(113 days)
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.
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.
The provided text describes a medical device, SOMNOscreen plus, and its FDA 510(k) clearance. The submission focuses on expanding the patient population to include children and adolescents, emphasizing that for this new population, only manual scoring by qualified personnel is allowed, with no automated analysis.
Here's an analysis of the acceptance criteria and study information, based only on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of "acceptance criteria" against "reported device performance" in a quantitative manner for specific diagnostic metrics (e.g., accuracy, sensitivity, specificity for detecting sleep-related breathing disorders). Instead, it discusses compliance with general safety and performance standards for electroencephalographs and polysomnographs.
However, we can infer some performance aspects based on the technical specifications and comparisons:
| Performance Aspect (Implied Acceptance Criteria) | Reported Device Performance (from text) |
|---|---|
| Signal Recording Capabilities | Complies with performance criteria set forth by SOMNOmedics, including minimum performance specifications recommended by the American Academy of Sleep Medicine (AASM). |
| Data Processing Resolution | Up to 16 Bit (consistent with predicates) |
| Data Processing Storage Rate | Up to 512 Hz (higher than Alice 5's 200 Hz, supporting improved signal quality) |
| Battery Life / Recording Duration | Up to 24 hours (consistent with predicates) |
| Integrated Display Functionality | Allows signal check, programmable time setting, menu control directly on the main device (advantage over Alice 5, which has no internal display) |
| Electrode Impedance Check | Capable (similar to Alice 5, but not on all predicates) |
| Calibration Check | Capable (similar to predicates) |
| Usability Engineering | Compliant with IEC 62366-1 |
| Safety (Electrical) | Compliant with IEC 60601-1 |
| Electromagnetic Compatibility (EMC) | Compliant with IEC 60601-1-2 |
| Risk Management | Applied according to ISO 14971 |
| Quality Management System | Compliant with ISO 13485 |
| Biocompatibility | Established according to ISO 10993 for new components; many accessories previously cleared. |
2. Sample Size Used for the Test Set and Data Provenance
The document explicitly states: "Clinical data were not relied upon for a determination of substantial equivalence." This means no specific clinical test set was used to evaluate the device's diagnostic performance for sleep-related breathing disorders in humans for this submission. The evaluation focused on technical and safety equivalence to predicate devices and adherence to standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
As no clinical data was relied upon, there was no test set requiring expert-established ground truth. The "ground truth" implicitly referred to here is compliance with technical standards and AASM recommendations for polysomnography signal acquisition. For pediatric applications, the text mentions "manual (visual) scoring by qualified RPSG" (Registered Polysomnographic Technologist), implying that human experts are crucial for interpreting the device's output, especially in the expanded pediatric population. However, this is about the use of the device, not the validation of its performance in a clinical study for this submission.
4. Adjudication Method for the Test Set
Not applicable, as no clinical test set was used or described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not done, as stated by "Clinical data were not relied upon for a determination of substantial equivalence." The document indicates that for pediatric populations, the software "only allows manual (visual) scoring by qualified RPSG. There is no automated analysis or highlighting available for pediatric patients." This suggests that any comparative effectiveness of human readers with AI assistance versus without AI assistance is not relevant to this specific clearance for the pediatric population, as AI assistance for scoring is explicitly not provided for them.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
No standalone algorithm performance study was described. In fact, for the new pediatric population, the device explicitly does not offer automated analysis or highlighting, emphasizing human interpretation.
7. The Type of Ground Truth Used
For the purposes of this 510(k) submission, the "ground truth" used was primarily compliance with recognized standards (IEC 60601-1, IEC 60601-1-2, ISO 14971, ISO 10993, IEC 62366-1) and technical specifications, as well as adherence to minimum performance specifications recommended by the American Academy of Sleep Medicine (AASM) for signal types. No clinical ground truth (like pathology, expert consensus on diagnostic outcomes, or long-term outcomes data) was used in a specific clinical study for this submission.
