ChitoZolve

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November 30, 2018 Gyrus ACMI, Inc Dolan Mills Sr. Specialist, Regulatory Affairs, ENT 136 Turnpike Road Southborough, MA 01772 Re: K181696 Trade/Device Name: ChitoZolve Regulation Number: 21 CFR 874.4780 Regulation Name: Intranasal Splint Regulatory Class: Class I Product Code: LYA, EMX Dated: October 31, 2018 Received: November 1, 2018 Dear Dolan Mills: 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. Although this letter refers to your product as a device. please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely. # Srinivas Nandkumar -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) K181696 Device Name ChitoZolve Indications for Use (Describe) Indicated for use in patients undergoing nasal/sinus surgery as a space occupying hemostat/splint to: - Separate tissue or structures compromised by surgical trauma - Separate and prevent adhesions between mucosal surfaces during mesothelial cell regeneration in the nasal cavity - Help control minimal bleeding following surgery or trauma - Help control minimal bleeding following surgery or nasal trauma by tamponade effect blood absorption and platelet aggregation - Act as an adjunct to aid in the natural healing process Indicated for use as a nasal hemostat to treat epistaxis. Intended for use under the direction of a licensed healthcare provider. | 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}------------------------------------------------ Traditional 510(k) Notification K181696 ## 510(k) Summary ## General Information | Manufacturer and 510(k) Submitter: | Gyrus ACMI, Inc., an Olympus company<br>136 Turnpike Road<br>Southborough, MA 01772-2104<br>Phone: 1-800-262-3540<br>Fax: 1-901-373-0220 | |-----------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------| | Establishment Registration Number: | 3003790304 | | Contact Person: | Dolan Mills<br>Senior Specialist, Regulatory Affairs | | Date Prepared: | Oct 31, 2018 | | <b>Device Description</b> | | | Classification Name: | Intranasal Splint | | Regulatory Class<br>Regulation Number<br>Review Panel<br>Product Code | Class 1<br>21 CFR 874.4780 / 874.4100<br>Ear, Nose, & Throat Panel<br>LYA / EMX | | Project Name: | Chitosan Splint (14-006) | | Trade Name(s): | ChitoZolve, Chitosan IntraNasal Pack | | Generic/Common Name: | Intranasal Splint | | Model Number: | CNS155 | {4}------------------------------------------------ #### Predicate Device Hemostasis PosiSep / PosiSep X: K122494 #### Product Description Intranasal splints are utilized to stop nasal hemorrhage and for the prevention of tissue adhesion in the nasal and/or sinus cavities. It is often used after FESS, nasal/sinus surgery, or surgical trauma in the event of excessive epistaxis. Splints are gently inserted into the nasal cavity. The device is designed to swell within the nasal cavity in order to exert pressure on the bleeding sites. The splint material is dissolvable. Splints can also be used following sinus surgery in order to hold cartilage and membranes in their proper places during healing following surgerv. The Chitosan Intranasal Splint is made from Carboxymethyl Chitosan, mixed with Methyl Cellulose, and Hydroxyethyl Cellulose to make an absorbent porous sponge that is flexible and dissolvable. The device acts as a nasal splint and temporary spacer. #### Technological Characteristics Chitosan is a polysaccharide derivative of chitin which can be obtained from a number of natural sources (ie. shellfish chitin) and has well-documented medical and healing properties. The device is used in the same way as the predicate. At the point of use, the splint is inserted by the surgeon into the patient's nasal cavity and reconstituted fully with a saline solution to expand and act as a moisture barrier and tissue spacer during healing. The nasal splints dissolve between 2-14 days after insertion. The technological differences between the subject and predicate device are: dry weight % of Chitosan, and the use of Methyl Cellulose instead of Carboxymethylcellulose. The performance of the device was compared against the known performance characteristics of the predicate device. Testing demonstrated that the performance requirements were met, and that the subject device meets all applicable user requirements. The technological differences do not impact the safety or efficacy of the device. ## Material The device uses the same or similar patient-contacting materials that are utilized in the predicate device. The Chitosan Intranasal Splint is made from Carboxymethyl Chitosan, mixed with Methyl Cellulose, and Hydroxyethyl Cellulose to make an absorbent porous sponge that is flexible and dissolvable. {5}------------------------------------------------ #### Intended Use / Indications Indicated for use in patients undergoing nasal/sinus surgery as a space occupying hemostat/splint to: - Separate tissue or structures compromised by surgical trauma - Separate and prevent adhesions between mucosal surfaces during mesothelial cell regeneration in the nasal cavity - Help control minimal bleeding following surgery or trauma - Help control minimal bleeding following surgery or nasal trauma by tamponade effect blood absorption and platelet aggregation - Act as an adjunct to aid in the natural healing process Indicated for use as a nasal hemostat to treat epistaxis. Intended for use under the direction of a licensed healthcare provider. #### Compliance to Standards The design of the device complies with the following standards: ISO 10993-1, 5, 10, Biological Evaluation of Medical Devices ISO 14971, Risk Analysis ISO 15223-1:2016, Medical Devices - Symbols to be used ISO 11137-1:2006, Sterilization of medical devices, Radiation ISO 11137-2:2013, Sterilization of medical devices, Radiation ISO 11607-1:2006, Packaging for Terminally Sterilized Medical Devices ISO 11607-2:2006, Packaging for Terminally Sterilized Medical Devices ISO 11737-1:2006, Sterilization of Medical Devices - Microbiological Methods Risk analysis was carried out in accordance with established in-house acceptance criteria based on ISO 14971. Design verification tests were identified and performed as a result of risk analysis assessment. ## Summary of Sterilization and Shelf Life Discussion The device is provided sterile, single-use. The device is sterilized with Gamma, using a cycle validated in accordance with ISO 11137 to provide a sterility assurance level of 10-6. {6}------------------------------------------------ The Shelf Life period for the device was determined via testing and through an analysis of the shelf-life stability of the materials used in the design of the device, as well as an analysis of the packaging materials and processes used with other Gyrus ACMI devices. Shelf-life studies are on file to support the labeled shelf life. #### Summary of Performance Testing Performance tests were executed to ensure that the device functions as intended and meets design specifications. The following non-clinical and preclinical tests and usability studies were conducted: ## Non-Clinical / Preclinical Performance Evidence of safety and effectiveness was obtained from two primary areas: - 1) non-clinical (mechanical, functional) performance testing - 2) preclinical (bench) evaluations and testing Non-clinical: Basic safety and performance testing was performed. In addition, verification and comparison bench studies were conducted to evaluate the mechanical and functional performance. #### Overview of Product Performance and Mechanical / Functional Testing - a. Reconstitution (volume) - b. Expansion (dimensional height) - c. Dissolution time (In vitro) - d. Platelet adhesion, whole blood coagulation - e. Firmness - f. Pliability - g. Thickness - h. pH Biocompatibility testing: The splints are classified in accordance with ISO 10993-1, as a Surface Device, Breached or Compromised Surfaces, for Prolonged exposure (<14 days.). ISO 10993-1 and FDA Blue Book memo #G95-1 guidelines recommend that these devices have supporting data for cytotoxicity, sensitization, and irritation. Full GLP biocompatibility testing (Cytotoxicity, sensitization, irritation, acute systemic toxicity, and material-mediated pyrogenicity) is on file for these devices. {7}------------------------------------------------ Stability: Production equivalent samples were subjected to accelerated and real time aging to confirm that the devices maintain functionality and continue to meet specifications over time. The results of the age testing demonstrate that the device will be stable for the stated shelf-life. Samples were also subjected to environmental conditioning and ship testing. Preclinical: Evidence obtained from preclinical bench studies demonstrate that the device performs substantially equivalent to the predicate device in relevant aspects associated with performance. Testing demonstrated that the device performs as well as or better than the predicate device. No animal or clinical testing was conducted. The use of the device type has been documented in published literature and indicates safe and effective use for the target procedures and expected patient populations. ## Substantial Equivalence The device is equivalent to the predicate device both physically and with respect to performance. The device has the same intended use / indications for use as the predicate. The device uses similar or same patient-contacting materials in similar quantities that are utilized in the predicate device. ## Conclusion The performance of the device was compared against the known performance characteristics of the predicate device. Testing demonstrated that the performance requirements were met, and that the device exhibited comparable performance characteristics to the predicate. In summary, the device is substantially equivalent to the predicate device and presents no new questions of safety or efficacy.