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

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

Aftamed® Spray provides temporary pain relief by adhering to the oral mucosa and forming a protective film over lesions and irritations for relief of tallering to the ordination of the many film ulcers caused by braces, ill-litting dentures or oral surgery

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

Aftamed® Junior Gel provides temporary pain relief by adhering to the oral mucosa and forming a protective film over lesions and irritations due to various ctiologics, including: aphthous ulcers caused by disease; traumatic ulcers caused by braces, or oral surgery.

Device Description

Aftamed® Mouthwash adheres to oral mucosa and forms a protective film over lesions and irritations due to various etiologies, including: aphthous ulcers caused by disease; traumatic ulcers caused by braces, illfitting dentures or oral surgery. The viscosity and adherence properties of the constituents of the device allow the device to form the protective film which protects the lesions for external insult.

Aftamed® Gel adheres to oral mucosa and forms a protective film over lesions and irritations due to various etiologies, including: aphthous ulcers caused by disease; traumatic ulcers caused by braces, illfitting dentures or oral surgery. The viscosity and adherence properties of the constituents of the device allow the device to form the protective film which protects the lesions for external insult.

Aftamed® Spray adheres to oral mucosa and forms a protective film over lesions and irritations due to various etiologies, including: aphthous ulcers caused by disease; traumatic ulcers caused by braces, illfitting dentures or oral surgery. The viscosity and adherence properties of the constituents of the device allow the device to form the protective film which protects the lesions for external insult.

Aftamed® Shield adheres to oral mucosa and forms a protective film over lesions and irritations due to various etiologies, including: aphthous ulcers caused by disease; traumatic ulcers caused by braces, illfitting dentures or oral surgery. The viscosity and adherence properties of the constituents of the device allow the device to form the protective film which protects the lesions for external insult.

A flamed® Junior Gel adheres to oral mucosa and forms a protective film over lesions and irritations due to various etiologies, including: aphthous ulcers caused by disease; traumatic ulcers caused by braces, illfitting dentures or oral surgery. The viscosity and adherence properties of the constituents of the device allow the device to form the protective film which protects the lesions for external insult.

AI/ML Overview

The provided document is a 510(k) summary for several Aftamed® products (Mouthwash, Gel, Spray, Shield, and Junior Gel). The purpose of this document is to demonstrate "substantial equivalence" to predicate devices, not to establish performance criteria for a novel device. Therefore, it does not contain the acceptance criteria or a study proving device performance in the manner typically expected for AI/ML devices or diagnostic tools.

Instead, the document focuses on demonstrating that the Aftamed® products are as safe and effective as their respective predicate devices (Gengigel products) by showing identical indications for use, similar ingredients and specifications, and comparable biocompatibility and physical testing results.

Here's an analysis based on the information provided, specifically addressing your points where data is available or noting its absence:

1. A table of acceptance criteria and the reported device performance

The document does not specify "acceptance criteria" in terms of performance metrics (e.g., sensitivity, specificity, accuracy) like one would see for a diagnostic device. Instead, the acceptance criteria are implicitly that the Aftamed products perform comparably to their predicate devices in terms of safety (biocompatibility) and physical characteristics relevant to their function (adhesion, protective film formation).

The "reported device performance" is presented as the results of non-clinical (biocompatibility) and physical testing.

