SEPRAGEL SINUS

K012532 · Genzyme Corp. · LYA · Oct 30, 2001 · Ear, Nose, Throat

Device Facts

• Record ID: K012532
• Device Name: SEPRAGEL SINUS
• Applicant: Genzyme Corp.
• Product Code: LYA · Ear, Nose, Throat
• Decision Date: Oct 30, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.4780
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

HylaSine is indicated for use in patients undergoing nasal/sinus surgery as a space-occupying gel stent to separate and prevent adhesions between mucosal surfaces in the nasal cavity, to help control minimal bleeding following surgery or nasal trauma, and to prevent lateralization of the middle turbinate during the postoperative period.

Device Story

Hylasine is a sterile, transparent, viscoelastic gel composed of cross-linked hyaluronan polymers. Applied by a physician in a clinical setting following nasal/sinus surgery or trauma, the gel acts as a space-occupying stent. It physically separates mucosal surfaces to prevent adhesions and provides a tamponade effect to control minimal bleeding. The device is bioresorbable, leaving the site via natural elimination or physician-directed aspiration. By maintaining anatomical separation during the healing process, it prevents middle turbinate lateralization, potentially improving surgical outcomes and patient recovery.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and intended use comparisons to legally marketed predicate devices.

Technological Characteristics

Sterile, transparent, viscoelastic gel; cross-linked hyaluronan polymers; bioresorbable. Form factor: gel stent. No electronic components, software, or external energy sources.

Indications for Use

Indicated for patients undergoing nasal/sinus surgery or experiencing nasal trauma to prevent mucosal adhesions, control minimal bleeding, and prevent middle turbinate lateralization.

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

• Xomed MeroGel™ Nasal Dressing and Sinus Stent (K982731)
• Custom Nasal Splint (Boston Medical, K972082)
• LactoSorb Ethmoid Stent (Walter Lorenz Surgical, K002131)

Submission Summary (Full Text)

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genzyme

# Section 7.0 510(k) Summary

Pursuant to Section 12, Part (a)(i)(3A) of the Safe Medical Devices Act of 1990, Genzyme Corporation is providing a summary of the safety and effectiveness information available for Hylasine™.

# 7.1 Sponsor/Applicant Name and Address

Genzyme Corporation One Kendall Square Cambridge, MA. 02139

### 7.2 Sponsor Contact Name

Alexander E. Kuta, Vice President, Regulatory Affairs Phone: [phone], Fax: [phone], e-mail: [e-mail]

# 7.3 Date that 510(k) Summary Was Prepared

June 26, 2001

### 7.4 Name of the Medical Device

Classification name: Intranasal Splint (Ear, Nose & Throat) Common/usual name: Intranasal Splint Proprietary name: Hylasine™

# 7.5 Legally Marketed Devices to Which Substantial Equivalence is Claimed

Xomed MeroGel™ Nasal Dressing and Sinus Stent (Xomed, K982731) Custom Nasal Splint (Boston Medical, K972082) LactoSorb Ethmoid Stent (Walter Lorenz Surgical, K002131)

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### Description of the Device 7.6

HylaSine™, hylan B gel is a sterile, transparent, viscoelastic gel composed of cross-linked polymers of hyaluronan. This hyaluranon is a bioresorbable material that functions to fill nasal/sinus cavities following surgery or trauma and to keep mucosal surfaces separate during the healing process. During this time, the tamponade effect helps control minimal bleeding normally associated with routine sinus surgery. HylaSine leaves the site of placement by natural elimination, or it may be aspirated from the cavity earlier at the discretion of the physician.

### Intended Use of the Device 7.7

HylaSine is indicated for use in patients undergoing nasal/sinus surgery as a space-occupying gel stent to separate and prevent adhesions between mucosal surfaces in the nasal cavity, to help control minimal bleeding following surgery or nasal trauma, and to prevent lateralization of the middle turbinate during the postoperative period.

# Technological Comparison between Subject and Predicate Devices 7.8

Boston Medical Products' Custom Nasal Splint and Lorenz Surgical's LactoSorb Ethmoid Stent have similar indications as the proposed Hylasine. Boston Medical Products' Custom Nasal Splint prevents adhesions between mucosal tissues after surgery.

