 Lowell Street Lexington, Massachusetts 02420
Re: K231620
Trade/Device Name: Nuubo Smart Regulation Number: 21 CFR 870.2800 Regulation Name: Medical Magnetic Tape Recorder Regulatory Class: Class II Product Code: DSH, DOK, DXH Dated: May 31, 2023 Received: June 2, 2023
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.
{1}------------------------------------------------
ce determination does not mean that FDA
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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Shruti N. Mistry -S
for
Jennifer Shih Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
Indications for Use
510(k) Number (if known) K231620
Device Name Nuubo Smart
Indications for Use (Describe)
The Nuubo Smart 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, fatigue, or anxiety. The Nuubo Smart continuously records and stores ECG and activity data for up to 30 days at a time. The Nuubo Smart detects arrhythmias at the end of each monitoring day upon download of the ECG data. The Nuubo Smart is Rx use device.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
510(k) SUMMARY
| Submitter Name: | Smart Solutions Technologies SL |
|---|---|
| Submitter Address: | Paseo de la Castellena 200MadridMadrid 28046ES |
| Company ContactPerson: | Borja Gonzalvez |
| Company contact Ph: | (+34) 961 344 497 |
| SubmissionCorrespondent: | Nandini Murthy |
| Date Prepared: | 31 May 2023 |
| Device Trade Name: | Nuubo Smart |
| Device Common Name: | ECG and arrhythmia detection monitor |
| Classification code, name: | 21 CFR 870.2800, Code DSH, Recorder, Magnetic Tape,Medical21 CFR 870.1425, Code DQK, Computer, Diagnostic,Programmable21 CFR 870.2800, Code DXH |
| Predicate Devices: | Nuubo System K173461SEEQTM System K133701 |
| Reference Devices: | Bodyguardian System K121197Stealth System S300 K162503MoMe Kardia Wireless Ambulatory ECG Monitoring AndDetection System K160064 |
| Intended use: | The Nuubo Smart developed by Smart SolutionsTechnologies S.L. (SST), is a wearable device designed forambulatory recording and transmitting electrocardiogram(ECG) up to 30 days. The intended use is identical to thepredicate Nuubo system. |
| Device Description: | Nuubo Smart is composed of the following maincomponents: |
{4}------------------------------------------------
Nuubo30 (wearable) - The Nuubo30 is the wearable box that contains one Nuubo30 textile unit, ECG conductive cream, patient instructions and washing bag. Each textile can be used for 30 days.
NuuboREC (recorder). 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 Dock - The Nuubo Dock is the element for downloading the data from the NuuboREC and uploads that data to the Nuubo Cloud. It consists of a plastic stand with a smartphone attached to it and a microUSB port where the NuuboREC is connected for recharge and data download. The smartphone is a single-purpose device that is intended to be always connected to the dock. The dock is intended to be connected to an outlet in the patient's home with the charger provided. The dock allows to charge the NuuboREC device, and during this charging, it downloads the data from the NuuboREC device into the smartphone. The smartphone is software restricted and can only run the Nuubo Dock App that transmits and receives data from the Nuubo Cloud.
Leonardo Smart - Is used for downloading, analysis, visualization and report of the ECG-data stored by the recorder device and for managing the recorder device. The new version Leonardo Smart allows a clinical professional previously authenticated in the platform, to download and review signals recorded by the NuuboREC device which have been uploaded using Nuubo Dock.
- Indications for Use: The Nuubo Smart 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 Smart continuously records and stores ECG and activity data for up to 30 days at a time. The Nuubo Smart detects arrhythmias at the end of each
{5}------------------------------------------------
monitoring day upon download of the ECG data. The Nuubo Smart is Rx use device.
