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 Description

iCodeConnect is a web based patient management system used to store and manage sleep compliance and efficacy data uploaded from a Luna CPAP or Auto-CPAP device.
iCodeConnect allows device patient data to be 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. The Wi-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.

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.

AI/ML Overview

The provided text describes the iCodeConnect device and compares it to a predicate device, EasyCare Online, to establish substantial equivalence. However, it explicitly states that clinical testing was NOT required to demonstrate the safety and effectiveness of iCodeConnect. Therefore, the document does not contain information about acceptance criteria for device performance based on a clinical study, nor does it detail a study proving the device meets such criteria.

The document focuses on non-clinical testing for functional verification and device performance, and software verification to demonstrate substantial equivalence to the predicate device.

Here's a breakdown of the information available based on your request, with an emphasis on what is not present:

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

No specific acceptance criteria for a clinical study are provided. The table in the "Substantial Equivalence" section (pages 8-9) compares features and functions of the proposed device (iCodeConnect) with the predicate device (EasyCare Online). This table demonstrates equivalence in various aspects, but these are generally functional and technical specifications, not clinical performance metrics with acceptance criteria.
Reported device performance (clinical): Not applicable, as clinical testing was not performed/required.
Reported device performance (non-clinical/functional): The document states that "Non-clinical testing of the iCodeConnect has been carried out to cover functional verification and device performance. The proposed iCodeConnect has been tested to appropriate standards and other applicable requirements." (page 6). It further concludes that "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." (page 11). No specific quantitative performance metrics from these tests are reported in the summary provided.

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

Not applicable as clinical testing was not conducted. Sample sizes for non-clinical functional testing are not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable as clinical testing was not conducted, and thus there was no "test set" requiring expert-established ground truth in a clinical context.

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

Not applicable as clinical testing was not conducted.

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. The iCodeConnect device is a patient management system for CPAP/Auto-CPAP data and remote settings, not an AI-assisted diagnostic tool that would typically involve an MRMC study.

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

This device is a patient management system and wireless data transmission module. Its "standalone" performance would likely refer to its functional accuracy in data transfer, storage, display, and remote setting capabilities. The document indicates these aspects were verified through non-clinical testing and software verification, concluding they meet design and performance requirements and are substantially equivalent to the predicate (pages 6, 11). However, specific metrics for this "standalone" performance are not provided.

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

Given the absence of clinical testing, there is no mention of ground truth established through expert consensus, pathology, or outcomes data. For functional testing, the "ground truth" would likely be defined by the expected behavior and output based on design specifications and engineering standards.

8. The sample size for the training set

Not applicable. The iCodeConnect is described as a web-based patient management system and a wireless data transmission module. There is no indication it uses machine learning or AI that would require a "training set" in the context of typical clinical algorithm development.

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

Not applicable for the reasons mentioned in point 8.

Summary

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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 (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

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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).

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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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.799 Overlook DriveWinter Haven, FL 33884
Phone	863-226-6285
Fax	863-226-6284
Email	alucio@3bproducts.com
Submission Correspondent	Alex Lucio3B Medical, Inc.799 Overlook DriveWinter Haven, FL 33884
Phone	863-226-6285
Fax	863-226-6284
Email	alucio@3bproducts.com

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Establishment Registration	# 3008566132
BMC Medical CO., LTD5/F Main Building No.19Gucheng StreetWest, 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 CPAPor Auto-CPAP device, is intended for use intreating obstructive sleep apnea (OSA) on adultpatients (>30 kg).iCodeConnect is intended to augment the standardfollow-up care of patients diagnosed withobstructive sleep apnea by displaying usage andtherapeutic information that has been transmittedfrom the patient's Luna CPAP or Auto-CPAPtherapy device located in the home to the clinicianor healthcare professional. iCodeConnect alsoprovides remote settings capabilities.
Device Description	iCodeConnect is a web based patient managementsystem used to store and manage sleep complianceand efficacy data uploaded from a Luna CPAP orAuto-CPAP device.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.

