(129 days)
Unknown
The summary mentions "analysis" of biophysical parameters and signals, and a "cloud-based software that analyses the signals". While this analysis could potentially involve AI/ML, the summary does not explicitly state the use of these technologies. There is no mention of AI, DNN, ML, training sets, or test sets, which are common indicators of AI/ML implementation in medical devices.
No.
The device is intended for recording, analysis, displaying, exporting, and storage of biophysical parameters to aid in the evaluation of patients with suspected obstructive sleep apnea (OSA). It is a diagnostic aid, not a therapeutic device.
Yes
The device is described as "a wearable device intended for use in the recording, analysis, displaying, exporting, and storage of biophysical parameters to aid in the evaluation of adult patients with, or with suspected, obstructive sleep apnea (OSA)". It is explicitly used as a 'home sleep apnea test' (HSAT), and the output includes "OSA diagnostic parameters", indicating its role in diagnosis.
No
The device description explicitly states that the AcuPebble Ox100 comprises both physiological sensing hardware devices (AcuPebble SA100 sensor and AcuPebble finger oximetry sensor) in addition to the software components (mobile app and cloud-based software).
Based on the provided information, the AcuPebble Ox100 is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood, tissue, and urine, derived from the human body, in order to provide information for diagnostic, monitoring or compatibility purposes.
- AcuPebble Ox100 Function: The AcuPebble Ox100 is a wearable device that records biophysical parameters (likely related to breathing sounds, heart sounds, and oxygen saturation) directly from the patient's body. It does not examine specimens derived from the human body in vitro.
- Intended Use: The intended use is to aid in the evaluation of adult patients with, or with suspected, obstructive sleep apnea (OSA) by recording, analyzing, displaying, exporting, and storing biophysical parameters. This is a direct measurement of physiological signals, not an in vitro test.
Therefore, the AcuPebble Ox100 falls under the category of a medical device that performs physiological monitoring and analysis, but it is not an IVD.
N/A
Intended Use / Indications for Use
AcuPebble Ox100 is a wearable device intended for use in the recording, analysis, displaying, exporting, and storage of biophysical parameters to aid in the evaluation of adult patients with, or with suspected, obstructive sleep apnea (OSA). The device is primarily intended for home setting use (although can also be used in healthcare settings) under the direction of a Healthcare Professional (HCP).
Product codes (comma separated list FDA assigned to the subject device)
MNR
Device Description
AcuPebble Ox100 is prescribed by a Health Care Professional for the patient to use in the home as a 'home sleep apnea test' (HSAT). AcuPebble Ox100 comprises: 1- A small physiological sensing device, identical to the previously cleared device AcuPebble SA100 (K210480) that is worn on the front of the neck around the suprasternal notch area (the "AcuPebble SA100 sensor"), and attaches with a single use biocompatible adhesive tape (same one as for "AcuPebble SA100" too); 2- Another physiological wireless sensing device ("AcuPebble finger oximetry sensor") worn on the finger; 3- A mobile device app (the "AcuPebble Ox100 app") that guides the patient through the steps of the test, collects the data from the sensor (continuously in the case of the "AcuPebble SA100 sensor", and at the end of the test in the case of the "AcuPebble finger oximetry sensor"), and uploads them in the cloud ; 4- A cloud-based software that analyses the signals from the "AcuPebble SA100 sensor" (already cleared as part of K210480); 5- A web app user interface for healthcare professionals where they can set up a study and see the results, including different physiological channel traces and OSA diagnostic parameters.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Front of the neck and finger
Indicated Patient Age Range
Adults
Intended User / Care Setting
Healthcare Professional (HCP) / Home settings, healthcare settings
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Diagnostic LR+: 29.36 /32.29
Diagnostic LR-: 0.08 /0.04 (CI- 0.03 to 0.19/0.01 to 0.16)
Diagnostic Sensitivity: 92.73% /95.92% (CI-82.41% to 97.98% /86.02% to 99.50%)
Diagnostic Specificity: 96.84% /97.03%
Pulse rate: 50-120bm (3.62bpm validation accuracy) when obtained from heart sounds PR from PPG meets the requirement of ±2bpm or ±2%.
