iCodeConnect

K160127 · 3B Medical, Inc. · BZD · Nov 10, 2016 · Anesthesiology

Device Facts

• Record ID: K160127
• Device Name: iCodeConnect
• Applicant: 3B Medical, Inc.
• Product Code: BZD · Anesthesiology
• Decision Date: Nov 10, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5905
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

iCodeConnect, in conjunction with a Luna CPAP or Auto-CPAP device, is intended for use in treating obstructive sleep apnea (OSA) on adult patients (>30 kg). iCodeConnect is intended to augment the standard follow-up care of patients diagnosed with obstructive sleep apnea by displaying usage and therapeutic information that has been transmitted from the patient's Luna CPAP or Auto-CPAP therapy device located in the home to the clinician or healthcare professional. iCodeConnect also provides remote settings capabilities.

Device Story

iCodeConnect is a web-based patient management system for remote monitoring and configuration of Luna CPAP/Auto-CPAP devices. Input data includes usage and therapeutic information collected by the CPAP device in the home. Data is transmitted to the iCodeConnect platform via manual entry, SD card, or a USB-connected Wi-Fi module. The system stores and displays this data for clinicians to review patient compliance and efficacy. Clinicians use the web interface to remotely update therapy settings (pressure, mode, comfort) on the patient's device. This workflow replaces manual SD card mailing, enabling timely data collection and remote clinical intervention. Benefits include improved follow-up care efficiency and remote management of OSA therapy.

Clinical Evidence

No clinical data. Safety and effectiveness were demonstrated through non-clinical bench testing, including functional verification, software validation, and compliance with IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, ISO 14971, and FCC 47 CFR Part 15.

Technological Characteristics

Web-based software platform and USB-connected Wi-Fi module. Connectivity via Wi-Fi. Power supplied by host CPAP device. Type BF applied part. IP22 ingress protection. Non-sterile, reusable. Software performs data storage, display, and remote parameter configuration.

Indications for Use

Indicated for adult patients (>30 kg) diagnosed with obstructive sleep apnea (OSA) to augment standard follow-up care via remote monitoring and settings adjustment of Luna CPAP or Auto-CPAP devices.

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

• EasyCare Online (K093684)

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

November 10, 2016

3B Medical, Inc. Alex Lucio Vice President 799 Overlook Drive Winter Haven, Florida 33884

Re: K160127

Trade/Device Name: iCodeConnect Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: Class II Product Code: BZD Dated: October 10, 2016 Received: October 12, 2016

Dear Alex Lucio:

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 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.

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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) K160127

Device Name iCodeConnect

#### Indications for Use (Describe)

iCodeConnect, in conjunction with a Luna CPAP or Auto-CPAP device, is intended for use in treating obstructive sleep apnea (OSA) on adult patients (>30 kg).

iCodeConnect is intended to augment the standard follow-up care of patients diagnosed with obstructive sleep apnea by displaying usage and therapeutic information that has been transmitted from the patient's Luna CPAP or Auto-CPAP therapy device located in the home to the clinician or healthcare professional. iCodeConnect also provides remote settings capabilities.

| Type of Use (Select one or both, as applicable) | |
|--------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------|
| <span> <span style="text-decoration: underline;"></span>Prescription Use (Part 21 CFR 801 Subpart D) </span> | <span>Over-The-Counter Use (21 CFR 801 Subpart C)</span> |

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# 510(k) Summary

| Device Trade Name | iCodeConnect |
|--------------------------|--------------------------------------------------------------------------------|
| Common/Usual Name | Noncontinuous ventilator (IPPB) |
| Date Prepared | November 10, 2016 |
| Sponsor Identification | 3B Medical, Inc.<br>799 Overlook Drive<br>Winter Haven, FL 33884 |
| Phone | 863-226-6285 |
| Fax | 863-226-6284 |
| Email | [e-mail] |
| Submission Correspondent | Alex Lucio<br>3B Medical, Inc.<br>799 Overlook Drive<br>Winter Haven, FL 33884 |
| Phone | 863-226-6285 |
| Fax | 863-226-6284 |
| Email | [e-mail] |

