The SOMNOtouch RESP is a portable physiological signal recorder. It is indicated for use in the recording, displaying, monitoring, printing, and storage of biophysical parameters for the purpose of assisting in the diagnosis of sleep disorders and sleep related respiratory disorders of adult patients. The device is intended to be prescribed for use by a physician in the office, sleep laboratory or patient's home.

This device is NOT designed to be used in life support situations.

Device Description

The SOMNOtouch™ RESP is a small, portable physiological signal recording system intended to be used to record, display, monitor, print and store biophysical parameters to aid in the diagnosis of sleep disorders. The device is intended to be prescribed for use by a physician in the office, sleep laboratory or patient's home.

The SOMNOtouch™ RESP consists of the following:

The recording device (worn on the thorax),
the finger probe, which is used to detect SpO2,
the external effort sensor,
two effort belts to measure thoracic and abdominal expansion,
the nasal cannula.
the Software DOMINOlight for visualization of the recorded data.

The SOMNOtouch™ RESP typically will be worn at the thorax, attached by a thorax belt. It contains a sensor to measure the respiratory effort signal of the thorax. The device has an internal accelerometer, measuring body position and motion activity. It provides a connector to attach a nasal cannula, which allows the recording of respiratory flow and snore signals with the internal pressure sensor. Arterial oxygen saturation (SpO2) and pulse rate can be determined via a pulse oximetric finger sensor. Abdominal respiratory effort is measured with an external sensor, attached with a belt to the abdomen. This information is stored in the internal memory of the device.

The system provides up to 10 internal channels for data acquisition, Pressure/Flow, Thoracic Effort, SpO2, Pulserate, Snoring, Finger Plethysmogram, Body Position, Movement, Patient Marker, CPAP, and 1 external Abdominal Effort Sensor. The data from all channels can be recorded separately or in any combination with the other channels.

Information is stored on an internal 512 MB flash memory and can be transferred to a PC via a USB docking station. The DOMINOlight software retrieves the data from the SOMNOtouch™ RESP, displays and analyzes the data, and can store data for future reference and comparison. The SOMNOtouch RESP does not provide automatic diagnosis and is not designed to be used in Life Support situations.

AI/ML Overview

The SOMNOtouch™ RESP device is a portable physiological signal recorder used to assist in diagnosing sleep disorders and sleep-related respiratory disorders in adult patients. The acceptance criteria and supporting study details are as follows:

1. Table of Acceptance Criteria and Reported Device Performance

Feature/Metric	Acceptance Criteria (Implicit from Equivalence)	Reported Device Performance
Clinical Performance	Ability to detect breathing events (hypopnea and apnea) with comparable quality to the predicate device (SOMNOscreen, K060708).	The clinical study aimed to assess SOMNOtouch™ RESP's ability to detect breathing events like hypopnea and apnea during sleep with comparable quality to the results from the predicate device. Statistical evaluation included regression analysis and sensitivity/specificity calculation for Apnea-Hypopnea Index (AHI). The comparison found the subject device can be expected to provide safety and effectiveness outcomes substantially equivalent to the predicates.
Safety	Compliance with electrical safety and electromagnetic compatibility standards.	Compliant with DIN EN 60601-1 and DIN EN 60601-1-2. No nonconformities detected. No adverse effects or complications occurred during the clinical study.
Functionality	All functions operate as designed and comply with device specifications.	All functions were verified to operate as designed. All tests were passed successfully.

2. Sample Size and Data Provenance (for test set, which is the clinical study)

Sample Size: "Subjects were recruited out of the regular patient collective of the sleep lab where the study was conducted." The exact number of subjects is not specified in the provided text.
Data Provenance: The study was performed in a "professional sleep lab" in Germany (based on the applicant's country). This indicates prospective data collection for the purpose of the study.

3. Number of Experts and Qualifications for Ground Truth (Test Set)

Number of Experts: "different qualified professionals"
Qualifications of Experts: Not explicitly stated beyond "qualified professionals". It is implied that they are qualified to manually score sleep study data.

4. Adjudication Method (Test Set)

The text states: "Data sets were scored manually by different qualified professionals." This implies independent scoring of the data by multiple experts, but it does not specify an adjudication method like 2+1 or 3+1 for resolving discrepancies.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was done regarding human readers' improvement with or without AI assistance. The study described compares the device's performance to a predicate device, not the impact on human reader performance.

6. Standalone Performance Study

Yes, a standalone study was performed. The clinical study evaluated the SOMNOtouch™ RESP's ability to detect breathing events and provide AHI measurements, which is the algorithm's direct output. The comparison was to the predicate device's output, indicating a standalone assessment of the new device.

