(101 days)
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.
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.
The provided document is a 510(k) summary for a medical device (Gelclair® CONCENTRATED ORAL GEL), focusing on demonstrating substantial equivalence to a predicate device rather than presenting a study proving performance against acceptance criteria. Therefore, most of the requested information regarding acceptance criteria, study details, and AI performance is not available in the provided text.
Based on the available text, here's what can be extracted:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state acceptance criteria or quantify device performance in terms of metrics like sensitivity, specificity, or improvement effect sizes. The submission focuses on demonstrating "substantial equivalence" to a predicate device, which inherently implies that if the new device has similar technological characteristics and intended use, its performance is considered acceptable.
| Acceptance Criteria (Not explicitly stated in the document) | Reported Device Performance (Implied) |
|---|---|
| Safety and Effectiveness | "Extensive functional and performance testing were conducted to assess the safety and effectiveness of Gelclair® CONCENTRATED ORAL GEL. All results are satisfactory." (This is a general statement, not specific performance metrics.) |
| Substantial Equivalence to Predicate Device | * Similar intended use (management and relief of pain for oral lesions).* Similar method of use (mix with water, take as needed).* Similar area of use (oral mucosa).* Similar disease state (Oral Mucositis/Stomatitis/Oral Lesions).* Similar product type (concentrate for dilution).* Similar presentation (non-sterile). |
2. Sample Size Used for the Test Set and Data Provenance
The document does not mention a specific "test set" in the context of an algorithm or AI. It refers to "Extensive functional and performance testing," but does not provide details on sample sizes or data provenance for these tests. There is no indication of retrospective or prospective data.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable. This document does not describe a study involving human experts establishing ground truth for a test set, as it relates to an oral gel, not an AI or diagnostic device that requires expert interpretation.
4. Adjudication Method
Not applicable. There's no mention of adjudication for a test set.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. The device is a "CONCENTRATED ORAL GEL" for pain management, not an AI-assisted diagnostic tool.
6. If a Standalone (Algorithm Only) Performance Study Was Done
No, a standalone (algorithm only) performance study was not done. This device is an oral gel, not an algorithm.
7. The Type of Ground Truth Used
Not applicable in the context of an AI device. For the oral gel, "ground truth" would relate to the clinical effectiveness of pain relief and mucosal adherence, likely assessed through clinical trials or user experience, which are not detailed in this 510(k) summary beyond the general statement of "satisfactory" results.
8. The Sample Size for the Training Set
Not applicable. There is no mention of a "training set" as the device is not an AI algorithm.
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no training set for this device.
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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 orBiologic |
| Classification Names: | Dressing, Wound & Burn, Hydrogel w/Drug orBiologic |
- 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.
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- 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 | SinclairPharmaceuticalsGelclair® | Carrington LabsRadiaCareTM |
|---|---|---|
| Ingredients | Purified Water,Propylene Glycol,Polyvinylpyrrolidone,Sodium Hyaluronate,Potassium Sorbate,Sodium Benzoate,Hydroxyethylcellulose,PEG-40 HydrogenatedCastor Oil, DisodiumEdetate, BenzalkoniumChloride, 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 ofapplications per day | Take as needed | Take as needed |
| Claim | Management and reliefof pain, does not sting,nonirritating, safe ifswallowed | Management and reliefof pain, does not sting,nonirritating, safe ifswallowed |
| Area of Use | Oral Mucosa | Oral Mucosa |
| Disease State | OralMucositis/Stomatitis/OralLesions | OralMucositis/Stomatitis/OralLesions |
| 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.
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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.
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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
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| 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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Over-The Counter Use
Petina Lucent for Guesse
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________
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