VF LIQUIGEL

{0}------------------------------------------------ Coapt Systems, Inc. Special 510(k) Premarket Notific VF LiquiGel # SEP 1 1 2009 #### 510(k) SUMMARY 10.0 #### 510(k) Summary 10.1 Coapt Systems is providing a summary of the safety and effectiveness information available for the VF LiquiGel. This 510(k) summary of safety and effectiveness information is submitted in accordance with the requirements of 21 CFR §807.92 and pursuant to Section 12, Part (a)(i)(3A) of the Safe Medical Devices Act of 1990. #### SPONSOR/APPLICANT NAME AND ADDRESS Coapt Systems, Inc. 1820 Embarcadero Road Palo Alto, CA Telephone: (650) 461-7600 Facsimile: (650) 213-9336 #### CONTACT INFORMATION Louis-Pierre Marcoux Manager, Regulatory Affairs Coapt Systems, Inc. 1820 Embarcadero Road Palo Alto, CA Telephone: (650) 461-7651 Facsimile: (650) 213-9336 Email: Imarcoux(@coaptsystems.com ### DATE OF PREPARATION OF 510(K) SUMMARY December 11, 2008 ### DEVICE TRADE OR PROPRIETARY NAME VF LiquiGel #### DEVICE COMMON OR CLASSIFICATION NAME Classification Name: Vocal Cord Medialization Implant Regulation Number: 874.3620 Class: II Product Code: MIX {1}------------------------------------------------ Coapt Systems, Inc. ## IDENTIFICATION OF THE LEGALLY MARKETED DEVICES TO WHICH EQUIVALENCE IS BEING CLAIMED | Name of Predicate Device | Product Code | Name of Manufacturer | 510(k) or PMA<br>Number | |--------------------------|--------------|----------------------|-------------------------| | VF Gel | MIX | Coapt Systems | K080956 | ### DEVICE DESCRIPTION Sterile, latex free, non-pyrogenic, highly thixotropic, high yield strength clear gel with a neutral pH. The durability of the gel is due to slow degradation of the synthetic gel carrier. The thixotropic character of the gel allows it to be a very thick and cohesive gel but able to be injected through very fine needles with minimal force. ### INTENDED USE STATEMENT The VF LiquiGel is indicated for vocal fold medialization in the treatment of vocal fold insufficiency, where insufficiency may be improved by injection of a soft tissue bulking agent. VF LiquiGel injection augments the size of the displaced or deformed vocal fold so that it may meet the opposing fold at the midline for improved glottal closure. Improved glottal closure may allow improved phonation, improvement of cough, and an improved ability to protect the airway during swallowing. ### SUBSTANTIAL EQUIVALANCE COMPARISON #### 1. Indications Summary The "Indication Statement" for the VF LiquiGel is substantiated by the results of the performance evaluations and comparison testing to the predicate device. The differences between the Subject and the Predicate do not affect the safety and effectiveness of the VF LiquiGel. VF LiguiGel is a temporary implant that degrades over time. The product is intended to be durable for a minimum of one month. #### 2. Technological Characteristics Summary The VF LiquiGel is substantially equivalent in design, materials and fundamental scientific technology to the predicate devices. Any differences between the Subject and the Predicate device are minor and do not raise issues regarding safety or effectiveness. #### 3. Performance Summary The VF LiquiGel performance data meet the applicable standards and fulfill the device requirements as defined in the user specifications. {2}------------------------------------------------ ・ 、 "----------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | Parameter | VF Gel (Predicate) | VF LiquiGel (Subject) | Comparison | Impact on Safety and Effectiveness | |----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|------------------------------------| | Indication for Use | The VF Gel is indicated for vocal fold medialization in the treatment of vocal fold insufficiency, where insufficiency may be improved by injection of a soft tissue bulking agent. VF Gel injection augments the size of the displaced or deformed vocal fold so that it may meet the opposing fold at the midline for improved glottal closure. Improved glottal closure may allow improved phonation, improvement of cough, and an improved ability to protect the airway during swallowing. VF Gel is a temporary implant that degrades over time. The product is intended to be durable for a minimum of one month. | The VF LiquiGel is indicated for vocal fold medialization in the treatment of vocal fold insufficiency, where insufficiency may be improved by injection of a soft tissue bulking agent. VF LiquiGel injection augments the size of the displaced or deformed vocal fold so that it may meet the opposing fold at the midline for improved glottal closure. Improved