(248 days)
GINGI-AID Gel is intended for gingival retraction prior to impression making and to control bleeding and gingival oozing in restorative and operative dentistry when used with gingival retraction cords. The gel facilitates the insertion of the cord into the sulcus.
Gingi-Aid Gel is a 25% Aluminum Chloride in a water-based, viscous gel that facilitates gingival 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. Gingi-Aid 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) Premarket Notification from the FDA regarding the Gingi-Aid Gel. It focuses on demonstrating the substantial equivalence of the Gingi-Aid Gel to an existing predicate device, rather than providing details on acceptance criteria and performance data for a new, AI-based device that would typically involve the comprehensive testing requested.
Therefore, most of the requested information regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" for an AI/CADe device, specifically:
- A table of acceptance criteria and the reported device performance: Not applicable. This document is for a dental gel, not an AI/CADe device. The "performance" is based on chemical and physical properties and intended use.
- Sample sized used for the test set and the data provenance: Not applicable in the context of AI/CADe. The "testing" here involves biocompatibility, bench testing for aluminum chloride content, and shelf-life testing, not a clinical study on a large test set of images or patient data.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI/CADe device is usually established by medical experts (e.g., radiologists, pathologists). This is a chemical product.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
- 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.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable in the AI/CADe sense. The "ground truth" for this device would be established by chemical analysis and standard biocompatibility testing.
- The sample size for the training set: Not applicable. This is not an AI/ML device.
- How the ground truth for the training set was established: Not applicable.
However, I can extract the following information relevant to the submission:
1. Device Description and Characteristics (replacing "Acceptance Criteria" with "Key Characteristics" and "Performance" with "Reported Data"):
The document primarily focuses on demonstrating substantial equivalence to predicate devices (Vista Clear, K193389, and ViscoStat Clear, K123215). The "acceptance criteria" are implicitly met by demonstrating that the Gingi-Aid Gel is chemically and functionally similar and safe.
| Key Characteristic | Acceptance Criteria (Implied by Predicate) | Reported Data (Gingi-Aid Gel) |
|---|---|---|
| Device Identification | 25% Aluminum Chloride in water-based gel | 25% Aluminum Chloride in a water-based, viscous gel |
| Primary Active Ingredient | Aluminum Chloride | 25% Aluminum Chloride |
| Formulation | Viscous Gel | Viscous gel |
| Intended Use | Gingival retraction, bleeding/oozing control (with cord) | Intended for gingival retraction prior to impression making and to control bleeding and gingival oozing in restorative and operative dentistry when used with gingival retraction cords. The gel facilitates the insertion of the cord into the sulcus. |
| Environment of Use | Healthcare facility/Dental office | Healthcare facility/Dental office |
| Target Population | Healthcare professionals | Healthcare professionals |
| Prescription/OTC | Prescription Use | Prescription Use |
| Anatomical Site | Oral Cavity | Oral Cavity |
| Mechanism of Action | Physical displacement of gingival tissue, facilitates cord insertion | Placement of the viscous gel results in physical displacement of gingival tissue from the tooth. Material also facilitates insertion of the cord into the sulcus. |
| pH | Similar to predicate (ViscoStat Clear: 2.65) | 2.62 (Compared to ViscoStat Clear's 2.65, demonstrating similarity) |
| Packaging Configuration | 1.2mL pre-filled syringe; 30mL syringe | 1.2mL pre-filled syringe with applicator tips; 30mL syringe with empty 1.2mL syringes and applicator tips. |
| Sterility | Non-sterile | Non-sterile (Gingi-Aid Gel is not supplied as sterile.) |
| Shelf-Life | At least 24 months | 24 months (Based on accelerated testing; real-time aging being performed to support shelf life). |
| Recommended Contact Time | 1-3 minutes | 1-3 minutes |
| Biocompatibility | Low cytotoxicity, no skin sensitization/irritation | Biocompatibility testing performed according to ISO 10993-1. Device demonstrated low cytotoxicity, no skin sensitization or skin irritation. (Testing included Cytotoxicity, Skin Sensitization, Skin Irritation). |
| Aluminum Chloride Content | Similar to predicate | Gingi-Aid Gel has been tested for aluminum chloride content and is found to be similar to predicate device. |
2. Study Design and Data Provenance (for this specific device which is NOT AI/CADe):
- Sample size and Data Provenance: Not applicable in the context of a clinical study for AI/CADe. The "study" here involves lab testing.
- Bench Testing: Gingi-Aid Gel's aluminum chloride content was compared to the predicate device.
- Biocompatibility Testing: Performed according to ISO 10993-1. (Specific sample sizes for these tests are not provided but are standard for material testing).
- Shelf-Life Testing: Accelerated testing supported 24 months, with real-time aging ongoing.
