Who is the manufacturer of SOMNOTOUCH RESP?

Somnomedics GmbH filed the 510(k) submission for SOMNOTOUCH RESP (K140861).

What is the FDA product code for SOMNOTOUCH RESP?

MNR. It is classified under 21 CFR 868.2375 as a Class 2 device in the Anesthesiology panel.

What is the regulatory pathway for SOMNOTOUCH RESP?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like SOMNOTOUCH RESP?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

SOMNOTOUCH RESP

K140861 · Somnomedics GmbH · MNR · Jan 30, 2015 · Anesthesiology

Device Facts

Record ID	K140861
Device Name	SOMNOTOUCH RESP
Applicant	Somnomedics GmbH
Product Code	MNR · Anesthesiology
Decision Date	Jan 30, 2015
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 868.2375
Device Class	Class 2

Intended Use

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 Story

Portable physiological signal recorder; worn on thorax via belt. Inputs: thoracic/abdominal respiratory effort (belts), SpO2/pulse rate (finger probe), respiratory flow/snore (nasal cannula), body position/motion (internal accelerometer). Data stored on internal 512MB flash memory; transferred via USB docking station to PC. Used in physician office, sleep lab, or home; operated by physician or patient. DOMINOlight software on PC displays/analyzes data for clinician review. Assists diagnosis of sleep-related respiratory disorders; does not provide automatic diagnosis. Benefits patient by enabling ambulatory sleep monitoring.

Clinical Evidence

Clinical study compared SOMNOtouch RESP to predicate (SOMNOscreen) in a professional sleep lab. Evaluated ability to detect apnea/hypopnea events. Primary endpoint: Apnea-Hypopnea Index (AHI). Analysis included regression, sensitivity, and specificity calculations. Results demonstrated substantial equivalence to predicate; no adverse effects or complications reported.

Technological Characteristics

Portable device, 84x55x18mm, 64g. 10 internal channels, 1 external channel. 12-bit ADC, sampling rates 1/60s to 512/s. Powered by 3.7V Li-Ion rechargeable battery. Connectivity: USB docking station. Standards: DIN EN 60601-1, DIN EN 60601-1-2, DIN EN 60601-1-11, DIN EN 62366, DIN EN ISO 14971, DIN EN IEC 62304, ISO 10993-1. IP22 rating.

Indications for Use

Indicated for adult patients suspected of having sleep disorders or sleep-related respiratory disorders. Not for use in life support situations.

Regulatory Classification

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.

Predicate Devices

SOMNOscreen (K060708)

Related Devices

K220631 — NomadAir PMU810 · Neurotronics, Inc. · Jul 15, 2022
K071556 — SOMNOSCREEN EEG10-20 · Somnomedics GmbH · Jul 18, 2007
K060708 — SOMNOSCREEN · Somnomedics GmbH & Co. KG · Jan 24, 2007
K041724 — COMPASS M10 SYSTEM · Medcare Flaga · Sep 28, 2004
K110064 — SNAP MODEL 8 SNORING AND APNEA RECORDING AND ANALYSIS SYSTEM · Snap Diagnostics, LLC · Mar 18, 2011

Submission Summary (Full Text)

