NASOPORE EAR, MODELS ND04, ND05

K062540 · Polyganics B.V., · KCN · Oct 18, 2006 · Ear, Nose, Throat

Device Facts

• Record ID: K062540
• Device Name: NASOPORE EAR, MODELS ND04, ND05
• Applicant: Polyganics B.V.,
• Product Code: KCN · Ear, Nose, Throat
• Decision Date: Oct 18, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.5220
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

Nasopore® Ear is a fragmentable ear packing and is indicated for use in patients, undergoing outer ear surgery, as a space occupying stent to separate and prevent adhesions between mucosal surfaces; to help control minimal bleeding, following ear surgery, by tamponade effect and blood absorption.

Device Story

Nasopore® Ear is a bioresorbable, fragmentable ear packing device; composed of poly(DL-lactide-co-caprolactone) urethane foam. Used as a space-occupying stent in the outer ear following surgery; functions by separating mucosal surfaces to prevent adhesions and controlling minimal bleeding through tamponade effect and blood absorption. Device fragments within several days post-insertion and is naturally drained from the cavity. Intended for single-use; supplied in a blister pack. Operated by surgeons in a clinical setting. Benefits include reduced adhesion formation and post-operative bleeding management.

Clinical Evidence

Bench testing only. Evidence includes in vitro degradation testing and shelf life testing to demonstrate safety and effectiveness.

Technological Characteristics

Material: bioresorbable poly(DL-lactide-co-caprolactone) urethane foam. Form factor: fragmentable ear packing/stent. Mechanism: physical tamponade and space occupation. Sterilization: not specified. Connectivity: none. Software: none.

Indications for Use

Indicated for patients undergoing outer ear surgery requiring a space-occupying stent to prevent mucosal adhesions and control minimal bleeding via tamponade and blood absorption.

Regulatory Classification

Identification

An ear, nose, and throat drug administration device is one of a group of ear, nose, and throat devices intended specifically to administer medicinal substances to treat ear, nose, and throat disorders. These instruments include the powder blower, dropper, ear wick, manual nebulizer pump, and nasal inhaler.

Predicate Devices

• Invotec Ear Tampon (Wick) w/String (K973578)
• Nasopore® nasal dressing (K052099)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/2 description: The image shows the words "bioresorbable solution" on the top line, followed by the word "POLYGANICS" on the second line. The third line shows the number "K062540". The text is black and the background is white.

# 510(k) Summary of Safety and Effectiveness

| Submitter: | Polyganics BV<br>L.J. Zielstraweg 1<br>9713 GX, Groningen<br>The Netherlands<br>www.polyganics.com | OCT 18 2006 |
|-----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| Contact Person: | Jan Nieuwenhuis<br>Managing Director<br>Tel : [phone]<br>Fax : [phone]<br>Mobile: [phone]<br>E-mail : [e-mail] | |
| Date Prepared: | August 18th, 2006 | |
| General Provisions: | Trade Name: Nasopore®<br>Common Name: Ear Wick<br>Classification Name: Ear Wick, 21 CFR 874.5220<br>Device Classification: Class I non exempt. | |
| Predicate Devices: | - Invotec Ear Tampon (Wick) w/String; Invotec Internat.; K973578<br>- Nasopore® nasal dressing, Polyganics, K052099 | |
| 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® Ear is a fragmentable ear packing and is indicated for use in pa-tients, undergoing outer ear surgery, as a space occupying stent to separate and prevent adhesions between mucosal surfaces; to help control minimal bleeding, following ear surgery, by tamponade effect and blood absorption. | |

{1}------------------------------------------------

Image /page/1/Picture/2 description: The image shows the words "bioresorbable solution" underlined, followed by the word "POLYGANICS" in large, bold letters. Below that is the number "K062540" in a handwritten style. The text appears to be part of a label or document, possibly related to a medical or scientific product.

- Device De-Nasopore® Ear is composed of a bioresorbable poly(DL-lactide-co-sscription caprolactone) urethane that fragments within several days after insertion in the outer ear, whereafter it is drained from the cavity.
The type of Nasopore® Ear is indicated on the label. Nasopore® Ear is packed in a blister closed by a medical paper lid. Nasopore® Ear is indicated for single-use.

The safety and effectiveness of the Nasopore® have been demonstrated via Performance Data: data collected from design verification tests and analyses. The design verification testing consisted of the following:

- In vitro degradation testing -
- Shelf life testing -

The intended use of Nasopore Ear is substantially equivalent to those fea-Summary of Substantial tured with the competitor device Invotec Ear Tampon (Wick) w/String (ref. Equivalence 510(k)973578). The safety (biocompatibility) and efficacv of Nasopore® Ear is demonstrated by its substantial equivalent Nasopore® Nasal dressing (ref. 510(k)052099; Polyganics BV).

> Polyganics BV already markets Nasopore® Nasal Dressing. The subject device, Nasopore® Ear, is made from the same material as Nasopore® Nasal Dressing. The subject device is substantially equivalent to Nasopore® Nasal Dressing with respect to physical characteristics and with regard to the intended use of the device, i.e. a space occupying stent to separate and prevent adhesions between mucosal surfaces and help control minimal bleeding following surgery, by tamponade effect and blood absorption, Nasopore® Nasal dressing in the nasal/sinus cavities and Nasopore® Ear in the outer ear. The predicate device Nasopore® Nasal Dressing is made of a fragmentable poly(DL-lactide-co-s-caprolactone) urethane and the identical manufacturing process is used to produce the foam. The subject and predicate device are made of poly(DL-lactide-co-s-caprolactone) urethanen, which has demonstrated to be satisfactory biocompatible.

{2}------------------------------------------------

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circle around the eagle. The eagle is composed of three curved lines that form the shape of the bird's body and wings. The text is in all capital letters and is evenly spaced around the circle.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Polyganics BV c/o Jan Nieuwenhuis L.J. Zielstraweg 1 9713 GX, Groningen The Netherlands

Re: K062540

Trade/Device Name: Nasopore® Ear Regulation Number: 21 CFR 874.5220 Regulation Name: ENT Synthetic Polymer Material Regulatory Class: Class I Product Code: KCN Dated: August 21, 2006 Received: August 30, 2006

Dear Mr. Nieuwenhuis:

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 indicetions for use stated in the enclosure) to legally marketed predicate devices market the 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, inc not. devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

OCT 1 8 2006

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 100-1050.

{3}------------------------------------------------

### Page 2 - Mr. Jan Nieuwenhuis

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 yours.

M.B. Eggleton, M.D.

Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

Nasopore® Ear

bioresorbable solution
**POLYGANICS**

### Indications for Use Form

3 143 11 15

510(k) Number:

K062540

Device Name:

Nasopore® Ear

Indications for Use:

Nasopore® Ear is a fragmentable ear packing and is indicated for use in patients, undergoing ear surgery, as a space occupying stent to separate and prevent adhesions between mucosal surfaces, to help control minimal bleeding, following ear surgery, by tamponade effect and blood absorption.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use x (Per 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-2-96)

(Division Sign-Off)

OR

510(k) Number _

Seimus Marden

(Division Sign-Off) Division of Ophthalmic Ea Nose and Throat Devi

510(k) Number

x Prescription Use (Per 21 CFR 801.109)

18 August 2006

Page 8 of 45