NOVASHIELD INJECTABLE NASAL PACKING AND STENT

K141704 · Medtronic, Inc. · LYA · Oct 6, 2014 · Ear, Nose, Throat

Device Facts

• Record ID: K141704
• Device Name: NOVASHIELD INJECTABLE NASAL PACKING AND STENT
• Applicant: Medtronic, Inc.
• Product Code: LYA · Ear, Nose, Throat
• Decision Date: Oct 6, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.4780
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

NovaShield™ is indicated for use in patients undergoing nasal/sinus surgery as a space occupying packing to: Separate tissue or structures compromised by surgical trauma; Separate and prevent adhesions between mucosal surfaces in the nasal cavity; Control minimal bleeding following surgery or trauma by tamponade effect, blood absorption and platelet aggregation; Act as an adjunct to aid in the natural healing process. NovaShield™ is indicated for use as a nasal packing to treat epistaxis.

Device Story

NovaShield is a single-use, injectable nasal packing and stent; composed of formulated chitosan and cellulose in a hydrated gel form. Delivered via prefilled syringe with an accordion cannula for application. Used in clinical settings following sinus surgery or for epistaxis treatment. Acts as a physical barrier to separate mucosal surfaces; prevents adhesions; provides tamponade for bleeding control. Eliminated via hydrolysis and gentle saline/water irrigation within 7-14 days. Provides local wound management for surgically/mechanically debrided wounds or wounds healing by secondary intention. Benefits include reduced adhesion formation and bleeding control.

Clinical Evidence

No clinical data. Evidence consists of bench testing and animal testing to demonstrate performance and intended use. In vitro antibacterial efficacy testing was performed against various bacterial strains (e.g., P. aeruginosa, S. aureus, MRSA) over 24 hours to 7 days; however, the document notes that in vitro efficacy is not correlated to clinical effectiveness.

Technological Characteristics

Materials: Chitosan and cellulose. Form: Hydrated gel in prefilled syringe with accordion cannula. Mechanism: Space-occupying physical barrier, tamponade, blood absorption, platelet aggregation. Elimination: Hydrolysis and irrigation. Single-use. Non-electronic.

Indications for Use

Indicated for patients undergoing nasal/sinus surgery or experiencing epistaxis. Used as space-occupying packing to separate traumatized tissue, prevent mucosal adhesions, control minimal bleeding via tamponade/absorption/platelet aggregation, and aid healing.

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

• PosiSep® and PosiSep® X Hemostat Dressings (K120958)
• Nasal/Epistaxis Pack (K113585)

Submission Summary (Full Text)

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

October 6, 2014

Medtronic, Inc. % Ms. Rishi Sinha Principal Regulatory Affairs Specialist 6743 Southpoint Drive North Jacksonville, FL 32259

Re: K141704

> Trade/Device Name: Novashield Injectable Nasal Packing And Stent Regulation Number: 21 CFR 21 CFR 874.4780 Regulation Name: Intranasal Splint Regulatory Class: Class I Product Code: LYA Dated: June 24, 2014 Received: June 25, 2014

Dear Ms. Sinha,

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 devicerelated 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" (21 CFR 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

## Indications for Use:

NovaShield "" is indicated for use in patients undergoing nasal/sinus surgery as a space occupying packing to:

- . Separate tissue or structures compromised by surgical trauma;
- Separate and prevent adhesions between mucosal surfaces in the nasal cavity; .
- . Control minimal bleeding following surgery or trauma by tamponade effect, blood absorption and platelet aqgreqation
- . Act as an adjunct to aid in the natural healing process

NovaShield™ is indicated for use as a nasal packing to treat epistaxis.

Prescription Use X (Per 21 CFR 801 Subpart D) AND/OR

Over-the-Counter Use (Per 21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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## 510(k) Summary

