(205 days)
StatStix is applied to control temporary bleeding caused by minor cuts and abrasions that may occur on gingival tissue during dental procedures.
StatStix is designed incorporating a hand-held polypropylene handle with a nylon polyamide applicator tip coated with a dried solution of 25% Aluminum Sulfate Hydrate Solution with Mint Flavor. The device is configured in two sizes to help control minor gingival bleeding intended for transient use by a dentist during dental restorative procedures.
The provided FDA document describes the premarket notification (510(k)) for the StatStix device (K200764). It details the device's intended use and compares its characteristics to a predicate device for substantial equivalence. However, it explicitly states that clinical testing has not been performed on this product. Therefore, a study proving the device meets acceptance criteria based on clinical performance in humans is not present in this document.
The document does, however, discuss non-clinical performance data and establishes acceptance criteria for those tests.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance (Non-Clinical):
| Acceptance Criteria (Non-Clinical) | Reported Device Performance (Non-Clinical) |
|---|---|
| Biocompatibility: | Meets ISO 10993-5 (cytotoxicity) |
| - Cytotoxicity | Meets ISO 10993-10 (sensitization/irritation) |
| - Sensitization/Irritation | |
| Physical Properties: | Performed according to standard laboratory benchtop practices |
| - FTIR | |
| - pH | |
| - Dosage Weight | |
| Shelf-Life: | Allows for a two-year expiration dating |
| - Consistent with ASTM F1980 |
2. Sample Size Used for the Test Set and Data Provenance:
- Clinical Test Set: Not applicable, as no clinical testing was performed for StatStix.
- Non-Clinical Test Set: Not specified for biocompatibility, physical properties, or shelf-life testing. The document states "standard laboratory benchtop practices" for physical properties and "consistent with ASTM F1980" for shelf-life, implying standard sample sizes for these types of tests would have been used, but specific numbers are not detailed.
- Data Provenance: Not explicitly stated, but assumed to be from Centrix Incorporated or their contracted laboratories given they are the submitter.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts:
- Clinical Test Set: Not applicable.
- Non-Clinical Test Set: Not specified. For non-clinical lab tests, "ground truth" is established by the methodologies and reference standards themselves, as opposed to expert human interpretation.
4. Adjudication Method for the Test Set:
- Clinical Test Set: Not applicable.
- Non-Clinical Test Set: Not applicable. Adjudication methods are typically relevant for subjective assessments or when multiple human readers/experts are involved in ground truth establishment.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document explicitly states, "Clinical testing has not been performed on this product." Therefore, there is no information on how much human readers improve with AI vs. without AI assistance. The StatStix device is a physical product (applicator with astringent), not an AI-powered diagnostic or assistive tool.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
- No, a standalone performance study in the context of an algorithm or AI was not done. StatStix is a physical device, not an algorithm.
7. Type of Ground Truth Used:
- Clinical Ground Truth: Not applicable, as no clinical testing was performed.
- Non-Clinical Ground Truth: Established through standardized laboratory testing methodologies (e.g., ISO, ASTM, FTIR/pH/dosage weight analysis) where the outcomes are measurable and objective.
8. Sample Size for the Training Set:
- Not applicable. This device is a physical product, not an AI/machine learning algorithm requiring a "training set" of data.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable, as there is no training set for this type of device.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
October 15, 2020
Centrix Incorporated % Roger Mastrony President MedTek LLC 2516 Kettle Creek Court Lincolnton, North Carolina 28092
Re: K200764
Trade/Device Name: Statstix Regulatory Class: Unclassified Product Code: MVL Dated: March 20, 2020 Received: March 24, 2020
Dear Roger Mastrony:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
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
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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for Srinivas "Nandu" Nandkumar, Ph.D. Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):
Device Name: StatStix
Indications for Use:
StatStix is applied to control temporary bleeding caused by minor cuts and abrasions that may occur on gingival tissue during dental procedures.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (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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Image /page/3/Picture/0 description: The image contains the logo for Centrix, a company that makes dentistry easier. The logo is in blue and white, with the word "centrix" in a bold, sans-serif font. Below the word "centrix" is the tagline "Making Dentistry Easier." The logo is simple and modern, and it conveys the company's mission of making dentistry more accessible.
