Vista Clear 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. Vista Clear facilitates the insertion of the cord into the sulcus.

Device Description

Vista Clear is used to facilitate sulcus retraction prior to taking a dental impression of a tooth. This entails placement of the device into the sulcus which provides physical displacement of the gingival tissue from the tooth. If using a gingival retraction cord, the subject device facilitates the insertion of the cord into the sulcus while also creating a physical barrier to prevent gingival bleeding and oozing from affecting restorative and tissue management procedures.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device called "Vista Clear." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than undergoing extensive clinical trials or performance testing against specific acceptance criteria for efficacy in the same way a novel device might.

Therefore, the document does not contain information on "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of clinical performance or diagnostic accuracy. Instead, the "device performance" described relates to non-clinical testing demonstrating equivalence to a predicate device.

Here's an analysis based on the provided text, addressing your questions to the extent possible, and highlighting what's not present:

Key Takeaway: This 510(k) summary is for a device with a clear physical/chemical function (sulcus retraction, bleeding control) and claims substantial equivalence based on technological characteristics and non-clinical testing, not clinical performance or diagnostic accuracy with human interpretation.

1. A table of acceptance criteria and the reported device performance

The concept of "acceptance criteria" in this 510(k) largely revolves around demonstrating substantial equivalence to the predicate device and meeting relevant non-clinical performance standards. There are no explicit quantitative clinical performance acceptance criteria (e.g., sensitivity, specificity, AUC) stated in the document, as it's not a diagnostic device.

Reported Device Performance (from "Non-Clinical Performance Testing and Compliance"):

Acceptance Criteria (Implied by Equivalence & Standards)	Reported Device Performance (Vista Clear)
Technological Characteristics Substantial Equivalence:
- Same Intended Use: Sulcus retraction and bleeding/gingival oozing control.	- Meets. Nearly identical indications for use as the predicate device.
- Same Common Name / Product Code Classification (MVL).	- Meets.
- Same Recommended Contact Time (1-3 minutes).	- Meets.
- Same Form/Mechanism: Aqueous gel for physical retraction.	- Meets. "identical to the predicate device as both products are aqueous gels which aid in the physical retraction of gingival tissue."
- Same Target Population & Anatomical Site: Healthcare professionals, oral cavity.	- Meets.
- Same Prescription Use classification.	- Meets.
- Same Packaging/Configuration.	- Meets. "offered in the same configurations as the predicate device (i.e. prefilled syringes with applicator tips, or bulk syringes with unfilled smaller syringes and applicator tips)."
- Similar Chemical Characteristics (Aluminum chloride based).	- Meets. Contains 26.6% aluminum chloride hexahydrate vs. predicate's 25% aluminum chloride. Stated this difference "does not raise any safety or efficacy concerns as they are analogous materials."
- Similar pH (Implied by "identical technological characteristics").	- Meets. "Both medical devices have an identical pH."
- Non-Sterile classification.	- Meets.
Non-Clinical Performance Acceptance Criteria:
- Analytical Testing: Verified manufacturing and comparable results to predicate.	- Meets. "Results from testing are commensurate with the predicate device, supporting substantial equivalence..."
- Cytotoxicity Testing (ISO 10993-1): No significant cytotoxicity, comparable to predicate.	- Meets. "Vista Clear exhibited the same cytotoxicity result as the predicate device (ViscoStat Clear) sold for the same intended use." This "confirms that the subject device is substantially equivalent to the predicate device."
- Microbiological Testing: Mitigation of contamination risks, support shelf stability.	- Meets. "Vista Clear exhibits bactericidal properties." This "helps to support shelf stability and multiple use of non-patient contacting materials." Note: Not claiming a "bactericidal effect" on the patient, but rather internal contamination control.
- Shelf-Life Testing: Demonstrate stability for stated shelf-life (24 months).	- Meets. "Based on accelerated testing, a shelf life of two years is supported for Vista Clear." (Predicate has 42 months, but this difference is deemed acceptable with appropriate labeling.) Real-time aging is ongoing.
- Transit Testing: Packaging withstands simulated transit conditions without negative effect on product.	- Meets. "Moreover, the products performed satisfactory post-transit. which confirms that transit did not have a negative effect on the products themselves."
- Compliance with applicable standards (e.g., ISO 10993-1, ISO 14971, ISO 594-1/2 for Luer taper).	- Stated that these standards were followed for evaluation and risk management. No specific results are given for general standards like ISO 14971 (risk management).

