(104 days)
Not Found
No
The summary describes a topical oral spray that forms a protective layer. There is no mention of AI, ML, image processing, or any data-driven analytical capabilities.
Yes
The device is indicated for pain relief and forms a protective film over mouth lesions, which are therapeutic actions aimed at treating or alleviating a condition.
No
Explanation: The device is indicated for pain relief and forms a protective film over mouth lesions, which are therapeutic functions, not diagnostic ones.
No
The device description clearly states it is a "viscous spray 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 and forming a protective film over mouth lesions. This is a therapeutic and protective function applied directly to the body, not a diagnostic test performed on a sample taken from the body.
- Device Description: The description details a viscous spray formulation applied to the oral mucosa. This is consistent with a topical treatment, not a diagnostic device.
- Lack of Diagnostic Elements: 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 Gel and Aloclair Oral Rinse) are also topical treatments for mouth lesions, not IVDs.
IVDs are devices intended to be used in vitro for the examination of specimens derived from the human body solely or principally for the purpose of providing information concerning a physiological or pathological state, or congenital abnormality, or to determine the safety and compatibility with potential recipients, or to monitor therapeutic measures. This description clearly does not fit the Aloclair Oral Spray.
N/A
Intended Use / Indications for Use
ALOCLAIR™ ORAL SPRAY 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 imitation.
Product codes
MGQ
Device Description
ALOCLAIR™ ORAL SPRAY is a viscous spray 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
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)
Extensive functional and performance testing were conducted to assess the safety and effectiveness of Aloclair® ORAL SPRAY. All results are satisfactory.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
JAN I 3 2005
Attachment 7 510(k) Summary
September 30, 2004
1. Submission Applicant & Correspondent:
Name: Sinclair Pharmaceuticals, Ltd. Address: Borough Road Godalming Surrey GU7 2AB United Kingdom
1 972 478 4380 Phone No .: Contact Person: Michael Killeen, Executive Vice President, North America
| 2. Name of Device: | ALOCLAIR™ ORAL SPRAY |
|---|---|
| Trade/Proprietary/Model Name: | ALOCLAIR™ ORAL SPRAY |
| Common or Usual Name: | Dressing, Wound & Burn, Hydrogel w/Drug or |
| Biologic | |
| Classification Names: | Dressing, Wound & Burn, Hydrogel w/Drug or |
| Biologic |
3. Devices to Which New Device is Substantially Equivalent:
Sinclair Aloclair Oral Gel cleared in 510(k) K049050
Sinclair Aloclair Oral Rinse cleared in 510(k) K023155
4. Device Description:
ALOCLAIR™ ORAL SPRAY is a viscous spray 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.
5. Intended Use of the Device:
Aloclair™ Oral Spray 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 imitation.
1
6. Summary of Technological Characteristics of the Device Compared to the Predicate Devices:
The ALOCLAIR™ ORAL SPRAY has the same intended/indications for use as the predicate Aloclair Oral Gel and Aloclair Rinse.
| Product
| Name | Aloclair Spray | Aloclair Gel | Aloclair Rinse |
|---|---|---|---|
| Method of | |||
| Use | Pre-mixed | Pre-mixed | Pre-mixed |
| # 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 | Aphthous Ulcers | ||
| Stomatitis, Oral | |||
| lesions | |||
| Type of | |||
| Product | Oral Gel | ||
| Rinse/Mouthwash | Oral Gel | ||
| Rinse/Mouthwash | Oral | ||
| Rinse/Mouthwash | |||
| 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 SPRAY. All results are satisfactory.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
Public Health Service
JAN 1 3 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Michael Killeen Executive Vice President Sinclair Pharmaceuticals, Limited Borough Road Godalming, Surrey, GU7 2AB UNITED KINGDOM
Re: K042722
Trade/Device Name: ALOCLAIR™ ORAL SPRAY Regulation Number: Unclassified Regulation Name: None Regulatory Class: None Product Code: MGQ Dated: September 29, 2004 Received: October 29, 2004
Dear Mr. Killeen:
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.
3
Page 2 - Mr. Killeen
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), please contact the Office of Compliance at (301) 594-0115. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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/dsma/dsmamain.html
Sincerely yours,
Carls
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 | |
|---|---|
| 510(k) Number (if known) | K042722 |
| Device Name | ALOCLAIR™ ORAL SPRAY |
| Indications for Use | ALOCLAIR™ ORAL SPRAY is indicated for all types of mouth lesions, aphthous stomatitis, aphthous ulcers, minor lesions, chafing and traumatic ulcers caused by braces and ill fitting dentures and diffused aphthous ulcers. |
Prescription Use _ ______________________________________________________________________________________________________________________________________________________________________________ AND/OR (Part 21 CFR 801 Subpart D) Subpart C)
Over-The-Counter Use _ V (21 CFR 807
PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Suser Runne
(Civision Sign-Off) ് vision of Anesthesiology, General Hospital, Intection Control, Dental Devices
510(k) Number:________________________________________________________________________________________________________________________________________________________________ KA 2722