510(k) SUMMARY
Premarket Notification Number K200764
This 510(k) summary information is being submitted in accordance with the requirements of 21 CFR 807.92.
510(k) Sponsor:
Centrix Incorporated 770 River Road Shelton, CT. 06484 800.235.5862
Submitted by:
Roger Mastrony MedTek LLC 2516 Kettle Creek Court Lincolnton, N.C. 28092 203.640.5047
Date of Submission: March 20, 2020
Trade Name: StatStix Common Name: Cord, Retraction Product Code: MVL Device Class: Unclassified
Devices for Which Substantial Equivalence is Claimed:
- Primary-Vista Clear, K193389 Unclassified, Product Code MVL, Vista Dental ● Products
- Reference Device- BendaWedge, K140144 Class 1 Medical Devices, Product Code ● EJB, Centrix Incorporated
Summary:
Device Description
StatStix is designed incorporating a hand-held polypropylene handle with a nylon polyamide applicator tip coated with a dried solution of 25% Aluminum Sulfate Hydrate Solution with Mint Flavor. The device is configured in two sizes to help control minor gingival bleeding intended for transient use by a dentist during dental restorative procedures.
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Image /page/4/Picture/0 description: The image shows the Centrix logo. The word "centrix" is written in a blue, rounded rectangle. Below the rectangle, the text "Making Dentistry Easier" is written in a smaller font. The letters "SM" are written as a superscript.
Indications for Use:
StatStix is applied to control temporary bleeding caused by minor cuts and abrasions that may occur on gingival tissue during dental procedures
Comparative Indications for Use Chart:
| Device | Category | Indications for Use |
|---|---|---|
| StatStix | Subject device | StatStix is applied to control temporarybleeding caused by minor cuts and abrasionsthat may occur on gingival tissue duringdental procedures |
| Vista Clear | Primary device | Vista Clear is intended for sulcus retractionprior to impression-making and to controlbleeding and gingival oozing in restorative andoperative dentistry used with gingivalretraction cord. |
| Benda Wedge | Reference device | Benda Wedge is an inter-proximal wedgecoated with an astringent to be used incombination with other devices to temporarilyretain composite or amalgam restorativematerial as well as to control gingival bleedingduring dental restorations. |
Technological Characteristics Comparison:
| Primary Predicate Vista Clear K193389 | StatStix K200764 |
|---|---|
| Contains 26.6% of an Aluminum ChlorideAstringent | Coated with dried 25% Aluminum Sulfateastringent Solution with Mint flavor |
| Intended for sulcus retraction prior toimpression taking and to control bleedingand gingival oozing in restorative andoperative dentistry used with gingivalretraction cord. Facilitates the insertion ofa cord into the sulcus | Substantially Equivalent in thatIndicated to Control Minor GingivalBleeding during dental procedures |
| Mode of Operation is to MechanicallyDesiccate Gingival Tissue with theaddition of Mechanical Pressure inconjunction with cord | Substantially Equivalent in thatplacement of the wetted StatStixapplicator results in tissue constrictionat intended site and subsequenthemostasis |
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Image /page/5/Picture/0 description: The image shows the Centrix logo. The word "centrix" is written in white letters on a blue background. Below the word "centrix" is the phrase "Making Dentistry Easier."
| Used in combination with other devices totemporarily retain composite or amalgamrestorative material during dentalrestorations | No Equivalency Claimed |
|---|---|
| -------------------------------------------------------------------------------------------------------------------------------------------- | ------------------------ |
Non Clinical Performance Data:
Biocompatibility testing was performed in accordance with ISO 10993-1 guidelines; specifically, biocompatibility testing was performed for cytotoxicity per ISO 10993-5 and sensitization/irritation per ISO 10993-10.
Physical property testing consisted of FTIR, pH and dosage weight evaluations and was performed according to standard laboratory benchtop practices.
Shelf-Life Testing
Shelf-life testing was performed consistent with ASTM F1980 and the obtained results allow for a two-year expiration dating of this device
Clinical Testing
Clinical testing has not been performed on this product
Conclusion
We believe given the StatStix device is substantially equivalent to the primary device referenced in this submission.
N/A