The SOMNOscreen is a non-life-supporting portable physiological signal recording device intended to be used for testing adult patients suspected of having sleep-related breathing disorders.

The SOMNOscreen is indicated for use in the recording, displaying, monitoring, and storage of biophysical parameters for the purpose of assisting in the diagnosis of Neurological and Sleep Disorders.

Device Description

The SOMNOscreen is a portable physiological signal recording system intended to be used to record, display, monitor, print and store biophysical events to aid in the diagnosis of neurologic and sleep disorders. The device is intended to be prescribed for use by a physician in the office, sleep laboratory or patient's home.

This device is NOT designed to be used in a Life Support situation. This device is not designed for use on patients with cardiac pacemakers.

The system provides up to 28 channels for data acquisition; 10 AC Channels, 8 Referential and 2 Differential, 11 Respiratory and AUX Channels, 7 Internal Channels (SPO2, Pulse Rate, Plethysmogram, Body Position, Light, Patient Marker, Thorax/Abdominal Respiratory Effort)

The SOMNOscreen is available in 6 different configurations. All configurations include a Compact Flash Card and Reader, Li ION Batteries, (2000mAh) with 1 x Battery Charger, a Carry Bag for housing the SOMNOscreen and Sensors, Instruction Manuals and the DOMINO software for Initialization, Data Transfer and Analysis.

AI/ML Overview

Here's a summary of the acceptance criteria and study details for the Somnomedics SOMNOscreen based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state quantitative "acceptance criteria" for the SOMNOscreen's clinical performance. Instead, it states that the device's clinical performance was found to be "equivalent to the predicate Sleepscreen and the manual scored Polysomnography." Therefore, the reported device performance is its equivalence to these established methods.

Acceptance Criteria (Implicit)	Reported Device Performance
Clinical performance equivalent to predicate device (Sleepscreen/ApnoeScreen Cardio)	The SOMNOscreen's clinical performance is equivalent to the predicate Sleepscreen.
Clinical performance equivalent to manual scored Polysomnography (PSG)	The SOMNOscreen's clinical performance is equivalent to manual scored Polysomnography.
Compliance with international standards for electrical safety and EMC	The SOMNOscreen was found to be compliant with these standards.
Functions operate as designed; measured parameters meet required ranges and accuracies	All functions verified to operate as designed; measured parameters met required ranges and accuracies.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: 25 patients
Data Provenance: Not explicitly stated, but the applicant (Somnomedics GmbH & Co.KG) is based in Kist, Germany. It is common for clinical studies associated with German manufacturers to originate from Germany or other European countries; however, this is not confirmed in the document. The study evaluates the device "when used as intended in the targeted patient population," implying prospective data collection for this validation.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

The document states that the comparison was made against "manual scored Polysomnography." This heavily implies that sleep experts (e.g., polysomnography technologists, sleep physicians) were involved in scoring the PSG data, which would serve as the ground truth. However:

Number of experts: Not specified.
Qualifications of experts: Not specified, but generally, manual PSG scoring is performed by registered polysomnographic technologists (RPSGTs) and interpreted by board-certified sleep physicians.

4. Adjudication Method for the Test Set

The document does not describe an explicit adjudication method (e.g., 2+1, 3+1). The "manual scored Polysomnography" itself is considered the reference standard, and deviations from this standard for the SOMNOscreen's output would be assessed.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. The study described compares the SOMNOscreen to a predicate device and manual PSG. It does not appear to be an MRMC study designed to evaluate the improvement in human reader performance with or without AI assistance. The SOMNOscreen, as described, is a physiological signal recording system, not an AI-assisted diagnostic tool in the sense of providing automated interpretations that would then be reviewed by human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, in essence. The study evaluates the "clinical performance of the SOMNOscreen" itself against predicate devices and manual PSG. While a human would still interpret the output from the SOMNOscreen, the study aims to validate the device's ability to record, display, monitor, print, and store biophysical events reliably, standalone from a human "AI assistance" workflow. The device does not appear to have an AI component for automated interpretation that would undergo a separate standalone performance evaluation.

7. The Type of Ground Truth Used

The ground truth used was manual scored Polysomnography (PSG), which is typically considered the gold standard for sleep disorder diagnosis.

