The SmartTouch is intended for single-patient use as an electronic data capture accessory for recording 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, nurses, and educators need to know if . a patient has actuated their prescribed MDI medication.
In self-management, where patients need to track their medication use as part of their . management plan.
The SmartTouch is not intended to indicate remaining quantity of medication in an MDI and does not include a dose counting function.

Device Description

SmartTouch is used to provide a compliance monitoring for use of a Metered Dose Inhaler (MDI).
SmartTouch is a clip-on device that attaches externally around the enclosure of an MDI. Optical and pressure sensor methods are used to detect MDI presence and actuation, and the device logs the usage history of the MDI. The device includes an LED indicator and control button to check device status and manually initiate communications functions. The SmartTouch has a Bluetooth interface to wirelessly exchange data with a communications device.

AI/ML Overview

The provided document describes the SmartTouch device, which is an electronic data capture accessory for recording actuations of Metered Dose Inhalers (MDIs). The submission is a 510(k) premarket notification, indicating the device's substantial equivalence to a legally marketed predicate device (K091803, SmartTrack System, Nexus6 Limited).

1. A table of acceptance criteria and the reported device performance

The document does not explicitly present a table of acceptance criteria and reported device performance in a quantitative manner as typically seen in clinical studies. Instead, it states that "non-clinical testing of the SmartTouch has been carried out to cover functional verification and device performance. This included completion of software and device verification procedures, with performance testing of the MDI presence and actuation sensor system to ensure data is logged accurately for MDI usage. This established correct functionality of the SmartTouch according to requirements."

Therefore, the acceptance criteria are implicitly related to the "correct functionality according to requirements" and "equivalent performance to the predicate device" for the MDI presence and actuation sensor system. The reported device performance is that it met these implicit criteria through bench testing.

Acceptance Criteria (Implicit):
- Accurate detection of MDI presence.
- Accurate detection of MDI actuation.
- Accurate logging of MDI usage history (date and time of actuations).
- Correct functionality of software and device features.
- Compliance with IEC 60601 series standards (electrical safety, EMC, environmental performance).
- Compliance with FCC regulations for radio frequency devices.
- Equivalent performance to the predicate device (K091803) for the MDI presence and actuation sensor system and communications technology.
Reported Device Performance:
- "Performance testing of the MDI presence and actuation sensor system to ensure data is logged accurately for MDI usage. This established correct functionality of the SmartTouch according to requirements."
- "Review and testing of the SmartTouch for compliance to IEC 60601 series standards... and FCC regulations... has been completed by external laboratories."
- "Finished device testing carried out for the SmartTouch indicates it meets design and performance functional requirements."
- "Software verification demonstrates that device features are effective, and functions equivalently to the predicate device meets standard requirements for wireless communications, electrical safety, electromagnetic compatibility, and environmental performance."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify a "test set" in the context of human clinical data or a specific number of MDI actuations or devices used for performance testing. All testing mentioned is non-clinical bench testing.

Sample size for test set: Not specified beyond general "non-clinical testing" and "performance testing."
Data provenance: Not applicable, as no clinical human data or geographical origin of data is mentioned. The testing was described as "bench testing."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. The ground truth for functional verification would have been established by engineering specifications and direct observation of MDI actuation mechanics, not by clinical expert consensus. "External laboratories" conducted compliance testing, implying qualified technical personnel.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. The testing described is functional and compliance bench testing, not a clinical study requiring adjudication of expert interpretations.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is an electronic data capture accessory, not an AI-powered diagnostic or interpretive tool that assists human readers. No MRMC study was conducted.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Yes, in essence, the "performance testing of the MDI presence and actuation sensor system to ensure data is logged accurately for MDI usage" constitutes standalone performance testing of the device's core functionality (the algorithm and sensors for detecting actuation). There is no "human-in-the-loop" component in the primary function of detecting and logging MDI actuations.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The ground truth for the non-clinical performance testing would have been based on:

Direct observation/measurement: For MDI actuation (e.g., physically actuating the MDI and verifying the device logs it).
Engineering specifications/requirements: For correct functionality, software verification, and compliance with standards (IEC, FCC).
Predicate device performance: For establishing equivalence in certain technological characteristics.

