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MEROGEL INJECTABLE BIORESORBABLE NASAL DRESSING AND SINUS STENT AND OTOLOGIC GEL

Q: Who is the manufacturer of MEROGEL INJECTABLE BIORESORBABLE NASAL DRESSING AND SINUS STENT AND OTOLOGIC GEL?

Medtronic Xomed filed the 510(k) submission for MEROGEL INJECTABLE BIORESORBABLE NASAL DRESSING AND SINUS STENT AND OTOLOGIC GEL (K122434).

Q: What is the FDA product code for MEROGEL INJECTABLE BIORESORBABLE NASAL DRESSING AND SINUS STENT AND OTOLOGIC GEL?

NHB. It is classified under 21 CFR 874.3620 as a Class 2 device in the Ear, Nose, Throat panel.

Q: What is the regulatory pathway for MEROGEL INJECTABLE BIORESORBABLE NASAL DRESSING AND SINUS STENT AND OTOLOGIC GEL?

510(k) clearance (submission type: Special).

Q: What are the predicate devices for MEROGEL INJECTABLE BIORESORBABLE NASAL DRESSING AND SINUS STENT AND OTOLOGIC GEL?

MeroGel Injectable Bioresorbable Stent (K070886).

K122434 · Medtronic Xomed · NHB · Oct 31, 2012 · Ear, Nose, Throat

Device Facts

Record ID	K122434
Device Name	MEROGEL INJECTABLE BIORESORBABLE NASAL DRESSING AND SINUS STENT AND OTOLOGIC GEL
Applicant	Medtronic Xomed
Product Code	NHB · Ear, Nose, Throat
Decision Date	Oct 31, 2012
Decision	SESE
Submission Type	Special
Regulation	21 CFR 874.3620
Device Class	Class 2
Attributes	Therapeutic

Intended Use

MeroGel Injectable Bioresorbable Nasal Dressing and Sinus Stent and Otologic Gel is a space occupying gel stent intended to separate and prevent adhesions between mucosal surfaces, help control minimal bleeding following surgery or nasal trauma, and act as an adjunct to aid in the natural healing process. MeroGel Injectable Bioresorbable Nasal Dressing and Sinus Stent and Otologic Gel is indicated for use in the middle ear and external ear canal following canalplasty, myringoplasty, tympanoplasty, and stapes and mastoid surgery. The device is indicated following nasal / sinus surgery or trauma to prevent lateralization of the middle turbinate and nasal adhesions during the post operative period.

Device Story

MeroGel is a sterile, transparent, viscoelastic, bioresorbable gel composed of cross-linked hyaluronic acid polymers. Supplied in a syringe, it is applied by a physician to ENT cavities following surgery or trauma. The gel acts as a space-occupying stent to separate mucosal surfaces, prevent adhesions, and provide a tamponade effect to control minimal bleeding. It aids the natural healing process and is either naturally eliminated or aspirated by the physician. Used in clinical settings (OR/clinic) by ENT specialists.

Clinical Evidence

No clinical data provided. Substantial equivalence supported by bench testing, including formulation analysis (viscosity, HA concentration), filling process validation, and terminal sterilization process validation.

Technological Characteristics

Material: Cross-linked hyaluronic acid polymers. Form: Viscoelastic gel in a syringe. Bioresorbable. Sterile. Class II device (21 CFR 874.3620).

Indications for Use

Indicated for patients undergoing middle ear or external ear canal surgery (canalplasty, myringoplasty, tympanoplasty, stapes, mastoid) or nasal/sinus surgery/trauma. Used to prevent mucosal adhesions and middle turbinate lateralization, and to control minimal post-operative bleeding.

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

MeroGel Injectable Bioresorbable Stent (K070886)

Related Devices

K070886 — MEROGEL INJECTABLE BIORESORBABLE STENT · Medtronic, Inc. · Apr 26, 2007
K043035 — SEPRAGEL ENT BIORESORBABLE PACKING/STENT · Genzyme Corporation · Jul 11, 2005
K993362 — HYLASINE · Biomatrix, Inc. · Mar 13, 2000
K063308 — ADVACOAT SINUS GEL, MODEL 9100, ADVA SINUS STENT, MODEL 9200 · Carbylan Biosurgery · Dec 4, 2006
K070496 — ADVACOAT SINUS GEL AND STENT · Carbylan Biosurgery · Mar 15, 2007

Submission Summary (Full Text)

