SOMNOscreen plus
Device Facts
| Record ID | K201054 |
|---|---|
| Device Name | SOMNOscreen plus |
| Applicant | Somnomedics GmbH |
| Product Code | OLV · Neurology |
| Decision Date | Aug 12, 2020 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 882.1400 |
| Device Class | Class 2 |
| Attributes | Pediatric |
Indications for Use
The SOMNOscreen® plus is indicated for use in the recording, displaying, monitoring, printing, and storage of biophysical parameters for the purpose of assisting in the diagnosis of Neurological and Sleep Disorders. The device is a non-life-supporting physiological signal recording device intended to be used for studies testing adults and children (age 2 to 12 years)/adolescents (age 12 and above) suspected of having sleep-related breathing disorders. 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.
Device Story
SOMNOscreen plus is a portable, non-life-supporting physiological signal recording system for sleep studies. It acquires signals via various sensors: thermistor, nasal cannula, effort belts, SpO2 sensor, microphone, headbox (EXG channels), body position sensor, activity sensor, EMG-PLM sensor, pressure sensor, and optional CO2 module. The device processes inputs using active signal filtering and 16-bit ADC; it stores data on a Compact Flash card. Used in hospitals, clinics, or sleep centers; operated by qualified personnel. For pediatric patients, the DOMINO software supports only manual visual scoring by a Registered Polysomnographic Technologist (RPSG); no automated analysis is available for this population. The device provides signal checks on an integrated display. Benefits include portable monitoring of biophysical parameters to assist in diagnosing neurological and sleep disorders.
Clinical Evidence
No clinical data were relied upon for the determination of substantial equivalence. The device underwent bench testing, including verification and validation against pre-specified requirements, electromagnetic compatibility (IEC 60601-1-2), and electrical safety (IEC 60601-1) standards. Biocompatibility was established per ISO 10993.
Technological Characteristics
Modular system with 13 AC channels (10 referential, 3 differential), 11 respiratory/AUX channels, and 8 internal channels. Features 16-bit ADC, active signal filtering, and Compact Flash storage. Powered by a 4.2V rechargeable Li-ION battery. Dimensions: 140x70x28 mm; weight: 220g. Connectivity includes Radio LAN. Sensors include thermistors, inductive effort belts, and SpO2 finger clips. Software is used for manual scoring.
Indications for Use
Indicated for adults and children (age 2-12) and adolescents (age 12+) suspected of having sleep-related breathing disorders. Contraindicated for use in life support situations and on patients with cardiac pacemakers.
Regulatory Classification
Identification
An electroencephalograph is a device used to measure and record the electrical activity of the patient's brain obtained by placing two or more electrodes on the head.
Predicate Devices
Submission Summary (Full Text)
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SOMNOmedics GmbH Dr. Stefanie Wolski Regulatory Affairs Am Sonnenstuhl 63 Randersacker, 97236 Germany
Re: K201054
Trade/Device Name: SOMNOscreen plus Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: Class II Product Code: OLV. MNR Dated: May 13, 2020 Received: May 14, 2020
### Dear Dr. Stefanie Wolski:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
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
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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for Jay Gupta Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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## Indications for Use
510(k) Number (if known) K201054
Device Name SOMNOscreen plus
Indications for Use (Describe)
The SOMNOscreen® plus is a non-life-supporting portable physiological signal recording device intended to be used for testing adults and children (age 2 to 12 years)/adolescents (age 12 and above) suspected of having sheep related breathing disorders.
| Type of Use (Select one or both, as applicable) |
|-------------------------------------------------|
|-------------------------------------------------|
X Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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# K201054 Traditional 510(k) Summary
The following information is provided as outlined in 21 CFR 807.92 to provide an understanding of the basis for a determination of substantial equivalence.
Submitter: SOMNOmedics GmbH Am Sonnenstuhl 63 Randersacker, Germany D-97236 Tel: 0049 931 3590 940 United States Address 815 Ponce de Leon Blvd Suite P-209 Coral Gables, FL 33134 1(866)361-9937 (931)451-3757 Contact Person:Dr. Stefanie Wolski SOMNOmedics GmbH Am Sonnenstuhl 63 Randersacker, Germany D-97236 Ph: +49 931 359094 62 Fax: +49 931 359094 49 sw@somnomedics.de
Date: August 11, 2020
## Subject Device
Trade Name SOMNOscreen® Plus
Classification Class II
Regulation Number & Name Electroencephalograph 21 CFR 882.1400 Neurology
Review Panel Neurology
Identification An electroencephalograph is a device used to measure and record the electrical activity of the patient's brain obtained by placing two or more electrodes on the head.
