3B RESMART CPAP AND AUTO CPAP, BMC RESMART CPAP AND AUTO CPAP 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 microprocessor-controlled, 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 a smaller and quieter blower. The air circuit, embedded software, and controller board were upgraded to provide better performance. The basic functional and performance characteristic of the RESmart CPAP and Auto CPAP are unchanged from the predicate device RESmart CPAP and Auto CPAP (K110629).

AI/ML Overview

This document is a 510(k) summary for the RESmart CPAP and Auto CPAP nP1.5 system. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study proving performance against specific acceptance criteria.

Therefore, much of the requested information regarding acceptance criteria, study details, and expert involvement is not available within the provided text. The document states that "Extensive non-clinical testing was conducted in according Non-Clinical Testing with ISO 17510-1:2007, Sleep Apnea Breathing Therapy-Part I: Sleep Apnea Breathing Therapy Equipment." and "Performance Bench Testing demonstrated substantial equivalence with the predicate device." However, it does not provide the specific acceptance criteria or the results of these tests in a detailed manner.

Here's a breakdown of what can be extracted and what is not available:

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

Acceptance Criteria	Reported Device Performance
Not explicitly stated in terms of specific numerical values or performance metrics from the document. The overarching criterion is Substantial Equivalence to the predicate device K110629.	"Performance Bench Testing demonstrated substantial equivalence with the predicate device."
"Testing and of component part upgrades establish validation substantial equivalence between predicate and proposed devices."

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

Not available. The document refers to "non-clinical testing" and "performance bench testing" but does not specify sample sizes or data provenance.
Data Provenance: The manufacturing company is BMC MEDICAL CO., LTD in Beijing, CHINA. The testing location is not specified, but typically, this type of non-clinical bench testing would be conducted in a lab environment.

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/Not available. This device is a CPAP machine, not an AI diagnostic tool requiring expert ground truth for image interpretation or similar tasks. The "testing" mentioned is non-clinical bench testing against a standard and comparison to a predicate device, not a study involving human experts to establish ground truth on patient data.

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

Not applicable/Not available. Adjudication methods are typically used in clinical studies where expert disagreement on ground truth needs to be resolved. This document describes non-clinical bench testing for device equivalence.

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

No. This is a CPAP device, not an AI-assisted diagnostic device. Therefore, MRMC studies are not relevant to its evaluation.

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

Yes, implicitly. The "Performance Bench Testing" and "non-clinical testing" would represent standalone testing of the device's physical and functional performance (e.g., pressure output, noise levels, flow characteristics) without human interaction. This is the nature of testing for a standalone medical device like a CPAP.

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

Not applicable in the conventional sense. For a CPAP device, the "ground truth" for performance would likely be established according to the requirements and specifications of the ISO 17510-1:2007 standard. This standard dictates the acceptable ranges for parameters like pressure accuracy, flow rates, humidification, and noise levels. The performance of the predicate device would also serve as a reference point for substantial equivalence.

8. The sample size for the training set

Not applicable/Not available. This is a hardware medical device with integrated software, not a machine learning algorithm that undergoes "training" on a dataset in the typical sense.

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

Not applicable/Not available. As above, there is no "training set" in the context of this device.

Summary of what is known from the document:

Device: RESmart CPAP and Auto CPAP nP1.5 system.
Intended Use: Deliver positive pressure for the treatment of Obstructive Sleep Apnea.
Key Change from Predicate: Smaller and quieter blower, upgraded air circuit, embedded software, and controller board.
Basis for Approval: Substantial equivalence to predicate device RESmart CPAP and Auto CPAP (K110629).
Testing Conducted: Extensive non-clinical testing according to ISO 17510-1:2007, and Performance Bench Testing.
Conclusion: The device is substantially equivalent to the predicate device due to the same intended use, operating principle, technology, materials, and manufacturing process, supported by design validation, verification, and performance bench testing.

Summary

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510(k) Summary

1 July, 2013

RESmart CPAP and Auto CPAP nP1.5

CPAP System, Auto CPAP System

Device Trade Name

Common/ Usual Name

Date Prepared

Sponsor Identification

Phone Fax Email

Submission Correspondent

Phone Fax Email

Establishment Registration #

3B Medical, Inc. 21301 Highway 27 N. Lake Wales, FL 33859 863-226-6285 863-226-6284 alucio@3bproducts.com

Alex Lucio 38 Medical, Inc. 21301 Highway 27 N. Lake Wales, FL 33859 863-226-6285 863-226-6284 alucio@3bproducts.com

3008566132

BMC MEDICAL CO., LTD 5/f Main Building No. 19 Gucheng Street West, Shijingshan Beijing, CHINA 100043

RESmart® CPAP and Auto CPAP System (K110629)

Class II Device Classification Classification Panel Medical Device Classification Reference 21 CFR 878.5905 . • BZD- Non-continuous Ventilator (Respirator) Product Code Medical Specialties Anesthesiology

Predicate Device(s)

K 132967 DEC - 6 2013

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510(k) Summary

Intended Use

RESmart CPAP and Auto CPAP System is a Device Description The microprocessor-controlled, 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 a smaller and quieter blower. The air circuit, embedded software, and controller board were upgraded to provide better performance. The basic functional and performance characteristic of the RESmart CPAP and Auto CPAP are unchanged from the predicate device RESmart CPAP and Auto CPAP (K110629).

Extensive non-clinical testing was conducted in according Non-Clinical Testing with ISO 17510-1:2007, Sleep Apnea Breathing Therapy-Part I: Sleep Apnea Breathing Therapy Equipment. Performance Bench Testing demonstrated substantial equivalence with the predicate device. Testing and of component part upgrades establish validation substantial equivalence between predicate and proposed devices.

The RESmart® CPAP and Auto CPAP System (K110629) Substantial Equivalence remain substantially equivalent to the proposed RESmart® CPAP and Auto CPAP System in that they have the same intended use, same operating principle, same technology, identical materials, and same manufacturing process. Design validation and verification tests were performed on the RESmart CPAP and Auto CPAP system because of the risk analysis and product requirements.

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Conclusions

A certification of truthfulness and accuracy of the proposed 丶 "Truthful and Accuracy RESmart CPAP and Auto CPAP System as described in this submission is provided in Section 8.

There have been no changes in the material composition, intended use, or operating principles. Validation and verification, as well as performance bench testing, demonstrate that the proposed device is substantially equivalent to the predicate device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows a seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the edge. In the center of the seal is a stylized eagle with its wings spread. The image is black and white and appears to be a scan of a document.

Public Health Service

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

December 6, 2013

3B Medical, Incorporated Alex Lucio Vice President 21301 Highway 27 N Lake Wales, FL 33859

Re: K132967

Trade/Device Name: RESmart CPAP and Auto-CPAP nP1.5 Regulation Number: 21 CFR 868.5905 Regulation Name: Non-continuous Ventilator (Respirator) Regulatory Class: Class II Product Code: BZD Dated: November 4, 2013 Received: November 7, 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.fdagov/McdicalDevices/Safety/ReportaProblem/default.hun 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 vours.

Tejashri Purohit-Sheth, M.D.
Clinical Deputy Director
DAGRID

FOR

Erin I. Keith, M.S. 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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Statement for Indications for Use

RESmart CPAP/Auto CPAP

Section 6 . . . . . . ... .. ...

Indications for Use

510(k) Number: K 132967

BMC RESmart® CPAP/Auto CPAP nP1.5

Indications for Use:

AND/OR Prescription Use _ X_

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Part 21 CFR 801 Subpart D)

(21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Anya C. Harry -S 2013.12.06 16:10:40 -05'00'

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).