(32 days)
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.
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, 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.
This 510(k) premarket notification entry (K063308) does not describe a study involving an AI/ML device, but rather a medical device (AdvaCoat™ Sinus Gel and Stent) which is a non-AI device. Therefore, many of the questions regarding AI/ML specific criteria (like sample size for test/training sets, number of experts, adjudication methods, MRMC studies, standalone performance, etc.) are not applicable to this submission.
The acceptance criteria for this non-AI device are based on demonstrating "substantial equivalence" to predicate devices already on the market. This means the device's technological characteristics, intended use, and safety/effectiveness are comparable to existing, legally marketed devices.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Demonstrated Substantial Equivalence) | Reported Device Performance (AdvaCoat™ Sinus Gel and Stent) |
|---|---|
| Intended Use: Comparable indications for use in patients undergoing nasal/sinus surgery. | Intended Use: 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, help control minimal bleeding, and act as an adjunct to aid in the natural healing process. (Identical to predicate devices). |
| Technological Characteristics: Similar design, material composition, absorbant qualities, sterility method, resorption time, biocompatibility, method of action, and removal. | Technological Characteristics: * Material/Construction: Derivative hyaluronic acid (same as Hyalsine and Merogel, different from MeroPack which uses hyaluronic acid AND collagen). * Absorbant Qualities: In excess of 10 times weight of the device (same as MeroPack and Merogel). * Sterility: E-beam irradiation (different from Gamma irradiation used by MeroPack and Merogel, but considered substantially equivalent as confirmed by the FDA). * Resorption Time: If material still seen at 14 days, may be removed by surgeon (same as predicate devices). * Biocompatibility: ISO 10993-1 (same as predicate devices). * 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). * Bioreabsorbable: Yes (same as predicate devices). |
| Safety and Effectiveness: No significant differences that adversely affect safety or effectiveness compared to predicate devices. | Safety and Effectiveness: Biocompatibility data supports safety. Technological characteristics, design, and intended use are "well known, low risk" and substantially equivalent to previously cleared predicate devices. The risks and benefits to the patient are the same as those normally attributed to the use of an intranasal splint. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not Applicable. This is a non-AI device submission. The "study" here is a demonstration of substantial equivalence to predicate devices, not a clinical trial with a test set of data in the context of AI/ML.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not Applicable. This is a non-AI device submission, and "ground truth" as it pertains to expert annotation of data is not relevant here. The ground for acceptance is based on regulatory assessment of substantial equivalence.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not Applicable. This is a non-AI device submission.
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 is a non-AI device submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not Applicable. This is a non-AI device submission.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not Applicable in the traditional AI sense. The "ground truth" for this submission is the regulatory standard of "substantial equivalence" to legally marketed predicate devices, supported by:
- Comparison of technological characteristics.
- Biocompatibility testing results (ISO 10993-1).
- Demonstration of similar intended use and safety/effectiveness profiles.
8. The sample size for the training set
Not Applicable. This is a non-AI device submission.
9. How the ground truth for the training set was established
Not Applicable. This is a non-AI device submission.
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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: 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 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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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 DeviceAdvaCoat™, Geland Stent | Hyalsine Hylan BGel (K012532) | MeroPack(K041381) | Merogel NasalDressing AndSinus Stent(K982731) |
|---|---|---|---|---|
| CompanyName: | CarbylanBioSurgery, Inc. | Genzyme | MedtronicXomed | 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, intranasalseptal | SAME | SAME | balloon, epistaxis |
| Intended Use | nasal / sinussurgery | SAME | SAME | SAME |
| Indications | Post-op, helpcontrol minimalbleeding and | SAME | SAME | SAME |
Technological Characteristics of AdvaCoat™ and Predicate Devices Table 1.1
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| separate mucosal surfaces / adhesion prevention | ||||
|---|---|---|---|---|
| Material /Construction | Derivativehyaluronic acid | SAME | Derivativehyaluronic acid andcollagen | SAME |
| AbsorbantQualities | In excess of 10times weight of thedevice | unknown | In excess of 10times weight of thedevice | In excess of 10times weight of thedevice |
| Sterility | E-beam irradiation | unknown | Gamma irradiation | Gamma irradiation |
| ResorptionTime | If the material is stillseen at 14 daysfollow-up, anyresidual materialmay be removed bythe surgeon | SAME | SAME | SAME |
| Biocompatibility | ISO 10993-1 | SAME | SAME | SAME |
| Method ofAction | Hygroscopic, formsgelatinous mass incontact with fluids | SAME | SAME | SAME |
| Method ofRemoval | Natural eliminationor gentle irrigationof 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 (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. 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
§ 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.