(137 days)
Unknown
The summary mentions "AcuPebble SA100 algorithms" for analysis but does not explicitly state whether these algorithms utilize AI or ML. The lack of mention of training/test sets or specific AI/ML terms makes it impossible to confirm.
No
The device is indicated for prescreening patients for obstructive sleep apnea (OSA) syndrome by sensing, recording, and interpreting physiological signals, and its results are used to assist healthcare professionals in patient evaluation. It is a diagnostic aid, not a therapeutic device.
Yes
The device is indicated to "sense, record, and interpret a patient's physiological signals... for the purpose of prescreening patients for obstructive sleep apnea (OSA) syndrome" and its "results are used to assist the healthcare professional's in the patient's evaluation", which describes a diagnostic function.
No
The device description explicitly states that the system comprises a "sensor that is worn on the front of the neck" which is described as a "small biocompatible enclosure with very low power sensors and electronics inside." This indicates the presence of hardware components beyond just software.
Based on the provided information, the AcuPebble SA100 is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- AcuPebble SA100 Function: The AcuPebble SA100 senses, records, and interprets physiological signals directly from the patient's body (respiratory pattern, body sounds) during sleep. It does not analyze samples taken from the body.
Therefore, the AcuPebble SA100 falls under the category of a medical device that monitors physiological parameters in vivo (within the living body), rather than an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
AcuPebble SA100 is indicated to sense, record, and interpret a patient's physiological signals (including respiratory pattern) during sleep for the purpose of prescreening patients for obstructive sleep apnea (OSA) syndrome. The designed for use in home-screening of adults with suspected possible sleep breathing disorders (although it can also be used in clinic). Results are used to assist the healthcare professional's in the patient's evaluation.
The system is not intended as a substitute for full polysomnography when additional parameters such as sleep stages, limb movements, or EEG activity are required.
Product codes
MNR
Device Description
AcuPebble SA100 comprises a sensor that is worn on the front of the neck around the suprasternal notch area (the "AcuPebble SA100 sensor"), a mobile device app that guides the patient through the steps of the test, collects the data from the sensor, and uploads them in the "AcuPebble SA100 app"), and a cloud-based analysis software (the "AcuPebble SA100 algorithms". The "AcuPebble SA100 Sensor" consists of a small biocompatible enclosure with very low power sensors and electronics inside. It is attached to the front of the neck (somewhere between the Adam's apple and the suprasternal notch area) by single-use biocompatible adhesive tape. The sensor measures physiological body sounds. The data sensed is streamed via a Bluetooth link to the "AcuPebble SA100 app" on a smart device (mobile phone/tablet). The data can be uploaded into the cloud where it is analyzed, any time after the sleep study test is finished at the tap of a button in the app. AcuPebble SA100 signal processing algorithms produce a number of OSA diagnostic traces and parameters. These can be accessed by the Health Care Professional through a healthcare professional portal, which can be accessed from any computer or smart device with an Internet connection.
AcuPebble SA100 is not intended to be used with patients with pacemakers or other implantable devices, or with patients with known or suspected arrhythmias. This device has not been validated in patients with congestive heart failure or patients with neuromuscular disorders. Patients with significant cardiopulmonary or neurological disorders need to be excluded from using the device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Front of the Neck around the suprasternal notch area (somewhere between the Adam's apple and the suprasternal notch area)
Indicated Patient Age Range
Adults
Intended User / Care Setting
Healthcare professional (evaluation). Designed for use in home-screening, but can also be used in clinic.
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical Validation: An accuracy validation clinical study was carried out to further support the substantial equivalence claims. The study involved 150 consecutive evaluation patients.
