(60 days)
No
The document describes an arrhythmia detection algorithm, but there is no mention of AI or ML being used in this algorithm or any other part of the device. The performance metrics provided are standard for ECG analysis algorithms and do not inherently indicate AI/ML.
Yes.
The device continuously records and stores ECG and activity data for up to 30 days and detects arrhythmias, which directly supports the diagnosis and management of conditions implied by symptoms like palpitations and shortness of breath. While it doesn't directly treat, it provides critical information for therapeutic decisions.
Yes
Explanation: The device continuously records and stores ECG and activity data for up to 30 days and detects arrhythmias. It is indicated for use on patients with transient symptoms such as palpitations, shortness of breath, and dizziness, and its purpose is for analysis, visualization, and reporting of ECG data, which are all diagnostic functions.
No
The device description clearly outlines multiple hardware components: the Nuubo30 wearable textile unit, the NuuboREC recorder (a physical device with a battery, accelerometer, and memory card), and the Nuubo Dock (a physical stand with a smartphone and microUSB port). While software is a critical part of the system (Nuubo Dock App, Leonardo Smart software), the system relies on these physical components to acquire and transmit data.
Based on the provided information, the Nuubo Smart is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the device records and analyzes ECG and activity data for patients with potential cardiac symptoms. This is a physiological measurement and analysis, not a test performed on biological samples in vitro (outside the body).
- Device Description: The components described (wearable, recorder, dock, software) are all focused on capturing, storing, and analyzing electrical signals from the body (ECG) and physical movement (activity). There is no mention of reagents, assays, or analysis of biological specimens like blood, urine, or tissue.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analysis of biological samples.
- Detection or measurement of substances in biological samples.
- Use of reagents or kits.
- Diagnosis based on in vitro testing.
The Nuubo Smart is a wearable medical device for ambulatory ECG monitoring and arrhythmia detection. It falls under the category of devices that measure physiological signals from the patient's body.
N/A
Intended Use / 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, 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.
Product codes
DSH, DOK, DXH
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Rx use device. Ambulatory environment.
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 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.
Summary of Performance Studies
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.
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.
Biocompatibility: The Nuubo Smart uses the same textile belt technology as Nuubo System (K173461), which was subject to the ISO10993 standards, including cytotoxicity, irritation, sensitization and material characterization per ISO 10993-18.
Software testing: Software passed all Unit Testing and System Verification and Validation Testing to show it met all requirements. 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.
EMI/EMC: The Nuubo Smart system successfully completed the EMI/EMC/Electrical safety test requirements per IEC60601.
Bench studies: Wearable and recorder verification and validation testing to confirm it met all requirements (design input), including for battery performance for the proposed up to 30 days of use.
Clinical Testing: 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).
Key Metrics
QRS Sensitivity and QRS Positive predictivity of over 99% against the MIT-BIH database, and over 97% against the AHA database.
Predicate Device(s)
Nuubo System K173461, SEEQTM System K133701
Reference Device(s)
Bodyguardian System K121197, Stealth System S300 K162503, MoMe Kardia Wireless Ambulatory ECG Monitoring And Detection System K160064
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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)
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3
510(k) SUMMARY
| Submitter Name: | Smart Solutions Technologies SL |
|---|---|
| Submitter Address: | Paseo de la Castellena 200 |
| Madrid | |
| Madrid 28046 | |
| ES | |
| Company Contact | |
| Person: | Borja Gonzalvez |
| Company contact Ph: | (+34) 961 344 497 |
| Submission | |
| Correspondent: | 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, |
| Medical | |
| 21 CFR 870.1425, Code DQK, Computer, Diagnostic, | |
| Programmable | |
| 21 CFR 870.2800, Code DXH | |
| Predicate Devices: | Nuubo System K173461 |
| SEEQTM System K133701 | |
| Reference Devices: | Bodyguardian System K121197 |
| Stealth System S300 K162503 | |
| MoMe Kardia Wireless Ambulatory ECG Monitoring And | |
| Detection System K160064 | |
| Intended use: | The Nuubo Smart developed by Smart Solutions |
| Technologies S.L. (SST), is a wearable device designed for | |
| ambulatory recording and transmitting electrocardiogram | |
| (ECG) up to 30 days. The intended use is identical to the | |
| predicate Nuubo system. | |
| Device Description: | Nuubo Smart is composed of the following main |
| components: |
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 System
K173461 | SEEQTM System
K133701 |
|------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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, pre-syncope,
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 | 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. | The NUVANT
(SEEQ) System is
intended to
continuously measure,
record and
periodically transmit
physiological data.
