ADVACOAT SINUS GEL, MODEL 9100, ADVA SINUS STENT, MODEL 9200

K063308 · Carbylan Biosurgery · LYA · Dec 4, 2006 · Ear, Nose, Throat

Device Facts

• Record ID: K063308
• Device Name: ADVACOAT SINUS GEL, MODEL 9100, ADVA SINUS STENT, MODEL 9200
• Applicant: Carbylan Biosurgery
• Product Code: LYA · Ear, Nose, Throat
• Decision Date: Dec 4, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.4780
• Device Class: Class 1
• Attributes: Therapeutic

Intended 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.

Device Story

AdvaCoat™ Sinus Gel and Stent are sterile, bioresorbable, viscoelastic materials composed of cross-linked derivatized hyaluronan. Provided as a gel (syringe-delivered) or dry stent, the device acts as a space-occupying dressing. Upon contact with fluids, it forms a gelatinous, hygroscopic mass that adheres to mucosal surfaces, preventing migration. Used in clinical settings by physicians following nasal/sinus surgery or trauma to separate mucosal surfaces, minimize edema, and control minimal bleeding. The device is naturally eliminated or removed via gentle irrigation; any residual material remaining at 14 days may be removed by the surgeon. Benefits include adhesion prevention and support of the natural healing process.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on bench testing, biocompatibility data (ISO 10993-1), and comparison of technological characteristics to legally marketed predicate devices.

Technological Characteristics

Material: Cross-linked derivatized hyaluronan. Form: Gel (syringe) or dry stent. Principle: Hygroscopic, forms gelatinous mass in contact with fluids. Biocompatibility: ISO 10993-1. Sterilization: E-beam radiation (SAL 10^-6). Resorption: Bioresorbable; residual material removable at 14 days. No electronic components or software.

Indications for Use

Indicated for patients undergoing nasal/sinus surgery or trauma; used as space-occupying dressing/stent to prevent adhesions, separate mucosal surfaces, minimize edema, control minimal bleeding, and aid natural healing.

Regulatory Classification

Identification

An intranasal splint is intended to minimize bleeding and edema and to prevent adhesions between the septum and the nasal cavity. It is placed in the nasal cavity after surgery or trauma. The intranasal splint is constructed from plastic, silicone, or absorbent material.

Predicate Devices

• Hyalsine Hylan B Gel (K012532)
• MeroPack (K041381)
• Merogel Nasal Dressing And Sinus Stent (K982731)

Submission Summary (Full Text)

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K 063308

### Premarket Notification 510(k) Summary

Tab 3

DEC - 4 2006

#### Date Prepared:

September 1, 2006

### Submitter (Contact):

Roxanne Dubois, VP, Regulatory Affairs Carbylan BioSurgery, Inc. Address: 3181 Porter Drive, Palo Alto, CA 94304 Telephone: [phone] Fax: [phone] Email: [e-mail]

#### 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 f, Per 21 CFR 874.4780 Product Code Number: LYA

#### Performance Standards:

No FDA performance standards exist for this product.

#### Predicate Devices:

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, non-swelling, viscoelastic, bioresorbable material composed of cross-linked polymers of a derivatized hyaluronan. AdvaCoat™ is produced from a nonanimal, non-pathogenic source using a highly purified hyaluronan. AdvaCoat™ Sinus Gel and Stent and its break down products are biocompatible, non-immunoqenic 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,

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K063308

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 10th 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 surqery 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<br>AdvaCoat™, Gel<br>and Stent | Hyalsine Hylan B<br>Gel (K012532) | MeroPack<br>(K041381) | Merogel Nasal<br>Dressing And<br>Sinus Stent<br>(K982731) |
|------------------|--------------------------------------------------|-----------------------------------|-----------------------|-----------------------------------------------------------|
| Company<br>Name: | Carbylan<br>BioSurgery, Inc. | Genzyme | Medtronic<br>Xomed | Xomed, Inc. |
| Date Cleared: | N/A | 10/30/01 | 9/10/04 | 2/2/99 |
| Code/Class: | LYA, Class I | SAME | SAME | EMX, Class I |
| 21 CFR No. | 874.4780 | SAME | SAME | SAME |
| Device Name | splint, intranasal<br>septal | SAME | SAME | balloon, epistaxis |
| Intended Use | nasal / sinus<br>surgery | SAME | SAME | SAME |
| Indications | Post-op, help<br>control minimal<br>bleeding and | SAME | SAME | SAME |

#### Technological Characteristics of AdvaCoat™ and Predicate Devices Table 1.1

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K063308

| | separate mucosal surfaces / adhesion prevention | | | |
|----------------------------|------------------------------------------------------------------------------------------------------------------------|---------|--------------------------------------------------|--------------------------------------------------|
| Material /<br>Construction | Derivative<br>hyaluronic acid | SAME | Derivative<br>hyaluronic acid and<br>collagen | SAME |
| Absorbant<br>Qualities | In excess of 10<br>times weight of the<br>device | unknown | In excess of 10<br>times weight of the<br>device | In excess of 10<br>times weight of the<br>device |
| Sterility | E-beam irradiation | unknown | Gamma irradiation | Gamma irradiation |
| Resorption<br>Time | If the material is still<br>seen at 14 days<br>follow-up, any<br>residual material<br>may be removed by<br>the surgeon | SAME | SAME | SAME |
| Biocompatibility | ISO 10993-1 | SAME | SAME | SAME |
| Method of<br>Action | Hygroscopic, forms<br>gelatinous mass in<br>contact with fluids | SAME | SAME | SAME |
| Method of<br>Removal | Natural elimination<br>or gentle irrigation<br>of residues | SAME | SAME | SAME |
| Bioreabsorbable | Yes | 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 (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.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Carbylan Biosurgery c/o Roxanne J. Dubois Vice President, Regulatory Affairs 3181 Porter Drive Palo Alto, CA 94304

DEC - 4 2006

Re: K063308

Trade/Device Name: AdvaCoat™ Sinus Gel and Stent Regulation Number: 21 CFR 874.4780 Regulation Name: Intranasal splint Regulatory Class: Class I Product Code: LYA Dated: November 1, 2006 Received: November 2, 2006

Dear Ms. Dubois:

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.

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#### Page 2 - Roxanne J. 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 [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

M.B. Eichelman SMD

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

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# Indications for Use

510(k) Number (if known):

Device Name: AdvaCoat™ Sinus Stent

Indications for Use:

AdvaCoat™ Sinus Stent 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

Kuu A. Bble

Division Sian-Off Division in Ophmalmic Far. Nose and Throat Devises

× Prescription Use (Per 21 CFR 801.109)

510(k) Number.

000023

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## 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

:

Karen A. Baker

n of Onthalmic Ear, e and Tribat Devises

510(k) Number

000022