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 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.

AI/ML Overview

This is a 510(k) premarket notification for a medical device (MeroGel Injectable Bioresorbable Nasal Dressing and Sinus Stent and Otologic Gel), not an AI/ML-driven diagnostic device. Therefore, the information typically found in a study proving the device meets AI/ML acceptance criteria (such as sample size for test/training sets, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance) is not applicable here.

The "study" in this context refers to the testing performed to demonstrate substantial equivalence to a predicate device.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a quantitative performance metric sense (e.g., sensitivity, specificity). Instead, it focuses on demonstrating substantial equivalence to a predicate device (K070886) by showing that the proposed device performs identically or similarly across key characteristics. The "performance" is implicitly deemed acceptable if it matches the predicate or meets established standards for safety and effectiveness for such a device.

Characteristic/Test	Acceptance Criteria (Implied: Equivalent to Predicate K070886 or established standards)	Reported Device Performance
Formulation	Viscosity and HA concentration to be equivalent to predicate.	Tested; results support equivalence.
Filling Process	To ensure consistent product characteristics and safety.	Tested; results support equivalence.
Terminal Sterilization Processes (primary and secondary)	To achieve sterility assurance level (SAL).	Tested; results support equivalence.
Assembly	To ensure proper device construction and functionality.	Tested; results support equivalence.
Biocompatibility	To ensure safety for use in the body (e.g., non-toxic, non-irritating, non-sensitizing per ISO 10993).	Tested; results support equivalence.
Labeling and Packaging	To meet regulatory requirements and ensure product integrity.	Tested; results support equivalence.
Intended Use / Indication	Identical to K070886.	Identical to K070886.
Material	Derivative hyaluronic acid (identical to K070886).	Derivative hyaluronic acid.
Bioresorbable	Yes (identical to K070886).	Yes.
Sterile	Yes (identical to K070886).	Yes.
Product Matrix	Gel in a syringe (identical to K070886).	Gel in a syringe.

2. Sample Size Used for the Test Set and the Data Provenance

This information is not provided in the document. The document describes tests performed on the device itself and its manufacturing processes, not a "test set" of patient data for evaluating an AI algorithm.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

This information is not provided and is not applicable to this type of device submission. Ground truth, in the context of AI/ML, refers to labels for data, which wasn't established for this device.

4. Adjudication Method for the Test Set

This information is not provided and is not applicable.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

This information is not provided and is not applicable. This device is a physical medical implant/dressing, not an AI-assisted diagnostic tool.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This information is not provided and is not applicable. This device is not an algorithm.

7. The Type of Ground Truth Used

This information is not provided and is not applicable. The assessment is based on physical and chemical properties and functional equivalence, not on a "ground truth" derived from patient outcomes or pathology.

8. The Sample Size for the Training Set

This information is not provided and is not applicable. This device is a manufactured product, not an AI model requiring a training set.

9. How the Ground Truth for the Training Set Was Established

This information is not provided and is not applicable.

Summary

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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, Inc6743 Southpoint Drive NorthJacksonville, Florida 32216-0980 USA904-296-9600904-296-2386 (FAX)
Contact Name	Antoine KouchakjyPrincipal Regulatory Affairs SpecialistMedtronic Xomed, Inc
Date Summary Prepared	August 9, 2012
Proprietary Name	MeroGel Injectable Bioresorbable Nasal Dressing and SinusStent 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

Intended Use

Indications for Use

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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 .

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Device Name	MeroGel Injectable Bioresorbable NasalDressing and Sinus Stent and Otologic GelMedtronic Xomed510(k) PROPOSED	MeroGel Injectable Bioresorbable StentMedtronic XomedK070886
Product Code	ENT synthetic polymer material	ENT synthetic polymer material
Intended Use / Indication	NHBSame as K070886:MeroGel Injectable Bioresorbable NasalDressing and Sinus Stent and Otologic Gelis a space occupying gel stent intended toseparate and prevent adhesions betweenmucosal surfaces, help control minimalbleeding following surgery or nasaltrauma, and act as an adjunct to aid in thenatural healing process.MeroGel Injectable Bioresorbable NasalDressing and Sinus Stent and Otologic Gelis indicated for use in the middle ear andexternal ear canal following canalplasty,myringoplasty, tympanoplasty, and stapesand mastoid surgery. The device isindicated following nasal / sinus surgery ortrauma to prevent lateralization of themiddle turbinate and nasal adhesionsduring the post operative period.	NHBMeroGel Injectable Bioresorbable Stent isa space occupying gel stent intended toseparate and prevent adhesions betweenmucosal surfaces, help control minimalbleeding following surgery or nasaltrauma, and act as an adjunct to aid in thenatural healing process.MeroGel Injectable Bioresorbable Stent isindicated for use in the middle ear andexternal ear canal following canalplasty,myringoplasty, tympanoplasty, and stapesand mastoid surgery. The device isindicated following nasal / sinus surgery ortrauma to prevent lateralization of themiddle turbinate and nasal adhesionsduring 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

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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 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

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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

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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 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)

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(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

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.