Who is the manufacturer of NOX T3, NOXTURNAL (PC APPLICATION)?

Nox Medical filed the 510(k) submission for NOX T3, NOXTURNAL (PC APPLICATION) (K082113).

What is the FDA product code for NOX T3, NOXTURNAL (PC APPLICATION)?

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

What is the regulatory pathway for NOX T3, NOXTURNAL (PC APPLICATION)?

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

What are the predicate devices for NOX T3, NOXTURNAL (PC APPLICATION)?

Embla N7000 (K024322); Compass M10 (K041724); 4100 Patient Oximeter Module (K043359).

Who can help prepare an FDA 510(k) submission like NOX T3, NOXTURNAL (PC APPLICATION)?

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.

NOX T3, NOXTURNAL (PC APPLICATION)

K082113 · Nox Medical · MNR · Nov 7, 2008 · Anesthesiology

Device Facts

Record ID	K082113
Device Name	NOX T3, NOXTURNAL (PC APPLICATION)
Applicant	Nox Medical
Product Code	MNR · Anesthesiology
Decision Date	Nov 7, 2008
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 868.2375
Device Class	Class 2
Attributes	Real-World Evidence, Pediatric

Real-World Evidence

Submission	Device	Sponsor	RWD Sources	RWE Use Summary	Key Tags
K082113 · Nov 7, 2008	NOX T3, NOXTURNAL (PC APPLICATION)	Nox Medical	Retrospective clinical sleep study recordings (Embla N7000)	The sponsor used a retrospective cohort of 1,057 clinical sleep recordings to validate the performance of the Noxturnal application's automatic scoring algorithm (AHI and ODI) by comparing it to manual scoring performed by certified technicians and physicians.	Retrospective cohort; Algorithm validation; Sleep study; Clinical performance

Clinical Evidence

Study Design	Population	Comparator	Key Endpoints
Noxturnal Automatic Scoring Validation; Retrospective analysis of clinical recordings	Patients undergoing sleep studies; Sample Size: 1057 recordings	Manual scoring of full PSG data by RPSGT certified technicians and physicians	Apnea Hypopnea Index (AHI) and Oxygen Desaturation Index (ODI) values

Indications for 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 Nox T3 system is indicated for use in patients greater than 2 years of age. The Nox T3 system is NOT intended for any patient monitoring or automatic diagnosis. The intended environments are hospitals, institutions, sleep clinics, or other test environments, including patient's home.

Device Story

Nox T3 is an ambulatory sleep recorder; records physiological signals during sleep for later analysis. Inputs: respiratory effort (abdominal/thoracic), oximetry (via wireless Bluetooth), nasal/mask pressure, snoring, body position/activity (3D accelerometer), audio (microphone), and two auxiliary channels (ECG, EMG, EEG, or EOG). Device is pocket-sized, battery-powered, worn on chest via respiratory effort belt. Data stored on device; downloaded via USB to PC running Noxturnal application. Used in hospitals, clinics, or home; operated by clinicians or patients (hook-up). Noxturnal software provides visualization, manual analysis, and automatic scoring of AHI/ODI. Output assists physicians in diagnosing sleep disorders. Benefits: enables ambulatory sleep studies, reducing need for in-lab polysomnography.

Clinical Evidence

No clinical trials; performance validated via bench testing and comparative analysis. Comparison of Nox T3 signals to Embla N7000 confirmed reliability. Validation of Noxturnal automatic scoring (AHI and ODI) performed using 1,057 historical Embla N7000 recordings previously scored by RPSGT-certified technicians and reviewed by physicians. Results demonstrated automatic scoring is substantially equivalent to manual scoring of full PSG data.

Technological Characteristics

ABS plastic housing; 79x63x21mm; 65g. Sensors: RIP respiratory effort, solid-state pressure, 3D accelerometer, microphone. Connectivity: USB 2.0 (PC), Bluetooth 2.0 (oximeter). Power: 1 AA battery. Software: Noxturnal application for PC (Windows 2000/XP). Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-25/26/40, FCC Part 15.

Indications for Use

Indicated for patients > 2 years of age suspected of Sleep Disordered Breathing (SDB) or Periodic Limb Movement Disorder (PLMD). Not for patient monitoring or automatic diagnosis.

