Who is the manufacturer of AcuPebble SA?

Acurable Limited filed the 510(k) submission for AcuPebble SA (K210480).

What is the FDA product code for AcuPebble SA?

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 SA?

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

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

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.

AcuPebble SA

K210480 · Acurable Limited · MNR · Jul 6, 2021 · Anesthesiology

Device Facts

Record ID	K210480
Device Name	AcuPebble SA
Applicant	Acurable Limited
Product Code	MNR · Anesthesiology
Decision Date	Jul 6, 2021
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 868.2375
Device Class	Class 2
Attributes	Software as a Medical Device

Indications for Use

AcuPebble SA100 is indicated to sense, record, and interpret a patient's physiological signals (including respiratory pattern) during sleep, for the purpose of prescreening patients for obstructive sleep apnea (OSA) syndrome. The device is designed for use in home-screening of adults with suspected possible sleep breathing disorders. Results are used to assist the healthcare professional in the patient's evaluation. The system is not intended as a substitute for full polysomnography when additional parameters such as sleep stages, limb movements, or EEG activity are required.

Device Story

AcuPebble SA100 is a wearable sensor worn on the front of the neck (suprasternal notch) to measure physiological body sounds during sleep. The sensor streams data via Bluetooth to a mobile app, which uploads the data to a cloud-based server for analysis. The system uses signal processing algorithms to produce OSA diagnostic traces and parameters, including AHI and ODI. Healthcare professionals access these results via a web portal to assist in patient evaluation. The device is intended for home-screening of adults, though it can be used in clinics. It benefits patients by providing a non-invasive, wearable method for OSA prescreening without requiring full polysomnography.

Clinical Evidence

Clinical validation study conducted on 150 patients per ISO 14155:2011. Primary endpoints included diagnostic accuracy for AHI and ODI (3% and 4% desaturation criteria). Results: AHI3 PPV 94.44%, NPV 95.83%; AHI4 PPV 94.00%, NPV 98.00%; ODI3 PPV 93.42%, NPV 90.54%; ODI4 PPV 85.71%, NPV 98.94%. Heart rate accuracy validation showed 94.0% of subjects had bias ≤ ±3 bpm and 93.3% had standard deviation ≤ 5 bpm compared to PPG-based polygraphy.

Technological Characteristics

Wearable sensor (29.5mm x 16mm, 7g) with biocompatible enclosure and adhesive. Sensing principle: microphones for physiological body sounds. Connectivity: Bluetooth to mobile app, cloud-based analysis. Power: rechargeable lithium polymer battery. Software: signal processing algorithms for OSA index calculation. Standards: ISO 10993 (biocompatibility), IEC 60601-1 (safety), IEC 60601-1-2 (EMC), IEC 60601-1-11 (home healthcare), IEC 62366-1 (usability), ISO 14971 (risk management).

Indications for Use

Indicated for adults with suspected sleep breathing disorders for prescreening of obstructive sleep apnea (OSA) syndrome. Contraindicated for patients with pacemakers, implantable devices, known or suspected arrhythmias, congestive heart failure, or neuromuscular disorders.

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

Drowzle (K173974)

Reference Devices

NightOwl (K191031)
Sleep Strip II (K112822)

