(113 days)
Not Found
No
The document does not mention AI, ML, or related concepts like deep learning, neural networks, or training/test sets for algorithms. The description focuses on physiological signal recording and analysis of movement parameters.
No
The device is used for recording and analyzing physiological signals to aid in the diagnosis of sleep disorders, not for treating them.
Yes
The device description explicitly states that the SOMNOwatch is intended "to aid in the diagnosis of sleep disorders."
No
The device description explicitly states it is a "physiological signal recording system" and a "small, portable physiological signal recording device," indicating it includes hardware components for data acquisition. It is described as a "typically wrist-worn activity monitor" and can be "affixed to the patients legs," further suggesting a physical device.
Based on the provided information, the SOMNOwatch is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
- SOMNOwatch Function: The SOMNOwatch is described as a portable physiological signal recording device that records biophysical events like limb movements. It analyzes these signals to aid in the diagnosis of sleep disorders.
- No Specimen Analysis: The description does not mention the SOMNOwatch analyzing any specimens taken from the body. It directly measures physiological signals from the patient's body (wrist and legs).
Therefore, the SOMNOwatch falls under the category of a physiological monitoring device rather than an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The SOMNOwatch is a non-life-supporting portable physiological signal recording device intended to be used for testing adult patients suspected of having movement-correlated sleep disturbances.
The SOMNOwatch is a small, typically wrist-worn activity monitor. The device is intended to be used to analyze circadian rhythms, automatically collect and score data for sleep parameters. These parameters, representing the number and intensity of limb movements, are directly associated to movement-correlated sleep disturbances. The unit can also be used to assess activity in any instance where quantifiable analysis of physical motion is desired. For PLM-detection two identical SOMNOwatches may be affixed to the patients legs, one to each leg.
Product codes (comma separated list FDA assigned to the subject device)
GWQ, MNR
Device Description
The SOMNOwatch is a small, portable physiological signal recording system intended to be used to record, display, monitor, print and store biophysical events to aid in the diagnosis of 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.
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
prescribed for use by a 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)
Performance testing was conducted to confirm compliance to device specifications. All functions were verified to operate as designed. Testing to the international standards for electrical safety and electromagnetic compatibility were performed. The SOMNOwatch was found to be compliant with the requirements of these standards for it's intended use.
Comparison studies of the SOMNOwatch and the predicate devices found the subject device can be expected to provide safety and effectiveness outcomes substantially equivalent to the predicates.
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
SOMNOwatch 510(k) Premarket Application
Section 5: 510(k) Summary
5681485 SEP 1 8 2008
510(k) Summary
Applicant:
Somnomedics GmbH Am Sonnenstuhl 63 Randersacker, Germany D-97236 Phone: +49 931 35 90 94 0 Facsimile: +49 931 35 90 94 49
US Contact:
M Squared Associates, Inc. Cherita James 901 King Street, Suite 200 Alexandria, Virginia 22314 Phone: 703-562-9800 ext. 257 Facsimile: 703-562-9797 E-mail: CJames(amsquaredassociates.com
May 28, 2008 Date submitted:
| Proprietary Name: | Somnomedics SOMNOwatch |
|---|---|
| Common Name: | Activity Recording Device |
| Classification Status: | Class II per regulations §882.1400, §868.2375 |
| Product Codes: | GWQ, MNR |
Establishment Registration Number: Applied for, not yet assigned
Manufacturing/
Distribution Address:
Somnomedics GmbH Am Sonnenstuhl 63 Randersacker, Germany D-97236
Predicate Devices:
- ActiTrac (K992410); Individual Monitoring Systems . (IM-systems), Inc.
- SOMNOscreen (K060708), SOMNOmedics GmbH .
1
Device Description
The SOMNOwatch is a small, portable physiological signal recording system intended to be used to record, display, monitor, print and store biophysical events to aid in the diagnosis of 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.
