3B RESMART CPAP AND AUTO CPAP SYSTEMS, BMC RESMART CPAP AND AUTO CPAP SYSTEMS by 3B MEDICAL, INC

The 3B and BMC RESmart CPAP and Auto CPAP Systems are intended to deliver positive pressure for the treatment of Obstructive Sleep Apnea. The optional integrated humidifier is indicated for the humidification and warming of air from the flow generator device. These devices are intended for single patient use by prescription in the home or hospital/institutional environment on adult patients.

Device Description

The RESmart CPAP and Auto CPAP System is a microprocessorcontrolled, blower-based system that generates positive airway pressure from 4 to 20 cm H2O. The device is intended for use with a patient circuit that is used to connect the device to the patient interface (mask). The RESmart CPAP and Auto CPAP device has been modified to include porting the iCode software to a web-based application. The basic functional and performance characteristic of the RESmart CPAP and Auto CPAP is unchanged from the predicate device RESmart CPAP and Auto CPAP (K110629).

AI/ML Overview

The provided text is a 510(k) Summary for the RESmart CPAP/Auto CPAP device (K131707). It describes modifications made to the iCode software feature of an existing device (K110629), porting it to a web-based application and developing a smartphone application for it.

The key takeaway is that this submission K131707 is NOT about the performance of the CPAP device itself in treating sleep apnea, but rather about the software modifications to the iCode feature, which is used for compliance reporting. The document explicitly states: "The basic functional and performance characteristic of the RESmart CPAP and Auto CPAP is unchanged from the predicate device RESmart CPAP and Auto CPAP (K110629)." and "There are no changes in logic, Rather the extent of the device algorithm, or function. modification is a simple change from a desktop environment to a web server based environment."

Therefore, the acceptance criteria and study information requested in the prompt, particularly those pertaining to medical device performance (e.g., effect size of human readers improving with AI, standalone algorithm performance, ground truth for medical outcomes), are not applicable to this specific 510(k) submission.

Here's the breakdown based on the provided text, focusing on the software modifications:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Software)	Reported Device Performance (Software)
Software Verification & Validation of iCode Report Generator	Demonstrated in "Software Requirement Specifications of iCode Report Generator, App. A" and "System Test Report of iCode Report Generator, App. B".
Software Verification & Validation of iCode Smartphone Application	Demonstrated in "Software Requirements Specification for 3B/BMC iCode Smartphone Applications, App. C" and "System Test Report of iCode Smartphone Application, App. D".
Porting iCode to web-based application without changing logic, algorithm, or function.	Successfully ported to a web-based application ("iCode Report Generator"). "No changes in logic, device algorithm, or function."
Smartphone application's ability to manually enter iCode string.	Smartphone application allows manual entry after optical character recognition (OCR) from a photograph of the device LCD.
Maintenance of substantial equivalence to predicate device (K110629).	"The RESmart CPAP and Auto CPAP System remain substantially equivalent to the RESmart CPAP and Auto CPAP System (K110629)... All tests were verified to meet the required acceptance criteria."

2. Sample Size Used for the Test Set and Data Provenance

Test Set Sample Size: Not applicable. The "test set" here refers to software testing, not clinical data for device performance. The evaluation was focused on the functionality and integrity of the software changes.
Data Provenance: Not applicable, as no clinical data for device performance was generated or used for this specific submission's modifications. The modifications relate to the iCode feature, which reports compliance data from the device, not clinical data about the device's efficacy.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Number of Experts: Not applicable. Ground truth in a clinical sense (e.g., expert consensus on medical images) is not relevant for this software modification. Software verification and validation are typically performed by software engineers and quality assurance personnel.
Qualifications of Experts: The document refers to "internal procedures" for code review and verification, implying software development and QA professionals were involved.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable in the context of clinical expert adjudication. Software testing methodologies (e.g., unit testing, integration testing, system testing, user acceptance testing) would have been used to verify the new software features.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Readers Improve with AI vs. Without AI Assistance

MRMC Study: No.
Effect Size of Human Readers with AI: Not applicable. This device is a CPAP machine, not an AI-assisted diagnostic tool that humans read. The software modifications are for compliance reporting, not clinical interpretation or assistance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Standalone Performance: While the "iCode Report Generator" could be considered an "algorithm" (processing the iCode string to generate reports), its standalone performance in a medical evaluative sense (e.g., diagnostic accuracy) is not applicable. Its function is to accurately process an input string and generate a report, verified through software testing. The smartphone app uses OCR, which is an algorithm, but its performance is in accurately recognizing the characters, not making medical diagnoses.

7. The Type of Ground Truth Used

Type of Ground Truth: For the software modifications, the "ground truth" would be the expected output and behavior based on the software requirements and design specifications. For the OCR component of the smartphone app, the ground truth would be the actual characters displayed on the RESmart LCD.

8. The Sample Size for the Training Set

Training Set Sample Size: Not applicable. There is no mention of a training set in the context of machine learning for medical outcomes. For the OCR component, the vendor would have used training data to develop the OCR model, but its specifics are not provided in this regulatory summary.

9. How the Ground Truth for the Training Set Was Established

Ground Truth for Training Set: Not applicable in a medical device performance context. If referring to the OCR component, the ground truth would have been established by human verification of scanned characters. This information is not provided in the 510(k) summary.

In summary: This 510(k) pertains to software modifications for a compliance reporting feature of an already cleared CPAP device. The evaluation criteria and studies are focused on software verification and validation, ensuring the new web-based and smartphone applications correctly handle the iCode data without altering the device's fundamental medical function or performance. Therefore, many of the typical questions asked about AI/medical device clinical studies are not applicable here.

