(90 days)
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.
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.
The provided text describes a medical device (Chitogel Endoscopic Sinus Surgery Kit) and its comparison to a predicate device (Novashield Injectable Nasal Packing and Stent) for FDA 510(k) clearance. This document is a Summary of Substantial Equivalence, not a detailed study report with all the specific information requested.
Therefore, much of the requested information regarding acceptance criteria, study methodologies, sample sizes, and ground truth establishment, particularly for a device with an AI/algorithm component, is not present in this document because this device is a physical medical product, not an AI/software device.
However, I can extract and infer some relevant information based on the typical content of such documents for medical devices:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of quantitative acceptance criteria for performance metrics typical of an AI algorithm (e.g., sensitivity, specificity, AUC). Instead, it focuses on qualitative equivalency to a predicate device and safety testing for a physical product.
The "acceptance criteria" here refer to meeting standards for biological safety, physical properties, and functional performance as demonstrated through various tests. The "reported device performance" is essentially that the device passed all these tests and met their respective acceptance criteria.
| Acceptance Criteria Category (Implied) | Reported Device Performance |
|---|---|
| Biological Safety Testing | All samples passed testing and met acceptance criteria for: Cytotoxicity, Sensitization, Acute Systemic Toxicity. |
| Simulated Clinical Performance (Animal Model) | Successfully combined into a gel, introduced into sinus cavities, maintained position after introduction, degraded over time using saline irrigation. No adverse events observed. |
| Physical/Chemical Properties (Non-Clinical Testing) | All samples passed testing and met acceptance criteria for: Viscosity, Gel time, Delivery of gel, Biodegradation, Packaging. |
| Clinical Performance (Human Studies - via published articles) | Demonstrated performance consistent with indications for use: separated tissue/structures, prevented adhesions, minimized ostial stenosis, controlled minimal bleeding, aided natural healing process. Confirmed in studies/peer-reviewed journals. |
| Sterilization | Passed testing for sterility (ETO & Gamma). |
| Single Use Confirmation | Confirmed as single use. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Test Set Sample Size: Not explicitly stated for specific tests.
- For biological testing (cytotoxicity, etc.), it would typically involve an adequate number of samples as per ISO standards, but no specific count is given.
- For non-clinical physical testing (viscosity, gel time, etc.), "All samples" passed, but the quantity of "samples" is not provided.
- For animal testing, it mentions "an animal model" (singular imply a single type of animal study, not necessarily a single animal), but no specific number of animals is provided.
- For "Clinical Experience", it refers to "Several clinical studies" and "randomized controlled studies," but the specific number of participants in these studies (i.e., the sample size of the test set) is not provided in this summary.
- Data Provenance:
- Clinical Experience: References multiple published journal articles involving "randomized controlled studies." While specific countries are not mentioned, one of the authors, "Wormald, PJ," is associated with the University of Adelaide, Australia, suggesting at least some data might originate from Australia. The company itself is based in New Zealand.
- Retrospective/Prospective: The description "randomized controlled studies" indicates these were prospective clinical trials.
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)
This information is not provided as the device is a physical product, not an AI system requiring expert labeling for ground truth. Clinical "observations were documented" and confirmed in studies, likely by the treating physicians and study investigators, but their specific qualifications or number for "ground truth establishment" in an AI context are not relevant here and thus not stated.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided and is generally not applicable for a physical medical device submission like this. Adjudication methods are typically relevant for complex subjective assessments in AI studies or clinical trials where multiple readers/assessors need to reach a consensus on ground truth or outcomes. For this device, the outcomes are observed clinical effects (e.g., bleeding control, adhesion prevention).
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
No, an MRMC comparative effectiveness study was not done or mentioned. This type of study is specifically designed for evaluating diagnostic AI systems where human readers' performance (e.g., radiologists, pathologists) is compared with and without AI assistance across multiple cases. This device is a physical surgical implant, not a diagnostic AI tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This question pertains to AI algorithms. The Chitogel device is a physical kit that forms a gel used by a surgeon. There is no "algorithm" to perform in a standalone capacity.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For the clinical effectiveness discussed, the "ground truth" was based on clinical observations and outcomes data from prospective randomized controlled trials. These include:
- Direct observation of tissue separation.
- Assessment of adhesion prevention.
- Measurement/assessment of bleeding control.
- Observation of the natural healing process.
- Histopathological analysis (implied by "wound healing" studies, potentially at a microscopic level in animal or human biopsies, but not explicitly stated as the primary ground truth source here).
8. The sample size for the training set
Not applicable. This device is a physical product and does not involve AI/machine learning, thus there is no "training set."
9. How the ground truth for the training set was established
Not applicable. See point 8.
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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.
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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 (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
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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)
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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 139Moray PlaceDunedin, 9016, New Zealand Tel: +6421 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 MathisonUS AgentT: 218.387.1559E: 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:
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- 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.
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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
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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 SinusSurgery Kit | Novashield | SE Discussion |
|---|---|---|---|
| Product code | LYA | LYA | Same |
| 510(k) number | K172179 | K141704 | Same |
| 21CFR | 874.4780 | 874.4780 | Same |
| DeviceClassification | Class 1 | Class 1 | Same |
| DeviceDescription | Chitosan based gel supplied in3 components mixed into a gelby user | Chitosan based pre-mixed gel | Equivalent |
| Method ofOperation | Gel injected into sinus cavity | Gel injected into sinus cavity | Equivalent |
| Intended Use | The Chitogel EndoscopicSinus Surgery Kit is indicatedfor use in patients undergoingnasal/sinus surgery as a spaceoccupying packing to:• Separate tissue or structurescompromised by surgicaltrauma;• Separate and preventadhesions between mucosalsurfaces in the nasal cavity andminimize ostial stenosisfollowing endoscopic sinussurgery• Control minimal bleedingfollowing surgery or traumaby tamponade effect, bloodabsorption and plateletaggregation• Act as an adjunct to aid inthe natural healing processThe Chitogel EndoscopicSinus Surgery Kit is indicatedfor use as a nasal packing totreat epistaxis. | NovaShield is indicated foruse in patients undergoingnasal/sinus surgery as a spaceoccupyingpacking to:• Separate tissue or structurescompromised by surgicaltrauma;• Separate and preventadhesions between mucosalsurfaces in the nasal cavity;• Control minimal bleedingfollowing surgery or traumaby tamponade effect, bloodabsorption andplatelet aggregation• Act as an adjunct to aid inthe natural healing processNovaShield is indicated foruse as a nasal packing to treatepistaxis. | Equivalent |
| Components | Dextran Aldehyde PowderSodium Phosphate BufferSolutionChitosan SuccinamideSolution | ChitosanCellulose | Equivalent |
| Sterilization | Supplied sterile - ETO &Gamma | Supplied sterile – unknownmethod | 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 |
| PublishedClinical Data | Yes | No | Equivalent - even though thepredicate device does not haveany published clinical data,both products have the sameintended use and clinicalapplication |
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Conclusion
The products are substantially equivalent as the indications for use, clinical application and materials are equivalent to existing legally marketed predicate products.
§ 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.