← Product Code [MNR](/submissions/AN/subpart-c%E2%80%94monitoring-devices/MNR) · K210480 # AcuPebble SA (K210480) _Acurable Limited · MNR · Jul 6, 2021 · Anesthesiology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/MNR/K210480 ## Device Facts - **Applicant:** Acurable Limited - **Product Code:** [MNR](/submissions/AN/subpart-c%E2%80%94monitoring-devices/MNR.md) - **Decision Date:** Jul 6, 2021 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 868.2375 - **Device Class:** Class 2 - **Review Panel:** Anesthesiology ## Intended 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. ## Device Story AcuPebble SA100 is a wearable sensor worn on the front of the neck (suprasternal notch) to measure physiological body sounds during sleep. The sensor streams data via Bluetooth to a mobile app, which uploads the data to a cloud-based server for analysis. The system uses signal processing algorithms to produce OSA diagnostic traces and parameters, including AHI and ODI. Healthcare professionals access these results via a web portal to assist in patient evaluation. The device is intended for home-screening of adults, though it can be used in clinics. It benefits patients by providing a non-invasive, wearable method for OSA prescreening without requiring full polysomnography. ## Clinical Evidence Clinical validation study conducted on 150 patients per ISO 14155:2011. Primary endpoints included diagnostic accuracy for AHI and ODI (3% and 4% desaturation criteria). Results: AHI3 PPV 94.44%, NPV 95.83%; AHI4 PPV 94.00%, NPV 98.00%; ODI3 PPV 93.42%, NPV 90.54%; ODI4 PPV 85.71%, NPV 98.94%. Heart rate accuracy validation showed 94.0% of subjects had bias ≤ ±3 bpm and 93.3% had standard deviation ≤ 5 bpm compared to PPG-based polygraphy. ## Technological Characteristics Wearable sensor (29.5mm x 16mm, 7g) with biocompatible enclosure and adhesive. Sensing principle: microphones for physiological body sounds. Connectivity: Bluetooth to mobile app, cloud-based analysis. Power: rechargeable lithium polymer battery. Software: signal processing algorithms for OSA index calculation. Standards: ISO 10993 (biocompatibility), IEC 60601-1 (safety), IEC 60601-1-2 (EMC), IEC 60601-1-11 (home healthcare), IEC 62366-1 (usability), ISO 14971 (risk management). ## Regulatory 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. ## Predicate Devices - Drowzle ([K173974](/device/K173974.md)) ## Reference Devices - NightOwl ([K191031](/device/K191031.md)) - Sleep Strip II ([K112822](/device/K112822.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {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 {2}------------------------------------------------ #### 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) #### 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}------------------------------------------------ # 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 | {4}------------------------------------------------ ### 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 | {5}------------------------------------------------ ### 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… --- **Source:** [https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/MNR/K210480](https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/MNR/K210480) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com