Who is the manufacturer of MEROPACK BIORESORBABLE NASAL PACKING AND SINUS STENT?

Medtronic Xomed, Inc. filed the 510(k) submission for MEROPACK BIORESORBABLE NASAL PACKING AND SINUS STENT (K041381).

What is the FDA product code for MEROPACK BIORESORBABLE NASAL PACKING AND SINUS STENT?

LYA. It is classified under 21 CFR 874.4780 as a Class 1 device in the Ear, Nose, Throat panel.

What is the regulatory pathway for MEROPACK BIORESORBABLE NASAL PACKING AND SINUS STENT?

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

What are the predicate devices for MEROPACK BIORESORBABLE NASAL PACKING AND SINUS STENT?

MeroGel™ Nasal Dressing and Sinus Stent; Seprapack/Sepragel (Genzyme).

Who can help prepare an FDA 510(k) submission like MEROPACK BIORESORBABLE NASAL PACKING AND SINUS 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.

MEROPACK BIORESORBABLE NASAL PACKING AND SINUS STENT

K041381 · Medtronic Xomed, Inc. · LYA · Sep 10, 2004 · Ear, Nose, Throat

Device Facts

Record ID	K041381
Device Name	MEROPACK BIORESORBABLE NASAL PACKING AND SINUS STENT
Applicant	Medtronic Xomed, Inc.
Product Code	LYA · Ear, Nose, Throat
Decision Date	Sep 10, 2004
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 874.4780
Device Class	Class 1
Attributes	Therapeutic

Intended Use

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 Story

MeroPack™ is a sterile, bioresorbable nasal dressing and sinus stent; composed of lyophilized, compressed HYAFF® (esterified hyaluronic acid) and collagen. Device functions as a space-occupying stent; placed in nasal cavity by physician post-surgery or trauma. Upon contact with fluids, device acts hygroscopically; absorbs fluid (exceeding 10x its weight) and swells to form a gelatinous mass. This mass provides tamponade to control minimal bleeding; separates mucosal surfaces to prevent adhesions; prevents middle turbinate lateralization. Device degrades over time; absorbed within 14 days or removed via gentle irrigation of residues by physician. Benefits include improved post-operative healing and reduced adhesion formation.

Clinical Evidence

Bench testing only. Data provided includes biocompatibility testing per ISO 10993-1 and FDA Guidance G95-1, and performance characterization (absorption capacity, resorption time). No clinical trials were conducted; substantial equivalence is based on technological and material similarities to legally marketed predicates.

Technological Characteristics

Materials: Esterified hyaluronic acid (HYAFF®) and collagen. Principle: Hygroscopic swelling to form gelatinous mass. Form factor: Lyophilized, compressed stent. Sterilization: Gamma irradiation. Biocompatibility: ISO 10993-1 and FDA Guidance G95-1 compliant. Resorption: Within 14 days.

Indications for Use

Indicated for patients undergoing nasal/sinus surgery or experiencing nasal trauma. Used as a space-occupying stent to prevent mucosal adhesions, control minimal bleeding via tamponade/absorption/platelet aggregation, and prevent middle turbinate lateralization post-operatively.

Regulatory Classification

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.

Predicate Devices

MeroGel™ Nasal Dressing and Sinus Stent
Seprapack/Sepragel (Genzyme)

Related Devices

K982731 — MEROGEL NASAL DRESSING AND SINUS STENT · Xomed, Inc. · Feb 2, 1999
K063308 — ADVACOAT SINUS GEL, MODEL 9100, ADVA SINUS STENT, MODEL 9200 · Carbylan Biosurgery · Dec 4, 2006
K052099 — NASOPORE NASAL DRESSING, MODEL NDOX-YYY/ZZ · Polyganics B.V., · Nov 21, 2005
K082276 — SYNTHEMED DEVICE · Synthemed, Inc. · Nov 18, 2008
K070496 — ADVACOAT SINUS GEL AND STENT · Carbylan Biosurgery · Mar 15, 2007

Submission Summary (Full Text)

{0}------------------------------------------------ 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 and address of submitter | Medtronic Xomed Inc. 6743 Southpoint Drive North Jacksonville, Florida 32216 Contact: David S. Dodd Phone: (904) 332-8746 Date Prepared: May 24, 2004 | |-------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Identification of 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. | | Predicate Device | MeroGel™ Nasal Dressing and Sinus Stent, and Seprapack/Sepragel (Genzyme) | | Description of Device | 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. | | Indications For Use | 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. | {1}------------------------------------------------ ## Summary of 510(k) Submission, Continued | | Predicate Device: Seprapack / Sepragel | Predicate Device: MeroGel™ Nasal Dressing and Sinus Stent | Proposed Device: MeroPack™ Nasal Packing and Sinus Stent | |----------------------------|-----------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------| | 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 | Post-op, help control minimal bleeding and separate mucosal surfaces / adhesion prevention | | Indications | nasal/sinus surgery | nasal/sinus surgery | nasal/sinus surgery | | Material / Construction | Chemically modified hyaluronic acid and carboxymethylcellulose | esterified hyaluronic acid | esterified hyaluronic acid and collagen | | Absorbent Qualities | unknown | in excess of 10 times weight of the device | in excess of 10 times weight 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 FDA Guidance G95-1 | | Method of Action | hygroscopic, forms gelatinous mass in contact with fluids | hygroscopic, forms gelatinous mass in contact with fluids | hygroscopic, forms gelatinous mass in contact with fluids | | Method of Removal | gentle irrigation of residues | gentle irrigation of residues | gentle irrigation of residues | ## Substantial Equivalence table: | Conclusions drawn from studies | Validity of Scientific Data | 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. | |--------------------------------------|--------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Substantial Equivalence | The data presented in this Premarket Notification support that the subject device is safe and effective and performs in the same manner as the predicate devices when used in accordance with the labeled directions for use and for the requested indication. | | | Risk and Benefits | The risks of the subject device, as well as the benefits to the patient, are the same as those normally attributed to the use of a space occupying nasal dressing/stent. | {2}------------------------------------------------ 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. {3}------------------------------------------------ ## 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 {4}------------------------------------------------ Koy 1381 510(k) Number (if known): Device Name: MeroPack™ Bioresorbable Nasal Dressing and Sinus Stent Indications For Use 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. (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) Or Over-the-Counter Use (Optional Format 1-2-96) KaunBoke ion of Oohthalmic Ear, Nose and Throat Day 510(k) Number