The SmartTrack System is intended for single-patient use as an electronic data capture accessory for recording and monitoring actuations of prescribed MDI usage. This may be used in the following applications:

In clinical trials, where researchers need to know when a patient has actuated their trial MDI medication;
In clinical practice, where specialists, general practitioners, and nurse educators need to know if a patient has actuated their prescribed MDI medication.
The SmartTrack is not intended to indicate remaining quantity of medication in an MDI and does not include a dose counting function.

Device Description

The SmartTrack System consists of three modules used to provide a compliance monitoring function for use of a Metered Dose Inhaler (MDI).

SmartTrack is a clip-on module that attaches externally around the enclosure of an MDI, using an optical sensor to detect MDI actuation, to log the usage history of the MDI. The device includes an LCD display and control buttons to review basic data and adjust device settings. Various device status conditions are indicated to the user, and logged to provide potentially relevant context for later review of MDI usage history data.
SmartTrack Docking Station is an optical interface cradle used to download data stored on the SmartTrack module, via USB cable connection to a PC, and allow for interaction by the offline software with device settings and status monitoring.
Respiratory Analyzer is a software application for use on a PC that provides for offline review of the MDI compliance data logged by the SmartTrack module. Data is stored in database files with patient, medication, and prescribed dose information, and is available for review and export in various table and graph formats to highlight MDI usage characteristics.

AI/ML Overview

Here's an analysis of the provided text regarding the SmartTrack System's acceptance criteria and studies:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied)	Reported Device Performance
Functional Verification: Correct logging of MDI actuation data.	"Software verification procedures, with performance testing of the MDI actuation sensor system to ensure data is logged accurately for MDI usage. This established correct functionality of the SmartTrack System according to requirements." (b)(1) "Hardware testing carried out for the SmartTrack System indicates it meets design and performance functional requirements. Software verification demonstrates that device features are effective, and the system configuration functions equivalently to the predicate devices." (b)(3)
Equivalence to Predicate Devices (Technological Characteristics): Configuration, microprocessor control, internal clock, battery, PC interface for data download, offline review software.	"Technological characteristics of the SmartTrack system are largely equivalent to the predicate devices listed above. Equivalent features between the devices include: configuration in attaching to the outside of an MDI enclosure; microprocessor control and use of an internal clock, to log date and time of MDI actuations; power supply from an internal battery; interface to a personal computer via an optical docking station to download MDI usage data; and offline review software providing for data handling, device interaction, and patient data reporting functions." (a)(6)
Equivalence to Predicate Devices (Sensor Technology Performance):	"The sensor technology used to detect MDI actuation is different from the predicate devices, and this aspect of the device has been verified by non-clinical testing to establish equivalent performance to the predicate devices." (a)(6)
Safety and Effectiveness: Overall device safety and effectiveness.	"This information indicates that the SmartTrack System is equivalent to the predicate devices in terms of device safety and effectiveness." (b)(3). While not explicitly stated as an "acceptance criterion" with a specific metric, the entire 510(k) submission process is to demonstrate safety and effectiveness for market clearance. The conclusions explicitly state this was achieved through bench testing and equivalence to predicates regarding safety and effectiveness. Pending: "Third party testing of the SmartTrack System for compliance to IEC 60601 series standards for general safety and electromagnetic compatibility, and IEC 60068 series standards for environmental testing, will be completed by an accredited laboratory before marketing of the device." (b)(1) "The device will meet standard requirements for electrical safety and electromagnetic compatibility before marketing." (b)(3)

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

Sample Size for Test Set: Not specified. The document states "performance testing of the MDI actuation sensor system" was conducted, but no details on the number of devices tested, number of actuations, or the type of MDIs used are provided.
Data Provenance: The testing was "non-clinical testing" and "bench testing." There is no mention of human subjects, geographical origin of data, or whether it was retrospective or prospective. It appears to be entirely laboratory-based.

