B&B BUBBLER

K133210 · S & T Medical Technologies, Inc. · BYE · Mar 28, 2014 · Anesthesiology

Device Facts

• Record ID: K133210
• Device Name: B&B BUBBLER
• Applicant: S & T Medical Technologies, Inc.
• Product Code: BYE · Anesthesiology
• Decision Date: Mar 28, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5965
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

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 Story

B&B Bubbler provides continuous positive airway pressure (CPAP) to neonates and infants < 10 kg. Device functions as a breathing attachment in hospital settings; operated by clinicians. Input is gas flow from a respiratory support system; device transforms flow into regulated positive pressure via bubble-based mechanism. Output is CPAP therapy delivered to patient. Benefits include non-invasive respiratory support for premature infants or those with respiratory distress. Clinicians monitor patient response to adjust therapy.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Positive end expiratory pressure (PEEP) breathing attachment. Mechanical bubble-based pressure regulation. Designed for neonatal/infant use (< 10 kg).

Indications for Use

Indicated for spontaneously breathing neonates and infants < 10 kg requiring CPAP for respiratory support due to prematurity or other conditions. Prescription use only in hospital settings.

Regulatory Classification

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.

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles a bird or a human figure with outstretched arms.

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.

{1}------------------------------------------------

## 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 [phone] or [phone] 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 [phone] or [phone] 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

{2}------------------------------------------------

5. 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 < 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.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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

AND/OR

## Concurrence of CDRH, Office of Device Evaluation (ODE)

Anya C. Harry -

S
20
17

2014.03.27 13:37:28 -04'00'

Page ____of____