(402 days)
Not Found
No
The device description details a chemical reaction to form a hydrogel paste and its physical mechanism of action. There is no mention of AI, ML, or any computational processing of data.
Yes.
The device is intended to relieve pain and protect against irritation by forming a protective layer over oral mucosa, which are therapeutic effects.
No
The device is a topical paste that forms a protective layer over oral lesions to relieve pain and protect against irritation. Its function is therapeutic, not diagnostic.
No
The device is a topical paste, which is a physical substance applied to the body, not a software program.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to form a protective layer over oral mucosa to protect against irritation and relieve pain in the management of various mouth lesions. This is a therapeutic or protective function applied directly to the body, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details the chemical reaction and physical properties of the paste, emphasizing its role in forming a physical covering for wounds. This aligns with a topical therapeutic device.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, saliva, tissue, etc.) or providing information about a patient's health status or condition based on such analysis. IVDs are designed to provide diagnostic information.
- Anatomical Site: The application is directly to the oral mucosa, which is a direct application to the body, not a sample collection site for diagnostic testing.
In summary, the Sucralfate HCI Topical Paste functions as a topical treatment or protective barrier, not as a diagnostic tool.
N/A
Intended Use / Indications for Use
Sucralfate HCI Topical Paste forms a protective layer over the oral mucosa by adhering to the mucosal surface which allows it to protect against further irritation and relieve pain. This paste may be used in the management of mouth lesions of all types including aphthous ulcer, stomatitis, mucositis, minor lesions, chafing and traumatic ulcers, abrasions caused by braces and ill fitting dentures, and lesions associated with oral surgery.
Product codes (comma separated list FDA assigned to the subject device)
MGQ, FRO
Device Description
Sucralfate HCI Topical Paste "10 is an amorphous hydrogel paste formed by the controlled reaction of sucralfate with a limited quantity of hydrochloric acid. This compounding process is intended for execution by a pharmacist, dentist, physician, podiatrist, veterinarian, other licensed prescriber or supervised staff trained to handle HCl 1.0N. The amorphous hydrogel paste formed by this reaction is intended to form a protective film that covers lesions where gastric acid or local wound bed acidity is not available or inconsistently present.
Sucralfate is reacted with HC1 1.0N in a ratio of approximately of 5 - 8 mL HCl per 5 gram sucralfate. Increased proportions of HCl produce thinner pastes. When reacted with hydrochloric acid sucralfate forms an amorphous hydrous gel that binds reversibly to wounds. Although reacted with strong acid, the polymerized sucralfate self-buffers to a pH of approximately 3.8. The sucralfate paste formed by this reaction may be administered directly to an accessible wound to provide an adherent physical covering of the wound bed.
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
Pharmacist, dentist, physician, podiatrist, veterinarian, other licensed prescriber or supervised staff.
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)
Multiple clinical studies demonstrate that the safety and effectiveness of topical sucralfate is at least equivalent to that of the identified predicate devices in those uses.
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
K043587\u20442
510K Summary Sucralfate HCl Topical Paste™
FEB 3 2006
Submission Applicant & Correspondent 1.
| Submission Date | December 17, 2004 |
|---|---|
| Name: | Patrick D. McGrath, Ph.D. |
| Address: | 1471 Greystone Drive |
| Gurnee, IL 60031 | |
| Phone No: | (847)-543-4138 |
| Contact Person | Patrick D. McGrath, Ph.D. |
2. Name of Device
| Common or Usual Name: | Sucralfate HCl Topical Paste™ |
|---|---|
| Trade/Proprietary/Model Name: | The following Trade Names will be used: |
| Katen Paste™ Kit |
Katen Paste Sucralfate Paste Kit TM
Dressing, Wound & Burn, Hydrogel w/Drug or Biologic Classification Name:
Product Code: MGQ FRO
Classification: Unclassified
Devices to Which New Device is Substantially Equivalent 3.
Gelclair Concentrated Oral Gel K013056 Salicept Oral Patch K012126
Device Description 4.
Sucralfate HCI Topical Paste "10 is an amorphous hydrogel paste formed by the controlled reaction of sucralfate with a limited quantity of hydrochloric acid. This compounding process is intended for execution by a pharmacist, dentist, physician, podiatrist, veterinarian, other licensed prescriber or supervised staff trained to handle HCl 1.0N. The amorphous hydrogel paste formed by this reaction is intended to form a protective film that covers lesions where gastric acid or local wound bed acidity is not available or inconsistently present.
Sucralfate is reacted with HC1 1.0N in a ratio of approximately of 5 - 8 mL HCl per 5 gram sucralfate. Increased proportions of HCl produce thinner pastes. When reacted with hydrochloric acid sucralfate forms an amorphous hydrous gel that binds reversibly to wounds. Although reacted with strong acid, the polymerized sucralfate self-buffers to a pH of approximately 3.8. The sucralfate paste formed by this reaction may be administered directly to an accessible wound to provide an adherent physical covering of the wound bed.
1
Image /page/1/Picture/0 description: The image shows a handwritten string of characters that appears to be a code or identifier. The string is "K043587" with a fraction "2/2" written as a subscript. The characters are written in a simple, slightly irregular style, suggesting they were written quickly or without precise attention to uniformity.
5. Intended Use of the Device
Sucralfate HCI Topical Paste™ forms a protective layer over the oral mucosa by adhering to the mucosal surface which allows it to protect against further irritation and relieve pain. The paste may be used in the management of mouth lesions of all types including aphthous ulcer, stomatitis, minor lesions, chafing and traumatic ulcers, abrasions caused by braces and ill fitting dentures, and lesions associated with oral surgery.
6. Summary of Technological Characteristics of the Device Compared to the Predicate Devices
Sucralfate HCI Topical Paste™ forms a protective layer over the oral mucosa by adhering to the mucosal surface which allows it to protect against further irritation and relieve pain. Multiple clinical studies demonstrate that the safety and effectiveness of topical sucralfate is at least equivalent to that of the identified predicate devices in those uses. In view of the long history of safe use of sucralfate in oral doses up to 4 grams daily and with no new adverse reactions reported after use of sucralfate applied topically, no new biocompatibility or other safety issues are raised.
7. Conclusions
The physical properties of the prepared sucralfate polymer would be expected to be at least as effective as those of the predicate devices. Since the safety of sucralfate taken orally as a drug in doses up to 4 gram daily has been well established, no new biocompatibility or other safety issues are raised.
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 stripes representing health, human services, and well-being. The eagle is positioned to the right of the department's name, which is arranged in a circular pattern around the logo.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 3
2006
Patrick D. McGrath, Ph.D. 1471 Greystone Drive Gurnee, Illinois 60031
Re: K043587
Trade/Device Name: Sucralfate HC1 Topical Paste Regulatory Class: Unclassified Product Code: FRO Dated: January 7, 2006 Received: January 10, 2006
Dear Dr. McGrath:
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, 1)rug, 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.
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.
3
Page 2 - Dr. McGrath
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-9115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,
Jarbace freem
Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known):
Device Name: Sucralfate HCI Topical Paste
Indications For Use:
Sucralfate HCI Topical Paste forms a protective layer over the oral mucosa by adhering to the mucosal surface which allows it to protect against further irritation and relieve pain. This paste may be used in the management of mouth lesions of all types including aphthous ulcer, stomatitis, mucositis, minor lesions, chafing and traumatic ulcers, abrasions caused by braces and ill fitting dentures, and lesions associated with oral surgery.
Prescription Use X (Part 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)
Barbara Buchner
Page 1 of
(Division Division of General, Restorative, and Neurological De rices
510(k) Number K043587