(67 days)
Not Found
No
The description focuses on hardware (sensors, recorder, software for reporting) and data collection, with no mention of AI/ML algorithms for analysis or interpretation. The analysis is described as generating a "report with the recorded and analyzed data," which doesn't imply advanced AI/ML processing.
No
The device is described as a "screening device to determine the need for clinical diagnosis and evaluation by polysomnography" and helps to "recognize sleep-related respiratory disorders." It does not directly provide therapy or treatment.
No
The device is described as a "screening device to determine the need for clinical diagnosis and evaluation by polysomnography," not a device that provides a definitive diagnosis itself.
No
The device description explicitly details hardware components including a recorder, sensors (pressure and oximetry), a belt, nasal cannula, and an XPOD, indicating it is not solely software.
Based on the provided information, the ApneaLink device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood, tissue, and urine, derived from the human body, solely or principally for the purpose of providing information concerning a physiological or pathological state, or concerning a congenital abnormality, or to determine the safety and compatibility of potential donors and recipients, or to monitor therapeutic measures.
- ApneaLink's Function: The ApneaLink device records physiological signals directly from the patient's body (respiratory nasal pressure, blood oxygen saturation, pulse rate) during sleep. It does not analyze specimens in vitro (outside the body).
- Intended Use: The intended use is to screen for sleep-related respiratory disorders by recording these physiological parameters, not by analyzing bodily fluids or tissues.
Therefore, the ApneaLink falls under the category of a physiological monitoring device rather than an IVD.
N/A
Intended Use / Indications for Use
ApneaLink records patient respiratory nasal pressure and blood oxygen saturation during sleep. The device is intended for use as a screening device to determine the need for clinical diagnosis and evaluation by polysomnography based on the patient's test score.
Product codes (comma separated list FDA assigned to the subject device)
MNR
Device Description
The ApneaLink is a further development of the original device microMESAM Basic-Set (K040576). This submission addresses the extension of the microMESAM Basic-Set by the NONIN pulse oximeter module known as the XPOD.
The ApneaLink recorder is a two-channels battery-powered respiratory pressure sensor and oximetry system and provides recordings of respiratory pressure, pulse rate and oxygen saturation during sleep. The physician 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 recorder 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 and pulse oximetry module. The disposable plastic nasal cannula is connected to the ApneaLink 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 again is connected to the ApneaLink recorder. After recording, the ApneaLink recorder must be returned to the physician. With the ApneaLink Software installed on a personnel computer the physician has the possibility to generate a report with the recorded and analyzed data. For further clinical diagnosis and evaluation by polysomnography, the physician has the possibility to send the reporting and that the sleep laboratority, the
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
Not Found
Intended User / Care Setting
Physician, patient home 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 were performed on the ApneaLink as a result of the risk analysis and product requirements. All tests confirmed the product met the predetermined acceptance criteria.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 868.2375 Breathing frequency monitor.
(a)
Identification. A breathing (ventilatory) frequency monitor is a device intended to measure or monitor a patient's respiratory rate. The device may provide an audible or visible alarm when the respiratory rate, averaged over time, is outside operator settable alarm limits. This device does not include the apnea monitor classified in § 868.2377.(b)
Classification. Class II (performance standards).