7. Type of Ground Truth Used

Expert Consensus: The ground truth for the clinical study was established by "manual scoring by different qualified professionals" of the sleep study data.

8. Sample Size for the Training Set

The document does not provide information on a training set or its sample size. This submission is for a medical device that records physiological signals for diagnosis, and the "clinical study" described is a validation study rather than directly evaluating an AI/ML algorithm that would typically require a training set. The device itself performs measurements and records data, which are then manually interpreted by experts.

9. How the Ground Truth for the Training Set Was Established

As no training set is mentioned or implied for an AI/ML algorithm, this information is not applicable.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular emblem with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other. The profiles are black against a white background.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

January 30, 2015

SOMNOmedics GmbH Mr. Matthias Broenner Am Sonnenstuhl 63 97236 Randersacker GERMANY

Re: K140861

Trade/Device Name: SOMNOtouch™ RESP Ventilatory Effort Recorder Regulation Number: 21 CFR 868.2375 Regulation Name: Breathing frequency monitor Regulatory Class: II Product Code: MNR Dated: December 31, 2014 Received: January 29, 2015

Dear Mr. Broenner:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. 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.

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Tejashri Purohit-Sheth, M.D.

Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR

Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K140861

Device Name: SOMNOtouch™ RESP

Indications For Use:

This device is NOT designed to be used in life support situations.

Prescription Use _____________________________________________________________________________________________________________________________________________________________

AND/OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Part 21 CFR 801 Subpart D)

(21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of ____________________________________________________________________________________________________________________________________________________________________

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Section 5: 510(k) Summary of Safety and Effectiveness

The following information is in conformance with 21 CFR 807.92.

Submitter's Information: 21 CFR 807.92(a)(1)

SOMNOmedics GmbH Am Sonnenstuhl 63 97236 Randersacker Germany

Phone:	+49 931 35 90 94 0
Fax:	+49 931 35 90 94 49
Contact Person:	Dr. Gert Küchler
Date Prepared:	April, 1st 2014

Trade Name, Common Name and Classification: 21 CFR 807.92(a)(2)

Trade Name:	SOMNOtouch™ RESP
Common Name:	Ventilatory Effort Recorder
Classification Name:	Breathing frequency monitor
Product code:	MNR
Regulation Number:	21 CFR 868.2375

Predicate Device: 21 CFR 807. 92(a)(3)

FDA has classified the predicate device (K060708) as Class II, CFR 868.2375, MNR. It is our understanding that SOMNOtouch™ RESP device falls under the same classification as the predicate device. Predicate device details are as follows:

Device Classification Name:	Breathing frequency monitor
510(k) Number:	K060708
Regulation Number:	21 CFR 868.2375
Device Name:	SOMNOscreen
Applicant:	SOMNOmedics GmbHAm Sonnenstuhl 6397236 RandersackerGermany
Classification Product Code:	MNR
Decision Date:	01/24/2007
Classification Advisory Committee:	Anesthesiology

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Device Description: 21 CFR 807 92(a)(4)

The SOMNOtouch™ RESP consists of the following:

1. The recording device (worn on the thorax),
the finger probe, which is used to detect SpO2, 2.
1. the external effort sensor,
two effort belts to measure thoracic and abdominal expansion, 4.
న్. the nasal cannula.
1. the Software DOMINOlight for visualization of the recorded data.

Indications for Use: 21 CFR 807 92(a)(5)

"The SOMNOtouch RESP is a portable physiological signal recorder. It is indicated for use in the recording, displaying, monitoring, printing, and storage of biophysical parameters for the purpose of assisting in the diagnosis of sleep disorders and sleep related respiratory disorders of adult patients. The device is intended to be prescribed for use by a physician in the office, sleep laboratory or patient's home.

This device is NOT designed to be used in life support situations."

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Technological Characteristics: 21 CFR 807 92(a)(6)

CHANNELS

10 Internal Channels:

(Body Position, Movement, Patient Marker, Thoracic Effort, SpO2, Plethysmography, Pulse Rate, Pressure/Flow sensor (CPAP) Snoring)

1 External Channel:

(Abdominal Effort)

DATA PROCESSING

12 Bit ADC

Different Sampling Rates Adjustable (1/60s - 512/s)

Technological Characteristics: Comparison/Discussion Table:

