Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary explicitly states that for pediatric patients, the software only allows manual scoring and there is no automated analysis or highlighting available. There is no mention of AI or ML being used for adult patients either.

Therapeutic

No
The device is described as a "physiological signal recording device" used for testing individuals suspected of having sleep-related breathing disorders, which indicates a diagnostic or monitoring function rather than a direct therapeutic intervention.

Diagnostic

Yes
The device is described as a "physiological signal recording device" intended for "testing adults and children ... suspected of having sleep related breathing disorders," which clearly indicates its use in the diagnosis of medical conditions.

SaMD (Software as a Medical Device)

No

The device description explicitly lists multiple hardware components (Thermistor, Nasal Canula, Effort belts, SpO2-Sensor, etc.) and describes the device as a "portable physiological signal recording device," indicating it includes hardware for data acquisition.

IVD (In Vitro Diagnostic)

Based on the provided information, the SOMNOscreen® plus is not an In Vitro Diagnostic (IVD) device.

Here's why:

Intended Use: The intended use is to record physiological signals for testing individuals suspected of having sleep-related breathing disorders. This involves measuring signals directly from the patient's body (e.g., breathing, effort, oxygen saturation, brain activity).
Device Description: The components listed are sensors and modules designed to capture physiological data from the patient.
Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The SOMNOscreen® plus does not process or analyze such specimens.

The SOMNOscreen® plus is a physiological signal recording device used for sleep studies (polysomnography).

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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 sheep related breathing disorders.

Product codes (comma separated list FDA assigned to the subject device)

OLV, MNR

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.

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

Adults and children (age 2 to 12 years)/adolescents (age 12 and above)

Intended User / Care Setting

Not Found

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)

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.

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.

K040595, K071556, K060708

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

Regulation Number and Section

§ 882.1400 Electroencephalograph.

(a)
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.(b)
Classification. Class II (performance standards).

Summary

0

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

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

1

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

2

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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3

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

4

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
SOMNOscreen
Product Code(s)	OLZ, OLV	MNR	MNR
Intended Use	Record, display, and print
physiological information to
clinicians/ physicians. These
parameters are presented
graphically on a computer screen
for diagnostic review, similar in
application to the use of a
traditional paper-based
polygraph recorder. The device
will be used in hospitals,
institutions, sleep centers or
clinics, or other test
environments where adults or
infant patients require the
documentation of various sleep
or other physiological disorders.
The device does not provide
alarms and is not intended for
use as an automated apnea	Used for testing adult
patients suspected of
having sleep-related
breathing disorders.	The SOMNOscreen 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.

Predicate Devices

5

K040595	K071556	K060708
Alice® 5
System	SOMNOscreen EEG10-20	SOMNOmedics
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.

6

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
(± 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
Storage: 10% - 95%, non-condensing

Technical Specifications of the SOMNOscreen Plus:

7

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.

8

Comparison of Technological Characteristics between Subject and Predicate Devices

