NOVASHIELD INJECTABLE NASAL PACKING AND STENT

• K Number: K141704
• Device Name: NOVASHIELD INJECTABLE NASAL PACKING AND STENT
• Manufacturer: MEDTRONIC INC.
• Date Cleared: 2014-10-06 ( 104 days)
• Product Code: LYA
• Regulation Number: 874.4780
• Type: Traditional
• Panel: Ear Nose & Throat
• Reference & Predicate Devices: K120958 , K113585
• Predicate For: K172179

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 aqgreqation
• . Act as an adjunct to aid in the natural healing process

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

Device Description

NovaShield™ is a single use, injectable nasal packing and stent for use following sinus surgery to prevent adhesions, control mild bleeding and provide a level of antibacterial effectiveness. NovaShield™ is composed of formulated chitosan and cellulose ingredients in a fully mixed and hydrated gel form provided in a prefilled delivery system. The syringe delivery system conveys the gel to the patient via an accordion cannula that can be manipulated to assist with the gel application. NovaShield™ is eliminated via hydrolysis and gentle irrigation using saline or water in approximately 7-14 days.

NovaShield™ is intended for use in patients undergoing sinus surgery as a space occupying packing to separate tissue or structures compromised by surgical trauma. NovaShield™ is designed to separate tissue and prevent adhesions between mucosal surfaces during healing in the nasal cavity and for the treatment of mild bleeding from topical surgical wounds and nosebleeds. NovaShield™ may be used for the local management of wounds that are prone to bleeding such as wounds that have been surgically or mechanically debrided and for the management of surgical or traumatic wounds which have been left to heal by secondary intention. NovaShield™ also has been shown in laboratory studies to provide a level of antibacterial activity.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the NovaShield™ Injectable Nasal Packing and Stent. This type of regulatory submission typically focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting extensive clinical studies with specific acceptance criteria for performance metrics like sensitivity, specificity, or reader studies for AI devices.

Therefore, the requested information regarding acceptance criteria, study details (like sample size, ground truth, expert qualifications), MRMC studies, or standalone algorithm performance, as typically found for AI/ML medical devices, is not applicable in this context. The NovaShield™ device is a physical medical device (nasal packing and stent), not an AI/ML diagnostic or prognostic tool.

Here's a breakdown based on the provided document:

1. Table of acceptance criteria and the reported device performance:

This device does not have acceptance criteria in the typical sense of sensitivity, specificity, or other performance metrics usually reported for diagnostic devices or AI solutions. The "acceptance criteria" here are implicitly linked to demonstrating substantial equivalence to predicate devices for its intended use through various tests.

• Acceptance Criteria (Implicit): The device must perform comparably to predicate devices in terms of its intended use functions and safety.
• Reported Device Performance:
  • Acts as a space-occupying packing to separate tissue/structures and prevent adhesions.
  • Controls minimal bleeding by tamponade effect, blood absorption, and platelet aggregation.
  • Acts as an adjunct to aid in the natural healing process.
  • Treats epistaxis.
  • Demonstrates antibacterial activity against various specified bacterial strains (in vitro only, not correlated to clinical effectiveness).

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

• Sample Size: Not explicitly stated in terms of patient numbers or a test set as for a clinical trial for performance metrics. Performance testing involved "bench and animal testing."
• Data Provenance: Not specified, but likely laboratory-based (bench testing) and animal studies.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

• Not Applicable. This is not a study requiring expert consensus or ground truth establishment in the context of diagnostic interpretation. The "ground truth" for this device would be its physical and biological performance in animal models and in vitro tests, validated by standard scientific methods and potentially surgical outcomes.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Not Applicable. This is not a study requiring adjudication of expert opinions for a test set.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• Not Applicable. This is not an AI device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• Not Applicable. This is not an AI device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

• The "ground truth" for this device's performance would be established through physical/material testing (bench testing), in vitro biological assays (antibacterial activity), and in vivo animal studies. For example, for antibacterial activity, the ground truth is the measured reduction in bacterial growth under controlled laboratory conditions. For prevention of adhesions or control of bleeding, it would be observed outcomes in animal models.

8. The sample size for the training set:

• Not Applicable. This is not an AI device, so there is no "training set."

9. How the ground truth for the training set was established:

• Not Applicable. No training set for an AI algorithm.

In summary: The provided document is a 510(k) clearance letter for a physical medical device. The focus of such submissions is on demonstrating substantial equivalence to existing devices through a combination of performance testing (bench and animal), material characterization, and safety data, rather than clinical trials with specific diagnostic performance metrics typically seen in AI/ML device submissions.

Summary

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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®6743 Southpoint Drive NorthJacksonville, Florida 32216
Contact Person:	Rishi SinhaPrincipal Regulatory Affairs SpecialistPhone: [phone]Fax: [phone]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 DressingsK113585 – Nasal/Epistaxis Pack
Device Description:	NovaShield™ is a single use, injectable nasal packing and stent for usefollowing sinus surgery to prevent adhesions, control mild bleeding andprovide a level of antibacterial effectiveness. NovaShield™ is composedof formulated chitosan and cellulose ingredients in a fully mixed andhydrated gel form provided in a prefilled delivery system. The syringedelivery system conveys the gel to the patient via an accordion cannulathat can be manipulated to assist with the gel application. NovaShield™is eliminated via hydrolysis and gentle irrigation using saline or water inapproximately 7-14 days.NovaShield™ is intended for use in patients undergoing sinus surgery asa space occupying packing to separate tissue or structures compromisedby surgical trauma. NovaShield™ is designed to separate tissue andprevent adhesions between mucosal surfaces during healing in the nasalcavity and for the treatment of mild bleeding from topical surgical woundsand nosebleeds. NovaShield™ may be used for the local managementof wounds that are prone to bleeding such as wounds that have beensurgically or mechanically debrided and for the management of surgicalor traumatic wounds which have been left to heal by secondary intention.NovaShield™ also has been shown in laboratory studies to provide alevel of antibacterial activity.
Indications for Use:	NovaShield™ is indicated for use in patients undergoingnasal/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.

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Substantial Equivalence:	NovaShield™ is substantially equivalent to the following devices:• Hemostasis® PosiSep and PosiSep X Hemostat Dressings (K120958)• CogENT® Nasal/Epistaxis Pack (K113585)
Performance Testing:	Performance testing was conducted on the NovaShield™ device toensure the product meets all of the intended design inputs. Bench andanimal testing conducted on NovaShield™ demonstrates the productwill perform as intended.
Antibacterial Information:	The antibacterial effectiveness of NovaShield™ was tested against thefollowing bacterial strains. The table below outlines the timeframe inwhich NovaShield™ demonstrated antibacterial activity to the testedbacterial strain. Note: In vitro efficacy is not correlated to clinicaleffectiveness.
	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		✓

Regulation Number and Section

§ 874.4780 Intranasal splint.

(a)
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.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 874.9.