(170 days)
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).
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.
Here's a summary of the acceptance criteria and the studies that prove the device meets those criteria, based on the provided text:
AcuPebble Ox200 Acceptance Criteria and Performance Study Summary
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria (Target or Reference Performance) | Reported Device Performance (AcuPebble Ox200) |
|---|---|---|
| OSA Diagnostic Indexes | AHI (3% desaturation criteria): Diagnostic Sensitivity > 81.3% (from reference device) | 92.73% |
| AHI (4% desaturation criteria): Diagnostic Sensitivity > 81.3% (from reference device) | 95.92% | |
| AHI (3% desaturation criteria): Diagnostic Specificity > 82.1% (from reference device) | 96.84% | |
| AHI (4% desaturation criteria): Diagnostic Specificity > 82.1% (from reference device) | 97.03% | |
| Pulse Rate (Acoustics) | 50-120bpm, RMS error < 3.62bpm (from predicate device) | 50-120bpm, 3.62bpm validation accuracy (from acoustics) |
| Pulse Rate (PPG) | 50-120bpm, RMS error < 2 bpm (from predicate device) | Arms (validation accuracy) < 1.23bpm (for both forehead and finger, average RMSE of 1.23 bpm across varying skin tones), worst case RMSE 1.66 bpm (using functional simulator) |
| Respiratory Rate | 4-35 bpm, accuracy ±2.7 bpm (from reference device Airmod K2427984) | Overall RMSD 2.52 bpm (4-30bpm, lab study with capnography); RMSD 2.46 bpm (during natural sleep, compared to Embletta MPR chest/abdomen bands). Claimed range: 4-30 bpm, resolution 1 bpm, accuracy ±3 bpm. |
| Respiratory Effort | Not inferior to reference device (Embletta MPR RIP bands) for differentiating no effort vs. effort | Agreement of 96.8% with manual scoring by two clinicians when distinguishing apnoea with no effort vs. with effort. Outperformed reference RIP bands of Embletta MPR (K122516) with 96.3% accuracy vs. 75.9% accuracy when using Embla RemLogic (K162140) automatic scoring as reference. |
| Body Position Detection | Not inferior to reference device (implied standard from reference device for accelerometer-based position sensing) | Lab study: 93.93% overall accuracy (supine, prone, left, right, upright). Natural sleep study: 79.00% accuracy overall; 83.59% accuracy in detecting supine vs. non-supine. |
| SpO2 Accuracy (Arms) | Comparable to predicate (implied standard, likely ISO 80601-2-61:2017 standards for accuracy with varying skin tones for pulse oximeters) | 1.86 (forehead), 2.25 (finger) in the range of 70% to 100%. Lightest skin tone (Fitzpatrick 1, Monk 1): 1.63 (forehead), 1.44 (finger). Darkest skin tone (Fitzpatrick 6, Monk 10): 0.66 (forehead), 1.36 (finger). (All values for SpO2 accuracy (Arms) are within typical acceptance for pulse oximetry). |
2. Sample Sizes and Data Provenance
- SpO2 and Pulse Rate: 12 subjects with varying skin tone. The study was performed by an independent testing lab. (Country of origin not specified, but the device manufacturer is UK-based.) Data appears to be prospective clinical validation.
- Respiratory Rate:
- Study 1: 31 healthy subjects. Conducted under laboratory conditions. (Country of origin not specified, but the device manufacturer is UK-based.) Data appears to be prospective clinical validation.
- Study 2: 150 patients referred for OSA diagnosis. Conducted during natural sleep. Royal Free London Hospital NHS Foundation Trust (UK). Data appears to be prospective clinical validation, with a trial registration number (NCT03544086).
- Respiratory Effort: 150 patients referred for OSA diagnosis. Conducted during natural sleep. Royal Free London Hospital NHS Foundation Trust (UK). Data appears to be prospective clinical validation, with a trial registration number (NCT03544086).
- Body Position Detection:
- Study 1: 17 volunteers. Conducted under laboratory conditions. (Country of origin not specified, but the device manufacturer is UK-based.) Data appears to be prospective clinical validation.
