ADVACOAT SINUS GEL AND STENT

{0}------------------------------------------------ K070496 # Premarket Notification 510(k) Summary #### Date Prepared: February 7, 2007 #### Submitter (Contact): MAR 1 5 2007 Roxanne Dubois, VP, Regulatory Affairs Carbylan BioSurgery, Inc. Address: 3181 Porter Drive, Palo Alto, CA 94304 Telephone: 650-855-6775 Fax: 650-855-9119 Email: rdubois@carbylan.com #### Device Name and Classification: Proprietary Name: AdvaCoat™ Sinus Gel and Stent Common Name: Sinus Packing, Gel or Stent Classification Name: Splint, Intranasal Splint Classification: Class I, Per 21 CFR 874.4780 Product Code Number: LYA #### Performance Standards: No FDA performance standards exist for this product. #### Predicate Devices: AdvaCoat Sinus Gel and Stent (K063308) Hyalsine Hylan B Gel (K012532) MeroPack (K041381) Merogel Nasal Dressing And Sinus Stent (K982731) #### Device Description: AdvaCoat™ Sinus Gel and Stent (AdvaCoat™) is a sterile, non-pyrogenic, viscoelastic, bioresorbable material composed of cross-linked polymers of a derivatized hyaluronan. AdvaCoat™ is produced from a non-animal, nonpathogenic source using a highly purified hyaluronan. AdvaCoat™ Sinus Gel and Stent and its break down products are biocompatible, non-immunogenic and non-toxic. AdvaCoat™ Sinus Gel and Stent are provided in two formats, a gel and a stent. The gel is delivered using a syringe and the stent is applied dry as a packing material. Due to its tissue adhesive properties, AdvaCoat™ will not migrate or be dislodged from the application site. AdvaCoat™ may be used as a space occupying dressing and/or stent to minimize bleeding. Upon application, {1}------------------------------------------------ AdvaCoat™ forms a viscous and transparent gel conforming to mucosal surfaces. The final packaged product is sterilized with E-beam radiation to a Sterility Assurance Level (SAL) of 10° and intended for single use only. The sterilization information for AdvaCoat™ is substantially equivalent to the data for the predicate devices. ### Significant Performance Characteristics There are no new performance characteristics for AdvaCoat™ compared to the substantially equivalent predicate devices marketed for sale. These devices are indicated for use to prevent adhesions and minimize edema and bleeding following nasal/sinus surgery or trauma. #### Indication For Use: AdvaCoat™ Sinus Gel and Stent are indicated for use in patients undergoing nasal/sinus surgery as a space-occupying dressing and/or stent intended to prevent adhesions in the nasal cavity, separate mucosal surfaces compromised by surgery or trauma, minimize edema and help control minimal bleeding following surgery or trauma, and act as an adjunct to aid in the natural healing process. ## Technological Characteristics: There are no significant differences in the technological characteristics of this device compared to the predicate devices which adversely affect safety or effectiveness. Provided below is a table summarizing and comparing the technological characteristics of AdvaCoat™ and the predicate devices. | Attribute | Proposed Device (Modified) AdvaCoat™, Gel and Stent | AdvaCoat™, Gel and Stent (K063308) | Hyalsine Hylan B Gel (K012532) | MeroPack (K041381) | Merogel Nasal Dressing And Sinus Stent (K982731) | |---------------|-----------------------------------------------------|------------------------------------|--------------------------------|--------------------|--------------------------------------------------| | Company Name: | Carbylan BioSurgery, Inc. | Carbylan BioSurgery, Inc. | Genzyme | Medtronic Xomed | Xomed, Inc. | | Date Cleared: | N/A | 12/4/06 | 10/30/01 | 9/10/04 | 2/2/99 | | Code/Class: | LYA, Class I | SAME | SAME | SAME | EMX, Class I | | 21 CFR No. | 874.4780 | SAME | SAME | SAME | SAME | | Device Name | splint, intranasal septal | SAME | SAME | SAME | balloon, epistaxis | | Intended Use | nasal / sinus surgery | SAME | SAME | SAME | SAME | | Indications | Post-op, help control minimal | SAME | SAME | SAME | SAME | #### Technological Characteristics of AdvaCoat™ and Predicate Devices Table 1.1 {2}------------------------------------------------ | | bleeding and<br>separate<br>mucosal<br>surfaces /<br>adhesion<br>prevention | | | | | |----------------------------|---------------------------------------------------------------------------------------------------------------------------|------|---------|--------------------------------------------------|--------------------------------------------------| | Material /<br>Construction | Derivative<br>hyaluronic acid | SAME | SAME | Derivative<br>hyaluronic acid<br>and collagen | SAME | | Absorbant<br>Qualities | In excess of 10<br>times weight of<br>the device | SAME | unknown | In excess of 10<br>times weight of<br>the device | In excess of 10<br>times weight of<br>the device | | Sterility | E-beam<br>irradiation | SAME | unknown | Gamma<br>irradiation | Gamma<br>irradiation | | Resorption<br>Time | If the material is<br>still seen at 14<br>days follow-up,<br>any residual<br>material may be<br>removed by the<br>surgeon | SAME | SAME | SAME | SAME | | Biocompatibility | ISO 10993-1 | SAME | SAME | SAME | SAME | | Method of<br>Action | Hygroscopic,<br>forms gelatinous<br>mass in contact<br>with fluids | SAME | SAME | SAME | SAME | | Method of<br>Removal | Natural<br>elimination or<br>gentle irrigation<br>of residues | SAME | SAME | SAME | SAME | | Bioresorbable | Yes | SAME | SAME | SAME | SAME | ### Summary of Substantial Equivalence: The information submitted in this Premarket Notification supports a determination that AdvaCoat™ Gel and Stent are substantially equivalent to the predicate devices. The design, technological characteristics and intended use (safety and effectiveness) of AdvaCoat™ are substantially equivalent to those for the predicate devices (AdvaCoat Sinus Gel and Stent, K063308; Hyalsine Hylan B Gel, K012532; MeroPack, K041381; and, Merogel Nasal Dressing And Sinus Stent, K982731). The risks and benefits to the patient are the same as those normally attributed to the use of an intranasal splint. The technological characteristics, design and intended use are well known, low risk, and are substantially equivalent to the previously cleared predicate devices. In addition, the biocompatibility data support the safety of the material. #### Conclusions The device meets all the biocompatibility test requirements and is substantially equivalent in design, intended use and technological characteristics to the predicate devices. Therefore, a determination can be made that AdvaCoat™ Gel and Stent are considered substantially equivalent to the predicate devices. {3}------------------------------------------------ Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three lines representing its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Carbylan BioSurgery c/o Ms. Roxanne Dubois 3181 Porter Drive Palo Alto, Ca 94304 MAR 1 5 2007 Re: K070496 Trade/Device Name: AdvaCoat Sinus Gel and Stent Regulation Number: 21 CFR 874.4780 Regulation Name: Sinus Packing Gel & Stent Regulatory Class: I Product Code: LYA Dated: February 15, 2007 Received: February 26, 2007 Dear Ms. Dubios: 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, Dr u 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, isting of devices, good manufacturing practice, labeling, and prohibitions against misbrandi,no 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, TDA movie 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. {4}------------------------------------------------ #### Page 2 - Ms. Roxanne Dubois 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 Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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, M B Egelman MD 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 {5}------------------------------------------------ # Indications for Use 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ Device Name: AdvaCoat™ Sinus Gel Indications for Use: AdvaCoat™ Sinus Gel is intended for use in patients undergoing nasal/sinus surgery as a space-occupying dressing and/or stent intended to prevent adhesions in the nasal cavity, separate mucosal surfaces compromised by surgery or trauma, minimize edema and help control minimal bleeding following surgery or trauma, and act as an adjunct to aid in the natural healing process. 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) Page 1 of 1 Karett Baker sion of Ophthalmic Ear. se and Throat Devise :10(k) Number K070496 Prescription Use (Per 21 CFR 801.109) 00034