Product Code OLV; Standard Polysomnograph with Electroencephalograph
Definition Acquire, display, store, and archive electroencephalographic signals from the brain and
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other signals (such as electromyography, respiratory and/or oximetry signals) for sleep recordings. May also be used to allow on-screen review, user-controlled annotation and user-controlled marking of data.
Secondary Product Code MNR; Ventilatory Effort Recorder (Class II, Breathing frequency monitor, 21 CFR 868.2375)
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 21 CFR 868.2377.
| | K040595 | K071556 | K060708 |
|-----------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Alice® 5 System | SOMNOscreen EEG10-20 | SOMNOmedics<br>SOMNOscreen |
| Product Code(s) | OLZ, OLV | MNR | MNR |
| Intended Use | Record, display, and print<br>physiological information to<br>clinicians/ physicians. These<br>parameters are presented<br>graphically on a computer screen<br>for diagnostic review, similar in<br>application to the use of a<br>traditional paper-based<br>polygraph recorder. The device<br>will be used in hospitals,<br>institutions, sleep centers or<br>clinics, or other test<br>environments where adults or<br>infant patients require the<br>documentation of various sleep<br>or other physiological disorders.<br>The device does not provide<br>alarms and is not intended for<br>use as an automated apnea | Used for testing adult<br>patients suspected of<br>having sleep-related<br>breathing disorders. | The SOMNOscreen is<br>indicated for use in the<br>recording, displaying,<br>monitoring, printing, and<br>storage of biophysical<br>parameters for the purpose<br>of assisting in the diagnosis<br>of Neurological and Sleep<br>Disorders. |
## Predicate Devices
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| K040595 | K071556 | K060708 |
|--------------------|----------------------|----------------------------|
| Alice® 5<br>System | SOMNOscreen EEG10-20 | SOMNOmedics<br>SOMNOscreen |
| monitor. | | |
Intended Use: The SOMNOscreen® plus is indicated for use in the recording, displaying, monitoring, printing, and storage of biophysical parameters for the purpose of assisting in the diagnosis of Neurological and Sleep Disorders. The device is a non-life-supporting physiological signal recording device intended to be used for studies testing adults and children/adolescents suspected of having sleep-related breathing disorders.
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.
Device Description: The SOMNOscreen® plus is a modular system with the following components available .: Thermistor, Nasal Canula, Effort belts with respective sensor, SpO2-Sensor, Microphone, Headbox (EXG Channels), external body position sensor, shoulder belts, activity sensor, EMG-PLM sensor, pressure sensor, gold cup electrodes and LoFlo CO2-module (optional). The SOMNOscreen® plus device provides 13 AC channels (10 Referential and 3 Differential), 11 Respiratory and AUX Channels, and 8 Internal Channels.
The SOMNOscreen plus is available in 4 different configurations.
- . Cardio-RESP
- Home Sleep
- PSG .
- . EEG 32
The purpose of this 510(k) submission is to expand the patient population to include children and adolescents. For the use in pediatric patients the DOMINO software only allows manual (visual) scoring by qualified RPSG. There is no automated analysis or highlighting available for pediatric patients.
