MEROPACK BIORESORBABLE NASAL PACKING AND SINUS STENT by MEDTRONIC XOMED, INC.

MeroPack™ Bioresorbable Nasal Dressing and Sinus Stent is indicated for use in patients undergoing nasal/sinus surgery as a space occupying stent to separate and prevent adhesions between mucosal surfaces during mesothelial cell regeneration in the nasal cavity; to help control minimal bleeding following surgery or nasal trauma by tamponade effect, blood absorption and platelet aggregation; and to prevent lateralization of the middle turbinate during the postoperative period.

Device Description

MeroPack™ is a sterile bioresorbable nasal dressing and sinus stent composed of lyophilized and compressed HYAFF® and Collagen. When placed appropriately, MeroPack™ absorbs fluid and swells, conforming to the nasal cavity and creating a tamponade effect that helps to control the minimal bleeding normally associated with routine sinus surgery. The stent gradually degrades over time and is slowly absorbed within 14 days, or it may be aspirated from the cavity earlier at the discretion of the physician.

AI/ML Overview

The provided text describes a 510(k) submission for the Medtronic XOMED MeroPack™ Nasal Packing and Sinus Stent, which is a medical device and not an AI/ML algorithm. Therefore, many of the requested fields for an AI/ML device study (like sample size for test/training sets, number of experts for ground truth, adjudication methods, MRMC studies) are not applicable to this document.

However, I can extract information related to the device's performance based on the provided text, primarily by comparing it to predicate devices to establish substantial equivalence.

Here's the relevant information:

1. Table of acceptance criteria and the reported device performance

Since this is a 510(k) for a medical device and not an AI/ML algorithm, the "acceptance criteria" are implied by the comparison to a legally marketed predicate device. The device is deemed substantially equivalent if it performs similarly across key characteristics.

Characteristic / Acceptance Criteria (Implied)	Predicate Device (MeroGel™) Performance	Proposed Device (MeroPack™) Performance	Assessment
Intended Use	Post-op, help control minimal bleeding and separate mucosal surfaces / adhesion prevention	Post-op, help control minimal bleeding and separate mucosal surfaces / adhesion prevention	Meets
Indications	nasal/sinus surgery	nasal/sinus surgery	Meets
Material/Construction	esterified hyaluronic acid	esterified hyaluronic acid and collagen	Similar (addition of collagen)
Absorbent Qualities	in excess of 10 times weight of the device	in excess of 10 times weight of the device	Meets
Sterility	gamma irradiation	gamma irradiation	Meets
Resorption time	approx. 14 days	Within 14 days	Meets
Biocompatibility	ISO 10993-1	ISO 10993-1 and FDA Guidance G95-1	Meets (additional compliance)
Method of Action	hygroscopic, forms gelatinous mass in contact with fluids	hygroscopic, forms gelatinous mass in contact with fluids	Meets
Method of Removal	gentle irrigation of residues	gentle irrigation of residues	Meets

Studies that prove the device meets acceptance criteria:

The submission states: "Studies were conducted both by a contract laboratory and by in-house laboratories; all followed scientific protocols. The data were determined to be scientifically valid under 21 CFR 860.7." However, the specific details or results of these studies are not provided in the summary. The "acceptance criteria" here are essentially being "substantially equivalent" to the predicate devices.

2. Sample size used for the test set and the data provenance:

Sample size: Not specified in the provided summary.
Data provenance: Not specified, but likely from laboratory testing (in-house and contract) rather than human subject data for "test sets" in the AI/ML sense.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. This is a medical device, not an AI/ML algorithm. The "ground truth" for a physical device is its material properties, performance characteristics (e.g., absorbency, resorption rate), and biocompatibility, typically established through laboratory testing and material science standards (like ISO 10993-1).

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable. This is a medical device.

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:

Not applicable. This is a medical device, not an AI or imaging diagnostic device.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

Not applicable. This is a physical medical device.

7. The type of ground truth used:

The ground truth relies on established scientific and engineering principles for medical devices, including:

Material composition analysis: To confirm the presence of esterified hyaluronic acid and collagen.
Physical property testing: To measure absorbency (e.g., "in excess of 10 times weight of the device").
Sterility testing: To confirm gamma irradiation effectiveness.
Biocompatibility testing: Conducted according to ISO 10993-1 and FDA Guidance G95-1 standards.
Degradation/resorption studies: To determine the "Within 14 days" resorption time.

8. The sample size for the training set:

Not applicable. This is a medical device, not an AI/ML algorithm.

9. How the ground truth for the training set was established:

Not applicable. This is a medical device, not an AI/ML algorithm.

Summary

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K041381

SEP 1 0 2004

Image /page/0/Picture/2 description: The image shows the Medtronic XOMED logo. The logo consists of a circular graphic on the left, with three figures arranged in a circular pattern. To the right of the graphic is the word "Medtronic" in a bold, sans-serif font, and below that is the word "XOMED" in a smaller font. A horizontal line runs beneath the text.

