SEPRAGEL ENT BIORESORBABLE PACKING/STENT

K043035 · Genzyme Corporation · KHJ · Jul 11, 2005 · Ear, Nose, Throat

Device Facts

• Record ID: K043035
• Device Name: SEPRAGEL ENT BIORESORBABLE PACKING/STENT
• Applicant: Genzyme Corporation
• Product Code: KHJ · Ear, Nose, Throat
• Decision Date: Jul 11, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.3620
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Sepragel ENT packing/stent is indicated for use in patients undergoing nasal/sinus, middle ear and external ear canal surgery as a space-occupying dressing and/or stent intended to prevent adhesions in the nasal cavity, separate mucosal surfaces, help control minimal bleeding following surgery or trauma, and act as an adjunct to aid in the natural healing process. The device is indicated for use in the middle ear following canalplasty, myringoplasty, tympanoplasty, stapes and mastoid surgery. The device is indicated following nasal/sinus surgery or trauma to prevent lateralization of the middle turbinate during the post operative period.

Device Story

Sepragel ENT is a sterile, transparent, viscoelastic, bioresorbable gel; composed of cross-linked hyaluronan molecules. Supplied in a syringe for application by surgeons in clinical settings (OR/clinic). Functions as a space-occupying dressing/stent to separate mucosal surfaces and provide tamponade for minimal bleeding post-surgery or trauma. Eliminates naturally from the site; may be aspirated from nasal/sinus cavities by physician. Benefits include adhesion prevention and support of natural healing process.

Clinical Evidence

No clinical data provided. Substantial equivalence based on technological characteristics and intended use comparison to legally marketed predicate devices.

Technological Characteristics

Viscoelastic gel composed of cross-linked hyaluronan. Delivered via syringe. Bioresorbable. Sterile, non-pyrogenic. Class II device (21 CFR 874.3620).

Indications for Use

Indicated for patients undergoing nasal/sinus, middle ear, or external ear canal surgery/trauma. Used as space-occupying dressing/stent to prevent adhesions, separate mucosal surfaces, control minimal bleeding, and aid healing. Specifically for post-op canalplasty, myringoplasty, tympanoplasty, stapes, and mastoid surgery, and to prevent middle turbinate lateralization.

Regulatory Classification

Identification

Ear, nose, and throat synthetic polymer material is a device material that is intended to be implanted for use as a space-occupying substance in the reconstructive surgery of the head and neck. The device is used, for example, in augmentation rhinoplasty and in tissue defect closures in the esophagus. The device is shaped and formed by the suregon to conform to the patient's needs. This generic type of device is made of material such as polyamide mesh or foil and porous polyethylene.

Predicate Devices

• Sepragel Sinus (K012532, K993362)
• MeroGel Nasal Otologic Pack (K001148, K002972)

Submission Summary (Full Text)

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043035

JUL 1 1 2005

# genzyme

7

Sepragel™ ENT Bioresorbable Packing/Stent Premarket |510(k)| Notification

# 510(K) SUMMARY (AS REQUIRED BY 21 CFR 807.92)

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 SeprageI™ ENT Bioresorbable packing/stent (SeprageI™ ENT).

# Sponsor/Applicant Name and Address: 7.1

Genzyme Corporation 500 Kendall Street Cambridge, MA 02142

### Sponsor Contact Information: 7.2

Barbara Pizza Manager, Regulatory Affairs Phone: [phone] FAX: [phone] email: [e-mail]

### Date of Preparation of 510(k) Summary: 7.3

Date

Device Trade or Proprietary Name: 7.4

SeprageI™ ENT Bioresorbable Packing/Stent

## Device Common/Usual or Classification Name: 7.5

Ear, nose and throat synthetic polymer material

# Identification of the Legally Marketed Devices to which Equivalence 7.6 is Being Claimed:

| 510(k) Number | Name of Predicate Device | Name of Manufacturer<br>(Town, State) |
|----------------------|-----------------------------------------------------------------------------------|---------------------------------------|
| K012532<br>(K993362) | SepragelTM Sinus | Genzyme Corporation<br>Cambridge, MA |
| K001148<br>(K002972) | MeroGelTM Nasal Otologic Pack<br>(MeroGelTM Control Gel ENT<br>Surgical Dressing) | Medtronic Xomed<br>Jacksonville, FL |

### Device Description: 7.7

Sepragel ENT is a sterile, non-pyrogenic, transparent, viscoelastic, bioresorbable gel composed of cross-linked molecules of hyaluronan. It is indicated for use in patients undergoing nasal/sinus, middle ear and external ear canal surgery as a space-occupying dressing and/or gel stent intended to separate and prevent adhesions between mucosal

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# genzyme

surfaces, to help control minimal bleeding following surgery or trauma, and act as an adjunct to aid in the natural healing process.

