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.

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.

AI/ML Overview

The provided 510(k) summary for the QDC-PRO device does not contain a specific table of acceptance criteria with reported device performance metrics in the format usually associated with clinical performance studies. Instead, it focuses on demonstrating substantial equivalence to predicate devices through technical characteristics and a general summary of performance testing.

However, based on the provided text, we can infer the acceptance criteria for signal quality and the overall conclusion regarding device performance.

1. Table of Acceptance Criteria and Reported Device Performance

Characteristic / Acceptance Criteria	Reported Device Performance
Signal Quality (General)	"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 Performance	"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."
Safety and Effectiveness	"Thorough internal and external testing has demonstrated that the QDC-PRO device is effective and safe for its intended use." "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." (FDA's substantial equivalence finding supports this.)
Compliance with Standards	"The ODC-PRO device complies with the applicable EMC and patient safety standards: IEC60601-1:2007 (Basic safety and essential performance), AAMI/ ANSI ES60601-1:2005 (Basic safety and essential performance), IEC62304 (Medical Device Software), ISO14971 (Risk Management), IEC 62366 (Usability Engineering)."
Usability	"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."

2. Sample Size Used for the Test Set and Data Provenance

The summary states that "Signal comparison tests" and "Quantitative Diagnostic Calibration (QDC) function comparison tests" were conducted, as well as "Clinical evaluation". However, it does not specify the sample size used for these test sets (e.g., number of patients, number of studies).

The data provenance is not explicitly stated as retrospective or prospective, nor are the specific countries of origin for the data provided. The overall context suggests internal testing and evaluation conducted by Nox Medical, with clinical evaluation comparing to publicly available data from predicate devices.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The document does not specify the number of experts or their qualifications used to establish ground truth for any test sets. The "clinical evaluation" mentions that signals were "comparable to the already validated and publicly available Respitrace QDC and Nox T3 device, respectively," implying a comparison to established performance of predicate devices rather than independent expert ground truth for novel data.

4. Adjudication Method for the Test Set

The document does not mention any adjudication method (e.g., 2+1, 3+1, none) for a test set.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done with human readers. The clinical evaluation focused on comparing the device's signals to those of predicate devices, not on assessing human reader performance with or without AI assistance.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

Yes, the studies described are analogous to standalone performance studies for the device's signal acquisition and processing capabilities. The signal comparison and QDC function comparison tests assess the direct output of the QDC-PRO device against established benchmarks (predicate devices), without involving human interpretation as part of the core performance measurement against a ground truth. The device is a "sensor unit" providing output signals for a 3rd party PSG system, so its primary performance is in accurate signal generation.

7. The Type of Ground Truth Used

The ground truth used for performance validation was primarily:

Established performance of predicate devices: The QDC-PRO's signals and QDC function were deemed "clinically equivalent" to those of the Respitace QDC and NOX T3. This implies that the performance of these legally marketed predicate devices serves as the benchmark or "ground truth" for comparison.
Compliance with recognized standards: The device's safety, software development, risk management, and usability were validated against relevant IEC, AAMI/ANSI, and ISO standards.

8. The Sample Size for the Training Set

The document does not provide any information regarding a training set sample size. Given that this is a sensor unit that produces physiological signals, it is unlikely to involve "training" in the machine learning sense that would require a distinct training set (beyond perhaps internal calibration data or development data which are not specified). The focus is on the accuracy of the physical measurements and signal processing.

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

As no training set is mentioned or implied in the context of machine learning, there is no information on how ground truth for a training set was established.

Summary

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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

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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.

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

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Intended Use

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.

