Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes signal processing and calibration techniques (Quantitative Diagnostic Calibration) but does not mention AI or ML. The processing appears to be based on established physiological signal analysis methods.

Therapeutic

No

The device is a sensor unit intended for measuring physiological signals during sleep, processing them, and providing the resulting signals for acquisition by a third-party polysomnography (PSG)/sleep recorder. It is indicated for diagnosis of various sleep disorders, not for treatment.

Diagnostic

Yes
The device is described as "a part of a full PSG, the gold standard sleep study, and its main objectives is to provide signals used for diagnoses of sleep disordered breathing (SDB)." While it provides signals to a 3rd party system for acquisition, it is specifically indicated to "provide signals used for diagnoses of sleep disordered breathing (SDB)," making it integral to the diagnostic process.

SaMD (Software as a Medical Device)

No

The device description explicitly states that the QDC-PRO device contains a sensor unit, respiratory effort sensors (RIP belts), and cables, and is worn by the patient. It also mentions being powered by a battery and having a display and buttons. These are all hardware components, indicating it is not a software-only device.

IVD (In Vitro Diagnostic)

Based on the provided information, the QDC-PRO device is not an In Vitro Diagnostic (IVD).

Here's why:

IVDs are used to examine specimens derived from the human body. The QDC-PRO device measures physiological signals directly from the patient's body (respiratory effort, position, activity, audio, nasal pressure, snore). It does not analyze samples like blood, urine, or tissue.
The intended use is for measuring physiological signals during sleep for diagnosis of sleep disorders. This is a direct measurement of bodily functions, not an analysis of a biological sample.
The device functions as an accessory to a PSG system. PSG is a clinical diagnostic tool that measures various physiological parameters during sleep. The QDC-PRO contributes to this measurement process by providing specific signals.

Therefore, the QDC-PRO device falls under the category of a medical device used for physiological monitoring and diagnosis, but not specifically an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The QDC-PRO device is a sensor unit intended for measuring of physiological signals during sleep. The signals measured are processed in the QDC-PRO device and the resulting signals made available at the output connector for acquisition by a 3rd party polysomnography (PSG)/sleep recorder.

The QDC-PRO device is indicated for use in patients greater than 2 years of age.

The intended environments are hospitals, institutions, sleep centers, sleep clinics, or other test environments.

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

MNR

Device Description

The ODC-PRO device is intended to function as an accessory for 3rd party PSG systems, delivering the respiratory signals needed in PSG studies along with position/activity signals.

Polysomnography (PSG) is a multi-parametric sleep study indicated for diagnosis of various sleep disorders. The ODC-PRO is therefore a part of a full PSG, the gold standard sleep study, and its main objectives is to provide signals used for diagnoses of sleep disordered breathing (SDB).

The signals measured by the ODC-PRO are provided as analog signals to a general 3rd party PSG amplifier that has DC inputs with characteristics matching the QDC-PRO device signal output specifications.

The output signals include:

Abdomen respiratory effort (RIP) .
. Thorax respiratory effort (RIP)
. SUM of abdomen and thorax respiratory effort (RIP)
Nasal pressure from nasal cannula .
Snore signal from nasal cannula .
. Body position
. Activity
Audio .

The respiratory effort is measured by the use of respiratory inductive plethysmography (RIP).

The QDC-PRO device provides calibration for the RIP signals by the use of Quantitative Diagnostic Calibration (QDC) technique. The calibrated RIP signals (Sum) represents the tidal volume of the respiration better than un-calibrated RIP signals.

The QDC-PRO contains a sensor unit, respiratory effort sensors (RIP belts) and cables. The QDC-PRO is worn by the patient. It measures signals from two respiratory effort sensors, audio via an inbuilt microphone, nasal pressure and snoring via a nasal cannula and patient 's position/activity data. The signals are processed within the device and the resulting signals made available at the output connector for acquisition by a 3rd party polysomnography (PSG)/sleep recorder.

