ApneaLink Air
Device Facts
| Record ID | K143272 |
|---|---|
| Device Name | ApneaLink Air |
| Applicant | Resmed Germany, Inc. |
| Product Code | MNR · Anesthesiology |
| Decision Date | Apr 30, 2015 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 868.2375 |
| Device Class | Class 2 |
Indications for 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.
Device Story
ApneaLink Air is a 5-channel battery-powered respiratory pressure sensor and oximetry system. Inputs: nasal airflow (via cannula), snoring, blood oxygen saturation (via finger oximeter), pulse, respiratory effort (via chest belt), and body position (via actigraphy sensor). Device transforms inputs into digital recordings stored as EDF+ files. Operated by patients at home or in hospital under HCP direction. HCPs use ApneaLink PC software to generate diagnostic reports (respiratory pressure, effort, pulse, SpO2). Body position data is stored separately and viewed via EDF viewer; it does not influence AHI or other diagnostic indices. Output aids HCPs in diagnosing sleep-related respiratory disorders. Benefits include home-based screening for sleep disordered breathing.
Clinical Evidence
Bench testing only. Verification included mechanical, environmental (IEC 60601-1-11), electrical safety (IEC 60601-1), and EMC (IEC 60601-1-2) testing. Respiratory event detection and index calculation algorithms were previously cleared under K083575 and K131932 and remain unchanged. Side-by-side testing confirmed body position accuracy against the Nox T3 predicate.
Technological Characteristics
Battery-powered (2x AAA) respiratory pressure and oximetry recorder. Sensors: nasal cannula (pressure), chest belt (respiratory effort), finger oximeter (Xpod 3012 LP). Connectivity: USB 2.0 for data transfer to PC. Software: ApneaLink PC software for report generation; EDF+ format for data storage. Actigraphy sensor for body position. Biocompatibility per ISO 10993-1. Electrical safety per IEC 60601-1; EMC per IEC 60601-1-2.
Indications for Use
Indicated for adult patients suspected of sleep disordered breathing. Used by healthcare professionals in home or hospital settings to aid in diagnosis.
Regulatory Classification
Identification
A breathing (ventilatory) frequency monitor is a device intended to measure or monitor a patient's respiratory rate. The device may provide an audible or visible alarm when the respiratory rate, averaged over time, is outside operator settable alarm limits. This device does not include the apnea monitor classified in § 868.2377.
Predicate Devices
Submission Summary (Full Text)
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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
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| DEPARTMENT OF HEALTH AND HUMAN SERVICES<br>Food and Drug Administration | |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | |
| | Form Approved: OMB No. 0910-0120 |
| | Expiration Date: January 31, 2017<br>See 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) | |
| <label><input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</label> | <label><input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</label> |
| 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 Nagel<br>Manager Regulatory Affairs |
| Official Contact | Larissa D'Andrea<br>Manager Regulatory Affairs<br>ResMed Corp.<br>9001 Spectrum Center Boulevard,<br>San Diego, CA 92123<br>USA<br>Tel: (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 device<br>Nox 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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| | PREDICATES | | NEW DEVICE | COMMENTS |
|---------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| CHARACTERISTIC | Nox T3, Noxturnal (PC<br>Application) (K082113) | ApneaLink Pro<br>(K131932) | ApneaLink Air | Predicates vs. ApneaLink Air |
| Intended Use | The Nox T3 device is intended<br>for ambulatory recording of<br>physiological signals during<br>sleep.<br>The recorded signals are then<br>downloaded to a PC where the<br>signals can be viewed an<br>analyzed by use of the Nox T3<br>application (Noxturnal). The<br>Nox T3 system is indicated for<br>use in patients greater than 2<br>years of age.<br>The Nox T3 system is NOT<br>intended for any patient<br>monitoring or automatic<br>diagnosis.<br>The intended environments are<br>hospitals, institutions, sleep<br>centers, sleep clinics, or other<br>test environments, including<br>patient's home.<br>The Nox T3 system is used for<br>patients suspected of suffering<br>from Sleep Disordered<br>Breathing (SDB) or Periodic<br>Limb Movement Disorder | The ApneaLink™ Pro device<br>is indicated for use by Health<br>Care Professionals (HCP), where<br>it may aid in the diagnosis of<br>sleep disordered breathing for<br>adult patients. ApneaLink Pro<br>records the following data: patient<br>respiratory nasal airflow, snoring,<br>blood oxygen saturation, pulse<br>and respiratory effort during<br>sleep. The device uses these<br>recordings to produce a report for<br>the HCP that may aid in the<br>diagnosis of sleep disordered<br>breathing or for further clinical<br>investigation. The device is<br>intended for home and hospital<br>use under the direction of a HCP. | The ApneaLink™ Air device<br>is indicated for use by Health<br>Care Professionals (HCP), where<br>it may aid in the diagnosis of<br>sleep disordered breathing for<br>adult patients. ApneaLink Air<br>records<br>the following data: patient<br>respiratory nasal airflow, snoring,<br>blood oxygen saturation, pulse,<br>respiratory effort and body<br>position during sleep. The device<br>uses these recordings to produce<br>a report for the HCP that may aid<br>in the diagnosis of sleep<br>disordered breathing or for further<br>clinical investigation. The device<br>is intended for home and hospital<br>use under the direction of a HCP. | Substantially Equivalent<br>ApneaLink Air is a further<br>development of the previously<br>cleared ApneaLink Pro (K131932).