0
ApneaLink Traditional 510(k) Premarket Notification
| 510(k) Summary - ApneaLink | ||||
|---|---|---|---|---|
| Date Prepared | 15th May, 2006 | JUL 25 2006 | ||
| Official Contact | David D'Cruz | |||
| V.P., Clinical & Regulatory Affairs | ||||
| ResMed Corp. | ||||
| 14040 Danielson St, | ||||
| Poway CA 92064-6857 | ||||
| USA | ||||
| Tel: +1 858-746-2282 | ||||
| Fax: +1 858-746-2900 | ||||
| Classification Reference | 21 CFR 868.2375 | |||
| Product Code | MNR - Ventilatory Effort Recorder | |||
| Common/Usual Name | Ventilatory Effort Recorder | |||
| Proprietary Name | ApneaLink | |||
| Predicate Devices | microMESAM Basic-Set (K040576) | |||
| Compass M10 System (K041724) | ||||
| Reason for submission | new device |
:
15tt May, 2006
RESMED
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Substantial Equivalence
The new device has the following similarities to the previously cleared devices:
- ﯩﺰ Intended use Similar
- ــﺰ Operating principle Same
- ﺮ Technologies Same
- ﺰ Manufacturing process Same
Design and Verification activities were performed on the ApneaLink as a result of the risk analysis and product requirements. All tests confirmed the product met the predetermined acceptance criteria. ResMed has determined that the ApneaLink is Substantially Equivalent to the predicate devices. The ApneaLink complies with the applicable standards and requirements referenced in the following:
- 产 FDA Guidance for the Content of Pre-market Submissions for Software Contained in Medical Devices (May 11, 2005)
- ﺎﺯ FDA Off-the-Shelf Software Use in Medical Devices (September 9,1999)
- ستر FDA General Principles of Software Validation (January 11, 2002)
- ﺰ IEC 60601-1-1 (Medical Electrical Equipment Part 1: General requirements for safety)
- ﯩﺰ IEC 60601-1-2 (Medical Electrical Equipment Part 1-2: General requirements for safety – Collateral standard: Electromagnetic compatibility - Requirements and tests)
- ﻨﺰﺍ IEC 60601-1-4 (Medical Electrical Equipment Part 1-4: General requirements for safety Collateral Standard: Programmable electrical medical systems)
- ﯩﺰ IEC 60068-2-1/ and the following (Environmental testing)
- ﺧﺰ ISO 10993-1 (Biological evaluation of medical devices - Part 1 Evaluation and testing)
- ﻨﺘﺰ EN ISO 14971: 2001 (Medical Devices – Application of risk management to medical devices)
Intended Use
ApneaLink records patient respiratory nasal pressure and blood oxygen saturation during sleep. The device is intended for use as a screening device to determine the need for clinical diagnosis and evaluation by polysomnography based on the patient's test score.
Device Description
The performance and functional characteristics of the ApneaLink includes all the user-friendly features of the predicate devices.
The ApneaLink is a further development of the original device microMESAM Basic-Set (K040576). This submission addresses the extension of the microMESAM Basic-Set by the NONIN pulse oximeter module known as the XPOD.
The ApneaLink recorder is a two-channels battery-powered respiratory pressure sensor and oximetry system and provides recordings of respiratory pressure, pulse rate and oxygen saturation during sleep. The physician 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 recorder 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 and pulse oximetry module. The disposable plastic nasal cannula is connected to the ApneaLink 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 again is connected to the ApneaLink recorder. After recording, the ApneaLink recorder must be returned to the physician. With the ApneaLink Software installed on a personnel computer the physician has the possibility to generate a report
2
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ApneaLink Traditional 510(k) Premarket Notification
with the recorded and analyzed data. For further clinical diagnosis and evaluation by polysomnography, the physician has the possibility to send the reporting and that the sleep laboratority, the
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes forming its wing, and the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" arranged in a circular pattern around the eagle. The logo is black and white and appears to be a low-resolution image.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 25 2006
ResMed Germany, Incorporated C/O Mr. David D` Cruz Vice President Clinical & Regulatory Affairs ResMed. Corporation 14040 Danielson Street Poway, California 92064-6857
Re: K061405
Trade/Device Name: ApneaLink Regulation Number: 868.2375 Regulation Name: Breathing Frequency Monitor Regulatory Class: II Product Code: MNR Dated: July 14, 2006 Received: July 20, 2006
Dear Mr. D' Cruz:
We have reviewed vour 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 H (PMA), it may be subject to such additional controls. Existing major regulations affecting vour 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. D' Cruz
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 (OS) 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 Office of Compliance at (240) 276-0120. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industrv/support/index.html.
Sincerely vours.
Clive
Chiu Lin. Ph.D. Director Division of Anesthesiology, General Hospital. Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
ApneaLink Traditional 510(k) Premarket Notification
RESMED
Indication for Use
510(k) Number (if known):
Device Name:
ApneaLink
Indication for Use
Apneal.ink records patient respiratory nasal pressure and blood oxygen saturation during sleep. The device is intended for use as a screening device to determine the need for clinical diagnosis and evaluation by polysomnography based on the patient's test score.
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)
Page 1 of 1
" ( . . . . . .
i lanber _____________________________________________________________________________________________________________________________________________________________________
15" May, 2006
ApneaLink 510(k) 200604 r of Anesthesiorogy, General Hospical, An Control. Dental Devices
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