(84 days)
Not Found
No
The description focuses on the mucoadhesive properties of a liquid rinse and does not mention any computational or analytical capabilities that would suggest AI/ML. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
Yes
The device is indicated for the management of oral mucositis/stomatitis and other oral wounds, and its mechanism involves forming a protective coating over the oral mucosa, which are therapeutic actions.
No
Explanation: The device is indicated for the management of oral mucositis/stomatitis and other oral wounds, and its description highlights its function as forming a protective coating. There is no mention of it being used to diagnose conditions.
No
The device is described as a viscous liquid supplied in plastic bottles, which is a physical substance, not software.
Based on the provided information, MuGard™ Mucoadhesive Oral Wound Rinse is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the management of oral mucositis/stomatitis and other oral wounds. This is a therapeutic or palliative purpose, not a diagnostic one. IVDs are used to diagnose, monitor, or screen for diseases or conditions using samples from the human body.
- Device Description: The description details a liquid that forms a protective coating over the oral mucosa. This is a physical barrier/coating mechanism, not a test or analysis of a biological sample.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (like saliva, tissue, etc.), detecting biomarkers, or providing diagnostic information.
- Performance Studies: The performance studies mentioned are biocompatibility tests, which assess the safety of the device in contact with the body, not its diagnostic accuracy.
- Predicate Devices: The predicate devices listed are also oral rinses/gels for wound management, not diagnostic devices.
Therefore, MuGard™ is a medical device intended for the management of oral conditions, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
MuGardTM Mucoadhesive Oral Wound Rinse is indicated for the management of oral mucositis/stomatitis (that may be caused by radiotherapy and/or chemotherapy) and all types of oral wounds (mouth sores and injuries), including aphthous ulcers/canker sores and traumatic ulcers, such as those caused by oral surgery or ill-fitting dentures or braces.
Product codes
MGQ
Device Description
MuGard™ Mucoadhesive Oral Wound Rinse is a viscous liquid supplied in plastic bottles and is designed for the management of oral mucositis/stomatitis and other oral wounds. When swirled gently round the mouth, the mucoadhesive formulation results in the formation of a protective coating over the oral mucosa.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
oral mucosa, oral wounds, mouth
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
The safety of MuGard™ Mucoadhesive Oral Wound Rinse has been established through biocompatibility testing according to ISO 10993. i.e., in vitro cytotoxicity tests. sensitization testing in guinea pigs and mucosal irritation testing in rabbits.
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
510(K) SUMMARY
DEC 1 1 2006
Submitter Information 5.1
| A. Company Name: | Access Pharmaceuticals, Inc. |
|---|---|
| B. Company Address: | 2600 Stemmons Freeway, Suite 176 |
| Dallas, TX 75207 | |
| C. Company Phone: | (214) 905-5100 |
| D. Company Facsimile: | (214) 905-5101 |
| E. Contact Person: | David P. Nowotnik |
| Senior Vice-President, Research & Development | |
| david.nowotnik@accesspharma.com |
Device Identification 5.2
| A. | Device Trade Name: | MuGardTM Mucoadhesive Oral Wound Rinse |
|---|---|---|
| B. | Common Name: | Dressing, Wound and Burn, Hydrogel w/ Drug |
| and/or Biologic | ||
| C. | Classification Name: | Unclassified |
| D. | Device Class: | Unclassified |
| E. | Device Code: | MGQ |
| E. | Advisory Panel: | General and Plastic Surgery |
5.3 Identification of Predicate Devices
The MuGard™ Mucoadhesive Oral Wound Rinse is substantially equivalent to the following predicate devices:
- OraMagicRx™ Oral Wound Rinse manufactured by MPM Medical, Inc. and cleared . for commercial distribution under 510(k) K024180.
- Gelclair® Concentrated Oral Gel manufactured by Sinclair Pharmaceuticals, Ltd. and . cleared for commercial distribution under 510(k) K013056.
1
5.4 Device Description
MuGard™ Mucoadhesive Oral Wound Rinse is a viscous liquid supplied in plastic bottles and is designed for the management of oral mucositis/stomatitis and other oral wounds. When swirled gently round the mouth, the mucoadhesive formulation results in the formation of a protective coating over the oral mucosa.
ર્સ્ડ Indications for Use
MuGard™ Mucoadhesive Oral Wound Rinse is indicated for the management of oral mucositis/stomatitis (that may be caused by radiotherapy and/or chemotherapy) and all types of oral wounds (mouth sores and injuries), including aphthous ulcers/canker sores and traumatic ulcers, such as those caused by oral surgery or ill-fitting dentures or braces.
5.6 Comparison to Predicate Devices
MuGard™ Mucoadhesive Oral Wound Rinse is similar in function and has the same intended use as OraMagicRx™ Oral Wound Rinse (MPM Medical, Inc.), Gelclair® Concentrated Oral Gel (Sinclair Pharmaceuticals, Ltd.) and other legally marketed hydrogel wound dressing products.
The mode of action of MuGard™ Mucoadhesive Oral Wound Rinse is achieved in an same manner to OraMagicRx™ Oral Wound Rinse and Gelclair® Concentrated Oral Gel. i.e., through the formation of a protective layer over the oral mucosa.
The composition of MuGard™ Mucoadhesive Oral Wound Rinse is similar to OraMagicRx™ Oral Wound Rinse and Gelclair® Concentrated Oral Gel, i.e., a mixture of film-forming polymers, pharmaceutical aids, preservatives and sweeteners/flavors.
The safety of MuGard™ Mucoadhesive Oral Wound Rinse has been established through biocompatibility testing according to ISO 10993. i.e., in vitro cytotoxicity tests. sensitization testing in guinea pigs and mucosal irritation testing in rabbits.
On the basis of this information. Access Pharmaceuticals concluded that MuGard™ Mucoadhesive Oral Wound Rinse is safe and effective for its intended use and performs equivalently to the identified legally marketed predicate devices.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features the department's name encircling a symbol. The symbol consists of four stylized human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 1 2006
Dr. David P. Nowotnik Senior Vice President, Research & Development Access Pharmaceuticals, Incorporated 2600 Stemmons Freeway, Suite 176 Dallas, Texas 75207
Re: K062795
Trade/Device Name: MuGard™ Mucoadhesive Oral Wound Rinse Regulation Number: Unclassified Regulation Name: None Regulatory Class: None Product Code: MGQ Dated: September 15, 2006 Received: September 18, 2006
Dear Dr. Nowotnik:
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 - Dr. Nowotnik
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-. 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.
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: To Be Assigned By FDA
MuGard™ Mucoadhesive Oral Wound Rinse Device Name:
Indications for Use:
MuGard™ Mucoadhesive Oral Wound Rinse is indicated for the management of oral mucositis/stomatitis (that may be caused by radiotherapy and/or chemotherapy) and all types of oral wounds (mouth sores and injuries), including aphthous ulcers/canker sores and traumatic ulcers, such as those caused by oral surgery or ill-fitting dentures or braces.
Prescription Use X (21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Henry General Hospital | |
|---|---|
| KA062795 |
CONFIDENTIAL