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| Establishment Registration | # 3008566132 |
|----------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| BMC Medical CO., LTD<br>5/F Main Building No.19Gucheng Street<br>West, Shijingshan,Beijing, CHINA 100043 | |
| Classification | Class II Device |
| Classification Name | Non-continuous ventilator |
| Classification Panel | Medical Device |
| Classification Reference | 21 CFR 878.5905 |
| Products Code | BZD |
| Medical Specialties | Anesthesiology |
| Predicate Device(s) | EasyCare Online (K093684) |
| Reason for Submission: | New Device |
| Intended Use | iCodeConnect, in conjunction with a Luna CPAP<br>or Auto-CPAP device, is intended for use in<br>treating obstructive sleep apnea (OSA) on adult<br>patients (>30 kg).<br>iCodeConnect is intended to augment the standard<br>follow-up care of patients diagnosed with<br>obstructive sleep apnea by displaying usage and<br>therapeutic information that has been transmitted<br>from the patient's Luna CPAP or Auto-CPAP<br>therapy device located in the home to the clinician<br>or healthcare professional. iCodeConnect also<br>provides remote settings capabilities. |
| Device Description | iCodeConnect is a web based patient management<br>system used to store and manage sleep compliance<br>and efficacy data uploaded from a Luna CPAP or<br>Auto-CPAP device.<br>iCodeConnect allows device patient data to be |

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uploaded using a variety of methods, including manual entry, SD Card, and wireless transmission. Use of wireless transmission (i.e. WiFi) can provide wireless compliance monitoring and remote settings update functions.

For wireless transmission, iCodeConnect consists of the wireless data transmission module Wi-Fi kit and web based iCodeConnect patient management software. TheWi-Fi Kit is intended to be used in conjunction with the Luna CPAP System (E-20C-H-O), Auto-CPAP System (E-20A-H-O / E-20AJ-H-O), which were cleared in K141770.

1) iCodeConnect Software is an analysis and management platform for the patient's therapy data. This platform, adopting the form of a website, not only realizes the uniform management of the patient's data and the information of the provider, the doctor and the patient, but also allows for the Wi-Fi Kit or other wireless communication module to transmit data and remotely updating therapy device settings, which reduces the inconvenience brought by the traditional mailing of SD card and makes data collection more timely.

Wi-Fi Kit is an accessory module that attaches via USB cable to the data output port of a Luna® CPAP or Auto-CPAP devices. The wireless module Wi-Fi Kit uploads the device's therapy data to the iCodeConnect software with the help of Wi-Fi off-the-shelf technology. After connecting to the internet. the wireless kit shall automatically collect the user information, statistical information and detailed information in the therapy device for uploading.

Non-Clinical Testing Non-clinical testing of the iCodeConnect has been

3

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carried out to cover functional verification and device performance. The proposed iCodeConnect has been tested to appropriate standards and other applicable requirements. The device was designed and tested according to:

- IEC 60601-1-2:2014, medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance -Collateral compatibility - Requirements and tests
- IEC 60601-1 Medical Electrical Equipment-Part 1: General requirements for basic safety and essential performance.
- IEC | 60601-1-1 | Medical | | Electrical Equipment- Part 1-11: General requirements for basic safety and essential performance-Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment.
- ISO14971:2007 | Medical | | devices Application of risk management to medical devices
- FCC Regulation 47 CFR Part 15 Radio Frequency Devices

Additional design considerations were applied based on published guidance and draft guidance documents from FDA:

1. FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (May 11, 2005)

2. FDA Guidance - Design Considerations for Devices Intended for Home Use (Nov24, 2014)

FDA Guidance -Content of of Premarket 3. Submissions for Management of Cybersecurity in Medical Devices (Oct 2, 2014)

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4. FDA Guidance - Radio Frequency Wireless Technology in Medical Devices (Aug 14, 2013)

All tests confirmed that iCodeConnect met the predetermined and demonstrated substantial equivalence to the predicate device.

Clinical Testing Clinical testing was not required to demonstrate the safety and effectiveness of the iCodeConnect. The product functionality has been adequately assessed

