(129 days)
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).
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.
The provided text describes the AcuPebble Ox100 device and its substantial equivalence to a predicate device (AcuPebble SA100, K210480) based on various performance data and testing. However, it does not contain a detailed study specifically proving that the device meets defined acceptance criteria for its effectiveness in aiding the evaluation of Obstructive Sleep Apnea (OSA).
The information provided primarily focuses on:
- Comparison to Predicate and Reference Devices: Highlighting similarities in indications for use, regulation, target population, environment of use, and certain performance metrics previously claimed for the predicate or a reference device (NightOwl, K191031).
- Compliance with Recognized Consensus Standards: For biocompatibility, electrical safety (EMC), home healthcare safety, risk management, and software development.
- High-level performance metrics: AHI, ODI, Diagnostic LR+, LR-, Sensitivity, Specificity, and Pulse rate/SpO2 performance, which appear to be inherited or similar to the predicate/reference device claims rather than outcomes of a new primary study for AcuPebble Ox100's specific combination of sensors.
Information NOT explicitly available in the provided text:
- A dedicated table of acceptance criteria for AcuPebble Ox100 with its own reported performance to demonstrate compliance.
- Detailed information about a specific clinical study conducted for AcuPebble Ox100 to prove its diagnostic performance. The diagnostic metrics listed (Sensitivity, Specificity, etc.) are presented as "Same" compared to the predicate, implying these are existing claims rather than results from a new study specific to Ox100 to justify a de novo clearance.
- Sample sizes for a test set specifically for demonstrating the performance of AcuPebble Ox100 in diagnosing OSA.
- Data provenance (country of origin, retrospective/prospective) for a study validating AcuPebble Ox100's diagnostic capabilities.
- Number of experts, their qualifications, or adjudication methods for establishing ground truth of a test set for AcuPebble Ox100's diagnostic performance.
- Whether a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done for AcuPebble Ox100, or any effect size of AI assistance.
- The type of ground truth used for a study validating AcuPebble Ox100's diagnostic capabilities.
- Sample size and ground truth establishment for the training set of AcuPebble Ox100's diagnostic algorithm.
Based on the provided text, here's what can be extracted, and what is missing or implied:
1. A table of acceptance criteria and the reported device performance:
The document doesn't explicitly present a standalone table of "acceptance criteria" for the AcuPebble Ox100 followed by "reported device performance" from a new study of this specific device. Instead, it compares the AcuPebble Ox100's characteristics and performance to its predicate (AcuPebble SA100) and a reference device (NightOwl) in a tabular format. The performance metrics listed are presented as "Same" to the predicate, implying that these are the established performance levels from the predicate device that the AcuPebble Ox100 is deemed to meet by being substantially equivalent.
Here's a reconstruction of the relevant performance metrics mentioned, noting that these are largely presented as being "Same" as the predicate:
| Performance Metric | Acceptance Criteria (Implied / From Predicate) | Reported Device Performance (Likely Inherited from Predicate) |
|---|---|---|
| Diagnostic LR+ | Not explicitly stated as acceptance criteria, but listed as 29.36 /32.29 for predicate | 29.36 /32.29 (Stated as "Same") |
| Diagnostic LR- | Not explicitly stated as acceptance criteria, but listed as 0.08 /0.04 for predicate | 0.08 /0.04 (CI- 0.03 to 0.19/0.01 to 0.16) (Stated as "Same") |
| Diagnostic Sensitivity | Not explicitly stated as acceptance criteria, but listed as 92.73% /95.92% for predicate | 92.73% /95.92% (CI-82.41% to 97.98% /86.02% to 99.50%) (Stated as "Same") |
| Diagnostic Specificity | Not explicitly stated as acceptance criteria, but listed as 96.84% /97.03% for predicate | 96.84% /97.03% (Stated as "Same") |
| Pulse rate (from heart sounds) | Not explicitly stated as acceptance criteria, but listed as 50-120bpm for predicate | 50-120bpm (3.62bpm validation accuracy) (Stated as "Same") |
| Pulse rate (from PPG) | ±2bpm or ±2% | Meets requirement of ±2bpm or ±2%. |