Xomed's MeroGel Nasal Dressing and Hylasine share a similar material composition in that they are both composed of derivatives of hyaluronic acid. Although Merogel has been cleared as an Epistaxis Balloon, it is used in the nasal/sinus cavity, as is an Intranasal Splint. Whether a hyaluronic acid product is classified as an Intranasal Splint or Epistaxis Balloon does not raise any new safety issues. Hylasine™ is also similar to Xomed's MeroGel Nasal Dressing and LactoSorb's LactoSorb Ethmoid Stent in that all three devices are bioresorbable.

Hylasine™, Boston Medical Products' Custom Nasal Splint and LactoSorb's LactoSorb Ethmoid Stent are all classified by the same product code of 77LYA with the generic name of Intranasal Solint

In conclusion, Hylasine™ has similar intended use, material composition, bioresorbability, and product code as other legally marketed devices.

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genzyme

| | Hylasine™ | MeroGel Nasal Dressing | Custom Nasal Splint | LactoSorb Ethmoid Stent |
|-----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Genzyme<br>Corporation | Xomed | Boston Medical<br>Products | Walter Lorenz Surgical |
| Device Name | PROPOSED | (K982731) | (K972082) | (K002131) |
| Product Code | Intranasal Splint | Epistaxis balloon | Intranasal Splint | Intranasal Splint |
| | 77LYA | 77EMX | 77LYA | 77LYA |
| Indications/Intended<br>Use | For use in patients<br>undergoing nasal/sinus<br>surgery as a space-<br>occupying gel stent to<br>separate and prevent<br>adhesions between<br>mucosal surfaces in the<br>nasal cavity, to help<br>control minimal bleeding<br>following surgery or nasal<br>trauma, and to prevent<br>lateralization of the middle<br>turbinate during the<br>postoperative period. | For use in the nasal/sinus<br>cavities as a space-occupying<br>dressing and/or stent, to<br>separate mucosal surfaces and<br>to help control minimal<br>bleeding following surgery. | To provide septal<br>support and reduce or<br>prevent adhesions<br>between the septum and<br>lateral nasal wall<br>following surgery | For use during ethmoidectomy procedures.<br><br>The LactoSorb Ethmoid Stent is intended to<br>keep the middle turbinate away from the lateral<br>nasal wall during the healing process after<br>nasal/sinus surgery. The stent provides enough<br>rigidity in the nasal cavity to keep the middle<br>turbinate from adhering to the lateral nasal<br>wall. |
| Material Composition | Derivative hyaluronic acid | Derivative hyaluronic acid | Plastic | LactoSorb 82%<br>PLLA/18% PGA |
| Bioresorbable | YES | YES | NO | YES |

# igure 7- 1Comparison to Marketed Device

Proprietary and Confidentia

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 3 0 2001

Ms. Nancy A. Immel Senior Regulatory Associate Genzyme Corporation 1125 Pleasant View Terrace Ridgefield. New Jersey 07657

Re: K012532

Trade Name: Hylasine™ Hylan B Gel Regulation Number: 21 CFR 874.4780 Regulatory Class: Class I Product Code: LYA Dated: August 2, 2001 Received: August 6, 2001

Dear Ms. Immel:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and have determined the device is substantially equivalent to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections. FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, the Food and Drug Administration (FDA) may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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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 promoted 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html

Sincerely yours,

A. Ralph Rosenthal

A. Ralph Rosenthal, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

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K012532

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Hylasine™ Hylan B Gel Premarket [510(k)] Notification

# Section 2.0 Statement of Intended Use

HylaSine is indicated for use in patients undergoing nasal/sinus surgery as a space-occupying gel stent to separate and prevent adhesions between mucosal surfaces in the nasal cavity, to help control minimal bleeding following surgery or nasal trauma, and to prevent lateralization of the middle turbinate during the postoperative period.

**Prescription Use**
**(Per 21 CFR 801.109)**

(Division Sign-Off)
Division of Ophthalmic Devices
510(k) Number K012532