(167 days)
No
The summary describes a device that records physiological data and generates a report for a healthcare professional to aid in diagnosis. There is no mention of AI, ML, or any algorithms that would suggest the use of such technologies for data analysis or interpretation beyond standard signal processing. The analysis of respiratory events and reported indices is stated to be unchanged from previous predicate devices, which were cleared before the widespread use of AI/ML in this context.
No
The device aids in the diagnosis of sleep-disordered breathing and does not provide any treatment or therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device "may aid in the diagnosis of sleep disordered breathing for adult patients."
No
The device description clearly outlines multiple hardware components including a recorder, sensors (respiratory pressure, respiratory effort, pulse oximetry), a nasal cannula, and a belt. While software is used for data analysis and reporting, the core functionality relies on these physical components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- ApneaLink Air Function: The ApneaLink Air device records physiological data directly from the patient's body (respiratory airflow, snoring, blood oxygen saturation, pulse, respiratory effort, body position) during sleep. It does not analyze samples taken from the body.
- Intended Use: The intended use clearly states it "may aid in the diagnosis of sleep disordered breathing" by recording and reporting physiological data. It's a diagnostic tool, but it works by monitoring the patient's physical state, not by analyzing in vitro samples.
Therefore, based on the provided information and the definition of an IVD, the ApneaLink Air is not an In Vitro Diagnostic device. It is a physiological monitoring and recording device used to aid in diagnosis.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
MNR
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Patient's chest, patient's nose, patient's finger
Indicated Patient Age Range
Adult patients
Intended User / Care Setting
Health Care Professionals (HCP) / home and hospital use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
ApneaLink Pro (K131932), Nox T3, Noxturnal PC application (K082113)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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.
1
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
2
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 SERVICES
| Food and Drug Administration | |
|---|---|
| Indications for Use | |
| Form Approved: OMB No. 0910-0120 | |
| Expiration Date: January 31, 2017 | |
| 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) | |
| 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
3
Image /page/3/Picture/1 description: The image shows the ResMed logo. The logo consists of the word "ResMed" in a bold, sans-serif font, with the letters slightly overlapping. Above the word "ResMed" is a curved line made up of a series of colored dots, starting with blue on the left and transitioning to red on the right. The dots are arranged in a wave-like pattern.
510(k) Summary – ApneaLink Air 5
510(k) Summary – ApneaLink Air
| Date Prepared | 30th April 2015 |
|---|---|
| Submitter | Tobias Nagel |
| Manager Regulatory Affairs | |
| Official Contact | Larissa D'Andrea |
| Manager Regulatory Affairs | |
| ResMed Corp. | |
| 9001 Spectrum Center Boulevard, | |
| San Diego, CA 92123 | |
| USA | |
| 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 |
| Nox T3, Noxturnal PC application (K082113) | |
| Reason for submission | Expanded indications |
4
Image /page/4/Picture/1 description: The image shows the logo for ResMed. The logo consists of a series of colored dots arranged in a curved line, transitioning from blue to purple to red. Below the dots is the word "ResMed" in a bold, sans-serif font.
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.
5
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 (PC | |||
| Application) (K082113) | ApneaLink Pro | |||
| (K131932) | ApneaLink Air | Predicates vs. ApneaLink Air | ||
| Intended Use | The Nox T3 device is intended | |||
| for ambulatory recording of | ||||
| physiological signals during | ||||
| sleep. | ||||
| The recorded signals are then | ||||
| downloaded to a PC where the | ||||
| signals can be viewed an | ||||
| analyzed by use of the Nox T3 | ||||
| application (Noxturnal). The | ||||
| Nox T3 system is indicated for | ||||
| use in patients greater than 2 | ||||
| years of age. | ||||
| The Nox T3 system is NOT | ||||
| intended for any patient | ||||
| monitoring or automatic | ||||
| diagnosis. | ||||
| The intended environments are | ||||
| hospitals, institutions, sleep | ||||
| centers, sleep clinics, or other | ||||
