Who is the manufacturer of AcuPebble Ox (200)?

Acurable Limited filed the 510(k) submission for AcuPebble Ox (200) (K243092).

What is the FDA product code for AcuPebble Ox (200)?

MNR. It is classified under 21 CFR 868.2375 as a Class 2 device in the Anesthesiology panel.

What is the regulatory pathway for AcuPebble Ox (200)?

510(k) clearance (submission type: Traditional).

Does AcuPebble Ox (200) use AI or machine learning?

Yes. AcuPebble Ox (200) (K243092) is flagged as an AI/ML-enabled medical device in the FDA's AI/ML device list.

Who can help prepare an FDA 510(k) submission like AcuPebble Ox (200)?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Can an AI/ML device like AcuPebble Ox (200) get a guaranteed FDA 510(k) clearance?

Yes. Innolitics offers a guaranteed FDA 510(k) clearance engagement for AI/ML Software as a Medical Device — combining engineering and regulatory execution under one agreement with a guaranteed clearance outcome. Eligibility: the device must be an AI/ML Software as a Medical Device (SaMD), and its performance must meet the criteria Innolitics determines during an initial regulatory strategy engagement to be necessary for FDA clearance. See https://innolitics.com/services/end-to-end-samd/ or contact https://innolitics.com/contact.

AcuPebble Ox (200)

K243092 · Acurable Limited · MNR · Mar 19, 2025 · Anesthesiology

Device Facts

Record ID	K243092
Device Name	AcuPebble Ox (200)
Applicant	Acurable Limited
Product Code	MNR · Anesthesiology
Decision Date	Mar 19, 2025
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 868.2375
Device Class	Class 2
Attributes	AI/ML

Intended Use

AcuPebble Ox200 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).

Device Story

AcuPebble Ox200 is a wearable home sleep apnea test (HSAT) system. It consists of a neck-worn acoustic/accelerometer sensor (suprasternal notch) and a PPG/accelerometer sensor (finger or forehead). A mobile app guides the patient, collects sensor data, and uploads it to a cloud-based server. Proprietary cloud software analyzes the signals to extract biophysical parameters, including SpO2, pulse rate, respiratory rate, respiratory effort, body position, and snoring. Healthcare professionals access results via a web interface to evaluate OSA diagnostic indexes (e.g., AHI). The device aids in OSA diagnosis by providing objective physiological data, potentially reducing the need for in-lab polysomnography.

Clinical Evidence

Clinical validation included: 1) SpO2/pulse rate validation (12 subjects, ISO 80601-2-61:2017) showing Arms 1.86-2.25 (forehead/finger) and pulse rate RMSE 1.23 bpm. 2) Respiratory rate validation (31 healthy subjects vs. capnography; 150 OSA patients vs. Embletta MPR) showing RMSD 2.46-2.52 bpm. 3) Respiratory effort validation (150 patients vs. RIP bands) showing 96.8% agreement with manual scoring and 96.3% accuracy vs. Embla RemLogic. 4) Position detection (17 volunteers; 60 patients) showing 79.00%-93.93% accuracy.

Technological Characteristics

Wearable sensors: piezoelectric microphones, LEDs/photodiodes, accelerometers. Materials: biocompatible adhesive tape, silicone gel, PC. Connectivity: Bluetooth to mobile app, cloud-based analysis. Power: rechargeable Li-ion polymer batteries. Standards: EN 60601-1, EN 60601-1-2, IEC 60601-1-11, ISO 80601-2-61, ISO 10993-1. Software: cloud-based proprietary analysis, mobile app for data collection.

Indications for Use

Indicated for adult patients with, or suspected of having, obstructive sleep apnea (OSA). Intended for use in home or healthcare settings under the direction of a healthcare professional.