{0}------------------------------------------------ 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. {1}------------------------------------------------ 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 {2}------------------------------------------------ # Indications for Use 510(k) Number (if known): K140861 Device Name: SOMNOtouch™ RESP Indications For Use: 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. 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 ____________________________________________________________________________________________________________________________________________________________________ {3}------------------------------------------------ # 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 GmbH Am Sonnenstuhl 63 97236 Randersacker Germany | | Classification Product Code: | MNR | | Decision Date: | 01/24/2007 | | Classification Advisory Committee: | Anesthesiology | {4}------------------------------------------------ # Device Description: 21 CFR 807 92(a)(4) 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: - 1. The recording device (worn on the thorax), - the finger probe, which is used to detect SpO2, 2. - 3. the external effort sensor, - two effort belts to measure thoracic and abdominal expansion, 4. - న్. the nasal cannula. - 6. 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. ## 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." {5}------------------------------------------------ # 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/Technical Information | SOMNOmedics SOMNOtouch™ RESP | SOMNOmedics SOMNOscreen | Discussion of differences | |------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 510(k) number | Not assigned | K060708 | n/a | | Product code | MNR | MNR | n/a | | Indications for Use | 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. | 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. | Indications for use and Intended Use sections have been merged. The use in life support situations was clarified. The differences do not raise concerns in safety or effectiveness. | | Features/Technical Information | SOMNOmedics SOMNOtouch™ RESP | SOMNOmedics SOMNOscreen | Discussion of differences | | Intended Use | 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. | 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. | Indications for use and Intended Use sections have been merged. The SOMNOscreen provides sensors for additional neurological measurement. The use in life support situations was clarified. The differences do not raise concerns in safety or effectiveness. | | Intended Patient Population | Adult Patients | Adult Patients | n/a | | Intended Environment | The intended environment are the physician's office, a sleep laboratory or the patient's home | The intended environment are the physician's office, a sleep laboratory or the patient's home | n/a | | Prescription Use | Yes | Yes | n/a | | Number of patients monitored simultaneously | 1 per Unit | 1 per Unit | n/a | | Number of Channels | 11 Channels | 28 Channels | The 11 channels are sufficient to fulfill the intended use. | | Features/Technical Information | SOMNOmedics SOMNOtouch™ RESP | SOMNOmedics SOMNOscreen | Discussion of differences | | Functions | Recording and processing of Pressure Flow, Thorax/Abdominal Respiratory Effort, SPO2, Snore, Pulse Rate, Plethysmogram, Body Position, Movement and Patient Marker for basic respiration screening or CPAP-titration. | Recording and processing of Pressure Flow. Thorax/Abdominal Respiratory Effort, SPO2, Snore, Pulse Rate, Plethysmogram, Body Position, Brightness and Patient Marker for basic respiration screening or CPAP-titration. Optional: Additional signals for full PSG recording with or without video, 24-hour ambulatory EEG recording. stationary EEG-monitoring with video control or 24- hour ECG and pulse oximetry. | The 11 channels of the SOMNOtouch RESP are sufficient to fulfill the intended use and already extend the basic requirements for a Type III or Type IV Home Sleep Testing device The additional channels are not required for the diagnosis of sleep-related respiratory disorders. The differences do not raise concerns in safety or effectiveness. | | 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 RESP is smaller, reducing the disturbance of the patient's sleep when using the device. The differences do not raise concerns in safety or effectiveness. | | Weight | 64 grams including battery (2.26 oz.) | 220 grams including battery (7.76 oz.) | The reduced weight does not raise concerns in safety or effectiveness. | | Device Application | Attachment to patient's thorax using an effort belt | Attachment to patient's thorax or waist using an effort belt | Application on the thorax is the preferred application position. The restriction to this position does not raise concerns in safety or effectiveness. | | Device User Interface | Power and control buttons Color Touch Display Status Indication LEDs | Power and control buttons Dot Matrix display Status Indication LEDs | The touch display allows a more intuitive interaction with the user interface. The differences do not raise concerns in safety or effectiveness. | | Data collection | Yes | Yes | n/a | | Features/Technical Information | SOMNOmedics SOMNOtouch™ RESP | SOMNOmedics SOMNOscreen | Discussion of differences | | Selectable Montage Configuration | Yes | Yes | n/a | | Calibration Check | No calibration required. Signal quality check on device display possible. | No calibration required. Signal quality check on device display possible. | n/a | | Sampling method | Analogue to digital conversation, 12 Bit | Analogue to digital conversation, 16 Bit | The 12-Bit A/D-converter used to transform the analogue signals from effort sensors and the pressure sensor is sufficient to fulfill all specifications and allows a smaller device size, as it is integrated in the microcontroller housing. The change does not affect the measurement quality compared with the predicate device, as also confirmed within the validation described in section 20: Performance Testing - Clinical. | | Sampling rates | Up to 512 Hz | Up to 512 Hz | n/a | | Raw Data Storage | Internal 512MB flash-memory | Compact Flash Card with a capacity up to 512 MB | The integrated memory card, allows a reduced size, minimizes errors in handling with the card and is an improved protection against unauthorized access to data stored on the memory card. The differences do not raise concerns in safety or effectiveness. | | Radio LAN Capabilities for Remote Live View of Data | No | Yes | The Live View of Data is required for fully attended sleep testing in the sleep lab. For basic home sleep testing the live view is not required and not relevant for the predicate device in that field of usage as well. The differences do not raise concerns in safety or effectiveness. | | Features/Technical Information | SOMNOmedics SOMNOtouch™ RESP | SOMNOmedics SOMNOscreen | 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 allows a direct communication with the device, prevents handling errors with the memory card, allows to check correct transfer of montage and patient data to the SOMNOtouch RESP and allows status indication (i.e. battery state) directly during device initialization. The differences do not raise…