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| Features/Technical Specifications | |
|-----------------------------------|-------------------------------------------------------------------------------------------------------------------|
| Modular Channels | 13 AC channels, 10 Referential and 3 Differential |
| | 11 Respiratory and AUX Channels |
| | 8 Internal Channels: |
| | - SPO2 |
| | - Pulse Rate |
| | - Plethysmogram |
| | - Body Position |
| | - Movement |
| | - Light |
| | - Patient Marker |
| | - Thorax/Abdominal Respiratory Effort |
| DATA PROCESSING | Active Signal Filtering |
| | 16 Bit ADC |
| | Recording rate individually programmable (4/s to 512/s) |
| POWER SUPPLY | Rechargeable Li ION battery (4,2 V) with recording time up to 24 hours. |
| | Integrated Safety Chip. The battery has an operating life of approximately |
| | 500 charging cycles. |
| EXTERNAL SENSORS | Abdominal Respiratory Effort |
| | Activity sensor (3-Axis) for Actigraphy Active sensor EMG for PLM |
| | Pressure sensor (-24 to +24 mbar) for: |
| | - Nasal-Oral Flow (Cannula) |
| | - CPAP-Pressure |
| | - CPAP-Flow |
| | - CPAP-Snore |
| | Additional pediatric sensors: |
| | - Soft Silicone Finger Sensor for Pulse Oximeter |
| | - Nasal cannula |
| | - External body position sensor |
| | - MUX Adapter (sensor for inductive effort belts) |
| | - Inductive effort belts for pediatrics |
| INTERACTIVE DISPLAY | Signal Check on the Display |
| | Programmable Time Setting |
| | Keyboard for Menu Control |
| | All menu text on the screen in displayed in capital letters. |
| | Maximum 32 characters on 2 lines (16 characters per line) and 2 fields (8 |
| | characters per field). |
| MEMORY | High-speed Compact Flash Card with a capacity up to 2 GB |
| DIMENSIONS AND WEIGHT | 140 x 70 x 28 mm |
| | 220 g including battery |
| TEMPERATURE | During operation: 5° C to 40° C Storage: 0° C to 50°C |
| SpO2-Modul | |
| O2 Saturation | 70 to 99 % |
| Pulse Rate | 18 to 300 Beats per Minute |
| Wavelength Red: | 660 Nanometer |
| Infrared: | 910 Nanometer |
| SpO2<br>(± 1 standard | 70 - 100% ± 2% for pediatrics when using the Finger Clip Sensor supplied. Sensor data under 70% are not specified |
| Pulse Rate | 18 to 300 Beats per Minute |
| Wavelength Red: | 660 Nanometer |
| Infrared: | 910 Nanometer |
| Features/Technical Specifications | |
| Temperature | During operation: 5°C to +50°C Storage: -20°C to +70°C |
| Humidity | During operation: 10% - 90%. non-condensing<br>Storage: 10% - 95%, non-condensing |
### Technical Specifications of the SOMNOscreen Plus:
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Indications for Use: The SOMNOscreen® plus is a non-life-supporting portable physiological signal recording device intended to be used for testing adults and children (age 2 to 12 years)/ adolescents (age 12 and above) suspected of having sleep-related breathing disorders.
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# Comparison of Technological Characteristics between Subject and Predicate Devices
| | SOMNOscreen®<br>plus<br>K201054 | Alice® 5 System<br>Primary predicate<br>K040595 | SOMNOscreen<br>EEG10-20<br>Additional<br>Predicate<br>K071556 | SOMNOscreen<br>Additional<br>Predicate<br>K060708 | Comments |
|--------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Code | OLV, MNR | OLZ, OLV | MNR | MNR | |
| File Number | K201054 | K040595 | K071556 | K060708 | |
| Indications for<br>Use | The<br>SOMNOscreen®<br>plus is a non-life-<br>supporting portable<br>physiological signal<br>recording device<br>intended to be used<br>for testing adults<br>and children (age 2<br>to 12 years)/<br>adolescents (age 12<br>and above)<br>suspected of having<br>sleep-related<br>breathing disorders. | The Alice 5 system<br>is a<br>polysomnography<br>system that is<br>intended to record,<br>display, and print<br>physiological<br>information for<br>clinicians/<br>physicians. These<br>parameters are<br>presented graphically<br>on a computer screen<br>for diagnostic<br>review, similar in<br>application to the use<br>of a traditional<br>paper-based | The<br>SOMNOscreen<br>EEG10-20 is a<br>non-life-<br>supporting<br>portable<br>physiological<br>signal recording<br>device intended to<br>be used for testing<br>adult patients<br>suspected of<br>having sleep-<br>related breathing<br>disorders. | The<br>SOMNOscreen is<br>a non-life-<br>supporting<br>portable<br>physiological<br>signal recording<br>device intended to<br>be used for testing<br>adult patients<br>suspected of<br>having sleep-<br>related breathing<br>disorders. | Similar target patient population and age range<br>as well as environment of use; all are<br>prescription use devices.<br>The primary predicate, Alice 5, provides<br>automatic detection of events whereas the<br>subject device is not intended to do so.<br>For pediatric populations, only manual scoring<br>by trained personnel should be applied, and the<br>environment of use is limited to hospital/ clinic<br>use for pediatric patients. |
| Intended Use | The<br>SOMNOscreen®<br>plus is indicated for<br>use in the recording,<br>displaying, | polygraph recorder.<br>The Alice 5 device<br>will be used in<br>hospitals,<br>institutions, sleep<br>center or clinics, or | The<br>SOMNOscreen is<br>indicated for use<br>in the recording,<br>displaying, | The<br>SOMNOscreen is<br>indicated for use in<br>the recording,<br>displaying, | The SOMNOscreen® plus, as well as the<br>predicate devices, is indicated for use in the<br>recording, displaying, monitoring, printing, and<br>storage of biophysical parameters for the<br>purpose of assisting in the diagnosis of |