8. The Sample Size for the Training Set

The document does not mention a training set or any details about an algorithm that would require one. The SOMNOscreen is described as a physiological signal recording system, implying it captures raw physiological data rather than employing a machine learning algorithm that would need training.

9. How the Ground Truth for the Training Set Was Established

Since no training set is mentioned and the device appears to be a data acquisition system rather than an AI/ML-based interpretive algorithm, this information is not applicable and not provided in the document.

Summary

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K060708

510(k) Summary

Applicant:	Somnomedics GmbH & Co.KGNonnengarten 8Kist, Germany D-97270Phone: +49 93 06 98 23 0Facsimile: +49 93 06 98 23 20	JAN 24
US Contact:	M Squared Associates, Inc.Cherita James719 A Street, NEWashington DC 20002Phone: 202-546-1262 ext. 257Facsimile: 202-546-3848E-mail: CJames@msquaredassociates.com
Date submitted:	January 11, 2007
Proprietary Name:	Somnomedics SOMNOscreen
Common Name:	Ventilatory Effort Recorder
Classification Status:	Class II per regulations §868.2375
Product Codes:	MNR
Establishment Registration Number:	Will be obtained prior to US distribution of the device.
Manufacturing/Distribution Address:	Somnomedics GmbH & Co.KGNonnengarten 8Kist, Germany D-97270
Predicate Devices:	SleepScreen/ApnoeScreen Cardio (K021138), CompumedicsSiesta System (K003175)

2007

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Device Description:

This device is NOT designed to be used in a Life Support situation. This device is not designed for use on patients with cardiac pacemakers.

Indication for Use: The SOMNOscreen is a non-life-supporting portable physiological signal recording device intended to be used for testing adult patients suspected of having sleep-related breathing disorders.

Intended Use:

The SOMNOscreen is indicated for use in the recording, displaying, monitoring, and storage of biophysical parameters for the purpose of assisting in the diagnosis of Neurological and Sleep Disorders.

Summary of Technological Characteristics:

Summary of Nonclinical Testing:

Performance testing was conducted to confirm compliance to device specifications; all functions were verified to operate as designed. Measured parameters met required ranges and accuracies. Testing to the international standards for electrical safety and electromagnetic compatibility were

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performed. The SOMNOscreen was found to be compliant with the requirements of these standards.

Summary of Clinical Testing:

A validation study of 25 patients evaluated with the SOMNOscreen, the predicate Sleepscreen from Viasys (K021138, originally Jaeger) and the manual scored Polysomnography demonstrates that the clinical performance of the SOMNOscreen when used as intended in the targeted patient population, is equivalent to the predicate Sleepscreen and the manual scored Polysmnography cleared for the evaluation of the recording, displaying, monitoring, printing, and storage of biophysical parameters for the purpose of assisting in the diagnosis of sleep-related respiratory disorders.

Conclusion

SOMNOMEDICS Somnoscreen has the same principles of operation and similar technological characteristics as the previously 510k cleared predicates. The differences do not present new issues of safety or effectiveness.

Based on extensive performance testing and a comparison to the predicate devices, the SOMNOMEDICS Somnoscreen is substantially equivalent to devices already on the market (cleared by the 510(k) process) and presents no new concerns about safety and effectiveness. Additionally, the device has identical indications to the predicate devices and the labeling of the device is consistent both with FDA's guidance as well as current medical practice.

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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the department's name written around the perimeter. In the center of the seal is an emblem that resembles an eagle or other bird-like figure, stylized with three curved lines representing the wings and body.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Somnomedics GmbH & Company KG C/O Ms. Cherita James Regulatory Consultant M Squared Associates, Incorporated 719 A Street. NE Washington, DC 20002

JAN 2 4 2007

Re: K060708

Trade/Device Name: SOMNOscreen Regulation Number: 21 CFR 868.2375 Regulation Name: Breathing Frequency Monitor Regulatory Class: II Product Code: MNR Dated: January 11, 2007 Received: January 12, 2007

Dear Ms. James:

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.

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Page 2 - Ms. James

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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

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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Indications for Use

510(k) Number: K060708

Device Name: SOMNOscreen

Indications For Use: The SOMNOscreen is a non-life-supporting portable physiological signal recording device intended to be used for testing adult patients suspected of having sleep-related breathing disorders.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(21 CFR 807 Subpart C)

(Part 21 CFR 801 Subpart D)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Wilm Wul

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).