Key Results for Diagnostic indexes:
AHI3 (AHI as defined by the AASM for airflow reductions and 3% desaturations): PPV 94.44% (CI 84.78%- 98.11%), NPV 95.83% (CI 89.94%- 98.34%), LR+ 29.36 (CI 9.62 to 89.64), LR- 0.08 (CI 0.03 to 0.19)
AHI4 (As above, but for 4% desaturations): PPV 94.00% (CI 83.69%- 97.95%), NPV 98.00% (CI 92.65% to 99.48%), LR+ 32.29 (CI 10.58 to 98.59), LR- 0.04 (CI 0.01 to 0.16)
ODI3 (ODI considering 3% desaturations): PPV 93.42% (CI 85.87%- 97.07%), NPV 90.54% (CI 82.48%- 95.11%), LR+ 13.11 (CI 5.61 to 30.62), LR- 0.10 (CI 0.05 to 0.20)
ODI4 (ODI considering 4% desaturations): PPV 85.71% (CI 75.50%- 92.11%), NPV 98.94% (CI 93.03%- 99.85%), LR+ 12.37 (CI 6.35-24.08), LR- 0.02 (CI 0.00-0.15)
The diagnostic criteria were based on the established thresholds, for OSA (i.e. 5, 15 and 30).
Performance of heart rate output was evaluated for the same 150 patients.
Heart Rate - Percentage of subjects with bias and standard deviations within different ranges:
Bias (μ) ≤ ±1 bpm: 62.0%
Bias (μ) ≤ ±3 bpm: 94.0%
Bias (μ) ≤ ±5 bpm: 98.7%
Standard Deviation (σ) ≤ 2 bpm: 28.7%
Standard Deviation (σ) ≤ 5 bpm: 93.3%
Standard Deviation (σ) ≤ 8 bpm: 98.7%
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
PPV, NPV, LR+, LR- are provided in the clinical validation summary. Sensitivity and Specificity are not explicitly provided.
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 868.2375 Breathing frequency monitor.
(a)
Identification. A breathing (ventilatory) frequency monitor is a device intended to measure or monitor a patient's respiratory rate. The device may provide an audible or visible alarm when the respiratory rate, averaged over time, is outside operator settable alarm limits. This device does not include the apnea monitor classified in § 868.2377.(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 is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
July 6, 2021
Acurable Limited Esther Rodriguez-Villegas CSO Finsgate, 5-7 Cranwood Street London, London EC1V 9EE United Kingdom
Re: K210480
Trade/Device Name: AcuPebble SA100 Regulation Number: 21 CFR 868.2375 Regulation Name: Breathing Frequency Monitor Regulatory Class: Class II Product Code: MNR Dated: Mav 28, 2021 Received: June 4, 2021
Dear Esther Rodriguez-Villegas:
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
1
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 (OS) 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,
Rachana Visaria, Ph.D. Assistant Director DHT1C: Division of ENT, Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known)
Device Name AcuPebble SA100
Indications for Use (Describe)
AcuPebble SA100 is indicated to sense, record, and interpret a patient's physiological signals (including respiratory pattern) during sleep for the purpose of prescreening patients for obstructive sleep apnea (OSA) syndrome. The designed for use in home-screening of adults with suspected possible sleep breathing disorders (although it can also be used in clinic). Results are used to assist the healthcare professional's in the patient's evaluation.
The system is not intended as a substitute for full polysomnography when additional parameters such as sleep stages, limb movements, or EEG activity are required.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
Q
510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR §807.92.
| 510(k) Submitter: | Acurable Limited
Finsgate
5-7 Cranwood Street
London EC1V 9EE
United Kingdom |
|------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact person: | Professor Esther Rodriguez-Villegas
CSO
Acurable Ltd
5th Floor, 21 Knightsbridge, London
SW1X 7LY, UK
esther@acurable.com
+442075946193 |
| Date summary prepared: | July 6, 2021 |
| Trade Name: | AcuPebble SA100 |
| Product Classification Name: | Ventilatory effort recorder |
| Regulation number: | 21 CFR §868.2375 (Breathing Frequency
Monitor) |
| Product Code: | MNR |
| Classification Panel: | Anaesthesiology |
| Device Classification: | Class II |
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1. Intended Use / Indications for Use
AcuPebble SA100 is indicated to sense, record, and interpret a patient's physiological signals (including respiratory pattern) during sleep, for the purpose of prescreening patients for obstructive sleep apnea (OSA) syndrome. The device is designed for use in home-screening of adults with suspected possible sleep breathing disorders. Results are used to assist the healthcare professional in the patient's evaluation.
