HYPER PULSE INTERMITTENT TOPICAL OXYGEN CHAMBER C-100, CB-100

K963777 · Stephenson Industries, Inc. · KPJ · Jul 28, 1997 · General, Plastic Surgery

Device Facts

• Record ID: K963777
• Device Name: HYPER PULSE INTERMITTENT TOPICAL OXYGEN CHAMBER C-100, CB-100
• Applicant: Stephenson Industries, Inc.
• Product Code: KPJ · General, Plastic Surgery
• Decision Date: Jul 28, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.5650
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

VENOUS STASIS ULCERS DECUBITUS ULCERS DIABETIC ULCERS BURNS FROSTBITE POST SURGICAL WOUNDS

Device Story

Hyper Pulse Intermittent Topical Oxygen Chamber (Models C-100, CB-100) provides topical oxygen therapy to wound sites. Device creates controlled environment around affected area to deliver intermittent oxygen pulses. Used in clinical settings under physician supervision for wound management. Output consists of localized oxygen delivery to promote healing in chronic or acute wounds. Benefits include potential acceleration of wound closure and tissue repair in indicated patient populations.

Clinical Evidence

No clinical data provided in the document.

Technological Characteristics

Topical oxygen delivery system; intermittent pulse mechanism; chamber-based form factor. No specific materials or software algorithms described.

Indications for Use

Indicated for patients with venous stasis ulcers, decubitus ulcers, diabetic ulcers, burns, frostbite, and post-surgical wounds.

Regulatory Classification

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.

Special Controls

*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.

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
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

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.

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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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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

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*STEPHENSON INDUSTRIES* 9088992049
P. 02
Page 1 of 1

510(k) Number (if known): K 963777

Device Name: Hyper Pulse Intermittent Topical Oxygen Chamber, Models C-100; CB-100

Indications For Use:
- VENOUS STASIS ULCERS
- DECUBITUS ULCERS
- DIABETIC ULCERS
- BURNS
- FROSTBITE
- POST SURGICAL WOUNDS

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)


Progenitor Use ☑
(PC1 21 CFR 801.109)

OR

Over-The-Counter Use ☐
(Optional Format 1-2-96)