- Study 2: 60 patients referred for OSA diagnosis. Conducted during natural sleep. Virgen Macarena Hospital, Spain. Data appears to be prospective clinical validation, with a trial registration number (NCT04028011).
3. Number of Experts and Qualifications for Ground Truth (Test Set)
- Respiratory Effort: "manual scoring by two clinicians". Qualifications of the clinicians are not explicitly stated (e.g., specific specialties or years of experience), but they are described as "clinicians." For the automatic scoring comparison, an FDA-cleared device (Embla RemLogic, K162140) served as a reference.
- Other parameters (SpO2, Pulse Rate, Respiratory Rate, Body Position): The ground truth relied on established reference devices and standards (e.g., functional simulator, capnography, RIP bands, ISO 80601-2-61:2017), rather than expert consensus on individual cases for the test set. For OSA diagnostic indexes, the performance is inherited from the predicate device, so the ground truth setup for that specific parameter is not detailed for AcuPebble Ox200 in this document.
4. Adjudication Method (Test Set)
- Respiratory Effort: Manual scoring was done by "two clinicians," and the agreement between them or a further adjudication process (e.g., 2+1) is not specified beyond "the agreement in distinguishing." However, a primary comparison for superiority was made against an FDA-cleared device's automatic scoring (Embla RemLogic).
- For other parameters, adjudication is not applicable as ground truth was established by reference devices/standards.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study is explicitly mentioned as having been performed to assess how much human readers improve with or without AI assistance for this device. The evaluations focus on the standalone performance of the device's outputs.
6. Standalone Performance (Algorithm Only)
Yes, standalone performance was done for several new parameters:
- SpO2 and Pulse Rate Output: Validated as per ISO 80601-2-61:2017 using an independent testing lab.
- Respiratory Rate: Validated in two studies against capnography and respiratory inductance plethysmography (RIP) bands.
- Respiratory Effort Detection: Validated against RIP bands and compared to automatic scoring of an FDA-cleared device.
- Body Position Detection: Validated in laboratory conditions and during natural sleep.
- The OSA diagnostic indexes (AHI) are explicitly stated to be "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." Their performance is inherited from the predicate.
7. Type of Ground Truth Used (Test Set)
The ground truth varied by parameter:
- SpO2 and Pulse Rate: Reference pulse oximetry and functional simulator, following ISO 80601-2-61:2017 standards for accuracy assessment.
- Respiratory Rate: Capnography (K150272) in a lab setting, and chest and abdomen respiratory effort bands of Embletta MPR Sleep Data Recording System (K122516) during natural sleep.
- Respiratory Effort: Manual scoring by two clinicians based on RIP bands (Respiratory Inductance Plethysmography) and automatic scoring from the FDA-cleared device Embla RemLogic (K162140).
- Body Position Detection: Presumed to be observational ground truth established by study personnel in lab, and potentially manually annotated based on video/observation in natural sleep studies, or potentially using other reference accelerometers. The document does not specify the exact method for ground truth for body posture.
8. Sample Size for the Training Set
The document does not explicitly state the sample size used for the training set for any of the algorithms. It focuses on the validation studies.
9. How the Ground Truth for the Training Set Was Established
As the training set information is not provided, the method for establishing its ground truth is also not detailed in this document. The document primarily describes the validation of the device's performance against established clinical standards and reference devices.
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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"
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(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).