SeprageI™ ENT hylan B gel, is a sterile, non-pyrogenic, transparent, viscoelastic gel composed of cross-linked molecules of hyaluronan. This hyaluronan is a bioresorbable material that functions to fill the sinus cavity, middle ear and external ear canal following surgery and to keep mucosal surfaces separate during the healing process. During this time, the tamponade effect helps control minimal bleeding normally associated with routine Otologic surgery. Sepragel ENT leaves the site of placement by natural elimination. In nasal/sinus applications it may be aspirated from the cavity earlier at the discretion of the physician.

### Intended Use: 7.8

Seprage! ENT packing/stent is indicated for use in patients undergoing nasal/sinus, middle ear and external ear canal surgery as a space-occupying dressing and/or stent intended to prevent adhesions in the nasal cavity, separate mucosal surfaces, help control minimal bleeding following surgery or trauma, and act as an adjunct to aid in the natural healing process. The device is indicated for use in the middle ear following canalplasty, myringoplasty, tympanoplasty, stapes and mastoid surgery. The device is indicated following nasal/sinus surgery or trauma to prevent lateralization of the middle turbinate during the post operative period.

# Comparison of Technological Characteristics of SeprageI™ ENT with 7.9 Legally Marketed Devices:

Table 4 is the Table of Similarities and Differences between Genzyme's Seprage1™ ENT Bioresorbable Packaing/Stent and the legally marketed devices identified in Section 7.6.

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genzyme

# able 4: Comparison to Marketed Device

| Device Name | Sepragel™ ENT | Hylasine™ (Sepragel Sinus) | MeroGel™Nasal Dressing/Sinus Stent<br>and Otologic Packing |
|----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Genzyme Corporation | Genzyme Corporation | Medtronic Xomed |
| | PROPOSED | (K993362, K012532) | (K001148) |
| | ENT synthetic polymer material | Epistaxis balloon/Intranasal Splint | Epistaxis balloon/ ENT synthetic polymer<br>material |
| Product Code | 77KHJ | 77EMX/LYA | 77KHJ |
| Intended<br>Use/Indication | For use in patients undergoing<br>nasal/sinus surgery as a space-<br>occupying gel stent to separate and<br>prevent adhesions between mucosal<br>surfaces in the nasal cavity, to help<br>control minimal bleeding following<br>surgery or nasal trauma, and to<br>prevent lateralization of the middle<br>turbinate during the postoperative<br>period. The device is also indicated<br>for use in the middle ear and external<br>ear canal following canalplasty,<br>myringoplasty, tympanoplasty and,<br>and stapes and mastoid surgery. | For use in patients undergoing<br>nasal/sinus surgery as a space-<br>occupying gel stent to separate and<br>prevent adhesions between mucosal<br>surfaces in the nasal cavity, to help<br>control minimal bleeding following<br>surgery or nasal trauma, and to<br>prevent lateralization of the middle<br>turbinate during the postoperative<br>period. | MeroGel Otologic Pack is a space<br>occupying dressing and/or stent intended to<br>separate mucosal surfaces, help control<br>minimal bleeding and act as an adjunct to<br>aid in the natural healing process. The<br>device is indicated for use in the middle<br>ear and external ear canal following<br>canalplasty, myringoplasty, tympanoplasty<br>and, and stapes and mastoid surgery. |
| Material<br>Composition | Derivative hyaluronic acid | Derivative hyaluronic acid | Derivative hyaluronic acid |
| Bioresorbable | YES | YES | YES |
| Product matrix | Gel in a syringe | Gel in a syringe | Non-woven pad in a protective folded<br>sheet |

roprietary and Confidentis

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its body and wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

JUL 1 1 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Genzyme Corporation c/o Barbara Pizza Manager Regulatory Affairs 55 Cambridge Parkway Cambridge, MA 02142

Re: K043035

Trade/Device Name: Seprage1™ ENT Nasal/Sinus and Otologic Dressing Regulation Number: 21 CFR 874.3620 Regulation Name: ENT synthetic polymer material Regulatory Class: Class II Product Code: KHJ Dated: June 17, 2005 Received: June 20, 2005

Dear Ms. Pizza:

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 - Barbara Pizza

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,

David M. Whipple

David M. Whipple Acting 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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# genzyme

510(k) Number (if known): New Application

Sepragel™ ENT Bioresorbable Packing/Stent Device Name:

Indications for Use:

Sepragel ENT packing/stent is indicated for use in patients undergoing nasal/sinus, middle ear and external ear canal surgery as a space-occupying dressing and/or stent intended to prevent adhesions in the nasal cavity, separate mucosal surfaces, help control minimal bleeding following surgery or trauma, and act as an adjunct to aid in the natural healing process. The device is indicated for use in the middle ear following canalplasty, myringoplasty, tympanoplasty, stapes and mastoid surgery. The device is indicated following nasal/sinus surgery or trauma to prevent lateralization of the middle turbinate during the post operative period.

# (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED.)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CRF 801.109)

sion Sign-Off ivision of Ophthalmic Ear Nose and Throat I

510(k) Number Proprietary and Confidential OR

Over-The-Counter Use (Optional Format 1-2-96)