The QDC-PRO is powered with one AA (1.5V) battery and has a display for status indication, signal integrity, and buttons for control.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

greater than 2 years of age

Intended User / Care Setting

hospitals, institutions, sleep centers, sleep clinics, or other test environments.

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Thorough internal and external testing has demonstrated that the QDC-PRO device is effective and safe for its intended use.

The ODC-PRO device complies with the applicable EMC and patient safety standards:

IEC60601-1:2007 Medical electrical equipment Part 1-2: General requirements for . basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests
AAMI/ ANSI ES60601-1:2005 Medical electrical equipment Part 1: General . requirements for basic safety and essential performance (IEC 60601-1).

The software in the QDC-PRO device was developed in compliance with the requirements listed in the standard: IEC62304 - Medical Device Software - Software Life Cycle Processes, which provides a framework of life cycle processes with activities and tasks necessary for the safe design and maintenance of medical device software, including testing, verification and validation.

The design of the QDC-PRO device was tested, verified and validated throughout the design process according to requirement specifications and intended use.

Risk analysis was performed according to the standard: ISO14971 - Medical devices -Application of risk management to medical devices, appropriate measures was implemented and their effectiveness verified and validated.

Signal comparison tests conducted for the QDC-PRO device confirm the quality of the signals being measured by the device. The results demonstrate that the QDC-PRO signals may be regarded as clinically equivalent to that of the predicates Respitrace QDC and NOX T3.

Quantitative Diagnostic Calibration (QDC) function comparison tests conclude that the QDC-PRO performance may be regarded as clinically equivalent to that of the predicate Respitrace QDC.

Usability testing compliant with the standard: IEC 62366 - Medical devices - Application of usability engineering to medical devices, demonstrates that the QDC-PRO device is simple and safe to operate and minimizes the likelihood of errors and lapses.

Clinical evaluation for the ODC-PRO device concludes that all of the signals measured and processed by the device are comparable to the already validated and publicly available Respitrace QDC and Nox T3 device, respectively.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K082113, K903011

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 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).

Summary

0

510(k) Summary

JUL 1 0 2013

Submitter

Nox Medical Vatnagordum 18 IS-104 Reykjavik Iceland

Tel: +354 570 7170

Establishment Registration Number: 3007389703

Contact person

Kolbrun E Ottosdottir Vatnagordum 18 IS-104 Reykjavik Iceland Email: keo@noxmedical.com Direct tel: +354 698 3555

Preparation Date

December 24, 2012

Trade Name:

Device

ODC-PRO

Common Name: Classification Name: Requlation Number: Product Code: Device Class: Classification Panel:

Respiratory Sensor Unit Ventilatory Effort Recorder 868.2375 MNR Class II Anesthesiology

Predicate Devices

NOX T3 from Nox Medical Product Code: MNR 510(k) Number: K082113

Respitrace QDC from SensorMedics Corporation Product Code: BZQ 510(k) Number: K903011

1

Device Description

The ODC-PRO device is intended to function as an accessory for 3rd party PSG systems, delivering the respiratory signals needed in PSG studies along with position/activity signals.

Polysomnography (PSG) is a multi-parametric sleep study indicated for diagnosis of various sleep disorders. The ODC-PRO is therefore a part of a full PSG, the gold standard sleep study, and its main objectives is to provide signals used for diagnoses of sleep disordered breathing (SDB).

The signals measured by the ODC-PRO are provided as analog signals to a general 3rd party PSG amplifier that has DC inputs with characteristics matching the QDC-PRO device signal output specifications.

The output signals include:

Abdomen respiratory effort (RIP) .
. Thorax respiratory effort (RIP)
. SUM of abdomen and thorax respiratory effort (RIP)
Nasal pressure from nasal cannula .
Snore signal from nasal cannula .
. Body position
. Activity
Audio .

The respiratory effort is measured by the use of respiratory inductive plethysmography (RIP).

