F&P InfoSmart

K161686 · Fisher & Paykel Healthcare, Ltd. · BZD · Jan 24, 2017 · Anesthesiology

Device Facts

• Record ID: K161686
• Device Name: F&P InfoSmart
• Applicant: Fisher & Paykel Healthcare, Ltd.
• Product Code: BZD · Anesthesiology
• Decision Date: Jan 24, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5905
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

InfoSmart™ is a software application for use with compatible Fisher & Paykel Healthcare OSA Flow generators. It allows for remote collection and management of device usage and therapeutic information. It also allows for remote therapy reporting and adjustment of device settings by a clinician.

Device Story

InfoSmart™ is a software reporting tool for Fisher & Paykel Healthcare OSA flow generators; collects and manages patient therapy data (compliance, AHI, leak, pressure). Data input via serial cable, USB, or wireless communications module; processed into reports for clinician review. Clinicians use the software to monitor patient compliance/efficacy, manage equipment/patient information, and remotely adjust device settings (operating mode, therapeutic pressures, comfort settings). Used in clinical settings (office, hospital); operated by healthcare providers. Benefits include streamlined therapy management and remote access to patient data, facilitating clinical decision-making.

Clinical Evidence

No clinical data. Safety and effectiveness demonstrated via non-clinical verification and validation testing, including functional acceptance testing, report accuracy testing, and device compatibility testing.

Technological Characteristics

Software application (web-based or on-premises). Supports wireless, serial cable, and USB data transfer. Compatible with F&P ICON series, Sleepstyle 200 series, and Sleepstyle 600 series flow generators. Functions include data collection, report generation, and remote device setting adjustment.

Indications for Use

Indicated for clinicians managing patients using compatible Fisher & Paykel Healthcare OSA Flow generators to collect, manage, and report therapy data and adjust device settings.

Regulatory Classification

Identification

A noncontinuous ventilator (intermittent positive pressure breathing-IPPB) is a device intended to deliver intermittently an aerosol to a patient's lungs or to assist a patient's breathing.

Predicate Devices

• InfoGSM (K110316)

Submission Summary (Full Text)

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

January 24, 2017

Fisher & Paykel Healthcare Ltd. Jayanti Karandikar Regulatory Affairs Specialist 15 Maurice Paykel Place East Tamaki, Auckland 2013 New Zealand

Re: K161686 Trade/Device Name: F&P InfoSmart™ Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: Class II Product Code: BZD Dated: December 16, 2016 Received: December 22, 2016

Dear Jayanti Karandikar:

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.

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

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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 Industry and Consumer Education at its toll-free number [phone] or [phone] 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Tejashri Purohit-Sheth, M.D.

Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR

Tina Kiang, Ph.D. 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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# Indications for Use

510(k) Number (if known) K161686

Device Name F&P InfoSmart™

### Indications for Use (Describe)

InfoSmart™ is a software application for use with compatible Fisher & Paykel Healthcare OSA Flow generators. It allows for remote collection and management of device usage and therapeutic information. It also allows for remote therapy reporting and adjustment of device settings by a clinician.

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

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

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F&P InfoSmart- Traditional 510(k)

Image /page/3/Picture/1 description: The image shows the logo for Fisher & Paykel Healthcare. The words "Fisher & Paykel" are in a larger font size on the top line, with a line underneath. The word "Healthcare" is in a smaller font size on the second line. The text is in blue.

### 510(k) Summary 5

| Contact person/submitter | Jayanti Karandikar |
|--------------------------|-----------------------------------------------------------------------------------------------------------------------------------|
| Date prepared | 22 December 2016 |
| Contact details | Address: 15 Maurice Paykel Place<br>East Tamaki<br>Auckland 2013, New Zealand<br>Telephone: [phone]<br>Fax: [phone] |
| Trade name | F&P InfoSmart™ |
| Common name | InfoSmart |
| Classification name | Non Continuous Ventilator (IPPB)<br>Class II (21 CFR §868.5905)<br>Product code BZD (Anaesthesiology) |
| Predicate device | InfoGSM (K110316) |

#### 5.1 Device Description

InfoSmart™ is a software reporting tool which provides reports on sleep therapy data including compliance, AHI, leak and pressure. This software can be used to report on data from compatible Fisher & Paykel Healthcare medical devices.

The software enables the Health Service Provider to:

- Access and review a patient's compliance and efficacy reports
- . Change device settings
- Manage equipment information ●
- . Manage patient information
- Share the above data with other health service providers and organisations involved in a patient's therapy.

