(87 days)
Not Found
Not Found
No
The summary describes a physical device for oxygen administration and contains no mention of AI, ML, image processing, or data analysis that would suggest the use of such technologies.
Yes
The device is intended to administer oxygen to infants, which is a therapeutic intervention.
No
The device is designed to administer oxygen for treatment, not to diagnose a condition.
No
The device description explicitly states "Infant Oxygen Treatment Hood," which is a physical hardware device designed to administer oxygen. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to administer oxygen to infants or small children within a hyperbaric chamber. This is a therapeutic intervention performed directly on the patient.
- Device Description: The device is an "Infant Oxygen Treatment Hood," which is a physical apparatus used for delivering gas.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) taken from the body to provide information about a person's health. The provided description does not mention any interaction with biological specimens or diagnostic testing.
Therefore, this device falls under the category of a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
"The new Infant Oxygen Treatment Hood is designed to administer oxygen, under supervision of a physician, to infants or small children within a mukiplace hyperbaric chamber without physically having to hold the infant or child.
Product codes
CBF
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
infants or small children
Intended User / Care Setting
physician, mukiplace hyperbaric chamber
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 868.5470 Hyperbaric chamber.
(a)
Identification. A hyperbaric chamber is a device that is intended to increase the environmental oxygen pressure to promote the movement of oxygen from the environment to a patient's tissue by means of pressurization that is greater than atmospheric pressure. This device does not include topical oxygen chambers for extremities (§ 878.5650).(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/2 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the department's name around the perimeter. In the center is an abstract image of an eagle-like bird with its wings spread.
AUG 1 6 2001
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. James William McCarthy Gulf Coast Hyperbarics, Inc. 4309 Greenleaf Circle Panama City, FL 32404
Re: K011565
Infant Oxygen Treatment Hood Regulation Number: 868.5470 Regulatory Class: II (two) Product Code: CBF Dated: May 10, 2001 Received: May 21, 2001
Dear Mr. McCarthy:
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 (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). 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 profistration, 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 to 895. A substantially equivalent determination assumes compliance 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
1
Page 2 - Mr. James William McCarthy
have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) prematert notification. The FDA finding of substantial equivalence of your device to a legally marketed notification. The I Dri Imaning of succion 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 11 you desire specific actives . In the diagnostic devices), please contact the Office of Compliance at additionally 609.10 for viro diagnestions on the promotion and advertising of your device, (201) 594-4040. Addinonally, for questions at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small miorination on your responsibilities and more (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
V. Oerk Tellh
ames E. Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Page I of
510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________
Device Name: Infant Oxygen Treatment Hood
Indications For Use:
"The new Infant Oxygen Treatment Hood is designed to administer oxygen, under supervision of a physician, to infants or small children within a mukiplace hyperbaric chamber without physically having to hold the infant or child.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division of Cardiovascular & Respiratory Devices
510(k) Number K011515
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
.