(70 days)
Not Found
No
The device description and intended use focus on the physical properties of the gel forming a protective layer. There is no mention of AI, ML, image processing, or data-driven algorithms.
Yes.
The device is indicated for pain relief and forms a protective film over lesions, which are therapeutic actions.
No
The device description indicates it is an oral gel for pain relief and protection in mouth lesions, not for diagnosing them. It forms a protective film and provides relief, which are therapeutic functions.
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 pain relief in mouth lesions by forming a protective film. This is a therapeutic or protective function, 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 processes related to analyzing biological samples for diagnostic purposes.
- Lack of IVD Indicators: There is no mention of analyzing samples (like saliva, tissue, etc.), detecting biomarkers, or providing information for diagnosis.
- Predicate Devices: The predicate devices listed (Aloclair Oral Rinse and Gelclair Concentrated Oral Gel) are also products for oral care and protection, not IVDs.
IVDs are devices 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
Aloclair™ Oral Gel is indicated for pain relief in all types of mouth lesions, aphthous stomatitis, aphthous ulcers, minor lesions, chafing and traumatic ulcers and abrasions caused by braces and ill fitting dentures and diffused aphthous ulcers. Aloclair Gel forms a protective film that covers lesions to provide rapid pain relief, and avoid further irritation.
Product codes
MGQ
Device Description
ALOCLAIR™ ORAL GEL is a viscous gel formulation, which is presented for over-thecounter use premixed in various sizes. This combination of substances, when rinsed 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
Over-The-Counter Use
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 Aloclair® ORAL GEL. All results are satisfactory.
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
JUN 2 1 2004
Attachment 7 510(k) Summary
April 9, 2004
- Submission Applicant & Correspondent: Sinclair Pharmaceuticals, Ltd. Name: Address:
Borough Road Godalming Surrey GU7 2AB United Kingdom
972 939 2442 Phone No .: Michael Killeen Contact Person:
| 2. Name of Device: | ALOCLAIR ™ ORAL GEL |
|---|---|
| Trade/Proprietary/Model Name: | ALOCLAIR™ 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:
Sinclair Aloclair Oral Rinse cleared in 510(k) K023155
Sinclair Gelclair Concentrated Oral Gel cleared in 510(k) K013056
-
- Device Description:
ALOCLAIR™ ORAL GEL is a viscous gel formulation, which is presented for over-thecounter use premixed in various sizes. This combination of substances, when rinsed around the mouth, forms a protective layer over the oral mucosa.
- Device Description:
- Intended Use of the Device:
Aloclair™ Oral Gel is indicated for pain relief in all types of mouth lesions, aphthous stomatitis, aphthous ulcers, minor lesions, chafing and traumatic ulcers and abrasions caused by braces and ill fitting dentures and diffused aphthous ulcers. Aloclair Gel forms a protective film that covers lesions to provide rapid pain relief, and avoid further irritation.
1
Image /page/1/Picture/0 description: The image shows a handwritten string of alphanumeric characters. The string appears to be "K040950". The characters are written in a simple, slightly slanted style, with varying stroke thicknesses. The image has a clean, white background, which makes the characters stand out.