{0}------------------------------------------------ K1a2434 OCT 31 2012 # 510(k) SUMMARY SUMMARY OF SAFETY AND EFFECTIVENESS FOR # MeroGel Injectable Bioresorbable Nasal Dressing and Sinus Stent and Otologic Gel | 510(k) Owner | Medtronic Xomed, Inc 6743 Southpoint Drive North Jacksonville, Florida 32216-0980 USA 904-296-9600 904-296-2386 (FAX) | |-----------------------|-----------------------------------------------------------------------------------------------------------------------------------| | Contact Name | Antoine Kouchakjy Principal Regulatory Affairs Specialist Medtronic Xomed, Inc | | Date Summary Prepared | August 9, 2012 | | Proprietary Name | MeroGel Injectable Bioresorbable Nasal Dressing and Sinus Stent and Otologic Gel | | Common Name | Polymer, Ear, Nose and Throat, Synthetic, Absorbable | | Classification Name | Ear, nose and throat synthetic polymer material (21 CFR 874.3620, Product Code NHB, Class II) | # Marketed device claiming equivalence to MeroGel Injectable Bioresorbable Nasal Dressing and Sinus Stent and Otologic Gel (MeroGel) is equivalent to Medtronic Xomed's MeroGel Injectable Bioresorbable Stent, K070886. # Device Description MeroGel is a sterile, transparent, viscoelactic, bioresorbable gel composed of cross-linked polymers of hyaluronic acid. The MeroGel device fills ENT cavities following surgery or trauma to keep tissues or structures separate during the healing process. During this time, the tamponade effect helps control minimal bleeding normally associated with routine ENT surgery. MeroGel 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 MeroGel Injectable Bioresorbable Nasal Dressing and Sinus Stent and Otologic Gel is a space occupying gel stent intended to separate and prevent adhesions between mucosal surfaces, help control minimal bleeding following surgery or nasal trauma, and act as an adjunct to aid in the natural healing process. # Indications for Use MeroGel Injectable Bioresorbable Nasal Dressing and Sinus Stent and Otologic Gel is indicated for use in the middle ear and external ear canal following canalplasty, myringoplasty, tympanoplasty, and stapes and mastoid surgery. The device is indicated following nasal / sinus surgery or trauma to prevent lateralization of the middle turbinate and nasal adhesions during the post operative period. {1}------------------------------------------------ # Summary of Changes - Manufacturing site change. . - . Secondary sterilization method change - Sterilization pouch material change. . # Summary of Testing The following tests were conducted in order to demonstrate that the MeroGel Injectable Bioresorbable Nasal Dressing and Sinus Stent and Otologic Gel is substantially equivalent to the MeroGel Injectable Bioresorbable Nasal Dressing and Sinus Stent and Otologic Gel of K070886. - Formulation for viscosity and HA concentration . - . Filling process - Terminal Sterilization processes (primary and secondary) . - Assembly . - Biocompatibility . - Labeling and Packaging . {2}------------------------------------------------ | Device Name | MeroGel Injectable Bioresorbable Nasal Dressing and Sinus Stent and Otologic Gel Medtronic Xomed 510(k) PROPOSED | MeroGel Injectable Bioresorbable Stent Medtronic Xomed K070886 | |---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Product Code | ENT synthetic polymer material | ENT synthetic polymer material | | Intended Use / Indication | NHB Same as K070886: MeroGel Injectable Bioresorbable Nasal Dressing and Sinus Stent and Otologic Gel is a space occupying gel stent intended to separate and prevent adhesions between mucosal surfaces, help control minimal bleeding following surgery or nasal trauma, and act as an adjunct to aid in the natural healing process. MeroGel Injectable Bioresorbable Nasal Dressing and Sinus Stent and Otologic Gel is indicated for use in the middle ear and external ear canal following canalplasty, myringoplasty, tympanoplasty, and stapes and mastoid surgery. The device is indicated following nasal / sinus surgery or trauma to prevent lateralization of the middle turbinate and nasal adhesions during the post operative period. | NHB MeroGel Injectable Bioresorbable Stent is a space occupying gel stent intended to separate and prevent adhesions between mucosal surfaces, help control minimal bleeding following surgery or nasal trauma, and act as an adjunct to aid in the natural healing process. MeroGel Injectable Bioresorbable Stent is indicated for use in the middle ear and external ear canal following canalplasty, myringoplasty, tympanoplasty, and stapes and mastoid surgery. The device is indicated following nasal / sinus surgery or trauma to prevent lateralization of the middle turbinate and nasal adhesions during the post operative period. | | Material | Derivative hyaluronic acid | Derivative hyaluronic acid | | Bioresorbable | YES | YES | | Sterile | YES | YES | | Product Matrix | Gel in a syringe | Gel in a syringe | . . Section 08 - 510(k) Summary : MeroGel Injectable {3}------------------------------------------------ # 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 consists of a stylized eagle with its wings spread, facing to the right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. #### Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002 OCT 31 2012 Medtronic Xomed, Inc. % Mr. Antoine Kouchakjy Principal Regulatory Affairs Specialist 6743 Southpoint Drive North Jacksonville, FL 32216-0980 Re: K122434 Trade/Device Name: MeroGel Injectable Bioresorbable Nasal Dressing and Sinus Stent and Otologic Gel Regulation Number: 21 CFR 874.3620 Regulation Name: Ear, nose, and throat synthetic polymer material Regulatory Class: Class II Product Code: NHB Dated: September 28, 2012 Received: October 1, 2012 Dear Mr. Kouchakjy: 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set {4}------------------------------------------------ forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. 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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Sincerely yours, Makin D. Ficklen, M.D. Malvina B. Eydelman, M Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ # Indications for Use 510(k) Number (if known): KI22434 Device Name: MeroGel Injectable Bioresorbable Nasal Dressing and Sinus Stent and Otologic Gel Indications For Use: MeroGel Injectable Bioresorbable Nasal Dressing and Sinus Stent and Otologic Gel is a space occupying gel stent intended to separate and prevent adhesions between mucosal surfaces, help control minimal bleeding following surgery or nasal trauma, and act as an adjunct to aid in the natural healing process. MeroGel Injectable Bioresorbable Nasal Dressing and Sinus Stent and Otologic Gel is indicated for use in the middle ear and external ear canal following canalplasty, myringoplasty, and stapes and mastoid surgery. The device is indicated following nasal / sinus surgery or trauma to prevent lateralization of the middle turbinate and nasal adhesions during the post operative period. Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C) Page 1 of (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Daniel C. Clupper Division Sign-Off) · >>vision of Ophthalmic, Neurological and Ear, ivose and Throat Devices K122434 510(k) Number