| | monitoring, printing,<br>and storage of<br>biophysical<br>parameters for the<br>purpose of assisting<br>in the diagnosis of<br>Neurological and<br>Sleep Disorders.<br>The device is non-<br>life-supporting<br>physiological signal<br>recording devices<br>intended to be used<br>for studies testing<br>adults and<br>children/adolescents<br>suspected of having<br>sleep-related<br>breathing disorders.<br>The subject is NOT<br>designed to be used<br>in a Life Support<br>situation.<br>The subject is not<br>designed for use on<br>patients with cardiac<br>pacemakers. | other test<br>environments where<br>adults or infant<br>patients require the<br>documentation of<br>various sleep or<br>other physiological<br>disorders.<br>This device does not<br>provide alarms and is<br>not intended for use<br>as an automated<br>apnea monitor. | monitoring,<br>printing, and<br>storage of<br>biophysical<br>parameters for the<br>purpose of<br>assisting in the<br>diagnosis of<br>Neurological and<br>Sleep Disorders. | monitoring,<br>printing, and<br>storage of<br>biophysical<br>parameters for the<br>purpose of<br>assisting in the<br>diagnosis of<br>Neurological and<br>Sleep Disorders. | Neurological and Sleep Disorders.<br>The subject and predicate devices are non-life-<br>supporting physiological signal recording<br>devices intended to be used for studies testing<br>adults, children, and adolescents suspected of<br>having sleep-related breathing disorders.<br>The subject and predicate devices are NOT<br>designed to be used in life support situations.<br>The subject and predicate devices are not<br>designed for use on patients with cardiac<br>pacemakers. |
| Prescription<br>Use | Yes | Yes | Yes | Yes | Similar |
| Channels | See Table Sensor<br>Comparison | The Alice 5 system<br>is a<br>polysomnographic<br>system that is<br>intended to record | See Table Sensor<br>Comparison | See Table Sensor<br>Comparison | Similar |
| | | display, and print<br>physiological<br>information for<br>clinicians/physicians.<br>These parameters are<br>presented graphically<br>on a computer screen<br>for diagnostic<br>review, similar in<br>application to the | | | |
| Configuration | Waist belt or<br>desktop | use of a traditional<br>paper-based<br>polygraph recorder. | Waist belt or<br>desktop | Waist Belt or<br>desktop | |
| Portable<br>Design | Yes | The device will be<br>used in hospitals,<br>institutions, sleep<br>center or clinics, or<br>other test<br>environments where<br>adults or infant<br>patients require the<br>documentation of<br>various sleep or<br>other physiological<br>disorders. | Yes | Yes | Similar |
| Number of<br>Patients can<br>monitor<br>simultaneously | 1 per unit | This device does not<br>provide alarms and is<br>not intended for use<br>as an automated<br>apnea monitor. | 1 per unit | 1 per unit | Similar |
| Data Collection | Yes | Yes | Yes | Yes | Similar |
| Report | Optional | See Table Sensor | Optional | Optional | Similar |
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| Generation | | Comparison | | | |
|----------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|-----------------------|----------|----------|-------------------------------------------------------------------------------------------|
| Capable of<br>Data Transfer<br>for<br>Analysis and<br>Report<br>Generation | Yes | Waist belt or desktop | Yes | Yes | Similar |
| Data Analysis<br>(Computer or<br>Computer<br>Assisted) | Optional, supports<br>only manual (visual)<br>scoring for<br>pediatrics by<br>qualified RPSG | Yes | Optional | Optional | SOMNOscreen plus<br>only supports manual<br>scoring for children<br>and adolescents |
| Comprehensive<br>Report<br>Generation | Optional | 1 per unit | Optional | Optional | Similar |
| Remote<br>Capability to<br>Monitor Lead<br>Quality | Yes | Yes | Yes | Yes | Similar |
| Electrode<br>Imped. Check | Yes | Optional | No | No | Similar; Electrode<br>impedance can be<br>measured in<br>SOMNOscreen plus<br>and Alice 5. |
| Calibration<br>Check | Yes | Yes | Yes | Yes | Similar |
| Selectable<br>Montage<br>Configuration | Yes | Optional | Yes | Yes | Similar |
| Annotations on<br>Study | Yes | Optional | Yes | Yes | Similar |
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| Study Modes | Polysomnography<br>Recording, Long<br>Term displaying,<br>Retrieval and<br>Replay | Yes | Polysomnography<br>Recording, Long<br>Term displaying,<br>Retrieval and<br>Replay | Polysomnography<br>Recording, Long<br>Term displaying,<br>Retrieval and<br>Replay | Similar |
|---------------------------|-----------------------------------------------------------------------------------|-----|-----------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|---------|
| Optional<br>Equipment | Digital Video /<br>Printer | Yes | Digital Video /<br>Printer | Digital Video /<br>Printer | Similar |
| Radio LAN<br>Capabilities | Yes | Yes | Yes | Yes | Similar |
The sensor principle of the sensors for SOMNOscreen plus has not changed compared to the previously cleared SOMNOscreen EEG10-20. Also, the materials for the external sensors have not changed.