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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
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Indications for Use
Submission Number (if known)
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)
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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 Limited2 Leman Street, London E1W 9US, UK |
|---|---|
| Contact person: | Professor Esther Rodriguez-VillegasCSOAcurable Ltd20 Victoria Street, SW1H ONB, London, UKesther@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 FrequencyMonitor) |
| Product Code: | MNR |
| Classification Panel: | Anaesthesiology |
| Device Classification: | Class II |
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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:
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| K number | Product Code | Class | Device Name |
|---|---|---|---|
| K242798 | BZQ | II | Airmod |
| K240285 | MNR | II | Huxley SANSA Home SleepApnea Test (1000-00) |
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4. Summary of Comparison to Predicate
| DEVICE SUBJECT OFTHIS APPLICATION | PREDICATE DEVICE | REFERENCE DEVICE (1) | REFERENCE DEVICE (2) | COMPARISON | |
|---|---|---|---|---|---|
| AcuPebble Ox200K243092, byAcurable Ltd | AcuPebble Ox100,K222950, byAcurable Ltd | AIRMOD,K242798, by HeroicFaith International Ltd. | HUXLEY SANSA HOMESLEEP APNEA TEST(1000-00),K240285, by HuxleyMedical | ||
| Indications foruse | AcuPebble Ox200 is awearable device intendedfor use in the recording,analysis, displaying,exporting, and storage ofbiophysical parameters toaid in the evaluation ofadult patients with, orwith suspected,obstructive sleep apnea(OSA).The device isprimarily intended forhome setting use(although it can also beused in healthcaresettings) under thedirection of a HealthcareProfessional (HCP). | AcuPebble Ox200 is awearable device intended foruse in the recording, analysis,displaying, exporting, andstorage of biophysicalparameters to aid in theevaluation of adult patientswith, or with suspected,obstructive sleep apnea(OSA).The device is primarilyintended for home setting use(although it can also be usedin healthcare settings) underthe direction of a HealthcareProfessional (HCP). | Airmod, when used inconjunction with AccurSoundElectronic Stethoscope AS-101,is a software as medical deviceintended to be used for thecontinuous, non-invasivemonitoring of respiratory rate(RR) in adult patients who aresubjected to proceduralsedation and/or anesthesia.Airmod is intended for use byhealthcare professionals inhospitals and healthcarefacilities who are legallycredentialed to performprocedural sedation and/oranesthesia. Airmod is intendedfor Android-based devices only | The Huxley Home Sleep ApneaTest (SANSA) is a wearable deviceintended for use in the recording,analysis, and storage ofbiophysical parameters to aid inthe evaluation of sleep-relatedbreathing disorders of adultssuspected of sleep apnea. Thedevice is intended for the clinicaland home use setting under thedirection of a HealthcareProfessional (HCP). | Same as predicate |
| Regulationnumber | 868.2375 | 868.2375 | 868.2375 | 868.2375 | Same as predicate |
18th Mar 2025 V- 4 of 14
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| ProductCode | MNR | MNR | BZQ | MNR/BZQ | Same as predicate | Means ofattachment | Adhesive (patient self-applied) | Adhesive (patient self-applied) | N/A | Adhesive | Same as predicate |
|---|---|---|---|---|---|---|---|---|---|---|---|
| GenericDevice Name | Ventilatory EffortRecorder | Ventilatory Effort Recorder | Breathing Frequency Monitor | Ventilatory EffortRecorder/Breathing FrequencyMonitor | Same as predicate | Sleep nightuse | 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 |
| Targetpopulation | Adults | Adults | Adults undergoing proceduralsedation and/or anesthesia | Adults (22 years age and older) | Same as predicate | Size andweight | 29.5mm diameter x16mm height, 7g weightfor neck sensor.17.25mm x 24.6mm x12.6 mm, 6g weight forfinger/forehead sensor. | 29.5mm diameter x 16mmheight, 7g weight for necksensor.38mm x 30mm x38mm, 15gweight for finger sensor. | N/A | 131mmx74mmx11mm, 13g,60mm x51mm x16mm, 45g | Substantially equivalent. Thefinger sensor is smaller. Thisdoes not pose any newquestions of safety andeffectiveness. |
| Intendedenvironmentfor use | Primarily homeenvironment, although itcan be used inhealthcare environments | Primarily homeenvironment, although itcan be used in healthcareenvironments | Hospitals and healthcarefacilities | Clinics and Home Use | Same as predicate | Recordingdevice | Mobile device recordssignals streamed fromthe sensors and uploadsthem into a cloud-basedserver | Mobile device recordssignals streamed from thesensor and uploads theminto a cloud-based server | Compatible stethoscope withmicrophone records acousticsignals | Chest patch sensor recordsignals then transferred via USB | Same as predicate |