| SpO2 performance (80%-100% range) | Compliant with ISO 80601-2-61 (2% root-mean-square difference) | 2% root-mean-square difference |
| SpO2 performance (70%-79% range) | Compliant with ISO 80601-2-61 (3% root-mean-square difference) | 3% root-mean-square difference |
| SpO2 performance (70-100% SaO2) | Compliant with ISO 80601-2-61 (≤4% root-mean-square difference) (from reference device) | (Implied to meet this based on specific ranges above) |
| Biocompatibility | ISO 10993 requirements (sensitization, irritation, cytotoxicity, USP class VI) | Complies (passing results for finger sensor, neck sensor same as cleared predicate) |
| General Safety and EMC | IEC 60601-1:2005:MOD, IEC 60601-1-2:2014 | Complies |
| Home Healthcare Environment Safety | IEC 60601-1-11:2015 | Complies |
| Risk Management | ISO 14971:2019 | Complies |
| Software Verification and Validation | IEC 62304:2006/A1:2016, FDA Cybersecurity Guidance | Complies (software level of concern: "moderate") |
2. Sample size used for the test set and the data provenance:
- Not specified for a new effectiveness study of AcuPebble Ox100. The performance metrics (Diagnostic LR+, LR-, Sensitivity, Specificity) are stated to be the "Same" as the predicate device (AcuPebble SA100). Therefore, any sample size and data provenance would refer to the previous clearance of K210480. This information is not provided in the document for K210480.
- For the SpO2 performance, compliance with ISO 80601-2-61 is stated. Such compliance typically requires specific testing against a reference oximeter in a clinical setting with a certain number of subjects across defined SpO2 ranges, but the specific sample size, country of origin, or retrospective/prospective nature of this verification for AcuPebble Ox100 is not detailed.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not specified for a new effectiveness study of AcuPebble Ox100. This information would be relevant for the diagnostic performance metrics, which are stated to be "Same" as the predicate. Details for the predicate (K210480) are not in this document.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not specified for a new effectiveness study of AcuPebble Ox100. This would relate to the diagnostic performance metrics, which are stated to be "Same" as the predicate. Details for the predicate (K210480) are not in this document.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No such study is mentioned or described for AcuPebble Ox100. The device is intended to aid in evaluation, but no comparative effectiveness study with human readers (with vs. without AI assistance) is detailed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The diagnostic performance metrics listed (Sensitivity, Specificity, LR+, LR-) usually reflect standalone algorithm performance against a gold standard. However, these are listed as "Same" to the predicate device (AcuPebble SA100). The document does not provide details of a new standalone study for AcuPebble Ox100 itself to derive these numbers. The "cloud-based software that analyses the signals" and "web app user interface for healthcare professionals" suggest an algorithmic analysis component.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not specified for a new effectiveness study of AcuPebble Ox100. For diagnostic assessments of OSA, polysomnography (PSG) scored by experts according to AASM guidelines is the typical gold standard/ground truth. However, the document does not confirm this for a specific study validating AcuPebble Ox100's performance.
8. The sample size for the training set:
- Not specified. The document refers to "A cloud-based software that analyses the signals" but does not provide details on its training set or how it was developed for AcuPebble Ox100.
9. How the ground truth for the training set was established:
- Not specified.
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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Rachana Visaria -S
Rachana Visaria, Ph.D. Assistant Director DHT1C: Division of Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
Device Name
AcuPebble Ox100
Indications for Use (Describe)
AcuPebble Ox100 is a wearable device intended for use in the recording, analysis, displaying, exporting, and storage of biophysical parameters to aid in the evaluation of adult patients with, or with suspected, obstructive sleep apnea (OSA). The device is primarily intended for home settings use (although can also be used in healthcare settings) under the direction of a Healthcare Professional (HCP).
