Gengigel® Prof Gel adheres to the oral mucosa and forms a protective film over the lesions and irritation due to various etiologies, including: oral surgery; traumatic ulcers caused by, braces or ill fitting dentures; diffuse aphthous ulcers; and oral mucositis/stomatitis (which may be caused by chemotherapy or radiotherapy). Gengigel® Prof Gel relieves pain by providing a barrier to protect the area from ongoing insult and discomfort.

Gengigel® Prof Fluid adheres to the oral mucosa and forms a protective film over the lesions and irritation due to various etiologies, including: oral surgery; traumatic ulcers caused by, braces or ill fitting dentures; diffuse aphthous ulcers; and oral mucositis/stomatitis (which may be caused by chemotherapy or radiotherapy). Gengigel® Prof Fluid relieves pain by providing a barrier to protect the area from ongoing insult and discomfort.

Gengigel® Junior provides temporary pain relief by adhering to the oral mucosa and forming a protective film over lesions and irritations due to various etiologies, including: oral surgery; traumatic ulcers caused by braces or ill fitting dentures; and aphthous ulcers.

Gengigel® Spray provides temporary pain relief by adhering to the oral mucosa and forming a protective film over lesions and irritations due to various etiologies, including: oral surgery; traumatic ulcers caused by braces or ill fitting dentures; and aphthous ulcers.

Gengigel® Gel provides temporary pain relief by adhering to the oral mucosa and forming a protective film over lesions and irritations due to various etiologies, including: oral surgery; traumatic ulcers caused by braces or ill fitting dentures; and aphthous ulcers.

Gengigel® Mouthrinse provides temporary pain relief by adhering to the oral mucosa and forming a protective film over lesions and irritations due to various etiologies, including: oral surgery; traumatic ulcers caused by braces or ill fitting dentures; and aphthous ulcers.

Device Description

Not Found

AI/ML Overview

I'm sorry, but based on the provided text, I cannot describe the acceptance criteria and the study that proves the device meets those criteria. The provided text consists of premarket notifications (510(k)) for several Gengigel® products (Prof Gel, Prof Fluid, Junior, Spray, Gel, and Mouthrinse).

These documents primarily focus on demonstrating substantial equivalence to predicate devices, not on proving device performance against specific acceptance criteria through clinical studies. The FDA's 510(k) pathway is for devices that are "substantially equivalent" to a legally marketed predicate device, meaning they have the same intended use and the same technological characteristics, or have different technological characteristics but do not raise different questions of safety and effectiveness.

The provided text does not contain information related to specific acceptance criteria (e.g., target true positive rate, false positive rate, or other metrics), the methodologies of a specific study to meet those criteria, or the detailed results of such a study.

Therefore, I cannot provide information on the following points:

A table of acceptance criteria and the reported device performance: No such criteria or performance data are detailed.
Sample size used for the test set and the data provenance: No test set or data provenance from a specific study is mentioned.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No experts or ground truth establishment for a test set are described.
Adjudication method: No adjudication method for a test set is mentioned.
Multi-reader multi-case (MRMC) comparative effectiveness study: No MRMC study or effect size related to human readers improving with AI is mentioned, as these are medical devices, not AI algorithms in the context of interpretation.
Standalone (i.e., algorithm only without human-in-the-loop performance): Not applicable as these are topical gels/mouthrinses, not algorithms.
Type of ground truth used: No ground truth for a performance study is described.
Sample size for the training set: No training set or machine learning aspects are mentioned.
How the ground truth for the training set was established: Not applicable.

The existing documents confirm that the Gengigel® products were deemed "substantially equivalent" to their respective predicate devices (Gelclair® Oral Gel and Aloclair™ Oral Gel/Spray/Rinse). This determination allows them to be marketed, subject to general controls. The basis for this substantial equivalence is the intended use as dressings for wound and burn (hydrogel with drug and/or biologic) and similar indications for temporary pain relief and protection of oral mucosa. The FDA letter confirms the regulatory decision based on the 510(k) submission.

