(63 days)
Not Found
No
The summary describes a gel formulation that forms a protective layer and does not mention any computational or analytical capabilities that would suggest AI/ML.
Yes
The product description explicitly states "provides rapid pain relief from aphthous ulcers, canker sores, and minor oral lesions," which indicates a therapeutic purpose. Additionally, the listed predicate devices are also oral rinses intended for therapeutic relief of oral lesions.
No
Explanation: The device, Aloclair Oral Rinse, is described as providing pain relief and forming a protective layer over oral mucosa. Its intended use is therapeutic (pain relief and protection from ulcers/lesions), not for diagnosing a condition.
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 to provide pain relief from oral lesions by forming a protective layer on the mucosal surface. This is a therapeutic or palliative action within the body, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details a viscous gel formulation that forms a protective layer when used as a rinse. This describes a physical barrier or coating, not a reagent or instrument used to analyze biological samples.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (like saliva, tissue, etc.) to detect or measure specific substances, identify conditions, or provide diagnostic information.
- Anatomical Site: While the anatomical site is the oral mucosa, the action is on the surface of the mucosa, not an analysis of the mucosa itself or substances within it.
IVDs are typically used to examine specimens (like blood, urine, tissue) to provide information about a person's health status, diagnose diseases, or monitor treatment. This device's function is to provide a physical barrier for pain relief, which falls outside the scope of an IVD.
N/A
Intended Use / Indications for Use
SINCLAIR ALOCLAIR™ ORAL RINSE Aloclair Oral Rinse with Aloe Vera extract, adheres to the mucosal surface and provides rapid pain relief from aphthous ulcers, canker sores, and minor oral lesions, including ulcers caused by braces and ill fitting dentures.
Product codes (comma separated list FDA assigned to the subject device)
MGO
Device Description
ALOCLAIR™ ORAL RINSE is a viscous gel formulation, which is presented for over-thecounter use premixed in containers of various sizes with plastic measuring cup. 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
: : Functional and performance testing were conducted to assess the safety and effectiveness of Aloclair® ORAL RINSE. All results are satisfactory.
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
K023/55
NOV 2 5 2002
Attachment 7 510(k) Summary
September 20, 2002
- Submission Applicant & Correspondent: Sinclair Pharmaceuticals, Ltd. Name: Address:
Borough Road Godalming Surrev GU7 2AB United Kingdom
Phone No .: +44 (0) 1483 428 611 Denise Swift, Director of Regulatory Affairs Contact Person:
| 2. Name of Device: | ALOCLAIR™ ORAL RINSE |
|---|---|
| Trade/Proprietary/Model Name: | ALOCLAIR™ ORAL RINSE |
| 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 Gelclair Concentrated Oral Gel cleared in 510(k) K013056
AloeCeuticals (Carrington Lab) OraRinse cleared in 510(k) K983182
- Device Description:
ALOCLAIR™ ORAL RINSE is a viscous gel formulation, which is presented for over-thecounter use premixed in containers of various sizes with plastic measuring cup. This combination of substances, when washed around the mouth, forms a protective layer over the oral mucosa.
- Intended Use of the Device:
- SINCLAIR ALOCLAIR™ ORAL RINSE Aloclair Oral Rinse with Aloe Vera extract, adheres to the mucosal surface and provides rapid pain relief from aphthous ulcers, canker sores, and minor oral lesions, including ulcers caused by braces and ill fitting dentures.
1
-
- Summary of Technological Characteristics of the Device Compared to the Predicate Devices:
The ALOCLAIR™ ORAL RINSE has the same intended/indications for use as the predicate Sinclair Gelclair™ Concentrated Oral Gel and AloeCeuticals (Carrington Lab) OraRinse™
- Summary of Technological Characteristics of the Device Compared to the Predicate Devices:
| Product
| Name | Aloclair | Gelclair | OraRinse |
|---|---|---|---|
| Method of | |||
| Use | Pre-mixed | Mix with water | 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 | Rapid relief from | ||
| pain, pleasant | |||
| taste, does not | |||
| sting, safe if | |||
| swallowed | |||
| Area of Use | Oral Mucosa | Oral Mucosa | Oral Mucosa |
| Disease State | Aphthous Ulcers, | ||
| Canker Sores, Oral | |||
| lesions | Oral | ||
| Mucositis/Stomatitis, | |||
| Oral lesions | Apthous Ulcers | ||
| and Canker Sores, | |||
| Oral lesions | |||
| Type of | |||
| Product | Oral | ||
| Rinse/Mouthwash | Oral Rinse | ||
| Concentrate for | |||
| dilution | Oral Rinse | ||
| Concentrate for | |||
| dilution | |||
| Presentation | Non Sterile | Non Sterile | Non Sterile |
7. Tests and Conclusions:
: : Functional and performance testing were conducted to assess the safety and effectiveness of Aloclair® ORAL RINSE. All results are satisfactory.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Denise Swift Director, Regulatory Affairs Sinclair Pharmaceuticals Limited Borough Road, Godalming, Surrey, GU 7 2AB UNITED KINGDOM
Re: K023155
Trade/Device Name: Sinclair Aloclair™ Oral Rinse Regulation Number: 21 CFR 878.4022 Regulation Name: Hydrogel Wound Dressing and Burn Dressing Regulatory Class: Unclassified Product Code: MGO Dated: September 20, 2002 Received: September 23, 2002
Dear Ms. Swift:
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 - Ms. Swift
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 (OS) 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 vou desire specific advice for your device on our labeling regulation (21 CFR Part 801), 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,
Timothy A. Ulatowski
Timothy/A. Ulatowski Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
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| Attachment 3 | Indications for Use Statement |
|---|---|
| 510(k) Number | |
| (if known) | K023155 |
| Device Name | SINCLAIR ALOCLAIR™ ORAL RINSE |
| Indications for Use | SINCLAIR ALOCLAIR™ ORAL with Aloe Vera extract, |
| adheres to the mucosal surface and provides rapid pain | |
| relief from aphthous ulcers, canker sores, and minor | |
| oral lesions, including ulcers caused by braces and ill |
fitting dentures.
.
: 上一篇: 上一篇:
PLEASE DO NOT WRITE BELOW/THIS LINE CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of Anesthesiology, General Hospital, Infection Control, Dental Devices | |
| 510(k) Number: | K023185 |
| Prescription Use (per 21 CFR 801.109) | OR | Over-The Counter Use | ✓ |
|---|---|---|---|
| --------------------------------------- | ---- | ---------------------- | -------------- |
Sinclair Pharmaceuticals, Ltd 510(k) Submission for Aloclair™ Oral Rinse
CONFIDENTIAL
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