| Submitter: | Medtronic® Xomed®<br>6743 Southpoint Drive North<br>Jacksonville, Florida 32216 |
|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Rishi Sinha<br>Principal Regulatory Affairs Specialist<br>Phone: [phone]<br>Fax: [phone]<br>E-mail: [e-mail] |
| Date Summary Prepared: | September 3rd, 2014 |
| Device Trade Name: | NovaShield™ Injectable Nasal Packing and Stent |
| Common Name: | Intranasal Packing and Stent, Intranasal Splint |
| Classification Name: | Intranasal Stent |
| Predicate Device: | K120958 – PosiSep® and PosiSep® X Hemostat Dressings<br>K113585 – Nasal/Epistaxis Pack |
| Device Description: | NovaShield™ is a single use, injectable nasal packing and stent for use<br>following sinus surgery to prevent adhesions, control mild bleeding and<br>provide a level of antibacterial effectiveness. NovaShield™ is composed<br>of formulated chitosan and cellulose ingredients in a fully mixed and<br>hydrated gel form provided in a prefilled delivery system. The syringe<br>delivery system conveys the gel to the patient via an accordion cannula<br>that can be manipulated to assist with the gel application. NovaShield™<br>is eliminated via hydrolysis and gentle irrigation using saline or water in<br>approximately 7-14 days.<br><br>NovaShield™ is intended for use in patients undergoing sinus surgery as<br>a space occupying packing to separate tissue or structures compromised<br>by surgical trauma. NovaShield™ is designed to separate tissue and<br>prevent adhesions between mucosal surfaces during healing in the nasal<br>cavity and for the treatment of mild bleeding from topical surgical wounds<br>and nosebleeds. NovaShield™ may be used for the local management<br>of wounds that are prone to bleeding such as wounds that have been<br>surgically or mechanically debrided and for the management of surgical<br>or traumatic wounds which have been left to heal by secondary intention.<br>NovaShield™ also has been shown in laboratory studies to provide a<br>level of antibacterial activity. |
| Indications for Use: | NovaShield™ is indicated for use in patients undergoing<br>nasal/sinus surgery as a space occupying packing to:<br>Separate tissue or structures compromised by surgical trauma. Separate and prevent adhesions between mucosal surfaces in the nasal cavity. Control minimal bleeding following surgery or trauma by tamponade effect, blood absorption and platelet aggregation. Act as an adjunct to aid in the natural healing process. NovaShield™ is indicated for use as a nasal packing to treat epistaxis. |

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| Substantial Equivalence: | NovaShield™ is substantially equivalent to the following devices:<br>• Hemostasis® PosiSep and PosiSep X Hemostat Dressings (K120958)<br>• CogENT® Nasal/Epistaxis Pack (K113585) | | | | | |
|----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|----------|--------|--------|--|
| Performance Testing: | Performance testing was conducted on the NovaShield™ device to<br>ensure the product meets all of the intended design inputs. Bench and<br>animal testing conducted on NovaShield™ demonstrates the product<br>will perform as intended. | | | | | |
| Antibacterial Information: | The antibacterial effectiveness of NovaShield™ was tested against the<br>following bacterial strains. The table below outlines the timeframe in<br>which NovaShield™ demonstrated antibacterial activity to the tested<br>bacterial strain. Note: In vitro efficacy is not correlated to clinical<br>effectiveness. | | | | | |
| | Bacterial Strain | ATCC # | 24 hours | 3 days | 7 days | |
| | Pseudomonas aeruginosa | 9027 | ✓ | ✓ | ✓ | |
| | Staphylococcus aureus | 25923 | | ✓ | ✓ | |

| Bacterial Strain | ATCC # | 24 hours | 3 days | 7 days |
|------------------------------------|--------|----------|--------|--------|
| Pseudomonas aeruginosa | 9027 | ✓ | ✓ | ✓ |
| Staphylococcus aureus | 25923 | | ✓ | ✓ |
| Staphylococcus epidermidis | 12228 | ✓ | ✓ | ✓ |
| Echerichia coli | 25922 | | | ✓ |
| Citrobacter freundii | 8090 | ✓ | ✓ | ✓ |
| Enterobacter aerogenes | 13048 | | | ✓ |
| Klebsiella pneumonia | 4352 | ✓ | ✓ | ✓ |
| Proteus mirabilis | 4630 | | ✓ | ✓ |
| Serratia marcescens | 13880 | | | ✓ |
| Haemophilus influenzae | 53782 | ✓ | ✓ | ✓ |
| Moraxella catarrhalis | 8193 | | ✓ | ✓ |
| Staphylococcus aureus(MRSA) | 33591 | | | ✓ |
| Staphylococcus saprophyticus | 15305 | ✓ | ✓ | ✓ |
| Micrococcus luteus | 49732 | | ✓ | ✓ |
| Streptococcus mutans | 25175 | | ✓ | ✓ |
| Streptococcus pneumoniae | 10015 | | | ✓ |
| Corynebacterium diphtheriae | 296 | | ✓ | |
| Corynebacterium tuberculostearicum | 35693 | | ✓ | |