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

Embla N7000 (K024322)
Compass M10 (K041724)
4100 Patient Oximeter Module (K043359)

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains a sequence of characters that appear to be handwritten. The characters are 'K0821113'. The characters are written in a simple, somewhat stylized manner, with varying stroke thicknesses. The overall impression is that of a handwritten code or identifier. # Nox Medic Nox Medical • Impra Keldnaholti • It 112 Reykjavik • Iceland • Tel.: • 354 570 7111 • www.noxmedical.com ### 510(k) Summary #### Submitter NOV - 7 2008 Nox Medical Keldnaholti IS-112 Reykjavik Iceland Tel: 011 354 522 9000 Fax: 011 354 522 9111 Registration Number: Nox Medical will register following FDA clearance #### Contact person Kolbrun E Ottosdottir Keldnaholti IS-112 Reykjavik Iceland Email: keo@noxmedical.com Direct tel: 011 354 522 9140 #### Preparation Date July 25, 2008 #### Device | Trade Name: | Nox T3 | |-----------------------|-----------------------------| | Common Name: | Sleep Recorder | | Classification Name: | Ventilatory Effort Recorder | | Regulation Number: | 868.2375 | | Product Code: | MNR | | Device Class: | Class II | | Classification Panel: | Anesthesiology | #### Predicate Devices Embla N7000 from Medcare Flaga Product Code: MNR 510(k) Number: K024322 Compass M10 from Medcare Flaga Product Code: MNR 510(k) Number: K041724 4100 Patient Oximeter Module from Nonin Medical Inc. Product Code: DQA 510(k) Number: K043359 {1}------------------------------------------------ Image /page/1/Picture/0 description: The image shows a handwritten string of characters. The string appears to be "K082113". The characters are written in black ink on a white background. The handwriting is somewhat stylized, with some characters slightly overlapping or connected. # nox Medical Nox Medical・Impra Keldnaholti・IS 112 Reykjavík・Iceland・Tel.: +354 570 7100・Fax: +354 570 711 ・www.noxmedical.com #### Device Description The Nox T3 is an ambulatory recording system. It includes a recording device, respiratory effort sensors, clip straps, filter tube connector and an USB cable for data download and the Nox T3 application (Noxturnal). The Nox T3 device is a pocket size battery powered digital recorder that incorporates electronics to record and store up to three nights of physiological parameters. The Nox T3 device is worn on the patient's chest by snapping it to the thoracic respiratory effort sensor belt and securing its position with the clip straps. It has a display for status indication, signal integrity and preliminary results, and buttons for control. The Nox T3 device records signals from five external sensors and three built-in sensors. The external sensors that can be used with the device are abdominal and thoracic respiratory effort sensors, oximeter (via wireless transmission), and two leads of the following: ECG, EMG, EEG or EOG. The built-in sensors include a pressure transducer allowing either recording of nasal pressure (via nasal cannula) or mask pressure and measuring of snoring, a three dimensional acceleration sensor for measure of patient's position and activity, and a microphone for true audio recording capabilities. The Nox T3 device includes a class II Bluetooth transmitter/receiver to allow for wireless transmission of data from Nonin´s Model 4100 Patient Oximeter Module. The Nox T3 application (Noxturnal) is used to configure the device for recording, and downloading, viewing and analyzing of recorded data on a PC. #### 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 Nox T3 system is indicated for use in patients greater than 2 years of age. The Nox T3 system is NOT intended for any patient monitoring or automatic diagnosis. The intended environments are hospitals, institutions, sleep clinics, or other test environments, including patient's home. The Nox T3 system is used for patients suspected of suffering from Sleep Disordered Breathing (SDB) or Periodic Limb Movement Disorder (PLMD). #### Technological Characteristics The comparison table below is provided as a summary of the most relevant characteristics of the Nox T3 system relative to the predicate devices. The comparison table demonstrates that the Nox T3 system has no significant differences from the predicate devices for the intended use that would adversely affect product safety and effectiveness. {2}------------------------------------------------ ■ ПОХ 【 П Ре С | C | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | able 1 Substantial Equivalence Summ | Characteristic | Embla N7000 (K024322) | Compass M10 System (K962865) | 4100 Patient Oximeter Module (K043359) | Nox T3 