(311 days)
STASIS Gel is intended for sulcus retraction prior to impression making and to control bleeding and gingival oozing in restorative and operative dentistry used with gingival retraction cord. STASIS Gel facilitates the insertion of the cord into the sulcus.
Stasis Gel is a 15.5% Ferric Sulfate in a water-based, viscous gel that facilitates sulcus retraction. When applied to the sulcus, the product provides physical displacement of the gingival tissue from the tooth, which in turn, provides a physical barrier to prevent gingival bleeding and oozing from following procedures. Stasis Gel is supplied in a 30 ml or 1.2 ml plastic syringe. The 30 ml syringe is used for bulk storage and 1.2 ml plastic syringe is used for delivery the gel to the sulcus.
This document is a 510(k) summary for the STASIS Gel, a dental device intended for sulcus retraction and control of bleeding/gingival oozing. It primarily focuses on demonstrating substantial equivalence to a predicate device (Vista FS) rather than presenting a detailed study with acceptance criteria for a new AI/software device. Therefore, much of the requested information regarding AI device testing (e.g., sample size for test set, expert qualifications, MRMC study, standalone performance) is not applicable or provided in this document.
However, based on the provided text, I can extract information related to the device's characteristics and the non-clinical testing performed to support its substantial equivalence.
Here's the information that can be extracted, and where the requested information is not applicable, it is noted.
1. A table of acceptance criteria and the reported device performance
Since this is a submission for a medical device (STASIS Gel) and not an AI/software device, the acceptance criteria are based on demonstrating similarity to a predicate device in terms of chemical characteristics, indications for use, and safety. The document does not explicitly state "acceptance criteria" in a quantitative performance metric sense for a software algorithm, but rather compares key attributes.
| Criteria/Characteristic (for comparison with Predicate) | Predicate Device (Vista FS / Vista FS Liquid) Performance | Subject Device (Stasis Gel) Performance |
|---|---|---|
| Indications for Use | Sulcus retraction prior to impression making and to control bleeding and gingival oozing in restorative and operative dentistry used with gingival retraction cord. Facilitates the insertion of the cord into the sulcus. | Sulcus retraction prior to impression making and to control bleeding and gingival oozing in restorative and operative dentistry used with gingival retraction cord. Facilitates the insertion of the cord into the sulcus. |
| Chemical Characteristics | 20% Ferric Sulfate (Vista FS), 15.5% Ferric Sulfate (Vista FS Liquid) | 15.5% Ferric Sulfate |
| Mechanism of Action | Physical displacement of gingival tissue by viscous gel; facilitates cord insertion. | Physical displacement of gingival tissue by viscous gel; facilitates cord insertion. |
| Viscosity | Unknown | ≥ 55,000 cps |
| pH | 1-3 | 1-3 |
| Biocompatibility | Cytotoxicity | Cytotoxicity, Skin Sensitization, Skin Irritation (all demonstrated low risk) |
| Ferric Sulfate Content | Not explicitly stated for performance, but implied by 15.5% / 20%. | Tested and found similar to predicate device. |
| Shelf-Life | 18 months | 24 months (based on accelerated testing, real-time ongoing) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This document describes the non-clinical testing of a physical medical device (STASIS Gel), not an AI/software device. There is no "test set" in the context of clinical images or patient data for AI performance evaluation. The "testing" refers to bench testing and biocompatibility 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 for a physical medical device, not an AI/software device requiring expert ground truth for image interpretation or diagnosis.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There is no test set or human adjudication process as this is not an AI/software device.
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 for a physical medical device, not an AI/software device, so an MRMC study is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is not an AI/software device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the physical characteristics and safety:
- Biocompatibility: In-vitro and in-vivo testing according to ISO 10993-1 standards, which serve as objective ground truth for safety assessments.
- Chemical Characteristics (Ferric Sulfate content, pH): Laboratory analytical methods that provide objective measurements.
- Viscosity: Laboratory rheometry methods that provide objective measurements.
- Shelf-Life: Accelerated aging studies and ongoing real-time aging studies, which provide objective data on product stability over time.
8. The sample size for the training set
Not applicable. This is not an AI/software device that uses "training sets."
9. How the ground truth for the training set was established
Not applicable. This is not an AI/software device.
