QDC-PRO, AND NOX-RIP

{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<br>for ambulatory recording of<br>physiological signals during<br>sleep. The recorded signals<br>are then downloaded to a PC<br>where the signals can be<br>viewed and analyzed by use of<br>the Nox T3 application<br>(Noxturnal). | The RESPITRACE QDC multi-<br>channel waveform generator<br>is indicated for diagnostic<br>polysomnograpy. This device<br>generates respiratory<br>waveforms from RESPITRACE<br>technology. | The QDC-PRO device is a<br>sensor unit intended for<br>measuring of physiological<br>signals during sleep. The<br>signals measured are<br>processed in the QDC-PRO<br>device and the resulting<br>signals made available at the<br>output connector for<br>acquisition by a 3rd party<br>Polysomnography (PSG)/sleep<br>recorder. | | | | | Contraindication<br>for Use | The Nox T3 system is NOT<br>intended for any patient<br>monitoring or automatic<br>diagnosis. | Not defined in labeling | The ODC-PRO device is NOT<br>intended for any patient<br>monitoring. | | | | | Intended<br>Environments | The intended environments<br>are hospitals, institutions,<br>sleep centers, sleep clinics, or<br>other test environments,<br>including patient's home. | Not defined in labeling | The intended environments<br>are hospitals, institutions,<br>sleep centers, sleep clinics, or<br>other test environments. | | | | | Patient<br>Population | The Nox T3 system is<br>indicated for use in patients<br>greater than 2 years of age | Not defined in labeling | The QDC-PRO device is<br>indicated for use in patients<br>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<br>Clips | Polyester/Steel | Not defined in labeling | Polyester/Steel | | | | | Material RIP<br>connection<br>cable | PVC and ABS/PC | Not defined in labeling | PVC and ABS/PC | | | | | RIP Belts<br>Material | Polyester/Dorlastan, latex free | Not defined in labeling | Polyester/Dorlastan, latex free | | | | | Dimension | 79mm (3.11") W<br>63mm (2.48")H<br>21mm(0.83") D | 195mm (76.8") W<br>275mm (108.3") H<br>110mm(43.3") D | 83mm (3.27") W<br>63mm (2.48")H<br>21mm(0.83") D | | | | | Weight | 65g | 2000g | 71g | | | | | Disposable<br>Components | Disposable respiratory effort<br>sensor/RIP belts.<br>Filter tube connector<br>Remaining portions require<br>cleaning. | Disposable respiratory effort<br>sensor/RIP belts.<br>Remaining components<br>require cleaning. | Disposable respiratory effort<br>sensor/RIP belts.<br>Remaining portions require<br>cleaning. | | | | | Acquisition<br>units | One unit | One unit | One unit | | | | | | Functional | | | | | | | Number of<br>channels | Eight channels. | Three channels. | Eight channels. | | | | Table 1 Comparison Summary of the New Device (QDC-PRO) and Predicate Devices {4}------------------------------------------------ | Characteristic | NOX T3<br>(K082113) | RESPITRACE QDC<br>(K903011) | QDC - PRO | |-------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------| | Operation time | 24 hours (depending on<br>batteries) | Undefined (mains operated) | 8 hours or longer (depending<br>on batteries) | | Data Acquisition<br>Control | Data acquisition<br>microprocessor controlled | Not defined in labeling | Data acquisition<br>microprocessor controlled | | Acquisition<br>parameter<br>Control | Acquisition parameters set<br>from application SW | Acquisition parameters<br>controlled from the device<br>software only | Acquisition parameters<br>controlled from the device<br>software only | | Calibration of<br>RIP | No | Yes | Yes | | Device Data<br>Storage | Yes | No | No | | Data Interface | Via USB connection to PC | Via analog interface to 3rd<br>party sleep system<br>Via serial port to PC | Via analog interface to 3rd<br>party sleep system | | Firmware<br>upgrade | Via USB connection to PC | Not defined in labeling | Via USB connection to PC | | Connection to<br>Patient | RIP belts for respiratory effort<br>RIP belts for attaching of<br>device and clip straps to<br>secure position of device<br>Plastic tubing and cannula for<br>pressure measurement<br>Probes or Flexi Wrap for<br>oximetry<br>Touch proof electrode cables | RIP belts for respiratory effort | RIP belts for respiratory effort<br>RIP belts for attaching of<br>device and clip straps to<br>secure position of device<br>Cannula for pressure<br>measurement | | Signals and Sensors | | | | ・ . . {5}------------------------------------------------ | Characteristic | NOX T3<br>(K082113) | RESPITRACE QDC<br>(K903011) | QDC - PRO | |-------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------| | Signals outputs | Respiratory Effort (Abdomen<br>and Thorax) | Respiratory Effort (Abdomen<br>and Thorax) - calibrated<br>RIP SUM | Respiratory Effort (Abdomen<br>and Thorax) - calibrated<br>RIP SUM | | | RIP SUM<br>Body position<br>Activity<br>Nasal /mask pressure<br>Airflow<br>Snore<br>Respiratory sound/audio<br>Oxygen Saturation<br>Pulse<br>EEG, EOG, EMG, ECG | | Body position<br>Activity<br>Nasal pressure<br>Snore<br>Respiratory sound /Audio<br>intensity | | Sensor<br>Technology<br>used in/with<br>the system | Solid state position/activity<br>sensor<br>Respiratory Effort Sensors<br>(RIP technology)<br>Microphone<br>Solid state pressure sensor<br>Oximetry<br>Gold cup electrodes<br>Ag/AgCL electrodes | Respiratory Effort Sensors<br>(RIP technology) | Solid state position/activity<br>sensor<br>Respiratory Effort Sensors<br>(RIP technology)<br>Microphone<br>Solid state pressure sensor | | | | Power and Isolation | | | Power Source | 1.5V by 1 AA battery (Data<br>Acquisition)<br>Host PC (Data Transfer) | 115/230V AC (Data<br>Acquisition) | 1.5V by 1 AA battery (Data<br>Acquisition)<br>Host PC (FW upgrade) | | Galvanic<br>Connection to<br>mains/Patient<br>Isolation | Device has no galvanic<br>connections to mains as it is a<br>battery operated device<br>Not possible to connect<br>auxiliary devices to the device | Yes via connection over mains<br>operated 3rd party amplifier<br>Isolation between mains and<br>applied part<br>Via isolation mains adapter<br>(mains operated) | Yes via connection over mains<br>operated 3rd party amplifier<br>Isolation between mains and<br>applied part | | | | User Interface | | | Data validation | The device has a display to<br>view signal integrity and<br>status of the device | No | The device has a display to<br>view signal integrity and<br>status of the device | | Control on<br>device | Push buttons | On/off button | Push buttons | | | | Standards | | | IEC60601-1 or<br>equivalent FDA<br>recognized<br>standard | Yes | Yes | Yes | | IEC60601-1-2<br>or equivalent<br>FDA recognized<br>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