System | |---------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended Use | The Embla N7000 is intended for use by a physician or trained technician for the acquisition of EEG and polysomnography (PSG) signals and transmission of these signals to a PC during neurophysiologic or sleep examinations. | General The intended use of the Compass M10 system is to record physiological signals during sleep, scan the signals for abnormalities and represent the count of abnormal events in a form of a summary report. The results of the scan may be manually overwritten or corrected by the physician. The device is intended for use as a screening device to determine the need for clinical diagnosis and evaluation by polysomnography based on the patient's count of abnormal events. It is not intended for any diagnosis. It is not intended to be a monitor. | The Nonin's Bluetooth® enabled Model 4100 Patient Oximeter Module is indicated for use in measuring and transmitting functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate, and plethysmographic data to a compatible Bluetooth® enabled device. | 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 Nox T3 system is NOT intended for any patient monitoring or automatic diagnosis. | | Intended Environments | The intended environments are hospitals, institutions, sleep centers, sleep clinics, or other test environments. | Not defined | Not defined | The Intended environments are hospitals, institutions, sleep centers, sleep clinics, or other test environments, including patient's home. | | Patient Population | Not defined | The Compass M10 system is intended to be used for adult and pediatric patients. | Not defined | The Nox T3 system is indicated for use in patients greater than 2 years of age. | | Prescription Use | Yes | Yes | Yes | Yes | | Standards/Listing/Registrations | | | | | | IEC60601-1:1988 | Yes | Yes | Yes | Yes | | IEC60601-1-2:2001 | Yes | Yes | Yes | Yes | | IEC 60601-2-25:1993 | Yes | NA | NA | Yes | | IEC 60601-2-26: 2002 | Yes (1994 version) | NA | NA | Yes | | IEC 60601-2-40: 1998 | Yes | NA | NA | Yes | | Characteristic | Embla N7000 (K024322) | Compass M10 System (K962865) | 4100 Patient Oximeter Module (K043359) | Nox T3 System | | 47 CFR Part 15 | NA | NA | Yes | Yes | | FCC registration | NA | NA | Yes | Yes | | Bluetooth EPL | NA | NA | Yes | Yes | | Case Material | ABS Plastic (Patient Unit) | ABS Plastic and Aluminum | NA | ABS Plastic | | RIP Belts Material | Polyester, latex free | Polyester, latex free | NA | Polyester, latex free | | Dimension | 80mm (2.5") W 111mm (4.9") H 18.5mm(0.8") D (Patient Unit) | 65mm (2.5") W 124mm (4.9") H 20mm(0.8") D | NA | 79mm (3.11") W 63mm (2.48")H 21mm(0.83") D | | Weight | 280g (Patient Unit) | 100g | NA | 65g | | Disposable Components | Disposable respiratory effort sensor/RIP belts. Nasal cannula Remaining components require cleaning. | Disposable respiratory effort sensor/RIP belts. Remaining components require cleaning. | NA | Disposable respiratory effort sensor/RIP belts. Filter tube connector Remaining components require cleaning. | | Acquisition units | Three units | One unit | NA | One unit | | Number of channels | Seven channels (Patient Unit). 40 channels (Bedside Unit). Eight auxiliary channels (Communication Unit). | Five channels. | NA | Eight channels. | | Recording time | Unlimited | Up to 12 hours | NA | Up to 24 hours | | Control | Data acquisition and data storage microprocessor controlled Acquisition parameters set from application SW | Data acquisition and data storage microprocessor controlled Acquisition parameters set from application SW | NA | Data acquisition and data storage microprocessor controlled Acquisition parameters set from application SW | | Device Data Storage | No | Yes | NA | Yes | Section 5 - Page 3 of 8 510(k) Summary {3}------------------------------------------------ Nox Medical. ■ NOX 【】 LE di C 【】【】【】【】】】【】】】】】【】】】【】【】】】【】【】】【】】【】】】【】】】【】】】【】】】【】】】【】】】【】】】【】】】】【】】】【】】】】【】 KO82113 510(k) Summary {4}------------------------------------------------ | medicar | | |-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--| | | | | ﻟﻠﻘﻀﺎﺀ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮ X ﻟ | | | l | | Nox Medical · Impra Keldnaholti · Is 112 Reykjavik · Iceland · Tel. +354 570 7111 · www.noxmedical.com | Characteristic | Embla N7000 (K024322) | Compass M10 System (K962865) | 4100 Patient Oximeter Module (K043359) | Nox T3 System | |----------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Interface (PC) | Ethernet | USB v1.1 | NA | USB v2.0 | | Connection to Patient | RIP belts for respiratory effort Probes or Flexi Wrap for oximetry Plastic tubing and cannula