(106 days)
ApneaLink (K070263)
No
The document describes a device that records physiological data and generates a report based on AASM criteria. There is no mention of AI or ML in the description of the device's functionality or analysis methods.
No
The device is indicated for aiding in the diagnosis of sleep disordered breathing, not for providing therapy.
Yes
The device "may aid in the diagnosis of sleep disordered breathing for adult patients" and "aid in the diagnosis of sleep disordered breathing or for further clinical investigation." It produces a report for the HCP for this purpose.
No
The device description explicitly details hardware components such as a recorder, sensors (respiratory pressure, respiratory effort, pulse oximetry), nasal cannula, XPOD, and a belt, which are integral to data acquisition. While software is used for analysis and reporting, the device is not solely software.
Based on the provided text, the ApneaLink™ Plus device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the human body. The ApneaLink Plus 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 diagnosis, not a device that performs tests on biological specimens.
The description clearly outlines the device's function as recording physiological parameters during sleep and generating a report based on these recordings. This aligns with the definition of a physiological monitoring device, not an IVD.
N/A
Intended Use / Indications for 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. Apneal ink Plus recred 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.
Product codes
MNR
Device Description
The ApneaLink Plus is a further development of the previously submitted device Apneal.ink (K070263). This submission addresses the expanded Indications for Use of Apnealink by including AASM criteria for detecting hypopneas and a respiratory effort sensor to differentiate between central, obstructive and mixed apneas.
The ApneaLink Plus recorder is a 3-channel battery-powered respiratory pressure sensor and oximetry system. ApneaLink Plus provides recordings of respiratory pressure, respiratory effort, pulse rate and oxvaen saturation during sleep. The phvsician prescribed device will help to recognize sleep-related respiratory disorders and lead to comprehensive clinical diagnosis and therapy. The patient may perform the recording at home by himself. The ApneaLink Plus 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 Plus 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 Plus recorder. The respiratory effort sensor is connected to the ApneaLink Plus recorder and held in place by the belt. After recording, the ApneaLink Plus recorder must be returned to the physician. With the ApneaLink Plus Software installed on a personnel computer the physician can generate a report with the recorded and analyzed data to aid in the diagnosis of sleep disordered breathing. 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
Not Found
Indicated Patient Age Range
adult patients
Intended User / Care Setting
Health Care Professionals (HCP) / at home
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
ApneaLink (K070263), Respironics Stardust II (K021845)
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
KOS-3575
510(k) Summary – ApneaLink Plus
MAR 1 9 2009
Date Prepared
28" November 2008
| Official Contact | David D'Cruz |
|---|---|
| V.P., Clinical & Regulatory Affairs | |
| ResMed Corp. | |
| 14040 Danielson St, | |
| Poway CA 92064-6857 | |
| USA | |
| Tel: +1 858-746-2238 | |
| Fax: +1 858-746-2915 | |
| Classification Reference | 21 CFR 868.2375 |
| Product Code | MNR - Ventilatory Effort Recorder |
| Common/Usual Name | Ventilatory Effort Recorder |
| Proprietary Name | ApneaLink Plus |
| Predicate Devices | ApneaLink (K070263) |
| Respironics Stardust II (K021845) | |
| Reason for submission | Expanded Indications |
28th November, 2008
:
1
Substantial Equivalence
The new device has the following similarities to the previously cleared devices:
- 产 Intended use Similar
- 公 Operating principle Same
- 必 Technologies Same
- 产 Manufacturing process Same
Design and Verification activities were performed on the ApneaLink Plus as a result of the risk analysis and product requirements. All tests confirmed the predetermined acceptance criteria. ResMed has determined that the ApneaLink Plus is Substantially Equivalent to the predicate devices. The ApneaLink complies with the applicable standards and requirements referenced in the following:
- ア FDA Guidance for the Content of Pre-market Submissions for Software Contained in Medical Devices (May 11, 2005)
- ﻨﺰ FDA Off-the-Shelf Software Use in Medical Devices (September 9,1999)
- ﺗﺮ FDA General Principles of Software Validation (January 11, 2002)
- ﮨﺰ IEC 60601-1 (Medical Electrical Equipment Part 1: General requirements for safety)
- ﺮ IEC 60601-1-2 (Medical Electrical Equipment Part 1-2: General requirements for safety -Collateral standard: Electromagnetic compatibility - Requirements and tests)
- IEC 60601-1-4 (Medical Electrical Equipment Part 1-4: General requirements for safety Collateral ﺰ Standard: Programmable electrical medical systems)
- A IEC 60068-2-1/ and the following (Environmental testing)
- ISO 10993-1 (Biological evaluation of medical devices -- Part 1 Evaluation and testing) A
- ﺗﺮ EN ISO 14971 (Medical Devices - Application of risk management to medical devices)
Intended Use
The Apneal.ink Plus device is indicated for use by Heath 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.
Device Description
The performance and functional characteristics of ApneaLink Plus includes all the user-friendly features of the predicate devices. The ApneaLink Plus is a further development of the previously submitted device Apneal.ink (K070263). This submission addresses the expanded Indications for Use of Apnealink by including AASM criteria for detecting hypopneas and a respiratory effort sensor to differentiate between central, obstructive and mixed apneas.
The ApneaLink Plus recorder is a 3-channel battery-powered respiratory pressure sensor and oximetry system. ApneaLink Plus provides recordings of respiratory pressure, respiratory effort, pulse rate and oxvaen saturation during sleep. The phvsician prescribed device will help to recognize sleep-related respiratory disorders and lead to comprehensive clinical diagnosis and therapy. The patient may perform the recording at home by himself. The ApneaLink Plus 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 Plus 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 Plus recorder. The respiratory effort sensor is connected to the ApneaLink Plus recorder and held in place by the belt. After recording, the ApneaLink Plus recorder must be returned to the physician. With the ApneaLink Plus Software installed on a personnel computer the physician can generate a report with the recorded and analyzed data to aid in the diagnosis of sleep disordered breathing. The recordings and the report can be sent via email to further clinical investigation.
280 November, 2008
2
Image /page/2/Picture/2 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" are arranged in a circular pattern around the eagle, indicating the department's name and national affiliation.
MAR 1 9 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
ResMed Germany. Incorporated C/O Mr. David D'Cruz Vice President, Clinical & Regulatory Affairs ResMed Corporation 14040 Danielson Street Poway, California 92064-6857
Re: K083575
Trade/Device Name: ApneaLink Plus Regulation Number: 21 CFR 868.2375 Regulation Name: Breathing Frequency Monitor Regulatory Class: II Product Code: MNR Dated: March 3, 2009 Received: March 5, 2009
Dear Mr. D'Cruz:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
3
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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Suven Runnes
Ginette Y. Michaud. M.D. Acting Director Division of Anesthesiology, General Hospital. Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number (if known):
Device Name:
ApneaLink Plus
Indication for 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. Apneal ink Plus recred 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.
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)
Susan Soares
Concurrence of CDRH; Office of Device Evaluation (ODE)
(Division Sian-Off) Division of Anesthesiology. General Hospital Intection Control, Dental Devices
510(k) Number. K083375
28th November, 2008
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