Summary

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Gengigel® Prof Gel Premarket Notification K053342 February 15, 2007

Summary of Safety and Effectiveness 3

MAR 1 3 2007

Date Summary Prepared:

February 15, 2007

Applicants Name:

Ricerfarma Srl Via Egadi, 7-20144 Milano, Italy

Contact Person:

Paul Ketteridge, (Consultant to Ricerfarma) 303 Patleigh Road Catonsville, MD 21228 443 729-0836 p.kett@comcast.net

Device Name: Classification Name:

Product Code: CFR Section: Device Class: Classification Panel:
Indications:

Gengigel® Prof Gel. Dressing, Wound and Burn, Hydrogel w/Drug and/or Biologic MGQ None Unclassified General and Plastic Surgery

Predicate Device

K013056
Gelclair® Oral Gel
Sinclair Pharmaceuticals, Ltd
Godalming, Surrey,UK
Product Code-MGQ

{1}------------------------------------------------

Gengigel® Prof Fluid Premarket Notification K053342 February 15, 2007

Summary of Safety and Effectiveness 3

Date Summary Prepared:

February 15, 2007

Applicants Name:

Ricerfarma Srl Via Egadi, 7-20144 Milano, Italy

Contact Person:

Paul Ketteridge, (Consultant to Ricerfarma) 303 Patleigh Road Catonsville, MD 21228 443 729-0836 p.kett@comcast.net

Device Name: Classification Name:

Product Code: CFR Section: Device Class: Classification Panel:
Gengigel® Prof Fluid. Dressing, Wound and Burn, Hydrogel w/Drug and/or Biologic MGQ None Unclassified General and Plastic Surgery

Indications: Gengigel® Prof Fluid adheres to the oral mucosa and forms a protective film over the lesions and irritation due to various etiologies, including: oral surgery; traumatic ulcers caused by, braces or ill fitting dentures; diffuse aphthous ulcers; and oral mucositis/stomatitis (which may be caused by chemotherapy or radiotherapy). Gengigel® Prof Fluid relieves pain by providing a barrier to protect the area from ongoing insult and discomfort.

Predicate Devices

K013056
Gelclair® Oral Gel
Sinclair Pharmaceuticals, Ltd
Godalming, Surrey,UK
Product Code-MGQ

{2}------------------------------------------------

K053342

Gengigel® Junior Premarket Notification K053342 February 15, 2007

Summary of Safety and Effectiveness 3

Date Summary Prepared:	February 15, 2007
Applicants Name:	Ricerfarma Srl
	Via Egadi, 7-20144
	Milano, Italy
Contact Person:	Paul Ketteridge, (Consultant to Ricerfarma)
	303 Patleigh Road
	Catonsville, MD 21228
	443 729-0836
	p.kett@comcast.net
Device Name:	Gengigel® Junior.
Classification Name:	Dressing, Wound and Burn, Hydrogel w/Drug and/or
	Biologic
Product Code:	MGQ
CFR Section:	None
Device Class:	Unclassified
Classification Panel:	General and Plastic Surgery

Indications: Gengigel® Junior provides temporary pain relief by adhering to the oral mucosa and forming a protective film over lesions and irritations due to various etiologies, including: oral surgery; traumatic ulcers caused by braces or ill fitting dentures; and aphthous ulcers.

: 1

Predicate Device

i .

