(47 days)
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Not Found
No
The summary describes a heater and booster for respiratory care, focusing on adding heat and moisture. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices.
Yes
The device is intended to feed additional heat and moisture into the respiratory system during anaesthesia and respiratory care, specifically when the patient has a moisture deficit. This directly addresses a physiological need to improve patient well-being, which aligns with the definition of a therapeutic device.
No
Explanation: The device is described as a heater and booster for adding heat and moisture during anesthesia and respiratory care, indicating a therapeutic or supportive function rather than a diagnostic one.
No
The device description is not found, but the intended use clearly describes a "Heater and Booster" which are hardware components used in anesthesia and respiratory care. This indicates it is not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device as adding heat and moisture to a respiratory system during anesthesia and respiratory care. This is a therapeutic or supportive function, not a diagnostic one.
- Lack of Diagnostic Purpose: There is no mention of the device being used to examine specimens derived from the human body to provide information for the diagnosis, monitoring, or treatment of a disease or condition.
IVD devices are specifically designed to perform tests on biological samples (like blood, urine, tissue) to gain information about a patient's health status. This device's function is entirely focused on supporting respiratory function.
N/A
Intended Use / Indications for Use
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.
Product codes
BTT
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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.
1
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
2
Section #3 -INDICATIONS FOR USE
510(k) Number (if known):
Unknown
Device Name:
MEDISIZE GOLD Heater and Booster
Indications for Use:
-
- 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)
- 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.
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