The QDC-PRO device provides calibration for the RIP signals by the use of Quantitative Diagnostic Calibration (QDC) technique. The calibrated RIP signals (Sum) represents the tidal volume of the respiration better than un-calibrated RIP signals.

The QDC-PRO contains a sensor unit, respiratory effort sensors (RIP belts) and cables. The QDC-PRO is worn by the patient. It measures signals from two respiratory effort sensors, audio via an inbuilt microphone, nasal pressure and snoring via a nasal cannula and patient 's position/activity data. The signals are processed within the device and the resulting signals made available at the output connector for acquisition by a 3rd party polysomnography (PSG)/sleep recorder.

The QDC-PRO is powered with one AA (1.5V) battery and has a display for status indication, signal integrity, and buttons for control.

2

Intended Use

The QDC-PRO device is a sensor unit intended for measuring of physiological signals during sleep. The signals measured are processed in the QDC-PRO device and the resulting signals made available at the output connector for acquisition by a 3rd party polysomnography (PSG)/sleep recorder.

The QDC-PRO device is indicated for use in patients greater than 2 years of age.

The intended environments are hospitals, institutions, sleep clinics, or other test environments.

Technological Characteristics

The comparison table below is provided as a summary of the most relevant characteristics of the QDC-PRO device relative to the predicate devices. The comparison table demonstrates that the QDC-PRO device has no significant differences from the predicate devices for the intended use that would adversely affect product safety and effectiveness.

3

Characteristic	NOX T3	RESPITRACE QDC	QDC - PRO
	(K082113)	(K903011)
		General
Intended Use	The Nox T3 device is intended
for ambulatory recording of
physiological signals during
sleep. The recorded signals
are then downloaded to a PC
where the signals can be
viewed and analyzed by use of
the Nox T3 application
(Noxturnal).	The RESPITRACE QDC multi-
channel waveform generator
is indicated for diagnostic
polysomnograpy. This device
generates respiratory
waveforms from RESPITRACE
technology.	The QDC-PRO device is a
sensor unit intended for
measuring of physiological
signals during sleep. The
signals measured are
processed in the QDC-PRO
device and the resulting
signals made available at the
output connector for
acquisition by a 3rd party
Polysomnography (PSG)/sleep
recorder.
Contraindication
for Use	The Nox T3 system is NOT
intended for any patient
monitoring or automatic
diagnosis.	Not defined in labeling	The ODC-PRO device is NOT
intended for any patient
monitoring.
Intended
Environments	The intended environments
are hospitals, institutions,
sleep centers, sleep clinics, or
other test environments,
including patient's home.	Not defined in labeling	The intended environments
are hospitals, institutions,
sleep centers, sleep clinics, or
other test environments.
Patient
Population	The Nox T3 system is
indicated for use in patients
greater than 2 years of age	Not defined in labeling	The QDC-PRO device is
indicated for use in patients
greater than 2 years of age.
Prescription Use	Yes	Yes	Yes
		Physical/Material
Material Case	ABS/PC	Painted metal housing	PC with 10% glass fiber
Material Device
Clips	Polyester/Steel	Not defined in labeling	Polyester/Steel
Material RIP
connection
cable	PVC and ABS/PC	Not defined in labeling	PVC and ABS/PC
RIP Belts
Material	Polyester/Dorlastan, latex free	Not defined in labeling	Polyester/Dorlastan, latex free
Dimension	79mm (3.11") W
63mm (2.48")H
21mm(0.83") D	195mm (76.8") W
275mm (108.3") H
110mm(43.3") D	83mm (3.27") W
63mm (2.48")H
21mm(0.83") D
Weight	65g	2000g	71g
Disposable
Components	Disposable respiratory effort
sensor/RIP belts.
Filter tube connector
Remaining portions require
cleaning.	Disposable respiratory effort
sensor/RIP belts.
Remaining components
require cleaning.	Disposable respiratory effort
sensor/RIP belts.
Remaining portions require
cleaning.
Acquisition
units	One unit	One unit	One unit
	Functional
Number of
channels	Eight channels.	Three channels.	Eight channels.