Test Category	Acceptance Criteria (Implicit)	Reported Device Performance (Aftamed® Mouthwash, Gel, Spray, Junior Gel)	Reported Device Performance (Aftamed® Shield)
Biocompatibility	Should not be significantly irritating, cytotoxic, or sensitizing. Comparable to predicate device.	- Irritation: Minimal irritant (Mouthwash, Gel); Non-irritant (Spray); Minimal irritant reaction (Junior Gel)	- Irritation (In Vitro EpiGingival™ Tissue Model): Mild/non-irritant
		- Cytotoxicity: Wholly devoid of cytotoxic/irritant effects on primary human fibroblasts (Mouthwash, Gel); Did not cause cytotoxic effects at all tested concentrations on fibroblasts (Spray); Did not show significant cytotoxic effects on fibroblasts (Junior Gel)	- Cytotoxicity (ISO 10993-5): Did not show significant cytotoxic effects on fibroblasts
		- Sensitization: Does not show significant cytotoxic effects on fibroblasts as a whole (Mouthwash - note: described as cytotoxicity result); Not sensitizing (Gel, Spray, Junior Gel)	- Sensitization (In Vitro THP-1 cell line): Is not considered as a suspect allergen
			- Protective Effect (In vitro, on oral epithelium): Shows epithelium barrier protective and repairing activity following surfactant-induced irritating stress
Physical Testing	Maintain consistent physical characteristics (organoleptic, viscosity, pH, density, weight, microbe count). Comparable to predicate device.	- Organoleptic characteristics inspected	- Organoleptic characteristics inspected
		- Viscosity measured	- Viscosity measured
		- pH measured	- pH measured
		- Density measured	- Density measured
		- Mean weight of package contents measured	- Mean weight of package contents measured
		- Microbe count performed	- Microbe count performed

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size: The document does not specify the sample size for the non-clinical or physical tests. For example, it doesn't state how many human subjects were involved in the Human Skin Irritation Test or how many biological samples were used for cytotoxicity evaluations.
Data Provenance: The document does not explicitly state the country of origin or whether the studies were retrospective or prospective. The applicant, BIOPLAX Limited, is based in London, UK, but the tests themselves could have been conducted elsewhere.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This type of information is not applicable to this submission. The "ground truth" here is objective scientific measurement for biocompatibility and physical properties, not expert consensus on medical image interpretation or clinical diagnosis.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This type of information is not applicable to this submission as it pertains to expert review in clinical studies or image interpretation, not laboratory testing for material properties.

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

This type of information is not applicable because the device is a medical product for temporary pain relief from oral lesions, not a diagnostic imaging device or an AI/ML-assisted tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This type of information is not applicable for the same reason as point 5.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for the non-clinical tests (biocompatibility) would be defined by the standardized methodologies of the ISO 10993 series, which outline acceptable levels of biological response (e.g., cell viability for cytotoxicity, skin reaction for irritation). For physical testing, the ground truth is based on engineering and chemical standards for measuring properties like viscosity, pH, and density.

8. The sample size for the training set

This type of information is not applicable. This submission is for a traditional medical device (hydrogel products), not an AI/ML device that requires training data.

9. How the ground truth for the training set was established

This type of information is not applicable for the same reason as point 8.

Summary

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle or bird symbol with three curved lines representing wings or feathers. The symbol is enclosed within a circular border, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is written around the border of the circle.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

April 4, 2014

BIOPLAX Limited c/o Mr. Paul Ketteridge PD Regulatory Consulting, LLC 472 S State Street, Unit 101 Bellingham, WA 98225

Re: K130959

Trade/Device Name: Aftamed® Mouthwash, Aftamed™ Gel. Aftamed® Spray, Aftamed® Shield, Aftamed™ Junior Gel Regulation Number: Unclassified Regulation Name: Dressing, Wound and Burn, Hydrogel with Drug and/or Biologic Regulatory Class: Unclassified Product Code: MGO Dated. December 30, 2013 Received: January 6, 2014

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

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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): medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Mary S. Runner -S

Erin I. Keith, M.S. Acting Division Director Division of Anesthesiology, General Hospital, Respiratory. Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use- Aftamed Mouthwash

510(k) Number (if known): K130959

Device Name: Aftamed® Mouthwash

Indications for Use:

Prescription Use(Part 21 CFR 801 Subpart D)
	AND/OR
	Over-The-Counter Use XXXX(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)

Sheena A. Green -S 2014.04.04 11:25:54 -04'00'

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Indications for Use- Aftamed Gel

510(k) Number (if known): K130959

Device Name: Aftamed™ Gel

Indications for Use:

