(90 days)
Not Found
No
The device description and performance studies focus on the physical and chemical properties of a biodegradable gel used as a nasal packing. There is no mention of AI, ML, image processing, or data analysis that would indicate the use of such technologies.
Yes
The device is used to treat medical conditions, specifically by providing a space-occupying packing to separate tissues, prevent adhesions, control bleeding, and aid in healing after nasal/sinus surgery, and to treat epistaxis. These are direct therapeutic actions.
No
Explanation: The device is indicated for use as a space-occupying packing, for separating tissue, preventing adhesions, controlling bleeding, and aiding in healing following nasal/sinus surgery, and for treating epistaxis. These are therapeutic and supportive functions, not diagnostic ones.
No
The device description clearly lists multiple physical components including vials, syringes, connectors, and cannulae, which are hardware.
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 physical packing material used during and after nasal/sinus surgery. It acts as a space-occupying packing, separates tissues, prevents adhesions, controls bleeding, and aids in healing. These are all physical or mechanical functions performed in vivo (within the body).
- Device Description: The device description details the components that are mixed to form a gel and then applied to the target area in vivo. It's a physical material applied to a surgical site.
- Lack of Diagnostic Purpose: There is no mention of the device being used to analyze samples from the body (like blood, urine, tissue, etc.) to provide diagnostic information about a patient's health status. IVDs are specifically designed for in vitro examination of specimens.
Therefore, the Chitogel Endoscopic Sinus Surgery Kit is a medical device used for therapeutic and supportive purposes in vivo, not an IVD.
N/A
Intended Use / Indications for Use
The Chitogel Endoscopic Sinus Surgery Kit 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 and minimize ostial stenosis following endoscopic sinus surgery
- 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
The Chitogel Endoscopic Sinus Surgery Kit is indicated for use as a nasal packing to treat epistaxis.
Product codes
LYA
Device Description
The Chitogel Endoscopic Sinus Surgery Kit consists of the following components:
- Sealed vial containing 300mg Dextran Aldehyde Powder
- Sealed vial containing 10ml Sodium Phosphate Buffer Solution
- Sealed vial containing 10ml Chitosan Succinaamide Solution
- 12cc control syringe
- Fluid dispensing connector
- Two (2) mixing cannulae
- Malleable cannula
The Chitogel Endoscopic Sinus Surgery Kit is used during nasal surgery. The components in the Chitogel Kit are mixed by the physician using the syringe and cannulae provided. The pre-measured components mix to form the biodegradable gel. Once the components are mixed and create the gel, the physician applies the gel to the target area using the malleable cannula and thereby creating a nasal packing.
All components are provide sterile and are for single use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Nasal cavity, sinus cavities
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physician
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)
Animal Testing:
The product was used per the product IFU - the individual components were mixed together forming the gel, the gel was injected into the sinus cavity via the nasal passage, the gel maintained its position in the sinus cavity and the gel was degraded over time using saline irrigation. The simulated use of the Chitogel product in an animal model showed it could be combined into a gel, introduced into the sinus cavities, maintained position after introduction and degraded over time using saline irrigation. No adverse events were observed.
Journal articles (animal study):
Athanasiadis, T, Beule, B, Robinson, B, Robinson, S, Shi, Z, Wormald, PJ; Effects of a Novel Chitosan Gel on Mucosal Wound Healing Following Endoscopic Sinus Surgery in a Sheep Model of Chronic Rhinosinusitis. The Laryngoscope 118: June 2008
Clinical Experience:
Several clinical studies involving the Chitogel product were completed. These randomized controlled studies were reported in published peer reviewed articles in scientific journals. The product was used per the product IFU and exhibited performance consistent with the indications for use. The Chitogel product was mixed into a gel and introduced into the sinus cavities via a cannula. Once in place, the following clinical observations were documented:
- The gel separated tissue or structures following surgery
- The gel separated and prevented adhesions between mucosal surfaces in the nasal cavity and minimized ostial stenosis following endoscopic sinus surgery
- The gel controlled minimal bleeding following surgery by a tamponade effect, blood absorption and platelet aggregation
- The gel acted as an adjunct to aid in the natural healing process
These observations were confirmed in the studies and submitted to and/or published in peer reviewed journals.