- Summary of Technological Characteristics of the Device Compared to the Predicate Devices:
The Aloclair™ ORAL GEL has the same intended/indications for use as the prodicate The ALOCEAIR - ORAL GEE The Cell and AloeCeuticals (Carrington Lab) OraRinse™
| Product
| Name | Aloclair Gel | Aloclair Rinse | Gelclair |
|---|---|---|---|
| Method of | |||
| Use | Pre-mixed | Pre-mixed | Mix with water |
| # of | |||
| applications | |||
| per day | Take as needed | Take as needed | Take as needed |
| Claim | Management and | ||
| relief of pain, non | |||
| irritating, does not | |||
| sting, safe if | |||
| swallowed | Management and | ||
| relief of pain, non | |||
| irritating, does not | |||
| sting, safe if | |||
| swallowed | Management and | ||
| relief of pain, non | |||
| irritating, does not | |||
| sting, safe if | |||
| swallowed | |||
| Area of Use | Oral Mucosa | Oral Mucosa | Oral Mucosa |
| Disease State | Aphthous Ulcers | ||
| Stomatitis, Oral | |||
| lesions | Aphthous Ulcers | ||
| Stomatitis, Oral | |||
| lesions | Oral | ||
| Mucositis/Stomatitis | |||
| s, Oral lesions | |||
| Type of | |||
| Product | Oral Gel | ||
| Rinse/Mouthwash | Oral Rinse/Mouthwash | Oral Rinse | |
| Concentrate for | |||
| dilution | |||
| Presentation | Non Sterile | Non Sterile | Non Sterile |
7. Tests and Conclusions:
Extensive functional and performance testing were conducted to assess the safety and effectiveness of Aloclair® ORAL GEL. All results are satisfactory.
2
Image /page/2/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract symbol that resembles an eagle or bird-like figure.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 1 2004
Mr. Michael Killeen Executive Director Sinclair Pharmaceuticals, Limited 2340 Trinity Mills, Suite 300 Carrollton, Texas 75006
Re: K040950
Trade/Device Name: Sinclair Aloclair™ Oral Gel Regulation Number: Unclassified Regulation Name: None Regulatory Class: None Product Code: MGQ Dated: April 3, 2004 Received: April 28, 2004
Dear Mr. Killeen:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your became ================================================================================================================================================= referenced above and have decemblics are) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device interstate comments, or to that have been reclassified in accordance with the provisions of Amendinents, on to de viees mat nave oost (Act) that do not require approval of a premarket the Federal Pood, Drug, und Ocomens , therefore, market the device, subject to the general approval application (1 Mill) - The general controls provisions of the Act include controls provisions of the Fet. "The girling 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 If your device is classified (see ass 10) ional controls. Existing major regulations affecting ( (FMA), It may of subject to sach adalaf Federal Regulations, Title 21, Parts 800 to 898. In your device can be found in the Seas nouncements concerning your device in the Federal Register.
3
Page 2 - Mr. Killeen
Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that FDA s issualled of a bases and on the sther Foderal eggenies mean that FDA nas made a decernmance and regulations administered by other Federal agencies.
of the Act or any Federal statutes and regulations administered by other Federal of the Act of ally rederal statues and registements, including, but not limited to: registration You must comply with an the Fec 3 require.com (21 CFR Part 801); good manufacturing practices in the Archives and and listing (21 CFR Fall 807), laboling (21 OFF CF 2017) (21 CFR Part 820); and if requirements as set forth in the quality Systems (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your lection 5 10(k) I his letter will anow you to begin marketing your device of your device to a premarket notification. The PDF milling or cassification 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), a If you desire specific advice to: your do at (301) 594-4613. Also, please note the regulation please contact the Other or Ochiphan promarket notification" (21 CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the may obtain other general international and Consumer Assistance at its toll-free Division of Online (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely vours,
Charles
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
| Attachment 3 | Indications for Use |
|---|---|
| -------------- | --------------------- |
| 510(k) Number (if known) | K040950 |
|---|---|
| Device Name | SINCLAIR ALOCLAIR™ ORAL GEL |
| Indications for Use | SINCLAIR ALOCLAIR™ ORAL GEL is indicated for pain relief in all types of mouth lesions, aphthous stomatitis, aphthous ulcers, minor lesions, chafing and traumatic ulcers and abrasions caused by braces and ill fitting dentures and diffused aphthous ulcers. Aloclair Gel forms a protective film that covers lesions to provide rapid pain relief, and avoid further irritation. |
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 and the same of the same of the same of the same of the same of the same and the same and the seat and the search and the search and the search and the comments of the commen
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices
| 510(k) Number: | 12040950 |
|---|---|
| ---------------- | ---------- |