(311 days)
- VENOUS STASIS S
- DECUBITUS STASIS UL CERS
- DIABETIC ULCERS
- вики с
- FROSTBITE
-POST SURGICAL WOUNDS
Hyper Pulse Intermittent Topical Oxygen Chamber, Models C-100; CB-100
I am sorry, but the provided text from the FDA 510(k) letter for the "Hyper Pulse Intermittent Topical Oxygen Chamber" does not contain information about acceptance criteria, device performance, or any studies conducted to prove the device meets specific criteria.
This document is a letter confirming the substantial equivalence of the device to a predicate device, allowing it to be marketed. It outlines the regulatory classification and general controls applicable to the device but does not detail any performance studies, test sets, ground truth establishment, or clinical effectiveness data.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles three human profiles facing to the right, stacked on top of each other, and stylized to look like an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Beverly Bennett President Stephenson Industries ... .................................................................................................................................................... 1648 Beaver Dam Road Point Pleasant, New Jersey 08742
JUL 2 8 1997
Re: K963777
Trade Name: Hyper Pulse Intermittent Topical Oxygen Chamber, Models C-100; CB-100 Regulatory Class: III Product Code: KPJ Dated: February 12, 1997 Received: February 18, 1997
Dear Ms. Bennett:
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 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 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 Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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}------------------------------------------------
Page 2 - Ms. Beverly Bennett
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) 594-4595. 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,
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
Page _ of _
510(k) Number (if known): K963777
Device Name: Hyper Pulse Intermittent Topical Oxygen
Chamber, Models C-100; CB-100
Indications For Use:
-
VENOUS STASIS S
-
DECUBITUS STASIS UL CERS - DIABETIC ULCERS - вики с - FROSTBITE -POST SURGICAL WOUNDS
(PLEASED DO MOT WILLTI DELOW TIDE LINE - CONTINUE ON ANOTHER FAUE IF NEEUEU)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Generel Restorative Devices
510(k) Number K963777
Presenption Usc (Pct 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
§ 878.5650 Topical oxygen chamber for extremities.
(a)
Identification. A topical oxygen chamber for extremities is a device that is intended to surround a patient's limb and apply humidified oxygen topically at a pressure slightly greater than atmospheric pressure to aid healing of chronic skin ulcers such as bedsores.(b)
Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance: Topical Oxygen Chamber for Extremities.” See § 878.1(e) for the availability of this guidance document.