NASOPORE-FD

K141423 · Polyganics B.V., · LYA · Aug 7, 2014 · Ear, Nose, Throat

Device Facts

• Record ID: K141423
• Device Name: NASOPORE-FD
• Applicant: Polyganics B.V.,
• Product Code: LYA · Ear, Nose, Throat
• Decision Date: Aug 7, 2014
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 874.4780
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

NASOPORE ® FD 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 FD is a bioresorbable, fragmentable nasal dressing; composed of poly(DL-lactide-co-s-caprolactone) urethane blended with PEG 20,000 and D&C Green color additive. Device functions as a space-occupying stent in the nasal cavity; provides tamponade effect and blood absorption to control minimal bleeding; prevents adhesions between mucosal surfaces post-surgery or trauma. Fragments within 48 hours in saline at 37°C; fragments are subsequently cleared via natural mucus flow. Used in clinical settings by physicians; supplied sterile in single-use blister packs. Benefits include reduced need for manual removal of packing due to bioresorbable fragmentation properties.

Clinical Evidence

Bench testing only. In vitro studies compared fragmentation time, shape integrity, compressive strength, porosity, intrinsic viscosity, and biocompatibility (ISO 10993) against the predicate. Results confirmed the new device performs equivalently to the cleared predicate.

Technological Characteristics

Bioresorbable poly(DL-lactide-co-s-caprolactone) urethane foam; blended with PEG 20,000 and D&C Green. Dimensions: 8cm. Sterilization: EtO (ISO 11135-1). Biocompatibility: ISO 10993 compliant. Packaging: Blister pack, aluminum pouch, silica gel. Shelf-life: 6 months (interim).

Indications for Use

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

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

• Nasopore Polyganics BV (K052099)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, stacked on top of each other. The profiles are rendered in a single, continuous line. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA".

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

August 7, 2014

Ms. Betty Ijmker Manager OA/RA c/o Polyganics Bv Rozenburglaan 15A GRONINGEN, NL 9727-DL

Re: K141423

Trade/Device Name: Nasopore-fd Regulation Number: 21 CFR 874.4780 Regulation Name: Intranasal Splint Regulatory Class: Class I Product Code: LYA Dated: July 8, 2014 Received: July 14, 2014

Dear Ms. Ijmker:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

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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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

## Eric A. Mann -S

for 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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## Indications for Use Statement

| 510(k) Number | K |
|---------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | NASOPORE ^® FD nasal dressing |
| Indications for Use | NASOPORE ^® FD 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. |

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)

OR

Over The Counter Use__________________________________________________________________________________________________________________________________________________________

Image /page/2/Picture/8 description: The image contains the name "Vasant G. Malshet-S" in a simple, sans-serif font. The text is arranged in two lines, with "Vasant G." on the top line and "Malshet-S" on the bottom line. In the background, there is a faded, stylized logo that appears to be a triangle with the letters "FDA" inside.

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## Special 510(k) Summary of Safety and Effectiveness Line extension to NASOPORE nasal dressing

| Submitter: | Polyganics BV<br>Rozenburglaan 15A<br>9727 DL Groningen<br>The Netherlands<br><a href="www.polyganics.com">www.polyganics.com</a> | | | | | | | | | | | | |
|-----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|-----------------------------------------|--------------|----------------|----------------------|-------------------|-------------------|---------|--------------|---------------|---------------|-----|
| Contact Person: | Betty IJmker<br>Manager QA/RA | | | | | | | | | | | | |
| Tel | : [phone] | | | | | | | | | | | | |
| Fax | : [phone] | | | | | | | | | | | | |
| E-mail | : <a href="mailto:[e-mail]">[e-mail]</a> | | | | | | | | | | | | |
| Date Prepared: | 27 May 2014 | | | | | | | | | | | | |
| General Provisions: | | | | | | | | | | | | | |
| | <table><tr><td>Trade Name:</td><td>NASOPORE^® FD Nasal Dressing</td></tr><tr><td>Common Name:</td><td>Nasal Dressing</td></tr><tr><td>Classification Name:</td><td>Intranasal splint</td></tr><tr><td>Regulatory class:</td><td>Class I</td></tr><tr><td>Regulation #</td><td>21CFR874.4780</td></tr><tr><td>Product code:</td><td>LYA</td></tr></table> | Trade Name: | NASOPORE ^® FD Nasal Dressing | Common Name: | Nasal Dressing | Classification Name: | Intranasal splint | Regulatory class: | Class I | Regulation # | 21CFR874.4780 | Product code: | LYA |
| Trade Name: | NASOPORE ^® FD Nasal Dressing | | | | | | | | | | | | |
| Common Name: | Nasal Dressing | | | | | | | | | | | | |
| Classification Name: | Intranasal splint | | | | | | | | | | | | |
| Regulatory class: | Class I | | | | | | | | | | | | |
| Regulation # | 21CFR874.4780 | | | | | | | | | | | | |
| Product code: | LYA | | | | | | | | | | | | |
| Predicate Device: | Nasopore Polyganics BV K052099 | | | | | | | | | | | | |
| Performance Standards | For the performance of intranasal splints, the FDA, under section 514 of the Food, Drug and Cosmetic Act, has not established standards. | | | | | | | | | | | | |
| Indications for Use | NASOPORE ^® FD 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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- NASOPORE "FD is composed of a bioresorbable poly(DL-lactide-co-s-Device Description caprolactone) 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® FD size and type are indicated on the label and are packed in a blister. NASOPORE "FD is indicated for single-use.