Summary

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510(k) Summary (K131707)

רשK13170

RESmart CPAP/Auto CPAP

510(k) Summary

Device Trade Name	RESmart CPAP and Auto CPAP
Common/ Usual Name	CPAP System, Auto CPAP System
Date Prepared	31 May, 2013
Sponsor Identification:	3B Medical, Inc.21301 Highway 27 N.Lake Wales, FL 33859	AUG 2 2 2013
Phone:	863-226-6285
Fax:	863-226-6284
Submission Correspondent	Alex LucioVice President3B Medical, Inc.21301 Highway 27 N.Lake Wales, FL 33859863-226-6285863-226-6284alucio@3bproducts.com
Establishment Registration #	3008566132BMC MEDICAL CO., LTD5/f Main Building No. 19Gucheng Street West, ShijingshanBeijing, CHINA 100043
Classification	Class II Device
Classification Panel	Medical Device
Classification Reference	21 CFR 868.5905
Product Code	BZD - Non-continuous Ventilator (Respirator)
Medical Specialties	Anesthesiology
Predicate Device(s)	RESmart CPAP and Auto CPAP System (K110629)

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Intended Use

Device Description:

Please see the Indications for Use Statement in Attachment 5.

Purpose of the Modifications: The purpose of this modification is to port the iCode feature, used to report compliance data for insurance reimbursement, to a web based program. There are no changes in logic, Rather the extent of the device algorithm, or function. modification is a simple change from a desktop environment to a web server based environment.

For those modifications involving a software change, all software has been verified and code reviewed using the methods provided in our internal procedures. The following paragraphs provide a summary of the modifications:

1. Modification is the porting of the iCode feature to a web based application, which is referred to as the "iCode Report Generator."
- . The purpose of the modification is to accommodate the needs of a fast changing marketplace, and is preferable

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to most homecare providers because it is web based, requires no software installation, and may also be used to empower patients by allowing patients to review their sleep data. The entire scheme of iCode is based on reading the device LCD display and recording the character string displayed. There is no software that directly connects, interfaces, or otherwise interacts with the RESmart device. The device modification consists only of porting the feature to a web based version.

Modification for using iCode, for Andriod and iPhone 2. devices, which is referred to as an application.
- The purpose of the modification was developed to . allow users to access the iCode Report Generator using their smartphone. The smartphone application allow manual entry of the iCode string displayed on the RESmart LCD display on the user's cell phone. The smartphone app interfaces with iCode Report Generator and forwards the iCode string in the URL call. The application promps the user to take a photograph, point and click. Using optical character recognition, the character string is extracted from the photograph, and then the string is passed to the iCode Report Generator.

(K110629) in that they have the same intended use, same

Non-clinical Testing	Non-clinical testing includes software verification and validationof the iCode Report Generator and iCode Smartphoneapplication. See Software Requirement Specifications of iCodeReport Generator, App. A; System Test Report of iCode ReportGenerator, App. B; Software Requirements Specification for3B/BMC iCode Smartphone Applications, App. C; System TestReport of iCode Smartphone Application, App. D; and theSoftware Summary of iCode Report Generator, App.E.
Substantial Equivalence	The RESmart CPAP and Auto CPAP System remain substantiallyequivalent to the RESmart CPAP and Auto CPAP System

Non-clinical Testing

Non-clinical testing includes software verification and validationof the iCode Report Generator and iCode Smartphoneapplication. See Software Requirement Specifications of iCodeReport Generator, App. A; System Test Report of iCode ReportGenerator, App. B; Software Requirements Specification for3B/BMC iCode Smartphone Applications, App. C; System TestReport of iCode Smartphone Application, App. D; and theSoftware Summary of iCode Report Generator, App.E.

Substantial Equivalence

The RESmart CPAP and Auto CPAP System remain substantiallyequivalent to the RESmart CPAP and Auto CPAP System

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Section 7	510(k) Summary (K131707)	RESmart CPAP/Auto CPAP
	operating principle, and same manufacturing process. Designverification tests were performed on the RESmart CPAP andAuto CPAP system because of the risk analysis and productrequirements. The modifications described within have beenevaluated in terms of both safety and effectiveness. All testswere verified to meet the required acceptance criteria. Insummary, the device described in this submission issubstantially equivalent to the predicate device.
Truthful & Accuracy	A certification of truthfulness and accuracy of the RESmart CPAPand Auto CPAP System as described in this submission isprovided in Attachment 8.
Conclusions	There have been no changes in:Intended use Operating principle Manufacturing process All other packaging labels and labeling(instructions for use, package insert, andoperator's manual) for the device areunchanged from the previously cleared version.

Verification and validation activities were conducted based on risk analysis and demonstrated substantial equivalence to the predicate.

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

August 22, 2013

3B Medical, Incorporated Mr. Alex Lucio Vice President 21301 Highway 27 North LAKE WALES FL 33859

Re: K131707

Trade/Device Name: BMC RESmart™ CPAP/Auto CPAP Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: II Product Code: BZD Dated: July 18, 2013 Received: July 23, 2013

Dear Mr. 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.

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Page 2 - Mr. Lucio

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 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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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" (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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Image /page/5/Picture/6 description: The image shows the text "Mary S. Runner - S". The text is in black font and is centered in the image. The letters "FDA" are in the middle of the text, but they are outlined and not filled in with color. The text is easy to read and is well-lit.

Kwame Ulmer M.S. Acting Division 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: K131707

BMC RESmart™ CPAP/Auto CPAP

Indications for Use:

Prescription Use	X
(Part 21 CFR 801 Subpart D)

AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

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· Division Sign-Off) Division of Anesthesiology, General Hospital nfection Control, Dental Devices

510(k) Number: _

CONFIDENTIAL

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).