(101 days)
Not Found
Not Found
No
The device description and intended use focus on the mechanical action of a gel forming a protective layer. There is no mention of AI, ML, image processing, or data analysis that would suggest the use of such technologies.
No.
The device acts mechanically to form a protective layer over the oral mucosa for pain relief and soothing, rather than treating a disease or condition therapeutically.
No
The device, Sinclair Gelclair® CONCENTRATED ORAL GEL, is described as having a "mechanical action" to manage and relieve pain by adhering to the mucosal surface and forming a protective layer. Its intended use is to soothe oral lesions and reduce irritation. There is no mention of it being used to identify, detect, or analyze any medical condition or anatomical anomaly. It is a treatment for symptoms rather than a tool for diagnosis.
No
The device description clearly states it is a "viscous gel formulation" and a "combination of substances," indicating it 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 is for the management and relief of pain associated with oral lesions by forming a protective layer. This is a therapeutic or palliative action, not a diagnostic one.
- Device Description: The description focuses on the physical properties of the gel and how it forms a protective layer. It doesn't mention any components or mechanisms for detecting or measuring substances in a sample from the body.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (like saliva, tissue, etc.) to diagnose a condition, monitor a disease, or determine a patient's health status.
- Performance Studies: The summary of performance studies mentions "functional and performance testing" to assess safety and effectiveness, which aligns with a therapeutic device, not a diagnostic one that would typically report metrics like sensitivity, specificity, etc.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnostic purposes. This device acts directly on the oral mucosa for pain relief and protection.
N/A
Intended Use / Indications for Use
Sinclair Gelclair® CONCENTRATED ORAL GEL, 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 also for diffuse aphthous ulcers.
Product codes
MGQ
Device Description
Sinclair Pharmaceuticals, Ltd. Gelclair® CONCENTRATED ORAL GEL is a viscous gel formulation, which is presented in a sachet of 15ml for mixing with 40ml of water. This combination of substances, when washed around the mouth, 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
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
Extensive functional and performance testing were conducted to assess the safety and effectiveness of Gelclair® CONCENTRATED ORAL GEL. All results are satisfactory.
Key Metrics
Not Found
Predicate Device(s)
Carrington Laboratories Radiacare™ Oral Wound Rinse.
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
Attachment 7
510(k) Summary
September 1, 2001
- Submission Applicant & Correspondent: Name: Sinclair Pharmaceuticals, Ltd. Address: Borough Road
Godalming Surrey GU7 2AB United Kingdom
Phone No.: +44 1483 428 611 Denise Swift, Director of Regulatory Affairs Contact Person:
| 2. Name of Device: | Gelclair® CONCENTRATED ORAL GEL |
|---|---|
| Trade/Proprietary/Model Name: | Gelclair® CONCENTRATED ORAL GEL |
| Common or Usual Name: | Dressing, Wound & Burn, Hydrogel w/Drug or |
| Biologic | |
| Classification Names: | Dressing, Wound & Burn, Hydrogel w/Drug or |
| Biologic |
- Devices to Which New Device is Substantially Equivalent:
Carrington Laboratories Radiacare™ Oral Wound Rinse.
4. Device Description:
Sinclair Pharmaceuticals, Ltd. Gelclair® CONCENTRATED ORAL GEL is a viscous gel formulation, which is presented in a sachet of 15ml for mixing with 40ml of water. This combination of substances, when washed around the mouth, forms a protective layer over the oral mucosa.
- Intended Use of the Device:
Sinclair Gelclair® ConcentRATED ORAL GEL, 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 also for diffuse aphthous ulcers.
1
-
- Summary of Technological Characteristics of the Device Compared to the Predicate Devices:
The Gelclair® Concentrated Oral GEL has the same intended/indications for use as the predicate Carrington Laboratories Radiacare™ Oral Wound Rinse.
- Summary of Technological Characteristics of the Device Compared to the Predicate Devices:
| Product Name | Sinclair
Pharmaceuticals
Gelclair® | Carrington Labs
RadiaCareTM |
|-----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------|
| Ingredients | Purified Water,
Propylene Glycol,
Polyvinylpyrrolidone,
Sodium Hyaluronate,
Potassium Sorbate,
Sodium Benzoate,
Hydroxyethylcellulose,
PEG-40 Hydrogenated
Castor Oil, Disodium
Edetate, Benzalkonium
Chloride, Flavor,
Saccharin Sodium,
Glycyrrhetinic Acid | Acemannan hydrogel,
Aspartame, Flavor,
Fructose, Maltodextrin,
Polyvinylpyrrolidone,
Potassium Sorbate,
Sodium Benzoate |
| Method of Use | Mix with water | Mix with water |
| Number of
applications per day | Take as needed | Take as needed |
| Claim | Management and relief
of pain, does not sting,
nonirritating, safe if
swallowed | Management and relief
of pain, does not sting,
nonirritating, safe if
swallowed |
| Area of Use | Oral Mucosa | Oral Mucosa |
| Disease State | Oral
Mucositis/Stomatitis/Oral
Lesions | Oral
Mucositis/Stomatitis/Oral
Lesions |
| Type of Product | Concentrate for dilution | Concentrate for dilution |
| Presentation | Non Sterile | Non Sterile |
7. Tests and Conclusions:
Extensive functional and performance testing were conducted to assess the safety and effectiveness of Gelclair® CONCENTRATED ORAL GEL. All results are satisfactory.
2
Image /page/2/Picture/2 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 in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Sinclair Pharmaceuticals, Incorporated Ms. Priscilla Cox Director, RA/QA Otterbrook Engineering 1 Alder Brook Chinley, High Peak, UNITED KINGDOM
DEC 21 2001
Re: K013056
Trade/Device Name: Gelclair Concentrated Oral Gel Regulation Number: None Regulation Name: None Regulatory Class: Unclassified Product Code: MGQ Dated: December 10, 2001 Received: December 11, 2001
Dear Ms. Cox:
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 mendments, or to devices that have been reclassified in accordance with the provisions of Amendinona, or to arrives 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 approvisions of the Act. The general controls provisions of the Act include contrements 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 (1 wr ), it hay ob easyed 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
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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 yours,
Patricia Ciccerite/for
Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
| Attachment 3 | Indications for Use Statement |
|---|---|
| -------------- | ------------------------------- |
| 510(k) Number (if known) | |
|---|---|
| Device Name | Sinclair Gelclair® CONCENTRATED ORAL GEL |
| Indications for Use | Sinclair Gelclair® CONCENTRATED ORAL GEL, 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 also for diffuse aphthous ulcers. |
PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (per 21 CFR 801.109)
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OR
Over-The Counter Use
Petina Lucent for Guesse
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________