The system is not intended as a substitute for full polysomnography when additional parameters such as sleep stages, limb movements, or EEG activity are required.
2. DEVICE DESCRIPTION
AcuPebble SA100 comprises a sensor that is worn on the front of the neck around the suprasternal notch area (the "AcuPebble SA100 sensor"), a mobile device app that guides the patient through the steps of the test, collects the data from the sensor, and uploads them in the "AcuPebble SA100 app"), and a cloud-based analysis software (the "AcuPebble SA100 algorithms". The "AcuPebble SA100 Sensor" consists of a small biocompatible enclosure with very low power sensors and electronics inside. It is attached to the front of the neck (somewhere between the Adam's apple and the suprasternal notch area) by single-use biocompatible adhesive tape. The sensor measures physiological body sounds. The data sensed is streamed via a Bluetooth link to the "AcuPebble SA100 app" on a smart device (mobile phone/tablet). The data can be uploaded into the cloud where it is analyzed, any time after the sleep study test is finished at the tap of a button in the app. AcuPebble SA100 signal processing algorithms produce a number of OSA diagnostic traces and parameters. These can be accessed by the Health Care Professional through a healthcare professional portal, which can be accessed from any computer or smart device with an Internet connection.
AcuPebble SA100 is not intended to be used with patients with pacemakers or other implantable devices, or with patients with known or suspected arrhythmias. This device has not been validated in patients with congestive heart failure or patients with neuromuscular disorders. Patients with significant cardiopulmonary or neurological disorders need to be excluded from using the device.
3. Predicate Device
The predicate device is shown in the Table below:
| K number | Product Code | Class | Device Name |
|---|---|---|---|
| K173974 | MNR | II | Drowzle |
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4. Summary of Comparison to Predicate
| | DEVICE SUBJECT
OF THIS
APPLICATION | PREDICATE DEVICE (1) | REFERENCE
DEVICE(1) | REFERENCE
DEVICE (2) |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | AcuPebble SA100
by Acurable Ltd | Drowzle by Resonea,
K173974 | NightOwl, K191031,
by Ectosense | Sleep Strip
II, K112822
(Note: this
device was
claimed as
predicate of
Drowzle
(predicate (1) in
this application) |
| Indications
for use | AcuPebble SA100 is
indicated to sense,
record, and interpret a
patient's physiological
signals (including
respiratory pattern)
during sleep for the
purpose of prescreening
patients for obstructive
sleep apnea (OSA)
syndrome. The device
is designed for use in
home-screening of
adults with suspected
possible sleep breathing
disorders. Results are
used to assist the
healthcare professional
in the patient's
evaluation.
The system is not
intended as a substitute
for full
polysomnography when
additional parameters
such as sleep stages,
limb movements, or
EEG activity are
required. | DROWZLE is indicated to
record a patient's
respiratory pattern during
sleep for the purpose of
prescreening patients for
obstructive sleep apnea
(OSA) syndrome. The
device is designed for use
in home-screening of
adults with suspected
possible sleep breathing
disorders. Results are
used to assist the
healthcare professional in
determining the need for
further diagnosis and
evaluation.