K040950
Aloclair™ Oral Gel
Sinclair Pharmaceuticals, Ltd
Godalming, Surrey,UK
Product Code-MGQ

{3}------------------------------------------------

K053342

Gengigel® Spray Premarket Notification K053342 February 15, 2007

Summary of Safety and Effectiveness 3

Date Summary Prepared:	February 15, 2007
Applicants Name:	Ricerfarma SrlVia Egadi, 7-20144Milano, Italy
Contact Person:	Paul Ketteridge, (Consultant to Ricerfarma)303 Patleigh RoadCatonsville, MD 21228443 729-0836p.kett@comcast.net
Device Name:	Gengigel® Spray.
Classification Name:	Dressing, Wound and Burn, Hydrogel w/Drug and/orBiologic
Product Code:	MGQ
CFR Section:	None
Device Class:	Unclassified
Classification Panel:	General and Plastic Surgery

Indications: Gengigel® Spray provides temporary pain relief by adhering to the oral mucosa and forming a protective film over lesions and irritations due to various etiologies, including: oral surgery; traumatic ulcers caused by braces or ill fitting dentures; and aphthous ulcers.

Predicate Device:

. .

K042722
Aloclair™ Oral Spray
Sinclair Pharmaceuticals, Ltd
Godalming, Surrey,UK
Product Code-MGQ

{4}------------------------------------------------

K053342

Gengigel® Gel Premarket Notification K053342 February 15, 2007

Summary of Safety and Effectiveness 3

February 15, 2007 Date Summary Prepared:

Applicants Name:

Ricerfarma Srl Via Egadi, 7-20144 Milano, Italy

Contact Person:

Paul Ketteridge, (Consultant to Ricerfarma) 303 Patleigh Road Catonsville, MD 21228 443 729-0836 p.kett@comcast.net

Device Name: Classification Name:

Product Code: CFR Section: Device Class: Classification Panel:
Gengigel® Gel. Dressing, Wound and Burn, Hydrogel w/Drug and/or Biologic MGQ None Unclassified General and Plastic Surgery

Indications: Gengigel® Gel provides temporary pain relief by adhering to the oral mucosa and forming a protective film over lesions and irritations due to various etiologies, including: oral surgery; traumatic ulcers caused by braces or ill fitting dentures; and aphthous ulcers.

Predicate Devices

K040950
Aloclair™ Oral Gel
Sinclair Pharmaceuticals, Ltd
Godalming, Surrey,UK
Product Code-MGQ

{5}------------------------------------------------

K053342

Gengigel® Mouthrinse Premarket Notification K053342 February 15, 2007

Summary of Safety and Effectiveness 3

Date Summary Prepared:	February 15, 2007
Applicants Name:	Ricerfarma SrlVia Egadi, 7-20144Milano, Italy
Contact Person:	Paul Ketteridge, (Consultant to Ricerfarma)303 Patleigh RoadCatonsville, MD 21228443 729-0836p.kett@comcast.net
Device Name:	Gengigel® Mouthrinse.
Classification Name:	Dressing, Wound and Burn, Hydrogel w/Drug and/orBiologic
Product Code:	MGQ
CFR Section:	None
Device Class:	Unclassified
Classification Panel:	General and Plastic Surgery

Indications: Gengigel® Mouthrinse provides temporary pain relief by adhering to the oral mucosa and forming a protective film over lesions and irritations due to various etiologies, including: oral surgery; traumatic ulcers caused by braces or ill fitting dentures; and aphthous ulcers.

Predicate Device

K023155
Aloclair™ Oral Rinse
Sinclair Pharmaceuticals, Ltd
Godalming, Surrey, UK
Product Code-MGQ

{6}------------------------------------------------

Image /page/6/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ricerfarma SRL C/O Mr. Paul Ketteridge Consultant PD Regulatory Consulting, LLC 303 Patleigh Road Catonsville, Maryland 21228

MAR 1 3 2007

Re: K053342

Trade/Device Name: Gengigel® Mouthrinse Regulation Number: Unclassified Regulation Name: None Regulatory Class: None Product Code: MGQ Dated: February 15, 2007 Received: February 16, 2007

Dear Mr. Ketteridge:

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.

{7}------------------------------------------------

Page 2 -Mr. Ketteridge

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 (240) 276-0115. 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/industry/support/index.html.

Sincerely yours,

Chiu Lin, Ph.D.

