AFTAMED MOUTHWASH; AFTAMED GEL; AFTAMED SPRAY; AFTAMED SHIELD; AFTAMED JUNIOR GEL

{0}------------------------------------------------ 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. {1}------------------------------------------------ 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 {2}------------------------------------------------ ## Indications for Use- Aftamed Mouthwash 510(k) Number (if known): K130959 Device Name: Aftamed® Mouthwash Indications for Use: 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. | Prescription Use<br>(Part 21 CFR 801 Subpart D) | | |-------------------------------------------------|-----------------------------------------------------| | | AND/OR | | | Over-The-Counter Use XXXX<br>(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' {3}------------------------------------------------ ## 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' {4}------------------------------------------------ ## Indications for Use- Aftamed Spray 510(k) Number (if known): K130959 Device Name: _Aftamed® Spray Indications for Use: 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 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' {5}------------------------------------------------ ## Indications for Use- Aftamed Shield 510(k) Number (if known): K130959 Device Name: Aftamed® Shield Indications for Use: 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. 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' {6}------------------------------------------------ Indications for Use- Junior Gel 510(k) Number (if known): K130959 Device Name: _Aftamed™ Junior Gcl Indications for Use: 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. | Prescription Use<br>(Part 21 CFR 801 Subpart D) | | |-----------------------------------------------------|--------| | | AND/OR | | Over-The-Counter Use XXXX<br>(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' {7}------------------------------------------------ Aftamed® K | 30959 ## 510(k) Summary- Aftamed Mouthwash Date Summary Prepared: April 3, 2014 | Applicants Name: | BIOPLAX Limited<br>6th Floor<br>32 Ludgate Hill<br>EC4M 7DR London - UK | |----------------------|--------------------------------------------------------------------------------------------------------------------------------------| | Contact Person: | Paul Ketteridge, (Consultant to BIOPLAX)<br>472 S State Street Unit 101<br>Bellingham, WA 98225<br>443-729-0836<br>p.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 | K053342<br>Gengigel Mouthwash<br>Ricerfarma Srl<br>Via Egadi, 7-20144<br>Milano, Italy<br>Product Code-MGQ | ## 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. ## Indications: 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. {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 Irritation<br>Test | ISO 10993-10 | Minimal irritant | | Cytotoxicity<br>Evaluation | ISO 10993-5 | Wholly devoid of cytotoxic/irritant effects<br>on primary human fibroblasts | | Sensitization | 10-993-10 | Does not show significant cytotoxic effects<br>on 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. {9}------------------------------------------------ ## 510(k) Summary- Aftamed Gel Date Summary Prepared: April 3, 2014 | Applicants Name: | BIOPLAX Limited<br>6th Floor<br>32 Ludgate Hill<br>EC4M 7DR London - UK | |----------------------|--------------------------------------------------------------------------------------------------------------------------------------| | Contact Person: | Paul Ketteridge, (Consultant to BIOPLAX)<br>472 S State Street Unit 101<br>Bellingham, WA 98225<br>443-729-0836<br>p.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 | K053342<br>Gengigel Gel<br>Ricerfarma Srl<br>Via Egadi, 7-20144<br>Milano, Italy<br>Product Code-MGQ | Device Description: 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. #### 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 | | Cytotoxicity<br>Evaluation | ISO 10993-5 | Wholly devoid of cytotoxic/irritant effects<br>on primary human fibroblasts | | Guinea Pig<br>Maximization 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. {11}------------------------------------------------ ## 510(k) Summary- Aftamed Spray Date Summary Prepared: April 3, 2014 | Applicants Name: | BIOPLAX Limited<br>6th Floor<br>32 Ludgate Hill<br>EC4M 7DR London - UK | |----------------------|--------------------------------------------------------------------------------------------------------------------------------------| | Contact Person: | Paul Ketteridge, (Consultant to BIOPLAX)<br>472 S State Street Unit 101<br>Bellingham, WA 98225<br>443-729-0836<br>p.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 | K053342<br>Gengigel Spray<br>Ricerfarma Srl<br>Via Egadi, 7-20144<br>Milano, Italy<br>Product Code-MGQ | Device Description: 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. #### 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 Irritation<br>Test | ISO 10993-10 | Non-irritant | | Cytotoxicity<br>Evaluation | ISO 10993-5 | Did not cause cytotoxic effects at all tested<br>concentrations 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 Limited<br>6th Floor<br>32 Ludgate Hill<br>EC4M 7DR London - UK | |----------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------| | Contact Person: | Paul Ketteridge, (Consultant to BIOPLAX)<br>472 S State Street Unit 101<br>Bellingham, WA 98225<br>443-729-0836<br>p.kett@pd-reg.com | | Device Name:<br>Classification Name:<br>Product Code:<br>CFR Section:<br>Device Class: | Aftamed® Shield.<br>Dressing, Wound and Burn, Hydrogel w/Drug and/or Biologic<br>MGQ<br>None<br>Unclassified | | Predicate Devices | K053342<br>Gengigel Gel<br>Ricerfarma Srl<br>Via Egadi, 7-20144<br>Milano, Italy<br>Product Code-MGQ | Device Description: 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. #### Indications: 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. {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 | |-----------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------| | <i>In Vitro</i> Assessment of<br>Irritation Potential on<br>EpiGingival™ Tissue<br>Model | Classify according to<br>its effect on cell<br>viability after topical<br>application on 3D<br>models similar to<br>gingival mucosa | Mild/non-irritant | | Cytotoxicity<br>Evaluation | ISO 10993-5 | Did not show significant cytotoxic effects on<br>fibroblasts as a whole | | <i>In Vitro</i> Assessment of<br>Sensitizing Potential<br>on cell line THP-1. | THP-1 cell line | Is not considered as a suspect allergen | | <i>In vitro</i> evaluation of<br>protective effect of<br>Aflamed Shield on<br>oral epithelium | Cytotoxicity test, cell<br>survival assay<br>following SLS-<br>induced irritating<br>stress | Shows epithelium barrier protective and<br>repairing activity following surfactant-<br>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 Limited<br>6th Floor<br>32 Ludgate Hill<br>EC4M 7DR London - UK | |----------------------|--------------------------------------------------------------------------------------------------------------------------------------| | Contact Person: | Paul Ketteridge, (Consultant to BIOPLAX)<br>472 S State Street Unit 101<br>Bellingham, WA 98225<br>443-729-0836<br>p.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 | K053342<br>Gengigel Junior Gel<br>Ricerfarma Srl<br>Via Egadi, 7-20144<br>Milano, Italy<br>Product Code-MGQ | ## Device Description: 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. ### 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 compared<br>with the negative control | | Cytotoxicity<br>Evaluation | ISO 10993-5 | Did not show significant cytotoxic effects<br>on 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.