(134 days)
No
The summary describes a device that records physiological data and generates a report based on "recorded and analyzed data," but there is no mention of AI, ML, or any learning algorithms. The performance studies focus on comparing event detection and reported indices to a predicate device, not on validating an AI/ML model.
No
The device aids in the diagnosis of sleep-disordered breathing and does not provide any treatment.
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" and that it produces a report for the HCP that "may aid in the diagnosis of sleep disordered breathing or for further clinical investigation."
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 analysis and reporting, the core data acquisition relies on physical hardware.
Based on the provided information, the ApneaLink™ Pro device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the human body. The ApneaLink Pro device records physiological data from the patient's body (airflow, snoring, oxygen saturation, pulse, respiratory effort) but it does not analyze biological samples like blood, urine, or tissue.
- The device's function is to record and analyze physiological signals. It acts as a monitoring and data collection device to aid in the diagnosis of sleep disordered breathing, which is a physiological condition.
- The intended use and device description clearly outline the recording of physiological parameters. There is no mention of analyzing biological specimens.
Therefore, the ApneaLink Pro falls under the category of a medical device used for physiological monitoring and data analysis, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
MNR
Device Description
The ApneaLink Pro recorder is a 4-channel battery-powered respiratory pressure sensor and oximetry system. ApneaLink Pro provides recordings of respiratory pressure, respiratory effort, pulse rate and oxygen saturation during sleep. The physician prescribed device will help to recognize sleep-related respiratory disorders. The patient may perform the recording at home by himself. The Apnealink Pro recorder and the respiratory effort sensor must be fastened with the re-usable belt on the patient's chest. 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 Pro 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 Pro recorder. The respiratory effort sensor is connected to the ApneaLink Pro 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 Pro recorder must be returned to the physician. With the ApneaLink Software installed on a personal computer the physician can generate a report with the recorded and analyzed data to aid in diagnosis. 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 Verification activities have been performed on the ApneaLink Pro as a result of the risk analysis and product requirements. External tests have been conducted for electrical safety, EMC, mechanical and environments. Additionally, side-by-side testing of the detection of respiratory events and reported indices was used to demonstrate that the Anneal.ink Pro is Substantially Equivalent to the ApneaLink Plus (K083575). In the side-by-side testing, the detection of all respiratory events is compared. These include tests comparing pulse/saturation, apnealtypopnea according classic definition, snoring, Cheyne-Stokes breathing, hypopnea, apnea classification and central apnea determination according to threshold apnealeffort pause. The recorded, analyzed, displayed values and reported apnea classification of obstructive/mixed/central apneas of Apneal.ink Pro are compared to those of the ApneaLink Plus. All internal and external tests confirmed that the product meets the predetermined acceptance criteria and the requirements of the relevant standards. No additional biocompatibility testing was required as none of the components in contact with patients have changed from the predicate. ResMed has determined that the ApneaLink Pro is Substantially Equivalent to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
ApneaLink Plus (K083575)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
ApneaLink Pro Traditional 510(k) Premarket Notification (Response) RESMED 510(k) Summary 5 510(k) Summary 4" October 2013 Date prepared NOV 0 8 2013 Submitter Tobias Nagel Manager Regulatory Affairs Official Contact Jim Cassi Vice President - Quality Assurance Americas ResMed Corp. 9001 Spectrum Center Boulevard, San Diego, CA 92123 USA Tel: (858) 836 6081 Classification Reference 21 CFR 868.2375 Product Code MNR - Ventilatory Effort Recorder Common/Usual Name Ventilatory Effort Recorder Proprietary Name ApneaLink Pro Predicate Device ApneaLink Plus (K083575) Reason for submission New device
5
1
Device Description
The ApneaLink Pro recorder is the successor model of the previously cleared ApneaLink Plus (KQ83575). The new development was required due to design changes and as various components of the ApneaLink Plus won't be available any longer.
The ApneaLink Pro recorder is a 4-channel battery-powered respiratory pressure sensor and oximetry system. ApneaLink Pro provides recordings of respiratory pressure, respiratory effort, pulse rate and oxygen saturation during sleep. The physician prescribed device will help to recognize sleep-related respiratory disorders. The patient may perform the recording at home by himself. The Apnealink Pro recorder and the respiratory effort sensor must be fastened with the re-usable belt on the patient's chest. 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 Pro 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 Pro recorder. The respiratory effort sensor is connected to the ApneaLink Pro 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 Pro recorder must be returned to the physician. With the ApneaLink Software installed on a personal computer the physician can generate a report with the recorded and analyzed data to aid in diagnosis. The recordings and the report can be sent via email to further clinical investigation.
Note: The ApneaLink Pro is prepared to support actigraphy in future versions of the device. In the current version which is object of this submission the feature is not activated and can't be activated by the user.