| test environments, including | ||||
| patient's home. | ||||
| The Nox T3 system is used for | ||||
| patients suspected of suffering | ||||
| from Sleep Disordered | ||||
| Breathing (SDB) or Periodic | ||||
| Limb Movement Disorder | The ApneaLink™ Pro 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 Pro | ||||
| records the following data: patient | ||||
| respiratory nasal airflow, snoring, | ||||
| blood oxygen saturation, pulse | ||||
| and respiratory effort 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 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. | Substantially Equivalent | |||
| ApneaLink Air is a further | ||||
| development of the previously | ||||
| cleared ApneaLink Pro (K131932). | ||||
| The modification of the intended | ||||
| use only addresses the additional | ||||
| recording of the body position of | ||||
| the patient during sleep. | ||||
| Body position recording offers | ||||
| additional information to the | ||||
| physician. It does not alter or | ||||
| influence any of the indices (like e. | ||||
| g. AHI or Apnea Index) or data | ||||
| generated by the ApneaLink | ||||
| Software report. | ||||
| Nox T3 incl. Noxturnal PC | ||||
| Application, K082113, has been | ||||
| selected as predicate device for | ||||
| the active body position channel. | ||||
| ApneaLink Air as well as Nox T3 | ||||
| record physiological data during | ||||
| sleep in the same intended | ||||
| environment. This data can be | ||||
| viewed and analyzed using PC | ||||
| software and aid the physician in | ||||
| the diagnosis of sleep disordered | ||||
| breathing. | ||||
| CHARACTERISTIC | PREDICATES | |||
| Nox T3, Noxturnal (PC Application) (K082113) | ApneaLink Pro (K131932) | NEW DEVICE | ||
| ApneaLink Air | COMMENTS | |||
| 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 | ||
| Analyzing – physician's practice, sleep laboratory | Equivalent | |||
| Target Population | Patients greater than 2 years | Adults | Substantially Equivalent | |
| Equivalent with ApneaLink Pro. | ||||
| Equivalent with Nox T3 regarding adult patients | ||||
| PREDICATES | NEW DEVICE | COMMENTS | ||
| CHARACTERISTIC | Nox T3, Noxturnal (PC | |||
| Application) (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 for
measurement of patient
respiratory nasal
pressure. - oximeter input to
measure degree of
oxygen saturation of the
blood and pulse rate. - effort channel to measure
the respiratory effort
using a pneumatic
principle. | - flow channel for
measurement of patient
respiratory nasal
pressure. - oximeter input to measure
degree of oxygen
saturation of the blood
and pulse rate. - effort channel to measure
the respiratory effort using
a pneumatic principle. - body position channel to
determine body position
of the patient during sleep | Substantially Equivalent
The body position channel was
already implemented in the
predicate device ApneaLink Pro
but not activated. In the ApneaLink
Air the additional channel is
activated.
Body position recording offers
additional information to the
physician. It does not alter or
influence any of the indices (like e.
g. AHI) or Apnea Index or data
generated by the ApneaLink
Software report.
The ApneaLink Air device shows
similar to the Nox T3 body position
information according to the angle
the device is tilted or rotated.
Additional channels of Nox T3 not
relevant for body position. |
| Method of
connection to
the Patient | Plastic tubing and cannula for
pressure sensing; RIP belts for
respiratory effort; probes or
Flexi Wrap for oximetry; touch
proof electrode cables; RIP
belts for attaching of device
and clip straps to secure
position of device. | Plastic tubing and cannula for
pressure sensing; elastic cloth
material belt to support unit and
the respiratory effort sensor. The
device is to be attached to a
patient's chest. The Xpod is fixed
at the belt via clip. Flexi Wrap to
fix the oximeter sensor to the | Plastic tubing and cannula for
pressure sensing; elastic cloth
material belt to support unit and
the respiratory effort sensor. The
device is to be attached to a
patient's chest. The new low
power Xpod is fixed at the belt via
clip. Flexi Wrap to fix the oximeter | Equivalent |
| | PREDICATES | | NEW DEVICE | COMMENTS |
| CHARACTERISTIC | Nox T3, Noxturnal (PC
Application) (K082113) | ApneaLink Pro
(K131932) | ApneaLink Air | Predicates vs. ApneaLink Air |
| | The device is worn on the
patient's chest. | patient's finger. | sensor to the patient's finger. | |
| Display
operation | The device has a display to
view signal integrity and
operation of the device. | Signal LED:
3 LED's beside flow, effort and oximeter connectors indicate correct
function of patient signals with a green light, and incorrect function by
a red light.
