Who is the manufacturer of APNEALINK PRO?

Resmed Germany, Inc. filed the 510(k) submission for APNEALINK PRO (K131932).

What is the FDA product code for APNEALINK PRO?

MNR. It is classified under 21 CFR 868.2375 as a Class 2 device in the Anesthesiology panel.

What is the regulatory pathway for APNEALINK PRO?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like APNEALINK PRO?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

APNEALINK PRO

K131932 · Resmed Germany, Inc. · MNR · Nov 8, 2013 · Anesthesiology

Device Facts

Record ID	K131932
Device Name	APNEALINK PRO
Applicant	Resmed Germany, Inc.
Product Code	MNR · Anesthesiology
Decision Date	Nov 8, 2013
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 868.2375
Device Class	Class 2

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.

Device Story

ApneaLink Pro is a 4-channel, battery-powered ventilatory effort recorder for sleep-disordered breathing diagnosis. Inputs: nasal airflow (via cannula), pulse/oxygen saturation (via finger oximetry sensor), and respiratory effort (via chest belt). Device processes signals via internal microcontroller; stores data in EDF+ format on internal memory/SD card. Operated by patient at home or in hospital; physician reviews data via ApneaLink Software on PC to generate diagnostic reports. Features include LED indicators for sensor attachment and test completion. Replaces ApneaLink Plus; adds digital pressure transducer, USB 2.0 interface, and improved display. Benefits include automated data collection and analysis to assist clinicians in identifying respiratory disorders.

Clinical Evidence

Bench testing only. Side-by-side comparative testing against the predicate device (ApneaLink Plus) was performed to validate the detection of respiratory events, including pulse/saturation, apnea/hypopnea, snoring, Cheyne-Stokes breathing, and apnea classification (obstructive/mixed/central). Results confirmed that the ApneaLink Pro meets predetermined acceptance criteria and demonstrates substantial equivalence to the predicate.

Technological Characteristics

Battery-powered (AAA) 4-channel recorder. Sensors: nasal cannula, optical oximetry finger sensor, elastic chest effort belt. Digital pressure transducer with on-chip calibration. Connectivity: USB 2.0, SD card storage (EDF+ format). Software: embedded firmware for data acquisition; PC-based software for analysis and reporting. Complies with IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, and IEC 62304.

Indications for Use

Indicated for adult patients to aid in the diagnosis of sleep disordered breathing. Used by healthcare professionals in home or hospital settings.

Regulatory Classification

Identification

A breathing (ventilatory) frequency monitor is a device intended to measure or monitor a patient's respiratory rate. The device may provide an audible or visible alarm when the respiratory rate, averaged over time, is outside operator settable alarm limits. This device does not include the apnea monitor classified in § 868.2377.

Predicate Devices

ApneaLink Plus (K083575)

Submission Summary (Full Text)

{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 Page 1 of_

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