Table 1 Comparison Summary of the New Device (QDC-PRO) and Predicate Devices

4

| Characteristic | NOX T3
(K082113) | RESPITRACE QDC
(K903011) | QDC - PRO |
|-------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Operation time | 24 hours (depending on
batteries) | Undefined (mains operated) | 8 hours or longer (depending
on batteries) |
| Data Acquisition
Control | Data acquisition
microprocessor controlled | Not defined in labeling | Data acquisition
microprocessor controlled |
| Acquisition
parameter
Control | Acquisition parameters set
from application SW | Acquisition parameters
controlled from the device
software only | Acquisition parameters
controlled from the device
software only |
| Calibration of
RIP | No | Yes | Yes |
| Device Data
Storage | Yes | No | No |
| Data Interface | Via USB connection to PC | Via analog interface to 3rd
party sleep system
Via serial port to PC | Via analog interface to 3rd
party sleep system |
| Firmware
upgrade | Via USB connection to PC | Not defined in labeling | Via USB connection to PC |
| Connection to
Patient | RIP belts for respiratory effort
RIP belts for attaching of
device and clip straps to
secure position of device
Plastic tubing and cannula for
pressure measurement
Probes or Flexi Wrap for
oximetry
Touch proof electrode cables | RIP belts for respiratory effort | RIP belts for respiratory effort
RIP belts for attaching of
device and clip straps to
secure position of device
Cannula for pressure
measurement |
| Signals and Sensors | | | |

・

.

5

| Characteristic | NOX T3
(K082113) | RESPITRACE QDC
(K903011) | QDC - PRO |
|-------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------|
| Signals outputs | Respiratory Effort (Abdomen
and Thorax) | Respiratory Effort (Abdomen
and Thorax) - calibrated
RIP SUM | Respiratory Effort (Abdomen
and Thorax) - calibrated
RIP SUM |
| | RIP SUM
Body position
Activity
Nasal /mask pressure
Airflow
Snore
Respiratory sound/audio
Oxygen Saturation
Pulse
EEG, EOG, EMG, ECG | | Body position
Activity
Nasal pressure
Snore
Respiratory sound /Audio
intensity |
| Sensor
Technology
used in/with
the system | Solid state position/activity
sensor
Respiratory Effort Sensors
(RIP technology)
Microphone
Solid state pressure sensor
Oximetry
Gold cup electrodes
Ag/AgCL electrodes | Respiratory Effort Sensors
(RIP technology) | Solid state position/activity
sensor
Respiratory Effort Sensors
(RIP technology)
Microphone
Solid state pressure sensor |
| | | Power and Isolation | |
| Power Source | 1.5V by 1 AA battery (Data
Acquisition)
Host PC (Data Transfer) | 115/230V AC (Data
Acquisition) | 1.5V by 1 AA battery (Data
Acquisition)
Host PC (FW upgrade) |
| Galvanic
Connection to
mains/Patient
Isolation | Device has no galvanic
connections to mains as it is a
battery operated device
Not possible to connect
auxiliary devices to the device | Yes via connection over mains
operated 3rd party amplifier
Isolation between mains and
applied part
Via isolation mains adapter
(mains operated) | Yes via connection over mains
operated 3rd party amplifier
Isolation between mains and
applied part |
| | | User Interface | |
| Data validation | The device has a display to
view signal integrity and
status of the device | No | The device has a display to
view signal integrity and
status of the device |
| Control on
device | Push buttons | On/off button | Push buttons |
| | | Standards | |
| IEC60601-1 or
equivalent FDA
recognized
standard | Yes | Yes | Yes |
| IEC60601-1-2
or equivalent
FDA recognized
standard | Yes | Yes | Yes |

6

Performance Testing Summary

Thorough internal and external testing has demonstrated that the QDC-PRO device is effective and safe for its intended use.