Features/TechnicalInformation	SOMNOmedicsSOMNOtouch™ RESP	SOMNOmedicsSOMNOscreen	Discussion of differences
510(k) number	Not assigned	K060708	n/a
Product code	MNR	MNR	n/a
Indications for Use	The SOMNOtouch RESP is aportable physiological signalrecorder. It is indicated foruse in the recording,displaying, monitoring,printing, and storage ofbiophysical parameters forthe purpose of assisting in thediagnosis of sleep disordersand sleep related respiratorydisorders of adult patients.The device is intended to beprescribed for use by aphysician in the office, sleeplaboratory or patient's home.This device is NOT designedto be used in life supportsituations.	The SOMNOscreen is anon-life-supporting portablephysiological signalrecording device intendedto be used for testing adultpatients suspected of havingsleep-related breathingdisorders.	Indications for use andIntended Use sectionshave been merged.The use in life supportsituations was clarified.The differences do notraise concerns in safety oreffectiveness.
Features/TechnicalInformation	SOMNOmedicsSOMNOtouch™ RESP	SOMNOmedicsSOMNOscreen	Discussion of differences
Intended Use	The SOMNOtouch RESP isa portable physiologicalsignal recorder. It isindicated for use in therecording, displaying,monitoring, printing, andstorage of biophysicalparameters for the purposeof assisting in the diagnosisof sleep disorders and sleeprelated respiratory disordersof adult patients. The deviceis intended to be prescribedfor use by a physician in theoffice, sleep laboratory orpatient's home.This device is NOT designedto be used in life supportsituations.	The SOMNOscreen isindicated for use in therecording, displaying,monitoring, printing, andstorage of biophysicalparameters for the purposeof assisting in the diagnosisof Neurological and SleepDisorders.	Indications for use andIntended Use sectionshave been merged.The SOMNOscreenprovides sensors foradditional neurologicalmeasurement.The use in life supportsituations was clarified.The differences do notraise concerns in safety oreffectiveness.
Intended PatientPopulation	Adult Patients	Adult Patients	n/a
IntendedEnvironment	The intended environment arethe physician's office, a sleeplaboratory or the patient'shome	The intended environmentare the physician's office, asleep laboratory or thepatient's home	n/a
Prescription Use	Yes	Yes	n/a
Number ofpatients monitoredsimultaneously	1 per Unit	1 per Unit	n/a
Number ofChannels	11 Channels	28 Channels	The 11 channels aresufficient to fulfill theintended use.
Features/TechnicalInformation	SOMNOmedicsSOMNOtouch™ RESP	SOMNOmedicsSOMNOscreen	Discussion of differences
Functions	Recording and processing ofPressure Flow,Thorax/AbdominalRespiratory Effort, SPO2,Snore, Pulse Rate,Plethysmogram, BodyPosition, Movement andPatient Marker for basicrespiration screening orCPAP-titration.	Recording and processingof Pressure Flow.Thorax/AbdominalRespiratory Effort, SPO2,Snore, Pulse Rate,Plethysmogram, BodyPosition, Brightness andPatient Marker for basicrespiration screening orCPAP-titration.Optional:Additional signals for fullPSG recording with orwithout video, 24-hourambulatory EEG recording.stationary EEG-monitoringwith video control or 24-hour ECG and pulseoximetry.	The 11 channels of theSOMNOtouch RESP aresufficient to fulfill theintended use and alreadyextend the basicrequirements for a TypeIII or Type IV HomeSleep Testing deviceThe additional channelsare not required for thediagnosis of sleep-relatedrespiratory disorders.The differences do notraise concerns in safety oreffectiveness.
Portable Design	Yes	Yes	n/a
Size	84 x 55 x 18 mm3( 3.3" x 2.2" x 0.7" )	140 x 70 x 28 mm3( 5.5" x 2.8" x 1.1" )	The SOMNOtouch RESPis smaller, reducing thedisturbance of thepatient's sleep when usingthe device.The differences do notraise concerns in safety oreffectiveness.
Weight	64 grams including battery(2.26 oz.)	220 grams including battery(7.76 oz.)	The reduced weight doesnot raise concerns insafety or effectiveness.
Device Application	Attachment to patient'sthorax using an effort belt	Attachment to patient'sthorax or waist using aneffort belt	Application on the thoraxis the preferred applicationposition. The restriction tothis position does not raiseconcerns in safety oreffectiveness.
Device UserInterface	Power and control buttonsColor Touch DisplayStatus Indication LEDs	Power and control buttonsDot Matrix displayStatus Indication LEDs	The touch display allows amore intuitive interactionwith the user interface.The differences do notraise concerns in safety oreffectiveness.
Data collection	Yes	Yes	n/a
Features/TechnicalInformation	SOMNOmedicsSOMNOtouch™ RESP	SOMNOmedicsSOMNOscreen	Discussion of differences
SelectableMontageConfiguration	Yes	Yes	n/a
Calibration Check	No calibration required.Signal quality check ondevice display possible.	No calibration required.Signal quality check ondevice display possible.	n/a
Sampling method	Analogue to digitalconversation, 12 Bit	Analogue to digitalconversation, 16 Bit	The 12-Bit A/D-converterused to transform theanalogue signals fromeffort sensors and thepressure sensor issufficient to fulfill allspecifications and allows asmaller device size, as it isintegrated in themicrocontroller housing.The change does not affectthe measurement qualitycompared with thepredicate device, as alsoconfirmed within thevalidation described insection 20: PerformanceTesting - Clinical.
