NASOPORE NASAL DRESSING, MODEL NDOX-YYY/ZZ

K052099 · Polyganics B.V., · LYA · Nov 21, 2005 · Ear, Nose, Throat

Device Facts

• Record ID: K052099
• Device Name: NASOPORE NASAL DRESSING, MODEL NDOX-YYY/ZZ
• Applicant: Polyganics B.V.,
• Product Code: LYA · Ear, Nose, Throat
• Decision Date: Nov 21, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.4780
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

Nasopore is a fragmentable nasal dressing and is indicated for use in patients undergoing nasal/sinus surgery as a space occupying stent to separate and prevent adhesions between mucosal surfaces; to help control minimal bleeding following surgery or nasal trauma by tamponade effect and blood absorption.

Device Story

Nasopore is a bioresorbable, fragmentable nasal dressing composed of poly(DL-lactide-co-e-caprolactone) urethane. Device functions as a space-occupying stent in the nasal cavity following surgery or trauma. Principle of operation is hygroscopic; material fragments in contact with fluids within several days post-insertion, allowing natural drainage via mucus flow. Used in clinical settings by physicians. Provides tamponade effect and blood absorption to manage minimal bleeding and prevent mucosal adhesions. Single-use device.

Clinical Evidence

Evidence includes biocompatibility testing per ISO 10993, mechanical and physical property testing, and in vitro fragmentation testing. Clinical trial data mentioned as part of the evaluation, though specific metrics are not detailed in the provided summary.

Technological Characteristics

Material: poly(DL-lactide-co-e-caprolactone) urethane. Form factor: fragmentable nasal dressing. Principle: hygroscopic, fragments in contact with fluids. Biocompatibility: ISO 10993. Sterilization: Not specified. Connectivity: None (standalone).

Indications for Use

Indicated for patients undergoing nasal/sinus surgery or nasal trauma requiring a space-occupying stent to prevent mucosal adhesions and control minimal bleeding via tamponade and blood absorption.

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

• Seprapack/Sepragel (K012532)
• Merogel™ nasal dressing (K982731)
• Meropack™ nasal dressing (K041381)

Submission Summary (Full Text)

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bioresorbable solution
**POLYGANICS**

# KOS2099

# NOV 2 1 2005

## 510(k) Summary of Safety and Effectiveness

| Submitter: | Polyganics BV<br>L.J. Zielstraweg 1<br>9713 GX, Groningen<br>The Netherlands<br><a href="www.polyganics.com">www.polyganics.com</a> |
|-----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Jan Nieuwenhuis<br>Managing Director<br>Tel : [phone]<br>Fax : [phone]<br>Mobile: [phone]<br>E-mail : <a href="mailto:[e-mail]">[e-mail]</a> |
| Date Prepared: | July 27, 2005 |
| General Provisions: | Trade Name: Nasopore®<br>Common Name: Nasal Dressing<br>Classification Name: Intranasal Splint, 21 CFR 874.4780<br>Device Classification: Class I |
| Predicate Devices: | - Seprapack/Sepragel; Genzyme; K012532<br>- Merogel™ nasal dressing; Xomed; K982731<br>- Meropack™ nasal dressing; Medtronic Xomed; K041381 |
| Performance Standards | For the Nasopore performance, the FDA, under section 514 of the Food, Drug and Cosmetic Act, has not established standards. |
| Indications for Use | Nasopore is a fragmentable nasal dressing and is indicated for use in patients undergoing nasal/sinus surgery as a space occupying stent to separate and prevent adhesions between mucosal surfaces; to help control minimal bleeding following surgery or nasal trauma by tamponade effect and blood absorption. |

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**bioresorbable solution**
POLYGANICS

Device De-Nasopore is composed of a fragmentable poly(DL-lactide-co-e-caprolactone) scription urethane that fragments within several days after insertion in the nasal cavity, whereafter it is drained from the nasal cavity via the natural mucus flow. The Nasopore size and type are indicated on the label and are packed in a Tyvek pouch. Nasopore is indicated for single-use. The safety and effectiveness of the Nasopore Nasal Dressing have been Performance demonstrated via data collected from design verification tests and analyses. Data: The design verification testing consisted of the following: In vitro fragmentation testing i Shelf life testing

The design, fundamental technology and intended use (safety and efficacy) Summary of Substantial featured with the Nasopore Nasal dressing are substantially equivalent to Equivalence those featured with the competitor devices Seprapack/Sepragel (ref. Genzyme, Corp.), Merogel™ nasal dressing (ref. 510(k)012532; 510(k)982731, Xomed Surgical products, Inc) and Meropack™ nasal dressing (ref. 510(k)041381; Medtronic Xomed).