Test complete light:
A Test complete LED is provided to signal sufficient recording time. | | Substantially equivalent |
| Power Source
recorder | Internally powered
1x battery LR6 / Mignon / AA/
1.5V
or
1x NiMh AA/1.5V | Internally powered
2 x batteries: LR03 / Micro / AAA / 1.5V / at least 1.0 Ah
or
2 x NiMh accumulators: HR03 / Micro / AAA / 1.2 V / at least 1.0 Ah | | Substantially equivalent |
| Communication
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
auxiliary devices to the device | | | Equivalent |
| Sensor
Technology | Solid state pressure sensor
Solid state position/activity
sensor
Respiratory Effort Sensors (RIP
technology)
Oximetry | Utilizes solid-state pressure
sensor for nasal flow and effort
that converts pressure changes to
electrical signal levels
Utilizes oximetry sensor | Utilizes solid-state pressure
sensor for nasal flow and effort
that converts pressure changes to
electrical signal levels
Utilizes oximetry sensor
Utilizes solid-state actigraphy | Substantially Equivalent |
| | PREDICATES | | NEW DEVICE | COMMENTS |
| CHARACTERISTIC | Nox T3, Noxturnal (PC
Application) (K082113) | ApneaLink Pro
(K131932) | ApneaLink Air | Predicates vs. ApneaLink Air |
| | | | sensor for position | |
| Processor | Microprocessor system
processes the recorder
patient's data | The microprocessor system
(LPC1853/7) processes the
recorder patient's data | The microprocessor system
(LPC1853) processes the
recorder patient's data | Substantially Equivalent
Sole difference between the
microprocessor systems of
ApneaLink Pro (K131932) and
ApneaLink Air is the internal flash
memory size (500kB in LPC1857
vs. 1MB in LPC1853) |
| Location of
linearization
(Transformation
of pressure
values in flow
values) | No transformation.
Airflow is displayed as pressure
value. | ApneaLink Pro recorder | ApneaLink Air recorder | Substantially Equivalent
Difference between Nox T3
(K082113) and ApneaLink Air is
not relevant for body position
recording. |
| Interface
between
embedded
software and
РС
software/EDF
viewer | Recorded data is stored in the
device. When the device is
connected to PC via USB cable
the device provides access to
its internal memory
All recorded data will be
transferred to the Noxturnal PC | Recorded data is stored in
European Data Format (EDF+)
file on SD card. When device is
connected to PC via USB the
device provides access to its
internal memory as mass storage
memory including the recorded
EDF+ files.
Data related to patient respiratory
nasal airflow, snoring, blood
oxygen saturation, pulse, | Recorded data is stored in
European Data Format (EDF+)
file on SD card. When device is
connected to PC via USB the
device provides access to its
internal memory as mass storage
memory including the recorded
EDF+ files.
Data related to patient respiratory
nasal airflow, snoring, blood
oxygen saturation, pulse, | Substantially Equivalent
In addition to the transfer of the
data recorded by the predicate
device ApneaLink Pro (K131932)
ApneaLink Air offers the possibility
to access body position data by an
EDF viewer.
No differences between Nox T3 |
| | Predicates | | New Device | Comments |
| CHARACTERISTIC | Nox T3, Noxturnal (PC
Application) (K082113) | ApneaLink Pro
(K131932) | ApneaLink Air | Predicates vs. ApneaLink Air |
| | application software. | respiratory effort can be
transferred to the ApneaLink
Software. | respiratory effort can be
transferred to the ApneaLink
Software.
Body position data can be
accessed by an EDF viewer. | (K082113) and ApneaLink Air that
are relevant for body position
recording/displaying. |
| Analyzing the
recorded data | The recorded data are
downloaded via USB cable.
Data related to air flow,
nasal/mask pressure, snoring,
oxygen saturation, pulse,
respiratory effort (abdomen and
thorax), body position, activity,
respiratory sound, EEG, EOG,
EMG and ECG can be
analyzed by the Noxturnal
Software and a report can be
generated automatically. | The recorded data are
downloaded via USB cable. Data
can be accessed via EDF viewer.
Data related to patient respiratory
nasal airflow, snoring, blood
oxygen saturation, pulse,
respiratory effort can be analyzed
by the ApneaLink Software and a
report can be generated
automatically. | The recorded data are
downloaded via USB cable. Data
can be accessed via EDF viewer.
Data related to patient respiratory
nasal airflow, snoring, blood
oxygen saturation, pulse,
respiratory effort can be analyzed
by the ApneaLink Software and a
report can be generated
automatically.