SpO2 performance: Compliant with ISO 80601-2-61 80%-100%, 2% root-mean-square difference 70%-79%, 3% root-mean-square difference
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
February 3, 2023
Acurable Limited Esther Rodriguez-Villegas Cso Finsgate, 5-7 Cranwood Street London, London EC1V 9EE United Kingdom
Re: K222950
Trade/Device Name: AcuPebble Ox100 Regulation Number: 21 CFR 868.2375 Regulation Name: Breathing Frequency Monitor Regulatory Class: Class II Product Code: MNR Dated: December 19, 2022 Received: December 27, 2022
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 -S
Rachana Visaria, Ph.D. Assistant Director DHT1C: Division of 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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Indications for Use
510(k) Number (if known)
Device Name
AcuPebble Ox100
Indications for Use (Describe)
AcuPebble Ox100 is a wearable device intended for use in the recording, analysis, displaying, exporting, and storage of biophysical parameters to aid in the evaluation of adult patients with, or with suspected, obstructive sleep apnea (OSA). The device is primarily intended for home settings use (although can also be used in healthcare settings) under the direction of a Healthcare Professional (HCP).
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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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: | February 2, 2023 |
| Trade Name: | AcuPebble Ox100 |
| Product Classification Name: | Ventilatory effort recorder |
| Regulation number: | 21 CFR §868.2375 (Breathing Frequency
Monitor) |
| Product Code: | MNR |
| Classification Panel: | Anesthesiology |
| Device Classification: | Class II |
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1. Intended Use / Indications for Use
AcuPebble Ox100 is a wearable device intended for use in the recording, analysis, displaying, exporting, and storage of biophysical parameters to aid in the evaluation of adult patients with, or with suspected, obstructive sleep apnea (OSA). The device is primarily intended for home setting use (although can also be used in healthcare settings) under the direction of a Healthcare Professional (HCP).
2. DEVICE DESCRIPTION
AcuPebble Ox100 is prescribed by a Health Care Professional for the patient to use in the home as a 'home sleep apnea test' (HSAT). AcuPebble Ox100 comprises: 1- A small physiological sensing device, identical to the previously cleared device AcuPebble SA100 (K210480) that is worn on the front of the neck around the suprasternal notch area (the "AcuPebble SA100 sensor"), and attaches with a single use biocompatible adhesive tape (same one as for "AcuPebble SA100" too); 2- Another physiological wireless sensing device ("AcuPebble finger oximetry sensor") worn on the finger; 3- A mobile device app (the "AcuPebble Ox100 app") that guides the patient through the steps of the test, collects the data from the sensor (continuously in the case of the "AcuPebble SA100 sensor", and at the end of the test in the case of the "AcuPebble finger oximetry sensor"), and uploads them in the cloud ; 4- A cloud-based software that analyses the signals from the "AcuPebble SA100 sensor" (already cleared as part of K210480); 5- A web app user interface for healthcare professionals where they can set up a study and see the results, including different physiological channel traces and OSA diagnostic parameters. Outputs of the device relevant to its intended use are further described in the comparison table below.
3. PREDICATE DEVICE
The predicate device is shown in the Table below:
| K number | Product Code | Class | Device Name |
|---|---|---|---|
| K210480 | MNR | II | AcuPebble |
| SA100 |
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QCUI e
4. Summary of Comparison to Predicate and Reference
| | DEVICE SUBJECT OF
THIS APPLICATION
AcuPebble Ox100 by
Acurable Ltd | PREDICATE DEVICE
AcuPebble SA100,
K210480, by Acurable
Ltd | REFERENCE DEVICE
NightOwl, K191031,
by Ectosense | COMPARISON |
|--------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications
for use | AcuPebble Ox100 is a
wearable device
intended for use in the
recording, analysis,
displaying, exporting,
and storage of
biophysical parameters
to aid in the evaluation
of adult patients with,
or with suspected,
obstructive sleep
apnea (OSA). The
device is primarily
intended for home
setting use (although it
can also be used in
healthcare settings)
under the direction of
a Healthcare
Professional (HCP). | 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
(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. | 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). | Substantially
equivalent to the
predicate and
identical to the
reference device.
This does not raise
additional issues of
safety or efficacy
since AcuPebble
Ox100 provides the
channels of
AcuPebble SA100
and complements
this with a PPG based
oximetry channel as
per the reference
device. In the
context of the
indications for use,
the additional
channels provided by
AcuPebble Ox100
when compared to
the reference device:
1- Were already
approved as part of
AcuPebble SA100; 2-
Complement
oximetry to aid in the
diagnosis of OSA |
| Regulation
number | 868.2375 | 868.2375 | 868.2375 | Same |
| Product Code | MNR | MNR | MNR | Same |
| Generic
Device Name | Ventilatory Effort
Recorder | Ventilatory Effort
Recorder | Ventilatory Effort
Recorder | Same |
| Prescription | Prescription | Prescription | Prescription | Same |
| Target | Adults | Adults | 22 years old and older | Same |
| population | | | | |
| Intended
environment
for use | Primarily home
environment, although
it can be used in
healthcare
environments | Primarily home
environment, although it
can be used in
healthcare
environments | Clinical and Home
environment | Same |
| Sensor
placement | Front of the neck and
finger | Front of the neck | Finger | Substantially
equivalent. The
sensor on the neck
allows sensing of
physiological signals
directly generated by
the cardiorespiratory
system, in the same
way as the predicate.
