(167 days)
The ApneaLink™ Air device is indicated for use by Health Care Professionals (HCP), where it may aid in the diagnosis of sleep disordered breathing for adult patients. ApneaLink Air records the following data: patient respiratory nasal airflow, snoring, blood oxygen saturation, pulse, respiratory effort and body position during sleep. The device uses these recordings to produce a report for the HCP that may aid in the diagnosis of sleep disordered breathing or for further clinical investigation. The device is intended for home and hospital use under the direction of a HCP.
The ApneaLink Air recorder is a 5-channel battery-powered respiratory pressure sensor and oximetry system. ApneaLink Air provides recordings of respiratory pressure, respiratory effort, pulse rate, oxygen saturation and body position during sleep. The physician prescribed device will help to recognize sleep-related respiratory disorders. The ApneaLink Air recorder and the respiratory effort sensor must be fastened with the re-usable belt on the patient's chest parallel to the spine. All relevant respiratory information during sleep will be collected via nasal cannula, pulse oximetry module and respiratory effort sensor. The disposable plastic nasal cannula is connected to the ApneaLink Air recorder and fixed at the patient's nose. The oximetry sensor is connected to the Xpod and fixed at the patient's finger. The Xpod is connected to the ApneaLink Air recorder. The respiratory effort sensor is connected to the ApneaLink Air recorder and held in place by the belt. LED's indicate if the sensors are attached correctly. A Test complete light advises at the end of a recording if sufficient data for analysis was recorded during the night. After recording, the ApneaLink Air recorder must be returned to the physician. With the ApneaLink Software the physician can generate a report with the recorded and analyzed data (respiratory pressure, respiratory effort, pulse rate, oxygen saturation) to aid in diagnosis. The body position data is stored as an EDF+ file on the recorder. It is accessible on a computer via USB connection using an EDF viewer.
The provided text describes the ApneaLink Air device, its indications for use, and a comparison to predicate devices, but it contains limited details regarding acceptance criteria for clinical performance and specific studies proving those acceptance criteria for the diagnosis of sleep-disordered breathing. The document focuses more on demonstrating substantial equivalence based on technical specifications and mechanical/electrical safety testing, particularly highlighting the addition of body position recording.
Here's an analysis based on the information provided in the text, structured according to your request:
1. Table of Acceptance Criteria and Reported Device Performance
Based on the provided text, the device's clinical performance acceptance criteria and reported performance for aiding in the diagnosis of sleep-disordered breathing are not explicitly stated as quantitative metrics (e.g., sensitivity, specificity, accuracy).
The document states:
- "Detection of respiratory events and reported indices was cleared under K083575 (ApneaLink Plus) and remained unchanged in ApneaLink Pro (K131932) and ApneaLink Air." This implies that the clinical performance related to detecting respiratory events (and thus deriving indices like AHI) is considered equivalent to the predicate ApneaLink Plus (K083575). However, the specific acceptance criteria and performance data for ApneaLink Plus are not detailed in this document.
- Regarding the new feature, body position recording: "Clinical data with regard to body position recording are not required as the body position data do not alter or influence any of the indices (like e.g. AHI or Apnea Index) or data generated by the testing and bench testing is sufficient to prove that body position recording results are as accurate as specified." And "Additional side by side testing has been performed by using a protractor to show the defined position around the body axis for ApneaLink Air and Nox T3."