2. Sample size used for the test set and the data provenance

Test Set (for non-clinical performance): The document does not specify a "test set" in the context of clinical or diagnostic performance data (e.g., number of patient cases, images). The testing refers to laboratory-based evaluations of the device's material properties, packaging, and stability.
- Data Provenance: N/A. This is a submission for a new device, and the data provenance refers to materials/engineering tests, not patient data. No country of origin for patient data (as there isn't any provided in text) or retrospective/prospective study type is mentioned as no clinical studies were performed.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

N/A. This information is relevant for studies involving human interpretation or diagnostic accuracy. For this type of device and 510(k) submission, ground truth relates to the results of objective laboratory tests (e.g., is it cytotoxic?), not expert consensus on clinical findings.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

N/A. As no expert consensus or human interpretation of clinical cases was performed, no adjudication method is relevant or described.

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

N/A. This device is a dental material, not an AI or diagnostic imaging device. Therefore, no MRMC study was conducted or is applicable.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

N/A. This is not an algorithm-based device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for this device is based on objective laboratory test results (e.g., analytical chemistry, toxicology, microbiology, stability) that confirm the material properties, safety, and functionality of the device compared to established scientific principles and the predicate device's known characteristics. It's not clinical outcomes or expert labels.

8. The sample size for the training set

N/A. This term is relevant for machine learning models. No training set is applicable for this type of medical device submission.

9. How the ground truth for the training set was established

N/A. As there is no training set, this question is not applicable.

Summary

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Image /page/0/Picture/0 description: The image contains 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.

March 4, 2020

Inter-Med / Vista Dental Products Alex Johnson Sr. Product Development Engineer 2200 South St. Ste. A Racine, Wisconsin 53404

Re: K193389

Trade/Device Name: Vista Clear Regulatory Class: Unclassified Product Code: MVL Dated: December 5, 2019 Received: December 6, 2019

Dear Alex Johnson:

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.

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) K193389

Device Name Vista Clear

Indications for Use (Describe)

VistaClear 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. Vista Clear facilitates the insertion of the cord into the sulcus.

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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Image /page/3/Picture/0 description: The image shows the logo for Intermed. The word "intermed" is written in blue, with the "i" and "n" connected. There is a blue globe to the right of the word "intermed". A black line is underneath the word "intermed".

K193389

Image /page/3/Picture/2 description: The image shows the logo for Vista Dental Products. The logo features the word "VISTA" in a blue sans-serif font, with a stylized mountain range above the letters. Below the word "VISTA" are the words "Dental Products" in a smaller, sans-serif font. There is a black line to the left of the word "VISTA".

510(k) Summary for Vista Clear

1. Applicant

Submitter's Name:	Alex Johnson, MSc
Date Summary Prepared:	December 5, 2019
Address:	Inter-Med / Vista Dental Products2200 South St. Ste ARacine, WI, USA 53404
Contact Person:	Alex Johnson, MSc
Phone:	(262) 631-5306
Email:	ajohnson@vista-dental.com
Fax:	(262) 636-9760

2. Device Name

Proprietary Name: Vista Clear Common Name: Cord, Retraction Product Code: MVL Device Class: Unclassified

3. Predicate Device

ViscoStat Clear (K123215) by Ultradent Products

Common Name: Cord, Retraction o
Product Code: MVL O
Device Class: Unclassified o

4. Device Description

This is the only 510(k) for these medical devices, no prior 510(k)s have been submitted.

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Image /page/4/Picture/0 description: The image shows the logos for Intermed Inc. and Vista Dental Products. The Intermed Inc. logo is on the left side of the image and consists of the word "intermed" in blue, with a blue globe to the right of the word. The letters "INC." are in black to the right of the globe. A black line runs underneath the Intermed Inc. logo. The Vista Dental Products logo is on the right side of the image and consists of a blue mountain range above the word "VISTA" in blue, with the words "Dental Products" in black underneath.

