(90 days)
Not Found
Not Found
No
The summary describes a topical oral rinse and does not mention any computational or analytical capabilities that would suggest the use of AI or ML.
Yes
The device is intended for "fast pain relief" and "healing of oral wounds, mouth sore injuries and ulcers of the oral mucosa," which are therapeutic claims.
No
The device, Caraloe Oral Rinse, is described for pain relief and healing of oral wounds and ulcers. Its intended use focuses on treatment and symptom relief rather than the identification or diagnosis of a disease or condition.
No
The device description clearly identifies the device as an "Oral Rinse," which is a liquid substance and therefore a physical product, 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 product applied directly to the oral mucosa for pain relief and wound management. This is a topical application for therapeutic purposes.
- Device Description: It's an "Oral Rinse," which is consistent with a topical application.
- Lack of IVD Characteristics: There is no mention of:
- Analyzing samples in vitro (outside the body).
- Detecting or measuring substances in biological samples (like blood, urine, saliva, etc.).
- Providing information for diagnosis, monitoring, or screening of diseases or conditions based on in vitro analysis.
IVDs are used to perform tests on samples taken from the body to provide information about a person's health. This oral rinse is applied to the body for local treatment.
N/A
Intended Use / Indications for Use
The Carrington Laboratories Caraloe Oral Rinse provides fast pain relief and is recommended for the conning of a lives of oral wounds, mouth sore injuries and ulcers of the oral mucosa, including canker son s and traumatic ulcers such as those caused by braces and ill-fitting dentures. Safe if swallowed
Product codes
MGQ
Device Description
Not Found
Mentions image processing
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Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
oral mucosa
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 U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of a caduceus, which is a symbol often associated with healthcare and medicine.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 0 1998
Carrington Laboratories, Incorporated C/O Mr. E. J. Smith Consultant Smith Associates P.O. Box 4341 21114 Crofton, Maryland
K983182 Re : Caraloe Oral Rinse Trade Name: Regulatory Class: Unclassified Product Code: MGQ Dated: September 11, 1998 September 11, 1998 Received:
Dear Mr. Smith:
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 1. burns .
- This device may not be labeled as having any accelerating 2. effect on the rate of wound healing or epithelization.
- This device may not be labeled as a long-term, 3 . permanent, or no-change dressing, or as an artificial (synthetic) skin.
- This device may not be labeled as a treatment or a cure 4 . 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).
1
Page 2 - Mr. Smith
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.
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 requlations affecting your device can be found in the Code of Federal Requlations (CFR), Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practices (GMP) for Medical Devices: General GMP requlation (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 requlations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA findinq 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,
Patricia Cucenitto/tor
Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
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Page 1 of 1
510(k) Number (if known):
Device Name: Carrir gton Laboratories Caraloe Oral Rinse
Classification Panel
Indications for Use:
The Carrington Laboratories Caraloe Oral Rinse provides fast pain relief and is recommended for the conning of a lives of oral wounds, mouth sore injuries and ulcers of the oral mucosa, including canker son s and traumatic ulcers such as those caused by braces and ill-fitting dentures.
Safe if swallowed
(PLEASE DO HOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) Perscription Use or Over the Counter Use over (Division Sign-Off)
( Colleton of Dental, Infection Control.
and General Hospital, Infection Control. and General Hospital Infection
Food General Hospital Devices 510(k) Number
ver the Counter Use