Regulatory Classification

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

AcuPebble Ox100 (K222950)

Reference Devices

Airmod (K242798)
Huxley SANSA Home Sleep Apnea Test (1000-00) (K240285)
AcuPebble SA100 (K210480)
Capnography (K150272)
Embletta MPR Sleep Data Recording System (K122516)
Embla RemLogic (K162140)

Related Devices

K222950 — AcuPebble OX100 · Acurable Limited · Feb 3, 2023
K210480 — AcuPebble SA · Acurable Limited · Jul 6, 2021
K220028 — NightOwl · Ectosense NV · Feb 24, 2022
K213463 — NightOwl · Ectosense NV · Dec 16, 2021
K191031 — NightOwl · Ectosense NV · Mar 6, 2020

Submission Summary (Full Text)

{0}------------------------------------------------ March 19, 2025 Image /page/0/Picture/1 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 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. Acurable Limited Esther Rodriguez-Villegas CSO 2 Leman Street London, E1W 9US United Kingdom Re: K243092 Trade/Device Name: AcuPebble Ox200 Regulation Number: 21 CFR 868.2375 Regulation Name: Breathing Frequency Monitor Regulatory Class: Class II Product Code: MNR Dated: February 10, 2025 Received: February 10, 2025 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 (the 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 available 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. Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" {1}------------------------------------------------ (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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). {2}------------------------------------------------ Sincerely, ### Rachana Visaria -S Rachana Visaria, Ph.D. Assistant Director DHT1C: Division of Anesthesia, Respiratory, and Sleep Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT, and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ ### Indications for Use Submission Number (if known) K243092 Device Name AcuPebble Ox200 Indications for Use (Describe) AcuPebble Ox200 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). 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 {4}------------------------------------------------ ### QCU ### 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 2 Leman Street, London E1W 9US, UK | |------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------| | Contact person: | Professor Esther Rodriguez-Villegas CSO Acurable Ltd 20 Victoria Street, SW1H ONB, London, UK esther@acurable.com +442075946193 | | Date summary prepared: | 18th Mar 2025 | | Trade Name: | AcuPebble Ox200 | | 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 | {5}------------------------------------------------ ### 1. Intended Use / Indications for Use AcuPebble Ox200 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 Ox200 is prescribed by a Health Care Professional for the patient to use in the home as a 'home sleep apnea test' (HSAT). AcuPebble Ox200 comprises: 1- A small microphones/accelerometer sensor, identical to the one in the previously cleared devices AcuPebble SA100 (K210480) and AcuPebble Ox100 (K222950) 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" and "AcuPebble Ox100)); 2- Another PPG/accelerometer sensor ("AcuPebble_oximetry sensor") worn either on the finger or on the forehead; 2- A mobile device app (the "AcuPebble Ox200 app") that guides the patient through the steps of the test, collects the data from the sensors, and uploads them in the cloud ; 3- A cloud-based software that analyses the collected signals as in the previously cleared devices; 4- 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, as in the previously cleared devices. The differences between AcuPebble Ox200 and the previously cleared device (K222950) are: - A new sensor for sensing the PPG signal and extraction of the SpO2 and pulse rate channel from. This new sensor can be placed either on the finger or the forehead. - The addition of new parameters extracted from the acoustic neck sensor including position, respiratory efforts and respiratory rate channels. The OSA diagnostic indexes are still extracted from the signals measured with the identical sensor as in the predicate (neck sensor only), and with the same algorithms, remain unchanged with respect to the predicate device (K222950) and hence have not been separately tested in this device. ### 3. Predicate Device The predicate device is shown in the Table below: | K number | Product Code | Class | Device Name | |----------|--------------|-------|-----------------| | K222950 | MNR | II | AcuPebble Ox100 | The reference devices are shown in the Table below: {6}------------------------------------------------ | K number | Product Code | Class | Device Name | |----------|--------------|-------|-------------------------------------------------| | K242798 | BZQ | II | Airmod | | K240285 | MNR | II | Huxley SANSA Home Sleep Apnea Test (1000-00) | {7}------------------------------------------------ ### 4. Summary of Comparison to Predicate | | DEVICE SUBJECT OF