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.

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.

AI/ML Overview

The ApneaLink Pro is a ventilatory effort recorder intended to aid healthcare professionals in diagnosing sleep-disordered breathing in adult patients.

Here's an analysis of the acceptance criteria and study data:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document describes a "side-by-side testing of the detection of respiratory events and reported indices" to demonstrate substantial equivalence to the predicate device, ApneaLink Plus (K083575). The "acceptance criteria" appear to be that the ApneaLink Pro's performance for detecting and classifying respiratory events is substantially equivalent to that of the predicate device.

Characteristic	Acceptance Criteria (Implied)	Reported Device Performance
Detection of all respiratory events	Substantially Equivalent to ApneaLink Plus (K083575): This encompasses: - Pulse/saturation detection - Apnea/hypopnea according to classic definition - Snoring detection - Cheyne-Stokes breathing detection - Hypopnea detection - Apnea classification (obstructive, mixed, central) - Central apnea determination according to threshold apnea/effort pause	Confirmed Substantially Equivalent to ApneaLink Plus (K083575): "side-by-side testing... used to demonstrate that the ApneaLink Pro is Substantially Equivalent to the ApneaLink Plus (K083575). In the side-by-side testing, the detection of all respiratory events is compared. The recorded, analyzed, displayed values and reported apnea classification... are compared to those of the ApneaLink Plus."
Recorded, analyzed, displayed values	Substantially Equivalent to ApneaLink Plus (K083575)	Confirmed Substantially Equivalent to ApneaLink Plus (K083575): "The recorded, analyzed, displayed values... of Apneal.ink Pro are compared to those of the ApneaLink Plus."
Reported apnea classification (obstructive/mixed/central)	Substantially Equivalent to ApneaLink Plus (K083575)	Confirmed Substantially Equivalent to ApneaLink Plus (K083575): "reported apnea classification of obstructive/mixed/central apneas of Apneal.ink Pro are compared to those of the ApneaLink Plus."
Meeting predetermined acceptance criteria and relevant standards	All internal and external tests confirm compliance with predetermined acceptance criteria and requirements of relevant standards. (This is a broader statement, encompassing electrical safety, EMC, mechanical, and environmental tests, in addition to the clinical performance comparison). This implies numerical or qualitative thresholds for each specific test, though these are not detailed in the provided text.	Confirmed: "All internal and external tests confirmed that the product meets the predetermined acceptance criteria and the requirements of the relevant standards."
Biocompatibility	No additional testing required as no changes from the predicate device in patient-contacting components.	Confirmed: "No additional biocompatibility testing was required as none of the components in contact with patients have changed from the predicate."

2. Sample Size and Data Provenance for the Test Set

Sample Size: The document does not explicitly state the sample size (number of patients or recordings) used for the side-by-side testing. It simply refers to "side-by-side testing... of the detection of all respiratory events."
Data Provenance: The document does not specify the country of origin of the data or whether the study was retrospective or prospective.

3. Number of Experts and Qualifications for Ground Truth

The document does not mention the number of experts used to establish ground truth or their specific qualifications. The study methodology described as "side-by-side testing" against a predicate device suggests that the predicate device's output itself served as a reference point for comparison, rather than an independent expert-established ground truth.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1, none). Given that the comparison is "side-by-side" against a predicate device, it's likely that the predicate's output was considered the de facto reference, and no separate human adjudication process is detailed for this comparison.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC study described: The document does not describe a multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance. The study focuses on comparing the new device (ApneaLink Pro) to an existing device (ApneaLink Plus) in terms of its ability to detect and report physiological events. The ApneaLink Pro is a recording and analysis device, not an AI-assisted diagnostic tool for human readers in the context of improving their performance.

6. Standalone (Algorithm Only) Performance

Standalone performance was the focus: The primary study described is a "side-by-side testing of the detection of respiratory events and reported indices" where the ApneaLink Pro's analytical software output is compared directly to the ApneaLink Plus's output. This is a form of standalone performance evaluation for the device's analytical capabilities, as it does not involve human interpretation of the raw data from the new device beyond what the predicate already provided. The device aids in diagnosis by producing a report; the reported performance is of the device's ability to generate this report.

7. Type of Ground Truth Used

Predicate Device Output: The ground truth for this comparison study was effectively the performance and outputs ("recorded, analyzed, displayed values and reported apnea classification") of the legally marketed predicate device, ApneaLink Plus (K083575). The goal was to establish "substantial equivalence," not necessarily absolute accuracy against a gold standard like polysomnography or pathology, within the scope of this particular submission.

8. Sample Size for the Training Set

The document does not mention a "training set" in the context of device development or performance evaluation. The ApneaLink Pro is described as a successor model with hardware and software changes, and the testing described is a comparison to a predicate, not a machine learning model requiring a training set.

9. How Ground Truth for the Training Set Was Established

Since no training set is described for a machine learning algorithm, there is no information on how ground truth for a training set was established. The device's "technology" section implies updates to a microprocessor and software for data handling, not necessarily a learning algorithm.

Summary

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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

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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.

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.

