MEDISIZE GOLD HEATER AND BOOSTER by MEDISIZE BV

The MEDISIZE GOLD Heater and Booster makes it possible to feed additional heat and moisture into the system, through a T-Piece or via the Medisize Gold, during anaesthesia and respiratory care, specifically, when the use of an HME alone is no longer adequate due to the patients moisture deficit.

Device Description

Not Found

AI/ML Overview

The provided text is a 510(k) premarket notification acceptance letter from the FDA for a medical device called the "MEDISIZE GOLD Heater and Booster." This document does not contain any information regarding acceptance criteria or a study proving the device meets acceptance criteria.

The letter states that the FDA has reviewed the Section 510(k) premarket notification and determined the device is substantially equivalent to legally marketed predicate devices. This means the device's safety and effectiveness are deemed comparable to already approved devices.

Therefore, I cannot provide the requested information based on the given input. The document focuses on regulatory approval based on substantial equivalence, not on specific performance acceptance criteria or a detailed study report.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Medisize B.V. C/O Ms. Patricia L. Murphy Responsible Third Party Official Kema Quality B.V. 4377 County Line Road Chalfont, Pennsylvania 18914

APR 3 0 2007

Re: K070714

Trade/Device Name: Medisize Gold Heater and Booster Regulation Number: 21 CFR 868.5450 Regulation Name: Respiratory Gas Humidifier Regulatory Class: II Product Code: BTT Dated: April 19, 2007 Received: April 20, 2007

Dear Ms. Murphy:

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 - Ms. Murphy

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 vour device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Chiu Lin, Ph.D.

Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Section #3 -INDICATIONS FOR USE

510(k) Number (if known):

Unknown

Device Name:

MEDISIZE GOLD Heater and Booster

Indications for Use:

1. The MEDISIZE GOLD Heater and Booster makes it possible to feed additional heat and moisture into the system, through a T-Piece or via the Medisize Gold, during anaesthesia and respiratory care, specifically, when the use of an HME alone is no longer adequate due to the patients moisture deficit.
  Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page __ of

(Posted November 13, 2003)

Chile Udo

sion Sign-Off)
Division of Anesthesiology, General Hospital,
infection Control, Dental Devices

510(K) Number: K070714

Regulation Number and Section

§ 868.5450 Respiratory gas humidifier.

(a)
Identification. A respiratory gas humidifier is a device that is intended to add moisture to, and sometimes to warm, the breathing gases for administration to a patient. Cascade, gas, heated, and prefilled humidifiers are included in this generic type of device.(b)
Classification. Class II (performance standards).