glottal closure may allow improved phonation, improvement of cough, and an improved ability to protect the airway during swallowing. VF LiquiGel is a temporary implant that degrades over time. The product is intended to be durable for a minimum of one month. | Equivalent | None | | Target Population | Patients requiring temporary vocal fold medialization | Same | Equivalent | None | | Surgical Approach | Percutaneous or transoral | Same | Equivalent | None | | Design | Cohesive gel supplied in a syringe ready to use | Same | Equivalent | None | | Materials | A gel of injection grade water, glycerin, mannitol, NaOH and Carbopol 974P NF | Same, with a slightly lower pH | Equivalent | None | | Biocompatibility | Meets ISO 10993 | Same | Equivalent | None | | Materials Standards | NF/USP requirements | Same | Equivalent | None | | Mechanism of Action | Gel providing temporary space filling | Same | Equivalent | None | | Human Factors/How Supplied | Supplied Sterile in a syringe premixed and ready for injection | Same | Equivalent | None | | Human Factors/ Quantity Supplied | Supplied pre-filled in a syringe filled to 0.5 and 1.3 cc for use in individual patients | Same | Equivalent | None | | Sterility | Supplied sterile ready to use, Not to be resterilized | Same | Equivalent | None | | Compatibility with other Devices | Syringe has Luer lock syringe that is compatible with needles with Luer fitting | Same | Equivalent | None | · #### Table 7: Substantial Equivalence Summarv Image /page/2/Picture/4 description: The image shows a sequence of numbers, specifically "0000033". The numbers are printed in a simple, slightly distorted font, giving them a somewhat vintage or digitized appearance. The sequence consists of five zeros followed by two threes, with a small period at the end. . {3}------------------------------------------------ 000034 ## SUBSTANTIAL EQUIVALENCE CONCLUSION Based on the design, materials, function, intended use, and performance evaluations discussed herein, Coapt Systems believes the VF LiquiGel is substantially equivalent to the predicate device currently marketed under the Federal Food, Drug and Cosmetic Act. No new issues of safety or effectiveness were raised for the VF LiquiGel Device. Therefore, safety and effectiveness are reasonably assured, justifying 510(k) clearance for commercial sale. {4}------------------------------------------------ Image /page/4/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular and contains the department's name around the perimeter. In the center is a stylized image of an eagle with its wings spread. SFP 1 1 2009 Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002 Coapt Systems, Inc. c/o Mr. Louis-Pierre Marcoux Regulatory Affairs Manager 1820 Embarcadero Road Palo Alto, CA 94303 Re: K083783 Trade/Device Name: VF LiquiGel™ Regulation Number: 21 CFR 874.3620 Regulation Name: Ear, Nose, and Throat Synthetic Polymer Material Regulatory Class: II Product Code: MIX Dated: August 21, 2009 Received: August 24, 2009 Dear Mr. Marcoux: 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. 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 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. {5}------------------------------------------------ ### Page 2 - Mr. Louis-Pierre Marcoux 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/CDRHQffices/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/cdrh/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely yours, E. R. Rehm, MD Malvina B. Eydelman, M. Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {6}------------------------------------------------ Coapt Systems, Inc. KOR 248.3 Special 510(k) Premarket Notification VF LiquiGel # STATEMENT OF INDICATIONS FOR USE 510(k) Number (if known): Not yet assigned Device Name: VF LiquiGel Indications For Use: The VF LiquiGel is indicated for vocal fold medialization in the treatment of vocal fold insufficiency, where insufficiency may be improved by injection of a soft tissue bulking agent. VF LiquiGel injection augments the size of the displaced or deformed vocal fold so that it may meet the opposing fold at the midline for improved glottal closure. Improved glottal closure may allow improved phonation, improvement of cough, and an improved ability to protect the airway during swallowing. VF LiquiGel is a temporary implant that degrades over time. The product is intended to be durable for a minimum of one month. (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Daniel C. Clapp (Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices 510(k) Number K083783 Over-The-Counter Use (21 CFR 807 Subpart C) 000013