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR §807.92.
| 510(k) Submitter: | Acurable LimitedFinsgate5-7 Cranwood StreetLondon EC1V 9EEUnited Kingdom |
|---|---|
| Contact person: | Professor Esther Rodriguez-VillegasCSOAcurable Ltd5th Floor, 21 Knightsbridge, LondonSW1X 7LY, UKesther@acurable.com+442075946193 |
| Date summary prepared: | February 2, 2023 |
| Trade Name: | AcuPebble Ox100 |
| Product Classification Name: | Ventilatory effort recorder |
| Regulation number: | 21 CFR §868.2375 (Breathing FrequencyMonitor) |
| 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 | AcuPebbleSA100 |
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QCUI e
4. Summary of Comparison to Predicate and Reference
| DEVICE SUBJECT OFTHIS APPLICATIONAcuPebble Ox100 byAcurable Ltd | PREDICATE DEVICEAcuPebble SA100,K210480, by AcurableLtd | REFERENCE DEVICENightOwl, K191031,by Ectosense | COMPARISON | |
|---|---|---|---|---|
| Indicationsfor use | AcuPebble Ox100 is awearable deviceintended for use in therecording, analysis,displaying, exporting,and storage ofbiophysical parametersto aid in the evaluationof adult patients with,or with suspected,obstructive sleepapnea (OSA). Thedevice is primarilyintended for homesetting use (although itcan also be used inhealthcare settings)under the direction ofa HealthcareProfessional (HCP). | AcuPebble SA100 isindicated to sense,record, and interpret apatient's physiologicalsignals (includingrespiratory pattern)during sleep for thepurpose of prescreeningpatients for obstructivesleep apnea (OSA)syndrome. The device isdesigned for use inhome-screening of adultswith suspected possiblesleep breathing disorders(although it can also beused in clinic). Results areused to assist thehealthcare professional'sin the patient'sevaluation. The system isnot intended as asubstitute for fullpolysomnography whenadditional parameterssuch as sleep stages, limbmovements, or EEGactivity are required. | The NightOwl is awearable deviceintended for use in therecording, analysis,displaying, exporting,and storage ofbiophysical parametersto aid in the evaluationof sleep-relatedbreathing disorders ofadult patients suspectedof sleep apnea. Thedevice is intended forthe clinical and homesetting use under thedirection of aHealthcare Professional(HCP). | Substantiallyequivalent to thepredicate andidentical to thereference device.This does not raiseadditional issues ofsafety or efficacysince AcuPebbleOx100 provides thechannels ofAcuPebble SA100and complementsthis with a PPG basedoximetry channel asper the referencedevice. In thecontext of theindications for use,the additionalchannels provided byAcuPebble Ox100when compared tothe reference device:1- Were alreadyapproved as part ofAcuPebble SA100; 2-Complementoximetry to aid in thediagnosis of OSA |
| Regulationnumber | 868.2375 | 868.2375 | 868.2375 | Same |
| Product Code | MNR | MNR | MNR | Same |
| GenericDevice Name | Ventilatory EffortRecorder | Ventilatory EffortRecorder | Ventilatory EffortRecorder | Same |
| Prescription | Prescription | Prescription | Prescription | Same |
| Target | Adults | Adults | 22 years old and older | Same |
| population | ||||
| Intendedenvironmentfor use | Primarily homeenvironment, althoughit can be used inhealthcareenvironments | Primarily homeenvironment, although itcan be used inhealthcareenvironments | Clinical and Homeenvironment | Same |
| Sensorplacement | Front of the neck andfinger | Front of the neck | Finger | Substantiallyequivalent. Thesensor on the neckallows sensing ofphysiological signalsdirectly generated bythe cardiorespiratorysystem, in the sameway as the predicate.This is in addition tothe surrogate signals(blood relatedfeatures) that aresensed on the fingeras in the referencedevice. |
| Physicalsensingelements | Piezoelectric(microphones)/LED+photodiode | Piezoelectric(microphones) | Piezoelectric(accelerometer)/LED+photodiode | Substantiallyequivalent. Theoptical sensors do notinterfere with theother ones and areused to extract SpO2as in the referencedevice. |
| Patientcontact | Yes | Yes | Yes | Same |
| Means ofattachment | Adhesive (patient self-applied) | Adhesive (patient self-applied) | Adhesive (patient self-applied) | Substantiallyequivalent. They bothuse adhesives andthey are both self-applied |
