(314 days)
No
The summary describes a physiological signal recording device and its software for data transfer and analysis, but there is no mention of AI or ML in the device description, intended use, or performance studies.
No
The device is a physiological signal recording device used for diagnosis, not for treating conditions.
Yes
The device explicitly states its purpose is "for the purpose of assisting in the diagnosis of Neurological and Sleep Disorders" and to "aid in the diagnosis of neurologic and sleep disorders."
No
The device description explicitly states it is a "portable physiological signal recording system" and lists hardware components such as AC Channels, Respiratory and AUX Channels, Internal Channels (SPO2, Pulse Rate, etc.), Compact Flash Card and Reader, Li ION Batteries, Battery Charger, and a Carry Bag. While it includes software (DOMINO), it is clearly a hardware device with accompanying software.
Based on the provided information, the SOMNOscreen is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the examination of specimens derived from the human body (such as blood, urine, or tissue) to provide information for diagnostic purposes.
- SOMNOscreen's Function: The SOMNOscreen records, displays, monitors, and stores biophysical parameters directly from the patient's body (like respiratory effort, body position, SpO2, etc.). It does not analyze specimens taken from the body.
- Intended Use: The intended use is to assist in the diagnosis of neurological and sleep disorders by recording physiological signals, not by analyzing biological samples.
Therefore, the SOMNOscreen falls under the category of a physiological signal recording device, not an IVD.
N/A
Intended Use / Indications for Use
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.
Product codes
MNR
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.
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
physician in the office, sleep laboratory or patient's 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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
SleepScreen/ApnoeScreen Cardio (K021138), Siesta System (K003175)
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
510(k) Summary
| Applicant: | Somnomedics GmbH & Co.KG
Nonnengarten 8
Kist, Germany D-97270
Phone: +49 93 06 98 23 0
Facsimile: +49 93 06 98 23 20 | JAN 24 |
|-----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|
| US Contact: | M Squared Associates, Inc.
Cherita James
719 A Street, NE
Washington DC 20002
Phone: 202-546-1262 ext. 257
Facsimile: 202-546-3848
E-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.KG
Nonnengarten 8
Kist, Germany D-97270 | |
| Predicate Devices: | SleepScreen/ApnoeScreen Cardio (K021138), Compumedics
Siesta System (K003175) | |
2007
.
1
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.
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:
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.
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
2
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.
4
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