Given this, a table summarizing explicitly stated acceptance criteria and performance for the diagnostic aid function cannot be fully constructed from the provided text. The document infers equivalence to predicate devices for its core diagnostic function and relies on bench testing for the new body position feature.
| Acceptance Criterion (Clinical Performance for Sleep Disordered Breathing Diagnosis) | Reported Device Performance |
|---|---|
| Not explicitly stated in this document for the ApneaLink Air itself. The document relies on equivalence to predicate devices (ApneaLink Plus K083575 and ApneaLink Pro K131932) for "Detection of respiratory events and reported indices." | Not explicitly stated for the ApneaLink Air itself. Performance is assumed to be equivalent to predicate devices. |
| For Body Position Recording (new feature): Accuracy of recording body position. | "bench testing is sufficient to prove that body position recording results are as accurate as specified." (Specific accuracy metrics not provided). Tested "using a protractor to show the defined position around the body axis for ApneaLink Air and Nox T3." |
2. Sample Size for the Test Set and Data Provenance
- Sample Size (Test Set): Not specified for clinical performance related to sleep-disordered breathing diagnosis. For the new body position recording feature, "Additional side by side testing has been performed by using a protractor" suggests direct comparison, but no specific number of subjects or samples is given.
- Data Provenance: Not explicitly stated for any clinical data mentioned or inferred. The document refers to "bench testing" and "side by side testing" without specifying if these involved human subjects or geographical origin. The device manufacturer is ResMed Germany Inc.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified. This information would typically be part of a clinical study report, which is not fully provided here.
4. Adjudication Method
- Adjudication Method: Not specified.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study: No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study evaluating human readers' improvement with AI vs. without AI assistance was not mentioned in this document. The device itself is an assessment tool, not an AI-assisted diagnostic aid for human readers in the context of this submission.
- Effect Size: Not applicable, as no such study was described.
6. Standalone (Algorithm Only) Performance Study
- Standalone Performance Study: The document states, "Detection of respiratory events and reported indices was cleared under K083575 (ApneaLink Plus) and remained unchanged in ApneaLink Pro (K131932) and ApneaLink Air." This implies that the algorithm's performance for detecting respiratory events and generating indices was established in prior submissions (K083575), and its performance remains unchanged. However, no specific details of that standalone study (e.g., metrics, study design) are provided in this document.
7. Type of Ground Truth Used
- For Detection of Respiratory Events and Indices (inherited from predicates): Not explicitly stated in this document. Typically, full polysomnography (PSG) interpreted by sleep specialists is considered the gold standard for ground truth in sleep-disordered breathing diagnosis.
- For Body Position Recording (new feature): The new body position feature relies on "bench testing" and "using a protractor to show the defined position around the body axis." This indicates a physical measurement/reference standard for ground truth for the sensor's accuracy, not a clinical ground truth like pathology or outcomes data.
8. Sample Size for the Training Set
- Sample Size (Training Set): Not specified. This document pertains to regulatory submission for a device, not the development or training of an algorithm. The core functionality and algorithms are "unchanged" from a prior cleared device (K083575), so any training data for those algorithms would have been part of that earlier submission.
9. How Ground Truth for Training Set Was Established
- Ground Truth for Training Set: Not specified in this document. As above, any ground truth establishment for algorithm training would have been part of the previous K083575 submission.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an emblem featuring three stylized human profiles facing to the right, representing health and human services.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 30, 2015
ResMed Germany Inc. Ms. Sandra Grunwald Director Quality Management & Regulatory Affairs Fraunhoferstr.16 Martinsried, Bavaria 82152 GERMANY
Re: K143272
Trade/Device Name: ApneaLink Air Regulation Number: 21 CFR 868.2375 Regulation Name: Breathing Frequency Monitor Regulatory Class: II Product Code: MNR Dated: March 25, 2015 Received: March 30, 2015
Dear Ms. Grunwald:
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. 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.
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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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
of Surveillance and Biometrics/Division of Postmarket Surveillance.
Sincerely yours,
Tejashri Purohit-Sheth, M.D.
Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR
Erin I. Keith, M.S. Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
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ApneaLink Air Traditional 510(k) Premarket Notification
Image /page/2/Picture/1 description: The image shows the logo for ResMed. The logo consists of a curved line of dots that transition in color from blue to red. Below the dots, the text "ResMed" is written in a bold, sans-serif font.
| DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration | |
|---|---|
| Indications for Use | |
| Form Approved: OMB No. 0910-0120 | |
| Expiration Date: January 31, 2017See PRA Statement below. | |
| 510(k) Number (if known) | |
| Device Name | ApneaLink Air |
| K143272 | |
| Indications for Use (Describe) | The ApneaLink™ Air device is indicated for use by Health Care Professionals (HCP), where it may aid in the diagnosis of sleep disordered breathing for adult patients. ApneaLink Air records the following data: patient respiratory nasal airflow, snoring, blood oxygen saturation, pulse, respiratory effort and body position during sleep. The device uses these recordings to produce a report for the HCP that may aid in the diagnosis of sleep disordered breathing or for further clinical investigation. The device is intended for home and hospital use under the direction of a HCP. |
| Type of Use (Select one or both, as applicable) | |
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
| CONTINUE ON A SEPARATE PAGE IF NEEDED. | |
| This section applies only to requirements of the Paperwork Reduction Act of 1995. | |
| DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW. | |
| The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect |
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
of this information collection, including suggestions for reducing this burden, to:
"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."
FORM FDA 3881 (8/14) 6th November 2014 Page 1 of 1 C167417
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510(k) Summary – ApneaLink Air 5
510(k) Summary – ApneaLink Air
| Date Prepared | 30th April 2015 |
|---|---|
| Submitter | Tobias NagelManager Regulatory Affairs |
| Official Contact | Larissa D'AndreaManager Regulatory AffairsResMed Corp.9001 Spectrum Center Boulevard,San Diego, CA 92123USATel: (858) 8366837 |
| Classification Reference | 21 CFR 868.2375 |
| Product Code | MNR |
| Common Name | Ventilatory Effort Recorder |
| Class Name | Breathing Frequency Monitor |
| Proprietary Name | ApneaLink Air |
| Predicate Devices | ApneaLink Pro (K131932) – primary predicate deviceNox T3, Noxturnal PC application (K082113) |
| Reason for submission | Expanded indications |
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Device Description
ApneaLink Air is a further development of the previously cleared Apneal.ink Pro (K131932). ApneaLink Pro was already prepared to support actigraphy but the feature was not activated while ApneaLink Air now offers body position data. The report generated by the ApneaLink (PC) Software remains unchanged from the predicate device, it does neither display data relating body position nor does the body position data influence the calculations made as a result of testing using the ApneaLink Air device, including most importantly, the overall apnea hypopnea index (AHI). The body position data is stored on in the recorder as an EDF+ file and can be displayed using an EDF viewer.
The ApneaLink Air recorder is a 5-channel battery-powered respiratory pressure sensor and oximetry system. ApneaLink Air provides recordings of respiratory pressure, respiratory effort, pulse rate, oxygen saturation and body position during sleep. The physician prescribed device will help to recognize sleep-related respiratory disorders. The ApneaLink Air recorder and the respiratory effort sensor must be fastened with the re-usable belt on the patient's chest parallel to the spine. All relevant respiratory information during sleep will be collected via nasal cannula, pulse oximetry module and respiratory effort sensor. The disposable plastic nasal cannula is connected to the ApneaLink Air recorder and fixed at the patient's nose. The oximetry sensor is connected to the Xpod and fixed at the patient's finger. The Xpod is connected to the ApneaLink Air recorder. The respiratory effort sensor is connected to the ApneaLink Air recorder and held in place by the belt. LED's indicate if the sensors are attached correctly. A Test complete light advises at the end of a recording if sufficient data for analysis was recorded during the night. After recording, the ApneaLink Air recorder must be returned to the physician. With the ApneaLink Software the physician can generate a report with the recorded and analyzed data (respiratory pressure, respiratory effort, pulse rate, oxygen saturation) to aid in diagnosis. The body position data is stored as an EDF+ file on the recorder. It is accessible on a computer via USB connection using an EDF viewer.