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

This information is not provided. Given that the testing was hardware and software functional verification (bench testing), it's unlikely that external medical experts were used to establish "ground truth" in the typical clinical sense. The ground truth for actuation detection would have been established by direct observation or automated mechanical means during the bench testing.

4. Adjudication Method for the Test Set

Not applicable/Not specified. As the testing was internal functional verification focusing on accurate data logging from a sensor, a formal adjudication method (like 2+1 or 3+1 used in image interpretation studies) is not described or implied. The "ground truth" for actuation detection would have been determined by the test setup itself.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. The document explicitly states: "Clinical testing was not required to demonstrate the safety and effectiveness of the SmartTrack System. The product functionality has been adequately assessed by bench testing as above." An MRMC study involves human readers, and the submitted information indicates absence of clinical testing involving human evaluation.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, a standalone (algorithm only) performance assessment was done within the scope of "bench testing." The "performance testing of the MDI actuation sensor system to ensure data is logged accurately for MDI usage" represents the device's standalone performance in detecting and logging actuations. There is no human-in-the-loop component described for this specific performance assessment.

7. The Type of Ground Truth Used

The ground truth for the "performance testing of the MDI actuation sensor system" was likely established through direct observation or mechanical measurement/simulation of MDI actuations during bench testing. For example, actuations could have been manually performed while simultaneously verifying the device's logged data, or automated systems could have repeatedly actuated MDIs, allowing for comparison with the SmartTrack's recorded events. It is not expert consensus, pathology, or outcomes data.

8. The Sample Size for the Training Set

Not applicable/Not specified. This device uses an optical sensor for actuation detection, not a machine learning model that would typically require a "training set" of data in the common sense. Therefore, there's no mention of a training set sample size.

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

Not applicable. As there is no mention of a training set, the method for establishing its ground truth is also not applicable.

Summary

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K091803

Image /page/0/Picture/1 description: The image shows the logo for Nexus 6. The logo consists of a plus sign made up of four squares, followed by the word "nexus6" in lowercase letters. The "6" is slightly raised and has a small "tm" symbol next to it, indicating a trademark.

OCT - 9 2009

Nexus 6 Limited Level 2, 109 Cook Street, Auckland 1010, New Zealand PO Box 106-612, Auckland 1143, New Zealand Phone +64 9 307 2771 Fax +64 9 307 2773

6 July 2009

510(k) SUMMARY

This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of 21 CFR §807.92:

(a)(1) Refer to information above and concluding this summary.

(a)(2) Name of the Device

Model Number / Name:	SmartTrack System
Classification Name:	Nebulizer (Direct Patient Interface)Anesthesiology Devices, 21 CFR §868.5630, Class II, CAF

(a)(3} Identification of Legally Marketed Devices

K990185	MDILog Model MDC-512	Medtrac Technologies Inc
K970344	MDILog Model MDC-511	Medtrac Technologies Inc
K935955	Doser MDI Counter	Newmed Corporation

(a)(4) Description of the Device

The SmartTrack System consists of three modules used to provide a compliance monitoring function for use of a Metered Dose Inhaler (MDI).

· SmartTrack is a clip-on module that attaches externally around the enclosure of an MDI, using an optical sensor to detect MDI actuation, to log the usage history of the MDI. The device includes an LCD display and control buttons to review basic data and adjust device settings. Various device status conditions are indicated to the user, and logged to provide potentially relevant context for later review of MDI usage history data.
SmartTrack Docking Station is an optical interface cradle used to download data stored on the SmartTrack module, via USB cable connection to a PC, and allow for interaction by the offline software with device settings and status monitoring.
Respiratory Analyzer is a software application for use on a PC that provides for offline review of the MDI compliance data logged by the SmartTrack module. Data is stored in database files with patient, medication, and prescribed dose information, and is available for review and export in various table and graph formats to highlight MDI usage characteristics.