- The "data provenance" is from in-house lab testing by the manufacturer (Belport Company, Inc. / Gingi-Pak). The document does not specify country of origin for the data, but the submission is to the US FDA. The nature of these tests is not "retrospective" or "prospective" in a clinical trial sense, but rather lab-based validation.
3-9. Information Not Applicable to this Type of Device (Gingi-Aid Gel is not an AI/CADe device):
As explained above, questions concerning experts for ground truth, adjudication methods, MRMC studies, standalone algorithm performance, direct patient ground truth, and training set details are entirely irrelevant to this submission, which is for a dental chemical product. The substantial equivalence is based on comparing its physical, chemical, and functional properties to similar, already-cleared predicate devices.
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January 10, 2022
Belport Company, Inc., Gingi-Pak Mohammed Islam Director of R&D 4825 Calle Alto Camarillo, California 93012
Re: K211419
Trade/Device Name: Gingi-Aid Gel Regulatory Class: Unclassified Product Code: MVL Dated: November 22, 2021 Received: November 29, 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/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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
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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 mediation-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.
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) K211419
Device Name GINGI-AID Gel
Indications for Use (Describe)
GINGI-AID Gel is intended for gingival retraction prior to impression making and to control bleeding and gingival oozing in restorative and operative dentistry when used with gingival retraction cords. The 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: | Xiaowen Xu |
| Email: | Xiao.Xu@Gingi-Pak.com |
| Tel: | (800) 292-6620 |
| Date Prepared: | 07/08/2020 |
| II. Device | |
| Device Trade Name: | GingiAid Gel |
| Common andClassification Names(s): | Cord, Retraction |
| Device Classification: | Unclassified |
| Product Code: | MVL |
| III. Predicate Device(s) | |
| Predicate Device TradeName: | Vista Clear |
| 510 (k) Number: | K193389 |
| Submitter: | Inter-Med/ Vista Dental Products |
| Device Classification: | Unclassified |
| Product Code: | MVL |
| Reference Device TradeName: | ViscoStat Clear |
| 510 (k) Number: | K123215 |
| Submitter: | Ultradent Products |
| Device Classification: | Unclassified |
| Product Code: | MVL |
510(k) Summary-K211419
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| IV. Device Description | |||
|---|---|---|---|
| Device Identification: | 25 % Aluminum Chloride in a water-based, viscous gel | ||
| Device Characteristic: | Gingi-Aid 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. | ||
| Environment of Use: | Healthcare facility/ Dental office | ||
| Summary (Description) of Device: | Gingi-Aid Gel is a 25% Aluminum Chloride in a water-based, viscous gel that facilitates gingival 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. | ||
| Material of Use: | Aluminum Chloride in a water-based gel | ||
| V. Indications for Use | |||
| Gingi-Aid 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. Gingi-Aid Gel facilitates the insertion of the cord into the sulcus. | |||
| VI. Comparison of Technological Characteristics with the Predicate Device | |||
| Predicate Device:Vista Clear | Reference Device:ViscoStat Clear | Subject Device:Gingi-Aid Gel | |
| 510(k) Number | K193389 | K123215 | K211419 |
| Common Name | Cord, Retraction | Cord, Retraction | Cord, Retraction |
| Device Classification | Unclassified | Unclassified | Unclassified |
| Product Code | MVL | MVL | MVL |
| Indication for Use | Vista Clear is intended for sulcus retraction prior to impression making and to control bleeding and gingival oozing in | ViscoStat Clear is intended for sulcus retraction prior to impression making and to control bleeding and gingival oozing in | GINGI-AID Gel is intended for gingival retraction prior to impression making and to control bleeding and gingival oozing in |
| restorative andoperativedentistry usedwith gingivalretraction cord.Vista Clearfacilitates theinsertion of thecord into thesulcus. | restorative andoperativedentistry usedwith gingivalretraction cordand/or the DentoInfusor. Thesegels facilitate theinsertion of thecord into thesulcus. | restorative andoperativedentistry usedwhen withgingival retractioncord. The 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 | 26.6% AluminumChlorideHexahydrate | 25% AluminumChloride | 25% AluminumChloride |
| 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. |
| pH | unknown | 2.65 | 2.62 |
| 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 | 24 months | 42 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, no skinsensitization or skin irritation. | ||
| Bench Testing | Gingi-Aid Gel has been tested for aluminum chloridecontent and is found to be similar to predicate device. | ||
| Gingi-Aid Gel is not supplied as sterile. | |||
| Sterility andShelf-Life Testing | Based on accelerated testing, a shelf life of two years issupported for Gingi-Aid Gel. Real time aging is beingperformed on Gingi-Aid to support shelf life during typicalstorage conditions. | ||
| VIII. Conclusion | |||
| Gingi- Aid is determined to be substantially equivalent to Vista Clear (K193389). 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 Gingi-Aid Gel is substantially equivalent to the predicate device, Vista Clear.
N/A