The recordings and the report can be sent via email to further clinical investigation.
Intended Use
The ApneaLink™ Air device is indicated for use by Health Care Professionals (HCP), where it may aid in the diagnosis of sleep disordered breathing for adult patients. ApneaLink Air records the following data: patient respiratory nasal airflow, snoring, blood oxygen saturation, pulse, respiratory effort and body position during sleep. The device uses these recordings to produce a report for the HCP that may aid in the diagnosis of sleep disordered breathing or for further clinical investigation. The device is intended for home and hospital use under the direction of a HCP.
Technology
The ApneaLink Air is different from the predicate device ApneaLink Pro (K131932) with respect to:
- A Body position recording
- O Actigraphy sensor provides body position of patient during sleep. Data can be viewed via an EDF viewer. Data is neither part of the report generated by ApneaLink Software nor does it influence or alter any index of the report.
- A Pulse oximeter module
- O Low power Xpod replaces previous Xpod model. Same accuracy and performance as the existing Xpod, but considerably lower power draw.
Substantial Equivalence
The table below provides an abbreviated summary of the primary relevant characteristics of ApneaLink Air compared to the predicate devices.
ApneaLink Pro (K131932) is the predecessor model of ApneaLink Air and the principal predicate device. With respect to the active body position channel Nox T3 including Noxturnal PC application (K082113) was selected as predicate device.
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Image /page/5/Figure/1 description: The image shows the logo for ResMed. The logo consists of a curved line made up of a series of dots that transition in color from blue to red. Below the line of dots is the word "ResMed" in a bold, sans-serif font.
| PREDICATES | NEW DEVICE | COMMENTS | ||
|---|---|---|---|---|
| CHARACTERISTIC | Nox T3, Noxturnal (PCApplication) (K082113) | ApneaLink Pro(K131932) | ApneaLink Air | Predicates vs. ApneaLink Air |
| Intended Use | The Nox T3 device is intendedfor ambulatory recording ofphysiological signals duringsleep.The recorded signals are thendownloaded to a PC where thesignals can be viewed ananalyzed by use of the Nox T3application (Noxturnal). TheNox T3 system is indicated foruse in patients greater than 2years of age.The Nox T3 system is NOTintended for any patientmonitoring or automaticdiagnosis.The intended environments arehospitals, institutions, sleepcenters, sleep clinics, or othertest environments, includingpatient's home.The Nox T3 system is used forpatients suspected of sufferingfrom Sleep DisorderedBreathing (SDB) or PeriodicLimb Movement Disorder | The ApneaLink™ Pro deviceis indicated for use by HealthCare Professionals (HCP), whereit may aid in the diagnosis ofsleep disordered breathing foradult patients. ApneaLink Prorecords the following data: patientrespiratory nasal airflow, snoring,blood oxygen saturation, pulseand respiratory effort duringsleep. The device uses theserecordings to produce a report forthe HCP that may aid in thediagnosis of sleep disorderedbreathing or for further clinicalinvestigation. The device isintended for home and hospitaluse under the direction of a HCP. | The ApneaLink™ Air deviceis indicated for use by HealthCare Professionals (HCP), whereit may aid in the diagnosis ofsleep disordered breathing foradult patients. ApneaLink Airrecordsthe following data: patientrespiratory nasal airflow, snoring,blood oxygen saturation, pulse,respiratory effort and bodyposition during sleep. The deviceuses these recordings to producea report for the HCP that may aidin the diagnosis of sleepdisordered breathing or for furtherclinical investigation. The deviceis intended for home and hospitaluse under the direction of a HCP. | Substantially EquivalentApneaLink Air is a furtherdevelopment