(231 days)
Not Found
Not Found
No
The summary describes a heated humidification system and ventilator circuits, with no mention of AI or ML capabilities.
Yes
The device "provides heated humidification for patients" and is used as a "gas conduit from the ventilator to the patient and back to the ventilator," indicating it treats a condition or provides life support, which falls under the definition of a therapeutic device.
No
Explanation: The device provides "heated humidification for patients" and a "gas conduit from the ventilator to the patient." These functions are therapeutic or life-supportive, not diagnostic. There is no mention of the device identifying or detecting a disease or condition.
No
The device description is not found, but the intended use clearly describes physical components like "heaters," "ventilator circuits," and a "column," indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes providing heated humidification and acting as a gas conduit for ventilation. This is a therapeutic and life-support function, not a diagnostic one.
- Device Description: While the description is "Not Found," the intended use clearly points to a respiratory support device.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing information for diagnosis, monitoring, or screening.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information about a person's health. This device's function is to support breathing, which falls outside the scope of IVD.
N/A
Intended Use / Indications for Use
Indications for Use (Column):
When used with Hudson RCI CONCHATHERM heaters and Hudson RCI ventilator circuits, the 385-40 While Column provides heated humidification for patients with and without an artificial airway in place.
Indications for Use (Circuit):
When used with the Hudson RCI CONCHATHERM heater and Cat. No. 385-40 column the 780-40, 780-41, 780-42, 780-43 circuit provides a gas conduit from the ventilator to the patient and back to the ventilator, and includes both conventional and heated wire circuit modes of neouatal ventilation.
Product codes
BTT
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
neouatal
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo consists of a circular emblem with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle or bird-like figure with three curved lines representing its body or wings.
Public Health Service
MAY 2 4 2000
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Charles Mierkiewicz Regulatory Affairs Specialist Hudson Respiratory Care, Inc. 27711 Diaz Rd. Temecula, CA 92589-9020
кадзаге Re: R33555 lason Rei Golfona Oblami, 1780-42, 780-43 Circuit Regulatory Class: II (two) 73 BTT Product Code: February 21, 2000 Dated: February 24, 2000 Received:
Dear Mr. Mierkiewicz:
We have reviewed your Section 510(k) notification of intent to market we nave referenced above and we have determined the device is che device foreivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in entrosure, co regarif marico 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 the general controls provisions of the Act. 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 (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 A substantially equivalent determination assumes compliance to 895. with the Current Good Manufacturing Practice requirements, 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.
1
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 regulation (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/dsma/dsmamain.html".
Sincerely yours,
James E. Dillard İII Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
510(k) Number (if Known):
Device Name: HRCI Cat. No. 385-40 Column (trade name to be determined)/ HRCI Cat. No. 780-40, 780-41, 780-42, 780-43 Circuit (trade name to be determined)
Indications for Use (Column):
When used with Hudson RCI CONCHATHERM heaters and Hudson RCI ventilator circuits, the 385-40 While Column provides heated humidification for patients with and without an artificial airway in place.
Indications for Use (Circuit):
When used with the Hudson RCI CONCHATHERM heater and Cat. No. 385-40 column the 780-40, 780-41, 780-42, 780-43 circuit provides a gas conduit from the ventilator to the patient and back to the ventilator, and includes both conventional and heated wire circuit modes of neouatal ventilation.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Christy foreman
K993355
(Division Sign-Off)
Division of Cardiovascular, Respiratory,
and Neurological Devices
| 510(k) Number | 993355 |
|---|---|
| --------------- | -------- |
| Prescription Use | OR | Over-the-Counter Use | ||
|---|---|---|---|---|
| Per 21 CFR 801.109 |
(Optional format 1-2-96)
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