### Technical Specification Comparison
| Features/Technical<br>Information | SOMNOscreen plus<br>K201054 | SOMNOscreen EEG10-<br>20 K071556 | SOMNOscreen K060708 | Alice® 5 System K040595 | Discussion/ Comment |
|-----------------------------------|-----------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------|
| Data processing | Active Signal Filtering<br>Resolution: up to 16 Bit<br>Storage rate: up to 512 Hz | Active Signal Filtering<br>Resolution: up to 16 Bit<br>Storage rate: up to 512 Hz | Active Signal Filtering<br>Resolution: up to 16 Bit<br>Storage rate: up to 512 Hz | Active Signal Filtering<br>Resolution: up to 16 Bit<br>Storage rate: up to 200 Hz | SOMNOscreen plus allows a<br>higher storage rate in order to<br>support an improved signal<br>quality. |
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| Features/Technical<br>Information | SOMNOscreen plus<br>K201054 | SOMNOscreen EEG10-<br>20 K071556 | SOMNOscreen K060708 | Alice® 5 System K040595 | Discussion/ Comment |
|-----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Power supply | Rechargeable Li ION<br>battery (4,2 V) with<br>recording time up to 24<br>hours. Integrated Safety<br>Chip. The battery has an<br>operating life of<br>approximately 500 charging<br>cycles. | Rechargeable Li ION<br>battery (4,2 V) with<br>recording time up to 24<br>hours. Integrated Safety<br>Chip. The battery has an<br>operating life of<br>approximately 500<br>charging cycles. | Rechargeable Li ION<br>battery (4,2 V) with<br>recording time up to 24<br>hours. Integrated Safety<br>Chip. The battery has an<br>operating life of<br>approximately 500<br>charging cycles. | The base station is<br>powered from a single<br>external medical grade<br>power supply unit: Model<br>MW 116 Power Supply<br>- MW116 Input: 100 to<br>240 VAC, 50/60 Hz 1.0 A<br>Output: 6.3 VDC, 5.0 A<br>- Base Station Input: 6.3<br>VDC, 5.0 A<br>The headbox receives its<br>power from the base<br>station via a cable. | Different power supply<br>between SOMNOscreen plus<br>and Alice 5.<br>SOMNOscreen's plus main<br>device is battery powered<br>allowing the patient to freely<br>move around. |
| Interactive display | Signal check on the display;<br>programmable time setting;<br>keyboard for menu control;<br>all menu text on the screen<br>in displayed in capital<br>letters. | Signal check on the<br>display; programmable<br>time setting; keyboard for<br>menu control; all menu<br>text on the screen in<br>displayed in capital<br>letters. | Signal check on the<br>display; programmable<br>time setting; keyboard for<br>menu control; all menu<br>text on the screen in<br>displayed in capital<br>letters. | No internal display<br>available | Alice 5 does not include an<br>internal display.<br>SOMNOscreen plus offers<br>the possibility to start<br>measurements and do a<br>signal check directly on the<br>main-device using the<br>integrated display. |
| Features/Technical<br>Information | SOMNOscreen plus<br>K201054 | SOMNOscreen EEG10-<br>20 K071556 | SOMNOscreen K060708 | Alice® 5 System K040595 | Discussion/ Comment |
| Raw data storage | High-speed Compact Flash<br>Card | High-speed Compact<br>Flash Card | High-speed Compact<br>Flash Card | Hard disk | Different storage<br>technologies between<br>SOMNOscreen plus and<br>Alice 5. These different<br>technological characteristics<br>do not raise safety and<br>effectiveness questions. |
| Dimensions and<br>weight | Main device:<br>Dimensions: 140 L x 70 W<br>x 28 H mm<br>Weight: 220 g<br>Headbox:<br>Dimensions: 75 L x 72 W x<br>23 H mm<br>Weight: 220 g | Main device:<br>Dimensions: 140 L x 70<br>W x 28 H mm<br>Weight: 220 g<br>Headbox:<br>Dimensions: 75 L x 72 W<br>x 23 H mm<br>Weight: 220 g | Main device:<br>Dimensions: 140 L x 70<br>W x 28 H mm<br>Weight: 220 g<br>Headbox:<br>Dimensions: 75 L x 72 W<br>x 23 H mm<br>Weight: 220 g | Main device:<br>Dimensions: 340 L x 110<br>W x 300 H mm<br>Weight: 4082 g<br>Headbox:<br>Dimensions – 230 L x 100<br>W x 40 H mm<br>Weight: 1361 g. | Main device and headbox of<br>SOMNOscreen plus are<br>smaller and lighter than the<br>ones from Alice 5 in order to<br>provide a comfortable use of<br>the SOMNOscreen plus<br>system. |