of the previouslycleared ApneaLink Pro (K131932).The modification of the intendeduse only addresses the additionalrecording of the body position ofthe patient during sleep.Body position recording offersadditional information to thephysician. It does not alter orinfluence any of the indices (like e.g. AHI or Apnea Index) or datagenerated by the ApneaLinkSoftware report.Nox T3 incl. Noxturnal PCApplication, K082113, has beenselected as predicate device forthe active body position channel.ApneaLink Air as well as Nox T3record physiological data duringsleep in the same intendedenvironment. This data can beviewed and analyzed using PCsoftware and aid the physician inthe diagnosis of sleep disorderedbreathing. |
| CHARACTERISTIC | PREDICATESNox T3, Noxturnal (PC Application) (K082113) | ApneaLink Pro (K131932) | NEW DEVICEApneaLink Air | COMMENTSPredicates vs. ApneaLink Air |
| (PLMD). | Verification and bench testing show that the ApneaLink Air is as safe and effective as the predicate devices and does not raise different questions of safety and effectiveness than the predicate devices. Clinical data with regard to body position recording are not required as the body position data do not alter or influence any of the indices or data generated by the testing and bench testing is sufficient to prove that body position recording results are as accurate as specified. | |||
| Intended Environment | The intended environments are hospitals, institutions, sleep centers, sleep clinics, or other test environments, including patient's home | Recording - in the home, hospital or other clinical settingAnalyzing – physician's practice, sleep laboratory | Equivalent | |
| Target Population | Patients greater than 2 years | Adults | Substantially EquivalentEquivalent with ApneaLink Pro.Equivalent with Nox T3 regarding adult patients | |
| PREDICATES | NEW DEVICE | COMMENTS | ||
| CHARACTERISTIC | Nox T3, Noxturnal (PCApplication) (K082113) | ApneaLink Pro(K131932) | ApneaLink Air | Predicates vs. ApneaLink Air |
| Channels | - air flow- nasal/mask pressure- oxygen saturation- pulse- respiratory effort(abdomen and thorax)- body position- activity- snore- respiratory sound- EEG, EOG, EMG,ECG | - flow channel formeasurement of patientrespiratory nasalpressure.- oximeter input tomeasure degree ofoxygen saturation of theblood and pulse rate.- effort channel to measurethe respiratory effortusing a pneumaticprinciple. | - flow channel formeasurement of patientrespiratory nasalpressure.- oximeter input to measuredegree of oxygensaturation of the bloodand pulse rate.- effort channel to measurethe respiratory effort usinga pneumatic principle.- body position channel todetermine body positionof the patient during sleep | Substantially EquivalentThe body position channel wasalready implemented in thepredicate device ApneaLink Probut not activated. In the ApneaLinkAir the additional channel isactivated.Body position recording offersadditional information to thephysician. It does not alter orinfluence any of the indices (like e.g. AHI) or Apnea Index or datagenerated by the ApneaLinkSoftware report.The ApneaLink Air device showssimilar to the Nox T3 body positioninformation according to the anglethe device is tilted or rotated.Additional channels of Nox T3 notrelevant for body position. |
| Method ofconnection tothe Patient | Plastic tubing and cannula forpressure sensing; RIP belts forrespiratory effort; probes orFlexi Wrap for oximetry; touchproof electrode cables; RIPbelts for attaching of deviceand clip straps to secureposition of device. | Plastic tubing and cannula forpressure sensing; elastic clothmaterial belt to support unit andthe respiratory effort sensor. Thedevice is to be attached to apatient's chest. The Xpod is fixedat the belt via clip. Flexi Wrap tofix the oximeter sensor to the | Plastic tubing and cannula forpressure sensing; elastic clothmaterial belt to support unit andthe respiratory effort sensor. Thedevice is to be attached to apatient's chest. The new lowpower Xpod is fixed at the belt viaclip. Flexi Wrap to fix the oximeter | Equivalent |