The system is not intended
as a substitute for full
polysomnography when
additional parameters such
as sleep stages, limb
movements, or EEG
activity are required. | The NightOwl is a
wearable device
intended for use in the
recording, analysis,
displaying, exporting,
and storage of
biophysical parameters
to aid in the evaluation
of sleep-related
breathing disorders of
adult patients
suspected of sleep
apnea. The device is
intended for the clinical
and home setting use
under the direction of a
Healthcare Professional
(HCP). | The SleepStrip
II is intended to
measure apnea
hypopnea
events during
sleep for the
purpose of
prescreening
patients for
sleep apnea
syndrome. The
device is
intended to be
used by adult
patients as
prescribed by a
physician in
either home,
hospital or
facility use
settings. |
| COMPARISON | | Substantially equivalent | | |
| Regulation
number | 868.2375 | 868.2375 | 868.2375 | 868.2375 |
| COMPARISON | | Same | | |
| Product
Code | MNR | MNR | MNR | MNR |
| COMPARISON | Same | | | |
6
| Generic
Device
Name | Ventilatory
Effort Recorder | Ventilatory Effort Recorder | Ventilatory Effort
Recorder | Ventilatory
Effort
Recorder |
|-----------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------|
| COMPARISON | Same | | | |
| Prescription | Prescription | Prescription | Prescription | Prescription |
| COMPARISON | Same | | | |
| Target
population | Adults | Adults | 22 years old and older | Adults |
| COMPARISON | Substantially equivalent | | | |
| Intended
environment
for use | Primarily home
environment, although
it can be used in
healthcare
environments | Home Environment | Clinical and Home
environment | Home or
healthcare
settings |
| COMPARISON | Substantially equivalent | | | |
| Sensor
placement | Front of the Neck | Smartphone placed within
24 inches of pillow | The
photoplethysmography
(PPG) sensor and
accelerometer
components
are worn on the
fingertip. | Over the lip,
under the
nose |
| COMPARISON | The sensor is placed in a different location which is directly contacting the patient compared to
the predicate which is not directly contacting the patient. This is similar to the reference device
which has direct contact. Having AcuPebble SA100 in contact with the body does not raise
different safety or effectiveness questions (see conformity with consensus standards.) | | | |
| Sensing
elements | Microphones | Microphones | LEDs/ accelerometer | Pressure
sensor |
| COMPARISON | Same | | | |
| Patient
contact | Yes | No | Yes | Yes |
| COMPARISON | Different but justified. Refer to the clinical validation data showing the equivalent
performance of AcuPebble SA100 with respect to the predicate. Also, this type of contact
approach has been used by the reference devices. | | | |
| Means of
attachment | Adhesive (patient self-
applied) | NA | Adhesive (patient self-
applied) | Adhesive
(patient self-
applied) |
| COMPARISON | Different but it is justified. Refer to the clinical validation data showing equivalent
performance of AcuPebble SA100 with respect to the predicate. Also, substantially
equivalent means of attachment to Reference Devices. | | | |
| Sleep night
use | Multiple nights
possible | Multiple nights possible | Multiple nights
possible | Single use |
| COMPARISON | Same | | | |
| Portability | Yes (Wearable) | NA | Yes (wearable) | Yes
(wearable) |
| Comparison | Not direct comparison with the predicate but Reference Devices are also wearable | | | |
| Size and
weight | 29.5mm diameter x
16mm height
7g | NA | 19x28x11mm
6g | Exact
dimensions
unknown but
from photos it
looks similar in
volume (with
different form
factor) |
| Recording
device | Mobile device records
sound streamed from
the sensor and
uploads them into a
cloud-based server | Mobile device records
sound and uploads them
into a cloud-based server | Mobile device records
data streamed from
the sensor and
uploads them into a
cloud-based server | Contained in
the device |
| Comparison | Same | | | |
| Channels to
determine
features
leading to
diagnostic
indexes | Sounds (Cardiac
features, respiratory
features, movement
features)) | Sounds (absence of them) | PAT, pulse rate,
oxygen saturation,
movement | Airflow |
| COMPARISON | Substantially equivalent | | | |
| Calculated
OSA indexes | ACU-AHI (with 3%
desaturation criteria),
ACU-AHI (with 4%
desaturation criteria),
ACU-ODI (for 3% and
4% desaturation
criteria) | Proprietary Resonea
Index | AHI (from PAT), oximetry | AHI with 4%
desaturation
criteria |
| COMPARISON | Substantially equivalent | | | |
| Clinical
Metrics
Reported | Calculated AHI/ODI
indexes as per AASM
definitions (and level of
OSA severity for each
index, following the
AASM thresholds (i.e.