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

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use XXXX (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)

Sheena A. Green -S 2014.04.04 11:26:17 -04'00'

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Indications for Use- Aftamed Spray

510(k) Number (if known): K130959

Device Name: _Aftamed® Spray

Indications for Use:

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use XXXX (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)

Sheena A. Green -S 2014.04.04 11:26:39 -04'00'

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Indications for Use- Aftamed Shield

510(k) Number (if known): K130959

Device Name: Aftamed® Shield

Indications for Use:

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use XXXXX (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 (ODF)

Page __ of __ (Posted November 13, 2003)

Sheena A. Green -S 2014.04.04 11:27:00 -04'00'

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Indications for Use- Junior Gel

510(k) Number (if known): K130959

Device Name: _Aftamed™ Junior Gcl

Indications for Use:

Prescription Use(Part 21 CFR 801 Subpart D)
	AND/OR
Over-The-Counter Use XXXX(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)

Sheena A. Green -S 2014.04.04 11:27:20 -04'00'

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Aftamed® K | 30959

510(k) Summary- Aftamed Mouthwash Date Summary Prepared: April 3, 2014

Applicants Name:	BIOPLAX Limited6th Floor32 Ludgate HillEC4M 7DR London - UK
Contact Person:	Paul Ketteridge, (Consultant to BIOPLAX)472 S State Street Unit 101Bellingham, WA 98225443-729-0836p.kett@pd-reg.com
Device Name:	Aftamed® Mouthwash.
Classification Name:	Dressing, Wound and Burn, Hydrogel w/Drug and/or Biologic
Product Code:	MGQ
CFR Section:	None
Device Class:	Unclassified
Predicate Devices	K053342Gengigel MouthwashRicerfarma SrlVia Egadi, 7-20144Milano, ItalyProduct Code-MGQ

Device Description:

Indications:

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

510(k) Summary- Aftamed Mouthwash (continued) Date Summary Prepared: April 3, 2014

Non-Clinical Testing:

The following table details the specific tests and results performed on the Aftamed Mouthwash.

Test	Test Description	Results
Human Skin IrritationTest	ISO 10993-10	Minimal irritant
CytotoxicityEvaluation	ISO 10993-5	Wholly devoid of cytotoxic/irritant effectson primary human fibroblasts
Sensitization	10-993-10	Does not show significant cytotoxic effectson fibroblasts as a whole

Non-Clinical Testing Conclusioin: These tests show that the product meets the required non-clinical testing requirements as detailed in the ISO 10993 guidance

Physical Testing

The following physical testing is performed on each lot of product to assure quality:

Organoleptic characteristics .
. Viscosity
pH ●
Density
Mean weight of package contents: ●
Microbe count

Substantial Equivalence:

In summary, the Aftamed Mouthwash and its predicate have identical indications and intended uses, are physically composed of very similar ingredients which serve the same function. Both the A flamed Mouthwash and its predicates share almost identical specifications, and their biocompatibility testing, both in the types of test performed, and its results are virtually identical. Therefore the Aftamed Mouthwash is substantially equivalent to its predicate.

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510(k) Summary- Aftamed Gel

Date Summary Prepared: April 3, 2014

Applicants Name:	BIOPLAX Limited6th Floor32 Ludgate HillEC4M 7DR London - UK
Contact Person:	Paul Ketteridge, (Consultant to BIOPLAX)472 S State Street Unit 101Bellingham, WA 98225443-729-0836p.kett@pd-reg.com
Device Name:	Aftamed® Gel.
Classification Name:	Dressing, Wound and Burn, Hydrogel w/Drug and/or Biologic
Product Code:	MGQ
CFR Section:	None
Device Class:	Unclassified
Predicate Devices	K053342Gengigel GelRicerfarma SrlVia Egadi, 7-20144Milano, ItalyProduct Code-MGQ

Device Description:

Indications:

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

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

Aftamed® K | 30959

510(k) Summary- Aftamed Gel (continued) Date Summary Prepared: April 3. 2014

Non-Clinical Testing:

The following table details the specific tests and results performed on the Aftamed Gel.