| PREDICATES | NEW DEVICE | COMMENTS | ||
| CHARACTERISTIC | Nox T3, Noxturnal (PCApplication) (K082113) | ApneaLink Pro(K131932) | ApneaLink Air | Predicates vs. ApneaLink Air |
| The device is worn on thepatient's chest. | patient's finger. | sensor to the patient's finger. | ||
| Displayoperation | The device has a display toview signal integrity andoperation of the device. | Signal LED:3 LED's beside flow, effort and oximeter connectors indicate correctfunction of patient signals with a green light, and incorrect function bya red light.Test complete light:A Test complete LED is provided to signal sufficient recording time. | Substantially equivalent | |
| Power Sourcerecorder | Internally powered1x battery LR6 / Mignon / AA/1.5Vor1x NiMh AA/1.5V | Internally powered2 x batteries: LR03 / Micro / AAA / 1.5V / at least 1.0 Ahor2 x NiMh accumulators: HR03 / Micro / AAA / 1.2 V / at least 1.0 Ah | Substantially equivalent | |
| CommunicationInterface | USB 2.0 | USB 2.0 connector plugged into the device | Equivalent | |
| Patient isolation | Device has no galvanic connections to mains as it is a battery-operated device. Not possible to connectauxiliary devices to the device | Equivalent | ||
| SensorTechnology | Solid state pressure sensorSolid state position/activitysensorRespiratory Effort Sensors (RIPtechnology)Oximetry | Utilizes solid-state pressuresensor for nasal flow and effortthat converts pressure changes toelectrical signal levelsUtilizes oximetry sensor | Utilizes solid-state pressuresensor for nasal flow and effortthat converts pressure changes toelectrical signal levelsUtilizes oximetry sensorUtilizes solid-state actigraphy | Substantially Equivalent |
| PREDICATES | NEW DEVICE | COMMENTS | ||
| CHARACTERISTIC | Nox T3, Noxturnal (PCApplication) (K082113) | ApneaLink Pro(K131932) | ApneaLink Air | Predicates vs. ApneaLink Air |
| sensor for position | ||||
| Processor | Microprocessor systemprocesses the recorderpatient's data | The microprocessor system(LPC1853/7) processes therecorder patient's data | The microprocessor system(LPC1853) processes therecorder patient's data | Substantially EquivalentSole difference between themicroprocessor systems ofApneaLink Pro (K131932) andApneaLink Air is the internal flashmemory size (500kB in LPC1857vs. 1MB in LPC1853) |
| Location oflinearization(Transformationof pressurevalues in flowvalues) | No transformation.Airflow is displayed as pressurevalue. | ApneaLink Pro recorder | ApneaLink Air recorder | Substantially EquivalentDifference between Nox T3(K082113) and ApneaLink Air isnot relevant for body positionrecording. |
| Interfacebetweenembeddedsoftware andРСsoftware/EDFviewer | Recorded data is stored in thedevice. When the device isconnected to PC via USB cablethe device provides access toits internal memoryAll recorded data will betransferred to the Noxturnal PC | Recorded data is stored inEuropean Data Format (EDF+)file on SD card. When device isconnected to PC via USB thedevice provides access to itsinternal memory as mass storagememory including the recordedEDF+ files.Data related to patient respiratorynasal airflow, snoring, bloodoxygen saturation, pulse, | Recorded data is stored inEuropean Data Format (EDF+)file on SD card. When device isconnected to PC via USB thedevice provides access to itsinternal memory as mass storagememory including the recordedEDF+ files.Data related to patient respiratorynasal airflow, snoring, bloodoxygen saturation, pulse, | Substantially EquivalentIn addition to the transfer of thedata recorded by the predicatedevice ApneaLink Pro (K131932)ApneaLink Air offers the possibilityto access body position data by anEDF viewer.No differences between Nox T3 |
| Predicates | New Device | Comments | ||
