(87 days)
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.
Infant Oxygen Treatment Hood
I'm sorry, but the provided text is a 510(k) clearance letter from the FDA for an "Infant Oxygen Treatment Hood." This document confirms that the device is substantially equivalent to a legally marketed predicate device and can proceed to market.
However, a 510(k) clearance letter typically does not contain the detailed information you are requesting regarding acceptance criteria and specific studies, sample sizes, expert qualifications, or ground truth establishment for software or AI-driven medical devices. These types of details are usually found in the original 510(k) submission document itself, which is not provided here.
Therefore, I cannot extract the following information from the given text:
- A table of acceptance criteria and the reported device performance
- Sample sizes used for the test set and the data provenance
- Number of experts used to establish the ground truth for the test set and their qualifications
- Adjudication method for the test set
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or the effect size
- If a standalone (algorithm only) performance study was done
- The type of ground truth used
- The sample size for the training set
- How the ground truth for the training set was established
The document focuses on the regulatory clearance process rather than the technical study results.
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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
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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
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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)
.
§ 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).