Rationale for Substantial Equivalence:
| Indications | Nuubo Smart | Nuubo SystemK173461 | SEEQTM SystemK133701 |
|---|---|---|---|
| Indicationsfor use | The Nuubo Smart isindicated for use onpatients who may beasymptomatic or whomay suffer from transientsymptoms such aspalpitations, shortness ofbreath, dizziness, light-headedness, pre-syncope,syncope, fatigue, oranxiety.The NuuboSmart continuouslyrecords and stores ECGand activity data for upto 30 days at a time. TheNuubo Smart detectsarrhythmias at the end ofeach monitoringday upon download ofthe ECG data. TheNuubo Smart is Rx usedevice | The Nuubo System isindicated for use onpatients who may beasymptomatic or whomay suffer fromtransient symptomssuch as palpitations,shortness of breath,dizziness, light-headedness, pre-syncope, syncope,fatigue, or anxiety.The Nuubo systemcontinuously recordsand stores ECG andactivity data for upto30 days at a time. TheNuubo System detectsarrhythmias at the endof the monitoringperiod upon downloadof the ECG data.The Nuubo System isa Rx use device. | The NUVANT(SEEQ) System isintended tocontinuously measure,record andperiodically transmitphysiological data.The System isindicated for thosepatients who requiremonitoring for thedetection of non-lethal cardiacarrhythmias such as,but not limited to,supraventriculartachycardias (e.g.atria] fibrillation,atrial flutter,paroxysmal SVTs),ventricular ectopy,bradyarrhythmias andconduction disorders.The NUVANTSystem monitors,derives and displays:* ECG* Heart Rate |
Substantial Equivalence Comparison: Indications for use
The Indications for Use statement for the Nuubo Smart differs slightly from that of the primary predicate device to address automatically detected events daily and not at the end of the monitoring; however, these differences do not alter the intended use of the device. Collectively, the subject device has the same intended use in cardiac arrhythmia diagnostics as the two predicate devices.
{6}------------------------------------------------
The Indications for Use statement for the Nuubo Smart differs slightly from the secondary predicate device (SEEQ). Both systems are indicated for the same population and detection of non-lethal cardiac arrhythmias, but the indications of use of Nuubo Smart are stated in terms of symptoms referred by the patient instead of arrhythmias detected. The SEEO System refers in the manual that, based on the indications, the system could be used in "patients with symptoms such as chest pain, syncope, lightheadedness or near syncope, vertigo, dizziness, fall, palpitations, transient ischemic episodes, and dyspnea (shortness of breath) that might be due to cardiac arrhythmias", which are nearly the same as Nuubo Smart. The type of arrhythmias detected are the same in both systems.
Differences in the proposed Indications for Use statement does not affect the safety and effectiveness profile of the subject device relative to the predicate devices. Therefore, the subject device can be considered substantially equivalent to the predicate devices.
Substantial Equivalence: Technology
| Characteristics | Nuubo Smart | Nuubo System(primary)K173461 | NuuboSmart vsNuuboSystemComparison | SEEQ™SystemK133701 | NuuboSmart vsSEEQSystemComparison |
|---|---|---|---|---|---|
| Product Code | DSH, DQK, DXH | DSH, DQK | Similar | DSI | Similar |
| Number of leads | Two leads | Two leads | Same | One lead | Similar.NuuboSmart hasone moreECG lead |
| Parameters | ECG and motion | ECG andmotion | Same | ECG | Similar |
| Event detection | Patienttriggered orautomatically byarrhythmiadetection.AutomaticAlgorithmanalysis everytime the patientuploads data. | Patienttriggered orautomaticallybyarrhythmiadetectionAlgorithm atthe end of themonitoringperiod. | Similar | Manually bypatientorautomaticallybyarrhythmiadetectionalgorithm | Similar. |
| Characteristics | Nuubo Smart | Nuubo System(primary)K173461 | NuuboSmart vsNuuboSystemComparison | SEEQTMSystemK133701 | NuuboSmart vsSEEQSystemComparison |
| Full Disclosureavailable | Yes | Yes | Same | Yes | Same |
