(82 days)
Not Found
No
The description focuses on the mechanical action and physical properties of the gel wafer, with no mention of AI or ML terms or functionalities.
Yes.
The device is indicated for the management and relief of pain associated with oral lesions of various etiologies, including oral mucositis/stomatitis, irritation due to oral surgery, traumatic ulcers, and diffuse aphthous ulcers, thereby providing a therapeutic effect.
No
The device is described as having a mechanical action to relieve pain by adhering to the mucosal surface and forming a protective layer, rather than diagnosing a condition. Its intended use is for management and relief of pain, not diagnosis.
No
The device description clearly states it is a "compressed powder, presented as 2200 mg slow dissolving wafer," which is 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 mechanical action to manage and relieve pain by adhering to the oral mucosa and soothing lesions. This is a direct interaction with the body for therapeutic purposes.
- Device Description: The device is a slow-dissolving wafer that forms a protective layer in the mouth. This is a physical barrier and not a diagnostic test performed on a sample taken from the body.
- Lack of Diagnostic Activity: There is no mention of analyzing biological samples (like blood, urine, tissue, etc.) to diagnose a condition, monitor a disease, or screen for a health issue.
- Predicate Devices: The predicate devices listed (Gelclair™ and RadiaCare ™ Oral Wound Rinse) are also products used directly in the mouth for therapeutic or protective purposes, not for in vitro diagnostic testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or screening purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
MUCOTROL™ CONCENTRATED ORAL GEL WAFER HAS A MECHANICAL ACTION INDICATED FOR THE MANAGEMENT OF PAIN AND RELIEF OF PAIN, BY ADHERING TO THE MUCOSAL SURFACE OF THE MOUTH, SOOTHING ORAL LESIONS OF VARIOUS ETIQLOGIES, INCLUDING: ORAL MUCOSITIS/STOMATITIS (MAY BE CAUSED BY CHEMOTHERAPY OR RADIOTHERAPY), IRRITATION DUE TO ORAL SURGERY AND TRAUMATIC ULCERS CAUSED BY BRACES OR ILL FITTING DENTURES OR DISEASES. ALSO INDICATED FOR DIFFUSE APTHOUS ULCERS.
Product codes
FRO
Device Description
Belcher Pharmaceutical's Mucotrol™ concentrated oral gel wafer is compressed powder, presented as 2200 mg slow dissolving wafer. This combination of substances, when slowly dissolved in the mouth, due to saliva, forms a protective layer over the oral mucosa.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
mucosal surface of the 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
Image /page/0/Picture/1 description: The image shows the logo for Belcher Pharmaceuticals, Inc. The word "Belcher" is written in a cursive font, with the "B" being much larger than the other letters. Below the word "Belcher" is the text "Pharmaceuticals, Inc.", written in a smaller, sans-serif font. The logo is simple and professional, and it is likely used on the company's products and marketing materials.
12393 Belcher Road, Suite 420 Largo, FL 33773 Ph: (727) 530-9751 Fax: (727) 530-9487
K04-2400
"510(k) Summary"
Sept. 1, 2004
- Submission applicant & correspondent:
| Name: | Belcher Pharmaceuticals, Inc. |
|---|---|
| Address: | 12393 Belcher Road, Suite 420 |
| Address: | Largo, Florida 33773. USA |
| Phone: | (727) 530-9751 |
| Contact person: | Kotha Sekharam, Ph. D |
Mucotrol™ Concentrated Oral gel wafer 2. Name of device:
Trade/proprietary name: Mucotrol™ Concentrated Oral gel wafer
Common or usual name: Dressing, Wound & burn, Hydrogel with drug or biologic
Classification names: Dressing, Wound & burn, Hydrogel with drug or biologic
- Devices to which new device is substantially equivalent:
Sinclair Pharmaceuticals Gelclair™ Concentrated Oral Gel (K013056) and Carrington Labs RadiaCare ™ Oral Wound Rinse (K964852) .
- Device description:
Belcher Pharmaceutical's Mucotrol™ concentrated oral gel wafer is compressed powder, presented as 2200 mg slow dissolving wafer. This combination of
1
substances, when slowly dissolved in the mouth, due to saliva, forms a protective layer over the oral mucosa.
5. Intended use of the device:
Mucotrol™ concentrated oral gel wafer has a mechanical action indicated for the management of pain and relief of pain, by adhering to the mucosal surface of the mouth, soothing oral lesions of various etiologies, including: Oral Mucositis/Stomatitis (may be caused by chemotherapy or radiotherapy), irritation due to oral surgery and traumatic ulcers caused by braces or ill fitting dentures or disease. Also indicated for diffuse apthous ulcers.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird-like figure with three stylized lines forming its body and wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 2 4 2004
Dr. Kotha Sekharam President Belcher Pharmaceuticals, Incorporated 12393 Belcher Road, Suite 420 Largo, Florida 33773
Re: K042400
Trade/Device Name: Mucotrol Concentrated Oral Gel Wafer Regulation Number: Unclassified Regulation Name: None Regulatory Class: None Product Code: FRO Dated: September 1, 2004 Received: September 3, 2004
Dear Dr. Sekharam:
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 vour 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.
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Page 2 - Dr. Sekharam
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 vour 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/dsma/dsmamain.html
Sincerely vours.
Chiu-Liang PhD
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
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Indications for Use
510(k) Number (if known): _(042400
Device Name: MUCOTROL™ CONCENTRATED ORAL GEL WAFER
Indications for Use: : MUCOTROL™ CONCENTRATED ORAL GEL WAFER HAS A MECHANICAL ACTION INDICATED FOR THE MANAGEMENT OF PAIN AND RELIEF OF PAIN, BY ADHERING TO THE MUCOSAL SURFACE OF THE MOUTH, SOOTHING ORAL LESIONS OF VARIOUS ETIQLOGIES, INCLUDING: ORAL MUCOSITIS/STOMATITIS (MAY BE CAUSED BY CHEMOTHERAPY OR RADIOTHERAPY), IRRITATION DUE TO ORAL SURGERY AND TRAUMATIC ULCERS CAUSED BY BRACES OR ILL FITTING DENTURES OR DISEASES. ALSO INDICATED FOR DIFFUSE APTHOUS ULCERS.
Over-The-Counter Use Prescription Use YES AND/OR (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Susan Rump
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number: K042400