| | SOMNOscreen®
plus
K201054 | Alice® 5 System
Primary predicate
K040595 | SOMNOscreen
EEG10-20
Additional
Predicate
K071556 | SOMNOscreen
Additional
Predicate
K060708 | Comments |
|--------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Code | OLV, MNR | OLZ, OLV | MNR | MNR | |
| File Number | K201054 | K040595 | K071556 | K060708 | |
| 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. | The Alice 5 system
is a
polysomnography
system that is
intended to record,
display, and print
physiological
information for
clinicians/
physicians. These
parameters are
presented graphically
on a computer screen
for diagnostic
review, similar in
application to the use
of a traditional
paper-based | The
SOMNOscreen
EEG10-20 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
a non-life-
supporting
portable
physiological
signal recording
device intended to
be used for testing
adult patients
suspected of
having sleep-
related breathing
disorders. | Similar target patient population and age range
as well as environment of use; all are
prescription use devices.
The primary predicate, Alice 5, provides
automatic detection of events whereas the
subject device is not intended to do so.
For pediatric populations, only manual scoring
by trained personnel should be applied, and the
environment of use is limited to hospital/ clinic
use for pediatric patients. |
| Intended Use | The
SOMNOscreen®
plus is indicated for
use in the recording,
displaying, | polygraph recorder.
The Alice 5 device
will be used in
hospitals,
institutions, sleep
center or clinics, or | The
SOMNOscreen is
indicated for use
in the recording,
displaying, | The
SOMNOscreen is
indicated for use in
the recording,
displaying, | The SOMNOscreen® plus, as well as the
predicate devices, is indicated for use in the
recording, displaying, monitoring, printing, and
storage of biophysical parameters for the
purpose of assisting in the diagnosis of |
| | monitoring, printing,
and storage of
biophysical
parameters for the
purpose of assisting
in the diagnosis of
Neurological and
Sleep Disorders.
The device is non-
life-supporting
physiological signal
recording devices
intended to be used
for studies testing
adults and
children/adolescents
suspected of having
sleep-related
breathing disorders.
The subject is NOT
designed to be used
in a Life Support
situation.
The subject is not
designed for use on
patients with cardiac
pacemakers. | other test
environments where
adults or infant
patients require the
documentation of
various sleep or
other physiological
disorders.
This device does not
provide alarms and is
not intended for use
as an automated
apnea monitor. | monitoring,
printing, and
storage of
biophysical
parameters for the
purpose of
assisting in the
diagnosis of
Neurological and
Sleep Disorders. | monitoring,
printing, and
storage of
biophysical
parameters for the
purpose of
assisting in the
diagnosis of
Neurological and
Sleep Disorders. | Neurological and Sleep Disorders.
The subject and predicate devices are non-life-
supporting physiological signal recording
devices intended to be used for studies testing
adults, children, and adolescents suspected of
having sleep-related breathing disorders.
The subject and predicate devices are NOT
designed to be used in life support situations.
The subject and predicate devices are not
designed for use on patients with cardiac
pacemakers. |
| Prescription
Use | Yes | Yes | Yes | Yes | Similar |
| Channels | See Table Sensor
Comparison | The Alice 5 system
is a
polysomnographic
system that is
intended to record | See Table Sensor
Comparison | See Table Sensor
Comparison | Similar |
| | | display, and print
physiological
information for
clinicians/physicians.
These parameters are
presented graphically
on a computer screen
for diagnostic
review, similar in
application to the | | | |
| Configuration | Waist belt or
desktop | use of a traditional
paper-based
polygraph recorder. | Waist belt or
desktop | Waist Belt or
desktop | |
| Portable
Design | Yes | The device will be
used in hospitals,
institutions, sleep
center or clinics, or
other test
environments where
adults or infant
patients require the
documentation of
various sleep or
other physiological
disorders. | Yes | Yes | Similar |
| Number of
Patients can
monitor
simultaneously | 1 per unit | This device does not
provide alarms and is
not intended for use
as an automated
apnea monitor. | 1 per unit | 1 per unit | Similar |
| Data Collection | Yes | Yes | Yes | Yes | Similar |
| Report | Optional | See Table Sensor | Optional | Optional | Similar |

9

10

11

Generation		Comparison
Capable of
Data Transfer
for
Analysis and
Report
Generation	Yes	Waist belt or desktop	Yes	Yes	Similar
Data Analysis
(Computer or
Computer
Assisted)	Optional, supports
only manual (visual)
scoring for
pediatrics by
qualified RPSG	Yes	Optional	Optional	SOMNOscreen plus
only supports manual
scoring for children
and adolescents
Comprehensive
Report
Generation	Optional	1 per unit	Optional	Optional	Similar
Remote
Capability to
Monitor Lead
Quality	Yes	Yes	Yes	Yes	Similar
Electrode
Imped. Check	Yes	Optional	No	No	Similar; Electrode
impedance can be
measured in
SOMNOscreen plus
and Alice 5.
Calibration
Check	Yes	Yes	Yes	Yes	Similar
Selectable
Montage
Configuration	Yes	Optional	Yes	Yes	Similar
Annotations on
Study	Yes	Optional	Yes	Yes	Similar

