(77 days)
-
- The Heat and Moisture Exchanger (HME) of the Medisize Gold is intended for passive humidification during anaesthesia and respiratory care.
-
- The integrated booster ability makes it possible to feed additional heat and moisture into the system during respiratory care, specifically, when the use of an HME alone is no longer adequate due to the patients moisture deficit.
Not Found
This is a Medical Device 510(k) Premarket Notification from the FDA to Medisize BV regarding their "Medisize Gold" Respiratory Gas Humidifier. It confirms that the device is substantially equivalent to legally marketed predicate devices and is thus cleared for marketing.
While the document refers to product performance and regulatory compliance, it does not contain the acceptance criteria or the study data proving the device meets those criteria. This type of information would typically be found in the manufacturer's submission package to the FDA, not in the FDA's clearance letter itself.
Therefore, I cannot provide the requested information from the provided text. The document is an approval letter, not a technical report on device performance.
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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 stylized eagle with three lines representing its body and wings. The eagle is positioned to the right of a circular text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The text is arranged around the circumference of the circle.
Public Health Service
2005 DEC 9
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Medisize BV C/O Mr. J.A. Van Vugt Responsible Third Party Official KEMA Quality B.V. 4377 County Line Road Chalfont, Pennsylvania 18914
Re: K052615
Trade/Device Name: Medisize Gold Regulation Number: 868.5450 Regulation Name: Respiratory Gas Humidifier Regulatory Class: II Product Code: BTT Dated: November 23, 2005 Received: November 28, 2005
Dear Mr. Van Vugt:
We have reviewed your Section 510(k) premarket notification of intent to market the device We nave roviewed your cermined the device is substantially equivalent (for the referenced above and have acteriminosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device mendments, or to devices that have been reclassified in accordance with the provisions of Amendinents, or to devices that have act (Act) that do not require approval of a premarket the I cuclar I ood, Drag, and Commay, therefore, market the device, subject to the general approval application (1177) . The general controls provisions of the Act include controls providens of an 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 If your device is classified (500 above) was controls. Existing major regulations affecting (1 Mrx), it may of subject to tack of Federal Regulations, Title 21, Parts 800 to 898. In your device ear be foundsh further announcements concerning your device in the Federal Register.
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Page 2 - Mr. Van Vugt
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 mean that IDA has made a decemmations administered by other Federal agencies. of the Act of ally i ecclai statutes and reguirements, including, but not limited to: registration You must comply with an the rice s requirements) and 801); good manufacturing practice and listing (21 CFR Part 007), labeling (21 CFR Part (QS) regulation (21 CFR Part 820); and if requirentents as set form in the quality of closens (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) I mis letter wif anow you to begin maiing of substantial equivalence of your device to a premiarket nothleation. The I Dr maing or 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), IT you desire specific aurros for your 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 may other general manufacturers, International and Consumer Assistance at its toll-free Division of Dinas 2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.
Sincerely yours,
Ques
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
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Section #3 -INDICATIONS FOR USE
510(k) Number (if known):
Unknown
Device Name:
Medisize Gold
Indications for Use:
-
- The Heat and Moisture Exchanger (HME) of the Medisize Gold is intended for passive humidification during anaesthesia and respiratory care.
-
- The integrated booster ability makes it possible to feed additional heat and moisture into the system during 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)
Amy Sullivant
on of Anesthesiclogy, General Hospital tion Control. Dental Dev
Page __ of __
(Posted November 13, 2003)
§ 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).