(16 days)
Not Found
No
The description focuses on the chemical composition and physical properties of the paste, with no mention of AI or ML.
Yes
The device is intended to relieve pain, protect against further irritation, and manage various types of oral lesions, which are therapeutic claims.
No
The device is described as forming a protective layer over oral mucosa to relieve pain and protect against irritation; it manages existing conditions rather than identifying or diagnosing them.
No
The device description clearly states it is a "Sucralfate HCl Topical Paste," which is a physical substance, 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 topical paste applied to the oral mucosa to form a protective layer and relieve pain for various mouth lesions. This is a therapeutic or protective function, not a diagnostic one.
- Device Description: The description details the composition and mechanism of action of the paste, which is to physically cover and protect the wound. This is consistent with a topical wound dressing, not a diagnostic test.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (like blood, saliva, or tissue), detecting biomarkers, or providing information for diagnosis.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
N/A
Intended Use / Indications for Use
CARAPASTE® Oral Wound Dressing 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, 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)
FRO
Device Description
CARAPASTE ® Oral Wound Dressing, Sucralfate HCl Topical Paste, is an amorphous hydrogel paste formed by the controlled reaction of sucralfate with a limited quantity of hydrochloric acid. The amorphous hydrogel paste formed by this reaction binds reversibly to wounds and is intended to form a protective film that covers lesions where gastric acid or local wound bed acidity is not available or is inconsistently present. CARAPASTE ® Oral Wound Dressing may be administered directly to an accessible oral wound to provide an adherent physical covering of the wound bed. Although prepared by reaction of sucralfate with strong acid, the polymerized sucralfate self-buffers to a pH of approximately 3.5.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
oral mucosa, 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): 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
510K Summary CARAPASTE® Oral Wound Dressing K082856
Submission Applicant & Correspondent 1.
| Submission Date | September 25, 2008 | |
|---|---|---|
| Name: | McGrath Pharmaceuticals, Inc. | |
| Address: | 683 Center Street Unit C | |
| Phone No: | Grayslake, IL 60030 | |
| (847)-548-7860 | ||
| 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 | |
| CARAPASTE® Oral Wound Dressing | ||
| Classification Name: | Dressing, Wound, Drug | |
| Product Code: | FRO | |
| Classification: | Unclassified |
Devices to Which New Device is Substantially Equivalent 3.
Sucralfate HCl Topical Paste K043587
4. Device Description
CARAPASTE ® Oral Wound Dressing, Sucralfate HCl Topical Paste, is an amorphous hydrogel paste formed by the controlled reaction of sucralfate with a limited quantity of hydrochloric acid. The amorphous hydrogel paste formed by this reaction binds reversibly to wounds and is intended to form a protective film that covers lesions where gastric acid or local wound bed acidity is not available or is inconsistently present. CARAPASTE ® Oral Wound Dressing may be administered directly to an accessible oral wound to provide an adherent physical covering of the wound bed. Although prepared by reaction of sucralfate with strong acid, the polymerized sucralfate self-buffers to a pH of approximately 3.5.
ട. Intended Use of the Device
CARAPASTE® Oral Wound Dressing 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, mucositis, minor lesions, chafing and traumatic ulcers, abrasions caused by braces and ill fitting dentures, and lessions associated with oral surgery.
1
6. Summary of Technological Characteristics of the Device Compared to the Predicate Devices
CARAPASTE® Oral Wound Dressing forms a protective layer over the oral mucosa, adheres to the mucosal surface and relieves pain and promotes wound healing of mouth lesions.
7. Conclusions
The physical wound covering properties of CARAPASTE® Oral Wound Dressing would be expected to be at least as effective as those of the predicate devices. 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 & Human Services. The logo consists of a stylized depiction of an eagle with its wings spread, positioned to the right. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES, USA" arranged in a circular fashion.
OCT 1 5 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
McGrath Pharmaceuticals, Inc. % Patrick D. McGrath Ph.D. President and Founder 683 Center Street, Unit C Grayslake, Illinois 60030
Re: K082856
Trade/Device Name: CARAPASTE® Oral Wound Dressing Regulatory Class: Unclassified Product Code: FRO Dated: September 25, 2008 Received: September 29, 2008
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, 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.
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 eestronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2 -- Patrick D. McGrath Ph.D.
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 1egally 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Mark N. Wilkerson
Mark N. Melkerson 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:___CARAPASTE® Oral Wound Dressing
Indications For Use:
CARAPASTE® Oral Wound Dressing 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, mucositis, minor lesions, chafing and traumatic ulcers, abrasions caused by braces and ill fitting dentures, and lesions associated with oral surgery.
Prescription Use × (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use __ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Neil R. Ronden for nxm
Division of General, Restorative, and Neurological Devices
Page 1 of
510(k) Number K082856