(302 days)
SOMNOscreen, K060708
Not Found
No
The description focuses on data acquisition, storage, and visualization with manual analysis. There is no mention of automated analysis or algorithms that would typically involve AI/ML. The performance study compares manual scoring to the device's data acquisition capabilities, not an automated diagnostic algorithm.
No
The device is described as a "portable physiological signal recorder" and is indicated for "assisting in the diagnosis of sleep disorders". It records and displays biophysical parameters to aid in diagnosis, but does not autonomously provide treatment or therapy. It also explicitly states, "This device is NOT designed to be used in life support situations".
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is for "assisting in the diagnosis of sleep disorders and sleep related respiratory disorders". The "Device Description" also indicates it is used "to aid in the diagnosis of sleep disorders."
No
The device description explicitly lists multiple hardware components (recording device, finger probe, external effort sensor, effort belts, nasal cannula) in addition to the software.
Based on the provided information, the SOMNOtouch RESP is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- SOMNOtouch RESP Function: The SOMNOtouch RESP is a physiological signal recorder that measures biophysical parameters directly from the patient's body (respiratory effort, SpO2, pulse rate, body position, movement, etc.). It does not analyze specimens taken from the body.
- Intended Use: The intended use is to assist in the diagnosis of sleep disorders by recording and analyzing physiological signals, not by analyzing biological samples.
Therefore, the SOMNOtouch RESP falls under the category of a physiological monitoring device rather than an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes
MNR
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, 2.
-
- the external effort sensor,
- two effort belts to measure thoracic and abdominal expansion, 4.
- న్. 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Thorax, abdomen (via effort belts), finger (for SpO2).
Indicated Patient Age Range
Adult Patients
Intended User / Care Setting
Prescribed for use by a physician in the office, sleep laboratory or patient's home.
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
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.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Nonclinical Testing:
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 and 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.
Clinical Testing:
Study type: Clinical Study for determination of the quality of acquired data.
Key results: 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 comparison studies found the subject device can be expected to provide safety and effectiveness outcomes substantially equivalent to the predicates.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
The statistical evaluation contained regression analysis as well as sensitivity specificity calculation.
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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
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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 ____________________________________________________________________________________________________________________________________________________________________
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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 GmbH |
| Am Sonnenstuhl 63 | |
| 97236 Randersacker | |
| Germany | |
| 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 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, 2.
-
- the external effort sensor,
- two effort belts to measure thoracic and abdominal expansion, 4.
- న్. 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.
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/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 concerns in safety or
effectiveness. |
| Data Review
Device | Personal computer | Personal computer | n/a |
| Operating System
for PC Software | Windows 7 | PC Windows 2000, XP and
Windows 7 | Windows 2000 and
Windows XP are not
supported by Microsoft
anymore and should not
be used in fields with
confidential data (i.e.
patient data).
The differences do not
raise concerns in safety or
effectiveness. |
| Software | DOMINO light | DOMINO | DOMINO provides
additional features needed
for the additional
SOMNOscreen channels
and options.
DOMINO light is
optimized for the
functionality of the
SOMNOtouch within the
intended use.
The differences do not
raise concerns in safety or
effectiveness. |
| Operating Voltage | 3.7 V | 3.7V | n/a |
| Power Source | Li Ion rechargeable battery | Li Ion rechargeable battery | n/a |
| Features/Technical
Information | SOMNOmedics
SOMNOtouch™ RESP | SOMNOmedics
SOMNOscreen | Discussion of differences |
| Patient isolation | Device has no galvanic
connection to mains, as it is
battery operated
Device has no galvanic
connection to patient
Device has no galvanic
connection to auxiliary
devices | Device has no galvanic
connection to mains, as it is
battery operated | Reduced connectivity of
the device minimizes the
risk of unintended patient
currents.
The differences do not
raise concerns in safety or
effectiveness. |
| Sensors | Abdomen and thorax effort
sensor
SpO2 Sensor (NONIN-type)
Solid state pressure sensor
Solid state activity/position
sensor | Abdomen and thorax effort
sensor
SpO2 Sensor (NONIN-
type)
Solid state pressure sensor
Solid state position sensor
Optional:
EEG, EOG, EMG, ECG,
Microphone, Thermistor,
Activity, Oesophageal
pressure | The available sensors of
the SOMNOtouch RESP
are sufficient to fulfill the
intended use.
The additional sensors are
not required to be used for
basic home sleep testing
(Type IV or Type II) with
the SOMNOscreen.
The differences do not
raise concerns in safety or
effectiveness. |
| Control | Data acquisition and data
storage are microprocessor
controlled | Data acquisition and data
storage are microprocessor
controlled | n/a |
| Reusable /
Disposable
Components with
skin contact | Nasal Cannula (Disposable)
SpO2 Sensor (Reusable) | Nasal Cannula (Disposable)
SpO2 Sensor (Reusable)
For PSG Options:
Electrodes for
EEG/EOG/EMG/ECG
(Disposable)
Cup Electrodes (reusable)
Microphone (reusable) | n/a, same materials/reuse
type |
| Ingress Protection
Rating Device | IP22 | IP20 | The SOMNOtouch RESP
provides an improved
Ingress Protection Rating.
The differences do not
raise concerns in safety or
effectiveness. |
| Features/Technical
Information | SOMNOmedics
SOMNOtouch™ RESP | SOMNOmedics
SOMNOscreen | Discussion of differences |
| Standards applied
during design and
performance
testing | DIN EN 60601-1 | DIN EN 60601-1 | Since development of
SOMNOscreen the
structure of the IEC 60601
standard family (which are
the underlying standards
of the listed DIN EN
60601 standards*) had
been revised completely.
E.g. DIN EN 60601-1-1
and 60601-1-4 got
integrated into DIN EN
60601-1.
DIN EN 62366 emerged
from DIN 60601-6, which
was not listed as an
applied standard for
SOMNOscreen but it was
applied implicitly to
ensure usability aspects.
During the filing of
SOMNOscreen there was
no requirement to
demonstrate fulfillment of
usability aspects.
In summary it could be
stated that certain
standards had been
reorganized which
explains why DIN EN
60601-1-1 and 60601-1-4
are no longer supported.
Other standards had been
added as the requirements
and common sense of
adequate development of
safe and effective medical
devices rose during the
last years. Finally the
standard related changes
do not lower the
requirements in any way
but they raise the
requirements and therefore
ensure a higher level of
safety and effectiveness.
The extended assessment
of standards does not raise
concerns regarding safety
or 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.