(86 days)
Not Found
No
The summary describes a wound dressing in powder form for reconstitution and does not mention any computational or analytical capabilities, let alone AI/ML.
Yes
The device is intended for the management of mucositis/stomatitis, oral wounds, and ulcers, which are conditions requiring therapeutic intervention.
No
The device description indicates it is a "wound dressing designed for the management of oral mucositis/stomatitis," which implies a therapeutic or management function rather than a diagnostic one.
No
The device description clearly states it is supplied as a dry powder in plastic bottles for reconstitution, indicating it is a physical substance and not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the management of oral conditions like mucositis, stomatitis, and ulcers. This involves treating or dressing wounds within the mouth.
- Device Description: The device is described as a "wound dressing" in the form of a powder for reconstitution into a rinse. This is a topical application for treating a physical condition.
- Lack of Diagnostic Function: There is no mention of the device being used to diagnose, monitor, or screen for any disease or condition by examining samples taken from the body (like blood, urine, or tissue).
IVDs are used to perform tests on samples from the body to provide information for diagnosis, monitoring, or screening. This device's function is therapeutic and protective, not diagnostic.
N/A
Intended Use / Indications for Use
For the management of mucositis/stomatitis, all types of oral wounds (mouth sores and injuries), aphthous ulcers/canker sores, and traumatic ulcers caused by ill-fitting dentures or braces.
Product codes (comma separated list FDA assigned to the subject device)
MGQ
Device Description
OraMagicRx™ Oral Wound Rinse is a wound dressing designed for the management of oral mucositis/stomatitis. The device is supplied in plastic bottles containing 7.1 g, 25 g or 37.5 g of dry powder for reconstitution with water prior to use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
oral
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)
The biocompatibility of this device has been established by a primary dermal irritation test in rabbits, a sensitization test in guinea pigs, and an in vitro cytotoxicity test.
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.
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
510 (k) SUMMARY
MAR 1 4 2003
1. ADMINISTRATIVE
Submitter: MPM Medical, Inc. 2301 Crown Court Irving, Texas 75038 (982) 893-4060
Contact Person: Paul R. Miller
Date of Preparation: February 25, 2003
II. DEVICE NAME
Proprietary Name: OraMagicRx™ Oral Wound Rinse Common Name: Mucositis/Stomatitis Oral Rinse Classification Name: Dressing, Wound and Burn, Hydrogel w/ Drug and/or Biologic
PREDICATE DEVICE ==============================================================================================================================================================================
Radiacare™ Oral Wound Rinse (K964852 Carrington Laboratories, Inc.)
IV. DEVICE DESCRIPTION
OraMagicRx™ Oral Wound Rinse is a wound dressing designed for the management of oral mucositis/stomatitis. The device is supplied in plastic bottles containing 7.1 g, 25 g or 37.5 g of dry powder for reconstitution with water prior to use.
INTENDED USE V.
For the management of mucositis/stomatitis, all types of oral wounds (mouth sores and injuries), aphthous ulcers/canker sores, and traumatic ulcers caused by ill-fitting dentures or braces.
The biocompatibility of this device has been established by a primary dermal irritation test in rabbits, a sensitization test in guinea pigs, and an in vitro cytotoxicity test.
VI. COMPARISON TO PREDICATE DEVICE
OraMagicRx™ Oral Wound Rinse is similar in composition, and identical in function and intended use, to Radiacare™ Oral Wound Rinse (Carrington Laboratories, Inc.) and other legally marketed hydrogel wound dressing products.
Accordingly, MPM Medical concluded that OraMagicRx™ Oral Wound Rinse is safe and effective for its intended use, and performs at least as well as legally marketed predicate devices, such as Carrington's Radiacare™ Oral Wound Rinse
1
Image /page/1/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 three human profiles facing to the right, with flowing lines representing hair or movement.
Public Health Service
MAR 1 4 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MPM Medical, Incorporated C/O Mr. Richard Hamer Consultant Richard Hamer Associates, Incorporated 48910 Denton Road, # 38 Belleville, Michigan 48111
Re: K024180
Trade/Device Name: OraMagicRxTM Oral Wound Rinse Regulation Number: None Regulation Name: Mucositis/Stomatitis Oral Rinse Regulatory Class: Unclassified Product Code: MGQ Dated: December 17, 2002 Received: December 18, 2002
Dear Mr. Hamer:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
2
Page 2 - Mr. Hamer
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (301) 594-4613. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Susan Runser
Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
510(k) Number (if known):
KO24180
Device Name:
OraMagicRx™ Oral Wound Rinse
Indications for Use:
For the management of oral mucositis/stomatitis, all types of oral wounds (mouth sores and injuries), aphthous ulcers/canker sores, and traumatic ulcers such as those caused by ill-fitting braces or dentures.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
| Division of Anesthesiology, General Hospital, Infection Control, Dental Devices | |
| 510(k) Number | K024180 |
| Prescription Use (Per 21 CFR 801.109) | X | OR | Over-the-Counter Use | |
|---|---|---|---|---|
| --------------------------------------- | --- | ---- | ---------------------- | -- |
(Optional Format 1-2-96)