This is in addition to
the surrogate signals
(blood related
features) that are
sensed on the finger
as in the reference
device. |
| Physical
sensing
elements | Piezoelectric
(microphones)/
LED+photodiode | Piezoelectric
(microphones) | Piezoelectric
(accelerometer)/LED+photodiode | Substantially
equivalent. The
optical sensors do not
interfere with the
other ones and are
used to extract SpO2
as in the reference
device. |
| Patient
contact | Yes | Yes | Yes | Same |
| Means of
attachment | Adhesive (patient self-
applied) | Adhesive (patient self-
applied) | Adhesive (patient self-
applied) | Substantially
equivalent. They both
use adhesives and
they are both self-
applied |
| Sleep night
use | Multiple nights possible | Multiple nights possible | Multiple nights possible | Same |
| Portability | Yes (Wearable) | Yes (wearable) | Yes (wearable) | Same |
| Size and
weight | 29.5mm diameter x
16mm height, 7g weight
for neck sensor. 38mm x
30mm x38mm, 15g
weight for finger
sensor. | 29.5mm diameter x
16mm height, 7g weight
for neck sensor. 38mm x
30mm x38mm | 19x28x11mm, 6g | Substantially
equivalent. The
sensor on the neck is
identical to the one in
the predicate. The
finger sensor is not in
the predicate but the
reference device uses
a sensor on the finger |
| | | | | which is comparable
to the one in this
device in size and
weight. |
| Recording
device | Mobile device records
signals streamed from
the sensors and uploads
them into a cloud-based
server | Mobile device records
signals streamed from
the sensor and uploads
them into a cloud-based
server | Mobile device records
signals streamed from
the sensor and uploads
them into a cloud-
based server | Same |
| Output
Channels | SPO2, PPG, Pulse rate
(x2 from PPG and from
sounds), activity
(movement), heart
sounds, respiration
inhalation and
exhalation patterns,
airflow (Acoustic
derived), snoring | Pulse rate (from
sounds), activity
(movement), heart
sounds, respiration
inhalation and exhalation
patterns, airflow
(Acoustic derived),
snoring | SPO2, PPG, Pulse rate,
activity (movement) | Substantially
equivalent. The
additional channels of
AcuPebble Ox100
provide extra
information that
serves to further
aid/support in the
interpretation and
subsequent
intervention/manage
ment of the disease
by a healthcare
professional. These
channels already
appear in other
|
| Physical
sensing
elements | Piezoelectric
(microphones)/
LED+photodiode | Piezoelectric
(microphones) | Piezoelectric
(accelerometer)/
LED+photodiode | Substantially
equivalent. The
optical sensors do not
interfere with the
other ones and are
used in the same way
as in the predicate. |
| Types of
events used
for OSA
indexes | Apneas/hypopneas | Apneas/hypopneas | Apneas/hypopneas | Same |
| Calculated
OSA AASM
recommended
indexes | AcuPebble_AHI
AcuPebble_ODI | AcuPebble_AHI
AcuPebble_ODI | NightOwl's AHI | Same as the
predicate (the
indexes are obtained
from acoustic derived
physiological
biomarkers).