Summary of 510(k) Submission

Name andaddress ofsubmitter	Medtronic Xomed Inc.6743 Southpoint Drive NorthJacksonville, Florida 32216Contact: David S. DoddPhone: (904) 332-8746Date Prepared: May 24, 2004
Identificationof Devices	Trade name: MeroPack™ Nasal Packing and Sinus Stent. Common or usual name: Ear, Nose and Throat Packing, Dressing, and/or Stent Classification Name: Intranasal Splint (per 21 CFR §874.4780) FDA Classification: Class I - Non-Exempt.
PredicateDevice	MeroGel™ Nasal Dressing and Sinus Stent, and Seprapack/Sepragel (Genzyme)
Description ofDevice	MeroPack™ is a sterile bioresorbable nasal dressing and sinus stentcomposed of lyophilized and compressed HYAFF® and Collagen.When placed appropriately, MeroPack™ absorbs fluid and swells,conforming to the nasal cavity and creating a tamponade effect thathelps to control the minimal bleeding normally associated with routinesinus surgery. The stent gradually degrades over time and is slowlyabsorbed within 14 days, or it may be aspirated from the cavity earlierat the discretion of the physician.
IndicationsFor Use	MeroPack™ Bioresorbable Nasal Dressing and Sinus Stent isindicated for use in patients undergoing nasal/sinus surgery as aspace occupying stent to separate and prevent adhesions betweenmucosal surfaces during mesothelial cell regeneration in the nasalcavity; to help control minimal bleeding following surgery or nasaltrauma by tamponade effect, blood absorption and plateletaggregation; and to prevent lateralization of the middle turbinateduring the postoperative period.

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Summary of 510(k) Submission, Continued

	Predicate Device:Seprapack / Sepragel	Predicate Device:MeroGel™ Nasal Dressingand Sinus Stent	Proposed Device:MeroPack™ NasalPacking and Sinus Stent
Intended Use	Post-op, help controlminimal bleeding andseparate mucosal surfaces /adhesion prevention	Post-op, help controlminimal bleeding andseparate mucosal surfaces/ adhesion prevention	Post-op, help controlminimal bleeding andseparate mucosalsurfaces / adhesionprevention
Indications	nasal/sinus surgery	nasal/sinus surgery	nasal/sinus surgery
Material /Construction	Chemically modifiedhyaluronic acid andcarboxymethylcellulose	esterified hyaluronic acid	esterified hyaluronic acidand collagen
AbsorbentQualities	unknown	in excess of 10 timesweight of the device	in excess of 10 timesweight of the device
Sterility	gamma irradiation	gamma irradiation	gamma irradiation
Resorption time	7-10 days	approx. 14 days	Within 14 days
Biocompatibility	ISO 10993-1	ISO 10993 1	ISO 10993 1 and FDAGuidance G95-1
Method ofAction	hygroscopic, formsgelatinous mass in contactwith fluids	hygroscopic, formsgelatinous mass in contactwith fluids	hygroscopic, formsgelatinous mass incontact with fluids
Method ofRemoval	gentle irrigation of residues	gentle irrigation of residues	gentle irrigation ofresidues

Substantial Equivalence table:

Conclusionsdrawn fromstudies	Validity ofScientific Data	Studies were conducted both by a contractlaboratory and by in-house laboratories; allfollowed scientific protocols. The data weredetermined to be scientifically valid under 21 CFR860.7.
	SubstantialEquivalence	The data presented in this Premarket Notificationsupport that the subject device is safe and effectiveand performs in the same manner as the predicatedevices when used in accordance with the labeleddirections for use and for the requested indication.
	Risk andBenefits	The risks of the subject device, as well as thebenefits to the patient, are the same as thosenormally attributed to the use of a space occupyingnasal dressing/stent.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of an eagle or bird-like figure, represented by three curved lines that suggest wings and a body.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 0 2004

Medtronic Xomed c/o David S. Dodd Sr. Regulatory Affairs Specialist 6743 Southpoint Drive North Jacksonville, FL 32216

K041381 Re:

Trade/Device Name: MetroPack™ Bioresorbable Nasal Dressing and Sinus Stent Regulation Number: 21 CFR 874.4780 Regulation Name: Intranasal splint Regulatory Class: Class I Product Code: LYA Dated: September 2, 2004 Received: September 3, 2004

Dear Mr. Dodd:

We have reviewed your Section 510(k) premarket notification of intent to market the device w f nave roview 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 (21 CFR Part 807), accems (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 - David S. Dodd

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 (301) 594-4613. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

A helyi Rosenthal

A. Ralph Rosenthal, 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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Koy 1381 510(k) Number (if known): Device Name: MeroPack™ Bioresorbable Nasal Dressing and Sinus Stent

Indications For Use

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

Prescription Use_ (Per 21 CFR 801.109)

Over-the-Counter Use

(Optional Format 1-2-96)

KaunBoke

ion of Oohthalmic Ear, Nose and Throat Day

510(k) Number

Regulation Number and Section

§ 874.4780 Intranasal splint.

(a)
Identification. An intranasal splint is intended to minimize bleeding and edema and to prevent adhesions between the septum and the nasal cavity. It is placed in the nasal cavity after surgery or trauma. The intranasal splint is constructed from plastic, silicone, or absorbent material.(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 the limitations in § 874.9.