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

{8}------------------------------------------------

K053342

Gengigel® Junior Premarket Notification K053342 February 15, 2007

Indications for Use 1

510(k) Number (if known): K053342

Device Name: Gengigel® Junior

Indications for Use:

Gengigel® Gengigel® Junior provides temporary pain relief by adhering to the oral mucosa and forming a protective film over lesions and irritations due to various etiologies, including: oral surgery; traumatic ulcers caused by braces or ill fitting dentures; and aphthous ulcers.
Prescription Use Prescription Use
(Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use XXX (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page _ of (Posted November 13, 2003)

Susan Bunner

KC53342

{9}------------------------------------------------

K053342

Gengigel® Prof Fluid Premarket Notification K053342 February 15, 2007

Indications for Use 1

510(k) Number (if known): K053342

Device Name: _Gengigel® Prof Fluid

Indications for Use:

Gengigel® Prof Fluid adheres to the oral mucosa and forms a Gengigel® protective film over the lesions and irritation due to various etiologies, including: oral surgery; traumatic ulcers caused by, braces or ill fitting dentures; diffuse aphthous ulcers; and oral mucositis/stomatitis (which may be caused by chemotherapy or radiotherapy). Gengigel® Prof Fluid relieves pain by providing a barrier to protect the area from ongoing insult and discomfort.

Prescription Use XX (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page of (Posted November 13, 2003)

Susan Runor

KCS3342

{10}------------------------------------------------

Gengigel® Spray Premarket Notification K053342 February 15, 2007

K053342

Indications for Use 1

510(k) Number (if known): K053342

Device Name: Gengigel® Spray

Indications for Use:

Gengigel Spray provides temporary pain relief by adhering to the Gengigel® oral mucosa and forming a protective film over lesions and irritations due to various etiologies, including: oral surgery; traumatic ulcers caused by braces or ill fitting dentures; and aphthous ulcers.

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use __ XX AND/OR (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page of (Posted November 13, 2003)

Susan Rumpes

{11}------------------------------------------------

K05334.2

Gengigel® Prof Gel Premarket Notification K053342 February 15, 2007

1 Indications for Use

510(k) Number (if known):

Device Name: _Gengigel® Prof Gel

Indications for Use:

Gengigel® Gengigel® Prof Gel adheres to the oral mucosa and forms a protective film over the lesions and irritation due to various etiologies, including: oral surgery; traumatic ulcers caused by, braces or ill fitting dentures; diffuse aphthous ulcers; and oral mucositis/stomatitis (which may be caused by chemotherapy or radiotherapy). Gengigel® Prof Gel relieves pain by providing a barrier to protect the area from ongoing insult and discomfort.

Prescription Use XX AND/OR (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page of of (Posted November 13, 2003)

Susan Runne

KC53342

{12}------------------------------------------------

K053342

Gengigel® Gel Premarket Notification K053342 February 15, 2007

Indications for Use 1

510(k) Number (if known): K053342

Device Name: Gengigel® Gel

Indications for Use:

Gengigel®

Gengigel Gel provides temporary pain relief by adhering to the oral mucosa and forming a protective film over lesions and irritations due to various etiologies, including: oral surgery; traumatic ulcers caused by braces or ill fitting dentures; and aphthous ulcers.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use XX (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page of of (Posted November 13, 2003)

Susan Runore

K053342

{13}------------------------------------------------

Gengigel® Mouthrinse Premarket Notification K053342 February 15, 2007

Indications for Use 1

510(k) Number (if known): K053342

Device Name: Gengigel® Mouthrinse

Indications for Use:

Gengigel Mouthrinse provides temporary pain relief by adhering to the oral mucosa and forming a protective film over lesions and irritations due to various etiologies, including: oral surgery; traumatic ulcers caused by braces or ill fitting dentures; and aphthous ulcers.

Prescription Use AND/OR (Part 21 CFR 801 Subpart D)

Over-The-Counter Use XX (21 CFR 801 Subpart C)

K053342

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page of (Posted November 13, 2003)

Susan Pamon

transportation

justification

Regulation Number and Section

N/A