| Temperature | During operation: 5° C to<br>40° C<br>Storage: 0° C to 50°C | During operation: 5° C to<br>40° C<br>Storage: 0° C to 50°C | During operation: 5° C to<br>40° C<br>Storage: 0° C to 50°C | During operation: 5° C to<br>35° C<br>Storage: -20° C to 60°C | SOMNOscreen plus comes<br>with a slightly extended<br>temperature range during<br>operation compared to Alice<br>5. Temperature range for<br>storage is larger for Alice 5<br>than for SOMNOscreen plus;<br>however, that does not affect<br>the system during operation. |
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### Performance Testing Summary
The SOMNOscreen plus was verified and validated throughout the design process according to prespecified requirement specifications, relevant performance standards according to the product's intended use to assure product safety, effectiveness, and reliability. Design and verification testing of all requirement specifications defined for the SOMNOscreen plus was conducted and passed.
The SOMNOscreen plus has been evaluated and found to conform to the following electromagnetic compatibility and electrical safety standards:
IEC 60601-1 Medical electrical equipment – Part 1: General requirements for basic safety and essential performance
IEC 60601-1-2 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility
Software documentation to support a moderate level of concern is provided.
### AASM Fulfillment
Signal recorded by the SOMNOscreen plus underwent performance testing demonstrating that all signal types being recorded comply with the performance criteria set forth by SOMNOmedics that includes the minimum performance specification recommended by the American Academy of Sleep Medicine (AASM). Submission provides a detailed analysis of the requirements from AASM manual, a wellestablished reference to clinicians when using devices to assist in the evaluation of PSG, and its fulfilment of SOMNOscreen plus compared to ALICE 5 System.
#### Biocompatibility
Many of the accessory components to be used with the SOMNOscreen plus have been previously cleared by FDA. For new components, the biocompatibility has been established according to ISO 10993.
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### Declarations of Conformity to the following standards is provided in the submission:
| Standard | FDA Recognition # |
|-------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------|
| ISO 14971 Medical devices -- Application of risk management to medical devices | 5-40 |
| ISO 13485 Medical devices - Quality management systems - Requirements for<br>regulatory purposes | N/A |
| ISO 10993-1 Evaluation and testing within a risk management process | 2-220 |
| ISO 10993-5 Tests for in vitro cytotoxicity | 2-245 |
| ISO 10993-10 Tests for irritation and skin sensitization | 2-174 |
| IEC/ANSI 60601-1:2005 | 19-4 |
| EN 60601-1-2:2015 (IEC 60601-1-2:2014) | 19-8 |
| IEC 62366-1 Edition 1.0 2015-02 Medical devices - Part 1: Application of usability<br>engineering to medical devices [Including CORRIGENDUM 1 (2016)] | 5-114 |
### Clinical Data
Clinical data were not relied upon for a determination of substantial equivalence.
### Conclusion
SOMNOscreen plus is substantially equivalent to the predicate devices Alice 5 and SOMNOscreen, SOMNOscreen EEG10-20. The performance testing demonstrated that the device met pre-specified requirements. Based on the methods and results, the subject device is substantially equivalent to the predicate device and is safe and effective for its intended use in the expanded patient population.
