K Number
K133210
Device Name
B&B BUBBLER
Date Cleared
2014-03-28

(162 days)

Product Code
Regulation Number
868.5965
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The B&B Bubbler is intended to provide CPAP, in a hospital environment, to spontaneously breathing neonates and infants < 10 kg who require breathing support due to conditions associated with prematurity or other conditions where CPAP is required or desired and is prescribed by a physician.
Device Description
Not Found
More Information

Not Found

Not Found

No
The summary does not mention AI, ML, or any related technologies, and the device description (though not found) and intended use point to a standard CPAP device.

Yes
The device is intended to provide CPAP (Continuous Positive Airway Pressure) to neonates and infants who require breathing support due to medical conditions, which is a therapeutic intervention.

No
The device provides therapeutic support (CPAP) rather than diagnosing conditions.

No

The intended use describes a device that provides CPAP, which is a hardware-based therapy requiring a physical device to deliver pressurized air. The summary does not mention any software components or functions.

Based on the provided information, the B&B Bubbler is not an IVD (In Vitro Diagnostic).

Here's why:

  • IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
  • B&B Bubbler Function: The description states the B&B Bubbler provides CPAP (Continuous Positive Airway Pressure) to spontaneously breathing neonates and infants. This is a therapeutic device that provides respiratory support directly to the patient, not a test performed on a sample outside the body.

The intended use clearly describes a device used for direct patient care and breathing support, which falls outside the scope of in vitro diagnostics.

N/A

Intended Use / Indications for Use

The B&B Bubbler is intended to provide CPAP, in a hospital environment, to spontaneously breathing neonates and infants

§ 868.5965 Positive end expiratory pressure breathing attachment.

(a)
Identification. A positive end expiratory pressure (PEEP) breathing attachment is a device attached to a ventilator that is used to elevate pressure in a patient's lungs above atmospheric pressure at the end of exhalation.(b)
Classification. Class II (performance standards).

0

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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

March 28, 2014

B&B Medical Technologies, Inc. Mr. Derick Corrente Director of Operations 1954 Kellogg Avenue, Suite 100 Carlsbad, CA 92008

Re: K133210

Trade/Device Name: B&B Bubbler Regulation Number: 21 CFR 868.5965 Regulation Name: Positive end expiratory pressure breathing attachment Regulatory Class: Class II Product Code: BYE Dated: February 27, 2014 Received: February 28, 2014

Dear Mr. Corrente:

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. Corrente

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/Resourcesfor You/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/ReportalProblem/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/1/Picture/8 description: The image contains a signature and some text. The text includes the name "Tejashri Purohit-Sheth, M.D." followed by the title "Clinical Deputy Director". The acronym "DAGRID" is also present in the image. Finally, the word "FOR" is at the bottom right.

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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  1. Indications for Use Statement

INDICATIONS FOR USE STATEMENT

510(k) Number (if known): K133210

Device Name: B&B Bubbler

Indications for Use:

The B&B Bubbler is intended to provide CPAP, in a hospital environment, to spontaneously breathing neonates and infants