RAND SURGICAL SPONGE

K971178 · Trans Aire · EFQ · Jun 27, 1997 · SU

Device Facts

• Record ID: K971178
• Device Name: RAND SURGICAL SPONGE
• Applicant: Trans Aire
• Product Code: EFQ · SU
• Decision Date: Jun 27, 1997
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

Intended to be placed directly on wound or burn to absorb excess body fluids or exudate

Device Story

Rand Surgical Sponge is a passive wound care device designed to absorb excess body fluids or exudate from wounds or burns. It is applied directly to the wound site by a clinician. The device functions as an absorbent dressing to manage wound moisture. It is intended for prescription use.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Absorbent surgical sponge; form factor designed for direct wound/burn application.

Indications for Use

Indicated for use on wounds or burns to absorb excess body fluids or exudate.

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

Mr. Duane Tracy
Vice President
Rand Scientific Corporation
Trans Air
4135 Northgate Boulevard, Suite 9
Sacramento, California 95834

JUN 27 1997

Re: K971178
Trade Name: Rand Surgical Sponge
Regulatory Class: I
Product Code: EFQ
Dated: March 27, 1997
Received: March 31, 1997

Dear Mr. Tracy:

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 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

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Page 2 - Mr. Duane Tracy

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) 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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From: D. TRACY, #602-404-0314

Page ___ of ___

510(k) Number (if known): K971178

Device Name: Rand Surgical Spurage

Indications For Use

Intended to be placed directly on wound or burn to absorb excess body fluids or exudate

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

Concurrence of CDRH, Office of Device Evaluation (ODE)




Prescription Use ☑ (Per 21 CFR 801.109)

OR

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