NASOPORE EAR

K070715 · Polyganics B.V., · NHB · May 7, 2007 · Ear, Nose, Throat

Device Facts

• Record ID: K070715
• Device Name: NASOPORE EAR
• Applicant: Polyganics B.V.,
• Product Code: NHB · Ear, Nose, Throat
• Decision Date: May 7, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.3620
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

Nasopore® Ear is a bioresorbable, fragmentable ear packing device composed of poly(DL-lactide-co-s-caprolactone) urethane. Used by surgeons in the outer or middle ear following surgery; acts as a space-occupying stent to separate mucosal surfaces and prevent adhesions; provides tamponade effect to control minimal bleeding. Device absorbs blood; fragments within several days post-insertion; fragments exit the body via natural mucus flow or fall out of the ear. Single-use; supplied in a blister pack.

Clinical Evidence

Bench testing only. Evidence includes in vitro degradation testing and shelf-life testing to demonstrate safety and performance. No clinical data provided.

Technological Characteristics

Material: bioresorbable poly(DL-lactide-co-s-caprolactone) urethane foam. Form factor: fragmentable ear packing/dressing. Mechanism: space-occupying stent, tamponade, blood absorption. Sterilization: not specified. Connectivity: none (standalone).

Indications for Use

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

Regulatory Classification

Identification

Ear, nose, and throat synthetic polymer material is a device material that is intended to be implanted for use as a space-occupying substance in the reconstructive surgery of the head and neck. The device is used, for example, in augmentation rhinoplasty and in tissue defect closures in the esophagus. The device is shaped and formed by the suregon to conform to the patient's needs. This generic type of device is made of material such as polyamide mesh or foil and porous polyethylene.

Predicate Devices

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

Reference Devices

• Nasopore® Ear (K062540)

Submission Summary (Full Text)

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Nasopore® Ear

Ko 70715

Traditional 510(k) Premarket Notification

bioresorbable soft
**POLYGANICS**

:

.

| | 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 |
| Contact Person: | Jan Nieuwenhuis<br>Managing Director<br>Tel : [phone]<br>Fax : [phone]<br>Mobile : [phone]<br>E-mail : [e-mail] |
| Date Prepared: | March 07, 2007 |
| | MAY - 7 2007 |
| General Provisions: | Trade Name: Nasopore®<br>Common Name: Fragmentable ear dressing<br>Classification Name: ENT synthetic polymer material<br>21 CFR 874.3620, Class II |
| 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 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. |

·

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Traditional 510(k) Premarket Notification

K070715

Device Nasopore® Ear is composed of a bioresorbable poly(DL-lactide-co-s-Description caprolactone) urethane that fragments within several days after insertion in the outer and / or middle ear, whereafter it will fall out of the ear or leaves the body by the natural mucus flow.

> 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 collected from design verification tests and analyses. The design Data: verification testing consisted of the following:

- In vitro degradation testing -
- Shelf life testing -

The intended use of Nasopore Ear is substantially equivalent to those Summary of featured with the competitor device Invotec Ear Tampon (Wick) w/String (ref. Substantial 510(k)973578). The safety (biocompatibility) and efficacy of Nasopore® Ear Equivalence 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. Next to the Nasopore® nasal dressing, Polyganics also markets Nasopore® Ear (K062540). This product is intended as a packing used after outer ear surgery. However the middle ear possesses a connection to the Eustachian tube, which indicates that the fragments, obtained during fragmentation, can leave the body via the natural mucus flow.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its wing and tail feathers. The eagle is positioned to the right of a circular text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA".

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

MAY - 7 2007

Re: K070715

Trade/Device Name: Polyganics Nasopore® Ear Regulation Number: 21 CFR 874.3620 Regulation Name: ENT Synthetic Polymer Material Regulatory Class: II Product Code: NHB Dated: March 12, 2007 Received: March 14, 2007

Dear Ms. 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 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 – 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. Eickelman SiwD

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

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Nasopore® Ear

Image /page/4/Picture/2 description: The image shows the words "bioresorbable solution" and "POLYGANICS". Above these words is the text "K070715" in a handwritten style. The words "bioresorbable solution" are in a smaller font size than the word "POLYGANICS".

## Indications for Use Form

510(k) Number:

K070915

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.

(PLEASE 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***_***_

Division Sign-Off)
Division of Ophthalmic Ear,
Nose and Throat Devises

510(k) Numbe 07 March 2007

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