(221 days)
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No
The description focuses on data collection, reporting, and remote device management, with no mention of AI or ML algorithms for analysis or interpretation.
No.
InfoSmart™ is a software application for remote collection and management of device usage and therapeutic information; it does not directly provide therapy.
No
The device is a software application for managing and reporting on sleep therapy data from compatible flow generators, including compliance, AHI, leak, and pressure. While it provides therapeutic information and reports, it does not actively diagnose conditions; instead, it reports on data that clinicians can use for diagnosis or management.
Yes
The device is described as a "software application" and a "software reporting tool" that interacts with compatible medical devices but is not itself a hardware component. While it receives data from hardware devices, the device being cleared is the software itself.
Based on the provided information, InfoSmart™ is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for remote collection and management of device usage and therapeutic information from OSA Flow generators, therapy reporting, and adjustment of device settings. This is related to managing a patient's therapy and device, not performing diagnostic tests on biological samples.
- Device Description: The description focuses on reporting sleep therapy data (compliance, AHI, leak, pressure), managing patient and equipment information, and facilitating communication between healthcare providers. It does not mention analyzing biological samples or providing diagnostic information based on such analysis.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analysis of biological samples (blood, urine, tissue, etc.)
- Detection or measurement of analytes in biological samples
- Providing information for the diagnosis, monitoring, or prognosis of a disease or condition based on biological sample analysis.
InfoSmart™ appears to be a software tool for managing data and settings related to a medical device used for sleep therapy. While it provides information about the patient's therapy, this information is derived from the device's operation and the patient's interaction with it, not from in vitro analysis of biological samples.
N/A
Intended Use / 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.
Product codes
BZD
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Office, hospital or other clinical setting
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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.
Clinical Performance Data: Clinical tests were not required to demonstrate the safety and effectiveness of InfoSmart™. Product functionality has been adequately assessed by non-clinical tests.
Key Metrics
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Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 868.5905 Noncontinuous ventilator (IPPB).
(a)
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.(b)
Classification. Class II (performance standards).
0
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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
1
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 (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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 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
2
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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FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
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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 |
| East Tamaki | |
| Auckland 2013, New Zealand | |
| Telephone: +64 9 574 0100 | |
| Fax: +64 9 574 0158 | |
| Trade name | F&P InfoSmart™ |
| Common name | InfoSmart |
| Classification name | Non Continuous Ventilator (IPPB) |
| Class II (21 CFR §868.5905) | |
| 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/
technological
characteristic | Subject device
(InfoSmart™) | Predicate device
(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
compliance reports | Device usage and compliance
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
data transfer options | Support for web based data
transfer options | |
| | On-premises variant: | | |
| | Centralised database | | |
| | Device usage and
compliance reports | | |
| | Efficacy reports | | |
| | Settings management | | |
| | Equipment management | | |
| | Patient management | | |
| Data upload | Web variant: | Wireless | Both the InfoSmart™ web variant and
the predicate device software provide
for wireless data transfer. Removable
media and serial data transmission are
also supported by one or more
variants. Regardless of the
transmission medium, identical data is
transmitted. |
| | Wireless, removable
media | | |
| | On-premises variant:
Removable media, serial
cable | | |
| Application
type | InfoSmart™ is provided as
two variants:
Web based application
on-premises application | InfoSmart™ Web is provided
as a Web based application
only. | InfoSmart™ is identical to the
predicate device software wherein it
provides a web variant.
The on-premises of InfoSmart™
consists of 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. |
| Reporting | Therapy compliance and
efficacy reporting. | Therapy compliance and
efficacy reporting. | Identical |
| Operating
Environment | Office, hospital or other clinical
setting | Office, hospital or other
clinical setting | Identical |
| Compatible
Flow
Generators | FPH OSA Flow Generators
(BZD) | FPH OSA Flow Generators
(BZD) | Identical type of therapy devices |
| | InfoSmart™ Web Version:
• F&P ICON series
(Auto/Premo/Novo)
• Sleepstyle 200 Auto
Series (HC254)
InfoSmart on-premises:
• Sleepstyle 200 series
(HC234, 238)
• Sleepstyle 600 Series
(HC604)
• F&P ICON series
(Auto/Premo/Novo) | InfoSmart Web version
• F&P ICON series
(Auto/Premo/Novo)
• Sleepstyle 200 Auto
Series (HC254) | |
| Device Settings
changed by the
software | Web version/
On-premises version:
• Device operating mode
• Therapeutic pressures
• Comfort settings
• User Interface | Web version:
• Device operating mode
• Therapeutic pressures
• Comfort settings
• User Interface | Identical |
| Performance
testing | • Functionality
• Reporting
• Device compatibility | • Functionality
• Reporting
• Device compatibility | Identical
• Reporting- Report testing
focuses on report accuracy,
ensuring all data processing
performed by the software is
accurate, and that this
information is correctly reflected
in therapy reports.
• Functionality- Functional
acceptance testing covers the
functional requirements of the
product, ensuring all functions
and features perform according
to specification.
• Device compatibility testing-
ensures all supported devices
function correctly with the
software and that data is
uploaded from the device.
Testing also ensures that device
settings can be changed by the
software and that these changes
are accurately reflected within
the device. |
| Indications for use | | | |
| Purpose and
function | InfoSmart transmits patient
compliance and efficacy data
from the CPAP devices and
allows this data to be reviewed
by a clinician. In addition,
remote adjustment of CPAP
device settings is possible.
InfoSmart™ Web is intended
for use with F&P ICON series
and Sleepstyle 200 Auto
Series flow generators and
InfoSmart on-premises is
intended for use with F&P
ICON series, Sleepstyle 200
series and Sleepstyle 600
Series flow generators. | The F&P InfoGSM™ is
intended for home and clinical
use as an accessory for the
F&P ICON™ CPAP
devices. The F&P InfoGSM™
transmits patient compliance
and efficacy data from the
CPAP device and allows this
data to be reviewed by a
clinician. In addition, remote
adjustment of CPAP device
settings is possible.
The InfoGSM™ is intended for
use with F&P Healthcare
ICON™ CPAP devices only
and should not be connected
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™. |
5
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.
7
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.