The Luna® CPAP and Auto CPAP System are intended to deliver pressure for the treatment of Obstructive Sleep Apnea. The optional integrated hunidifier is indicated for the humidification and warming of air from the flow generator. These devices are intended for single patient use by prescription in the home or hospital/institutional environment on adult patients.

Device Description

The materials of water chamber of Luna® CPAF and Auto CPAP device were changed. The suppliers of Polycarbonate and silicone were changed. The basic functional and performance characteristics of the Luna® CPAP and Auto CPAF devices are unchanged from the predicate devices (K141770).

AI/ML Overview

This document (K153387) is a 510(k) premarket notification for a medical device (Luna® CPAP and Auto CPAP System) to the U.S. Food and Drug Administration (FDA). It is not a study report that describes the acceptance criteria and performance of an AI/ML device in the way requested. Instead, it is a submission seeking clearance to market a modified version of an existing device (K141770) based on demonstrating "substantial equivalence" to the predicate device.

Therefore, the specific information requested about acceptance criteria, study details, sample sizes, ground truth establishment, expert involvement, and MRMC studies for an AI/ML device is not present in this document.

The document primarily focuses on:

Device Modification: The only modification is a change in the materials used for the water chamber of the Luna® CPAP and Auto CPAP system. The suppliers of Polycarbonate and silicone were changed.
Demonstration of Substantial Equivalence: The submission asserts that the modified device is substantially equivalent to the predicate device (K141770) because it has the "same intended use, same operating principle, same technology, and same manufacturing process."
Non-Clinical Testing for Material Change: To address the material change, biological and mechanical tests were conducted on the new materials and the water chamber.

Here's how the information provided in the document relates to your request, highlighting what can be extracted and what cannot:

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

Not Applicable in the AI/ML context. This document is about a material change in a CPAP device, not an AI/ML diagnostic or prognostic tool.
What is shown: The document refers to "appropriate biological tests conducted and passed for these components, in accordance with FDA guidance #G95-1" and "Series mechanical tests were also conducted to demonstrate the mechanical performance of the water chamber, including: drop test, leak test, and humidity performance test." The specific acceptance criteria for these tests (e.g., maximum allowable leakage, specific drop test pass/fail conditions) are not detailed in this summary, nor are the quantitative results of these tests, beyond a statement that they "demonstrated substantial equivalence."

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

Not Applicable in the AI/ML context. This is not an AI/ML study.
What is shown: The document does not specify sample sizes (e.g., number of water chambers tested for biocompatibility or mechanical performance). It also does not mention data provenance in the context of clinical studies, as this is a non-clinical material change submission.

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 in the AI/ML context. There is no "ground truth" establishment in the sense of expert review of images or clinical data for this type of submission. The "ground truth" here is the biological and mechanical safety/performance of the new materials, assessed through standardized lab tests.

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

Not Applicable in the AI/ML context. No adjudication method is described as there's no diagnostic or interpretative task involved.

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. This is not an AI/ML device, and no MRMC study was performed or is relevant to this submission.

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

Not Applicable. This is not an AI/ML algorithm.

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

What is shown: The "ground truth" for this submission are the results of standardized biocompatibility tests (ISO 10993 series, including Genotoxicity, Cytotoxicity, Implantation, Sensitization, and Irritation tests, plus Intracutaneous Reactivity, Ames test, In vitro Mammalian Cell Gene Mutation Test, Skin Sensitization Mammalian Test, In vitro Chromosome Aberration In Vitro Cytotoxicity Test and Muscle Implantation Test) and mechanical performance tests (drop test, leak test, and humidity performance test). The acceptance is that the new materials and components pass these established safety and performance standards.

8. The sample size for the training set

Not Applicable. This is not an AI/ML device where a training set is relevant.

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

Not Applicable. See point 8.

In summary, this document is a regulatory submission for a minor device modification (material change) of a CPAP system and does not contain the information typically found in an AI/ML device study report.

Summary

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

September 8, 2016

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

Re: K153387

Trade/Device Name: Luna® CPAP and Auto CPAP System Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: Class II Product Code: BZD Dated: July 28, 2016 Received: August 8, 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known) :
K153387

Device Name

Luna& CPAP and Auto CPAP System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
-------------------------------------------------

[X] Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)
----------------------------------------------------------------------------------------------------------	----------------------------------------------------------

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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510(k) Summary

Device Trade Name	Luna® CPAP and Auto CPAP System
Common/Usual Name	CPAP System, Auto CPAP system
Date Prepared	September 8, 2016
Sponsor Identification	3B Medical, Inc.799 Overlook DriveWinter Haven, FL 33884
PhoneFaxEmail	863-226-6285863-226-6284alucio@3bproducts.com
Submission Correspondent	Alex Lucio3B Medical, Inc.799 Overlook DriveWinter Haven, FL 33884
PhoneFaxEmail	863-226-6285863-226-6284alucio@3bproducts.com

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Establishment Registration	# 3008566132
	BMC Medical CO., LTD5/F Main Building No.19Gucheng Street West, ShijingshanBeijing, CHINA 100043
Classification	Class II Device
Classification Name	Non-continuous ventilator
Classification Panel	Medical Device
Classification Reference	21 CFR 868.5905
Products Code	BZD
Medical Specialties	Anesthesiology
Predicate Device(s)	Luna® CPAP and Auto-CPAP Systems(K141770)
Reason for Submission:	Device Modification
Intended Use	The Luna® CPAP and Auto CPAP Systems areintended to deliver positive pressure for thetreatment of Obstructive Sleep Apnea. Theoptional integrated heated humidifier is indicatedfor the humidification and warming of air from theflow generator. These devices are intended forsingle patient use by prescription in the home orhospital / institutional environment on adultpatients.
Device Description	The materials of water chamber of Luna® CPAFand Auto CPAP device were changed. Thesuppliers of Polycarbonate and silicone werechanged.The basic functional and performancecharacteristics of the Luna® CPAP and Auto CPAFdevices are unchanged from the predicate devices
	2

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(K141770).

The modification of the device just changed in the Non-Clinical Testing materials, it did not refer to the modification of specification and performance. Biological tests about the change of materials have been done. Extensive non-clinical testing was conducted in according with ISO 10993 series standards.

Materials used in the construction of components that contact the heated humidified gas pathway are classified as permanent "external communicating devices" (with tissue/ bone/ dentin).

The appropriate biological tests conducted and passed for these components, in accordance with FDA guidance #G95-1- were:

I ISO 10993-3 Genotoxicity,
ISO 10993-5 Cytotoxicity
1 ISO 10993-6 Implantation and
I ISO 10993-10 Sensitization and Irritation

Series mechanical tests were also conducted to demonstrate the mechanical performance of the water chamber, including: drop test, leak test, and humidity performance test.

These test reports demonstrated substantial equivalence between the proposed and predicate devices.

Biocompatibility The materials used in the chamber have been changed. In order to prove the new materials have no effect on safety, BMC conducted a series of tests on finished water chamber, including Intracutaneous Reactivity test, Ames test, In vitro Mammalian Cell Gene Mutation Test, Skin Sensitization Mammalian Test, In vitro

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Test. Chromosome Aberration In Vitro Cytotoxicity Test and Muscle Implantation Test.

Substantial Equivalence

The Luna® CPAP and Auto CPAP System (K141770) remain substantially equivalent to the proposed Luna® CPAP and Auto CPAP System in that they have the same intended use, same operating principle, same technology, and same manufacturing process. Biological tests were performed on the Luna® CPAP and Auto-CPAP System to prove the change of material does not affect the safety and effectiveness.

Conclusions

There have been no changes in the intended use, or operating principles. Biological testing demonstrated that the proposed device 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).