Test	Test Description	Results
Irritation Test	ISO 10993-10	Minimal irritant compared to control
CytotoxicityEvaluation	ISO 10993-5	Wholly devoid of cytotoxic/irritant effectson primary human fibroblasts
Guinea PigMaximization Test	ISO 10993-10	Not sensitizing

Non-Clinical Testing Conclusioin: These tests show that the product meets the required non-clinical testing requirements as detailed in the ISO 10993 guidance

Physical Testing

The following physical testing is performed on each lot of product to assure quality:

Organoleptic characteristics
Viscosity ●
pH
Density .
. Mean weight of package contents:
Microbe count

Substantial Equivalence:

In summary, the Aflamed Gel and its predicate have identical indications and intended uses, are physically composed of very similar ingredients or ingredients which serve the same function. Both the Aflamed Gel and its predicates share almost identical specifications, and their biocompatibility testing, both in the types of test performed, and its results are virtually identical. Therefore the Aftamed Gel is substantially equivalent to its predicate.

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510(k) Summary- Aftamed Spray Date Summary Prepared: April 3, 2014

Applicants Name:	BIOPLAX Limited6th Floor32 Ludgate HillEC4M 7DR London - UK
Contact Person:	Paul Ketteridge, (Consultant to BIOPLAX)472 S State Street Unit 101Bellingham, WA 98225443-729-0836p.kett@pd-reg.com
Device Name:	Aftamed® Spray.
Classification Name:	Dressing, Wound and Burn, Hydrogel w/Drug and/or Biologic
Product Code:	MGQ
CFR Section:	None
Device Class:	Unclassified
Predicate Devices	K053342Gengigel SprayRicerfarma SrlVia Egadi, 7-20144Milano, ItalyProduct Code-MGQ

Device Description:

Indications:

Aftamed® 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: aphthous ulcers caused by disease; traumatic ulcers caused by braces, ill-fitting dentures or oral surgery.

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

510(k) Summary- Aftamed Spray (continued) Date Summary Prepared: April 3, 2014

Non-Clinical Testing:

The following table details the specific tests and results performed on the Aftamed Spray.

Test	Test Description	Results
Human Skin IrritationTest	ISO 10993-10	Non-irritant
CytotoxicityEvaluation	ISO 10993-5	Did not cause cytotoxic effects at all testedconcentrations on fibroblasts
Sensitization	ISO 10993-10	Not Sensitizing

Non-Clinical Testing Conclusioin: These tests show that the product meets the required non-clinical testing requirements as detailed in the ISO 10993 guidance

Physical Testing

The following physical testing is performed on each lot of product to assure quality:

Organoleptic characteristics ●
Viscosity
. pH
Density
. Mean weight of package contents:
Microbe count .

Substantial Equivalence:

In summary, the Aftamed Spray and its predicate have identical indications and intended uses, are physically composed of very similar ingredients which serve the same function. Both the Aftamed Spray and its predicates share almost identical specifications, and their biocompatibility testing, both in the types of test performed, and its results are virtually identical. Therefore the Aftamed Spray is substantially equivalent to its predicate.

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

510(k) Summary- Aftamed Shield Date Summary Prepared: April 3, 2014

Applicants Name:	BIOPLAX Limited6th Floor32 Ludgate HillEC4M 7DR London - UK
Contact Person:	Paul Ketteridge, (Consultant to BIOPLAX)472 S State Street Unit 101Bellingham, WA 98225443-729-0836p.kett@pd-reg.com
Device Name:Classification Name:Product Code:CFR Section:Device Class:	Aftamed® Shield.Dressing, Wound and Burn, Hydrogel w/Drug and/or BiologicMGQNoneUnclassified
Predicate Devices	K053342Gengigel GelRicerfarma SrlVia Egadi, 7-20144Milano, ItalyProduct Code-MGQ

