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 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, 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.

AI/ML Overview

This 510(k) premarket notification (K070496) for the AdvaCoat™ Sinus Gel and Stent device is a claim of substantial equivalence to previously cleared predicate devices, rather than a study demonstrating that the device meets specific acceptance criteria through novel performance data.

The FDA's review for a 510(k) submission primarily focuses on comparing the new device's technological characteristics and intended use to those of a legally marketed predicate device(s). If the new device is "substantially equivalent," meaning it is as safe and effective as the predicate device(s), it can be cleared for market without requiring new clinical trials or extensive performance testing beyond demonstrating this equivalence.

Therefore, the input document does not contain the detailed information typically found in a study designed to "prove the device meets acceptance criteria" for a novel device. Instead, it argues that the device's characteristics are similar enough to existing, cleared devices that new performance studies are not necessary to demonstrate safety and effectiveness.

Here's an analysis based on the provided document, addressing the requested points where possible, and noting where the information is not applicable due to the nature of a 510(k) relying on substantial equivalence:

Description of Acceptance Criteria and Study to Prove Device Meets Them (K070496)

The submission for AdvaCoat™ Sinus Gel and Stent (K070496) is a Premarket Notification (510(k)) which claims substantial equivalence to predicate devices. This means that the "acceptance criteria" are primarily met by demonstrating that the new device shares the same intended use and similar technological characteristics as devices already legally on the market, without raising new questions of safety or effectiveness. The "study" demonstrating this is the comparison presented in the submission itself.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a substantial equivalence claim, the "acceptance criteria" are implied by the characteristics of the predicate devices. The "reported device performance" is a demonstration that the new device's characteristics are sufficiently similar or identical to the predicate's for the intended use.

Attribute/Acceptance Criteria (Based on Predicate Devices)	Proposed Device (AdvaCoat™) Performance (as reported)
Intended Use: Nasal/sinus surgery for adhesion prevention, mucosal separation, edema/bleeding control, and aid in healing.	Same as predicate devices.
Material/Construction: Derivative hyaluronic acid	Derivative hyaluronic acid
Absorbant Qualities: In excess of 10 times weight of the device	In excess of 10 times weight of the device
Sterility: E-beam irradiation	E-beam irradiation (substantially equivalent to predicate gamma irradiation)
Resorption Time: Material still seen at 14 days follow-up, residual material may be removed by surgeon.	Same as predicate devices.
Biocompatibility: ISO 10993-1 compliant	ISO 10993-1 compliant
Method of Action: Hygroscopic, forms gelatinous mass in contact with fluids.	Same as predicate devices.
Method of Removal: Natural elimination or gentle irrigation of residues.	Same as predicate devices.
Bioresorbable: Yes	Yes
Risk/Benefit Profile: Same as predicate devices (low risk).	Same as predicate devices.

2. Sample size used for the test set and the data provenance

Not applicable / No specific test set data provided.
- This submission relies on demonstrating substantial equivalence to existing predicate devices rather than presenting new performance data from a specific test set. The efficacy and safety data of the predicate devices implicitly serve as the "proven" performance. The document states, "There are no new performance characteristics for AdvaCoat™ compared to the substantially equivalent predicate devices marketed for sale."
- The "data provenance" for the underlying safety and efficacy of the predicate devices would be based on their original clearances, which are not detailed here.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable.
- No specific "test set" and corresponding "ground truth" establishment by experts is described for this 510(k) submission. The FDA's review process (which includes internal expert review) determined that the information provided supported substantial equivalence.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable.
- No explicit adjudication method for a test set is described, as the submission focuses on comparing characteristics to predicates rather than presenting de novo clinical or performance data for adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable.
- This device is a physical sinus gel/stent and does not involve AI or any form of "human reader" interpretation (e.g., in medical imaging). Therefore, an MRMC study is irrelevant to this submission.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable.
- As noted above, this device does not involve an algorithm or AI.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not applicable / Implied by predicate clearance.
- For this 510(k), the "ground truth" for proving safety and effectiveness relies on the prior clearance of the predicate devices. Those predicates would have established their safety and effectiveness through various studies (e.g., biocompatibility testing, clinical outcomes, animal studies) potentially using expert consensus, pathology, and/or outcomes data, but these details are not provided in this submission for the AdvaCoat™ device.

8. The sample size for the training set

Not applicable.
- This device is a physical medical device, not an AI or machine learning algorithm that requires a "training set."

9. How the ground truth for the training set was established

Not applicable.
- As no training set is relevant, this question is not applicable.

Summary

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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 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.

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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:

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

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	bleeding andseparatemucosalsurfaces /adhesionprevention
Material /Construction	Derivativehyaluronic acid	SAME	SAME	Derivativehyaluronic acidand collagen	SAME
AbsorbantQualities	In excess of 10times weight ofthe device	SAME	unknown	In excess of 10times weight ofthe device	In excess of 10times weight ofthe device
Sterility	E-beamirradiation	SAME	unknown	Gammairradiation	Gammairradiation
ResorptionTime	If the material isstill seen at 14days follow-up,any residualmaterial may beremoved by thesurgeon	SAME	SAME	SAME	SAME
Biocompatibility	ISO 10993-1	SAME	SAME	SAME	SAME
Method ofAction	Hygroscopic,forms gelatinousmass in contactwith fluids	SAME	SAME	SAME	SAME
Method ofRemoval	Naturalelimination orgentle irrigationof 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.

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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.

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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

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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

Karett Baker

sion of Ophthalmic Ear. se and Throat Devise

:10(k) Number K070496

Prescription Use (Per 21 CFR 801.109)

00034

Regulation Number and Section

§ 874.4780 Intranasal splint.

(a)
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.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 874.9.