| CHARACTERISTIC | Nox T3, Noxturnal (PCApplication) (K082113) | ApneaLink Pro(K131932) | ApneaLink Air | Predicates vs. ApneaLink Air |
| application software. | respiratory effort can betransferred to the ApneaLinkSoftware. | respiratory effort can betransferred to the ApneaLinkSoftware.Body position data can beaccessed by an EDF viewer. | (K082113) and ApneaLink Air thatare relevant for body positionrecording/displaying. | |
| Analyzing therecorded data | The recorded data aredownloaded via USB cable.Data related to air flow,nasal/mask pressure, snoring,oxygen saturation, pulse,respiratory effort (abdomen andthorax), body position, activity,respiratory sound, EEG, EOG,EMG and ECG can beanalyzed by the NoxturnalSoftware and a report can begenerated automatically. | The recorded data aredownloaded via USB cable. Datacan be accessed via EDF viewer.Data related to patient respiratorynasal airflow, snoring, bloodoxygen saturation, pulse,respiratory effort can be analyzedby the ApneaLink Software and areport can be generatedautomatically. | The recorded data aredownloaded via USB cable. Datacan be accessed via EDF viewer.Data related to patient respiratorynasal airflow, snoring, bloodoxygen saturation, pulse,respiratory effort can be analyzedby the ApneaLink Software and areport can be generatedautomatically.Body position data can be viewedusing an EDF viewer. | Substantially EquivalentAdditional channels of Nox T3 notrelevant for body position. |
| Analysis result(Indices) | The following indices aregenerated from the NoxturnalSoftware:AHI, Apnea Index, Apneas(central, mixed, obstructive),Hypopnea Index, Hypopneas,Snore Index, Flow LimitationIndex, LongestApnea/Hypopnea, AverageApnea, Average Hyponea,Desaturation Index/Count,SpO2 (Lowest, average, | The following indices aregenerated from the ApneaLink Software:AHI, RI, Apnea Index (unclassified, central, mixed, obstructive),Hypopnea Index, Number of flow limited breaths without snoring,Number of flow limited breaths with snoring, Cheyne-Stokes Breathing,ODI, Average saturation, Minimum saturation, Maximum saturation,Basal saturation, Minimum Pulse Rate, Maximum Pulse Rate, AveragePulse Rate | Substantially equivalentRecorded body position data canbe viewed using an EDF viewerbut is not displayed in the reportgenerated by the ApneaLinkSoftware. The body position datadoes not alter or influence any ofthe mentioned indices like e. g.AHI or Apnea Index. Informationregarding body position serves asadditional information. Thus the | |
| CHARACTERISTIC | PREDICATES | NEW DEVICE | COMMENTS | |
| Nox T3, Noxturnal (PCApplication) (K082113) | ApneaLink Pro(K131932) | ApneaLink Air | Predicates vs. ApneaLink Air | |
| baseline), Desaturation <90%,<85%, SpO2 time <90%, <85%,Pulse (Average, Highest,Lowest), Pulse time <40bpm,>100bpm, Average (Pulse SD,Desat Drop, Low Desat),Supine/non-supine time,upright time, activity time,Invalid data time, oximeterquality, flow quality, RIPquality, paradoxical index, est.sleep efficiency, respirationrate | indices generated from theApneaLink Software in the reportremain unchanged.Additional analysis results of NoxT3 not relevant for body position. | |||
| ISO 10993-1(Biocompatibilitytesting) | Cleared under K082113 | Cleared under K131932 | Identical materials are used fromApneaLink Pro (K131932) with thesame type and duration of patientcontact. | Equivalent |
| IEC 60601-1-2(EMC) | Cleared under K082113 | Cleared under K131932 | Radiated emission for thecombination of ApneaLink Air withthe new low power Xpod hasbeen retested to verify thecombination has equivalentemission behavior compared tothe previous device and is stillsignificantly below the limits. | Equivalent |
| IEC 60601-1(Electrical | Cleared under K082113 | Cleared under K131932 | ApneaLink Pro (K131932) wastested for IEC 60601-1. Test | Equivalent |
| PREDICATES | NEW DEVICE | COMMENTS | ||
| CHARACTERISTIC | Nox T3, Noxturnal (PC Application) (K082113) | ApneaLink Pro (K131932) | ApneaLink Air | Predicates vs. ApneaLink Air |