Journal articles (clinical studies):
Ha, T., Valentine, R., Moratti, S., Robinson, L., Wormald, PJ. A blinded randomized controlled trial evaluating the efficacy of Chitosan gel on ostial stenosis following endoscopic sinus surgery. Submitted to International Forum of Allergy & Rhinology (IFAR)
Valentine, R., Athanasiadis, T., Moratti, S., Hanton, L., Robinson, S., Workald, PJ. The efficacy of a novel chitosun gel on hemostatsis and wound healing after endoscopic sinus surgery. American Journal of Allergy & Rhinology, January-February 2010 Vol.24 No. 1
Ha, T., Valentine, R., Moratti, S., Hanton, L., Robinson, S., Wormald, PJ. The efficacy of a novel budesonide chitosan gel on wound healing following endoscopic sinus surgery. Submitted to International Forum of Allergy & Rhinology (IFAR)
Non-Clinical Testing:
Testing was conducted on sterile final product. Product testing followed the appropriate standards and guidance documents, with appropriate modifications following risk assessment. Testing plans were based upon FDA guidance documents and international standards. Testing was performed on baseline (non-aged) and aged products. Testing included:
- viscosity
- gel time
- delivery of gel
- biodegradation
- packaging
All samples passed testing and met the acceptance criteria of the specification.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or clothing.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 17, 2017
Chitogel, Ltd. % Gregory Mathison President Regulatory Strategies. Inc. 3924 Cascade Beach Road Lutsen, MN 55612
Re: K172179 Trade/Device Name: Chitogel Endoscopic Sinus Surgery Kit Regulation Number: 21 CFR 874.4780 Regulation Name: Intranasal Splint Regulatory Class: Class I Product Code: LYA Dated: July 10, 2017 Received: July 19, 2017
Dear Gregory Mathison:
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
510(k) Number (if known) K172179
Device Name
Chitogel Endoscopic Sinus Surgery Kit
| Indications for Use (Describe) | |
|---|---|
| -------------------------------- | -- |
The Chitogel Endoscopic Sinus Surgery Kit 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 and minimize ostial stenosis following endoscopic sinus surgery
-
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
The Chitogel Endoscopic Sinus Surgery Kit is indicated for use as a nasal packing to treat epistaxis.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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3
510(k) Summary - K172179
This 510(k) summary information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
General Information
| Applicant: | Chitogel Ltd 139
Moray Place
Dunedin, 9016, New Zealand Tel: +64
21 969 149 |
|------------------------|--------------------------------------------------------------------------------------|
| Trade Name: | Chitogel Endoscopic Sinus Surgery Kit |
| Common Name: | Nasal packing |
| Classification Name: | Intranasal splint |
| Number: | 21 CFR §874.4780 |
| Device Classification: | Class I |
| Product Code: | LYA |
| Predicate Devices: | Novashield Injectable Nasal Packing and Stent
(K141704) |
| Contact | Gregory Mathison
US Agent
T: 218.387.1559
E: gmathison@att.net |
| Date: | October 8, 2017 |
Substantially Equivalent to:
The Chitogel Endoscopic Sinus Surgery Kit is equivalent in intended use, principal of operation and technological characteristics to the Novashield Injectable Nasal Packing and Stent (K141704).
Description of the device subject to premarket notification
The Chitogel Endoscopic Sinus Surgery Kit consists of the following components:
4
- Sealed vial containing 300mg Dextran Aldehyde Powder ●
- Sealed vial containing 10ml Sodium Phosphate Buffer Solution ●
- Sealed vial containing 10ml Chitosan Succinaamide Solution ●
- 12cc control syringe
- Fluid dispensing connector
- Two (2) mixing cannulae
- Malleable cannula ●
The Chitogel Endoscopic Sinus Surgery Kit is used during nasal surgery. The components in the Chitogel Kit are mixed by the physician using the syringe and cannulae provided. The pre- measured components mix to form the biodegradable gel. Once the components are mixed and create the gel, the physician applies the gel to the target area using the malleable cannula and thereby creating a nasal packing.
All components are provide sterile and are for single use only.
Indications for Use
The Chitogel Endoscopic Sinus Surgery Kit 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 and minimize ostial stenosis following endoscopic sinus surgery
- · 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
The Chitogel Endoscopic Sinus Surgery Kit is indicated for use as a nasal packing to treat epistaxis.
Materials
The Chitogel Endoscopic Sinus Surgery Kit consists of well-known and commonly used materials. All materials are purchased from reputable vendors. Testing included the following:
- Cytotoxicity
- . Sensitization
- Acute Systemic Toxicity ●
Animal Testing
Animal testing was conducted to assess the simulated clinical performance of the Chitogel Endoscopic Sinus Surgery Kit. The product was used per the product IFU - the individual components were mixed together forming the gel, the gel was injected into the sinus cavity via the nasal passage, the gel maintained its position in the sinus cavity and the gel was removed using saline irrigation. The simulated use of the Chitogel product in an animal model showed it could be combined into a gel, introduced into the sinus cavities, maintained position after introduction and degraded over time using saline irrigation. No adverse events were observed.