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue. July 6, 2021 Acurable Limited Esther Rodriguez-Villegas CSO Finsgate, 5-7 Cranwood Street London, London EC1V 9EE United Kingdom Re: K210480 Trade/Device Name: AcuPebble SA100 Regulation Number: 21 CFR 868.2375 Regulation Name: Breathing Frequency Monitor Regulatory Class: Class II Product Code: MNR Dated: Mav 28, 2021 Received: June 4, 2021 Dear Esther Rodriguez-Villegas: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's {1}------------------------------------------------ requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Rachana Visaria, Ph.D. Assistant Director DHT1C: Division of ENT, Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ #### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration ### Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below. 510(k) Number (if known) Device Name AcuPebble SA100 #### Indications for Use (Describe) AcuPebble SA100 is indicated to sense, record, and interpret a patient's physiological signals (including respiratory pattern) during sleep for the purpose of prescreening patients for obstructive sleep apnea (OSA) syndrome. The designed for use in home-screening of adults with suspected possible sleep breathing disorders (although it can also be used in clinic). Results are used to assist the healthcare professional's in the patient's evaluation. The system is not intended as a substitute for full polysomnography when additional parameters such as sleep stages, limb movements, or EEG activity are required. Type of Use (Select one or both, as applicable) > Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # Q ## 510(k) Summary This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR §807.92. | 510(k) Submitter: | Acurable Limited Finsgate 5-7 Cranwood Street London EC1V 9EE United Kingdom | |------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact person: | Professor Esther Rodriguez-Villegas CSO Acurable Ltd 5th Floor, 21 Knightsbridge, London SW1X 7LY, UK esther@acurable.com +442075946193 | | Date summary prepared: | July 6, 2021 | | Trade Name: | AcuPebble SA100 | | Product Classification Name: | Ventilatory effort recorder | | Regulation number: | 21 CFR §868.2375 (Breathing Frequency Monitor) | | Product Code: | MNR | | Classification Panel: | Anaesthesiology | | Device Classification: | Class II | {4}------------------------------------------------ ### 1. Intended Use / Indications for Use AcuPebble SA100 is indicated to sense, record, and interpret a patient's physiological signals (including respiratory pattern) during sleep, for the purpose of prescreening patients for obstructive sleep apnea (OSA) syndrome. The device is designed for use in home-screening of adults with suspected possible sleep breathing disorders. Results are used to assist the healthcare professional in the patient's evaluation. The system is not intended as a substitute for full polysomnography when additional parameters such as sleep stages, limb movements, or EEG activity are required. ### 2. DEVICE DESCRIPTION AcuPebble SA100 comprises a sensor that is worn on the front of the neck around the suprasternal notch area (the "AcuPebble SA100 sensor"), a mobile device app that guides the patient through the steps of the test, collects the data from the sensor, and uploads them in the "AcuPebble SA100 app"), and a cloud-based analysis software (the "AcuPebble SA100 algorithms". The "AcuPebble SA100 Sensor" consists of a small biocompatible enclosure with very low power sensors and electronics inside. It is attached to the front of the neck (somewhere between the Adam's apple and the suprasternal notch area) by single-use biocompatible adhesive tape. The sensor measures physiological body sounds. The data sensed is streamed via a Bluetooth link to the "AcuPebble SA100 app" on a smart device (mobile phone/tablet). The data can be uploaded into the cloud where it is analyzed, any time after the sleep study test is finished at the tap of a button in the app. AcuPebble SA100 signal processing algorithms produce a number of OSA diagnostic traces and parameters. These can be accessed by the Health Care Professional through a healthcare professional portal, which can be accessed from any computer or smart device with an Internet connection. AcuPebble SA100 is not intended to be used with patients with pacemakers or other implantable devices, or with patients with known or suspected arrhythmias. This device has not been validated in patients with congestive heart failure or patients with neuromuscular disorders. Patients with significant cardiopulmonary or neurological disorders need to be excluded from using the device. ### 3. Predicate Device The predicate device is shown in the Table below: | K number | Product Code | Class | Device Name | |----------|--------------|-------|-------------| | K173974 | MNR | II | Drowzle | {5}------------------------------------------------ ### 4. Summary of Comparison to Predicate | | DEVICE