(67 days)
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.
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.
Acceptance Criteria and Study Details for ApneaLink (K061405)
The provided document (K061405) for the ApneaLink device is a 510(k) Premarket Notification. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting detailed clinical study data to prove the device meets specific acceptance criteria in the way a de novo or PMA submission might.
The document states: "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." However, it does not explicitly list the specific acceptance criteria or provide the detailed results of these tests that would typically be presented in a clinical performance study.
Given the context of a 510(k) for a "Ventilatory Effort Recorder" and its intended use as a screening device for sleep apnea, the "acceptance criteria" would likely relate to the device's ability to accurately record respiratory nasal pressure and blood oxygen saturation, and to provide a "test score" that can be used to determine the need for clinical diagnosis. The substantial equivalence argument relies on the device being similar in intended use, operating principle, and technology to the predicate devices (microMESAM Basic-Set K040576 and Compass M10 System K041724).
Therefore, based solely on the provided text, a table of acceptance criteria and reported performance cannot be fully constructed with quantitative measures as they are not detailed in this public summary. The document focuses on regulatory compliance and substantial equivalence rather than a clinical performance study with specific metrics.
Here's an attempt to answer the questions based on the available information, noting where information is not provided:
1. Table of Acceptance Criteria and Reported Device Performance
As noted above, the specific quantitative acceptance criteria and their corresponding reported performance are not explicitly detailed in the provided 510(k) summary. The document broadly states that "All tests confirmed the product met the predetermined acceptance criteria." These criteria would likely be related to the accuracy and reliability of measuring respiratory nasal pressure and blood oxygen saturation for screening purposes, consistent with predicate devices.
| Acceptance Criteria Category (Inferred) | Specific Metric (Inferred) | Acceptance Threshold (Not specified in document) | Reported Device Performance (Not specified in document) |
|---|---|---|---|
| Respiratory Pressure Measurement Accuracy | e.g., Correlation with PSG, RMS Error | (Would be based on predicate performance or clinical needs) | (Not provided) |
| Oxygen Saturation Measurement Accuracy | e.g., SpO2 % +/- error | (Would be based on predicate performance or clinical needs) | (Not provided) |
| Pulse Rate Measurement Accuracy | e.g., bpm +/- error | (Would be based on predicate performance or clinical needs) | (Not provided) |
| System Functionality & Reliability | e.g., Data integrity, ease of use, stability | (All functional requirements met as per internal testing) | "All tests confirmed the product met the predetermined acceptance criteria." |
| Safety | Electrical safety (IEC 60601-1-1/2/4), Biocompatibility (ISO 10993-1) | Compliance with standards | "The ApneaLink complies with the applicable standards and requirements referenced..." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a sample size for a clinical "test set" or its data provenance (country of origin, retrospective/prospective). The submission describes "Design and Verification activities" and "All tests," which typically refer to internal engineering and functional testing, rather than a clinical performance study with human subjects.
3. Number of Experts and Qualifications for Ground Truth
The document does not mention the use of experts to establish ground truth for a test set in the context of a clinical performance study. For a 510(k), ground truth for performance claims is often established through comparison to a well-accepted and legally marketed predicate device, or by relying on existing scientific literature for the underlying technology.
4. Adjudication Method
As no clinical test set requiring expert ground truth is described, an adjudication method for such a set is not mentioned.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
There is no mention of an MRMC comparative effectiveness study in the provided document. The submission focuses on substantial equivalence of the device itself (hardware and basic functionality) as a screening tool, not on the impact of AI assistance on human readers.
6. Standalone Performance Study (Algorithm Only)
The provided text does not describe a standalone algorithm-only performance study. While the device does generate a "test score" based on recorded data, the details of how this score is derived and its standalone diagnostic performance are not elaborated. The submission is for a "Ventilatory Effort Recorder" used as a "screening device to determine the need for clinical diagnosis and evaluation by polysomnography," implying the output is for physician interpretation, not a definitive diagnosis by the device itself.
7. Type of Ground Truth Used
The type of "ground truth" for the device's main function (recording respiratory nasal pressure and blood oxygen saturation) would typically be established by comparison to reference gold standard sensors or established polysomnography (PSG) equipment during the device development and verification stages. However, this specific detail is not provided in the 510(k) summary. Given the device's intention to screen for the need for PSG, PSG itself would be the ultimate clinical ground truth for sleep apnea diagnosis.
8. Sample Size for the Training Set
The document does not specify a sample size for a "training set." The ApneaLink is a device that records physiological signals; it is not explicitly described as employing a machine learning algorithm that requires a dedicated training set in the context of this 510(k) summary. The "test score" it generates is likely based on pre-defined algorithms rather than a trained AI model.
9. How the Ground Truth for the Training Set Was Established
Since no explicit "training set" or AI/ML algorithm requiring one is described in the provided summary, the method for establishing its ground truth is not applicable/not provided.
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ApneaLink Traditional 510(k) Premarket Notification
| 510(k) Summary - ApneaLink | ||||
|---|---|---|---|---|
| Date Prepared | 15th May, 2006 | JUL 25 2006 | ||
| Official Contact | David D'CruzV.P., Clinical & Regulatory AffairsResMed Corp.14040 Danielson St,Poway CA 92064-6857USATel: +1 858-746-2282Fax: +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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RESMED
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
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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
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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
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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)
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i lanber _____________________________________________________________________________________________________________________________________________________________________
15" May, 2006
ApneaLink 510(k) 200604 r of Anesthesiorogy, General Hospical, An Control. Dental Devices
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§ 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).