| Sensorplacement | Front of the neck andeither finger or forehead | Front of the neck and finger | Neck | Chest | Same as predicate if placed infinger. If placed in the foreheadsubstantially equivalent.Performance validated as perISO 80601-2-61:2017. | Channels | SPO2, PPG, Pulse rate (x2from PPG and fromsounds), activity(movement), heartsounds, respirationinhalation and exhalationpatterns, airflow,respiratory effort,respiratory rate, snoring,position | SPO2, PPG, Pulse rate (x2from PPG and from sounds),activity (movement), heartsounds, respirationinhalation and exhalationpatterns, airflow, snoring | Respiratory rate | Oximetry, Heartrate, Chestmovement, Snoring, Bodyposition, Respiratory effort,Actigraphy, Sleep stage(Sleep/Wake), ECG (Referencechannel only) | AcuPebble Ox200 issubstantially equivalent to thepredicate device. WhileAcuPebble Ox200 outputsadditional channels comparedto the predicate device, theseoutputs are technologicallyconsistent with those of thereference device. Validationtesting has demonstrated thatthe additional outputs perform |
| Physicalsensingelements | Piezoelectric(microphones)/LED+photodiode/accelerometers | Piezoelectric (microphones)/LED+photodiode/accelerometers | N/A (Software to be used inconjunction with AccurSoundElectronic Stethoscope AS-101) | Accelerometer, ECG,ReflectancePhotoplethysmography | Same as predicate | ||||||
| Patientcontact | Yes | Yes | N/A | Yes | Same as predicate |
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| Types ofevents usedfor OSAindexes | Apneas/hypopneas | Apneas/hypopneas | N/A | N/A | equivalently to the referencedevice, and no new questionsof safety and effectiveness areraised. | |
|---|---|---|---|---|---|---|
| CalculatedOSA AASMrecommended indexes | AHI (with 3%desaturation criteria),AHI (with 4%desaturation criteria) | AHI (with 3% desaturationcriteria), AHI (with 4%desaturation criteria) | N/A | SDB | Same as predicate | |
| DiagnosticSensitivity | 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 | |
| DiagnosticSpecificity | 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 (3.62bpmvalidation accuracy fromacoustics,Arms < 1.23bpm fromPPG) | 50-120bpm (3.62bpmvalidation accuracy fromacoustics,Arms < 2 bpm from PPG) | N/A | 30-250bpm: Arms ≤ 3 bpm | Same as predicate foracoustics. Substantiallyequivalent for pulse rate to thepredicate and this does notraise any new question ofsafety and effectiveness. | |
| Respiratoryrate | 4-30 bpm, resolution 1bpm, accuracy ±3 bpm | N/A | 4-35 bpm, ±2.7 bpm | N/A | This is an additional outputwith respect to the predicate.However, this output istechnologically consistent withthose of the reference deviceand validation testing hasdemonstrated that it performsequivalently to the referencedevice. Hence no newquestions of safety andeffectiveness are raised. | |
| Real-timerespiratoryrate output | No | N/A | Yes (with alarm) | N/A | Same as predicate | |
| Respiratoryeffort | The accuracy indifferentiating betweensegments with nobreathing effort vs witheffort (ie what therespiratory effortchannels are used in thecontext of the intendeduse ) is 96.3%. (clinicaltesting) | N/A | N/A | Non-clinical bench testing. | This is an additional outputwith respect to the predicate.However, this output istechnologically consistent withthose of the reference deviceand validation testing hasdemonstrated that it is notinferior to the latter. Hence nonew questions of safety andeffectiveness are raised. | |
| Position | 93.93% accuracy incontrolled condition and79.00% accuracy duringnatural sleep inidentifying supine, | N/A | N/A | Using accelerometer, non-clinical bench testing. | This is an additional outputwith respect to the predicate.However, this output istechnologically consistent withthose of the reference device | |
| prone, left, right, andupright position | and validation testing hasdemonstrated that it is notinferior to the latter. Hence nonew questions of safety andeffectiveness are raised. | |||||
| DataTransfer | From the sensor to themobile phone usingBluetooth and from thephone to the cloud(server) through asmartphone by wirelessconnection. | From the sensor to themobile phone usingBluetooth and from thephone to the cloud (server)through a smartphone bywireless connection. | From the compatiblestethoscope to the Androidmobile phone | Patient data is physicallytransferred via USB after studyconclusion. | Same as predicate | |
| Microcontroller+Communication chip | Nordic nRF52832(Bluetoothcommunication) | Nordic nRF52832(Bluetooth communication) | N/A | N/A | Same as predicate | |