Sampling rates	Up to 512 Hz	Up to 512 Hz	n/a
Raw Data Storage	Internal 512MB flash-memory	Compact Flash Card with acapacity up to 512 MB	The integrated memorycard, allows a reducedsize, minimizes errors inhandling with the card andis an improved protectionagainst unauthorizedaccess to data stored onthe memory card.The differences do notraise concerns in safety oreffectiveness.
Radio LANCapabilities forRemote Live Viewof Data	No	Yes	The Live View of Data isrequired for fully attendedsleep testing in the sleeplab. For basic home sleeptesting the live view is notrequired and not relevantfor the predicate device inthat field of usage as well.The differences do notraise concerns in safety oreffectiveness.
Features/TechnicalInformation	SOMNOmedicsSOMNOtouch™ RESP	SOMNOmedicsSOMNOscreen	Discussion of differences
Data interface	Serial data transfer	Serial data transfer	n/a
Transfer method	Docking station	External card reader on PC	The docking station allowsa direct communicationwith the device, preventshandling errors with thememory card, allows tocheck correct transfer ofmontage and patient datato the SOMNOtouchRESP and allows statusindication (i.e. batterystate) directly duringdevice initialization.The differences do notraise concerns in safety oreffectiveness.
Data ReviewDevice	Personal computer	Personal computer	n/a
Operating Systemfor PC Software	Windows 7	PC Windows 2000, XP andWindows 7	Windows 2000 andWindows XP are notsupported by Microsoftanymore and should notbe used in fields withconfidential data (i.e.patient data).The differences do notraise concerns in safety oreffectiveness.
Software	DOMINO light	DOMINO	DOMINO providesadditional features neededfor the additionalSOMNOscreen channelsand options.DOMINO light isoptimized for thefunctionality of theSOMNOtouch within theintended use.The differences do notraise concerns in safety oreffectiveness.
Operating Voltage	3.7 V	3.7V	n/a
Power Source	Li Ion rechargeable battery	Li Ion rechargeable battery	n/a
Features/TechnicalInformation	SOMNOmedicsSOMNOtouch™ RESP	SOMNOmedicsSOMNOscreen	Discussion of differences
Patient isolation	Device has no galvanicconnection to mains, as it isbattery operatedDevice has no galvanicconnection to patientDevice has no galvanicconnection to auxiliarydevices	Device has no galvanicconnection to mains, as it isbattery operated	Reduced connectivity ofthe device minimizes therisk of unintended patientcurrents.The differences do notraise concerns in safety oreffectiveness.
Sensors	Abdomen and thorax effortsensorSpO2 Sensor (NONIN-type)Solid state pressure sensorSolid state activity/positionsensor	Abdomen and thorax effortsensorSpO2 Sensor (NONIN-type)Solid state pressure sensorSolid state position sensorOptional:EEG, EOG, EMG, ECG,Microphone, Thermistor,Activity, Oesophagealpressure	The available sensors ofthe SOMNOtouch RESPare sufficient to fulfill theintended use.The additional sensors arenot required to be used forbasic home sleep testing(Type IV or Type II) withthe SOMNOscreen.The differences do notraise concerns in safety oreffectiveness.
Control	Data acquisition and datastorage are microprocessorcontrolled	Data acquisition and datastorage are microprocessorcontrolled	n/a
Reusable /DisposableComponents withskin contact	Nasal Cannula (Disposable)SpO2 Sensor (Reusable)	Nasal Cannula (Disposable)SpO2 Sensor (Reusable)For PSG Options:Electrodes forEEG/EOG/EMG/ECG(Disposable)Cup Electrodes (reusable)Microphone (reusable)	n/a, same materials/reusetype
Ingress ProtectionRating Device	IP22	IP20	The SOMNOtouch RESPprovides an improvedIngress Protection Rating.The differences do notraise concerns in safety oreffectiveness.
Features/TechnicalInformation	SOMNOmedicsSOMNOtouch™ RESP	SOMNOmedicsSOMNOscreen	Discussion of differences
Standards appliedduring design andperformancetesting	DIN EN 60601-1	DIN EN 60601-1	Since development ofSOMNOscreen thestructure of the IEC 60601standard family (which arethe underlying standardsof the listed DIN EN60601 standards*) hadbeen revised completely.E.g. DIN EN 60601-1-1and 60601-1-4 gotintegrated into DIN EN60601-1.DIN EN 62366 emergedfrom DIN 60601-6, whichwas not listed as anapplied standard forSOMNOscreen but it wasapplied implicitly toensure usability aspects.During the filing ofSOMNOscreen there wasno requirement todemonstrate fulfillment ofusability aspects.In summary it could bestated that certainstandards had beenreorganized whichexplains why DIN EN60601-1-1 and 60601-1-4are no longer supported.Other standards had beenadded as the requirementsand common sense ofadequate development ofsafe and effective medicaldevices rose during thelast years. Finally thestandard related changesdo not lower therequirements in any waybut they raise therequirements and thereforeensure a higher level ofsafety and effectiveness.The extended assessmentof standards does not raiseconcerns regarding safetyor effectiveness
	DIN EN 60601-1-2	DIN EN 60601-1-1
	DIN EN 60601-1-11	DIN EN 60601-1-2
	DIN EN 62366	DIN EN 60601-1-4
	DIN EN ISO 14971	DIN EN ISO 14971
	DIN EN IEC 62304
	ISO 10993-1

