VF GEL PLUS

{0}------------------------------------------------ 1 4 5 ్లూ, #### 12 510(k) SUMMARY #### 12.0 510(k) Summary Coapt Systems is providing a summary of the safety and effectiveness information available for the VF Gel Plus. 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 94303 Telephone: (650) 461-7600 Facsimile: (650) 213-9336 #### CONTACT INFORMATION Linda Ruedy Director, Regulatory and Clinical Affairs Coapt Systems, Inc. 1820 Embarcadero Road Palo Alto, CA 94303 Telephone: (650) 461-7647 Facsimile: (650) 213-9336 Email: lruedy@coaptsystems.com DATE OF PREPARATION OF 510(K) SUMMARY February 6, 2008 # DEVICE TRADE OR PROPRIETARY NAME VF Gel Plus #### DEVICE COMMON OR CLASSIFICATION NAME Classification Name: Vocal Cord Medialization Implant Regulation Number: 874.3620 Class: II Product Code: MIX ## 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 | |--------------------------------------------------------|--------------|----------------------|-------------------------| | Radiesse Injectable Laryngeal<br>Medialization Implant | MIX | Bioform Medical | K033398 | {1}------------------------------------------------ ## DEVICE DESCRIPTION Sterile, latex free, non-pyrogenic, semi-solid, cohesive subdermal implant. The principal durable component is synthetic calcium hydroxylapatite. The semi-solid nature is created by suspending the calcium hydroxylapatite particles in a high yield strength thixotropic gel. The isotonic gel carrier consists primarily of sterile water for injection (USP), glycerin (USP) and mannitol (USP). The thixotropic high yield strength gel is created by the carbomer (NF). The calcium hydroxylapatite particles are 25 to 45 microns in size while being smooth but irregular in shape and are present in the product at 30% by volume. # INTENDED USE STATEMENT The VF Gel Plus 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 Plus 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 Plus is a temporary implant that degrades over time. The product is intended to be durable for a minimum of one month. ## SUBSTANTIAL EQUIVALANCE COMPARISON #### 1. Indications Summary The "Indication Statement" for the VF Gel Plus 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 Gel Plus. #### 2. Technological Characteristics Summary The VF Gel Plus is substantially equivalent in design, materials and fundamental scientific technology to the predicate device. 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 Gel Plus performance data meet the applicable standards and fulfill the device requirements as defined in the user specifications. #### SUBSTANTIAL EQUIVALENCE CONCLUSION Based on the design, materials, function, intended use, and performance evaluations discussed herein, Coapt Systems believes the VF Gel Plus 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 Gel Plus Device. Therefore, safety and effectiveness are reasonably assured, justifying 510(k) clearance for commercial sale. {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the eagle. The eagle is depicted in a simple, abstract style with thick, black lines. The text is also in black and appears to be in a sans-serif font. Public Health Service FEB 15 2008 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Coapt Systems, Inc. c/o Ms. Linda Ruedy Director, Regulatory and Clinical Affairs 1820 Embarcadero Road Palo Alto, CA 94303 Re: K071663 Trade/Device Name: VF Gel Plus Regulation Number: 21 CFR 874.3620 Regulation Name: Ear, nose, and throat synthetic polymer material Regulatory Class: Class II Product Code: MIX Dated: January 24, 2008 Received: January 25, 2008 Dear Ms. Ruedy: 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 such 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); 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. {3}------------------------------------------------ Page 2 -Ms. Linda Ruedy This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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. Mating B. Septatis, und Malvina B. Eydelman, M.I Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ # (71662 # STATEMENT OF INDICATIONS FOR USE 510(k) Number (if known): K071663 Device Name: VF Gel Plus The VF Gel Plus is indicated for vocal fold medialization in the Indications for Use: treatment of vocal fold insufficiency, where insufficiency may be improved by injection of a soft tissue bulking agent. VF Gel Plus 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 Plus is a temporary implant that degrades over time. The product is intended to be durable for a minimum of one month. Prescription Use X (Part 21 CFR 801 Subpart D) And/Or Over-the-Counter (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation Daniel C. Clum **510(k) Number** K071663