The modification in this submission concerns a line extension to the predicate device NASOPORE "with a NASOPORE" FD that fragments faster than the cleared predicate device.

- Performance Data: In vitro testing for this line extension demonstrated that the technological characteristics and performance criteria of the additional NASOPORE type are comparable to the currently cleared NASOPORE nasal dressing and that they can perform in a manner equivalent to NASOPORE devices currently on the market for the same intended use. The results of the in vitro testing are summarized below:

| Properties | Method | Current<br>NASOPORE® | New NASOPORE FD |
|--------------------------------------------------------|----------------------------------------|----------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------|
| Shape integrity<br>(shape intact in<br>saline at 37°C) | Visual | >36 hour(in Saline) | >36 hour (in Saline) |
| Fragmentation time<br>(In saline at 37°C) | Fragmentation<br>test | 96hours | 48 hours |
| Compression | Compressive<br>strength<br>measurement | >3 kPa (Firm) | >3 kPa |
| Porosity | Porosity<br>measurement | 95-98 % | 95-98 % |
| Color | Visual | Off-white | Blue/Green |
| IV (intrinsic<br>viscosity) | IV measurement | IV ≥ 0.8 dl/g | IV ≥ 0.8 dl/g |
| Biocompatibility | ISO 10993 | Biocompatible:<br>Non-cytotoxic<br>Non-irritating<br>(intracutaneous and<br>oral)<br>Non-sensitive | Biocompatible:<br>Non-cytotoxic<br>Non-irritating<br>(intracutaneous and<br>oral)<br>Non-sensitive |
| Sterility | ISO11135-1 | SAL 10-6 (half cycle<br>validation) | SAL 10-6 (rationale,<br>identical blister pack<br>and density) |
| EtO Residuals | ISO10993-7 | < 2 mg/device | < 2 mg/device |
| Composition | In process<br>verification | Conform<br>Polyurethane<br>specification | Conform<br>Polyurethane<br>specification<br>additionally blended<br>with with PEG20.000<br>and D&C Green |
| Package integrity | ISO11607 | Qualified, Sterilized<br>blisterpack | Qualified, Sterilized<br>blisterpack |
| Shelf-life | ASTM F1980:<br>Real time aging | 18 months | 6 months (interim<br>results) |

Table 1: Summary of bench testing

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## Summary of Substantial Equivalence

The design, materials, fundamental technology and intended use (safety and effectiveness) featured with the NASOPORE® FD Nasal Dressing are substantially equivalent to those featured with the following cleared device: Nasopore nasal dressing (K052099; Polyganics BV). The basis for equivalence is demonstrated by the comparisons in the following table:

| | NASOPORE® FD (this<br>submission) | CURRENT NASOPORE®<br>(K052099) |
|---------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended use | NASOPORE® is a fragmentable<br>nasal dressing and is indicated<br>for use in patients undergoing<br>nasal/sinus surgery as a space<br>occupying stent to separate<br>and prevent adhesions<br>between mucosal surfaces; to<br>help control minimal bleeding<br>following surgery or nasal<br>trauma by tamponade effect<br>and blood absorption. | NASOPORE® is a fragmentable<br>nasal dressing and is indicated<br>for use in patients undergoing<br>nasal/sinus surgery as a space<br>occupying stent to separate<br>and prevent adhesions<br>between mucosal surfaces; to<br>help control minimal bleeding<br>following surgery or nasal<br>trauma by tamponade effect<br>and blood absorption. |
| Materials | poly(urethane) blended with a<br>color additive and PEG20.000 | poly(urethane) |
| Design | Foam | Foam |
| Sizes | 8cm | 4 and 8 cm |
| Sterilization | EtO | EtO |
| Shelf-life | 6 months (interim result) | 18 months |
| Packaging | Single use, blister, aluminium<br>pouch and silica gel,<br>cardboard box | Single use, blister, cardboard<br>box |

Differences between the devices do not raise any significant issues of safety and effectiveness.