Chitogel Endoscopic Sinus Surgery Kit

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or clothing. #### DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 October 17, 2017 Chitogel, Ltd. % Gregory Mathison President Regulatory Strategies. Inc. 3924 Cascade Beach Road Lutsen, MN 55612 Re: K172179 Trade/Device Name: Chitogel Endoscopic Sinus Surgery Kit Regulation Number: 21 CFR 874.4780 Regulation Name: Intranasal Splint Regulatory Class: Class I Product Code: LYA Dated: July 10, 2017 Received: July 19, 2017 Dear Gregory Mathison: 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}------------------------------------------------ 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 devicerelated 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 Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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. Eric A. Mann -S for Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K172179 #### Device Name Chitogel Endoscopic Sinus Surgery Kit | Indications for Use (Describe) | | |--------------------------------|--| |--------------------------------|--| The Chitogel Endoscopic Sinus Surgery Kit is indicated for use in patients undergoing nasal/sinus surgery as a space occupying packing to: - Separate tissue or structures compromised by surgical trauma - Separate and prevent adhesions between mucosal surfaces in the nasal cavity and minimize ostial stenosis following endoscopic sinus surgery - Control minimal bleeding following surgery or trauma by tamponade effect, blood absorption and platelet aggregation - Act as an adjunct to aid in the natural healing process The Chitogel Endoscopic Sinus Surgery Kit is indicated for use as a nasal packing to treat epistaxis. | Type of Use (Select one or both, as applicable) | |-------------------------------------------------| |-------------------------------------------------| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # 510(k) Summary - K172179 This 510(k) summary information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92. ## General Information | Applicant: | Chitogel Ltd 139<br>Moray Place<br>Dunedin, 9016, New Zealand Tel: +64<br>21 969 149 | |------------------------|--------------------------------------------------------------------------------------| | Trade Name: | Chitogel Endoscopic Sinus Surgery Kit | | Common Name: | Nasal packing | | Classification Name: | Intranasal splint | | Number: | 21 CFR §874.4780 | | Device Classification: | Class I | | Product Code: | LYA | | Predicate Devices: | Novashield Injectable Nasal Packing and Stent<br>(K141704) | | Contact | Gregory Mathison<br>US Agent<br>T: 218.387.1559<br>E: gmathison@att.net | | Date: | October 8, 2017 | # Substantially Equivalent to: The Chitogel Endoscopic Sinus Surgery Kit is equivalent in intended use, principal of operation and technological characteristics to the Novashield Injectable Nasal Packing and Stent (K141704). ### Description of the device subject to premarket notification The Chitogel Endoscopic Sinus Surgery Kit consists of the following components: {4}------------------------------------------------ - Sealed vial containing 300mg Dextran Aldehyde Powder ● - Sealed vial containing 10ml Sodium Phosphate Buffer Solution ● - Sealed vial containing 10ml Chitosan Succinaamide Solution ● - 12cc control syringe - Fluid dispensing connector - Two (2) mixing cannulae - Malleable cannula ● The Chitogel Endoscopic Sinus Surgery Kit is used during nasal surgery. The components in the Chitogel Kit are mixed by the physician using the syringe and cannulae provided. The pre- measured components mix to form the biodegradable gel. Once the components are mixed and create the gel, the physician applies the gel to the target area using the malleable cannula and thereby creating a nasal packing. All components are provide sterile and are for single use only. # Indications for Use The Chitogel Endoscopic Sinus Surgery Kit is indicated for use in patients undergoing nasal/sinus surgery as a space occupying packing to: - · Separate tissue or structures compromised by surgical trauma - · Separate and prevent adhesions between mucosal surfaces in the nasal cavity and minimize ostial stenosis following endoscopic sinus surgery - · Control minimal bleeding following surgery or trauma by tamponade effect, blood absorption and platelet aggregation - · Act as an adjunct to aid in the natural healing process The Chitogel Endoscopic Sinus Surgery Kit is indicated for use as a nasal packing to treat epistaxis. ## Materials The Chitogel Endoscopic Sinus Surgery Kit consists of well-known and commonly used materials. All materials are purchased from reputable vendors. Testing included the following: - Cytotoxicity - . Sensitization - Acute Systemic Toxicity ● # Animal Testing Animal testing was conducted to assess the simulated clinical performance of the Chitogel Endoscopic Sinus Surgery Kit. The product was used per the product IFU - the individual components were mixed together forming the gel, the gel was injected into the sinus cavity via the nasal passage, the gel maintained its position in the sinus cavity and the gel was removed using saline irrigation. The simulated use of the Chitogel product in an animal model showed it could be combined into a gel, introduced into the sinus cavities, maintained position after introduction and degraded over time using saline irrigation. No adverse events were observed. {5}------------------------------------------------ ### Journal articles: Athanasiadis, T, Beule, B, Robinson, B, Robinson, S, Shi, Z, Wormald, PJ; Effects of a Novel Chitosan Gel on Mucosal Wound Healing Following Endoscopic Sinus