In the reference
device they are
calculated from
optically obtained
biomarkers (this
includes SpO2
obtained from the
PPG signal. |
| | | | | |
| Diagnostic
LR+ | 29.36 /32.29 | 29.36 /32.29 | 5.10 | Same |
| Diagnostic
LR- | 0.08 /0.04
(CI- 0.03 to 0.19/0.01 to
0.16) | 0.08 /0.04
(CI- 0.03 to 0.19/0.01 to
0.16) | 0.04
(CI- 0.01 to 0.17) | Same |
| Diagnostic
Sensitivity | 92.73% /95.92%
(CI-82.41% to 97.98%
/86.02% to 99.50%) | 92.73% /95.92%
(CI- 82.41% to 97.98%
/86.02% to 99.50%) | 96.55% (CI- 88.09% to
99.58%) | Same |
| Diagnostic
Specificity | 96.84% /97.03% | 96.84% /97.03% | 70.4% to 81.08% | Same |
| Pulse rate | 50-120bm (3.62bpm
validation accuracy)
when obtained from
heart sounds
PR from PPG meets the
requirement of ±2bpm
or ±2%. | 50-120bm (3.62bpm
validation accuracy)
when obtained from
heart sounds | 50-118bpm (2.26bpm
validation accuracy) | Same |
| SpO2
performance | Compliant with ISO
80601-2-61
80%-100%, 2% root-
mean-square
difference
70%-79%, 3% root-
mean-square
difference | Not applicable | Compliant with ISO
80601-2-61, i.e. SpO2
accuracy with a root-
mean-square difference
of less or equal to 4%
over 70-100% SaO2. | Same |
| 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. | From the sensor to the
mobile phone using
Bluetooth and from the
phone to the cloud
(server) through a
smartphone by 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. | Same |
| Microcontroll
er+Communi
cation chip | Nordic nRF52832
(Bluetooth
communication) | Nordic nRF52832
(Bluetooth
communication) | Nordic nRF52832
(Bluetooth
communication) | Same |
| Sensor Power
Source | Rechargeable lithium
polymer battery (neck
sensor), and
rechargeable lithium
ion battery (ring
oximeter sensor) | Rechargeable lithium
polymer battery (neck
sensor) | Rechargeable lithium
ion polymer battery | Substantially
equivalent. Same
chemistry, similar
capacity, just two
batteries (not
connected within the
same circuits), one
for each sensor |
| Sensor | Firmware is limited to
control the recording | Firmware is limited to
control the recording | Firmware is limited to
control the recording | Same |
| Software | and communications
processes. No
presentation of OSA test
results to the patient.
Data analyzed and
presented in a separate
software suite. | and communications
processes. No
presentation of OSA test
results to the patient.
Data analyzed and
presented in a separate
software suite. | and communications
processes. No
presentation of test
results to the patient.
Data analyzed and
presented in a separate
software suite. | |
| 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. | Same |
| Display OSA
test results | Smartphone (or tablet)
or computer screen for
healthcare
professionals. Smart
phone (or tablet) for
patients app. | Smartphone (or tablet)
or computer screen for
healthcare professionals.
Smart phone (or tablet)
for patients app. | Smartphone for
patients. For healthcare
professionals, one or
several of: smartphone
(or tablet) or computer
screen (unclear which
ones) | Same |
| Patient
connection | 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. | Device has no galvanic
connections to mains as
it is a battery-operated
device. | Same |
| Sterilization | Non sterile | Non sterile | Non sterile | Same |
| Biocompatibi
lity | Assessed to ISO10993-
1:2009 requirements for
sensitization, irritation
and cytotoxicity, and
USP class VI | Assessed to ISO10993-
1:2009 requirements for
sensitization, irritation
and cytotoxicity, and
USP class VI | Assessed to ISO10993-1:2009 requirements
for sensitization,
irritation and
cytotoxicity | Same |
6
7
8
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5. PERFORMANCE DATA
Biocompatibility
The enclosure and adhesive of the neck sensor of AcuPebble Ox100 are the same as in the predicate device (K210480).
The enclosure of the finger sensor has undergone biocompatibility testing as per the recognized consensus standard ISO 10993 (Biological Evaluation of Medical Devices) with passing results. Following the principles described in ISO 10993, the device falls into the category of surface-contacting, limited exposure (A) devices. More specifically it is a skin contact device (i.e. a device that contacts skin surfaces only), which is to be used for less than 24h.
General Requirements for Safety and Electromagnetic Compatibility (EMC)
AcuPebble Ox100 complies with the following recognized consensus standards:
- . IEC 60601-1:2005:MOD - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance.
- . IEC 60601-1-2:2014 - Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests.
10
Home Healthcare Environment Safety
AcuPebble Ox100 complies 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.
Risk Management
AcuPebble Ox100 risk management complies with the recognized consensus standard ISO 14971:2019 "Application of risk management to medical devices".
Further information regarding this is included in this submission.
Quality Management
Acurable is ISO 13485:2016 certified by MTIC InterCert SRL.
Software Verification and Validation Testing
AcuPebble Ox100 has been tested and found to comply with the recognized consensus standard IEC 62304:2006/A1:2016 ("Medical device software - Software life cycle processes"), including sections "5.6 Software integration and integration testing" and "5.7 Software system testing". The software for this device was considered as "moderate" level of concern.
Furthermore, the cybersecurity risks were addressed according to FDA's cybersecurity guidance document ("Content of Premarket Submissions for Management of Cybersecurity in Medical Devices", October 2, 2014)
6. CONCLUSION
Based on the performance data and testing in conformance to consensus standards, AcuPebble Ox100 has been demonstrated to be substantially equivalent to the predicate device.