8. The Sample Size for the Training Set
No training set information is provided, as the submission did not rely on clinical data or automated algorithms that would require a training set for this clearance. The "training" here refers to the design and verification process of the device itself against engineering and safety requirements.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as no training set for an AI algorithm was described. The device's "training" in an engineering sense involved verification and validation against pre-specified requirement specifications and relevant performance standards, ensuring basic safety and essential performance.
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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
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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 | SOMNOmedicsSOMNOscreen | |
| Product Code(s) | OLZ, OLV | MNR | MNR |
| Intended Use | Record, display, and printphysiological information toclinicians/ physicians. Theseparameters are presentedgraphically on a computer screenfor diagnostic review, similar inapplication to the use of atraditional paper-basedpolygraph recorder. The devicewill be used in hospitals,institutions, sleep centers orclinics, or other testenvironments where adults orinfant patients require thedocumentation of various sleepor other physiological disorders.The device does not providealarms and is not intended foruse as an automated apnea | Used for testing adultpatients suspected ofhaving sleep-relatedbreathing disorders. | The SOMNOscreen isindicated for use in therecording, displaying,monitoring, printing, andstorage of biophysicalparameters for the purposeof assisting in the diagnosisof Neurological and SleepDisorders. |
Predicate Devices
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| K040595 | K071556 | K060708 |
|---|---|---|
| Alice® 5System | SOMNOscreen EEG10-20 | SOMNOmedicsSOMNOscreen |
| 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(± 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-condensingStorage: 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®plusK201054 | Alice® 5 SystemPrimary predicateK040595 | SOMNOscreenEEG10-20AdditionalPredicateK071556 | SOMNOscreenAdditionalPredicateK060708 | Comments | |
|---|---|---|---|---|---|
| Product Code | OLV, MNR | OLZ, OLV | MNR | MNR | |
| File Number | K201054 | K040595 | K071556 | K060708 | |
| Indications forUse | TheSOMNOscreen®plus is a non-life-supporting portablephysiological signalrecording deviceintended to be usedfor testing adultsand children (age 2to 12 years)/adolescents (age 12and above)suspected of havingsleep-relatedbreathing disorders. | The Alice 5 systemis apolysomnographysystem that isintended to record,display, and printphysiologicalinformation forclinicians/physicians. Theseparameters arepresented graphicallyon a computer screenfor diagnosticreview, similar inapplication to the useof a traditionalpaper-based | TheSOMNOscreenEEG10-20 is anon-life-supportingportablephysiologicalsignal recordingdevice intended tobe used for testingadult patientssuspected ofhaving sleep-related breathingdisorders. | TheSOMNOscreen isa non-life-supportingportablephysiologicalsignal recordingdevice intended tobe used for testingadult patientssuspected ofhaving sleep-related breathingdisorders. | Similar target patient population and age rangeas well as environment of use; all areprescription use devices.The primary predicate, Alice 5, providesautomatic detection of events whereas thesubject device is not intended to do so.For pediatric populations, only manual scoringby trained personnel should be applied, and theenvironment of use is limited to hospital/ clinicuse for pediatric patients. |
| Intended Use | TheSOMNOscreen®plus is indicated foruse in the recording,displaying, | polygraph recorder.The Alice 5 devicewill be used inhospitals,institutions, sleepcenter or clinics, or | TheSOMNOscreen isindicated for usein the recording,displaying, | TheSOMNOscreen isindicated for use inthe recording,displaying, | The SOMNOscreen® plus, as well as thepredicate devices, is indicated for use in therecording, displaying, monitoring, printing, andstorage of biophysical parameters for thepurpose of assisting in the diagnosis of |