| safety) | results remain valid for ApneaLink Air. The actigraphy sensor was already physically incorporated in ApneaLink Pro. The new low power Xpod was successfully tested for compliance with IEC 60601-1 by manufacturer Nonin. The combination of both devices introduces no additional electrical safety risk as the low power Xpod is powered by ApneaLink Air and has no additional power source. | |||
| Environmental testing | Cleared under K082113 | Cleared under K131932 | ApneaLink Pro (K131932) was tested for IEC 60601-1-11. Test results remain valid for ApneaLink Air. | Equivalent |
| Dimensions Recorder LxWxD (inches) | 2.48" x 3.11" x 0.83" | 2.4" x 4" x 1.2" | Equivalent | |
| Xpod oximeter | Nonin 3150 Pulse oximeterNonin 4100 Pulse oximeter | Nonin Xpod 3012 | Nonin Xpod 3012 LP. | Substantially EquivalentApneaLink Pro was tested for IEC 60601-1 (K131932). Test results remain valid for ApneaLink Air. The new low power Xpod was successfully tested for compliance with IEC 60601-1 by manufacturer |
| PREDICATES | NEW DEVICE | COMMENTS | ||
| CHARACTERISTIC | Nox T3, Noxturnal (PCApplication) (K082113) | ApneaLink Pro(K131932) | ApneaLink Air | Predicates vs. ApneaLink Air |
| Nonin. The combination of bothdevices introduces no additionalelectrical safety risk as the lowpower Xpod is powered byApneaLink Air and has noadditional power source.Xpod 3012 and Xpod 3012 LPhave equivalent performance andclinical accuracy.Different types of pulse oximetersused with Nox T3 and ApneaLinkAir are not relevant for body | ||||
| position recording. | ||||
| DimensionsPulse OximeterHxWxD (inches) | N/A | 2.1" x 0.8" x 0.6" | Equivalent |
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The table above shows that there are no signification Apnealink Air and the predicate devices that adversely and effectiveness.
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Testing summary
Design and system verification testing in regards to mechanical and environmental testing according to IEC 60601-1-11:2010, electrical safety testing according to IEC 60601-1:2005 and EMC testing according to IEC 60601-1-2:2007 has been performed. All features that were changed from the predicate device ApneaLink Pro (K131932) are covered by additional verification testing as required. Detection of respiratory events and reported indices was cleared under K083575 (ApneaLink Plus) and remained unchanged in ApneaLink Pro (K131932) and ApneaLink Air. Thus side testing results from ApneaLink Pro comparing detection of all respiratory events remain valid.
Mechanical verification testing was performed on the subject device. The mechanical testing includes the following:
- · Specification Conformance Testing
- · Cleaning and Disinfection Test
- Durability Testing for the connectors, the button, the battery cap and battery contact
- · Screw Stripping
- Sharp Edges Test
- · Pressure Test
The device and the tested components passed the mechanical verification tests. Additional side by side testing has been performed by using a protractor to show the defined position around the body axis for ApneaLink Air and Nox T3.
All tests confirmed that the subject device meets the predetermined acceptance criteria and the requirements of the relevant standards. ResMed has determined that the ApneaLink Air is Substantially Equivalent to the predicate devices.
Conclusion: Based on the results of the performance testing for ApneaLink Air and the substantial equivalence comparison with the predicate devices with regard to the active body position channel no new concerns about safety and effectiveness were raised and we believe that the presented information is sufficient to determine that ApneaLink Air is substantially equivalent to the predicate devices ApneaLink Pro, K131932, and Nox T3, Noxturnal (PC Application), K082113.
§ 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).