THIS APPLICATION | PREDICATE DEVICE | REFERENCE DEVICE (1) | REFERENCE DEVICE (2) | COMPARISON | |------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------| | | AcuPebble Ox200 K243092, by Acurable Ltd | AcuPebble Ox100, K222950, by Acurable Ltd | AIRMOD, K242798, by Heroic Faith International Ltd. | HUXLEY SANSA HOME SLEEP APNEA TEST (1000-00), K240285, by Huxley Medical | | | Indications for use | AcuPebble Ox200 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 Ox200 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). | Airmod, when used in conjunction with AccurSound Electronic Stethoscope AS-101, is a software as medical device intended to be used for the continuous, non-invasive monitoring of respiratory rate (RR) in adult patients who are subjected to procedural sedation and/or anesthesia. Airmod is intended for use by healthcare professionals in hospitals and healthcare facilities who are legally credentialed to perform procedural sedation and/or anesthesia. Airmod is intended for Android-based devices only | The Huxley Home Sleep Apnea Test (SANSA) is a wearable device intended for use in the recording, analysis, and storage of biophysical parameters to aid in the evaluation of sleep-related breathing disorders of adults suspected of sleep apnea. The device is intended for the clinical and home use setting under the direction of a Healthcare Professional (HCP). | Same as predicate | | Regulation number | 868.2375 | 868.2375 | 868.2375 | 868.2375 | Same as predicate | 18th Mar 2025 V- 4 of 14 {8}------------------------------------------------ | Product Code | MNR | MNR | BZQ | MNR/BZQ | Same as predicate | Means of attachment | Adhesive (patient self- applied) | Adhesive (patient self- applied) | N/A | Adhesive | Same as predicate | |------------------------------------|-----------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------|---------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Generic Device Name | Ventilatory Effort Recorder | Ventilatory Effort Recorder | Breathing Frequency Monitor | Ventilatory Effort Recorder/Breathing Frequency Monitor | Same as predicate | Sleep night use | Multiple nights possible | Multiple nights possible | N/A | Multiple nights possible | Same as predicate | | Prescription | Prescription | Prescription | Prescription | Prescription | Same as predicate | Portability | Yes (Wearable) | Yes (Wearable) | N/A | Yes (Wearable) | Same as predicate | | Target population | Adults | Adults | Adults undergoing procedural sedation and/or anesthesia | Adults (22 years age and older) | Same as predicate | Size and weight | 29.5mm diameter x 16mm height, 7g weight for neck sensor. 17.25mm x 24.6mm x 12.6 mm, 6g weight for finger/forehead sensor. | 29.5mm diameter x 16mm height, 7g weight for neck sensor. 38mm x 30mm x38mm, 15g weight for finger sensor. | N/A | 131mmx74mmx11mm, 13g, 60mm x51mm x16mm, 45g | Substantially equivalent. The finger sensor is smaller. This does not pose any new questions of safety and effectiveness. | | 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 | Hospitals and healthcare facilities | Clinics and Home Use | Same as predicate | 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 | Compatible stethoscope with microphone records acoustic signals | Chest patch sensor record signals then transferred via USB | Same as predicate | | Sensor placement | Front of the neck and either finger or forehead | Front of the neck and finger | Neck | Chest | Same as predicate if placed in finger. If placed in the forehead substantially equivalent. Performance validated as per ISO 80601-2-61:2017. | Channels | SPO2, PPG, Pulse rate (x2 from PPG and from sounds), activity (movement), heart sounds, respiration inhalation and exhalation patterns, airflow, respiratory effort, respiratory rate, snoring, position | SPO2, PPG, Pulse rate (x2 from PPG and from sounds), activity (movement), heart sounds, respiration inhalation and exhalation patterns, airflow, snoring | Respiratory rate | Oximetry, Heartrate, Chest movement, Snoring, Body position, Respiratory effort, Actigraphy, Sleep stage (Sleep/Wake), ECG (Reference channel only) | AcuPebble Ox200 is substantially equivalent to the predicate device. While AcuPebble Ox200 outputs additional channels compared to the predicate device, these outputs are technologically consistent with those of the reference device. Validation testing has demonstrated that the additional outputs perform | | Physical sensing elements | Piezoelectric (microphones)/ LED+photodiode/acceler ometers | Piezoelectric (microphones)/ LED+photodiode/accelerom eters | N/A (Software to be used in conjunction with AccurSound Electronic Stethoscope AS- 101) | Accelerometer, ECG, Reflectance Photoplethysmography | Same as predicate | | | | | | | | Patient contact | Yes | Yes | N/A | Yes | Same as predicate | | | | | | | {9}------------------------------------------------ {10}------------------------------------------------ | | Types of events used for OSA indexes | Apneas/hypopneas | Apneas/hypopneas | N/A | N/A | equivalently to the reference device, and no new questions of safety and effectiveness are raised. | |--------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Calculated OSA AASM recommende d indexes | AHI (with 3% desaturation criteria), AHI (with 4% desaturation criteria) | AHI (with 3% desaturation criteria), AHI (with 4% desaturation criteria) | N/A | SDB | Same as predicate | | | 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%) | N/A | 88.2% (CI: 81.3% to 93.2%) | Same as predicate | | | Diagnostic Specificity | 96.84% /97.03% | 96.84% /97.03% | N/A | 87.3% (CI: 82.1% to 91.5%) | Same as predicate | | | Pulse rate | 50-120bpm (3.62bpm validation accuracy from acoustics, Arms < 1.23bpm from PPG) | 50-120bpm (3.62bpm validation accuracy from acoustics, Arms < 2 bpm from PPG) | N/A | 30-250bpm: Arms ≤ 3 bpm | Same as predicate for acoustics. Substantially equivalent for pulse rate to the predicate and this does not raise any new question of safety and effectiveness. | | Respiratory rate | 4-30 bpm, resolution 1 bpm, accuracy ±3 bpm | N/A | 4-35 bpm, ±2.7 bpm | N/A | This is an additional output with respect to the predicate. However, this output is technologically consistent with those of the reference device and validation testing has demonstrated that it performs equivalently to the reference device. Hence no new questions of safety and effectiveness are raised. | | | Real-time respiratory rate output | No | N/A | Yes (with alarm) | N/A | Same as predicate | | | Respiratory effort | The accuracy in differentiating between segments with no breathing effort vs with effort (ie what the respiratory effort channels are used in the context of the intended use ) is 96.3%. (clinical testing) | N/A | N/A | Non-clinical bench testing. | This is an additional output with respect to the predicate. However, this output is technologically consistent with those of the reference device and validation testing has demonstrated that it is not inferior to the latter. Hence no new questions of safety and effectiveness are raised. | | | Position | 93.93% accuracy in controlled condition and 79.00% accuracy during natural sleep in identifying supine, | N/A | N/A | Using accelerometer, non- clinical bench testing. | This is an additional output with respect to the predicate. However, this output is technologically consistent with those of the reference device | | | | prone, left, right, and upright position | | | | and validation testing has demonstrated that it is not inferior to the latter. Hence no new questions of safety and effectiveness are raised. | | | 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 compatible stethoscope to the Android mobile phone | Patient data is physically transferred via USB after study conclusion. | Same as predicate | | | Microcontrol ler+ Communicati on chip | Nordic nRF52832 (Bluetooth communication) | Nordic nRF52832 (Bluetooth communication) | N/A | N/A | Same as predicate | | | Sensor Power Source | Rechargeable lithium ion polymer batteries | Rechargeable lithium polymer battery (neck sensor), and rechargeable lithium ion battery (ring oximeter sensor) | N/A | Rechargeable Lithium Polymer Battery | Same as predicate | | | Sensor Software | Firmware is limited to control the recording and communications processes. No presentation of OSA test results to the patient. Data analyzed and | 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. | N/A | The patient data is physically transferred via USB after study conclusion. | Same as predicate | | | | 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 | Analysis performed off the recording device, on a compatible cloudbased software platform. | Same as predicate | | | 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. | N/A | Software portal where physiological tracings are made available for diagnostic purposes. | Same as predicate | | | 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. | N/A | Device has no galvanic connections to mains as it is a battery-operated device. | Same as predicate | | | Sterilization | Non sterile | Non sterile | N/A | Non sterile | Same as predicate | | | Biocompatibi lity | The materials in contact with the body are identical for both the neck and the finger/forehead sensor. The neck sensor is the same as the neck sensor in the predicate. | Contact materials corresponding to the neck sensor and different ones corresponding to the finger sensor. | N/A | The device is considered as a surface device in contact with intact skin per ISO 10993-1. The biocompatibility evaluation was completed and included Cytotoxicity, Sensitization and Irritation testing. All testing passed. | Same as predicate | | | Duration of contact as | Limited exposure | Limited exposure | N/A | Limited exposure | Same as predicate | | | per ISO 10993 | | | | | | | | Attachment to the body materials | Hypoallergenic