(90 days)
Not Found
Not Found
No
The summary describes a simple, non-technological medical device (cotton gauze sponges) and contains no mention of AI, ML, image processing, or any other related concepts.
No
Cotton Gauze Sponges are described as general use medical devices for wound management, which are typically considered supportive or protective, not therapeutic in the sense of actively treating or curing a disease or condition.
No
Cotton Gauze Sponges are used for wound management, which is a treatment or general care purpose, not for diagnosing a condition.
No
The device description explicitly states "Cotton Gauze Sponges," which are physical, hardware medical devices, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "in the management of wounds." This describes a device used directly on or in the body for treatment or care, not for testing samples taken from the body to diagnose or monitor a condition.
- Device Description: "Cotton Gauze Sponges" are physical materials used for wound care, not reagents, instruments, or systems designed for in vitro testing.
- Lack of IVD Indicators: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing diagnostic information
- Mentioning laboratory settings or procedures
IVDs are specifically designed to be used outside the body to examine specimens and provide information about a person's health status. Cotton gauze sponges are used on the body for wound management.
N/A
Intended Use / Indications for Use
Cotton Gauze Sponges are designed as single use, and general use medical devices in the management of wounds.
Product codes
EFQ
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Not Found
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
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 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
1
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
2
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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