Intended Use
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 aduit 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.
Technology
The ApneaLink Pro is different from the predicate device ApneaLink Plus (K083575) with respect to:
- ﻨﺰ Display operation
- 0 More user friendly display (Test Complete Indicator LED; Sensor LEDs , Start/Stop LED)
- ア Microprocessor
- New microcontroller with technology regarding interfaces and USB 0 driver
- ど Communication between embedded software and PC application
- 0 Data is stored in EDF+ files instead of proprietary data format file. Additionally device serves as mass storage device
Substantial Equivalence
The table below provides an abbreviated summary of the primary relevant characteristics of ApneaLink Pro compared to the predicate device.
2
RESMED
spneaLink Pro Traditional 510(k) Premarket Notification (Response)
| CHARACTERISTIC | PREDICATE
ApneaLink Plus
(K083575) | NEW DEVICE
ApneaLink Pro | COMMENTS
ApneaLink Plus vs. ApneaLink Pro |
|-----------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The ApneaLink™ Plus 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 Plus 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 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. | Substantially Equivalent
Intended use is identical except for last
sentence: clarification of use
environment only |
| Intended
Environment | Recording - in the home, hospital or other clinical setting
Analyzing - physician's practice, sleep laboratory | | Equivalent |
| Target
Population | | Adults | Equivalent |
| Channels | - respiratory nasal flow.
- oxygen saturation and
pulse rate. - respiratory effort | - respiratory nasal flow.
- oxygen saturation and
pulse rate. - respiratory effort | Equivalent |
| CHARACTERISTIC | PREDICATE
ApneaLink Plus
(K083575) | NEW DEVICE
ApneaLink Pro. | COMMENTS
ApneaLink Plus vs. ApneaLink Pro |
| Method of
connection to
the Patient | - Nasal cannula - Optical oximetry finger sensor
- Elastic cloth effort belt | - Nasal cannula
- Optical oximetry finger sensor
- Elastic cloth effort belt | Equivalent |
| Display
operation | Signal LED:
1 LED on the front panel indicates
the correct function of patient
signals with a green light, and
incorrect function by a red light. | 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:
ApneaLink Pro: Additional signal LED's
introduced to inform user which signal
is incorrect. |
| Power Source
recorder | Internally powered
2 x batteries: LR6 / Mignon / AA /
1.5V/ at least 1.9 Ah
or
2 x NiMh accumulators: Mignon /
AA/1.2V/ at least 1.9 Ah | 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 | ApneaLink Pro: Test complete LED
informs user after recording if
recording needs to be repeated
because of insufficient data |
| Communication
Interface | USB 1.1 connector plugged into
the device | USB 2.0 connector plugged into the
device | Equivalent |
| CHARACTERISTIC | PREDICATE
ApneaLink Plus
(K083575) | NEW DEVICE
ApneaLink Pro | COMMENTS
ApneaLink Plus vs. ApneaLink Pro |
| 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 | 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 | Analog pressure transducer and
AD converter | Digital pressure transducer with on-
chip calibration | Equivalent |
| Processor | The processor processes the
recorder patient's data | The micro processor system
processes the recorder patient's
data | Substantially equivalent:
Operating principle of collecting and
storing data is unchanged |
| Interface
between
embedded
software and
PC software | Recorded data is stored in
proprietary data format file. | 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. | Substantially equivalent:
Data is stored in files. Additionally
recorder serves as mass storage
device. |
| Analyzing the
recorded data | The recorded data are downloaded
via USB cable. Data are analyzed
and a report can be generated
automatically | The recorded data are downloaded
via USB cable. Data are analyzed
and a report can be generated
automatically | Equivalent |
| CHARACTERISTIC | PREDICATE
ApneaLink Plus
(K083575) | NEW DEVICE
ApneaLink Pro | COMMENTS
ApneaLink Plus vs. ApneaLink Pro |
| Analysis result
(Indices) | 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 | 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 | Equivalent |
| Dimensions
Recorder
LxWxD
(inches) | 4.6" x 2.4" x 1.2" | 2.4" x 4" x 1.2" | Substantially Equivalent:
Orientation was changed from vertical
to horizontal |
| Dimensions
Pulse Oximeter
HxWxD
(inches) | 2.1" x 0.8" x 0.6" | 2.1" x 0.8" x 0.6" | Equivalent |
3
pneaLink Pro Traditional 510(k) Premarket Notification (Response
Page 4
RESMED
4
oneaLink Pro Traditional 510(k) Premarket Notification (Response
RESMED
Page 5
5
RESMED
The table above shows that there are no significant differences between Apnealink Pro and the predicate on the product safety and
6
RESMED
Testing summary
Design and Verification activities have been performed on the ApneaLink Pro as a result of the risk analysis and product requirements. External tests have been conducted for electrical safety, EMC, mechanical and environments. Additionally, side-by-side testing of the detection of respiratory events and reported indices was used to demonstrate that the Anneal.ink Pro is Substantially Equivalent to the ApneaLink Plus (K083575). In the side-by-side testing, the detection of all respiratory events is compared. These include tests comparing pulse/saturation, apnealtypopnea according classic definition, snoring, Cheyne-Stokes breathing, hypopnea, apnea classification and central apnea determination according to threshold apnealeffort pause. The recorded, analyzed, displayed values and reported apnea classification of obstructive/mixed/central apneas of Apneal.ink Pro are compared to those of the ApneaLink Plus. All internal and external tests confirmed that the product meets the predetermined acceptance criteria and the requirements of the relevant standards. No additional biocompatibility testing was required as none of the components in contact with patients have changed from the predicate. ResMed has determined that the ApneaLink Pro is Substantially Equivalent to the predicate device.
