AcuPebble OX100

K222950 · Acurable Limited · MNR · Feb 3, 2023 · Anesthesiology

Device Facts

• Record ID: K222950
• Device Name: AcuPebble OX100
• Applicant: Acurable Limited
• Product Code: MNR · Anesthesiology
• Decision Date: Feb 3, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.2375
• Device Class: Class 2

Intended 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).

Device Story

AcuPebble Ox100 is a wearable home sleep apnea test (HSAT) system. It consists of a neck-worn physiological sensor (identical to AcuPebble SA100), a finger-worn pulse oximetry sensor, a mobile app, and cloud-based analysis software. The neck sensor captures acoustic signals (heart sounds, respiration, snoring) and movement; the finger sensor captures PPG signals. The mobile app guides the patient, collects data, and uploads it to the cloud. Cloud software analyzes signals to derive OSA diagnostic parameters (AHI, ODI). Healthcare professionals access results via a web interface to evaluate patients. The device aids in OSA diagnosis by providing objective physiological data, potentially reducing the need for full polysomnography in appropriate cases.

Clinical Evidence

No clinical data provided. Substantial equivalence is supported by bench testing, including biocompatibility (ISO 10993), electrical safety (IEC 60601-1), EMC (IEC 60601-1-2), home healthcare environment safety (IEC 60601-1-11), and software validation (IEC 62304). SpO2 performance is compliant with ISO 80601-2-61.

Technological Characteristics

Neck sensor: piezoelectric microphones; Finger sensor: LED/photodiode (PPG). Connectivity: Bluetooth to mobile app, then cloud-based analysis. Power: Rechargeable Li-poly (neck) and Li-ion (finger) batteries. Biocompatibility: ISO 10993-1. Software: Moderate level of concern. Non-sterile.

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 SA100 (K210480)

Reference Devices

• NightOwl (K191031)

Submission Summary (Full Text)

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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

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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 ([e-mail]) or phone [phone] 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)

K222950

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)

| <div> <span> <svg height="16" width="16"> <rect fill="white" height="16" stroke="black" stroke-width="1" width="16"></rect> <path d="M2,2 L14,14 M14,2 L2,14" stroke="black" stroke-width="2"></path> </svg> </span> Prescription Use (Part 21 CFR 801 Subpart D) </div> |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| <div> <span> <svg height="16" width="16"> <rect fill="white" height="16" stroke="black" stroke-width="1" width="16"></rect> </svg> </span> Over-The-Counter Use (21 CFR 801 Subpart C) </div> |

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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<br>Finsgate<br>5-7 Cranwood Street<br>London EC1V 9EE<br>United Kingdom |
|------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact person: | Professor Esther Rodriguez-Villegas<br>CSO<br>Acurable Ltd<br>5th Floor, 21 Knightsbridge, London<br>SW1X 7LY, UK<br>[e-mail]<br>[phone] |
| Date summary prepared: | February 2, 2023 |
| Trade Name: | AcuPebble Ox100 |
| Product Classification Name: | Ventilatory effort recorder |
| Regulation number: | 21 CFR §868.2375 (Breathing Frequency<br>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<br>SA100 |

