(102 days)
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.
The Nox T3 system is used for patients suspected of suffering from Sleep Disordered Breathing (SDB) or Periodic Limb Movement Disorder (PLMD).
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.
Here's an analysis of the acceptance criteria and study detailed in the provided document for the Nox T3 device:
The document (510(k) summary) describes the Nox T3 as an ambulatory recording system for physiological signals during sleep. The primary goal of the "performance testing summary" is to demonstrate substantial equivalence to predicate devices, rather than establishing specific performance metrics against a predefined acceptance criterion. The key performance claims for this device focus on its ability to record reliable signals and the accuracy of its automated scoring software (Noxturnal) compared to manual scoring.
Here's the breakdown as requested:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Signal Reliability & Usability | "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." |
| Automatic Scoring Accuracy (AHI) | "The analysis comparison result demonstrates that the Noxturnal application scores AHI...events in a substantially equivalent manner to the manual scoring on full PSG recordings obtained using Embla N7000 recorders." (No specific numerical target or statistical metric [e.g., agreement percentage, correlation coefficient] is provided in the summary.) |
| Automatic Scoring Accuracy (ODI) | "The analysis comparison result demonstrates that the Noxturnal application scores ...ODI values in a substantially equivalent manner to the manual scoring on full PSG recordings obtained using Embla N7000 recorders." (No specific numerical target or statistical metric is provided in the summary.) |
| Ease of Operation | "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." |
| Compliance to Standards | The device underwent external testing to comply with applicable standards regarding EMC and patient safety (e.g., IEC60601-1, IEC60601-1-2, IEC 60601-2-25, IEC 60601-2-26, IEC 60601-2-40) and FCC requirements for R&TTE approval. (Compliance is stated; no specific results of these tests and how they meet criteria are detailed in this summary.) |
Note: The document explicitly states that the comparisons "do not raise new questions of safety and effectiveness and demonstrate the same effectiveness and safety as that of the predicates." This implies that the 'acceptance criteria' are primarily based on demonstrating equivalence rather than achieving absolute performance thresholds.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Automatic Scoring Comparison: 1057 Embla N7000 recordings.
- Data Provenance: The document does not explicitly state the country of origin. It indicates the data consisted of "Embla N7000 recordings." Embla is a brand associated with sleep diagnostics, and both Medcare Flaga (the predicate's manufacturer) and Nox Medical are based in European countries (Medcare Flaga in the past was associated with Iceland, though it might have had broader presence; Nox Medical is in Iceland). Given the context of a 510(k) submission to the FDA, it's highly probable that the data was collected from clinical settings, likely retrospectively as they were "recordings which had all gone through the process of being manually scored."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
- Number of Experts: Not explicitly stated as a specific number. The ground truth was established by "Sleep Technicians with RPSGT certification" and "then reviewed by a Physician." This suggests at least one technician and one physician per recording, but doesn't give an aggregate count of unique individuals.
- Qualifications of Experts:
- Sleep Technicians: "RPSGT certification" (Registered Polysomnographic Technologist).
- Physician: "reviewed by a Physician." (Specific specialization like a sleep physician is implied but not explicitly stated.)
4. Adjudication Method for the Test Set
- The method described is sequential: "manually scored by Sleep Technicians with RPSGT certification, and then reviewed by a Physician." This implies a form of hierarchical review, where the technician's scoring is the initial pass, followed by a physician's oversight. It is not explicitly stated if there was a consensus process (e.g., 2+1, 3+1) if the physician disagreed with the technician, or if the physician's review constituted the final ground truth.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, What was the Effect Size of How Much Human Readers Improve with AI vs without AI Assistance
- No, a MRMC comparative effectiveness study involving human readers with vs. without AI assistance was not performed or reported in this summary. The study reported compared the device's standalone automatic scoring (Noxturnal application) against manual scoring by human experts. The study's focus was on the performance of the automated algorithm, not on improving human reader performance.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
- Yes, a standalone performance evaluation of the algorithm was done. The "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." This directly assesses the algorithm's performance without a human in the loop during the scoring process.
7. The Type of Ground Truth Used
- The ground truth used was expert consensus/manual scoring. Specifically, "manual scoring of full PSG data" performed by "Sleep Technicians with RPSGT certification" and "then reviewed by a Physician."
8. The Sample Size for the Training Set
- The document does not specify a sample size for the training set. It only mentions the "recordings used consisted of 1057 Embla N7000 recordings" for the validation study. It is common for 510(k) summaries to omit details about training data, but its absence here means we cannot ascertain the training set size from this document.
9. How the Ground Truth for the Training Set was Established
- The document does not provide information on how the ground truth for the training set was established. Given the lack of detail on the training set itself, this information is not available in the provided text.
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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
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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.
