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 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.

AI/ML Overview

This is an application for a 510(k) premarket notification for a medical device, which typically establishes substantial equivalence to a predicate device rather than strictly proving acceptance criteria through a standalone study with specific performance metrics and statistical analyses as might be seen for novel devices or AI/software.

The document describes a MeroGel Injectable Bioresorbable Dressing (Stent). The key to its acceptance is demonstrating substantial equivalence to already legally marketed devices. Therefore, the "acceptance criteria" are primarily related to conforming to the characteristics and intended use of its predicate devices, rather than predefined performance thresholds against a ground truth dataset.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) for a physical medical device (a bioresorbable dressing) rather than an AI/software device, the concept of "acceptance criteria" and "device performance" in the context of accuracy, sensitivity, or specificity against a ground truth as described in the prompt is not directly applicable.

Instead, the acceptance criteria are met by demonstrating substantial equivalence to predicate devices across several key characteristics. The "reported device performance" is essentially the device's characteristics aligning with those of the predicates.

Feature/Criterion (Acceptance Criteria are implied by equivalence to predicates)	MeroGel Injectable Bioresorbable Stent (Proposed Device)	Sepragel™ ENT Nasal/Sinus and Otologic Dressing (Predicate 1)	MeroGel™ Otologic Pack (Predicate 2)
Intended Use/Indications	- Space occupying gel stent	- Space-occupying gel stent	- Space occupying dressing/stent
	- Separate & prevent adhesions	- Separate & prevent adhesions	- Separate mucosal surfaces
	- Help control minimal bleeding	- Help control minimal bleeding	- Help control minimal bleeding
	- Act as adjunct to aid natural healing	- Act as adjunct to aid natural healing	- Act as adjunct to aid natural healing
	- Use in middle/external ear (canalplasty,	- Use in middle/external ear (canalplasty,	- Use in middle/external ear (canalplasty,
	myringoplasty, tympanoplasty, stapes/mastoid surgery)	myringoplasty, tympanoplasty, stapes/mastoid surgery)	myringoplasty, tympanoplasty, stapes/mastoid surgery)
	- Use in nasal/sinus (prevent lateralization, adhesions)	- Use in nasal/sinus (prevent lateralization, adhesions)	- (Not explicitly listed for nasal/sinus - pack)
Material	Derivative hyaluronic acid	Derivative hyaluronic acid	Derivative hyaluronic acid
Bioresorbable	YES	YES	YES
Sterile	YES	YES	YES
Product Matrix	Gel in a syringe	Gel in a syringe	Non-woven pad in a protective folded sheet
Product Code	77NHB	77KHJ	77KHJ

Summary of Device Performance: The proposed MeroGel Injectable Bioresorbable Stent matches its primary predicate (Sepragel™ ENT) very closely in intended use, indications, material, bioresorbability, sterility, and product matrix (gel in a syringe). It also shares similar features with the secondary predicate (MeroGel™ Otologic Pack) concerning material, bioresorbability, sterility, and some ear indications, although the form factor (gel vs. pad) differs. The differences in product code (NHB vs KHJ) likely reflect minor classification distinctions, but the fundamental properties for demonstrating substantial equivalence are present.

The subsequent points (2-9) are not applicable to this 510(k) submission, as it relates to a physical medical device and not an AI/software-based diagnostic or prognostic tool. The document does not describe any study involving AI, machine learning, image analysis, or any process that would require a "test set," "training set," "ground truth established by experts," "adjudication," or "MRMC comparative effectiveness study."

This 510(k) is a regulatory filing for a device based on its physical and chemical properties and intended use, demonstrating equivalence to already approved devices. The "study" here is essentially the comparison presented in the table above and supporting documentation (not provided in full here, but typically includes biocompatibility, sterilization validation, material characterization, etc.).

Summary

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K070886

APR 2 6 2007

510(k) SUMMARY SUMMARY OF SAFETY AND EFFECTIVENESS FOR MeroGel Injectable Bioresorbable Dressing

510(k) Owner	Medtronic Xomed, Inc6743 Southpoint Drive NorthJacksonville, Florida 32216-0980 USA904-296-9600904-296-2386 (FAX)
Contact Name	Jayme WilsonSenior Regulatory Affairs SpecialistMedtronic Xomed, Inc
Date Summary Prepared	April 24, 2006
Proprietary Name	MeroGel Injectable Bioresorbable Dressing (Finalname 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

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Intended Use

Indications for Use

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Device Name	Comparison to Marketed DevicesMeroGel™ Injectable Bioresorbable StentMedtronic XomedPROPOSED	Sepragel™ ENT Nasal/Sinus andOtologic DressingGenzyme CorporationK043035	MeroGel™ Otologic PackMedtronic XomedK001148
Product Code	ENT synthetic polymer material77NHB	ENT synthetic polymer material77KHJ	ENT synthetic polymer material77KHJ
IntendedUse/Indication	MeroGel Injectable Bioresorbable Stent isa space occupying gel stent intended toseparate and prevent adhesions betweenmucosal surfaces, help control minimalbleeding following surgery or nasal trauma,and act as an adjunct to aid in the naturalhealing process. MeroGel InjectableBioresorbable Stent is indicated for use inthe middle ear and external ear canalfollowing canalplasty, myringoplasty,tympanoplasty, and stapes and mastoidsurgery. The device is indicated followingnasal/sinus surgery or trauma to preventlateralization of the middle turbinate andnasal adhesions during the post operativeperiod.	For use in patients undergoingnasal/sinus surgery as a space-occupying gel stent to separate andprevent adhesions betweenmucosal surfaces in the nasalcavity, to help control minimalbleeding following surgery ornasal trauma, and to preventlateralization of the middleturbinate during the postoperativeperiod. The device is alsoindicated for use in the middle earand external ear canal followingcanalplasty, myringoplasty,tympanoplasty and, stapes andmastoid surgery	MeroGel Otologic Pack is a spaceoccupying dressing and/or stentintended to separate mucosalsurfaces, help control minimalbleeding and act as an adjunct toaid in the natural healing process.MeroGel Otologic Pack isindicated for use in the middle earand external ear canal followingcanalplasty, myringoplasty,tympanoplasty, and stapes andmastoid surgery.
MaterialBioresorbable	Derivative hyaluronic acidYES	Derivative hyaluronic acidYES	Derivative hyaluronic acidYES
Sterile	YES	YES	YES
ProductMatrix	Gel in a syringe	Gel in a syringe	Non-woven pad in a protectivefolded sheet

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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.

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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 .

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INDICATIONS FOR USE

510(k) Number (if known): _ Kon 08862

MeroGel Injectable Bioresorbable Stent (Final name to be Device Name: determined)

Indications for Use:

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)

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Regulation Number and Section

§ 874.3620 Ear, nose, and throat synthetic polymer material.

(a)
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.(b)
Classification. Class II.