Indication for Use
The SOMNOwatch is a non-life-supporting portable physiological signal recording device intended to be used for testing adult patients suspected of having movement-correlated sleep disturbances.
Intended Use
The SOMNOwatch is a small, typically wrist-worn activity monitor. The device is intended to be used to analyze circadian rhythms, automatically collect and score data for sleep parameters. These parameters, representing the number and intensity of limb movements, are directly associated to movement-correlated sleep disturbances. The unit can also be used to assess activity in any instance where quantifiable analysis of physical motion is desired. For PLM-detection two identical SOMNOwatches may be affixed to the patients legs, one to each leg.
Technical Specifications of the SOMNOwatch
| CHANNELS | 6 Internal Channels:
(3 Activity Sensors for X-Y-Z Axis,
Body Position, Ambient Light, Patient Marker) |
|-----------------|---------------------------------------------------------------------------------------------------------------------------|
| DATA PROCESSING | 12 Bit ADC
Different Sampling Rates Adjustable (1/120s - 128/s)
Different Storage Rates Adjustable (1/120s - 128/s) |
Summary of Technological Characteristics
The SOMNOwatch utilizes a motion sensor, an accelerometer ,to monitor the occurrence and degree of motion. This type of sensor provides an analog signal where the amplitude and speed of motion produces a signal whose magnitude and duration depend on the amount of motion. The activity signals are amplified and digitized by on-board circuits within the device. This information is stored in the internal memory of the device. The system provides
2
up to 6 channels for data acquisition; 3 Acceleration for X-Y-Z Axis, Ambient Light, Patient Marker and Body Position.
Information is stored on an internal 8 MB Flash and can be transferred to a PC via a USB docking station. The DOMINOlight software retrieves the data from the SOMNOwatch, displays the data, and can store data for future reference and comparison. DOMINOlight also allows automatic analysis of all signals including the body position.
Summary of Nonclinical Testing
Performance testing was conducted to confirm compliance to device specifications. All functions were verified to operate as designed. Testing to the international standards for electrical safety and electromagnetic compatibility were performed. The SOMNOwatch was found to be compliant with the requirements of these standards for it's intended use.
Clinical Testing
Comparison studies of the SOMNOwatch and the predicate devices found the subject device can be expected to provide safety and effectiveness outcomes substantially equivalent to the predicates.
Conclusion
SOMNOmedics SOMNOwatch has the same principles of operation and similar technological characteristics as the Actitrac. While the principle of operation and method of data collection differ from the SOMNOscreen, the differences do not present new issues of safety or effectiveness as demonstrated in the clinical comparison.
Based on performance testing, the SOMNOmedics SOMNOwatch is substantially equivalent to devices already on the market and presents no new concerns of safety and effectiveness. Additionally, the device has similar indications to the predicate devices and the labeling of the device is consistent both with FDA's guidance as well as current medical practice.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three wing-like shapes extending upwards. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
SEP 18 2008
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Somnomedics GmbH C/O Ms. Cherita James Regulatory Consultant M Squared Associates, Incorporated 901 King Street, Suite 200 Alexandria, Virginia 22314
Re: K081485
Trade/Device Name: SOMNOwatch Regulation Number: 21 CFR 868.2376 Regulation Name: Breathing Frequency Monitor Regulatory Class: II Product Code: MNR Dated: May 28, 2008 Received: May 28, 2008
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 approvisions of the Act. The general controls provisions of the Act include controls provide of 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 (1 wrt), it may of election in the Code of Federal Regulations, Title 21, Parts 800 to 898. In your device our of found in firsher 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 (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 vours.
Dr. Samuels Ludewig foey
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
Enclosures
5
Indications for Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: SOMNOwatch
Indications For Use: The SOMNOwatch is a non-life-supporting portable physiological signal recording device intended to be used for testing adult patients suspected of having movement-correlated sleep disturbances.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use _ (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)
M Th
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number. K081485