0-5, 5-15, 15-30 and
30); average heart
(pulse). | Number of breathing
sound gaps >10
seconds; Average
number of >10
second breathing
sound gaps per hour;
Risk classification
based on standard
questionnaires: | Calculated AHI index from
PAT. they output validated
oximetry values and from
there the ODI can be
obtained. | Counts
apnea/hypop
nea events |
| | | STOP-BANG Epworth
Sleepiness
Scale; Calculated
Resonea Index | | |
| COMPARISON | Substantially equivalent | | | |
| Data
Transfer | From the sensor to the
mobile phone using
Bluetooth and from the
phone to the cloud
(server) through a
smartphone by
wireless connection. | Wireless connection | From the sensor to the
mobile phone using
Bluetooth and from the
phone to the cloud
(server) through a
smartphone by
wireless connection. | Not applicable |
| COMPARISON | Substantially equivalent | | | |
| Microcontrol
ler+Commun
ication chip | Nordic nRF52832
(Bluetooth
communication) | NA | Nordic nRF52832
(Bluetooth
communication) | NA |
| Comparison | Substantially equivalent | | | |
| Sensor
Power
Source | Rechargeable lithium
polymer battery | NA | Rechargeable lithium
ion battery | Battery |
| COMPARISON | Substantially equivalent | | | |
| Sensor
Software | Firmware is limited to
control the recording
and communications
processes. No
presentation of test
results to the patient.
Data analyzed and
presented in a
separate software
suite. | NA | Firmware is limited to
control the recording
and communications
processes. No
presentation of test
results to the patient.
Data analyzed and
presented in a
separate software
suite. | Not applicable |
| COMPARISON | Same as Reference Device (1) (Not directly comparable to Predicate because
there is not a worn part of the system) | | | |
| Analysis
Software -
location | Analysis performed off
the recording device,
exclusively cloud-
based, by the
proprietary software. | Analysis performed off the
recording device,
exclusively cloud-based by
the proprietary software. | Analysis performed off
the recording device,
exclusively cloud-
based by the
proprietary software. | Analysis
performed in
the device |
| COMPARISON | Same | | | |
| Display type | Smartphone (or tablet)
for patients;
smartphone (or tablet)
or computer screen for | Smartphone | Smartphone for
patients. For
healthcare
professionals, one or
several of: | LED display |
| | healthcare
professionals | | smartphone (or tablet)
or computer screen
(unclear which ones) | |
| COMPARISON | Substantially equivalent | | | |
| Patient
connection | Device has no
galvanic connections
to mains as it is a
battery-operated
device. | NA | Device has no
galvanic connections
to mains as it is a
battery-operated
device. | Device has
no galvanic
connections
to mains as it
is a battery-
operated
device. |
| COMPARISON | Same as the Reference Devices | | | |
| Sterilization | Non sterile | Not applicable | Non sterile | Non sterile |
| COMPARISON | Same as the Reference Devices | | | |
| Heart/Pulse
Rate Output
Range | 50-120bmp | NA | 50-118bmp | NA |
| COMPARISON | Substantially Equivalent to the reference device (the difference is not
significant) | | | |
| Heart/Pulse
Rate
validation
accuracy | 3.62 bpm (patients
signals from 50bpm-
110bpm during a night
sleep), 0.664 (artificial
signals as per clause
201.12.1.101.15 of
IEC 60601-2-27:2011,
from 50bpm to
120bpm) | NA | 2.26bmp | NA |
| COMPARISON | Substantially Equivalent to the reference device (the difference is not
significant when taking into account the intended use) | | | |
| Reusability/
Reprocessin
g | Yes (cleaning after
use) | Yes (cleaning after use) | Yes (cleaning after
use) | No |
7
8
9
10
5. PERFORMANCE DATA
Biocompatibility
Theenclosure of AcuPebble SA100 has undergone biocompatibility testing as per the recognized consensus standard ISO 10993 (Biological Evaluation of Medical Devices) with passing results.
The adhesive is also medical grade, and was tested as per ISO 10993, with passing results. The tests conducted were: in vitro cytotoxicity; mem elution; primary skin irritation; Guinea pig sensitization.
General Requirements for Safety and Electromagnetic Compatibility (EMC)
AcuPebble SA100 has been tested and found to comply with the following recognized consensus standards:
- IEC 60601-1:2006 +A11:2011+A1:2013- Medical electrical equipment Part 1: General requirements for basic safety and essential performance.
