(135 days)
Not Found
Not Found
No
The 510(k) summary describes a topical cream for wound management and does not mention any AI or ML components.
Yes
The product is intended to aid in the management of various types of wounds and skin irritations, falling under the definition of a therapeutic device.
No
Explanation: The "Intended Use / Indications for Use" section describes the device as a cream used for the management and support of wound healing, not for diagnosing conditions.
No
The device description clearly identifies the device as a "Cream," which is a physical substance and not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a cream applied externally to the skin for wound management. This is a topical application for therapeutic purposes, not for testing samples taken from the body to diagnose or monitor a condition.
- Device Description: The device is described as a "Cream," which is consistent with a topical treatment.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), using reagents, or providing diagnostic information based on laboratory testing.
IVDs are devices used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This cream does not fit that description.
N/A
Intended Use / Indications for Use
MacroPro Cream may be used to aid in the management of superficial and partial thickness burns; pressure ulcers (stages I-IV); venous, diabetic, and arterial ulcers; donor graph sites; superficial through full thickness wounds such as surgical wounds, minor abrasions and lacerations; and irritations of the skin.
MacroPro Cream provides a moist environment which supports in the autolytic debridement of wounds with scattered areas of necrosis and slough.
For external use only. Do not use on patients with known allergies to plants such as gum oat.
Product codes
MGQ
Device Description
Brennen Medical Beta Glucan Cream, "MacroPro"
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
N/A
0
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Jul 29 1998
Mr. Kenneth B. Herland Director, Regulatory Affairs & Quality Assurance Brennen Medical, Inc. 1290 Hammond Road St. Paul, Minnesota 55110
Re: K980962
Trade Name: Brennen Medical Beta Glucan Cream, "MacroPro" Regulatory Class: Unclassified Product Code: MGQ Dated: May 21, 1998 Received: May 22, 1998
Dear Mr. Herland:
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 (the Act). You may, therefore, market your device subject to the general controls provisions of the Federal Food, Drug, and Cosmetic Act (Act) and the following limitations:
-
- This device may not be labeled for use on third degree burns.
-
- This device may not be labeled as having any accelerating effect on the rate of wound healing or epithelization.
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- This device may not be labeled as a long-term, permanent, or no-change .. dressing, or as an artificial (synthetic) skin.
-
- This device may not be labeled as a treatment or a cure for any type of wound.
The labeling claims listed above would be considered a major modification in the intended use of the device and would require a premarket notification submission (21 CFR 807.81). The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practices, labeling, and prohibitions against misbranding and adulteration.
1
Page 2 - Mr. Kenneth B. Herland
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 (CFR), Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practices (GMP) 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.
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,
M. Witten, Ph.D., M.D.
. ".
Cel
Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
JUL-13-98 MON 13:50
FAX NO. 4298020
K980962
Page 1 of 1
510(k) Number (If Known): K980962
Device Name: Brennen Medical Beta Glucan Cream, MacroPro
INDICATIONS FOR USE:
MacroPro Cream may be used to aid in the management of superficial and partial thickness burns; pressure ulcers (stages I-IV); venous, diabetic, and arterial ulcers; donor graph sites; superficial through full thickness wounds such as surgical wounds, minor abrasions and lacerations; and irritations of the skin.
MacroPro Cream provides a moist environment which supports in the autolytic debridement of wounds with scattered areas of necrosis and slough.
For external use only. Do not use on patients with known allergies to plants such as gum oat.
(PLEASE DO NOT WRITE BELOW THIS I.INE-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)
on Sign-Off)
ion of General Restorative Devices 4 8996f 2
Livision of General Re 510(k) Number