(89 days)
Not Found
No
The device description and intended use are for a topical anesthetic wound dressing, and there is no mention of AI or ML in the provided text.
Yes
The device is intended for the "management of, and temporary relief of pain associated with, all types of mouth sores, ulcers of the oral mucosa," and described as a "wound dressing containing 10% w/w benzocaine as a topical anesthetic intended for use in the local management of painful oral mucositis/stomatitis." These descriptions indicate a therapeutic purpose.
No
The device description states it is a wound dressing containing a topical anesthetic for the management and temporary relief of pain associated with mouth sores and ulcers. It does not mention any function for identifying or determining a medical condition.
No
The device description clearly states it is a wound dressing containing benzocaine supplied as a dry powder for reconstitution, indicating it is a physical substance, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Description: The description clearly states that OraMagic™ Plus Oral Wound Rinse is a "wound dressing containing 10% w/w benzocaine as a topical anesthetic intended for use in the local management of painful oral mucositis/stomatitis." It is applied directly to the oral mucosa.
- Intended Use: The intended use is for the "management of, and temporary relief of pain associated with, all types of mouth sores, ulcers of the oral mucosa..." This is a therapeutic application, not a diagnostic test performed on a sample.
The device is a topical treatment applied to the body, not a test performed on a sample taken from the body. Therefore, it falls under the category of a medical device, but not an IVD.
N/A
Intended Use / Indications for Use
For the management of, and temporary relief of pain associated with, all types of mouth sores, ulcers of the oral mucosa including canker sores, aphthous ulcers, and injuries such as traumatic ulcers caused by braces and ill-fitting dentures.
Product codes
MGO
Device Description
OraMagic™ Plus Oral Wound Rinse is a wound dressing containing 10% w/w benzocaine as a topical anesthetic intended for use in the local management of painful oral mucositis/stomatitis. The device is supplied non-sterile in plastic bottles containing 7.1 g or 25g 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 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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
MAY 10 2005
510 (K) SUMMARY
I. ADMINISTRATIVE
Submitter: MPM Medical, Inc. 2301 Crown Court Irving, Texas 75038 (982) 893-4060
Contact Person: Paul R. Miller
Date of Preparation: February 3, 2006
II. DEVICE NAME
Proprietary Name: Oramagic™Plus Oral Wound Rinse
Common Name: Mucositis/Stomatitis Oral Rinse
Classification Name: Dressing, Wound and Bum, Hydrogel w/Drug and/or Biologic
III. PREDICATE DEVICE
OramagicRx™ Oral Wound Rinse KO24180 (MPM Medical, Inc.)
IV. DEVICE DESCRIPTION
OraMagic™ Plus Oral Wound Rinse is a wound dressing containing 10% w/w benzocaine as a topical anesthetic intended for use in the local management of painful oral mucositis/stomatitis. The device is supplied non-sterile in plastic bottles containing 7.1 g or 25g of dry powder for reconstitution with water prior to use.
V. INTENDED USE
For the management of, and temporary relief of pain associated with, all types of mouth sores, ulcers of the oral mucosa including canker sores, aphthous ulcers, and injuries such as traumatic ulcers caused by braces and ill-fitting dentures.
1
The biocompatibility of the predicate device has been established by a primary dermal irritation test in rabbits, a sensitization test in guinea pigs, and an in vivo cytotoxicity test. Since the safety of topical benzocaine (up to 20%) has been well established through a long history of over-the-counter use, the addition of 10% benzocaine to the original formulation does not raise any new biocompatibility issues.
VI. COMPARISON TO PREDICATE DEVICE
OraMagic™ Plus Oral Wound Rinse is similar in composition, function and intended use to MPM Medical's OraMagicRx™ Oral Wound Rinse and other legally marketed hydrogel wound dressing products.
Accordingly, MPM Medical, Inc. concluded that OraMagic™Plus Oral Wound Rinse is safe and effective for its intended use and performs as least as well as legally marketed predicate devices, such as MPM Medical's OraMagicRx™ Oral Wound Rinse.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines forming its head and neck. The eagle is encircled by the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 1 0 2006
MPM Medical, Incorporated C/O Mr. Richard A. Hamer Richard Hamer Associates, Incorporated 897 Chancery Court Monroe, Michigan 48161
Re: K060340
Trade/Device Name: OraMagic™ Plus Oral Wound Rinse Regulation Number: None Regulation Name: None Regulatory Class: Unclassified Product Code: MGO Dated: February 3, 2006 Received: February 15, 2006
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.
3
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 (240) 276-0115. 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/industry/support/index.html.
Sincerely yours.
Chiu Lin, Ph.D.
Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number if known: 5060340
Device Name: OraMagic™ Plus Oral Wound Rinse
Indications for Use: For the management of, and temporary relief of pain associated with, all types of mouth sores, ulcers of the oral mucosa including canker sores, aphthous ulcers, and injuries such as traumatic ulcers caused by braces and ill-fitting dentures.
Prescription Use AND/OR Over-The-Counter Use X (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Devaluation (ODE)
Susa Runge
Page 1 of 1
f Anesthesiology, General Hospital,
ion Control, Dental Devices
Number: K060386