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## QCUI e

### 4. Summary of Comparison to Predicate and Reference

| | DEVICE SUBJECT OF<br>THIS APPLICATION<br>AcuPebble Ox100 by<br>Acurable Ltd | PREDICATE DEVICE<br>AcuPebble SA100,<br>K210480, by Acurable<br>Ltd | REFERENCE DEVICE<br>NightOwl, K191031,<br>by Ectosense | COMPARISON |
|--------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications<br>for use | AcuPebble Ox100 is a<br>wearable device<br>intended for use in the<br>recording, analysis,<br>displaying, exporting,<br>and storage of<br>biophysical parameters<br>to aid in the evaluation<br>of adult patients with,<br>or with suspected,<br>obstructive sleep<br>apnea (OSA). The<br>device is primarily<br>intended for home<br>setting use (although it<br>can also be used in<br>healthcare settings)<br>under the direction of<br>a Healthcare<br>Professional (HCP). | AcuPebble SA100 is<br>indicated to sense,<br>record, and interpret a<br>patient's physiological<br>signals (including<br>respiratory pattern)<br>during sleep for the<br>purpose of prescreening<br>patients for obstructive<br>sleep apnea (OSA)<br>syndrome. The device is<br>designed for use in<br>home-screening of adults<br>with suspected possible<br>sleep breathing disorders<br>(although it can also be<br>used in clinic). Results are<br>used to assist the<br>healthcare professional's<br>in the patient's<br>evaluation. The system is<br>not intended as a<br>substitute for full<br>polysomnography when<br>additional parameters<br>such as sleep stages, limb<br>movements, or EEG<br>activity are required. | The NightOwl is a<br>wearable device<br>intended for use in the<br>recording, analysis,<br>displaying, exporting,<br>and storage of<br>biophysical parameters<br>to aid in the evaluation<br>of sleep-related<br>breathing disorders of<br>adult patients suspected<br>of sleep apnea. The<br>device is intended for<br>the clinical and home<br>setting use under the<br>direction of a<br>Healthcare Professional<br>(HCP). | Substantially<br>equivalent to the<br>predicate and<br>identical to the<br>reference device.<br>This does not raise<br>additional issues of<br>safety or efficacy<br>since AcuPebble<br>Ox100 provides the<br>channels of<br>AcuPebble SA100<br>and complements<br>this with a PPG based<br>oximetry channel as<br>per the reference<br>device. In the<br>context of the<br>indications for use,<br>the additional<br>channels provided by<br>AcuPebble Ox100<br>when compared to<br>the reference device:<br>1- Were already<br>approved as part of<br>AcuPebble SA100; 2-<br>Complement<br>oximetry to aid in the<br>diagnosis of OSA |
| Regulation<br>number | 868.2375 | 868.2375 | 868.2375 | Same |
| Product Code | MNR | MNR | MNR | Same |
| Generic<br>Device Name | Ventilatory Effort<br>Recorder | Ventilatory Effort<br>Recorder | Ventilatory Effort<br>Recorder | Same |
| Prescription | Prescription | Prescription | Prescription | Same |
| Target | Adults | Adults | 22 years old and older | Same |
| population | | | | |
| Intended<br>environment<br>for use | Primarily home<br>environment, although<br>it can be used in<br>healthcare<br>environments | Primarily home<br>environment, although it<br>can be used in<br>healthcare<br>environments | Clinical and Home<br>environment | Same |
| Sensor<br>placement | Front of the neck and<br>finger | Front of the neck | Finger | Substantially<br>equivalent. The<br>sensor on the neck<br>allows sensing of<br>physiological signals<br>directly generated by<br>the cardiorespiratory<br>system, in the same<br>way as the predicate.<br>This is in addition to<br>the surrogate signals<br>(blood related<br>features) that are<br>sensed on the finger<br>as in the reference<br>device. |
| Physical<br>sensing<br>elements | Piezoelectric<br>(microphones)/<br>LED+photodiode | Piezoelectric<br>(microphones) | Piezoelectric<br>(accelerometer)/LED+photodiode | Substantially<br>equivalent. The<br>optical sensors do not<br>interfere with the<br>other ones and are<br>used to extract SpO2<br>as in the reference<br>device. |
| Patient<br>contact | Yes | Yes | Yes | Same |
