(104 days)
Not Found
No
The device description focuses on the material composition and mechanical function of the nasal packing, with no mention of AI or ML technologies.
Yes
The device is indicated for use in patients undergoing nasal/sinus surgery to separate tissue, prevent adhesions, control bleeding, and aid in healing, as well as to treat epistaxis. These actions are therapeutic interventions.
No
The device description indicates that NovaShield™ is used to separate tissues, prevent adhesions, control bleeding, and aid in healing after nasal/sinus surgery or for epistaxis. These are therapeutic and supportive functions, not diagnostic ones. There is no mention of the device being used to identify or analyze medical conditions.
No
The device description clearly states it is a "single use, injectable nasal packing and stent" composed of "formulated chitosan and cellulose ingredients in a fully mixed and hydrated gel form provided in a prefilled delivery system." This describes a physical, material-based device, not software.
Based on the provided information, this device is NOT an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as a nasal packing and stent used in patients undergoing nasal/sinus surgery for purposes like separating tissue, preventing adhesions, controlling bleeding, and aiding healing. It is also indicated for treating epistaxis (nosebleeds). These are all therapeutic or supportive functions performed directly on or within the patient's body.
- Device Description: The description reinforces its use as an injectable nasal packing and stent composed of materials that are placed within the nasal cavity. It describes its physical form (gel), delivery system (syringe), and how it is eliminated (hydrolysis and irrigation). Again, this points to a device used in vivo.
- Lack of IVD Characteristics: An IVD device is used in vitro (outside the body) to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnostic, monitoring, or compatibility purposes. The provided text does not mention any of these activities. There is no mention of analyzing patient samples or providing diagnostic information based on such analysis.
In summary, NovaShield™ is a medical device used therapeutically and supportively within the patient's body, not an IVD used to analyze samples outside the body for diagnostic purposes.
N/A
Intended 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.
Product codes (comma separated list FDA assigned to the subject device)
LYA
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Nasal cavity, nasal/sinus
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance testing was conducted on the NovaShield™ device to ensure the product meets all of the intended design inputs. Bench and animal testing conducted on NovaShield™ demonstrates the product will perform as intended.
The antibacterial effectiveness of NovaShield™ was tested against the following bacterial strains. The table below outlines the timeframe in which NovaShield™ demonstrated antibacterial activity to the tested bacterial strain. Note: In vitro efficacy is not correlated to clinical effectiveness.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines connecting them. The logo is black and white.
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.
1
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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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
2
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)
3
510(k) Summary
| Submitter: | Medtronic® Xomed®
6743 Southpoint Drive North
Jacksonville, Florida 32216 |
|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Rishi Sinha
Principal Regulatory Affairs Specialist
Phone: (269) 903-4373
Fax: (269) 353-5924
E-mail: rishi.k.sinha@medtronic.com |
| 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
K113585 – Nasal/Epistaxis Pack |
| 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. |
| 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 aggregation. Act as an adjunct to aid in the natural healing process. NovaShield™ is indicated for use as a nasal packing to treat epistaxis. |
4
| 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 to
ensure the product meets all of the intended design inputs. Bench and
animal testing conducted on NovaShield™ demonstrates the product
will perform as intended. | | | | | |
| Antibacterial Information: | The antibacterial effectiveness of NovaShield™ was tested against the
following bacterial strains. The table below outlines the timeframe in
which NovaShield™ demonstrated antibacterial activity to the tested
bacterial strain. Note: In vitro efficacy is not correlated to clinical
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 | ✓ |