Who is the manufacturer of MEROGEL INJECTABLE BIORESORBABLE STENT?

Medtronic, Inc. filed the 510(k) submission for MEROGEL INJECTABLE BIORESORBABLE STENT (K070886).

What is the FDA product code for MEROGEL INJECTABLE BIORESORBABLE STENT?

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

What is the regulatory pathway for MEROGEL INJECTABLE BIORESORBABLE STENT?

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

What are the predicate devices for MEROGEL INJECTABLE BIORESORBABLE STENT?

Sepragel 104 ENT Nasal/Sinus and Otologic Dressing (K043035); MeroGel Otologic Pack (K001148).

Who can help prepare an FDA 510(k) submission like MEROGEL INJECTABLE BIORESORBABLE STENT?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

MEROGEL INJECTABLE BIORESORBABLE STENT

K070886 · Medtronic, Inc. · NHB · Apr 26, 2007 · Ear, Nose, Throat

Device Facts

Record ID	K070886
Device Name	MEROGEL INJECTABLE BIORESORBABLE STENT
Applicant	Medtronic, Inc.
Product Code	NHB · Ear, Nose, Throat
Decision Date	Apr 26, 2007
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 874.3620
Device Class	Class 2
Attributes	Therapeutic

Intended Use

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.

Device Story

Sterile, transparent, viscoelastic, bioresorbable gel composed of cross-linked hyaluronic acid polymers; supplied in syringe. Used in ENT surgery/trauma to fill cavities, separate mucosal surfaces, and provide tamponade for minimal bleeding. Applied by physician in clinical setting. Acts as physical barrier during healing; naturally eliminated or aspirated. Benefits include adhesion prevention and support of natural healing process.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and material similarity to legally marketed predicate devices.

Technological Characteristics

Cross-linked hyaluronic acid polymer gel; sterile; viscoelastic; bioresorbable; syringe-based delivery; non-electronic; no software.

Indications for Use

Indicated for patients undergoing middle ear/external ear canal surgery (canalplasty, myringoplasty, tympanoplasty, stapes, mastoid) or nasal/sinus surgery/trauma to prevent adhesions and 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 104 ENT Nasal/Sinus and Otologic Dressing (K043035)
MeroGel Otologic Pack (K001148)

Related Devices

K043035 — SEPRAGEL ENT BIORESORBABLE PACKING/STENT · Genzyme Corporation · Jul 11, 2005
K122434 — MEROGEL INJECTABLE BIORESORBABLE NASAL DRESSING AND SINUS STENT AND OTOLOGIC GEL · Medtronic Xomed · Oct 31, 2012
K993362 — HYLASINE · Biomatrix, Inc. · Mar 13, 2000
K012532 — SEPRAGEL SINUS · Genzyme Corp. · Oct 30, 2001
K070496 — ADVACOAT SINUS GEL AND STENT · Carbylan Biosurgery · Mar 15, 2007

Submission Summary (Full Text)

{0}------------------------------------------------ K070886 APR 2 6 2007 # 510(k) SUMMARY SUMMARY OF SAFETY AND EFFECTIVENESS FOR MeroGel Injectable Bioresorbable Dressing | 510(k) Owner | Medtronic Xomed, Inc 6743 Southpoint Drive North Jacksonville, Florida 32216-0980 USA 904-296-9600 904-296-2386 (FAX) | |-----------------------|-----------------------------------------------------------------------------------------------------------------------------------| | Contact Name | Jayme Wilson Senior Regulatory Affairs Specialist Medtronic Xomed, Inc | | Date Summary Prepared | April 24, 2006 | | Proprietary Name | MeroGel Injectable Bioresorbable Dressing (Final name TBD) | | 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 Stent is equivalent to Genzyme Corporation's Sepragel 104 ENT Nasal/Sinus and Otologic Dressing, K043035 and Medtronic Xomed's MeroGei™ Otologic Pack, K001148. #### Device Description MeroGel Injectable Bioresorbable Stent is a sterile, transparent, viscoelactic, bioresorbable gel composed of cross-linked polymers of hyaluronic acid. The MeroGel Injectable Bioresorbable Stent fills ENT cavities following surgery or trauma to keep to 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 Injectable leaves the site of placement by natural elimination, or it may be aspirated from the cavity earlier at the discretion of the physician. {1}------------------------------------------------ # Intended Use 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. ## Indications for Use 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. {2}------------------------------------------------ | Device Name | Comparison to Marketed Devices MeroGel™ Injectable Bioresorbable Stent Medtronic Xomed PROPOSED | Sepragel™ ENT Nasal/Sinus and Otologic Dressing Genzyme Corporation K043035 | MeroGel™ Otologic Pack Medtronic Xomed K001148 | |----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Product Code | ENT synthetic polymer material 77NHB | ENT synthetic polymer material 77KHJ | ENT synthetic polymer material 77KHJ | | Intended Use/Indication | 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. | 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. The device is also indicated for use in the middle ear and external ear canal following canalplasty, myringoplasty, tympanoplasty and, stapes and mastoid surgery | MeroGel Otologic Pack is a space occupying dressing and/or stent intended to separate mucosal surfaces, help control minimal bleeding and act as an adjunct to aid in the natural healing process. MeroGel Otologic Pack is indicated for use in the middle ear and external ear canal following canalplasty, myringoplasty, tympanoplasty, and stapes and mastoid surgery. | | Material Bioresorbable | Derivative hyaluronic acid YES | Derivative hyaluronic acid YES | Derivative hyaluronic acid YES | | Sterile | YES | YES | YES | | Product Matrix | Gel in a syringe | Gel in a syringe | Non-woven pad in a protective folded sheet | . {3}------------------------------------------------ Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle or bird-like figure with outstretched wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird. The logo is black and white. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Medtronic Xomed c/o Jayme Wilson 6743 Southpoint Drive North Jacksonville, Florida 32216-0980 APR 2 6 2007 Re: K070886 Trade/Device Name: MeroGel™ Injectable Bioresorbable Stent Regulation Number: 21 CFR 874.3620 Regulation Name: Ear Nose & Throat Synthetic Polymer Material Regulatory Class: II Product Code: NHB Dated: March 29, 2007 Received: March 30, 2007 Dear Ms. Wilson: 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. {4}------------------------------------------------ Page 2 - Jayme Wilson 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 SimD 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 . {5}------------------------------------------------ ### INDICATIONS FOR USE 510(k) Number (if known): _ Kon 08862 MeroGel Injectable Bioresorbable Stent (Final name to be Device Name: determined) Indications for Use: 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. Prescription Use X AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) C) (21 CFR 801 Subpart (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE OF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Keun Bahn Division Sign-Off) ivision of Opnthalmic Ear, Nose and Throat Devises **510(k) Number** K070886 | Prescription Use | | |----------------------|------------------------------------------------------| | (Per 21 CFR 801.109) | | 9 of 56