Xomed MeroGel™ Nasal Dressing and Sinus Stent is intended for use in the nasal/sinus cavities as a space-occupying dressing and/or stent, to separate mucosal surfaces and to help control minimal bleeding following surgery.

Device Description

Xomed MeroGel™ Nasal Dressing and Sinus Stent is a biomaterial composed of HYAFF®, an ester of hyaluronic acid, a natural occurring constituent of the extracellular matrix. Due to its absorption properties, MeroGel™ may be used to help control minimal bleeding. In contact with body fluids, it changes into viscous and transparent gel, conforming to mucosal surfaces and eventually dissolves or may be irrigated from the cavity.

AI/ML Overview

The provided text is a 510(k) summary for the Xomed MeroGel™ Nasal Dressing and Sinus Stent. This document focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a study report that quantitatively proves device performance against those criteria.

Therefore, the following information is not present in the provided text:

A table of acceptance criteria and reported device performance.
Sample size used for a test set and data provenance.
Number of experts used to establish ground truth.
Adjudication method for a test set.
Results from a multi-reader multi-case (MRMC) comparative effectiveness study, or effect size.
Results from a standalone (algorithm only) performance study.
Type of ground truth used for performance validation.
Sample size for the training set.
How the ground truth for the training set was established.

Summary of available information related to acceptance criteria and study:

The device's "acceptance criteria" in this context are primarily defined by its intended use and demonstrating substantial equivalence to predicate devices, rather than specific performance metrics (like accuracy, sensitivity, specificity) against a clinical endpoint.

Intended Use:

MeroGel™ Nasal Dressing and Sinus Stent is intended for use in the nasal/sinus cavities as a space-occupying dressing and/or stent, to separate mucosal surfaces and to help control minimal bleeding following surgery.

Study (Demonstration of Substantial Equivalence):

The device's acceptance is based on a comparative analysis to existing predicate devices, the Merocel® Sinus-Pak™ and Merocel® Standard Nasal Dressing. The study is a reasoned argument for substantial equivalence, not a clinical trial with specific performance metrics.

Acceptance Criteria & Reported Device Performance: This information is not explicitly stated in a table with performance metrics in the provided document. The "acceptance" is the FDA's marketing clearance based on substantial equivalence. The "performance" is described qualitatively:
- Predicate Device Performance (Implied): Controls bleeding, aids in prevention of adhesions, absorbant for postop fluids.
- MeroGel™ Performance: Similar intended use and indications; changes into a viscous and transparent gel, conforming to mucosal surfaces; eventually dissolves or may be irrigated; helps control minimal bleeding; highly absorbent.
- Difference and Justification: The key difference is that MeroGel™ dissolves/forms a gelatinous mass and can be removed by irrigation, unlike the predicate devices which require manual removal. This difference is presented as not raising new safety or effectiveness concerns, supported by the material (HYAFF®) being biocompatible.
Sample size used for the test set and the data provenance: Not applicable for this type of submission. There is no "test set" in the sense of a dataset for a performance study. The comparison is conceptual, based on intended use and material properties.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth, in a clinical performance sense, is not established or discussed for a test set.
Adjudication method for the test set: Not applicable.
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: Not applicable. This device is not an AI/imaging device requiring MRMC studies.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used: Not applicable. The "truth" in this submission is the established safety and effectiveness of the predicate devices and the biocompatibility of the new material, which infer similar performance.
The sample size for the training set: Not applicable. There is no "training set" for an algorithm.
How the ground truth for the training set was established: Not applicable.

Summary

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FEB 2

X. 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

1.0 Date Prepared

August 3, 1998

2.0 Submitter (Contact)

Roy Berens, Manager Regulatory Affairs Xomed Surgical Products Jacksonville, FL 32216 Telephone: 904-296-6454 904-281-1057 Fax: e-mail:rberens@xomed.com

3.0 Device Name

Xomed MeroGel™ Nasal Dressing and Sinus Stent Proprietary Name:

Absorbent Intranasal Splint Common Name(s): Absorbent Intranasal Packing Material Non-Woven Surgical Packing Non-Woven Wound Dressing Non-Woven Compress

Classification Name: Intranasal splint and/or Non-Woven Wound Dressing

4.0 Device Classification

Intranasal Splint	ProCode 77LYA	Class I ; 21 CFR 874.4780 (proposed)
	or
Wound Dressing	ProCode 79MGQ	Class I ; 21 CFR 878.4022
	or
Wound Dressing	ProCode 79MGP	Class II ; 21 CRF 878.4012

5.0 Device Description

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6.0 Intended Use

MeroGel™ Nasal Dressing and Sinus Stent is intended for use in the nasal/sinus cavities as a space-occupying dressing and/or stent, to separate mucosal surfaces and to help control minimal bleeding following surgery.

7.0 Substantial Equivalence

Xomed markets both Merocel® Sinus-Pak™ and Merocel® Standard Nasal Dressing for use in nasal/sinus cavities to control bleeding and/or ald in the prevention of adhesions after surgery. These predicate devices are indicated for nasal/sinus surgery and/or trauma. Xomed MeroGel™ Nasal Dressing and Sinus Stent is substantially equivalent to these predicate products in that it has a similar intended use and indications. The subject and predicate devices are made from materials which have demonstrated satisfactory biocompatibility, are highly absorbent for collecting postop fluids, and are sterile single use.

The difference are that the Xomed MeroGel™ Nasal Dressing and Sinus Stent changes from its original form of a white fibrous material with a physical appearance similar to spun cotton to a gelatinous mass whereas the predicate devices do not dissolve or form a gelatinous mass. Xomed MeroGel™ Nasal Dressing and Sinus Stent can be removed via gentle irrigation whereas the predicate devices require manual removal by moistening and extracting engorged sponge with forceps.

In conclusion, Xomed MeroGel™ Nasal Dressing and Sinus Stent has the same intended use as the predicate devices and differs only in the material which has been shown as biocompatible, as based on the data in the submission raises no new issue of safety or effectiveness.

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Image /page/2/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in all caps and is in a bold, sans-serif font. The text is centered in the image and is the only element present.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

2 1599 FEB

Manager, Quality Systems Regulations

Re:

K982731 MeroGel™ Nasal Dressing and Sinus Stent Dated: January 11, 1999 Received: January 13, 1999 Regulatory class: I 21 CFR 874.4100/Procode: 77 EMX

Dear Mr. Berens:

6743 Southpoint Dr. N.

Jacksonville, FL 32216-0980

Roy Berens

Xomed® Inc.

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory action. In addition. FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Capt. Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Intended Use Statement

510(k) Number (if known): K982732

Device Name: MeroGel TM Nasal Dressing and Sinus Stent

Indications for Use: Xomed MeroGel™ Nasal Dressing and Sinus Stent is intended for use in the nasal/sinus cavities as a space occupying dressing and/or stent, to separate mucosal surfaces and help control minimal bleeding following surgery.

(Please do not write below this line - continue on another page if needed) Concurrence of CDRH, Office of Device Evaluation (ODE)

Or

Prescription Use __

(Per 21 CFR 801.109)

Over-the-Counter Use

(Optional Format 1-2-96)

(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number K982731

Regulation Number and Section

§ 874.4100 Epistaxis balloon.

(a)
Identification. An epistaxis balloon is a device consisting of an inflatable balloon intended to control internal nasal bleeding by exerting pressure against the sphenopalatine artery.(b)
Classification Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 874.9.