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■ 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 useby a physician or trained technicianfor the acquisition of EEG andpolysomnography (PSG) signals andtransmission of these signals to a PCduring neurophysiologic or sleepexaminations. | GeneralThe intended use of the CompassM10 system is to record physiologicalsignals during sleep, scan the signalsfor abnormalities and represent thecount of abnormal events in a formof a summary report. The results ofthe scan may be manuallyoverwritten or corrected by thephysician. The device is intended foruse as a screening device todetermine the need for clinicaldiagnosis and evaluation bypolysomnography based on thepatient's count of abnormal events.It is not intended for any diagnosis.It is not intended to be a monitor. | The Nonin's Bluetooth® enabledModel 4100 Patient Oximeter Moduleis indicated for use in measuring andtransmitting functional oxygensaturation of arterial hemoglobin(SpO2), pulse rate, andplethysmographic data to acompatible Bluetooth® enableddevice. | The Nox T3 device is intended forambulatory recording of physiologicalsignals during sleep. The recordedsignals are then downloaded to a PCwhere the signals can be viewed andanalyzed by use of the Nox T3application (Noxturnal).The Nox T3 system is NOT intendedfor any patient monitoring orautomatic diagnosis. |
| Intended Environments | The intended environments arehospitals, institutions, sleep centers,sleep clinics, or other testenvironments. | Not defined | Not defined | The Intended environments arehospitals, institutions, sleep centers,sleep clinics, or other testenvironments, including patient'shome. |
| Patient Population | Not defined | The Compass M10 system is intendedto be used for adult and pediatricpatients. | Not defined | The Nox T3 system is indicated foruse in patients greater than 2 yearsof 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") W111mm (4.9") H18.5mm(0.8") D(Patient Unit) | 65mm (2.5") W124mm (4.9") H20mm(0.8") D | NA | 79mm (3.11") W63mm (2.48")H21mm(0.83") D |
| Weight | 280g (Patient Unit) | 100g | NA | 65g |
| Disposable Components | Disposable respiratory effortsensor/RIP belts.Nasal cannulaRemaining components requirecleaning. | Disposable respiratory effortsensor/RIP belts.Remaining components requirecleaning. | NA | Disposable respiratory effortsensor/RIP belts.Filter tube connectorRemaining components requirecleaning. |
| 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 storagemicroprocessor controlledAcquisition parameters set fromapplication SW | Data acquisition and data storagemicroprocessor controlledAcquisition parameters set fromapplication SW | NA | Data acquisition and data storagemicroprocessor controlledAcquisition parameters set fromapplication SW |
| Device Data Storage | No | Yes | NA | Yes |
Section 5 - Page 3 of 8
510(k) Summary
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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 ﺍﻟﻤﺴﺘﻮXﻟ | |
| 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 effortProbes or Flexi Wrap for oximetryPlastic tubing and cannula forpressure sensingTouch proof electrode cablesThermistorSnore SensorPiezo belts for respiratory effortElastic cloth material for support ofdevice | RIP belts for respiratory effortProbes or Flexi Wrap for oximetryElastic cloth material for support ofdevice | NA | RIP belts for respiratory effortProbes or Flexi Wrap for oximetryPlastic tubing and cannula forpressure sensingTouch proof electrode cablesRIP belts for attaching of device andclip straps to secure position ofdevice |
| Signals Recorded | Respiratory Effort (Abdomen andThorax)Body positionActivityOxygen SaturationPulseNasal/mask pressureAirflowSnoreRespiratory soundEEG, EOG, EMG, ECG | Signals and SensorsRespiratory Effort (Abdomen andThorax)Body positionActivityOxygen SaturationPulse | NA | Respiratory Effort (Abdomen andThorax)Body positionActivityOxygen SaturationPulseNasal/mask pressureAirflowSnoreRespiratory soundEEG, EOG, EMG, ECG |
| Sensor Technology usedin/with the system | Solid state pressure sensorSolid state position/activity sensorRespiratory Effort Sensors (RIPtechnology)Oximetry | Solid state position/activity sensorRespiratory Effort Sensors (RIPtechnology)Oximetry | NA | Solid state pressure sensorSolid state position/activity sensorRespiratory Effort Sensors (RIPtechnology)Oximetry |
| Characteristic | Embla N7000(K024322) | Compass M10 System(K962865) | 4100 Patient Oximeter Module(K043359) | Nox T3 System |
| Microphone | Gold cup electrodesAg/AgCL electrodesPiezobelts for respiratory effortThermistorPiezo snoring sensor | MicrophoneGold cup electrodesAg/AgCL electrodes | ||
| Power Source | 115/230V AC | Power and Isolation3V by 2 AA batteries (DataAcquisition) | Two 1.5V AA batteries | 1.5V by 1 AA battery (DataAcquisition) |
| Patient Isolation | Isolation between mains and applied part | Host PC (Data Transfer)Device has no galvanic connectionsto mains as it is a battery operateddevice | Device has no galvanic connectionsto mains as it is a battery operateddevice | Host PC (Data Transfer)Device has no galvanic connectionsto mains as it is a battery operateddevice |
| Not possible to connect auxiliarydevices to the device | Not possible to connect auxiliarydevices to the device | Not possible to connect auxiliarydevices 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 analysisEvent marking (scoring) | NA | Automatic, result may be manipulated.Manual analysisEvent 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
510(k) Summary
.
{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
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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).
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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:
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§ 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).