The ODC-PRO device complies with the applicable EMC and patient safety standards:

IEC60601-1:2007 Medical electrical equipment Part 1-2: General requirements for . basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests
AAMI/ ANSI ES60601-1:2005 Medical electrical equipment Part 1: General . requirements for basic safety and essential performance (IEC 60601-1).

The software in the QDC-PRO device was developed in compliance with the requirements listed in the standard: IEC62304 - Medical Device Software - Software Life Cycle Processes, which provides a framework of life cycle processes with activities and tasks necessary for the safe design and maintenance of medical device software, including testing, verification and validation.

The design of the QDC-PRO device was tested, verified and validated throughout the design process according to requirement specifications and intended use.

Risk analysis was performed according to the standard: ISO14971 - Medical devices -Application of risk management to medical devices, appropriate measures was implemented and their effectiveness verified and validated.

Signal comparison tests conducted for the QDC-PRO device confirm the quality of the signals being measured by the device. The results demonstrate that the QDC-PRO signals may be regarded as clinically equivalent to that of the predicates Respitrace QDC and NOX T3.

Quantitative Diagnostic Calibration (QDC) function comparison tests conclude that the QDC-PRO performance may be regarded as clinically equivalent to that of the predicate Respitrace QDC.

Usability testing compliant with the standard: IEC 62366 - Medical devices - Application of usability engineering to medical devices, demonstrates that the QDC-PRO device is simple and safe to operate and minimizes the likelihood of errors and lapses.

Clinical evaluation for the ODC-PRO device concludes that all of the signals measured and processed by the device are comparable to the already validated and publicly available Respitrace QDC and Nox T3 device, respectively.

7

Conclusion

Based on the testing, risk analysis, verification and validation activates described above and Besed on the essang, how analysis) - chivices provided in Table 1 above, it is the conclusion of Nox Medical that the QDC-PRO device is substantially equivalent to the predicates NOX T3 from Nox Medical (K082113) and Respitrace QDC from SensorMedics Corporation (K903011) and presents no new concerns about safety and effectiveness.

8

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

July 10, 2013

Nox Medical C/O Ms. Kolbrun E. Ottosdottir Quality/Regulatory Manager Katrinartuni 2 Reykjavik, Iceland IS-105

Re: K124062

・

Trade/Device Name: QDC-PRO Regulation Number: 21 CFR 868.2375 Regulation Name: Ventilatory Effort Recorder Regulatory Class: II Product Code: MNR Dated: June 5, 2013 Received: June 10, 2013

Dear Ms. Ottosdottir:

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 10 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. Ilsting 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 cither 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.

9

Page 2 - Ms. Ottosdottir

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 of medical devicerelated 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 Small Manufacturers, International and Consumer Assistance at its tollfree 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.hun 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 Small Manufacturers, International and Consumer Assistance 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.

Kwame Ulmer, M.S Acting Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

10

Indication for Use

510(k) Number (if known): Kl24062

Device Name: QDC-PRO

Indications For Use:

The QDC-PRO device is a sensor unit intended for measuring of physiological signals during sleep. The signals measured are processed in the QDC-PRO device and the resulting signals made available at the output connector for acquisition by a 3rd party polysomnography (PSG)/sleep recorder.

The QDC-PRO device is indicated for use in patients greater than 2 years of age.

The intended environments are hospitals, institutions, sleep centers, sleep clinics, or other test environments.

× Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use_ (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Anya C. Harry

Digitally signed by	Anya C. Harry
DN: c=US, o=U.S. Government, ou=HHS,
ou=FDA, ou=People, cn=Anya C. Harry,
0.9.2342.19200300.100.1.1=0011315590
Date:	2013.07.09 16:24:57 -04'00'

Page 1 of 1

(Division Sign-Off) (Division Sign-Oil)
Division of Anesthesio:ogy, General Hospital Infection Control, Dental Devices

510(k) Number: K124062