INFANT OXYGEN TREATMENT HOOD

K011565 · Gulf Coast Hyperbarics, Inc. · CBF · Aug 16, 2001 · Anesthesiology

Device Facts

• Record ID: K011565
• Device Name: INFANT OXYGEN TREATMENT HOOD
• Applicant: Gulf Coast Hyperbarics, Inc.
• Product Code: CBF · Anesthesiology
• Decision Date: Aug 16, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5470
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The new Infant Oxygen Treatment Hood is designed to administer oxygen, under supervision of a physician, to infants or small children within a mukiplace hyperbaric chamber without physically having to hold the infant or child.

Device Story

Infant Oxygen Treatment Hood designed for use within multiplace hyperbaric chambers; allows oxygen administration to infants or small children without requiring manual holding by caregivers. Device functions as a containment hood to deliver oxygen therapy in a pressurized environment. Used in clinical hyperbaric settings under physician supervision. Benefits include reduced physical burden on caregivers and consistent oxygen delivery to pediatric patients during hyperbaric treatment.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Infant oxygen containment hood for use in multiplace hyperbaric chambers. Mechanical device; no electronic components, software, or energy source.

Indications for Use

Indicated for infants or small children requiring oxygen administration within a multiplace hyperbaric chamber under physician supervision.

Regulatory Classification

Identification

A hyperbaric chamber is a device that is intended to increase the environmental oxygen pressure to promote the movement of oxygen from the environment to a patient's tissue by means of pressurization that is greater than atmospheric pressure. This device does not include topical oxygen chambers for extremities (§ 878.5650).

Submission Summary (Full Text)

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AUG 1 6 2001

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. James William McCarthy Gulf Coast Hyperbarics, Inc. 4309 Greenleaf Circle Panama City, FL 32404

Re: K011565

Infant Oxygen Treatment Hood Regulation Number: 868.5470 Regulatory Class: II (two) Product Code: CBF Dated: May 10, 2001 Received: May 21, 2001

Dear Mr. McCarthy:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 profistration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might

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Page 2 - Mr. James William McCarthy

have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) prematert notification. The FDA finding of substantial equivalence of your device to a legally marketed notification. The I Dri Imaning of succion for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and 11 you desire specific actives . In the diagnostic devices), please contact the Office of Compliance at additionally 609.10 for viro diagnestions on the promotion and advertising of your device, [phone]. Addinonally, for questions at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small miorination on your responsibilities and more [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

V. Oerk Tellh

ames E. Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page I of

510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________

Device Name: Infant Oxygen Treatment Hood

Indications For Use:

"The new Infant Oxygen Treatment Hood is designed to administer oxygen, under supervision of a physician, to infants or small children within a mukiplace hyperbaric chamber without physically having to hold the infant or child.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Division of Cardiovascular & Respiratory Devices
510(k) Number K011515

Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use

(Optional Format 1-2-96)

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