| Sleep nightuse | Multiple nights possible | Multiple nights possible | Multiple nights possible | Same |
| Portability | Yes (Wearable) | Yes (wearable) | Yes (wearable) | Same |
| Size andweight | 29.5mm diameter x16mm height, 7g weightfor neck sensor. 38mm x30mm x38mm, 15gweight for fingersensor. | 29.5mm diameter x16mm height, 7g weightfor neck sensor. 38mm x30mm x38mm | 19x28x11mm, 6g | Substantiallyequivalent. Thesensor on the neck isidentical to the one inthe predicate. Thefinger sensor is not inthe predicate but thereference device usesa sensor on the finger |
| which is comparableto the one in thisdevice in size andweight. | ||||
| Recordingdevice | Mobile device recordssignals streamed fromthe sensors and uploadsthem into a cloud-basedserver | Mobile device recordssignals streamed fromthe sensor and uploadsthem into a cloud-basedserver | Mobile device recordssignals streamed fromthe sensor and uploadsthem into a cloud-based server | Same |
| OutputChannels | SPO2, PPG, Pulse rate(x2 from PPG and fromsounds), activity(movement), heartsounds, respirationinhalation andexhalation patterns,airflow (Acousticderived), snoring | Pulse rate (fromsounds), activity(movement), heartsounds, respirationinhalation and exhalationpatterns, airflow(Acoustic derived),snoring | SPO2, PPG, Pulse rate,activity (movement) | Substantiallyequivalent. Theadditional channels ofAcuPebble Ox100provide extrainformation thatserves to furtheraid/support in theinterpretation andsubsequentintervention/management of the diseaseby a healthcareprofessional. Thesechannels alreadyappear in other |
| Physicalsensingelements | Piezoelectric(microphones)/LED+photodiode | Piezoelectric(microphones) | Piezoelectric(accelerometer)/LED+photodiode | Substantiallyequivalent. Theoptical sensors do notinterfere with theother ones and areused in the same wayas in the predicate. |
| Types ofevents usedfor OSAindexes | Apneas/hypopneas | Apneas/hypopneas | Apneas/hypopneas | Same |
| CalculatedOSA AASMrecommendedindexes | AcuPebble_AHIAcuPebble_ODI | AcuPebble_AHIAcuPebble_ODI | NightOwl's AHI | Same as thepredicate (theindexes are obtainedfrom acoustic derivedphysiologicalbiomarkers).In the referencedevice they arecalculated fromoptically obtainedbiomarkers (thisincludes SpO2obtained from thePPG signal. |
| DiagnosticLR+ | 29.36 /32.29 | 29.36 /32.29 | 5.10 | Same |
| DiagnosticLR- | 0.08 /0.04(CI- 0.03 to 0.19/0.01 to0.16) | 0.08 /0.04(CI- 0.03 to 0.19/0.01 to0.16) | 0.04(CI- 0.01 to 0.17) | Same |
| 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%) | 96.55% (CI- 88.09% to99.58%) | Same |
| DiagnosticSpecificity | 96.84% /97.03% | 96.84% /97.03% | 70.4% to 81.08% | Same |
| Pulse rate | 50-120bm (3.62bpmvalidation accuracy)when obtained fromheart soundsPR from PPG meets therequirement of ±2bpmor ±2%. | 50-120bm (3.62bpmvalidation accuracy)when obtained fromheart sounds | 50-118bpm (2.26bpmvalidation accuracy) | Same |
| SpO2performance | Compliant with ISO80601-2-6180%-100%, 2% root-mean-squaredifference70%-79%, 3% root-mean-squaredifference | Not applicable | Compliant with ISO80601-2-61, i.e. SpO2accuracy with a root-mean-square differenceof less or equal to 4%over 70-100% SaO2. | Same |
| Data Transfer | 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 asmartphone by wirelessconnection. | From the sensor to themobile phone usingBluetooth and from thephone to the cloud(server) through asmartphone bywireless connection. | Same |
| Microcontroller+Communication chip | Nordic nRF52832(Bluetoothcommunication) | Nordic nRF52832(Bluetoothcommunication) | Nordic nRF52832(Bluetoothcommunication) | Same |
| Sensor PowerSource | Rechargeable lithiumpolymer battery (necksensor), andrechargeable lithiumion battery (ringoximeter sensor) | Rechargeable lithiumpolymer battery (necksensor) | Rechargeable lithiumion polymer battery | Substantiallyequivalent. Samechemistry, similarcapacity, just twobatteries (notconnected within thesame circuits), onefor each sensor |
| Sensor | Firmware is limited tocontrol the recording | Firmware is limited tocontrol the recording | Firmware is limited tocontrol the recording | Same |
