3B RESMART CPAP AND AUTO CPAP, BMC RESMART CPAP AND AUTO CPAP

K132967 · 3B Medical, Inc. · BZD · Dec 6, 2013 · Anesthesiology

Device Facts

• Record ID: K132967
• Device Name: 3B RESMART CPAP AND AUTO CPAP, BMC RESMART CPAP AND AUTO CPAP
• Applicant: 3B Medical, Inc.
• Product Code: BZD · Anesthesiology
• Decision Date: Dec 6, 2013
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 868.5905
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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 Story

Microprocessor-controlled, blower-based system generating positive airway pressure (4-20 cm H2O) for Obstructive Sleep Apnea treatment. Device connects to patient via circuit and mask; optional integrated humidifier warms/humidifies air. Operated by adult patients in home or clinical settings. System utilizes upgraded blower, air circuit, and controller board compared to predicate. Healthcare providers use device to deliver prescribed pressure therapy; patient benefits from improved airway patency during sleep. Performance validated via bench testing per ISO 17510-1:2007.

Clinical Evidence

Bench testing only. Performance bench testing conducted in accordance with ISO 17510-1:2007 (Sleep Apnea Breathing Therapy Equipment) demonstrated substantial equivalence to the predicate device.

Technological Characteristics

Microprocessor-controlled blower-based system; pressure range 4-20 cm H2O. Includes optional integrated humidifier. Upgraded controller board and blower assembly. Complies with ISO 17510-1:2007. Embedded software control.

Indications for Use

Indicated for adult patients with Obstructive Sleep Apnea requiring positive airway pressure therapy. For use in home or hospital/institutional settings by prescription.

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

• RESmart CPAP and Auto CPAP System (K110629)

Submission Summary (Full Text)

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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 [e-mail]

Alex Lucio 38 Medical, Inc. 21301 Highway 27 N. Lake Wales, FL 33859 863-226-6285 863-226-6284 [e-mail]

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

1

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510(k) Summary

Intended Use

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.

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

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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 [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" (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 [phone] or [phone] 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

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

## Indications for Use

510(k) Number: K 132967

BMC RESmart® CPAP/Auto CPAP nP1.5

Indications for Use:

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.

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'