<br>The modification of the intended<br>use only addresses the additional<br>recording of the body position of<br>the patient during sleep.<br>Body position recording offers<br>additional information to the<br>physician. It does not alter or<br>influence any of the indices (like e.<br>g. AHI or Apnea Index) or data<br>generated by the ApneaLink<br>Software report.<br>Nox T3 incl. Noxturnal PC<br>Application, K082113, has been<br>selected as predicate device for<br>the active body position channel.<br>ApneaLink Air as well as Nox T3<br>record physiological data during<br>sleep in the same intended<br>environment. This data can be<br>viewed and analyzed using PC<br>software and aid the physician in<br>the diagnosis of sleep disordered<br>breathing. |
| CHARACTERISTIC | PREDICATES<br>Nox T3, Noxturnal (PC Application) (K082113) | ApneaLink Pro (K131932) | NEW DEVICE<br>ApneaLink Air | COMMENTS<br>Predicates 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 setting<br>Analyzing – physician's practice, sleep laboratory | | Equivalent |
| Target Population | Patients greater than 2 years | Adults | | Substantially Equivalent<br>Equivalent with ApneaLink Pro.<br>Equivalent with Nox T3 regarding adult patients |
| | PREDICATES | | NEW DEVICE | COMMENTS |
| CHARACTERISTIC | Nox T3, Noxturnal (PC<br>Application) (K082113) | ApneaLink Pro<br>(K131932) | ApneaLink Air | Predicates vs. ApneaLink Air |
| Channels | - air flow<br>- nasal/mask pressure<br>- oxygen saturation<br>- pulse<br>- respiratory effort<br>(abdomen and thorax)<br>- <b>body position</b><br>- activity<br>- snore<br>- respiratory sound<br>- EEG, EOG, EMG,<br>ECG | - flow channel for<br>measurement of patient<br>respiratory nasal<br>pressure.<br>- oximeter input to<br>measure degree of<br>oxygen saturation of the<br>blood and pulse rate.<br>- effort channel to measure<br>the respiratory effort<br>using a pneumatic<br>principle. | - flow channel for<br>measurement of patient<br>respiratory nasal<br>pressure.<br>- oximeter input to measure<br>degree of oxygen<br>saturation of the blood<br>and pulse rate.<br>- effort channel to measure<br>the respiratory effort using<br>a pneumatic principle.<br>- <b>body position</b> channel to<br>determine body position<br>of the patient during sleep | Substantially Equivalent<br>The body position channel was<br>already implemented in the<br>predicate device ApneaLink Pro<br>but not activated. In the ApneaLink<br>Air the additional channel is<br>activated.<br>Body position recording offers<br>additional information to the<br>physician. It does not alter or<br>influence any of the indices (like e.<br>g. AHI) or Apnea Index or data<br>generated by the ApneaLink<br>Software report.<br>The ApneaLink Air device shows<br>similar to the Nox T3 body position<br>information according to the angle<br>the device is tilted or rotated.<br>Additional channels of Nox T3 not<br>relevant for body position. |
| Method of<br>connection to<br>the Patient | Plastic tubing and cannula for<br>pressure sensing; RIP belts for<br>respiratory effort; probes or<br>Flexi Wrap for oximetry; touch<br>proof electrode cables; RIP<br>belts for attaching of device<br>and clip straps to secure<br>position of device. | Plastic tubing and cannula for<br>pressure sensing; elastic cloth<br>material belt to support unit and<br>the respiratory effort sensor. The<br>device is to be attached to a<br>patient's chest. The Xpod is fixed<br>at the belt via clip. Flexi Wrap to<br>fix the oximeter sensor to the | Plastic tubing and cannula for<br>pressure sensing; elastic cloth<br>material belt to support unit and<br>the respiratory effort sensor. The<br>device is to be attached to a<br>patient's chest. The new low<br>power Xpod is fixed at the belt via<br>clip. Flexi Wrap to fix the oximeter | Equivalent |
| | PREDICATES | | NEW DEVICE | COMMENTS |
| CHARACTERISTIC | Nox T3, Noxturnal (PC<br>Application) (K082113) | ApneaLink Pro<br>(K131932) | ApneaLink Air | Predicates vs. ApneaLink Air |
| | The device is worn on the<br>patient's chest. | patient's finger. | sensor to the patient's finger. | |
| Display<br>operation | The device has a display to<br>view signal integrity and<br>operation of the device. | Signal LED:<br>3 LED's beside flow, effort and oximeter connectors indicate correct<br>function of patient signals with a green light, and incorrect function by<br>a red light.<br>Test complete light:<br>A Test complete LED is provided to signal sufficient recording time. | | Substantially equivalent |
| Power Source<br>recorder | Internally powered<br>1x battery LR6 / Mignon / AA/<br>1.5V<br>or<br>1x NiMh AA/1.5V | Internally powered<br>2 x batteries: LR03 / Micro / AAA / 1.5V / at least 1.0 Ah<br>or<br>2 x NiMh accumulators: HR03 / Micro / AAA / 1.2 V / at least 1.0 Ah | | Substantially equivalent |
| Communication<br>Interface | 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 connect<br>auxiliary devices to the device…