Conformance to standards
The Apneal.ink Pro complies with the applicable standards referenced in the following:
- ﺮ ﺍ Reviewer Guidance for Premarket Notification Submissions, Anesthesiology and Respiratory Devices Branch (November 1993)
- ﺮ FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (May 11, 2005)
- r FDA Guidance for Industry, FDA Reviewers and Compliance on Off-the-Shelf Software Use in Medical Devices (September 9, 1999)
- ﺰ FDA General Principles of Software Validation, Final Guidance for Industry and FDA Staff (January 11, 2002)
- , l Guidance for Industry and FDA Premarket and Design Control Reviewers Medical Device Use-Safety: Incorporating Human Factors Engineering into Risk Management, 2000
- , A FDA Draft Guidance for Industry and Food and Drug Administration Staff - Applying Human Factors and Usability Engineering to Optimize Medical Device Design, 2011
- ﯩﺰ IEC 60601-1 Medical electrical equipment - Part 1: General requirements for safety
- ﺰ IEC 60601-1-2 Medical electrical equipment - Part 1-2: General requirements for basic safety Collateral standard: Electromagnetic compatibility - Requirements and tests
- ﺮﻧ Medical electrical equipment – Part 1-6: General requirements for basic safety IEC 60601-1-6 and essential performance - Collateral standard: usability
- IEC 60601-1-11 Medical electrical equipment ~ Part 1-11; General requirements for basic ﯩﺰ safety and essential performance - Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
- ﺮ IEC 62304 Medical device software - Software life cycle processes
- Biological evaluation of medical devices Part 1: Evaluation and testing within 产 ISO 10993-1 a risk management process
- ﺮ ISO 14971 Medical Devices - Application of risk management to medical devices
Conclusion: Based on the results of the performance testing for the ApneaLink Pro and the substantial equivalence comparison to the predicate device no new concerns about safety and effectiveness were raised and we believe that the presented information is sufficient to determine that ApneaLink Pro is substantially equivalent to the predicate device ApneaLink Plus (K083575).
7
Image /page/7/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the emblem.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Comrol Center - WO66-G609 Silver Spring, MD 20993-0002
November 8. 2013
ResMed Corporation Mr. Jim Cassi Vice President - Quality Assurance Americas 9001 Spectrum Center Boulevard SAN DIEGO, CA 92123
Re: K131932
Trade/Device Name: ApneaLink Pro Regulation Number: 21 CFR 868.2375 Regulation Name: Ventilatory Effort Recorder Regulatory Class: Class II Product Code: MNR Dated: October 4, 2013 Received: October 9, 2013
Dear Mr. Cassi:
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.
8
Page 2 - Mr. Cassi
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 of Surveillance and Biometrics/Division of Postmarket Surveillance.
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/Resourcesfor You/Industry/default.htm.
Sincerely vours,
Image /page/8/Picture/8 description: The image contains a combination of text and graphic elements. The text includes "Teashri Purohit Sheth, M.D.", "Clinical Deputy Director", and "DAGRID". The graphic elements appear to be a signature or logo with stylized lines and shapes. The overall image seems to be a scan or photocopy of a document with some handwritten or stamped elements.
Kwame Ulmer M.S. Acting Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
9
4 Indications For Use Statement
Indication for Use
510(k) Number (if known): K131932
Device Name:
ApneaLink Pro
Indication for Use
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. Apneal.ink 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.
Prescription Use ....................
AND/OR
Over-The-Counter Use_
(Part 21 CFR 801 Subpart D)
(Part 21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH; Office of Device Evaluation (ODE) sioned by Anya C. Karry -S ·U.S. Government, ou=KHS, to anya C Harry 00.100.3.1=0011315590
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