| SensorPowerSource | Rechargeable lithium ionpolymer batteries | Rechargeable lithiumpolymer battery (necksensor), and rechargeablelithium ion battery (ringoximeter sensor) | N/A | Rechargeable Lithium PolymerBattery | Same as predicate | |
| SensorSoftware | Firmware is limited tocontrol the recordingand communicationsprocesses. Nopresentation of OSA testresults to the patient.Data analyzed and | Firmware is limited tocontrol the recording andcommunications processes.No presentation of testresults to the patient. Dataanalyzed and presented in aseparate software suite. | N/A | The patient data is physicallytransferred via USB after studyconclusion. | Same as predicate | |
| presented in a separatesoftware suite. | ||||||
| AnalysisSoftware -location | Analysis performed offthe recording device,exclusively cloud-based,by the proprietarysoftware. | Analysis performed off therecording device, exclusivelycloud-based by theproprietary software. | Analysis performed off therecording device | Analysis performed off therecording device, on acompatible cloudbasedsoftware platform. | Same as predicate | |
| Display OSAtest results | Smartphone (or tablet)or computer screen forhealthcare professionals.Smart phone (or tablet)for patients app. | Smartphone (or tablet) orcomputer screen forhealthcare professionals.Smart phone (or tablet) forpatients app. | N/A | Software portal wherephysiological tracings are madeavailable for diagnosticpurposes. | Same as predicate | |
| Patientconnection | Device has no galvanicconnections to mains asit is a battery-operateddevice. | Device has no galvanicconnections to mains as it isa battery-operated device. | N/A | Device has no galvanicconnections to mains as it is abattery-operated device. | Same as predicate | |
| Sterilization | Non sterile | Non sterile | N/A | Non sterile | Same as predicate | |
| Biocompatibility | The materials in contactwith the body areidentical for both theneck and thefinger/forehead sensor.The neck sensor is thesame as the neck sensorin the predicate. | Contact materialscorresponding to the necksensor and different onescorresponding to the fingersensor. | N/A | The device is considered as asurface device in contact withintact skin per ISO 10993-1. Thebiocompatibility evaluation wascompleted and includedCytotoxicity, Sensitization andIrritation testing. All testingpassed. | Same as predicate | |
| Duration ofcontact as | Limited exposure | Limited exposure | N/A | Limited exposure | Same as predicate | |
| per ISO10993 | ||||||
| Attachmentto the bodymaterials | Hypoallergenic acrylateMedical Adhesive | Hypoallergenic acrylateMedical AdhesivePlus: 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 | |
| ElectricalSafetyTesting(StandardsCompliance) | 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 | |
| Homeenvironmenttesting(StandardsCompliance) | 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
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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
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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 Ventilation Clinic at the Royal Free London Hospital NHS Foundation Trust (Trial registration number: NCT03544086).
Based on manual scoring by two clinicians, the agreement in distinguishing between apnoea with no breathing effort versus apnoea with effort was 96.8% when compared to RIP band scoring as the reference.
Furthermore, using automatic scoring from the FDA-cleared device Embla RemLogic (K162140) — which was worn by patients simultaneously — the respiratory effort channel of AcuPebble Ox200 outperformed the reference RIP bands of the Embletta MPR Sleep System (K122516) in identifying segments with breathing effort versus no effort. The accuracy was 96.3% when AcuPebble's respiratory effort channels were used, compared to 75.9% accuracy when the RIP bands were used.
The body position detection has been validated for supine, prone, left, right, and upright positions in two studies:
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- First study: Conducted under laboratory conditions with 17 volunteers, achieving an overall accuracy of 93.93%.
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- Second study: Conducted using data collected during natural sleep from 60 patients referred for OSA diagnosis at Virgen Macarena Hospital, Spain (Trial registration number:
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NCT04028011). The accuracy in this study was 79.00% In detecting supine versus non-supine positions, AcuPebble demonstrated an accuracy of 83.59%.
6. Conclusion
The AcuPebble Ox200 is substantially equivalent to the legally marketed predicate device as demonstrated by the similar indication for use, similar technologies and performance data, and does not raise different questions of safety and effectiveness.
§ 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).