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March 14, 2022
Belport Company, Inc., Gingi-Pak Mohammed Islam Director of R&D 4825 Calle Alto Camarillo, California 93012
Re: K211420
Trade/Device Name: Stasis Gel Regulatory Class: Unclassified Product Code: MVL Dated: June 29, 2021 Received: July 23, 2021
Dear Mohammed Islam:
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/cfpmp/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 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
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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 Michael E. Adjodha, M.ChE. Assistant Director DHT1B: Division of Dental and ENT 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) K211420
Device Name STASIS Gel
Indications for Use (Describe)
STASIS Gel is intended for sulcus retraction prior to impression making and to control bleeding and gingival oozing in restorative and operative dentistry used with gingival retraction cord. STASIS Gel facilitates the insertion of the cord into the sulcus.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
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| I. SUBMITTER | |
|---|---|
| Name: | Gingi-Pak, a Division of Belport Co. |
| Address: | 4825 Calle AltoCamarillo, CA 93012 |
| Contact Person: | Summeya Islam |
| Email: | Su.islam@Gingi-Pak.com |
| Tel: | (805)484-1051 |
| Date Prepared: | 01/12/2021 |
| II. Device | |
| Device Trade Name: | Stasis Gel |
| Common andClassification Names(s): | Cord, Retraction |
| Device Classification: | Unclassified |
| Product Code: | MVL |
| III. Predicate Device(s) | |
| Predicate Device TradeName: | Vista FS |
| 510 (k) Number: | K190220 |
| Submitter: | Inter-Med/ Vista Dental Products |
| Device Classification: | Unclassified |
| Product Code: | MVL |
| Reference Device TradeName: | Vista FS Liquid |
| 510 (k) Number: | K190220 |
| Submitter: | Inter-Med/ Vista Dental Products |
| Device Classification: | Unclassified |
| Product Code: | MVL |
510(k) Summary - K211420
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| IV. Device Description | |||
|---|---|---|---|
| Device Identification: | 15.5% Ferric Sulfate in a water-based, viscous gel | ||
| Device Characteristic: | Stasis Gel is supplied in a 30 ml or 1.2 ml plastic syringe.The 30 ml syringe is used for bulk storage and 1.2 mlplastic syringe is used for delivery the gel to the sulcus. | ||
| Environment of Use: | Healthcare facility/ Dental office | ||
| Summary (Description) of Device: | Stasis Gel is a 15.5% Ferric Sulfate in a water-based,viscous gel that facilitates sulcus retraction. When appliedto the sulcus, the product provides physical displacementof the gingival tissue from the tooth, which in turn, providesa physical barrier to prevent gingival bleeding and oozingfrom following procedures. | ||
| Material of Use: | Ferric Sulfate in a water-based gel | ||
| V. Indications for Use | |||
| Stasis Gel is intended for sulcus retraction prior toimpression making and to control bleeding and gingivaloozing in restorative and operative dentistry used withgingival retraction cord. Stasis Gel facilitates the insertionof the cord into the sulcus. | |||
| VI. Comparison of Technological Characteristics with the Predicate Device | |||
| Predicate Device:Vista FS | Reference Device:Vista FS Liquid | Subject Device:Stasis Gel | |
| Oral Cavity | Oral Cavity | Oral Cavity | |
| 510(k) Number | K190220 | K190220 | K211420 |
| Common Name | Cord, Retraction | Cord, Retraction | Cord, Retraction |
| Device Classification | Unclassified | Unclassified | Unclassified |
| Product Code | MVL | MVL | MVL |
| Indication for Use | Vista FS isintended forsulcus retraction | Vista FSLiquid is intendedfor sulcusretraction | Stasis Gel isintended forsulcus retraction |
| prior toimpressionmaking and tocontrol bleedingand gingivaloozing inrestorative andoperativedentistry usedwith gingivalretraction cord.Vista FSfacilitates theinsertion of thecord into thesulcus. | prior toimpressionmaking and tocontrolbleeding andgingivaloozing inrestorativeand operativedentistry usedwithgingival retractioncord. This devicefacilitate theinsertionof the cord intothesulcus. | prior toimpressionmaking and tocontrol bleedingand gingivaloozing inrestorative andoperativedentistry usedwith gingivalretraction cord.Stasis Gelfacilitates theinsertion of thecord into thesulcus. | |
| Environment of Use | Healthcare offices/ Dental offices | Healthcare offices/ Dental offices | Healthcare offices/ Dental offices |
| Target Population | Health careprofessionals | Health careprofessionals | Health careprofessionals |
| Prescription/ OTC | Prescription | Prescription | Prescription |
| Anatomical Site | Oral Cavity | Oral Cavity | Oral Cavity |
| ChemicalCharacteristics | 20% FerricSulfate | 15.5% FerricSulfate | 15.5% FerricSulfate |
| Mechanism of Action | Placement of theviscous gelresults in physicaldisplacement ofgingival tissuefrom the tooth.Material alsofacilitatesinsertion of thecord into thesulcus. | Placement of theviscous gelresults in physicaldisplacement ofgingival tissuefrom the tooth.Material alsofacilitatesinsertion of thecord into thesulcus. | Placement of theviscous gelresults in physicaldisplacement ofgingival tissuefrom the tooth.Material alsofacilitatesinsertion of thecord into thesulcus. |
| Viscosity | Unknown | Unknown | ≥ 55,000 cps |
| pH | Unknown | 1-3 | 1-3 |
| Packaging Configuration | 1.2mL pre-filledsyringe withapplicator tips;30mL syringe withempty 1.2mLsyringes andapplicator tips. | 1.2mL pre-filledsyringe withapplicator tips;30mL syringe withempty 1.2mLsyringes andapplicator tips | 1.2mL pre-filledsyringe withapplicator tips;30mL syringewith empty 1.2mLsyringes andapplicator tips. |
| Sterility | Non-sterile | Non-sterile | Non-sterile |
| Shelf-Life | 18 months | 18 months | 24 months |
| Recommended ContactTime | 1-3 minutes | 1-3 minutes | 1-3 minutes |
| Biocompatibility | Cytotoxicity | Cytotoxicity | CytotoxicitySkin SensitizationSkin Irritation |
| VII. Summary of Testing (Non-Clinical) | |||
| Biocompatibility | Biocompatibility testing are performed according to ISO10993-1. Device demonstrated low cytotoxicity, skinsensitization and skin irritation. | ||
| Bench Testing | Stasis Gel has been tested for Ferric Sulfate content andis found to be similar to predicate device. | ||
| Sterility andShelf-Life Testing | Stasis Gel is not supplied as sterile. | ||
| Based on accelerated testing, a shelf life of two years is | |||
| supported for Stasis Gel. Real time aging is beingperformed on Stasis Gel to support shelf life during typicalstorage conditions. | |||
| VIII. Conclusion | |||
| Stasis Gel is determined to be substantially equivalent to Vista FS (K190220). The |
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subject medical device has a nearly identical intended use and chemical characteristics and delivery system as the predicate device. Any differences between the subject medical device and predicate medical device do not significantly alter the product's use and do not result in unacceptable or unnecessary risks to the patients or users. Therefore, we conclude that Stasis Gel is substantially equivalent to the predicate device, Vista FS.
N/A