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.

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

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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:

FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (May 11, 2005)
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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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/Function	Proposed Device	Predicate Device	Comments
	iCodeConnect(510K Number: K160127)	EasyCare Online(510K Number: K093684)
Product Code	BZD	BZD	Same as predicate
RegulationNumber	868.5905	868.5905	Same as predicate
RegulationName	Noncontinuousventilator (IPPB)	Noncontinuousventilator (IPPB)	Same as predicate
Intended Use	iCodeConnect, in conjunction with a LunaCPAP or Auto-CPAP device, is intended foruse in treating obstructive sleep apnea (OSA)on adult patients (>30 kg).iCodeConnect is intended to augment thestandard follow-up care of patients diagnosedwith obstructive sleep apnea by displayingusage and therapeutic information that has beentransmitted from the patient's Luna CPAP orAuto-CPAP therapy device located in the hometo the clinician or healthcare professional.iCodeConnect also provides remote settingscapabilities.	EasyCare Online is intended toaugment the standard follow-up careofpatients diagnosed withobstructive sleep apnea bydisplaying usage and therapeuticinformation that has been transmittedfrom the patient's flow generatorlocated in the home to the care giver.EasyCare Online also providesremote settings capabilities.It is intended to be used byClinicians in conjunction withResMed compatible flow generators.
Features/Function	Proposed Device	Predicate Device
	iCodeConnect(510K Number: K160127)	EasyCare Online(510K Number: K093684)	Comments
DeviceComposition	A web-based software and a wireless module	A web-based software and a wirelessmodule	Same as predicate
SoftwareFunction	The iCodeConnect Software is designed todisplay the data which was uploaded from theCPAP / Auto-CPAP device, store theinformation in a database and provide a secureinterface, allowing the user to query and viewpatient and treatment information.The iCodeConnect Software supports applyingnew settings to the CPAP/Auto-CPAP deviceremotely from the clinician's PC.	The Server System of EasycareOnline is designed to display thedata which was got from the flowgenerator, store the information in adatabase and provide a secureinterface, allowing the user to queryand view patient and treatmentinformation.The Server System Softwaresupports to apply new settings to theflow generator device remotely fromthe clinician's PC.	Same as predicate
RemoterSettingsChangeFunction	Flow generator settings can be changed,through wireless module can be made from theclinicians' PC by iCodeConnect Software.	Flow generator settings canbechanged, through wireless modulecan be made from the clinicians' PCby Server System.	Same as predicate
Data TransferTechnology	Wireless	Wireless	Same as predicate
Connectivity	WiFi	GSM	Boththewirelessmodulesarepre-approved.
Features/Function	Proposed Device	Predicate Device
	iCodeConnect(510K Number: K160127)	EasyCare Online(510K Number: K093684)	Comments
TherapySetting	PressureModeComfort	PressureModeComfort	Same as predicate
PowerRequirements	The wireless module is powered via electricalconnection form the flow generator.	The wireless module is powered viaelectrical connection form the flowgenerator.	Same as predicate
EnvironmentalSpecifications	Operating temperature:5°C to 35°COperating humidity :15% ~ 93%, Non-condensingStorage and transport temperature:-25°C ~ 70°CStorage and transport humidity:≤ 93%, Non-condensing	Operating temperature:5°C to 35°COperating humidity :10 to 95% non-condensingStorage and transport temperature:-20°C to 60°CStorage and transport humidity:10 to 95% non-condensing	Both the devices meetthe requirement.
Degree ofProtectionAgainstElectric Shock	Type BF Vertical Applied Part	Type BF Vertical Applied Part	Same as predicate
Degree ofProtectionAgainst Ingressof Water	IP22	IP21	Both the devices meetthe requirement.
Sterilization/Reuse	Not provided sterileReusable with cleaning instructions	Not provided sterileReusable 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.

Regulation Number and Section

§ 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).