| MonitoringDataTransmission | Cellulartransmission. | None. DatadownloadedthroughmicroSD card(USB) at theend ofmonitoring | Different.Nuubo Smartincludescellulartransmissionthrough theNuubo Dockwhen thepatientrechargesthe device. | Bluetooth andcellulartransmission. | Similar |
| Duration of use | Up to 30 days | Up to 30 days | Same | Up to 30 days | Same |
| Key Systemcomponents | 1. Nuubo30(wearablesensor)2. NuuboREC(recorder)3. Nuubo SmartApp(transmitter)4. NuuboLeonardoSmart(analysis) | Nuubo30(wearablesensor)NuuboREC(recorder)NuuboLeonardo(Software) | Similar.Nuubo Smartincludes aDock and anapp totransmit thedataperiodically | 1. SEEQ™MCTWearableSensor(Piix)2. SEEQ™MCTTransmitter (zLink)3. Software | Same. Keycomponents are thesame (asensor, atransmitter and asoftware) |
| Arrhythmiasdetected | - AtrialFibrillation- Pauses- Tachycardia- Bradycardia | - AtrialFibrillation- Pauses- Tachycardia- Bradycardia | Same | - Tachycardia- Bradycardia- Pauses- AtrialFibrillation | Similar.Arrhythmiasdetected arenearly thesame. |
| Characteristics | Nuubo Smart | Nuubo System(primary)K173461 | NuuboSmart vsNuuboSystemComparison | SEEQ™SystemK133701 | NuuboSmart vsSEEQSystemComparison |
| - SupraventricularRun- VentricularRun- VentricularEctopy- SupraventricularEctopy | - Supraventricular Run- VentricularRun- VentricularEctopy- Supraventricular Ectopy | - VentricularTachycardia /VentricularFibrillation | |||
| Electrode type | Textileelectrode | TextileElectrode | Same | Patch withAg/AgCl "wet"electrodeassembly | Different.Validation oftextileelectrode,comparisonandSubstantialEquivalenceto a wetAg/AgClelectrodewas alreadysubmitted inNuuboSystem(K173561) |
Comparison of Nuubo Features to Predicate Device
{7}------------------------------------------------
{8}------------------------------------------------
The Nuubo and the predicate devices are similar with following features:
- Include an ECG recording feature о
- Monitor additional parameters like motion (primary predicate) o
- Include 1-2 leads O
- Use same electrode type and sensor assembly (Nuubo30 from primary predicate o device)
- Allow patients to record events O
- Are used in the ambulatory environment for ECG recording O
- Store recorded parameters on the local hardware (recorder) (primary predicate) o
- O Send data periodically to be reviewed (secondary predicate)
{9}------------------------------------------------
- Create reports with relevant findings periodically and at the end of the o monitoring.
- Include proprietary arrhythmia detection with same type of arrhythmias o
Both systems are validated for applicable performance features like biocompatibility. packaging/shipping, EMI/EMC/Electrical safety and validation of the arrhythmia detection algorithm.
Differences:
The Indications for Use statement for the Nuubo Smart differs slightly from that of the primary predicate device to address automatically detected events daily and not at the end of the monitoring; however, these differences do not alter the intended use of the device. Collectively, the subject device has the same intended use in cardiac arrhythmia diagnostics as the two predicate devices. Differences in the proposed Indications for Use statement are not critical to the intended use of the device, nor do they affect the safety and effectiveness of the subject device relative to the predicate devices. The only difference with respect to detection of arrhythmias is that the secondary predicate device detects Ventricular Fibrillation. This is a potentially lethal arrhythmia which needs immediate medical attention and therefore it is not needed to be detected in a nonattended ambulatory monitoring technology like Nuubo Smart where there are no real time alarms or events. The electrodes used for recording the ECG are different between the Nuubo Smart (textile electrode) and the secondary predicate device (wet Ag/Agcl electrode). The validation of the textile electrodes was submitted in Nuubo System submission (K173561), where substantial equivalence was granted against a very similar patch with wet Ag/Agcl electrode assembly. Therefore, the subject device can be considered substantially equivalent to the predicate devices.
Another difference between the Nuubo and the predicate devices is that the data is sent to the cloud via a commercial phone with an app (secondary predicate uses a specific device for this purpose). However, there is another cardiac monitor reference device, Bodyguardian System (K121197), which similar to Nuubo Smart, uses a commercial phone as an accessory to enable cellular communications and use a Android App to get protected access to the cloud.
Another difference between the Nuubo and the predicate devices is the way the data is downloaded from the recording device. However, there is another cardiac monitor reference device, Stealth System S300 (K162503), which similar to Nuubo Smart, uses a custom dock as a cable/connector to enable communications between the recording device and the software to analyze the data.
Another difference between the Nuubo and the predicate devices is the technology to store and process signals in the cloud. However, there is another cardiac monitor reference device, MoMe Kardia Wireless Ambulatory ECG Monitoring and Detection System (K160064), which similar to Nuubo Smart, stores the information and analyzes the data via the embedded algorithm in the cloud and, when indicated, data identified by the algorithm is flagged for physician review.
{10}------------------------------------------------
Declaration of Conformity to Standards:
Preclinical software/algorithm testing, biocompatibility, shipping/packaging and usability study results validate Nuubo Smart towards its proposed intended use, and supports substantial equivalence to the predicate, and conformance to applicable harmonized standards.
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.
- · Recognition Number 19-4: AAMI / ANSI ES60601-1:2005/(R)2012 and A1:2012, c1:2009/(r)2012 and a2:2010/(t)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 62133 Safety Requirements for portable secondary cells, which applies for the lithium polymer battery
| Test | Results |
|---|---|
| Section 14: Shipping and packaging tests | The Transport Simulation test according to ASTM D 7386 TS-4 of Nuubo Smart box, the Transport Simulation test according to ASTM D 4169 DC 13 of 4 Nuubo Smart units 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. |
Summary of Bench testing
{11}------------------------------------------------
| Test | Results |
|---|---|
| Section 15:Biocompatibility | The Nuubo Smart uses the same textile belt technology as NuuboSystem (K173461), which was subject to the ISO10993 standards,including cytotoxicity, irritation, sensitization and materialcharacterization per ISO 10993-18 |
| Section 16 –Software testing | Software passed all Unit Testing and System Verification andValidation Testing to show it met all requirements |
| The Nuubo Leonardo Arrhythmia detection algorithm (same asNuubo System K173461) was tested per requirements ofIEC60601-2-47, and showed a QRS Sensitivity and QRS Positivepredictivity of over 99% against the MIT-BIH database, and over97% against the AHA database | |
| Section 17 –EMI/EMC | The Nuubo Smart system successfully completed theEMI/EMC/Electrical safety test requirements per IEC60601. |
| Section 18 – Benchstudies | Wearable and recorder verification and validation testing toconfirm it met all requirements (design input), including for batteryperformance for the proposed up to 30 days of use |
Summary of Clinical Testing:
Section 20: Summative usability testing was completed demonstrating that patients and caregivers did not encounter any difficulties associated with a risk for potential of serious harm (critical tasks).
Conclusion:
The design, function, specifications, and performance of the Nuubo Smart are similar to the identified legally marketed predicate and reference devices. Further, the Nuubo Smart is compliant with applicable harmonized standards, and where any differences relative to the predicate have been verified and validated. Therefore, the subject device is substantially equivalent to the existing legally marketed devices.
§ 870.1425 Programmable diagnostic computer.
(a)
Identification. A programmable diagnostic computer is a device that can be programmed to compute various physiologic or blood flow parameters based on the output from one or more electrodes, transducers, or measuring devices; this device includes any associated commercially supplied programs.(b)
Classification. Class II (performance standards).