InfoSmart™ may be provided as an on-premises software application, or a web application. Data from a compatible device can be transferred to InfoSmart™ in a number of ways; including a serial cable, a USB stick, or wirelessly though a communications module. Data is transferred to a central database from which it can be accessed and displayed on the health service provider's computer.

#### 5.2 Intended Use and Indications for Use

InfoSmart™ is a software application for use with compatible Fisher & Paykel Healthcare OSA Flow generators. It allows for remote collection and management of device usage and therapeutic information. It also allows for remote therapy reporting and adjustment of device settings by a clinician.

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Image /page/4/Picture/1 description: The image shows the logo for Fisher & Paykel Healthcare. The words "Fisher & Paykel" are in a large, bold, blue font. Below that, the word "HEALTHCARE" is in a smaller, bold, blue font with a line above it.

### 5.3 Technological Characteristics Comparison

| Design/<br>technological<br>characteristic | Subject device<br>(InfoSmart™) | Predicate device<br>(InfoGSM ) | Comments |
|-----------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Features | Web variant: | Web variant: | Comments |
| | Centralised database | Centralised database | InfoSmart™ provides similar features to its predicate with the web variant being identical. |
| | Device usage and<br>compliance reports | Device usage and compliance<br>reports | The on-premises variant has similar features to the web except that it does not support web based data transfer. Data is still communicated to the central database via other means ie serial cable, removable media via USB. |
| | Efficacy reports | Efficacy reports | |
| | Settings management | Settings management | |
| | Equipment management | Equipment management | |
| | Patient management | Patient management | |
| | Support for web based<br>data transfer options | Support for web based data<br>transfer options | |
| | On-premises variant: | | |
| | Centralised database | | |
| | Device usage and<br>compliance reports | | |
| | Efficacy reports | | |
| | Settings management | | |
| | Equipment management | | |
| | Patient management | | |
| Data upload | Web variant: | Wireless | Both the InfoSmart™ web variant and<br>the predicate device software provide<br>for wireless data transfer. Removable<br>media and serial data transmission are<br>also supported by one or more<br>variants. Regardless of the<br>transmission medium, identical data is<br>transmitted. |
| | Wireless, removable<br>media | | |
| | On-premises variant:<br>Removable media, serial<br>cable | | |
| Application<br>type | InfoSmart™ is provided as<br>two variants:<br>Web based application<br>on-premises application | InfoSmart™ Web is provided<br>as a Web based application<br>only. | InfoSmart™ is identical to the<br>predicate device software wherein it<br>provides a web variant.<br><br>The on-premises of InfoSmart™<br>consists of a software application that<br>can be installed on a local PC or<br>server. Similar to its web counterpart,<br>InfoSmart™ on-premises version,<br>allows users to download data to the<br>system, generate reports and adjust<br>device settings. |
| Reporting | Therapy compliance and<br>efficacy reporting. | Therapy compliance and<br>efficacy reporting. | Identical |
| Operating<br>Environment | Office, hospital or other clinical<br>setting | Office, hospital or other<br>clinical setting | Identical |
| Compatible<br>Flow<br>Generators | FPH OSA Flow Generators<br>(BZD) | FPH OSA Flow Generators<br>(BZD) | Identical type of therapy devices |
| | InfoSmart™ Web Version:<br>• F&P ICON series<br>(Auto/Premo/Novo)<br>• Sleepstyle 200 Auto<br>Series (HC254)<br>InfoSmart on-premises:<br>• Sleepstyle 200 series<br>(HC234, 238)<br>• Sleepstyle 600 Series<br>(HC604)<br>• F&P ICON series<br>(Auto/Premo/Novo) | InfoSmart Web version<br>• F&P ICON series<br>(Auto/Premo/Novo)<br>• Sleepstyle 200 Auto<br>Series (HC254) | |
| Device Settings<br>changed by the<br>software | Web version/<br>On-premises version:<br>• Device operating mode<br>• Therapeutic pressures<br>• Comfort settings<br>• User Interface | Web version:<br>• Device operating mode<br>• Therapeutic pressures<br>• Comfort settings<br>• User Interface | Identical |
| Performance<br>testing | • Functionality<br>• Reporting<br>• Device compatibility | • Functionality<br>• Reporting<br>• Device compatibility | Identical<br>• Reporting- Report testing<br>focuses on report accuracy,<br>ensuring all data processing<br>performed by the software is<br>accurate, and that this<br>information is correctly reflected<br>in therapy reports.<br>• Functionality- Functional<br>acceptance testing covers the<br>functional requirements of the<br>product, ensuring all functions<br>and features perform according<br>to specification.<br>• Device compatibility testing-<br>ensures all supported devices<br>function correctly with the<br>software and that data is<br>uploaded from the device.<br>Testing also ensures that device<br>settings can be changed by the<br>software and that these changes<br>are accurately reflected within<br>the device. |
| Indications for use | | | |
| Purpose and<br>function | InfoSmart transmits patient<br>compliance and efficacy data<br>from the CPAP devices and<br>allows this data to be reviewed<br>by a clinician. In addition,<br>remote adjustment of CPAP<br>device settings is possible.<br><br>InfoSmart™ Web is intended<br>for use with F&P ICON series<br>and Sleepstyle 200 Auto<br>Series flow generators and<br>InfoSmart on-premises is<br>intended for use with F&P<br>ICON series, Sleepstyle 200<br>series and Sleepstyle 600<br>Series flow generators. | The F&P InfoGSM™ is<br>intended for home and clinical<br>use as an accessory for the<br>F&P ICON™ CPAP<br>devices. The F&P InfoGSM™<br>transmits patient compliance<br>and efficacy data from the<br>CPAP device and allows this<br>data to be reviewed by a<br>clinician. In addition, remote<br>adjustment of CPAP device<br>settings is possible.<br><br>The InfoGSM™ is intended for<br>use with F&P Healthcare<br>ICON™ CPAP devices only<br>and should not be connected<br>to any other device. | InfoSmart™ has a similar purpose over its predicate device software InfoSmart Web in that it allows for remote collection and management of device and therapeutic information. It also allows for adjustment of device settings.InfoSmart™ consists of an on- premises which is a software application that can be installed on a local PC or server.Similar to its web counterpart InfoSmart™ on-premises version, allows users to download data to the system, generate reports and adjust device settings.Expanding the scope to include additional F&P devices does not affect the functionality or safety of InfoSmart™. |

