Who is the manufacturer of QDC-PRO, AND NOX-RIP?

Nox Medical filed the 510(k) submission for QDC-PRO, AND NOX-RIP (K124062).

What is the FDA product code for QDC-PRO, AND NOX-RIP?

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

What is the regulatory pathway for QDC-PRO, AND NOX-RIP?

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

What are the predicate devices for QDC-PRO, AND NOX-RIP?

NOX T3 (K082113); Respitrace QDC (K903011).

Who can help prepare an FDA 510(k) submission like QDC-PRO, AND NOX-RIP?

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

QDC-PRO, AND NOX-RIP

K124062 · Nox Medical · MNR · Jul 10, 2013 · Anesthesiology

Device Facts

Record ID	K124062
Device Name	QDC-PRO, AND NOX-RIP
Applicant	Nox Medical
Product Code	MNR · Anesthesiology
Decision Date	Jul 10, 2013
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 868.2375
Device Class	Class 2
Attributes	Pediatric

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.

Device Story

QDC-PRO is a wearable sensor unit for polysomnography (PSG) studies; measures respiratory effort via respiratory inductive plethysmography (RIP) belts, nasal pressure/snoring via nasal cannula, body position, activity, and audio via internal microphone. Device processes signals internally, including Quantitative Diagnostic Calibration (QDC) of RIP signals to estimate tidal volume; outputs analog signals to 3rd party PSG amplifiers. Used in hospitals, sleep clinics, or test environments; operated by clinicians/technicians. Provides calibrated respiratory data to assist in diagnosis of sleep-disordered breathing. Powered by 1.5V AA battery; features status display and control buttons.

Clinical Evidence

Bench testing only. No clinical trials performed. Evidence includes signal comparison tests against predicate devices (NOX T3, Respitrace QDC) confirming signal quality and clinical equivalence. QDC function performance verified against Respitrace QDC. Compliance with IEC60601-1, IEC60601-1-2, and ISO14971 risk management standards documented.

Technological Characteristics

Materials: PC with 10% glass fiber case, polyester/steel clips, PVC/ABS/PC cables, latex-free polyester/Dorlastan RIP belts. Sensing: RIP technology, solid-state position/activity sensor, solid-state pressure sensor, microphone. Connectivity: Analog output to 3rd party PSG systems; USB for firmware updates. Power: 1.5V AA battery. Standards: IEC60601-1, IEC60601-1-2, IEC62304, IEC62366, ISO14971.

Indications for Use

Indicated for patients > 2 years of age requiring measurement of physiological signals during sleep for polysomnography studies. No specific contraindications defined.

Regulatory Classification

Identification

A breathing (ventilatory) frequency monitor is a device intended to measure or monitor a patient's respiratory rate. The device may provide an audible or visible alarm when the respiratory rate, averaged over time, is outside operator settable alarm limits. This device does not include the apnea monitor classified in § 868.2377.

Predicate Devices

NOX T3 (K082113)
Respitrace QDC (K903011)

Related Devices

K020607 — SLEEPFLO, MODEL 101501 · Biomec, Inc. · Aug 30, 2002
K250460 — WatchPAT400 (WP400) · Itamar Medical , Ltd. · Sep 5, 2025
K040194 — COMPUMEDICS SUMMIT IP · Compumedics USA, Ltd. · Apr 23, 2004
K171304 — Maxxi Rip Sensor · Neurovirtual USA, Inc. · Jun 24, 2019
K982216 — ULTIMA RESPIRATORY EFFORT SENSOR MODELS 0520 AND 0522 · Braebon Medical Corp. · Sep 11, 1998

Submission Summary (Full Text)

{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