Surgery in a Sheep Model of Chronic Rhinosinusitis. The Laryngoscope 118: June 2008 ## Clinical Experience Several clinical studies involving the Chitogel product were completed. These randomized controlled studies were reported in published peer reviewed articles in scientific journals. The product was used per the product IFU and exhibited performance consistent with the indications for use. The Chitogel product was mixed into a gel and introduced into the sinus cavities via a cannula. Once in place, the following clinical observations were documented: - · The gel separated tissue or structures following surgery - The gel separated and prevented adhesions between mucosal surfaces in the nasal cavity and minimized ostial stenosis following endoscopic sinus surgery - The gel controlled minimal bleeding following surgery by a tamponade effect, blood absorption and platelet aggregation - · The gel acted as an adjunct to aid in the natural healing process These observations were confirmed in the studies and submitted to and/or published in peer reviewed iournals. ### Journal articles: Ha, T., Valentine, R., Moratti, S., Robinson, L., Wormald, PJ. A blinded randomized controlled trial evaluating the efficacy of Chitosan gel on ostial stenosis following endoscopic sinus surgery. Submitted to International Forum of Allergy & Rhinology (IFAR) Valentine, R., Athanasiadis, T., Moratti, S., Hanton, L., Robinson, S., Workald, PJ. The efficacy of a novel chitosun gel on hemostatsis and wound healing after endoscopic sinus surgery. American Journal of Allergy & Rhinology, January-February 2010 Vol.24 No. 1 Ha, T., Valentine, R., Moratti, S., Hanton, L., Robinson, S., Wormald, PJ. The efficacy of a novel budesonide chitosan gel on wound healing following endoscopic sinus surgery. Submitted to International Forum of Allergy & Rhinology (IFAR) ### Non-Clinical Testing Testing was conducted on sterile final product. Product testing followed the appropriate standards and guidance documents, with appropriate modifications following risk assessment. Testing plans were based upon FDA guidance documents and international standards. Testing was performed on baseline (non- aged) and aged products. Testing included: - viscosity - gel time ● - delivery of gel - biodegradation - packaging {6}------------------------------------------------ All samples passed testing and met the acceptance criteria of the specification. ## Basis for Determination of Substantial Equivalence Upon reviewing the safety information provided in this submission and comparing intended use, principle of operation and overall technological characteristics, the Chitogel Endoscopic Sinus Surgery Kit is determined to be substantially equivalent to existing legally marketed devices. ### Comparison of Product Features | Trade name | Chitogel Endoscopic Sinus<br>Surgery Kit | Novashield | SE Discussion | |----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Product code | LYA | LYA | Same | | 510(k) number | K172179 | K141704 | Same | | 21CFR | 874.4780 | 874.4780 | Same | | Device<br>Classification | Class 1 | Class 1 | Same | | Device<br>Description | Chitosan based gel supplied in<br>3 components mixed into a gel<br>by user | Chitosan based pre-mixed gel | Equivalent | | Method of<br>Operation | Gel injected into sinus cavity | Gel injected into sinus cavity | Equivalent | | Intended Use | The Chitogel Endoscopic<br>Sinus Surgery Kit is indicated<br>for use in patients undergoing<br>nasal/sinus surgery as a space<br>occupying packing to:<br>• Separate tissue or structures<br>compromised by surgical<br>trauma;<br>• Separate and prevent<br>adhesions between mucosal<br>surfaces in the nasal cavity and<br>minimize ostial stenosis<br>following endoscopic sinus<br>surgery<br>• Control minimal bleeding<br>following surgery or trauma<br>by tamponade effect, blood<br>absorption and platelet<br>aggregation<br>• Act as an adjunct to aid in<br>the natural healing process<br>The Chitogel Endoscopic<br>Sinus Surgery Kit is indicated<br>for use as a nasal packing to<br>treat epistaxis. | NovaShield is indicated for<br>use in patients undergoing<br>nasal/sinus surgery as a space<br>occupying<br>packing to:<br>• Separate tissue or structures<br>compromised by surgical<br>trauma;<br>• Separate and prevent<br>adhesions between mucosal<br>surfaces in the nasal cavity;<br>• Control minimal bleeding<br>following surgery or trauma<br>by tamponade effect, blood<br>absorption and<br>platelet aggregation<br>• Act as an adjunct to aid in<br>the natural healing process<br>NovaShield is indicated for<br>use as a nasal packing to treat<br>epistaxis. | Equivalent | | Components | Dextran Aldehyde Powder<br>Sodium Phosphate Buffer<br>Solution<br>Chitosan Succinamide<br>Solution | Chitosan<br>Cellulose | Equivalent | | Sterilization | Supplied sterile - ETO &<br>Gamma | Supplied sterile – unknown<br>method | Equivalent | | Single use | Yes | Yes | Equivalent | | Shelf life | 3 months | Unknown | Equivalent | | Packaging | Tyvex / poly header pouch | Unknown | Industry standard packaging | | Materials | Chitosan based gel | Chitosan based gel | Equivalent | | Biodegradable | Yes | Yes | Equivalent | | Published<br>Clinical Data | Yes | No | Equivalent - even though the<br>predicate device does not have<br>any published clinical data,<br>both products have the same<br>intended use and clinical<br>application | {7}------------------------------------------------ {8}------------------------------------------------ # Conclusion The products are substantially equivalent as the indications for use, clinical application and materials are equivalent to existing legally marketed predicate products.