Device Description:

Indications:

{14}------------------------------------------------

510(k) Summary- Aftamed Shield (continued) Date Summary Prepared: April 3, 2014

Non-Clinical Testing:

The following table details the specific tests and results performed on the Aflamed Shield,

Test	Test Description	Results
In Vitro Assessment ofIrritation Potential onEpiGingival™ TissueModel	Classify according toits effect on cellviability after topicalapplication on 3Dmodels similar togingival mucosa	Mild/non-irritant
CytotoxicityEvaluation	ISO 10993-5	Did not show significant cytotoxic effects onfibroblasts as a whole
In Vitro Assessment ofSensitizing Potentialon cell line THP-1.	THP-1 cell line	Is not considered as a suspect allergen
In vitro evaluation ofprotective effect ofAflamed Shield onoral epithelium	Cytotoxicity test, cellsurvival assayfollowing SLS-induced irritatingstress	Shows epithelium barrier protective andrepairing activity following surfactant-induced irritating stress

Non-Clinical Testing Conclusioin: These tests show that the product meets the required non-clinical testing requirements as detailed in the ISO 10993 guidance

Physical Testing

The following physical testing is performed on cach lot of product to assure quality:

Organoleptic characteristics .
Viscosity ●
pH
Density .
Mean weight of package contents: .
Microbe count .

Substantial Equivalence:

In summary, the Aftamed Shield and its predicate have identical indications and intended uses, arc physically composed of very similar ingredients which serve the same function. Both the Aftamed Shield and its predicates share almost identical specifications, and their biocompatibility testing. both in the types of test performed, and its results are virtually identical. Therefore the Aflamed Shield is substantially equivalent to its predicate.

{15}------------------------------------------------

Aftamed@ K 130959

510(k) Summary- Aftamed Junior Gel Date Summary Prepared: April 3, 2014

Applicants Name:	BIOPLAX Limited6th Floor32 Ludgate HillEC4M 7DR London - UK
Contact Person:	Paul Ketteridge, (Consultant to BIOPLAX)472 S State Street Unit 101Bellingham, WA 98225443-729-0836p.kett@pd-reg.com
Device Name:	Aftamed® Junior Gel.
Classification Name:	Dressing, Wound and Burn, Hydrogel w/Drug and/or Biologi
Product Code:	MGQ
CFR Section:	None
Device Class:	Unclassified
Predicate Devices	K053342Gengigel Junior GelRicerfarma SrlVia Egadi, 7-20144Milano, ItalyProduct Code-MGQ

Device Description:

Indications:

Aftamed® Junior 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: aphthous ulcers caused by disease; traumatic ulcers caused by braces, or oral surgery.

{16}------------------------------------------------

510(k) Summary- Aftamed Junior Gel (con't) Date Summary Prepared: April 3, 2014

Non-Clinical Testing:

The following table details the specific tests and results performed on the Aftamed Junior Gel.

Test	Test Description	Results
Irritation Test	ISO 10993-10	Showed minimal irritant reaction comparedwith the negative control
CytotoxicityEvaluation	ISO 10993-5	Did not show significant cytotoxic effectson fibroblasts as a whole
Sensitization	ISO 10993-10	Not sensitizing

Non-Clinical Testing Conclusioin: These test show that the product meets the required non-clinical testing requirements as detailed in the ISO 10993 guidance

Physical Testing

The following physical testing is performed on each lot of product to assure quality:

Organoleptic characteristics
. Viscosity
pH
Density
. Mean weight of package contents:
. Microbe count

Substantial Equivalence:

In summary, the Aftamed Junior Gel and its predicate have identical indications and intended uses, are physically composed of very similar ingredients which serve the same function. Both the Aftamed Junior Gel and its predicates share almost identical specifications, and their biocompatibility testing, both in the types of test performed, and its results are virtually identical. Therefore the Aflamed Junior Gel is substantially equivalent to its predicate.

Regulation Number and Section

N/A