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# F&P InfoSmart– Traditional 510(k)

Image /page/5/Picture/1 description: The image shows the logo for Fisher & Paykel Healthcare. The words "Fisher & Paykel" are on the top line in a bold, sans-serif font. Below that is a horizontal line, and below that is the word "HEALTHCARE" in a smaller, sans-serif font. The text is all in a dark blue color.

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Image /page/6/Picture/1 description: The image shows the logo for Fisher & Paykel Healthcare. The words "Fisher & Paykel" are in a large, bold, sans-serif font, with the "&" symbol connecting the two names. Below this, the word "HEALTHCARE" is written in a smaller, sans-serif font. All the text is in a dark blue color.

The key differences are that InfoSmart™:

- . Has an intended use with an expanded scope to be used with compatible F&P devices versus the predicate which was indicated to be used with the ICON CPAP devices only. Plus the subject device includes an on-premises variant which is to be installed on a PC or server. Introduction of additional compatible F&P devices and an on-premises variant does not introduce any safety or functionality concerns.
- . Supports various means of data transfer. Depending on the variant, data can be obtained from a device via removable media, serial cable or wirelessly. The web variant of InfoSmart™ is identical to the predicate device software where in data can be obtained wirelessly from a compatible device via a communications module. The on-premises variant uses other methods via removable media or serial cable which does not affect the data transmitted.

#### 5.4 Non-Clinical Performance Data

Verification and validation testing on the subject InfoSmart™ was carried out ensuring data was transferred, uploaded and displayed accurately and that device settings updates were accurately communicated back to the compatible device. All tests confirmed that the software met the predetermined acceptance criteria.

The testing above also demonstrated comparable safety and effectiveness of InfoSmart™ in comparison to the predicate.

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Image /page/7/Picture/1 description: The image shows the logo for Fisher & Paykel Healthcare. The words "Fisher & Paykel" are in a bold, sans-serif font, with the "&" symbol connecting the two names. A horizontal line underlines the company name. Below the line, the word "HEALTHCARE" is written in a similar bold, sans-serif font, completing the logo.

#### Clinical Performance Data 5.5

Clinical tests were not required to demonstrate the safety and effectiveness of InfoSmart™. Product functionality has been adequately assessed by non-clinical tests.

#### 5.6 Conclusions

Results obtained from non-clinical testing demonstrate that, InfoSmart™ meets the design and functional requirements providing performance and is as safe and as effective as the predicate device. The differences between the subject and predicate do not raise new issues of safety and effectiveness.

It is therefore concluded that InfoSmart™ is substantially equivalent to the predicate device.