5. Intended Use / Indication for Use

6. Technological Characteristics and Substantial Equivalence

	Predicate Device: ViscoStat® Clear(Ultradent Products)	Vista Clear(Inter-Med / Vista Dental Products)
510(k) Number	K123215	Pending(subject device for this 510(k) submission)
Common Name	Cord, Retraction	Cord, Retraction
DeviceClassification	Unclassified	Unclassified
Product Code	MVL	MVL
Indication for Use	ViscoStat Clear is intended for sulcusretraction prior to impression making and tocontrol bleeding and gingival oozing inrestorative and operative dentistry used withgingival retraction cord and/or the DentoInfusor. These gels facilitate the insertion ofthe cord into the sulcus.	Vista Clear is intended for sulcus retractionprior to impression making and to controlbleeding and gingival oozing in restorativeand operative dentistry used with gingivalretraction cord. Vista Clear facilitates theinsertion of the cord into the sulcus.
Where used	Dental offices and health care offices	Dental offices and health care offices
Target population	Health care professionals	Health care professionals
Anatomical site	Oral cavity	Oral cavity
Chemicalcharacteristics	25% Aluminum chloride	26.6% Aluminum chloride hexahydrate
Mechanism ofAction	Placement of the viscous gel results inphysical displacement of gingival tissue fromthe tooth. Material also facilitates insertion ofthe cord into the sulcus.	Placement of the viscous gel results inphysical displacement of gingival tissue fromthe tooth. Material also facilitates insertion ofthe cord into the sulcus.
Viscosity	Viscous gel	Viscous gel
Packaging	1.2mL pre-filled syringe with applicator tips	1.2mL pre-filled syringe with applicator tips
Configuration	30mL syringe with empty 1.2mL syringes andapplicator tips.	30mL syringe with empty 1.2mL syringes andapplicator tips.

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Image /page/5/Picture/0 description: The image shows the logo for Intermed INC. The word "intermed" is written in blue, with a line underneath it. To the right of the word is a blue globe, and to the right of the globe is the word "INC." in black.

Image /page/5/Picture/1 description: The image shows the logo for Vista Dental Products. The logo features a stylized mountain range above the word "VISTA" in a light blue sans-serif font. Below "VISTA" are the words "Dental Products" in a smaller, darker font. There is a black line underneath the words "Dental Products".

	Predicate Device: ViscoStat® Clear(Ultradent Products)	Vista Clear(Inter-Med / Vista Dental Products)
Sterility	Non-sterile	Non-sterile
Shelf-Life	42 months	24 months
BiocompatibilityTesting Performed	Cytotoxicity	Cytotoxicity
RecommendedContact Time	1-3 minutes	1-3 minutes
Prescription / OTC	Prescription	Prescription

Similarities between the subject device (Vista Clear) and predicate device (ViscoStat Clear)

Vista Clear has nearly identical indications for use as the predicate device, ViscoStat Clear.
Vista Clear is classified under product code MVL and shares the identical common name "Cord, Retraction" as the predicate device.
Vista Clear has the same recommended contact time (1-3 minutes) as the predicate, ViscoStat Clear. ●
Vista Clear is identical to the predicate device as both products are aqueous gels which aid in the ● physical retraction of gingival tissue.
Vista Clear is used in the same target population and anatomical site as the predicate device.
Identical to the predicate device, Vista Clear is for prescription use only by healthcare professionals.
Vista Clear is offered in the same configurations as the predicate device (i.e. prefilled syringes with ● applicator tips, or bulk syringes with unfilled smaller syringes and applicator tips).
Vista Clear has identical technological characteristics to the predicate device: ●
- o Both medical devices contain an aqueous solution of a trivalent cationic salt (aluminum chlorite).
- Both medical devices have an identical pH. O
- Both medical devices exhibited identical results within cytotoxicity and microbiological O testing.

Vista Clear shares similar intended uses, technical characteristics, and methods of application to the predicate device (ViscoStat Clear). Therefore, Vista Clear is substantially equivalent to the predicate device.

This is the only 510(k) for this medical device, no prior 510(k)s have been submitted.

Differences between the subject device (Vista Clear) and predicate device (ViscoStat Clear)

Inter-Med, Inc. | 2200 South Street, Racine, WI 53404

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Image /page/6/Picture/0 description: The image shows the logo for Intermed INC. The word "intermed" is written in blue, with a black line underneath. To the right of the word is a blue globe, and to the right of the globe is the word "INC." in black.