Body position data can be viewed
using an EDF viewer. | Substantially Equivalent
Additional channels of Nox T3 not
relevant for body position. |
| Analysis result
(Indices) | The following indices are
generated from the Noxturnal
Software:
AHI, Apnea Index, Apneas
(central, mixed, obstructive),
Hypopnea Index, Hypopneas,
Snore Index, Flow Limitation
Index, Longest
Apnea/Hypopnea, Average
Apnea, Average Hyponea,
Desaturation Index/Count,
SpO2 (Lowest, average, | The following indices are
generated 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, Average
Pulse Rate | | Substantially equivalent
Recorded body position data can
be viewed using an EDF viewer
but is not displayed in the report
generated by the ApneaLink
Software. The body position data
does not alter or influence any of
the mentioned indices like e. g.
AHI or Apnea Index. Information
regarding body position serves as
additional information. Thus the |
| CHARACTERISTIC | PREDICATES | | NEW DEVICE | COMMENTS |
| | Nox T3, Noxturnal (PC
Application) (K082113) | ApneaLink Pro
(K131932) | ApneaLink Air | Predicates vs. ApneaLink Air |
| | baseline), Desaturation 100bpm, Average (Pulse SD,
Desat Drop, Low Desat),
Supine/non-supine time,
upright time, activity time,
Invalid data time, oximeter
quality, flow quality, RIP
quality, paradoxical index, est.
sleep efficiency, respiration
rate | | | indices generated from the
ApneaLink Software in the report
remain unchanged.
Additional analysis results of Nox
T3 not relevant for body position. |
| ISO 10993-1
(Biocompatibility
testing) | Cleared under K082113 | Cleared under K131932 | Identical materials are used from
ApneaLink Pro (K131932) with the
same type and duration of patient
contact. | Equivalent |
| IEC 60601-1-2
(EMC) | Cleared under K082113 | Cleared under K131932 | Radiated emission for the
combination of ApneaLink Air with
the new low power Xpod has
been retested to verify the
combination has equivalent
emission behavior compared to
the previous device and is still
significantly below the limits. | Equivalent |
| IEC 60601-1
(Electrical | Cleared under K082113 | Cleared under K131932 | ApneaLink Pro (K131932) was
tested 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 oximeter
Nonin 4100 Pulse oximeter | Nonin Xpod 3012 | Nonin Xpod 3012 LP
. | Substantially Equivalent
ApneaLink 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 (PC
Application) (K082113) | ApneaLink Pro
(K131932) | ApneaLink Air | Predicates vs. ApneaLink Air |
| | | | | 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.
Xpod 3012 and Xpod 3012 LP
have equivalent performance and
clinical accuracy.
Different types of pulse oximeters
used with Nox T3 and ApneaLink
Air are not relevant for body |
| | | | | position recording. |
| Dimensions
Pulse Oximeter
HxWxD (inches) | N/A | | 2.1" x 0.8" x 0.6" | Equivalent |
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Image /page/6/Picture/1 description: The image shows the logo for ResMed. The logo features the company name "ResMed" in bold, sans-serif font. Above the name is a curved line made up of a series of colored dots that transition from blue on the left to red on the right. The dots are arranged to create a wave-like pattern above the company name.
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Image /page/9/Picture/1 description: The image shows the ResMed logo. The logo features a curved line made up of a series of colored dots, transitioning from blue to red. Below the line of dots is the company name, "ResMed," in a bold, sans-serif font.
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Image /page/10/Picture/4 description: The image shows the ResMed logo. The logo features a curved line made of dots that transition in color from blue to red. Below the line of dots is the text "ResMed" in a bold, sans-serif font.
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Image /page/11/Figure/1 description: The image shows the logo for ResMed. The logo consists of the company name "ResMed" in a bold, sans-serif font, positioned below a stylized graphic. The graphic is a curved line made up of a series of circles that transition in color from blue on the left to red on the right, creating a gradient effect.
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Image /page/12/Picture/1 description: The image shows the logo for ResMed. The logo features the company name "ResMed" in a bold, sans-serif font, with the letters slightly overlapping. Above the name is a curved line made up of a series of colored dots, transitioning from blue on the left to red on the right. The dots decrease in size as they move towards the center of the curve.
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Image /page/13/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 purple to red. Below the line of dots is the word "ResMed" in a bold, sans-serif font.
The table above shows that there are no signification Apnealink Air and the predicate devices that adversely and effectiveness.
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Image /page/14/Picture/1 description: The image shows the logo for ResMed. The logo consists of the company name "ResMed" in bold, black font, positioned below a curved line of colored dots. The dots transition in color from blue on the left, through purple in the middle, to red on the right, creating a gradient effect.
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.