for pressure sensing Touch proof electrode cables Thermistor Snore Sensor Piezo belts for respiratory effort Elastic cloth material for support of device | RIP belts for respiratory effort Probes or Flexi Wrap for oximetry Elastic cloth material for support of device | NA | RIP belts for respiratory effort Probes or Flexi Wrap for oximetry Plastic tubing and cannula for pressure sensing Touch proof electrode cables RIP belts for attaching of device and clip straps to secure position of device | | Signals Recorded | Respiratory Effort (Abdomen and Thorax) Body position Activity Oxygen Saturation Pulse Nasal/mask pressure Airflow Snore Respiratory sound EEG, EOG, EMG, ECG | Signals and Sensors Respiratory Effort (Abdomen and Thorax) Body position Activity Oxygen Saturation Pulse | NA | Respiratory Effort (Abdomen and Thorax) Body position Activity Oxygen Saturation Pulse Nasal/mask pressure Airflow Snore Respiratory sound EEG, EOG, EMG, ECG | | Sensor Technology used in/with the system | Solid state pressure sensor Solid state position/activity sensor Respiratory Effort Sensors (RIP technology) Oximetry | Solid state position/activity sensor Respiratory Effort Sensors (RIP technology) Oximetry | NA | Solid state pressure sensor Solid state position/activity sensor Respiratory Effort Sensors (RIP technology) Oximetry | | Characteristic | Embla N7000 (K024322) | Compass M10 System (K962865) | 4100 Patient Oximeter Module (K043359) | Nox T3 System | | Microphone | Gold cup electrodes Ag/AgCL electrodes Piezobelts for respiratory effort Thermistor Piezo snoring sensor | | | Microphone Gold cup electrodes Ag/AgCL electrodes | | Power Source | 115/230V AC | Power and Isolation 3V by 2 AA batteries (Data Acquisition) | Two 1.5V AA batteries | 1.5V by 1 AA battery (Data Acquisition) | | Patient Isolation | Isolation between mains and applied part | Host PC (Data Transfer) Device has no galvanic connections to mains as it is a battery operated device | Device has no galvanic connections to mains as it is a battery operated device | Host PC (Data Transfer) Device has no galvanic connections to mains as it is a battery operated device | | | | Not possible to connect auxiliary devices to the device | Not possible to connect auxiliary devices to the device | Not possible to connect auxiliary devices to the device | | | | Transmitter | | | | RF Data Transfer | No | No | Bluetooth wireless technology | Bluetooth wireless technology | | Bluetooth Specification | NA | NA | Version 1.1 | Version 2.0 | | RF Operating frequency | NA | NA | 2.4-2.4835 GHz | 2.4-2.4835 GHz | | RF Emissions CISPR 11 | NA | NA | Group 2 | Group 2 | | | | | Class B | Class B | | Output power | NA | NA | <1.1mW (Class II) | < 1.62mW (Class II) | | Antenna Type | NA | NA | Internal | Internal | | Modulation Type | NA | NA | Frequency Shift Keying | Frequency Shift Keying | | | | | Frequency Hopping Spread Spectrum | Frequency Hopping Spread Spectrum | | Network Topology | NA | NA | Point-to-Point: | Point-to-Point: | | Bandwidth | NA | NA | 1 MHz | 1 MHz | | | | User Interface | | | | Characteristic | Embla N7000 (K024322) | Compass M10 System (K962865) | 4100 Patient Oximeter Module (K043359) | Nox T3 System | | Data validation | On-line in the application SW (not a part of the system). Status light on Bedside Unit | Visual verification of the respiratory signals by light indicators on device | Connection status LED | The device has a display to view signal integrity and operation of the device. | | Operating System | No PC application | Microsoft Windows™ 2000 and XP | NA | Microsoft Windows™ 2000 and XP | | Data review on PC | No PC application | Yes: Real-time waveforms | NA | Yes: Real-time waveforms | | Generate/Print reports | No PC application | Yes | NA | Yes | | Patient data entry | No PC application | Yes | NA | Yes | | Analysis | No PC application | Automatic, result may be manipulated. Manual analysis Event marking (scoring) | NA | Automatic, result may be manipulated. Manual analysis Event marking (scoring) | 510(k) Summary {5}------------------------------------------------ ■ ПОХ ㅣ П Ре С Г С ( С ( С ) С ( С ) С ( С ) - 3 5 4 570 710 - Fax: +354 570 7111 - www.noxmedical.com Nox Medical Impra Keldnaholti IS 112 Reykjavik Iceland Tel.: +354 570 7100 Fax: +354 570 7111 [www.noxmedical.com](http://www.noxmedical.com) 510(k) Summary . K082113 {6}------------------------------------------------ Nox Medical ■ ПОХ ↑ Medical • Medical • Iceland • Tel. +354 570 7100 • Fax: +354 570 7111 • www.noxmedical.com Nox Medical • Impra Keldnaholt • IS 112 Reykjavik • Iceland • Tel. +354 57 Section 5 -- Page 7 of 8 {7}------------------------------------------------ K082113 # nox Medical Nox Medical • Impra Keldnaholi • IS 112 Reykjavik • Iceland • Tel.: +354 570 7111 • www.noxmedical.com #### Performance Testing Summary The Nox T3 system has been tested and verified in various phases to include internal testing, verification and validation as well as external testing to assure product safety, effectiveness and reliability. The design was verified and validated throughout the design process according to requirement specifications and intended use. Risk analysis was performed according to ISO 14971:2007, appropriate measures were implemented and their effectiveness verified and validated. External test house was used to conduct testing needed to comply with applicable standards reqarding EMC and patient safety as well as additional RF testing to assure compliance to FCC requirements for R&TTE (The Radio and Telecommunications Terminal Equipment Directive) approval. The general process from configuration of device to reading out the results and generating report was validated by having untrained person perform this actions. The results demonstrates that the Nox T3 system has meet its objective of being easy to operate, the Noxturnal interface guides the user appropriately, minimizing the likelihood of errors and lapses, and the design of the Nox T3 components and user instruction allows the hook-up to be performed by untrained people. #### Performance Data The signals recorded with the Nox T3 system were compared to signals recorded with the predicate device Embla N7000. The result demonstrates the reliability and usability of all signals recorded with the Nox T3 system. Analysis comparison was performed to validate the quality of the automatic scoring performed by the Noxturnal application compared to manual scoring of full PSG data. The validation study focused on the comparison of the Apnea Hypopnea Index (AHI) values and the Oxygen Desaturation Index (ODI) values. The recordings used consisted of 1057 Embla N7000 recordings which had all gone through the process of being manually scored by Sleep Technicians with RPSGT certification, and then reviewed by a Physician. The analysis comparison result demonstrates that the Noxturnal application scores AHI and ODI events in a substantially equivalent manner to the manual scoring on full PSG recordings obtained using Embla N7000 recorders. #### Conclusion Verification testing, validation, risk analysis, technological characteristic and performance data comparisons have been performed for the Nox T3 system. The results of this testing and comparisons do not raise new questions of safety and effectiveness and demonstrate the same effectiveness and safety as that of the predicates Compass M10, Embla N7000 and Model 4100 Patient Oximeter Module. The Nox T3 system is therefore substantial equivalent to the predicates Compass M10 from Medcare Flaga (K041724) and Embla N7000 from Medcare Flaga (K024322). The wireless function of the Nox T3 system is therefore substantial equivalent to that of the predicate Model 4100 Patient Oximeter Module from Nonin Medical (K043359). {8}------------------------------------------------ Image /page/8/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes representing the three levels of government: federal, state, and local. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" are arranged in a circular pattern around the eagle. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 NOV - 7 2008 Ms. Kolbrun E. Ottosdottir Quality Manager Nox Medical Impra Keldnaholti IS 112 Reykjavik ICELAND Re: K082113 Trade/Device Name: Nox T3 Regulation Number: 21 CFR 868.2375 Regulation Name: Breathing Frequency Monitor Regulatory Class: II Product Code: MNR Dated: October 20, 2008 Received: October 23, 2008 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 to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely yours, Sylitte Y. Mchue O MD FOR DR CHILE LIN Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, 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): KOBA\/ 3 Device Name: Nox T3 Indications For 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 Nox T3 system is indicated for use in patients greater than 2 years of age. The Nox T3 system is NOT intended for any patient monitoring or automatic diagnosis. The intended environments are hospitals, institutions, sleep centers, sleep clinics, or other test environments, including patient's home. 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) Emmett J. Michael Dmd. Division Sign-Off) Division of Anesthesiology, General Hospital infection Control, Dental Devices 4-082113 510(k) Number: Page 1 of 1

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