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## Substantial Equivalence

| Features/<br>Function | Proposed Device | Predicate Device | Comments |
|--------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------|
| | iCodeConnect<br>(510K Number: K160127) | EasyCare Online<br>(510K Number: K093684) | |
| Product Code | BZD | BZD | Same as predicate |
| Regulation<br>Number | 868.5905 | 868.5905 | Same as predicate |
| Regulation<br>Name | Noncontinuous<br>ventilator (IPPB) | Noncontinuous<br>ventilator (IPPB) | Same as predicate |
| Intended Use | iCodeConnect, in conjunction with a Luna<br>CPAP or Auto-CPAP device, is intended for<br>use in treating obstructive sleep apnea (OSA)<br>on adult patients (>30 kg).<br><br>iCodeConnect is intended to augment the<br>standard follow-up care of patients diagnosed<br>with obstructive sleep apnea by displaying<br>usage and therapeutic information that has been<br>transmitted from the patient's Luna CPAP or<br>Auto-CPAP therapy device located in the home<br>to the clinician or healthcare professional.<br>iCodeConnect also provides remote settings<br>capabilities. | EasyCare Online is intended to<br>augment the standard follow-up care<br>of<br>patients diagnosed with<br>obstructive sleep apnea by<br>displaying usage and therapeutic<br>information that has been transmitted<br>from the patient's flow generator<br>located in the home to the care giver.<br>EasyCare Online also provides<br>remote settings capabilities.<br><br>It is intended to be used by<br>Clinicians in conjunction with<br>ResMed compatible flow generators. | |
| Features/<br>Function | Proposed Device | Predicate Device | |
| | iCodeConnect<br>(510K Number: K160127) | EasyCare Online<br>(510K Number: K093684) | Comments |
| Device<br>Composition | A web-based software and a wireless module | A web-based software and a wireless<br>module | Same as predicate |
| Software<br>Function | The iCodeConnect Software is designed to<br>display the data which was uploaded from the<br>CPAP / Auto-CPAP device, store the<br>information in a database and provide a secure<br>interface, allowing the user to query and view<br>patient and treatment information.<br>The iCodeConnect Software supports applying<br>new settings to the CPAP/Auto-CPAP device<br>remotely from the clinician's PC. | The Server System of Easycare<br>Online is designed to display the<br>data which was got from the flow<br>generator, store the information in a<br>database and provide a secure<br>interface, allowing the user to query<br>and view patient and treatment<br>information.<br>The Server System Software<br>supports to apply new settings to the<br>flow generator device remotely from<br>the clinician's PC. | Same as predicate |
| Remoter<br>Settings<br>Change<br>Function | Flow generator settings can be changed,<br>through wireless module can be made from the<br>clinicians' PC by iCodeConnect Software. | Flow generator settings can<br>be<br>changed, through wireless module<br>can be made from the clinicians' PC<br>by Server System. | Same as predicate |
| Data Transfer<br>Technology | Wireless | Wireless | Same as predicate |
| Connectivity | WiFi | GSM | Both<br>the<br>wireless<br>modules<br>are<br>pre-<br>approved. |
| Features/<br>Function | Proposed Device | Predicate Device | |
| | iCodeConnect<br>(510K Number: K160127) | EasyCare Online<br>(510K Number: K093684) | Comments |
| Therapy<br>Setting | Pressure<br>Mode<br>Comfort | Pressure<br>Mode<br>Comfort | Same as predicate |
| Power<br>Requirements | The wireless module is powered via electrical<br>connection form the flow generator. | The wireless module is powered via<br>electrical connection form the flow<br>generator. | Same as predicate |
| Environmental<br>Specifications | Operating temperature:<br>5°C to 35°C<br>Operating humidity :<br>15% ~ 93%, Non-condensing<br>Storage and transport temperature:<br>-25°C ~ 70°C<br>Storage and transport humidity:<br>≤ 93%, Non-condensing | Operating temperature:<br>5°C to 35°C<br>Operating humidity :<br>10 to 95% non-condensing<br>Storage and transport temperature:<br>-20°C to 60°C<br>Storage and transport humidity:<br>10 to 95% non-condensing | Both the devices meet<br>the requirement. |
| Degree of<br>Protection<br>Against<br>Electric Shock | Type BF Vertical Applied Part | Type BF Vertical Applied Part | Same as predicate |
| Degree of<br>Protection<br>Against Ingress<br>of Water | IP22 | IP21 | Both the devices meet<br>the requirement. |
| Sterilization/<br>Reuse | Not provided sterile<br>Reusable with cleaning instructions | Not provided sterile<br>Reusable with cleaning instructions | Same as predicate |

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510K) Summary

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510K) Summary

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510K) Summary

iCodeConnect

## Conclusions

Hardware testing carried out for iCodeConnect indicates it meets design and performance functional requirements. Software verification demonstrates that device features and the system configuration functions are substantially equivalent to the predicate device. This information indicates that the iCodeConnect is substantially equivalent to the predicate device.