(932 days)
None
Not Found
No
The summary contains no mention of AI, ML, image processing, or any other indicators typically associated with AI/ML medical devices. The device name "HYDRO-HEAT® Condensate Control System" also suggests a non-AI/ML technology.
No.
The provided text describes a "Condensate Control System," which is typically used for managing condensation, not for medical therapy. There is no information in the input that suggests it has a therapeutic purpose or any medical application.
No
The provided text describes a "HYDRO-HEAT® Condensate Control System" and does not contain any information indicating it is used for diagnosis, medical imaging, or any other diagnostic purpose. The "Intended Use / Indications for Use" section is "Not Found".
No
The device description "HYDRO-HEAT® Condensate Control System" strongly suggests a hardware-based system for controlling condensation, not a software-only medical device.
Based on the provided information, it is highly unlikely that the HYDRO-HEAT® Condensate Control System is an IVD (In Vitro Diagnostic) device.
Here's why:
- Lack of Intended Use/Indications for Use: The most crucial piece of information for determining if a device is an IVD is its intended use. This section is explicitly marked as "Not Found." IVDs are specifically intended for the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. Without an intended use related to analyzing biological samples, it cannot be an IVD.
- Device Description: The description "HYDRO-HEAT® Condensate Control System" suggests a system for managing condensation, likely in a non-diagnostic context. This type of system is not typically associated with in vitro diagnostic procedures.
- Absence of Other IVD Indicators: The lack of information regarding image processing, AI/ML, input imaging modality, anatomical site, patient age range, intended user/care setting, training/test set details, performance studies, key metrics, and predicate/reference devices further supports the conclusion that this is not an IVD. These are common elements found in submissions for IVD devices.
In summary, the provided information strongly indicates that the HYDRO-HEAT® Condensate Control System is not an In Vitro Diagnostic device. Its function appears to be related to controlling condensation, which is not a diagnostic activity.
N/A
Intended Use / Indications for Use
Not Found
Product codes
73 BZE
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 868.5270 Breathing system heater.
(a)
Identification. A breathing system heater is a device that is intended to warm breathing gases before they enter a patient's airway. The device may include a temperature controller.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle-like symbol with three curved lines representing the bird's body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC - 2 1997
Mr. Bernard R. Paluch Nova-Ventrx, Inc. 1974 Raymond Drive 60062 Northbrook, Illinois
K952267 Re : HYDRO-HEAT® Condensate Control System Requlatory Class: II (two) Product Code: 73 BZE Dated: May 1, 1997 Received: May 6, 1997
Dear Mr. Paluch:
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 to 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 registration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst 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 requirement, 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 have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Mr. Bernard R. Paluch
This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97).
Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Thomas J. Callahan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health