- IEC 60601-1-2:2015- Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests.
Home Healthcare Environment Safety
AcuPebble SA100 has been tested and found to comply with the following recognized consensus standard:
- IEC 60601-1-11:2015: Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment.
Usability
AcuPebble SA100 has been developed, tested and complies with the following recognized consensus standards:
- IEC 62366-1:2015 Medical devices-Part 1: Application of usability engineering to medical devices
- IEC60601-1-6: 2013Medical electrical equipment Part 1-6: General requirements for basic safety ● and essential performance - Collateral standard: Usability.
Risk Management
AcuPebble SA100 risk management complies with the recognised consensus standard ISO 14971:2012 "Application of risk management to medical devices".
Quality Management
Acurable is ISO 13485:2016 certified by MTIC InterCert SRL.
11
Software Verification and Validation Testing
AcuPebble SA100 has been tested and found to comply with the recognised consensus standard IEC 62304:2006/A1:2016 ("Medical device software - Software life cycle processes"). The software level of concern is moderate.
Acurable Software Verification and Validation Testing included 3 levels of testing, as defined in the Verification and Validation Plan:
- Unit testing at component level
- . Integration testing at component level
- Full system or end-to-end testing at product level.
Additionally, usability testing is carried out for system validation purposes.
Clinical Validation
An accuracy validation clinical study, in compliance with the recognized consensus standard ISO 14155:2011 ("Clinical investigation of medical devices for human subjects - Good clinical practice") was carried out to further support the substantial equivalence claims. The Clinical Investigations were hence conducted in accordance with good clinical practice (GCP) as described in 21 CFR 812.28(a)(1). The study involved 150 consecutive evaluation patients. A summary of the outcomes of the study is presented in the table below.
| Diagnostic index | Positive
Predictive Value
(PPV) | Negative
Predictive Value
(NPV) | Positive
Likelihood Ratio
(LR+) | Negative
Likelihood Ratio
(LR-) |
|-----------------------------------------------------------------------------------------------------|---------------------------------------|---------------------------------------|---------------------------------------|---------------------------------------|
| AHI3
(AHI as defined by
the AASM for
airflow reductions
and 3%
desaturations) | 94.44%
(CI 84.78%- 98.11%) | 95.83%
(CI 89.94%- 98.34%) | 29.36
(CI 9.62 to 89.64) | 0.08
(CI 0.03 to 0.19) |
| AHI4
(As above, but for
4% desaturations) | 94.00%
(CI 83.69%-
97.95%) | 98.00%
(CI 92.65% to
99.48%) | 32.29
(CI 10.58 to
98.59) | 0.04
(CI 0.01 to 0.16) |
| ODI3
(ODI considering
3% desaturations) | 93.42%
(CI 85.87%- 97.07%) | 90.54%
(CI 82.48%- 95.11%) | 13.11
(CI 5.61 to 30.62) | 0.10
(CI 0.05 to 0.20) |
| ODI4
(ODI considering
4% desaturations) | 85.71%
(CI 75.50%-
92.11%) | 98.94%
(CI 93.03%-
99.85%) | 12.37
(CI 6.35-24.08) | 0.02
(CI 0.00-0.15) |
The diagnostic criteria were based on the established thresholds, for OSA (i.e. 5, 15 and 30).
12
The performance of heart rate output was evaluated for the same 150 patients, using as an index test the heart rate obtained from the PPG signal of the polygraphy system.
The following table lists the percentage of subjects with bias and standard deviation within a certain range.
| Heart Rate- Percentage of subjects with bias and standard deviations within different
| ranges | |||||
|---|---|---|---|---|---|
| Bias (μ) | Standard Deviation (σ) | ||||
| ≤ ±1 bpm | ≤ ±3 bpm | ≤ ±5 bpm | ≤ 2 bpm | ≤ 5 bpm | ≤ 8 bpm |
| 62.0% | 94.0% | 98.7% | 28.7% | 93.3% | 98.7% |
6. Conclusion
Based on the performance data and testing in conformance to consensus standards, AcuPebble SA100 has been demonstrated to be substantially equivalent to the predicate device.