(197 days)
Not Found
No
The description focuses on data transmission, storage, and display, with no mention of AI/ML algorithms for data analysis or decision-making.
No
The device is an accessory that transmits data and allows for remote adjustment of settings for a CPAP device; it does not directly provide therapy.
No
The device transmits patient compliance and efficacy data for review and remote adjustment of CPAP device settings, which are functions for monitoring and controlling a therapy device, not for diagnosing a condition.
No
The device description explicitly states that the system consists of both the "InfoGSM" and "InfoSmart Web Software". The InfoGSM is described as an "accessory module that attaches via USB cable" and includes a "wireless modem", indicating it is a hardware component.
Based on the provided information, the F&P InfoGSM™ is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to transmit patient compliance and efficacy data from a CPAP device and allow for remote adjustment of CPAP settings. This is related to monitoring and managing a patient's therapy, not performing diagnostic tests on biological samples.
- Device Description: The device is described as an accessory that connects to a CPAP device to transfer data wirelessly. It does not interact with biological samples or perform any diagnostic analysis.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring specific analytes
- Providing diagnostic information about a disease or condition
The F&P InfoGSM™ is a data transmission and remote management system for a medical device (CPAP). Its function is to facilitate the monitoring and adjustment of therapy based on data collected by the CPAP device itself, not to perform a diagnostic test.
N/A
Intended Use / Indications for Use
The F&P InfoGSM™ is intended for home and clinical use as an accessory for the F&P ICON™ CPAP device. 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.
Product codes
BZD
Device Description
The InfoGSM is an accessory for use with Fisher & Paykel Healthcare !CON Series CPAP devices to provide wireless compliance monitoring and remote settings update functions. The system consists of the InfoGSM and InfoSmart Web Software.
- InfoGSM is an accessory module that attaches via USB cable to the data output port of Fisher & Paykel Healthcare ICON CPAP devices. Compliance data is transferred from the ICON CPAP and uploaded via wireless modem to a secure database server.
- InfoSmart Web is server database and internet application software for review of compliance data uploaded from the InfoGSM. It includes display, reporting, and data management functions to assist in assessing CPAP usage and effectiveness, and allows for remotely updating ICON CPAP device settings.
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
home and clinical use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical testing of the InfoGSM has been carried out to cover functional verification and device performance. This included completion of software verification procedures, with performance testing of the modem and software to ensure data is transferred, uploaded, and displayed accurately, and that CPAP settings updates were accurately communicated back to the device. This established correct functionality of the InfoGSM according to requirements.
Third party testing of the InfoGSM for compliance to IEC 60601 series standards for electrical safety and electromagnetic compatibility, IEC 60068 series standards for environmental testing, and FCC and CTIA PTCRB industry certification requirements for GSM mobile devices, will be completed by accredited laboratories before marketing of the device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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
Image /page/0/Picture/0 description: The image shows the logo for Fisher & Paykel Healthcare. The logo is black and white and features the company name in a bold, sans-serif font. Above the logo is the text "K110316".
AUG 1 9 2011
4 August 2011
Fisher & Paykel Healthcare Limited 15 Maurice Paykel Place, East Tamaki P O Box 14 348, Panmure Telephone: +64 9 574 0100 Facsimile: +64 9 574 0158 Website: www.fphcare.com
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} Contact Details
| Company Details: | Refer to information above. |
|---|---|
| Contact Person: | James Thompson, Regulatory Affairs Manager - OSA |
(a)(2) Name of the Device
Model Number / Name: InfoGSM Classification Name: Noncontinuous Ventilator (IPPB) Anesthesiology Devices 21 CFR §868.5905 Class II, BZD
(a)(3) Identification of Legally Marketed Devices
K081029 SleepStyle 200 Auto Series HC254 Fisher & Paykel Healthcare Ltd K083862 MedApps 2.0 Remote Patient Monitoring System MedApps Inc
(a)(4) Description of the Device
The InfoGSM is an accessory for use with Fisher & Paykel Healthcare !CON Series CPAP devices to provide wireless compliance monitoring and remote settings update functions. The system consists of the InfoGSM and InfoSmart Web Software.
- InfoGSM is an accessory module that attaches via USB cable to the data output port of Fisher & Paykel Healthcare ICON CPAP devices. Compliance data is transferred from the ICON CPAP and uploaded via wireless modem to a secure database server.
- InfoSmart Web is server database and internet application software for review of compliance data uploaded from the InfoGSM. It includes display, reporting, and data management functions to assist in assessing CPAP usage and effectiveness, and allows for remotely updating ICON CPAP device settings.
1
(a)(5) Statement of the Intended Use
The F&P InfoGSM™ is intended for home and clinical use as an accessory for the F&P ICON™ CPAP device. 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.
{a)(6) Technological Characteristics Summary
Technological characteristics of the InfoGSM system are equivalent to the predicate devices listed above. Equivalent features between the devices include: transfer of compliance and efficacy data from an attached CPAP device; microprocessor control and use of a pre-approved RF wireless module; power supply from a rechargeable internal battery; interface to a secure server database via RF wireless technology to upload CPAP usage data; and website review software providing for patient data review and reporting functions.
(b)(1)_Discussion of the Non-Clinical Tests
Non-clinical testing of the InfoGSM has been carried out to cover functional verification and device performance. This included completion of software verification procedures, with performance testing of the modem and software to ensure data is transferred, uploaded, and displayed accurately, and that CPAP settings updates were accurately communicated back to the device. This established correct functionality of the InfoGSM according to requirements.
Third party testing of the InfoGSM for compliance to IEC 60601 series standards for electrical safety and electromagnetic compatibility, IEC 60068 series standards for environmental testing, and FCC and CTIA PTCRB industry certification requirements for GSM mobile devices, will be completed by accredited laboratories 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 InfoGSM 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 InfoGSM 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 specified standard requirements for electrical safety, electromagnetic compatibility, environmental performance, and industry certification requirements for GSM mobile devices, before marketing,
This information indicates that the InfoGSM is equivalent to the predicate devices in terms of device safety and effectiveness.
2
13 June 2011
INDICATIONS FOR USE
510(k) Number: K110316
Device Name: InfoGSM
Indications for Use:
The F&P InfoGSM™ is intended for home and clinical use as an accessory for the F&P ICON™ CPAP device. 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.
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)
.. I
3
Image /page/3/Picture/1 description: The image shows the seal for the Department of Health & Human Services USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the seal is an abstract symbol that resembles three stylized human figures.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Mr. James Thompson Regulatory Affairs Manager - OSA Fisher & Paykel Healthcare Limited 15 Maurice Paykel Place, East Tamaki Auckland New Zealand 1701
AUG 1 9 2011
Re: K110316
Trade/Device Name: InfoGSM Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator Regulatory Class: II Product Code: BZD Dated: August 4, 2011 Received: August 5, 2011
Dear Mr. Thompson:
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.
4
Page 2 – Mr. Thompson
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that I DA 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/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.
Anthony D. Anzar
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
5
13 June 2011
INDICATIONS FOR USE
510(k) Number: K110316
Device Name: InfoGSM
Indications for Use:
The F&P InfoGSM™ is intended for home and clinical use as an accessory for the F&P ICON™ CPAP device. 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.
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. Schultheis
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
110316 510(k) Number: