Luna CPAP and Auto CPAP System

K153387 · 3B Medical, Inc. · BZD · Sep 8, 2016 · Anesthesiology

Device Facts

• Record ID: K153387
• Device Name: Luna CPAP and Auto CPAP System
• Applicant: 3B Medical, Inc.
• Product Code: BZD · Anesthesiology
• Decision Date: Sep 8, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5905
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Luna® CPAP and Auto CPAP Systems are intended to deliver positive pressure for the treatment of Obstructive Sleep Apnea. The optional integrated heated humidifier 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 Story

Luna CPAP and Auto CPAP system delivers positive airway pressure to treat Obstructive Sleep Apnea; includes optional integrated heated humidifier for air warming/humidification. Device used in home or hospital/institutional settings by adult patients. Modification involves change in water chamber materials (polycarbonate and silicone suppliers). Device operates as flow generator; basic functional/performance characteristics remain unchanged from predicate. Healthcare providers prescribe device; patient uses device for therapy delivery.

Clinical Evidence

No clinical data. Substantial equivalence supported by non-clinical bench testing, including biocompatibility (ISO 10993-3, -5, -6, -10) and mechanical performance testing (drop, leak, and humidity tests).

Technological Characteristics

Flow generator with integrated heated humidifier. Materials: Polycarbonate and silicone (compliant with ISO 10993 standards). Energy source: Electrical. Form factor: Desktop/portable CPAP unit. Connectivity: Not specified. Sterilization: Not specified.

Indications for Use

Indicated for adult patients with Obstructive Sleep Apnea requiring positive airway pressure therapy. Used in home or hospital/institutional settings by prescription. Optional integrated humidifier provides air warming and humidification.

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

• Luna® CPAP and Auto-CPAP Systems (K141770)

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

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 [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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### 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)

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.

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

| <span style="text-decoration: underline;"><b>[X] Prescription Use (Part 21 CFR 801 Subpart D)</b></span> | <span>Over-The-Counter Use (21 CFR 801 Subpart C)</span> |
|----------------------------------------------------------------------------------------------------------|----------------------------------------------------------|
|----------------------------------------------------------------------------------------------------------|----------------------------------------------------------|

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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.<br>799 Overlook Drive<br>Winter Haven, FL 33884 |
| Phone<br>Fax<br>Email | 863-226-6285<br>863-226-6284<br>[e-mail] |
| Submission Correspondent | Alex Lucio<br>3B Medical, Inc.<br>799 Overlook Drive<br>Winter Haven, FL 33884 |
| Phone<br>Fax<br>Email | 863-226-6285<br>863-226-6284<br>[e-mail] |

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| Establishment Registration | # 3008566132 |
|----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | BMC Medical CO., LTD<br>5/F Main Building No.19<br>Gucheng Street West, Shijingshan<br>Beijing, 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<br>(K141770) |
| Reason for Submission: | Device Modification |
| Intended Use | The Luna® CPAP and Auto CPAP Systems are<br>intended to deliver positive pressure for the<br>treatment of Obstructive Sleep Apnea. The<br>optional integrated heated humidifier is indicated<br>for the humidification and warming of air from the<br>flow generator. These devices are intended for<br>single patient use by prescription in the home or<br>hospital / institutional environment on adult<br>patients. |
| Device Description | The materials of water chamber of Luna® CPAF<br>and Auto CPAP device were changed. The<br>suppliers of Polycarbonate and silicone were<br>changed.<br>The basic functional and performance<br>characteristics of the Luna® CPAP and Auto CPAF<br>devices 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.