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(a)(5) Statement of the Intended Use

In clinical trials, where researchers need to know when a patient has actuated their trial MDI medication;
. In clinical practice, where specialists, general practitioners, and nurse educators need to know if a patient has actuated their prescribed MDI medication.

The SmartTrack is not intended to indicate remaining quantity of medication in an MDI and does not include a dose counting function.

(a)(6) Technological Characteristics Summary

Technological characteristics of the SmartTrack system are largely equivalent to the predicate devices listed above. Equivalent features between the devices include: configuration in attaching to the outside of an MDI enclosure; microprocessor control and use of an internal clock, to log date and time of MDI actuations; power supply from an internal battery; interface to a personal computer via an optical docking station to download MDI usage data; and offline review software providing for data handling, device interaction, and patient data reporting functions.

The sensor technology used to detect MDI actuation is different from the predicate devices, and this aspect of the device has been verified by non-clinical testing to establish equivalent performance to the predicate devices.

(b)(1) Discussion of the Non-Clinical Tests

Non-clinical testing of the SmartTrack system has been carried out to cover functional verification and device performance. This included completion of software verification procedures, with performance testing of the MDI actuation sensor system to ensure data is logged accurately for MDI usage. This established correct functionality of the SmartTrack System according to requirements.

Third party testing of the SmartTrack System for compliance to IEC 60601 series standards for general safety and electromagnetic compatibility, and IEC 60068 series standards for environmental testing, will be completed by an accredited laboratory before marketing of the device.

(b)(2) Discussion of the Clinical Tests

Clinical testing was not required to demonstrate the safety and effectiveness of the SmartTrack System. The product functionality has been adequately assessed by bench testing as above.

(b)(3) Conclusions Demonstrating Safety, Effectiveness and Performance

Hardware testing carried out for the SmartTrack System indicates it meets design and performance functional requirements. Software verification demonstrates that device features are effective, and the system configuration functions equivalently to the predicate devices. The device will meet standard requirements for electrical safety and electromagnetic compatibility before marketing.

This information indicates that the SmartTrack System is equivalent to the predicate devices in terms of device safety and effectiveness.

Garth Sutherland Chief Operating Officer Nexus6 Ltd

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-0609 Silver Spring, MD 20993-0002

Nexus6 Limited C/O Mr. Morten Simon Christensen Responsible Third Party Official Underwriters Laboratories, Incorporated 455 East Trimble Road San Jose, California 95131-1230

OCT - 9 2009

Re: K091803

Trade/Device Name: SmartTrack System Regulation Number: 21 CFR 868.5630 Regulation Name: Nebulizer Regulatory Class: II Product Code: CAF Dated: September 22, 2009 Received: September 24, 2009

Dear Mr. Christensen:

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 additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Mr. Christensen

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 (reporting of medical device-related 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 go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/cdrh/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

h for

Susan Runner, D.D.S., M.A. Acting Division Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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Nexus6 Limited Level 2, 109 Cook Street, Auckland 1010, New Zealand PO Box 106-612, Auckland 1143, New Zealand Phone +64 9 307 2771 Fax +64 9 307 2773

9 October 2009

INDICATIONS FOR USE

510(k) Number: K091803

SmartTrack System Device Name:

Indications for Use:

In clinical trials, where researchers need to know when a patient has actuated their . trial MDI medication;
In clinical practice, where specialists, general practitioners, and nurse educators need . to know if a patient has actuated their prescribed MDI medication.

The SmartTrack is not intended to indicate remaining quantity of medication in an MDI and does not include a dose counting function.

Prescription Use ✓ (21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

Concurrence of CDRH, Office of Device Evaluation (ODE)

L. Schulten

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K091803

Regulation Number and Section

§ 868.5630 Nebulizer.

(a)
Identification. A nebulizer is a device intended to spray liquids in aerosol form into gases that are delivered directly to the patient for breathing. Heated, ultrasonic, gas, venturi, and refillable nebulizers are included in this generic type of device.(b)
Classification. Class II (performance standards).