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Characteristic	NOX T3	RESPITRACE QDC	QDC - PRO
	(K082113)	(K903011)
		General
Intended Use	The Nox T3 device is intendedfor ambulatory recording ofphysiological signals duringsleep. The recorded signalsare then downloaded to a PCwhere the signals can beviewed and analyzed by use ofthe Nox T3 application(Noxturnal).	The RESPITRACE QDC multi-channel waveform generatoris indicated for diagnosticpolysomnograpy. This devicegenerates respiratorywaveforms from RESPITRACEtechnology.	The QDC-PRO device is asensor unit intended formeasuring of physiologicalsignals during sleep. Thesignals measured areprocessed in the QDC-PROdevice and the resultingsignals made available at theoutput connector foracquisition by a 3rd partyPolysomnography (PSG)/sleeprecorder.
Contraindicationfor Use	The Nox T3 system is NOTintended for any patientmonitoring or automaticdiagnosis.	Not defined in labeling	The ODC-PRO device is NOTintended for any patientmonitoring.
IntendedEnvironments	The intended environmentsare hospitals, institutions,sleep centers, sleep clinics, orother test environments,including patient's home.	Not defined in labeling	The intended environmentsare hospitals, institutions,sleep centers, sleep clinics, orother test environments.
PatientPopulation	The Nox T3 system isindicated for use in patientsgreater than 2 years of age	Not defined in labeling	The QDC-PRO device isindicated for use in patientsgreater 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 DeviceClips	Polyester/Steel	Not defined in labeling	Polyester/Steel
Material RIPconnectioncable	PVC and ABS/PC	Not defined in labeling	PVC and ABS/PC
RIP BeltsMaterial	Polyester/Dorlastan, latex free	Not defined in labeling	Polyester/Dorlastan, latex free
Dimension	79mm (3.11") W63mm (2.48")H21mm(0.83") D	195mm (76.8") W275mm (108.3") H110mm(43.3") D	83mm (3.27") W63mm (2.48")H21mm(0.83") D
Weight	65g	2000g	71g
DisposableComponents	Disposable respiratory effortsensor/RIP belts.Filter tube connectorRemaining portions requirecleaning.	Disposable respiratory effortsensor/RIP belts.Remaining componentsrequire cleaning.	Disposable respiratory effortsensor/RIP belts.Remaining portions requirecleaning.
Acquisitionunits	One unit	One unit	One unit
	Functional
Number ofchannels	Eight channels.	Three channels.	Eight channels.

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

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Characteristic	NOX T3(K082113)	RESPITRACE QDC(K903011)	QDC - PRO
Operation time	24 hours (depending onbatteries)	Undefined (mains operated)	8 hours or longer (dependingon batteries)
Data AcquisitionControl	Data acquisitionmicroprocessor controlled	Not defined in labeling	Data acquisitionmicroprocessor controlled
AcquisitionparameterControl	Acquisition parameters setfrom application SW	Acquisition parameterscontrolled from the devicesoftware only	Acquisition parameterscontrolled from the devicesoftware only
Calibration ofRIP	No	Yes	Yes
Device DataStorage	Yes	No	No
Data Interface	Via USB connection to PC	Via analog interface to 3rdparty sleep systemVia serial port to PC	Via analog interface to 3rdparty sleep system
Firmwareupgrade	Via USB connection to PC	Not defined in labeling	Via USB connection to PC
Connection toPatient	RIP belts for respiratory effortRIP belts for attaching ofdevice and clip straps tosecure position of devicePlastic tubing and cannula forpressure measurementProbes or Flexi Wrap foroximetryTouch proof electrode cables	RIP belts for respiratory effort	RIP belts for respiratory effortRIP belts for attaching ofdevice and clip straps tosecure position of deviceCannula for pressuremeasurement
Signals and Sensors

・

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Characteristic	NOX T3(K082113)	RESPITRACE QDC(K903011)	QDC - PRO
Signals outputs	Respiratory Effort (Abdomenand Thorax)	Respiratory Effort (Abdomenand Thorax) - calibratedRIP SUM	Respiratory Effort (Abdomenand Thorax) - calibratedRIP SUM
	RIP SUMBody positionActivityNasal /mask pressureAirflowSnoreRespiratory sound/audioOxygen SaturationPulseEEG, EOG, EMG, ECG		Body positionActivityNasal pressureSnoreRespiratory sound /Audiointensity
SensorTechnologyused in/withthe system	Solid state position/activitysensorRespiratory Effort Sensors(RIP technology)MicrophoneSolid state pressure sensorOximetryGold cup electrodesAg/AgCL electrodes	Respiratory Effort Sensors(RIP technology)	Solid state position/activitysensorRespiratory Effort Sensors(RIP technology)MicrophoneSolid state pressure sensor
		Power and Isolation
Power Source	1.5V by 1 AA battery (DataAcquisition)Host PC (Data Transfer)	115/230V AC (DataAcquisition)	1.5V by 1 AA battery (DataAcquisition)Host PC (FW upgrade)
GalvanicConnection tomains/PatientIsolation	Device has no galvanicconnections to mains as it is abattery operated deviceNot possible to connectauxiliary devices to the device	Yes via connection over mainsoperated 3rd party amplifierIsolation between mains andapplied partVia isolation mains adapter(mains operated)	Yes via connection over mainsoperated 3rd party amplifierIsolation between mains andapplied part
		User Interface
Data validation	The device has a display toview signal integrity andstatus of the device	No	The device has a display toview signal integrity andstatus of the device
Control ondevice	Push buttons	On/off button	Push buttons
		Standards
IEC60601-1 orequivalent FDArecognizedstandard	Yes	Yes	Yes
IEC60601-1-2or equivalentFDA recognizedstandard	Yes	Yes	Yes

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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.

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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.

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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.

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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

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Indication for Use

510(k) Number (if known): Kl24062

Device Name: QDC-PRO

Indications For Use:

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

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).