| Means of<br>attachment | Adhesive (patient self-<br>applied) | Adhesive (patient self-<br>applied) | Adhesive (patient self-<br>applied) | Substantially<br>equivalent. They both<br>use adhesives and<br>they are both self-<br>applied |
| Sleep night<br>use | Multiple nights possible | Multiple nights possible | Multiple nights possible | Same |
| Portability | Yes (Wearable) | Yes (wearable) | Yes (wearable) | Same |
| Size and<br>weight | 29.5mm diameter x<br>16mm height, 7g weight<br>for neck sensor. 38mm x<br>30mm x38mm, 15g<br>weight for finger<br>sensor. | 29.5mm diameter x<br>16mm height, 7g weight<br>for neck sensor. 38mm x<br>30mm x38mm | 19x28x11mm, 6g | Substantially<br>equivalent. The<br>sensor on the neck is<br>identical to the one in<br>the predicate. The<br>finger sensor is not in<br>the predicate but the<br>reference device uses<br>a sensor on the finger |
| | | | | which is comparable<br>to the one in this<br>device in size and<br>weight. |
| Recording<br>device | Mobile device records<br>signals streamed from<br>the sensors and uploads<br>them into a cloud-based<br>server | Mobile device records<br>signals streamed from<br>the sensor and uploads<br>them into a cloud-based<br>server | Mobile device records<br>signals streamed from<br>the sensor and uploads<br>them into a cloud-<br>based server | Same |
| Output<br>Channels | SPO2, PPG, Pulse rate<br>(x2 from PPG and from<br>sounds), activity<br>(movement), heart<br>sounds, respiration<br>inhalation and<br>exhalation patterns,<br>airflow (Acoustic<br>derived), snoring | Pulse rate (from<br>sounds), activity<br>(movement), heart<br>sounds, respiration<br>inhalation and exhalation<br>patterns, airflow<br>(Acoustic derived),<br>snoring | SPO2, PPG, Pulse rate,<br>activity (movement) | Substantially<br>equivalent. The<br>additional channels of<br>AcuPebble Ox100<br>provide extra<br>information that<br>serves to further<br>aid/support in the<br>interpretation and<br>subsequent<br>intervention/manage<br>ment of the disease<br>by a healthcare<br>professional. These<br>channels already<br>appear in other<br> |
| Physical<br>sensing<br>elements | Piezoelectric<br>(microphones)/<br>LED+photodiode | Piezoelectric<br>(microphones) | Piezoelectric<br>(accelerometer)/<br>LED+photodiode | Substantially<br>equivalent. The<br>optical sensors do not<br>interfere with the<br>other ones and are<br>used in the same way<br>as in the predicate. |
| Types of<br>events used<br>for OSA<br>indexes | Apneas/hypopneas | Apneas/hypopneas | Apneas/hypopneas | Same |
| Calculated<br>OSA AASM<br>recommended<br>indexes | AcuPebble_AHI<br>AcuPebble_ODI | AcuPebble_AHI<br>AcuPebble_ODI | NightOwl's AHI | Same as the<br>predicate (the<br>indexes are obtained<br>from acoustic derived<br>physiological<br>biomarkers).<br>In the reference<br>device they are<br>calculated from<br>optically obtained<br>biomarkers (this<br>includes SpO2<br>obtained from the<br>PPG signal. |
| | | | | |
| Diagnostic<br>LR+ | 29.36 /32.29 | 29.36 /32.29 | 5.10 | Same |
| Diagnostic<br>LR- | 0.08 /0.04<br>(CI- 0.03 to 0.19/0.01 to<br>0.16) | 0.08 /0.04<br>(CI- 0.03 to 0.19/0.01 to<br>0.16) | 0.04<br>(CI- 0.01 to 0.17) | Same |
| Diagnostic<br>Sensitivity | 92.73% /95.92%<br>(CI-82.41% to 97.98%<br>/86.02% to 99.50%) | 92.73% /95.92%<br>(CI- 82.41% to 97.98%<br>/86.02% to 99.50%) | 96.55% (CI- 88.09% to<br>99.58%) | Same |
| Diagnostic<br>Specificity | 96.84% /97.03% | 96.84% /97.03% | 70.4% to 81.08% | Same |
| Pulse rate | 50-120bm (3.62bpm<br>validation accuracy)<br>when obtained from<br>heart sounds<br>PR from PPG meets the<br>requirement of ±2bpm<br>or ±2%. | 50-120bm (3.62bpm<br>validation accuracy)<br>when obtained from<br>heart sounds | 50-118bpm (2.26bpm<br>validation accuracy) | Same |
| SpO2<br>performance | Compliant with ISO<br>80601-2-61<br>80%-100%, 2% root-<br>mean-square<br>difference<br>70%-79%, 3% root-<br>mean-square<br>difference | Not applicable | Compliant with ISO<br>80601-2-61, i.e. SpO2<br>accuracy with a root-<br>mean-square difference<br>of less or equal to 4%<br>over 70-100% SaO2. | Same |
| Data Transfer | From the sensor to the<br>mobile phone using<br>Bluetooth and from the<br>phone to the cloud<br>(server) through a<br>smartphone by wireless<br>connection.…