DRYODINE CADEXOMER-IODINE GEL

{0}------------------------------------------------ 510 (k) Premarket Notification CONFIDENTIAL JUN 1 8 2010 ### SECTION 9 ﺍﻟﺘﻮ SUBSECTION 9.5 APPENDICES 510(k) Summary of Safety and Effectiveness #### તે જે રે 510(k) Summary of Safety and Effectiveness Collegium Pharmaceutical, Incorporated Dryodine™ Antibacterial Gel October 22, 2009 #### 9.5.1 Sponsor Name Collegium Pharmaceutical, Incorporated 400 Highland Corporate Drive Cumberland, RI 02864 Contact Individual: Mark W. Trumbore, Ph.D. Director, Product Research & Development Collegium Pharmaceutical, Inc. 401-762-2000 X17 401-762-2043 (fax) mtrumbore@collegiumpharma.com #### 9.5.2 Device Name Proprietary Name: Dryodine™ Antibacterial Gel Common/Usual Name: Wound Dressing #### Identification of Predicate or Legally Marketed Device 9.5.3 Dryodine™ Antibacterial Gel is substantially equivalent to the following predicate devices: - Iodosorb Gel cleared under 510(k) K905069, from Perstorp Pharma. o - Triosyn T40 Antimicrobial Dressing under 510(k) K051452, from Triosyn O Corporation #### 9.5.4 Device Description Dryodine™ Antibacterial Gel consists of 0.1mm diameter biodegradable hydrophilic beads of cadexomer dispersed in a hydrophilic gel comprised of polyethylene glycol and poloxamer and contains 0.9% by weight iodine. The device is presented as a prescription product that requiring a physician to diagnosis the disease state and prescribe the product. --- {1}------------------------------------------------ 09 3320 page 2 of 2 ### Dryodine™ Antibacterial Gel 510 (k) Premarket Notification CONFIDENTIAL # SECTION 9 ### SUBSECTION 9.6 ## APPENDICES # 510(k) Summary of Safety and Effectiveness ## 9.5.5 Intended Use Dryodine™ Antibacterial Gel is indicated for use in the management/cleaning of wet Dryounds - Innouvids such as venous stasis ulcers, pressure sores, diabetic foot ulcers, and traumatic and surgical wounds. Dryodine™ Antibacterial Gel assists to keep lesions soft and pliable. #### Comparison of Technological Characteristics 9.5.6 Both the proposed Dryodine™ Antibacterial Gel and the predicate device Iodosorb Gel Donsist of 0.1mm diameter biodegradable hydrophilic beads of cadexomer dispersed in a bydrophilic Gel comprised of polyethylene glycol and poloxamer and contain 0.9% by weight iodine. Both the proposed and predicate devices are designed to be highly absorbent while providing a moist wound healing environment. #### Performance Testing 9.5.7 In vitro effectiveness tests were conducted on Dryodine™ Antibacterial Gel. #### 9.5.8 Statement of Equivalency Dryodine™ Antibacterial Gel is substantially equivalent in design, materials, construction and intended use to that of the predicate devices. The principal of operation of Dryodine™ Antibacterial Gel and the predicate devices is exactly the same. Since of Dryodine™ Antibacterial Gel has the same intended use and technological characteristics Di yound - Antouvererial Gel mas Antibacterial Gel does not raise any new safety and efficacy concerns when compared to the similar legally marketed devices. Testing and labeling demonstrate that Dryodine™ Antibacterial Gel is substantially equivalent to the predicate devices and is capable of safely and accurately performing the stated intended use. {2}------------------------------------------------ Image /page/2/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 with three stripes forming its wing, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circle around the eagle. The text is in all caps and appears to be in a sans-serif font. The logo is black and white. Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -W066-G609 Silver Spring, MD 20993-0002 JUN 1 8 2010 Collegium Pharmaceutical Inc. % Mark W. Trumbore, Ph.D. Director, Product Research & Development 400 Highland Corporate Drive ... Cumberland, Rhode Island 02864 Re: K093320 Trade/Device Name: Dryodine™ Antibacterial Gel Regulatory Class: Unclassified Product Code: FRO Dated: May 14, 2010 Received: May 17, 2010 Dear Dr. Trumbore: 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. 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 {3}------------------------------------------------ Page 2 - Mark W. Trumbore, Ph.D. 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/Resourcesfor You/Industry/default.htm. Sincerely yours, Mark N. Melkerson Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ Page 1 of 1 Dryodine™ Antibacterial Gel 510 (k) Premarket Notification CONFIDENTIAL SECTION 1 # SUBSECTION 1.8 # GENERAL INFORMATION # Statement of Indications for Use ### 1.7 Statement of Indications for Use 510(k) Number (if known): K093320 Device Name: Dryodine™ Antibacterial Gel Indications For Use: Dryodine™ Antibacterial Gel is indicated for use in the management/cleaning of wet ulcers and wounds such as venous stasis ulcers, pressure sores, diabetic foot ulcers, and traumatic and surgical wounds. Dryodine™ Antibacterial Gel assists to keep lesions soft and pliable. Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Daniel Krenz for MXM (Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices 510(k) Number K093320