| monitoring, printing,and storage ofbiophysicalparameters for thepurpose of assistingin the diagnosis ofNeurological andSleep Disorders.The device is non-life-supportingphysiological signalrecording devicesintended to be usedfor studies testingadults andchildren/adolescentssuspected of havingsleep-relatedbreathing disorders.The subject is NOTdesigned to be usedin a Life Supportsituation.The subject is notdesigned for use onpatients with cardiacpacemakers. | other testenvironments whereadults or infantpatients require thedocumentation ofvarious sleep orother physiologicaldisorders.This device does notprovide alarms and isnot intended for useas an automatedapnea monitor. | monitoring,printing, andstorage ofbiophysicalparameters for thepurpose ofassisting in thediagnosis ofNeurological andSleep Disorders. | monitoring,printing, andstorage ofbiophysicalparameters for thepurpose ofassisting in thediagnosis ofNeurological andSleep Disorders. | Neurological and Sleep Disorders.The subject and predicate devices are non-life-supporting physiological signal recordingdevices intended to be used for studies testingadults, children, and adolescents suspected ofhaving sleep-related breathing disorders.The subject and predicate devices are NOTdesigned to be used in life support situations.The subject and predicate devices are notdesigned for use on patients with cardiacpacemakers. | |
| PrescriptionUse | Yes | Yes | Yes | Yes | Similar |
| Channels | See Table SensorComparison | The Alice 5 systemis apolysomnographicsystem that isintended to record | See Table SensorComparison | See Table SensorComparison | Similar |
| display, and printphysiologicalinformation forclinicians/physicians.These parameters arepresented graphicallyon a computer screenfor diagnosticreview, similar inapplication to the | |||||
| Configuration | Waist belt ordesktop | use of a traditionalpaper-basedpolygraph recorder. | Waist belt ordesktop | Waist Belt ordesktop | |
| PortableDesign | Yes | The device will beused in hospitals,institutions, sleepcenter or clinics, orother testenvironments whereadults or infantpatients require thedocumentation ofvarious sleep orother physiologicaldisorders. | Yes | Yes | Similar |
| Number ofPatients canmonitorsimultaneously | 1 per unit | This device does notprovide alarms and isnot intended for useas an automatedapnea 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 ofData TransferforAnalysis andReportGeneration | Yes | Waist belt or desktop | Yes | Yes | Similar |
| Data Analysis(Computer orComputerAssisted) | Optional, supportsonly manual (visual)scoring forpediatrics byqualified RPSG | Yes | Optional | Optional | SOMNOscreen plusonly supports manualscoring for childrenand adolescents |
| ComprehensiveReportGeneration | Optional | 1 per unit | Optional | Optional | Similar |
| RemoteCapability toMonitor LeadQuality | Yes | Yes | Yes | Yes | Similar |
| ElectrodeImped. Check | Yes | Optional | No | No | Similar; Electrodeimpedance can bemeasured inSOMNOscreen plusand Alice 5. |
| CalibrationCheck | Yes | Yes | Yes | Yes | Similar |
| SelectableMontageConfiguration | Yes | Optional | Yes | Yes | Similar |
| Annotations onStudy | Yes | Optional | Yes | Yes | Similar |
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| Study Modes | PolysomnographyRecording, LongTerm displaying,Retrieval andReplay | Yes | PolysomnographyRecording, LongTerm displaying,Retrieval andReplay | PolysomnographyRecording, LongTerm displaying,Retrieval andReplay | Similar |
|---|---|---|---|---|---|
| OptionalEquipment | Digital Video /Printer | Yes | Digital Video /Printer | Digital Video /Printer | Similar |
| Radio LANCapabilities | 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/TechnicalInformation | SOMNOscreen plusK201054 | SOMNOscreen EEG10-20 K071556 | SOMNOscreen K060708 | Alice® 5 System K040595 | Discussion/ Comment |