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RESMED

spneaLink Pro Traditional 510(k) Premarket Notification (Response)

CHARACTERISTIC	PREDICATEApneaLink Plus(K083575)	NEW DEVICEApneaLink Pro	COMMENTSApneaLink Plus vs. ApneaLink Pro
Intended Use	The ApneaLink™ Plus deviceis indicated for use by Health CareProfessionals (HCP), where it mayaid in the diagnosis of sleepdisordered breathing for adultpatients. ApneaLink Plus recordsthe following data: patientrespiratory nasal airflow, snoring,blood oxygen saturation, pulse andrespiratory effort during sleep. Thedevice uses these recordings toproduce a report for the HCP thatmay aid in the diagnosis of sleepdisordered breathing or for furtherclinical investigation.	The ApneaLink™ Pro deviceis indicated for use by Health CareProfessionals (HCP), where it mayaid in the diagnosis of sleepdisordered breathing for adultpatients. ApneaLink Pro recordsthe following data: patientrespiratory nasal airflow, snoring,blood oxygen saturation, pulse andrespiratory effort during sleep. Thedevice uses these recordings toproduce a report for the HCP thatmay aid in the diagnosis of sleepdisordered breathing or for furtherclinical investigation. The device isintended for home and hospital useunder the direction of a HCP.	Substantially EquivalentIntended use is identical except for lastsentence: clarification of useenvironment only
IntendedEnvironment	Recording - in the home, hospital or other clinical settingAnalyzing - physician's practice, sleep laboratory		Equivalent
TargetPopulation		Adults	Equivalent
Channels	- respiratory nasal flow.- oxygen saturation andpulse rate.- respiratory effort	- respiratory nasal flow.- oxygen saturation andpulse rate.- respiratory effort	Equivalent
CHARACTERISTIC	PREDICATEApneaLink Plus(K083575)	NEW DEVICEApneaLink Pro.	COMMENTSApneaLink Plus vs. ApneaLink Pro
Method ofconnection tothe Patient	- Nasal cannula- Optical oximetry finger sensor- Elastic cloth effort belt	- Nasal cannula- Optical oximetry finger sensor- Elastic cloth effort belt	Equivalent
Displayoperation	Signal LED:1 LED on the front panel indicatesthe correct function of patientsignals with a green light, andincorrect function by a red light.	Signal LED:3 LED's beside flow, effort andoximeter connectors indicatecorrect function of patient signalswith a green light, and incorrectfunction by a red light.Test complete light:A Test complete LED is provided tosignal sufficient recording time.	Substantially Equivalent:ApneaLink Pro: Additional signal LED'sintroduced to inform user which signalis incorrect.
Power Sourcerecorder	Internally powered2 x batteries: LR6 / Mignon / AA /1.5V/ at least 1.9 Ahor2 x NiMh accumulators: Mignon /AA/1.2V/ at least 1.9 Ah	Internally powered2 x batteries: LR03 / Micro / AAA /1.5V/ at least 1.0 Ahor2 x NiMh accumulators: HR03 /Micro / AAA / 1.2 V / at least 1.0 Ah	ApneaLink Pro: Test complete LEDinforms user after recording ifrecording needs to be repeatedbecause of insufficient data
CommunicationInterface	USB 1.1 connector plugged intothe device	USB 2.0 connector plugged into thedevice	Equivalent
CHARACTERISTIC	PREDICATEApneaLink Plus(K083575)	NEW DEVICEApneaLink Pro	COMMENTSApneaLink Plus vs. ApneaLink Pro
Patientisolation	Device has no galvanicconnections to mains as it is abattery-operated device. Notpossible to connect auxiliarydevices to the device	Device has no galvanicconnections to mains as it is abattery-operated device. Notpossible to connect auxiliarydevices to the device	Equivalent
SensorTechnology	Analog pressure transducer andAD converter	Digital pressure transducer with on-chip calibration	Equivalent
Processor	The processor processes therecorder patient's data	The micro processor systemprocesses the recorder patient'sdata	Substantially equivalent:Operating principle of collecting andstoring data is unchanged
Interfacebetweenembeddedsoftware andPC software	Recorded data is stored inproprietary data format file.	Recorded data is stored inEuropean Data Format (EDF+) fileon SD card. When device isconnected to PC via USB thedevice provides access to itsinternal memory as mass storagememory including the recordedEDF+ files.	Substantially equivalent:Data is stored in files. Additionallyrecorder serves as mass storagedevice.
Analyzing therecorded data	The recorded data are downloadedvia USB cable. Data are analyzedand a report can be generatedautomatically	The recorded data are downloadedvia USB cable. Data are analyzedand a report can be generatedautomatically	Equivalent
CHARACTERISTIC	PREDICATEApneaLink Plus(K083575)	NEW DEVICEApneaLink Pro	COMMENTSApneaLink Plus vs. ApneaLink Pro
Analysis result(Indices)	The following indices aregenerated from the ApneaLinkSoftware:AHI, RI, Apnea Index (unclassified,central, mixed, obstructive),Hypopnea Index, Number of flowlimited breaths without snoring,Number of flow limited breaths withsnoring, Cheyne-Stokes Breathing,ODI, Average saturation, Minimumsaturation, Maximum saturation,Basal saturation, Minimum PulseRate, Maximum Pulse Rate,Average Pulse Rate	The following indices aregenerated from the ApneaLinkSoftware:AHI, RI, Apnea Index (unclassified,central, mixed, obstructive),Hypopnea Index, Number of flowlimited breaths without snoring,Number of flow limited breaths withsnoring, Cheyne-Stokes Breathing,ODI, Average saturation, Minimumsaturation, Maximum saturation,Basal saturation, Minimum PulseRate, Maximum Pulse Rate,Average Pulse Rate	Equivalent
DimensionsRecorderLxWxD(inches)	4.6" x 2.4" x 1.2"	2.4" x 4" x 1.2"	Substantially Equivalent:Orientation was changed from verticalto horizontal
DimensionsPulse OximeterHxWxD(inches)	2.1" x 0.8" x 0.6"	2.1" x 0.8" x 0.6"	Equivalent

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pneaLink Pro Traditional 510(k) Premarket Notification (Response

Page 4

RESMED

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oneaLink Pro Traditional 510(k) Premarket Notification (Response

RESMED

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RESMED

The table above shows that there are no significant differences between Apnealink Pro and the predicate on the product safety and

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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).

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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.

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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

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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

Page 1 of_

Regulation Number and Section

§ 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).