SUBJECT OF THIS APPLICATION | PREDICATE DEVICE (1) | REFERENCE DEVICE(1) | REFERENCE DEVICE (2) | |------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | AcuPebble SA100 by Acurable Ltd | Drowzle by Resonea, K173974 | NightOwl, K191031, by Ectosense | Sleep Strip II, K112822 (Note: this device was claimed as predicate of Drowzle (predicate (1) in this application) | | Indications for use | AcuPebble SA100 is indicated to sense, record, and interpret a patient's physiological signals (including respiratory pattern) during sleep for the purpose of prescreening patients for obstructive sleep apnea (OSA) syndrome. The device is designed for use in home-screening of adults with suspected possible sleep breathing disorders. Results are used to assist the healthcare professional in the patient's evaluation. The system is not intended as a substitute for full polysomnography when additional parameters such as sleep stages, limb movements, or EEG activity are required. | DROWZLE is indicated to record a patient's respiratory pattern during sleep for the purpose of prescreening patients for obstructive sleep apnea (OSA) syndrome. The device is designed for use in home-screening of adults with suspected possible sleep breathing disorders. Results are used to assist the healthcare professional in determining the need for further diagnosis and evaluation. The system is not intended as a substitute for full polysomnography when additional parameters such as sleep stages, limb movements, or EEG activity are required. | The NightOwl is a wearable device intended for use in the recording, analysis, displaying, exporting, and storage of biophysical parameters to aid in the evaluation of sleep-related breathing disorders of adult patients suspected of sleep apnea. The device is intended for the clinical and home setting use under the direction of a Healthcare Professional (HCP). | The SleepStrip II is intended to measure apnea hypopnea events during sleep for the purpose of prescreening patients for sleep apnea syndrome. The device is intended to be used by adult patients as prescribed by a physician in either home, hospital or facility use settings. | | COMPARISON | | Substantially equivalent | | | | Regulation number | 868.2375 | 868.2375 | 868.2375 | 868.2375 | | COMPARISON | | Same | | | | Product Code | MNR | MNR | MNR | MNR | | COMPARISON | Same | | | | {6}------------------------------------------------ | Generic Device Name | Ventilatory Effort Recorder | Ventilatory Effort Recorder | Ventilatory Effort Recorder | Ventilatory Effort Recorder | |-----------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------| | COMPARISON | Same | | | | | Prescription | Prescription | Prescription | Prescription | Prescription | | COMPARISON | Same | | | | | Target population | Adults | Adults | 22 years old and older | Adults | | COMPARISON | Substantially equivalent | | | | | Intended environment for use | Primarily home environment, although it can be used in healthcare environments | Home Environment | Clinical and Home environment | Home or healthcare settings | | COMPARISON | Substantially equivalent | | | | | Sensor placement | Front of the Neck | Smartphone placed within 24 inches of pillow | The photoplethysmography (PPG) sensor and accelerometer components are worn on the fingertip. | Over the lip, under the nose | | COMPARISON | The sensor is placed in a different location which is directly contacting the patient compared to the predicate which is not directly contacting the patient. This is similar to the reference device which has direct contact. Having AcuPebble SA100 in contact with the body does not raise different safety or effectiveness questions (see conformity with consensus standards.) | | | | | Sensing elements | Microphones | Microphones | LEDs/ accelerometer | Pressure sensor | | COMPARISON | Same | | | | | Patient contact | Yes | No | Yes | Yes | | COMPARISON | Different but justified. Refer to the clinical validation data showing the equivalent performance of AcuPebble SA100 with respect to the predicate. Also, this type of contact approach has been used by the reference devices. | | | | | Means of attachment | Adhesive (patient self- applied) | NA | Adhesive (patient self- applied) | Adhesive (patient self- applied) | | COMPARISON | Different but it is justified. Refer to the clinical validation data showing equivalent performance of AcuPebble SA100 with respect to the predicate. Also, substantially equivalent means of attachment to Reference Devices. | | | | | Sleep night use | Multiple nights possible | Multiple nights possible | Multiple nights possible | Single use | | COMPARISON | Same | | | | | Portability | Yes (Wearable) | NA | Yes (wearable) | Yes (wearable) | | Comparison | Not direct comparison with the predicate but Reference Devices are also wearable | | | | | Size and weight | 29.5mm diameter x 16mm height 7g | NA | 19x28x11mm 6g | Exact dimensions unknown but from photos it looks similar in volume (with different form factor) | | Recording device | Mobile device records sound streamed from the sensor and uploads them into a cloud-based server | Mobile device records sound and uploads them into a cloud-based server | Mobile device records data streamed from the sensor and uploads them into a cloud-based server | Contained in the device | | Comparison | Same | | | | | Channels to determine features leading to diagnostic indexes | Sounds (Cardiac features, respiratory features, movement features)) | Sounds (absence of them) | PAT, pulse rate, oxygen saturation, movement | Airflow | | COMPARISON | Substantially equivalent | | | | | Calculated OSA indexes | ACU-AHI (with 3% desaturation criteria), ACU-AHI (with 4% desaturation criteria), ACU-ODI (for 3% and 4% desaturation criteria) | Proprietary Resonea Index | AHI (from PAT), oximetry | AHI with 4% desaturation criteria | | COMPARISON | Substantially equivalent | | | | | Clinical Metrics Reported | Calculated AHI/ODI indexes as per AASM definitions (and level of OSA severity for each index, following the AASM thresholds (i.e. 0-5, 5-15, 15-30 and >30); average heart (pulse). | Number of breathing sound gaps >10 seconds; Average number of >10 second breathing sound gaps per hour; Risk classification based on standard questionnaires: | Calculated AHI index from PAT. they output validated oximetry values and from there the ODI can be obtained. | Counts apnea/hypop nea events | | | | STOP-BANG Epworth Sleepiness Scale; Calculated Resonea Index | | | | COMPARISON | Substantially equivalent | | | | | Data Transfer | From the sensor to the mobile phone using Bluetooth and from the phone to the cloud (server) through a smartphone by wireless connection. | Wireless connection | From the sensor to the mobile phone using Bluetooth and from the phone to the cloud (server) through a smartphone by wireless connection. | Not applicable | | COMPARISON | Substantially equivalent | | | | | Microcontrol ler+Commun ication chip | Nordic nRF52832 (Bluetooth communication) | NA | Nordic nRF52832 (Bluetooth communication) | NA | | Comparison | Substantially equivalent | | | | | Sensor Power Source | Rechargeable lithium polymer battery | NA | Rechargeable lithium ion battery | Battery | | COMPARISON | Substantially equivalent | | | | | Sensor Software | Firmware is limited to control the recording and communications processes. No presentation of test results to the patient. Data analyzed and presented in a separate software suite. | NA | Firmware is limited to control the recording and communications processes. No presentation of test results to the patient. Data analyzed and presented in a separate software suite. | Not applicable | | COMPARISON | Same as Reference Device (1) (Not directly comparable to Predicate because there is not a worn part of the system) | | | | | Analysis Software - location | Analysis performed off the recording device, exclusively cloud- based, by the proprietary software. | Analysis performed off the recording device, exclusively cloud-based by the proprietary software. | Analysis performed off the recording device, exclusively cloud- based by the proprietary software. | Analysis performed in the device | | COMPARISON | Same | | | | | Display type | Smartphone (or tablet) for patients; smartphone (or tablet) or computer screen for | Smartphone | Smartphone for patients. For healthcare professionals, one or several of: | LED display | | | healthcare professionals | | smartphone (or tablet) or computer screen (unclear which ones) | | | COMPARISON | Substantially equivalent | | | | | Patient connection | Device has no galvanic connections to mains as it is a battery-operated device. | NA | Device has no galvanic connections to mains as it is a battery-operated device. | Device has no galvanic connections to mains as it is a battery- operated device. | | COMPARISON | Same as the Reference Devices | | | | | Sterilization | Non sterile | Not applicable | Non sterile | Non sterile | | COMPARISON | Same as the Reference Devices | | | | | Heart/Pulse Rate Output Range | 50-120bmp | NA | 50-118bmp | NA | | COMPARISON | Substantially Equivalent to the reference device (the difference is not significant) | | | | | Heart/Pulse Rate validation accuracy | 3.62 bpm (patients signals from 50bpm- 110bpm during a night sleep), 0.664 (artificial signals as per clause 201.12.1.101.15 of IEC 60601-2-27:2011, from 50bpm to 120bpm) | NA…

AcuPebble SA

Device Facts

Indications for Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Predicate Devices

Reference Devices

Submission Summary (Full Text)

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AcuPebble SA

Device Facts

Indications for Use

Device Story

Clinical Evidence

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Indications for Use

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Predicate Devices

Reference Devices

Submission Summary (Full Text)

Panel 1

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