Image /page/6/Picture/1 description: The image shows the logo for Vista Dental Products. The logo features a stylized mountain range above the word "VISTA" in blue, with a trademark symbol next to it. Below "VISTA" are the words "Dental Products" in a smaller font size. There is a horizontal line below the word "VISTA".

. Vista Clear contains 26.6% aluminum chloride hexahydrate whereas the predicate device contains 25% aluminum chloride.
- However, this different does not raise any safety or efficacy concerns as they are analogous O materials (i.e. aluminum chloride). In fact, Vista Clear is analogously effective as the predicate device yet includes a lower amount of aluminum chloride.
- Therefore, this difference does not raise any additional safety or efficacy concerns and the O subject device remains substantially equivalent to the predicate device.
Vista Clear has a shelf-life of 24 months, whereas the predicate device has a shelf-life of 42 months. ●
- This difference does not raise any safety or efficacy risks as the subject device has shown O safety and efficacy commensurate with the listed shelf-life and the product has labeling which adequately communicates shelf-life to the user.

Applicable Standards

ISO 10993-1 Biological Evaluation of Medical Devices Part 1 Evaluation and Testing ●
ISO 14971 Application of Risk Management to Medical Devices ●
ISO 594-1 Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical ● equipment - Part 1: General requirements
ISO 594-2 Conical fittings with 6 % (Luer) taper for syringes, needles and certain other medical ● equipment - Part 2: Lock fittings

7. Non-Clinical Performance Testing and Compliance

The following non-clinical tests were conducted to evaluate the functionality, performance, safety, and substantial equivalence of Vista Clear to ViscoStat Clear:

Analytical Testing
- Testing verified manufacturing of Vista Clear. Results from testing are commensurate o with the predicate device, supporting substantial equivalence of the subject device to an existing commercialized device.
Cytotoxicity Testing ●
- Vista Clear exhibited the same cytotoxicity result as the predicate device (ViscoStat O Clear) sold for the same intended use.
- This testing confirms that the subject device is substantially equivalent to the predicate o device. Combined with DHF-10043-BS and DHF-10043-CER, Inter-Med concludes that no further biocompatibility testing or clinical evaluation is needed before release of this product to the market.
Shelf-Life Testing ●

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Image /page/7/Picture/0 description: The image shows the logo for Intermed INC. The word "intermed" is written in blue, with a blue line underneath it. To the right of the word is a blue globe. The letters "INC." are written in black to the right of the globe.

Image /page/7/Picture/1 description: The image shows the logo for Vista Dental Products. The logo features a stylized mountain range above the word "VISTA" in a sans-serif font. Below "VISTA" is the text "Dental Products" in a smaller font. There is a horizontal line below the text.

Based on accelerated testing, a shelf life of two years is supported for Vista Clear. Real o time aging is being performed on Vista Clear to support shelf life during typical storage conditions.
Microbiological Testing
- Contamination risks from manufacturing are mitigated as Vista Clear exhibits O bactericidal properties. Furthermore, these results help to support shelf stability and multiple use of non-patient contacting materials, such as the syringes, as any introduced microbes will not remain viable within the medical device.
- It should be noted that Vista Dental Products is not claiming any "bactericidal" effect O of the subject medical device. This testing was performed solely to evaluate risk of contamination during manufacturing.
Transit Testing
- o This test confirms that the packaging configurations are sufficient and withstand simulated transit conditions. Moreover, the products performed satisfactory post-transit. which confirms that transit did not have a negative effect on the products themselves.

8. Clinical Performance Testing and Compliance

Clinical performance is not deemed necessary.

9. Conclusion

Vista Clear is to be marketed by Inter-Med / Vista Dental Products, 2200 South St. Ste. A., Racine, WI 53404, and is substantially equivalent to ViscoStat Clear (K123215). The subject medical device has a nearly identical intended use and technological characteristics as the predicate device. Any differences between the subject medical device and predical device do not significantly alter the product's use and do not result in unacceptable or unnecessary risks to the patients or users. Therefore, Inter-Med concludes that Vista Clear is substantially equivalent to the predicate device. ViscoStat Clear.

Regulation Number and Section

N/A