The System is
indicated for those
patients who require
monitoring for the
detection of non-
lethal cardiac
arrhythmias such as,
but not limited to,
supraventricular
tachycardias (e.g.
atria] fibrillation,
atrial flutter,
paroxysmal SVTs),
ventricular ectopy,
bradyarrhythmias and
conduction disorders.
The NUVANT
System 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 | Nuubo
Smart vs
Nuubo
System
Comparison | SEEQ™
System
K133701 | Nuubo
Smart vs
SEEQ
System
Comparison |
|------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Code | DSH, DQK, DXH | DSH, DQK | Similar | DSI | Similar |
| Number of leads | Two leads | Two leads | Same | One lead | Similar.
Nuubo
Smart has
one more
ECG lead |
| Parameters | ECG and motion | ECG and
motion | Same | ECG | Similar |
| Event detection | Patient
triggered or
automatically by
arrhythmia
detection.
Automatic
Algorithm
analysis every
time the patient
uploads data. | Patient
triggered or
automatically
by
arrhythmia
detection
Algorithm at
the end of the
monitoring
period. | Similar | Manually by
patient
or
automatically
by
arrhythmia
detection
algorithm | Similar. |
| Characteristics | Nuubo Smart | Nuubo System
(primary)
K173461 | Nuubo
Smart vs
Nuubo
System
Comparison | SEEQTM
System
K133701 | Nuubo
Smart vs
SEEQ
System
Comparison |
| Full Disclosure
available | Yes | Yes | Same | Yes | Same |
| Monitoring
Data
Transmission | Cellular
transmission. | None. Data
downloaded
through
microSD card
(USB) at the
end of
monitoring | Different.
Nuubo Smart
includes
cellular
transmission
through the
Nuubo Dock
when the
patient
recharges
the device. | Bluetooth and
cellular
transmission. | Similar |
| Duration of use | Up to 30 days | Up to 30 days | Same | Up to 30 days | Same |
| Key System
components | 1. Nuubo30
(wearable
sensor)
2. NuuboREC
(recorder)
3. Nuubo Smart
App
(transmitter)
4. Nuubo
Leonardo
Smart
(analysis) | Nuubo30
(wearable
sensor)
NuuboREC
(recorder)
Nuubo
Leonardo
(Software) | Similar.
Nuubo Smart
includes a
Dock and an
app to
transmit the
data
periodically | 1. SEEQ™
MCT
Wearable
Sensor
(Piix)
2. SEEQ™
MCT
Transmitt
er (zLink)
3. Software | Same. Key
componen
ts are the
same (a
sensor, a
transmitte
r and a
software) |
| Arrhythmias
detected | - Atrial
Fibrillation
- Pauses
- Tachycardia
- Bradycardia | - Atrial
Fibrillation - Pauses
- Tachycardia
- Bradycardia | Same | - Tachycardia
- Bradycardia
- Pauses
- Atrial
Fibrillation | Similar.
Arrhythmias
detected are
nearly the
same. |
| Characteristics | Nuubo Smart | Nuubo System
(primary)
K173461 | Nuubo
Smart vs
Nuubo
System
Comparison | SEEQ™
System
K133701 | Nuubo
Smart vs
SEEQ
System
Comparison |
| | - Supraventricular
Run - Ventricular
Run - Ventricular
Ectopy - Supraventricular
Ectopy | - Supraventricula
r Run - Ventricular
Run - Ventricular
Ectopy - Supraventricula
r Ectopy | | - Ventricular
Tachycardia /
Ventricular
Fibrillation | |
| Electrode type | Textile
electrode | Textile
Electrode | Same | Patch with
Ag/AgCl "wet"
electrode
assembly | Different.
Validation of
textile
electrode,
comparison
and
Substantial
Equivalence
to a wet
Ag/AgCl
electrode
was already
submitted in
Nuubo
System
(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 Nuubo |
| System (K173461), which was subject to the ISO10993 standards, | |
| including cytotoxicity, irritation, sensitization and material | |
| characterization per ISO 10993-18 | |
| Section 16 – | |
| Software testing | Software passed all Unit Testing and System Verification and |
| Validation Testing to show it met all requirements | |
| 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 | |
| Section 17 – | |
| EMI/EMC | The Nuubo Smart system successfully completed the |
| EMI/EMC/Electrical safety test requirements per IEC60601. | |
| Section 18 – Bench | |
| studies | Wearable and recorder verification and validation testing to |
| confirm it met all requirements (design input), including for battery | |
| performance 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.