> Biocompatibility, mechanical and physical property testing and in vitro fragmentation testing provide scientific evidence that Nasopore nasal dressing is substantially equivalent to the predicate devices. Evaluation of the Polyganics Nasopore® nasal dressing based on biocompatibility testing, clinical trial, and the comparison of the Nasopore nasal dressing with its predicate devices, shows that the Nasopore® is safe for use as a nasal dressing.

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Image /page/2/Picture/2 description: The image shows the words "bioresorbable solution" in a small font at the top. Below that, the word "POLYGANICS" is written in a large, bold font. The text appears to be a logo or brand name.

sopore® nasal dressing is substantially equivalent to the currently marketed predicate devices.

| | Nasopore® | Sepra-<br>pack/Sepragel | MeroGel™ | MeroPack™ |
|----------------------|-----------------------------------------------------------------|--------------------------------------------------------------------------|--------------------------------------------------------------|--------------------------------------------------------------|
| Company | Polyganics | Genzyme corporation | Xomed Surgical Products | Medtronic Xomed Inc. |
| 510(k) Reference | This 510(k) | K012532 | K982731 | K041381 |
| Device name | Intranasal Splint | Intranasal Splint | Intranasal Splint /<br>woven wound dressing | non Intranasal Splint |
| Indications | Nasal/sinus surgery | Nasal/sinus surgery | Nasal/sinus surgery | Nasal/sinus surgery |
| Material composition | fragmentable<br>poly(DL-lactide-co-ε-<br>caprolactone)<br>thane | Chemically modified<br>hyaluronic acid and<br>ure-carboxymethylcellulose | Esterified hyaluronic acid | Esterified hyaluronic acid<br>and collagen |
| Method of action | Hygroscopic, frag-<br>ments in contact<br>with fluids | Hygroscopic, forms<br>gelatinous mass in<br>contact with fluids | Hygroscopic, forms gelatinous mass in contact with<br>fluids | Hygroscopic, forms gelatinous mass in contact<br>with fluids |
| Biocompatibility | ISO 10993 | ISO 10993 | ISO 10993 | ISO 10993 and FDA<br>guidance G95-1 |

#### Device Characteristics of the Subject and Predicate devices

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Image /page/3/Picture/2 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. In the center of the seal is a stylized image of an eagle.

NOV 2 1 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Polyganics BV c/o J.B. Hak, Ph.D. Manager Clinical and Regulatory Affairs L.J. Zielstraweg 1 NL-9713-GX Groningen The Netherlands

Re: K052099

Trade/Device Name: Polyganics Nasopore® nasal dressing Regulation Number: 21 CFR 874.4780 Regulation Name: Intranasal splint Regulatory Class: Class I Product Code: LYA Dated: November 7, 2005 Received: November 9, 2005

Dear Mr. Hak:

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 - J.B. Hak, Ph.D.

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 [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours,

David M. Whipple

Acting 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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bioresorbable solution
**POLYGANICS**

#### Indications for Use Form

510(k) Number:

K052099

Device Name:

Nasopore® nasal dressing

Indications for Use:

Nasopore® nasal dressing is a fragmentable nasal dressing and is indicated for reacopying hasal/sinus surgery as a space occupying stent to separate and prevent adhesions between mucosal surfaces; to help control suparate and provent following surgery or nasal trauma by tamponade effect and blood absorption.

## (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

OR

(Division Sign-Off)

Prescription Use × (Per 21 CFR 801.109)

510(k) Number _

Over-The-Counter Use_

(Optional Format 1-2-96)

Amablit

(Divis on Sion-Nose an

510(k) Number K052099

29-Jul-2005

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