acrylate Medical Adhesive | Hypoallergenic acrylate Medical Adhesive Plus: silicon gel and PC (finger) | N/A | Unpublished information | Same as predicate | | | EMC Testing & Compliance | EN 60601-1-2 (2015) / A1 (2021) | EN 60601-1-2 (2015) | N/A | 60601-1-2 | Same as predicate | | | Electrical Safety Testing (Standards Compliance) | EN 60601-1: 2006 + A11: 2011 + A1:2013 + A2:2021 / EN 60601-1- 6:2010 + A1:2015 / EN 62366- 1:2015 + A1:2020 | IEC 60601-1:2006 +A11:2011 +A1:2013 | N/A | 60601-1 | Same as predicate | | | Home environment testing (Standards Compliance) | IEC 60601-1-11:2015 | IEC 60601-1-11:2015 | N/A | 60601-1-11 | Same as predicate | | | SPO2 testing | ISO 80601-2-61:2017 | ISO 80601-2-61:2017 | N/A | 80601-2-61 | Same as predicate | | 18th Mar 2025 {11}------------------------------------------------ 18th Mar 2025 V- 8 of 14 {12}------------------------------------------------ {13}------------------------------------------------ 18th Mar 2025 V- 10 of 14 {14}------------------------------------------------ 18th Mar 2025 V- 11 of 14 {15}------------------------------------------------ ### 5. PERFORMANCE DATA ### Biocompatibility The materials of both sensors in AcuPebble Ox200 that come in contact with the body are the same as in the previously cleared device K210480. The duration and type of exposure is exactly the same too. ### General Requirements for Safety and Electromagnetic Compatibility (EMC) AcuPebble Ox200 complies with the following recognized consensus standards: - . EN 60601-1: 2006 + A11: 2011 + A1:2013 + A2:2021 / EN 60601-1-6:2010 + A1:2015 / EN 62366-1:2015 + A1:2020- Medical electrical equipment - Part 1: General requirements for basic safety and essential performance. - . EN 60601-1-2 (2015) / A1 (2021)- 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 Ox200 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. ### Usability AcuPebble Ox200 complies with the following recognized consensus standards: - . IEC 62366-1 2020- Medical devices-Part 1: Application of usability engineering to medical devices - . IEC 60601-1-6 2020- Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability. ### Risk Management AcuPebble Ox200 risk management complies with the recognised consensus standard ISO 14971:2019 "Application of risk management to medical devices". ### 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") and includes "Software integration and integration testing" and "Software system testing" and FDA's software functions guidance {16}------------------------------------------------ document ("Content of Premarket Submissions for Device Software Functions", June 14, 2023). Furthermore, the cybersecurity risks were addressed according to FDA's cybersecurity guidance document ("Cybersecurity in Medical Devices: Quality System Content of Premarket Submissions", September 27, 2023). ### Clinical Validation Summary The performance of the SpO2 and pulse rate output has been validated as per ISO 80601-2-61:2017 by an independent testing lab. The validation was performed on 12 subjects with varying skin tone. The Arms of the OxiPebble SpO2 validated in the range of 70% to 100% was comparable to the predicate, at 1.86 and 2.25 when used on the forehead and on the finger respectively. On the subject whose skin tone was the lightest (Fitzpatrick scale 1 and Monk scale 1), the Arms for the SpO2 is 1.63 and 1.44 when used on the forehead and on the finger respectively. On the subject whose skin tone was the darkest (Fitzpatrick scale 6 and Monk scale 10), the Arms for the SpO2 is 0.66 and 1.36 when used on the forehead and on the finger respectively. For the pulse rate, the average RMSE was found to be 1.23 bpm for both when worn on the forehead and on the finger. The pulse rate output was also tested at the claimed range 50-120 bpm using a functional simulator (Contec SpO2 Simulator MS100, Contec Medical System), where the average RMSE was 0.55 bpm and worst case RMSE was 1.66 bpm. The respiratory rate has been validated for the 4-30 bpm range in two studies. The first study included 31 healthy subjects. The study was conducted under laboratory conditions against capnography (K150272). The overall RMSD was 2.52 bpm for a range 4-30bpm. The second evaluation was during natural sleep in 150 patients who had been referred for diagnosis of OSA to the Sleep and Ventilation clinic at the Royal Free London Hospital NHS Foundation Trust (Trial registration number: NCT03544086) where the RMSD was 2.46 bpm compared to the chest and abdomen respiratory effort band of Embletta MPR Sleep Data Recording System (K122516). This accuracy and range are comparable to the reference devices (Airmod K2427984. 4-35 bpm, ±2.7 bpm), which also obtained the RR from an acoustic respiratory signal. The respiratory effort detection has been validated against respiratory inductance plethysmography (RIP) bands during natural sleep in 150 patients referred for OSA diagnosis at the Sleep and V…