ALADDIN II MONITORING OXYGEN/AIR MONITOR

K990293 · Hamilton Medical, Inc. · BZR · Mar 16, 1999 · Anesthesiology

Device Facts

• Record ID: K990293
• Device Name: ALADDIN II MONITORING OXYGEN/AIR MONITOR
• Applicant: Hamilton Medical, Inc.
• Product Code: BZR · Anesthesiology
• Decision Date: Mar 16, 1999
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 868.5330
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Aladdin Monitoring Oxygen/Air Mixer is intended to mix and air and oxygen gases and provide the mixed gas at the prescribed oxygen concentration level via flowmeter (1 to 10 LPM). the device is intended for use within the hospital or institutional environment.

Device Story

Aladdin Monitoring Oxygen/Air Mixer mixes air and oxygen gases to deliver a specific oxygen concentration to patients. Device operates via flowmeter with output range of 1 to 10 LPM. Intended for use in hospital or institutional environments by healthcare professionals. Provides controlled gas mixture to support respiratory therapy. Benefits patient by ensuring accurate oxygen concentration delivery.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Oxygen/air gas mixer; flowmeter output 1-10 LPM; hospital/institutional use; Class II device (21 CFR 868.5330).

Indications for Use

Indicated for patients in hospital or institutional settings requiring delivery of mixed air and oxygen gases at prescribed concentrations via flowmeter (1 to 10 LPM).

Regulatory Classification

Identification

A breathing gas mixer is a device intended for use in conjunction with a respiratory support apparatus to control the mixing of gases that are to be breathed by a patient.

Submission Summary (Full Text)

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 6 2002

Mr. Timothy Y. Cowart Hamilton Medical, Inc. 3371 Lenora Church Road Snellville, GA 30039

K990293 Re:

> Aladdin II Monitoring Oxygen/Air Mixer Regulation Number: 868.5330 Regulation Name: Mixer, Breathing Gases, Anesthesia Inhalation Regulatory Class: II (two) Product Code: 73 BZR

Dear Mr. Cowart:

This letter corrects our substantially equivalent letter of March 16, 1999, regarding the Aladdin II Monitoring Oxygen/Air Mixer. Our letter identified the product code as 73 BZD. This is in error; the correct product code is 73 BZR as indicated above.

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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## Page 2 - Mr. Timothy Y. Cowart

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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification 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 additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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.qov/cdrh/dsma/dsmamain.html

Sincerely yours,

Daula Talk

Bram D. Zuckerman, M.D.
Acting Director
Division of Cardiovascular and
Respiratory Devices
Office of Device Evaluation
Center for Devices and
Radiological Health

Enclosure

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Page 1 of 1

kg40293 510(k) Number (if known)

Device Name: Aladdin Monitoring Oxygen/Air Mixer

Indications for Use

**CONFIDENTIAL**

Aladdin Monitoring Oxygen/Air Mixer is intended to mix and air and oxygen gases and provide the mixed gas at the prescribed oxygen concentration level via flowmeter (1 to 10 LPM). the device is intended for use within the hospital or institutional environment.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

(Optional Format 1-2-96)

*All A. Call*
(Division Sign-Off)
Division of Cardiovascular, Respiratory,
and Neurological Devices
510(k) Number K990293

6

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K990293 510(k) Number (if known)______________________________________________________________________________________________________________________________________________________

Device Name: Aladdin Monitoring Oxygen/Air Mixer

Indications for Use:

**CONFIDENTIAL**

Aladdin Monitoring Oxygen/Air Mixer is intended to mix and oxygen gases and provide the mixed gas at the prescribed oxygen concentration level via flowmeter (1 to 10 LPM). the device is intended for use within the hospital or institutional environment.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use __ (Per 21 CFR 801.109)

OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

Ah. A. Cish.

(Division Sign-Off) Division of Cardiovascular. Respiratory, and Neurological Devices

4980293 510(k) Number ................................................................................................................................................................