12

| Study Modes | Polysomnography
Recording, Long
Term displaying,
Retrieval and
Replay | Yes | Polysomnography
Recording, Long
Term displaying,
Retrieval and
Replay | Polysomnography
Recording, Long
Term displaying,
Retrieval and
Replay | Similar |
|---------------------------|-----------------------------------------------------------------------------------|-----|-----------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|---------|
| Optional
Equipment | Digital Video /
Printer | Yes | Digital Video /
Printer | Digital Video /
Printer | Similar |
| Radio LAN
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
Information | SOMNOscreen plus
K201054 | SOMNOscreen EEG10-
20 K071556 | SOMNOscreen K060708 | Alice® 5 System K040595 | Discussion/ Comment |
|-----------------------------------|-----------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------|
| Data processing | Active Signal Filtering
Resolution: up to 16 Bit
Storage rate: up to 512 Hz | Active Signal Filtering
Resolution: up to 16 Bit
Storage rate: up to 512 Hz | Active Signal Filtering
Resolution: up to 16 Bit
Storage rate: up to 512 Hz | Active Signal Filtering
Resolution: up to 16 Bit
Storage rate: up to 200 Hz | SOMNOscreen plus allows a
higher storage rate in order to
support an improved signal
quality. |

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| Features/Technical
Information | SOMNOscreen plus
K201054 | SOMNOscreen EEG10-
20 K071556 | SOMNOscreen K060708 | Alice® 5 System K040595 | Discussion/ Comment |
|-----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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. | 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. | 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. | The base station is
powered from a single
external medical grade
power supply unit: Model
MW 116 Power Supply

MW116 Input: 100 to
240 VAC, 50/60 Hz 1.0 A
Output: 6.3 VDC, 5.0 A
Base Station Input: 6.3
VDC, 5.0 A
The headbox receives its
power from the base
station via a cable. | Different power supply
between SOMNOscreen plus
and Alice 5.
SOMNOscreen's plus main
device is battery powered
allowing the patient to freely
move around. |
| 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. | Signal check on the
display; programmable
time setting; keyboard for
menu control; all menu
text on the screen in
displayed in capital
letters. | Signal check on the
display; programmable
time setting; keyboard for
menu control; all menu
text on the screen in
displayed in capital
letters. | No internal display
available | Alice 5 does not include an
internal display.
SOMNOscreen plus offers
the possibility to start
measurements and do a
signal check directly on the
main-device using the
integrated display. |
| Features/Technical
Information | SOMNOscreen plus
K201054 | SOMNOscreen EEG10-
20 K071556 | SOMNOscreen K060708 | Alice® 5 System K040595 | Discussion/ Comment |
| Raw data storage | High-speed Compact Flash
Card | High-speed Compact
Flash Card | High-speed Compact
Flash Card | Hard disk | Different storage
technologies between
SOMNOscreen plus and
Alice 5. These different
technological characteristics
do not raise safety and
effectiveness questions. |
| Dimensions and
weight | Main device:
Dimensions: 140 L x 70 W
x 28 H mm
Weight: 220 g
Headbox:
Dimensions: 75 L x 72 W x
23 H mm
Weight: 220 g | Main device:
Dimensions: 140 L x 70
W x 28 H mm
Weight: 220 g
Headbox:
Dimensions: 75 L x 72 W
x 23 H mm
Weight: 220 g | Main device:
Dimensions: 140 L x 70
W x 28 H mm
Weight: 220 g
Headbox:
Dimensions: 75 L x 72 W
x 23 H mm
Weight: 220 g | Main device:
Dimensions: 340 L x 110
W x 300 H mm
Weight: 4082 g
Headbox:
Dimensions – 230 L x 100
W x 40 H mm
Weight: 1361 g. | Main device and headbox of
SOMNOscreen plus are
smaller and lighter than the
ones from Alice 5 in order to
provide a comfortable use of
the SOMNOscreen plus
system. |
| Temperature | During operation: 5° C to
40° C
Storage: 0° C to 50°C | During operation: 5° C to
40° C
Storage: 0° C to 50°C | During operation: 5° C to
40° C
Storage: 0° C to 50°C | During operation: 5° C to
35° C
Storage: -20° C to 60°C | SOMNOscreen plus comes
with a slightly extended
temperature range during
operation compared to Alice

Temperature range for
storage is larger for Alice 5
than for SOMNOscreen plus;
however, that does not affect
the system during operation. |

14

15

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
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
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.