| Software | and communicationsprocesses. Nopresentation of OSA testresults to the patient.Data analyzed andpresented in a separatesoftware suite. | and communicationsprocesses. Nopresentation of OSA testresults to the patient.Data analyzed andpresented in a separatesoftware suite. | and communicationsprocesses. Nopresentation of testresults to the patient.Data analyzed andpresented in a separatesoftware suite. | |
| AnalysisSoftware- location | Analysis performed offthe recording device,exclusively cloud-based,by the proprietarysoftware. | Analysis performed offthe recording device,exclusively cloud-based,by the proprietarysoftware. | Analysis performed offthe recording device,exclusively cloud-basedby the proprietarysoftware. | Same |
| Display OSAtest results | Smartphone (or tablet)or computer screen forhealthcareprofessionals. Smartphone (or tablet) forpatients app. | Smartphone (or tablet)or computer screen forhealthcare professionals.Smart phone (or tablet)for patients app. | Smartphone forpatients. For healthcareprofessionals, one orseveral of: smartphone(or tablet) or computerscreen (unclear whichones) | Same |
| Patientconnection | Device has no galvanicconnections to mains asit is a battery-operateddevice. | Device has no galvanicconnections to mains asit is a battery-operateddevice. | Device has no galvanicconnections to mains asit is a battery-operateddevice. | Same |
| Sterilization | Non sterile | Non sterile | Non sterile | Same |
| Biocompatibility | Assessed to ISO10993-1:2009 requirements forsensitization, irritationand cytotoxicity, andUSP class VI | Assessed to ISO10993-1:2009 requirements forsensitization, irritationand cytotoxicity, andUSP class VI | Assessed to ISO10993-1:2009 requirementsfor sensitization,irritation andcytotoxicity | Same |
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5. PERFORMANCE DATA
Biocompatibility
The enclosure and adhesive of the neck sensor of AcuPebble Ox100 are the same as in the predicate device (K210480).
The enclosure of the finger sensor has undergone biocompatibility testing as per the recognized consensus standard ISO 10993 (Biological Evaluation of Medical Devices) with passing results. Following the principles described in ISO 10993, the device falls into the category of surface-contacting, limited exposure (A) devices. More specifically it is a skin contact device (i.e. a device that contacts skin surfaces only), which is to be used for less than 24h.
General Requirements for Safety and Electromagnetic Compatibility (EMC)
AcuPebble Ox100 complies with the following recognized consensus standards:
- . IEC 60601-1:2005:MOD - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance.
- . IEC 60601-1-2:2014 - Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests.
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Home Healthcare Environment Safety
AcuPebble Ox100 complies with the following recognized consensus standard:
- IEC 60601-1-11:2015: Medical electrical equipment Part 1-11: General requirements for basic safety and ● essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment.
Risk Management
AcuPebble Ox100 risk management complies with the recognized consensus standard ISO 14971:2019 "Application of risk management to medical devices".
Further information regarding this is included in this submission.
Quality Management
Acurable is ISO 13485:2016 certified by MTIC InterCert SRL.
Software Verification and Validation Testing
AcuPebble Ox100 has been tested and found to comply with the recognized consensus standard IEC 62304:2006/A1:2016 ("Medical device software - Software life cycle processes"), including sections "5.6 Software integration and integration testing" and "5.7 Software system testing". The software for this device was considered as "moderate" level of concern.
Furthermore, the cybersecurity risks were addressed according to FDA's cybersecurity guidance document ("Content of Premarket Submissions for Management of Cybersecurity in Medical Devices", October 2, 2014)
6. CONCLUSION
Based on the performance data and testing in conformance to consensus standards, AcuPebble Ox100 has been demonstrated to be substantially equivalent to the predicate device.
§ 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).