(90 days)
Cotton Gauze Sponges are designed as single use, and general use medical devices in the management of wounds.
Cotton Gauze Sponges
I am sorry, but based on the provided document, I cannot answer your request. The document is a 510(k) clearance letter for "priMED 'Prime-Plus' Cotton Gauze Sponges" and a "Statement of Indications for Use."
This type of document primarily confirms that a medical device is "substantially equivalent" to a legally marketed predicate device, meaning it has the same intended use and technological characteristics as a device already on the market, or is as safe and effective.
The provided text does not contain any information about acceptance criteria for device performance, study details, sample sizes, expert qualifications, or ground truth establishment. These details are typically found in the full 510(k) submission, study reports, or design control documentation, which are not part of these specific pages.
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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 stylized depiction of a human figure with three heads in profile, representing the department's focus on health and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the figure.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 20 1997
Mr. Guy J. Plamondon President PrimeLine Medical Products, Inc. 2235 - 27 Avenue N.E. Calgary, Alberta T2E 7M4 Canada
Re: K971075
Trade Name: priMED "Prime-Plus" Cotton Gauze Sponges Regulatory Class: Unclassified Product Code: EFQ Dated: March 18, 1997 Received: March 24, 1997
Dear Mr. Plamondon:
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
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Page 2 - Mr. Guy J. Plamondon
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) premarket notification. The FDA inding 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,
Wha Wilk
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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STATEMENT OF INDICATIONS FOR USE 7.
510 (K) NUMBER (if known) __________________971075
DEVICE NAME PrimeLine Medical Products Inc. Cotton Gauze Sponges.
INDICATIONS FOR USE
Cotton Gauze Sponges are designed as single use, and general use medical devices in the management of wounds.
Guy J Plamondon, President
PrimeLine Medical Products Inc.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrance of CDRH, Office of Device Evaluation (ODE)
Statis Clurdes
(Division Sign-Off)
Division of General Restorative Devices K971075
510(k) Number
Prescripton Use (Per 21 CFR 801 109)
OR
Over-the-Counter Use_
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N/A