8. The sample size for the training set

Not applicable. There is no mention of machine learning or AI models requiring a training set in the classical sense. The device uses optical and pressure sensors with microprocessor control, falling under traditional embedded systems and signal processing, not a system that is "trained" on data.

9. How the ground truth for the training set was established

Not applicable, as no training set for machine learning was used.

Summary

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K 133951

Image /page/0/Picture/1 description: The image shows the date APR 2 5 2014 at the top. Below the date is the logo for nexus6 LTD. The logo is black and white.

Nexus 6 Limited Suite 205, 8 Commerce Street, Auckland 1010, New Zealand PO Box 106-612, Auckland 1143, New Zealand Phone +64 9 307 2771

20 December 2013

510(k) SUMMARY

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

(a)(1) Submitter Information

Company Details:	Refer to information above
Contact Person:	Garth Sutherland, Chief Executive Officer

(a)(2) Name of the Device

Model Number / Name:	SmartTouch
Classification Name:	Nebulizer (Direct Patient Interface)
	Anesthesiology Devices 21 CFR 868 5630 Class II, CAF

(a)(3) Identification of Legally Marketed Devices

K091803, SmartTrack System, Nexus6 Limited

(a)(4) Description of the Device

SmartTouch is used to provide a compliance monitoring for use of a Metered Dose Inhaler (MDI).

SmartTouch is a clip-on device that attaches externally around the enclosure of an MDI. Optical and pressure sensor methods are used to detect MDI presence and actuation, and the device logs the usage history of the MDI. The device includes an LED indicator and control button to check device status and manually initiate communications functions. The SmartTouch has a Bluetooth interface to wirelessly exchange data with a communications device.

(a){5) Statement of the Intended Use

The SmartTouch is intended for single-patient use as an electronic data capture accessory for recording 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, nurses, and educators need to know if . a patient has actuated their prescribed MDI medication.

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In self-management, where patients need to track their medication use as part of their management plan.
The SmartTouch 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 SmartTouch are largely equivalent to the predicate device 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 communications device to upload MDI usage data; and capability to provide compliance data for further analysis using remote review software.

The sensor technology used to detect MDI actuation is different from the predicate device, as is the communications technology. These aspects of the device have been verified by non-clinical testing to establish equivalent performance to the predicate device.

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

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

Review and testing of the SmartTouch for compliance to IEC 60601 series standards for electrical safety, electromagnetic compatibility, and environmental performance; and FCC regulations for radio frequency devices; has been completed by external laboratories.

(b)(2) Discussion of the Clinical Tests

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

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

Finished device testing carried out for the SmartTouch indicates it meets design and performance functional requirements. Software verification demonstrates that device features are effective, and functions equivalently to the predicate device meets standard requirements for wireless communications, electrical safety, electromagnetic compatibility, and environmental performance.

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

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

April 25, 2014

Nexus6, Ltd. Mr. Garth Sutherland Chief Executive Officer Suite 205 8 Commerce Street Auckland, 1010 New Zeland

Re: K133951

Trade/Device Name: SmartTouch Regulation Number: 21 CFR 868.5630 Regulation Name: Nebulizer (Nebulizer) Regulatory Class: Class H Product Code: CAF Dated: April 22, 2014 Received: April 23, 2014

Dear Mr. Sutherland,

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. 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 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. Garth Sutherland

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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR 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.htm 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.

Sincerely yours,

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Erin I. Keith, M.S. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Nexus6 Limited Suite 205, 8 Commerce Street, Auckland 1010, New Zealand PO Box 106-612, Auckland 1143, New Zealand Phone +64 9 307 2771

20 December 2013

INDICATIONS FOR USE

KI33951 510(k) Number:

SmartTouch Device Name:

Indications for Use:

The SmartTouch is intended for single-patient use as an electronic data capture accessory for recording 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, nurses, and educators need to know if . a patient has actuated their prescribed MDI medication.
In self-management, where patients need to track their medication use as part of their . management plan.

The SmartTouch 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)

Deepika A*Lakh 2014.04.25

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).