5
Journal articles:
Athanasiadis, T, Beule, B, Robinson, B, Robinson, S, Shi, Z, Wormald, PJ; Effects of a Novel Chitosan Gel on Mucosal Wound Healing Following Endoscopic Sinus Surgery in a Sheep Model of Chronic Rhinosinusitis. The Laryngoscope 118: June 2008
Clinical Experience
Several clinical studies involving the Chitogel product were completed. These randomized controlled studies were reported in published peer reviewed articles in scientific journals. The product was used per the product IFU and exhibited performance consistent with the indications for use. The Chitogel product was mixed into a gel and introduced into the sinus cavities via a cannula. Once in place, the following clinical observations were documented:
- · The gel separated tissue or structures following surgery
- The gel separated and prevented adhesions between mucosal surfaces in the nasal cavity and minimized ostial stenosis following endoscopic sinus surgery
- The gel controlled minimal bleeding following surgery by a tamponade effect, blood absorption and platelet aggregation
- · The gel acted as an adjunct to aid in the natural healing process
These observations were confirmed in the studies and submitted to and/or published in peer reviewed iournals.
Journal articles:
Ha, T., Valentine, R., Moratti, S., Robinson, L., Wormald, PJ. A blinded randomized controlled trial evaluating the efficacy of Chitosan gel on ostial stenosis following endoscopic sinus surgery. Submitted to International Forum of Allergy & Rhinology (IFAR)
Valentine, R., Athanasiadis, T., Moratti, S., Hanton, L., Robinson, S., Workald, PJ. The efficacy of a novel chitosun gel on hemostatsis and wound healing after endoscopic sinus surgery. American Journal of Allergy & Rhinology, January-February 2010 Vol.24 No. 1
Ha, T., Valentine, R., Moratti, S., Hanton, L., Robinson, S., Wormald, PJ. The efficacy of a novel budesonide chitosan gel on wound healing following endoscopic sinus surgery. Submitted to International Forum of Allergy & Rhinology (IFAR)
Non-Clinical Testing
Testing was conducted on sterile final product. Product testing followed the appropriate standards and guidance documents, with appropriate modifications following risk assessment. Testing plans were based upon FDA guidance documents and international standards. Testing was performed on baseline (non- aged) and aged products. Testing included:
- viscosity
- gel time ●
- delivery of gel
- biodegradation
- packaging
6
All samples passed testing and met the acceptance criteria of the specification.
Basis for Determination of Substantial Equivalence
Upon reviewing the safety information provided in this submission and comparing intended use, principle of operation and overall technological characteristics, the Chitogel Endoscopic Sinus Surgery Kit is determined to be substantially equivalent to existing legally marketed devices.
Comparison of Product Features
| Trade name | Chitogel Endoscopic Sinus
Surgery Kit | Novashield | SE Discussion |
|----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product code | LYA | LYA | Same |
| 510(k) number | K172179 | K141704 | Same |
| 21CFR | 874.4780 | 874.4780 | Same |
| Device
Classification | Class 1 | Class 1 | Same |
| Device
Description | Chitosan based gel supplied in
3 components mixed into a gel
by user | Chitosan based pre-mixed gel | Equivalent |
| Method of
Operation | Gel injected into sinus cavity | Gel injected into sinus cavity | Equivalent |
| Intended Use | The Chitogel Endoscopic
Sinus Surgery Kit 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 and
minimize ostial stenosis
following endoscopic sinus
surgery
• 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
The Chitogel Endoscopic
Sinus Surgery Kit is indicated
for use as a nasal packing to
treat epistaxis. | 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. | Equivalent |
| Components | Dextran Aldehyde Powder
Sodium Phosphate Buffer
Solution
Chitosan Succinamide
Solution | Chitosan
Cellulose | Equivalent |
| Sterilization | Supplied sterile - ETO &
Gamma | Supplied sterile – unknown
method | Equivalent |
| Single use | Yes | Yes | Equivalent |
| Shelf life | 3 months | Unknown | Equivalent |
| Packaging | Tyvex / poly header pouch | Unknown | Industry standard packaging |
| Materials | Chitosan based gel | Chitosan based gel | Equivalent |
| Biodegradable | Yes | Yes | Equivalent |
| Published
Clinical Data | Yes | No | Equivalent - even though the
predicate device does not have
any published clinical data,
both products have the same
intended use and clinical
application |
7
8
Conclusion
The products are substantially equivalent as the indications for use, clinical application and materials are equivalent to existing legally marketed predicate products.