|---|---|---|---|---|---|
| Data processing | Active Signal FilteringResolution: up to 16 BitStorage rate: up to 512 Hz | Active Signal FilteringResolution: up to 16 BitStorage rate: up to 512 Hz | Active Signal FilteringResolution: up to 16 BitStorage rate: up to 512 Hz | Active Signal FilteringResolution: up to 16 BitStorage rate: up to 200 Hz | SOMNOscreen plus allows ahigher storage rate in order tosupport an improved signalquality. |
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| Features/TechnicalInformation | SOMNOscreen plusK201054 | SOMNOscreen EEG10-20 K071556 | SOMNOscreen K060708 | Alice® 5 System K040595 | Discussion/ Comment |
|---|---|---|---|---|---|
| Power supply | Rechargeable Li IONbattery (4,2 V) withrecording time up to 24hours. Integrated SafetyChip. The battery has anoperating life ofapproximately 500 chargingcycles. | Rechargeable Li IONbattery (4,2 V) withrecording time up to 24hours. Integrated SafetyChip. The battery has anoperating life ofapproximately 500charging cycles. | Rechargeable Li IONbattery (4,2 V) withrecording time up to 24hours. Integrated SafetyChip. The battery has anoperating life ofapproximately 500charging cycles. | The base station ispowered from a singleexternal medical gradepower supply unit: ModelMW 116 Power Supply- MW116 Input: 100 to240 VAC, 50/60 Hz 1.0 AOutput: 6.3 VDC, 5.0 A- Base Station Input: 6.3VDC, 5.0 AThe headbox receives itspower from the basestation via a cable. | Different power supplybetween SOMNOscreen plusand Alice 5.SOMNOscreen's plus maindevice is battery poweredallowing the patient to freelymove around. |
| Interactive display | Signal check on the display;programmable time setting;keyboard for menu control;all menu text on the screenin displayed in capitalletters. | Signal check on thedisplay; programmabletime setting; keyboard formenu control; all menutext on the screen indisplayed in capitalletters. | Signal check on thedisplay; programmabletime setting; keyboard formenu control; all menutext on the screen indisplayed in capitalletters. | No internal displayavailable | Alice 5 does not include aninternal display.SOMNOscreen plus offersthe possibility to startmeasurements and do asignal check directly on themain-device using theintegrated display. |
| Features/TechnicalInformation | SOMNOscreen plusK201054 | SOMNOscreen EEG10-20 K071556 | SOMNOscreen K060708 | Alice® 5 System K040595 | Discussion/ Comment |
| Raw data storage | High-speed Compact FlashCard | High-speed CompactFlash Card | High-speed CompactFlash Card | Hard disk | Different storagetechnologies betweenSOMNOscreen plus andAlice 5. These differenttechnological characteristicsdo not raise safety andeffectiveness questions. |
| Dimensions andweight | Main device:Dimensions: 140 L x 70 Wx 28 H mmWeight: 220 gHeadbox:Dimensions: 75 L x 72 W x23 H mmWeight: 220 g | Main device:Dimensions: 140 L x 70W x 28 H mmWeight: 220 gHeadbox:Dimensions: 75 L x 72 Wx 23 H mmWeight: 220 g | Main device:Dimensions: 140 L x 70W x 28 H mmWeight: 220 gHeadbox:Dimensions: 75 L x 72 Wx 23 H mmWeight: 220 g | Main device:Dimensions: 340 L x 110W x 300 H mmWeight: 4082 gHeadbox:Dimensions – 230 L x 100W x 40 H mmWeight: 1361 g. | Main device and headbox ofSOMNOscreen plus aresmaller and lighter than theones from Alice 5 in order toprovide a comfortable use ofthe SOMNOscreen plussystem. |
| Temperature | During operation: 5° C to40° CStorage: 0° C to 50°C | During operation: 5° C to40° CStorage: 0° C to 50°C | During operation: 5° C to40° CStorage: 0° C to 50°C | During operation: 5° C to35° CStorage: -20° C to 60°C | SOMNOscreen plus comeswith a slightly extendedtemperature range duringoperation compared to Alice5. Temperature range forstorage is larger for Alice 5than for SOMNOscreen plus;however, that does not affectthe 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 forregulatory 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 usabilityengineering 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.
§ 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).