(70 days)
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.
ALOCLAIR™ ORAL GEL is a viscous gel formulation, which is presented for over-the-counter use premixed in various sizes. This combination of substances, when rinsed around the mouth, forms a protective layer over the oral mucosa.
The provided text does not contain detailed information about specific acceptance criteria or an in-depth study proving the device meets those criteria, as one might find for a more complex medical device with quantifiable performance metrics (e.g., diagnostic accuracy, sensitivity, specificity).
The document is a 510(k) summary for Sinclair Aloclair™ Oral Gel, which is a wound and burn dressing (hydrogel with drug or biologic) for oral use. The approval for this device is based on substantial equivalence to predicate devices already on the market, rather than a novel claim requiring extensive new clinical trials with detailed performance metrics.
Based on the provided text, here's what can be extracted and inferred:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria (Inferred from Substantial Equivalence) | Reported Device Performance |
|---|---|
| Intended Use: Pain relief in various mouth lesions (aphthous stomatitis, ulcers, minor lesions, chafing, traumatic ulcers, abrasions from braces/dentures, diffused aphthous ulcers). | Indication: "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." (This is essentially the stated intended use). |
| Technological Characteristics: Similar method of use, number of applications per day, claim (pain management/relief, non-irritating, non-stinging, safe if swallowed), area of use (oral mucosa), disease state (aphthous ulcers, stomatitis, oral lesions), product type (oral gel/rinse/mouthwash), presentation (non-sterile). | The device's characteristics are presented as "the same" as predicate devices (Aloclair Rinse cleared in K023155, Gelclair Concentrated Oral Gel cleared in K013056, and AloeCeuticals OraRinse™). The table provided lists these characteristics and shows how Aloclair Gel aligns with its predicates. |
| Safety and Effectiveness: Demonstrate safety and effectiveness comparable to predicate devices for the stated intended use. | "Extensive functional and performance testing were conducted to assess the safety and effectiveness of Aloclair® ORAL GEL. All results are satisfactory." (This is a general statement without specific data or metrics). |
| Regulatory Classification: Unclassified. | The FDA letter confirms the device is unclassified and can be legally marketed subject to general controls. |
2. Sample size used for the test set and the data provenance:
- The document does not specify a sample size for a test set in the context of a clinical performance study.
- The review is based on substantial equivalence to predicate devices, implying that the safety and effectiveness were primarily supported by the established history and regulatory status of those predicates, combined with functional and performance testing (likely bench or in-vitro, but not specified as a human clinical test set).
- The provenance of data for any "functional and performance testing" is not detailed (e.g., country of origin, retrospective/prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. The document does not describe a clinical study that required expert consensus for ground truth establishment.
4. Adjudication method for the test set:
- Not applicable. There is no described clinical test set requiring adjudication.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This device is a topical oral gel, not an AI-powered diagnostic or treatment device, so MRMC studies are not relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a topical oral gel, not an algorithm.
7. The type of ground truth used:
- The "ground truth" for the substantial equivalence claim is largely established by the regulatory history and accepted safety and effectiveness of the predicate devices for their indications. For the functional and performance testing mentioned, the "ground truth" would be objective measures of the gel's properties (e.g., pH, viscosity, stability, barrier formation ability), but these are not detailed in the summary.
8. The sample size for the training set:
- Not applicable. This device is a medical product, not an AI model, so there is no "training set."
9. How the ground truth for the training set was established:
- Not applicable.
{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 orBiologic |
| Classification Names: | Dressing, Wound & Burn, Hydrogel w/Drug orBiologic |
- 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™
| ProductName | Aloclair Gel | Aloclair Rinse | Gelclair |
|---|---|---|---|
| Method ofUse | Pre-mixed | Pre-mixed | Mix with water |
| # ofapplicationsper day | Take as needed | Take as needed | Take as needed |
| Claim | Management andrelief of pain, nonirritating, does notsting, safe ifswallowed | Management andrelief of pain, nonirritating, does notsting, safe ifswallowed | Management andrelief of pain, nonirritating, does notsting, safe ifswallowed |
| Area of Use | Oral Mucosa | Oral Mucosa | Oral Mucosa |
| Disease State | Aphthous UlcersStomatitis, Orallesions | Aphthous UlcersStomatitis, Orallesions | OralMucositis/Stomatitiss, Oral lesions |
| Type ofProduct | Oral GelRinse/Mouthwash | Oral Rinse/Mouthwash | Oral RinseConcentrate fordilution |
| 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 |
|---|---|
| ---------------- | ---------- |
N/A