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Performance Data from nonclinical Testing: 21 CFR 807 92(b)(1)

A Hazard Analysis, in accordance with DIN EN ISO 14971 was performed to identify and address the design and operation of the SOMNOtouch 100 RESP.

Testing included, but was not limited to, verification in accordance following internationally accepted standards for electrical safety and electromagnetic compatibility

. Medical Electrical Equipment, Part 1: General requirements for Safety, DIN EN 60601-1
Medical Electrical Equipment, Part 1-2: Electromagnetic Compatibility, DIN EN 60601-1-2 .

The SOMNOtouch™ RESP was found to be compliant with the requirements of these standards, no nonconformities have been detected.

Performance testing was conducted to confirm compliance to device specifications. All functions were verified to operate as designed.

The SOMNOtouch™ RESP was found to be compliant with the requirements of these standards for its intended use. All tests had been passed successfully and did not raise new concerns regarding safety and effectiveness of the device.

Performance Data from clinical Testing: 21 CFR 807 92(b)(2)

For determination of the quality of the acquired data, SOMNOtouch™ RESP was evaluated in a clinical study according to the most recent FDA recommendations and US clinical standards. The aim of this study was to assess SOMNOtouch RESPs ability to detect breathing events like hypopnea and apnea during sleep with comparable quality to the results from the predicate device (SOMNOscreen, K060708). The Apnea-Hypopnea Index (AHI) served as underlying measure for the comparison. The statistical evaluation contained regression analysis as well as sensitivity specificity calculation. Severity classification was defined in accordance with the definition of the American Academy of Sleep Medicine.

The study was performed in a professional sleep lab under the supervision of qualified sleep technicians. Data sets were scored manually by different qualified professionals.

Subjects were recruited out of the regular patient collective of the sleep lab where the study was conducted.

During the study no adverse effects and no complications occurred.

The comparison studies found the subject device can be expected to provide safety and effectiveness outcomes substantially equivalent to the predicates.

Conclusion: 21 CFR 807 92(b)(3)

SOMNOmedics SOMNOtouch™ RESP has the same principles of operation and similar technological characteristics as the predicate device SOMNOscreen from SOMNOmedics GmbH. Clinical testing supports substantial equivalence of the clinical performance of the subject and predicate devices.

Based on performance testing, the SOMNOmedics SOMNOtouch™ RESP is substantially equivalent to devices already on the market and presents no new concerns of safety and effectiveness. Additionally, the device has similar indications to the predicate devices and the labeling of the device is consistent both with FDA's guidance as well as current medical practice.

Regulation Number and Section

§ 868.2375 Breathing frequency monitor.

(a)
Identification. A breathing (ventilatory) frequency monitor is a device intended to measure or monitor a patient's respiratory rate. The device may provide an audible or visible alarm when the respiratory rate, averaged over time, is outside operator settable alarm limits. This device does not include the apnea monitor classified in § 868.2377.(b)
Classification. Class II (performance standards).