Vista Dyes are colored agents that when applied to the suspected carious areas of the tooth stains the carious dentin. The method of operation and placement of Vista Dyes are similar to that of the primary predicate and reference device, Caries Finder (K955445) and Pulpdent Snoop (K964430), respectively. A drop of the dye is applied to the carious dentine, rinsed with water and air dispersed. The stained carious tissue is then removed with a low speed rotary bur. The process may be repeated until there are no more stainable tissues in the carious cavity.

AI/ML Overview

The device described is "Vista Dyes", a caries detection device. Based on the provided text, there is no detailed study provided that presents specific acceptance criteria and device performance metrics in a quantitative manner. The submission primarily relies on demonstrating substantial equivalence to predicate devices (Caries Finder and Pulpdent Snoop) based on identical indications for use, technological characteristics, and methods of application, rather than presenting a performance study with specific acceptance criteria.

The document states: "Clinical performance is not deemed necessary to support the substantial equivalence of the proposed device." Therefore, there is no information about acceptance criteria, reported device performance, sample size, ground truth establishment, or expert involvement for a performance study.

However, based on the information provided, we can infer some aspects of what would typically be considered "acceptance criteria" through the comparative analysis with predicate devices.

Here's an analysis of the provided information in response to your questions:

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

No explicit quantitative acceptance criteria or reported device performance (e.g., sensitivity, specificity) were provided in the document. The substantial equivalence argument serves as the "acceptance criteria" here, meaning that the device's characteristics must be sufficiently similar to the predicate devices to not raise new questions of safety or effectiveness.

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. No clinical or performance test set was described.

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. No clinical or performance test set requiring expert ground truth was described.

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

Not applicable. No clinical or performance test set was 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

Not applicable. This device is a dye, not an AI-assisted device, and no MRMC study was performed.

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

Not applicable. This device is a dye, not an algorithm.

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

Not applicable. No performance study requiring ground truth was conducted or described. The safety and effectiveness are established by substantial equivalence to legally marketed predicate devices, implying that the known performance characteristics of the predicate devices implicitly serve as a "ground truth" for what is acceptable.

8. The sample size for the training set

Not applicable. This is not an AI/ML device, so there is no training set.

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

Not applicable. This is not an AI/ML device, so there is no training set or associated ground truth establishment.

Summary of Acceptance Criteria and Performance (Inferred from Substantial Equivalence):

Acceptance Criteria Category	Reported Device Performance / Justification
Indications for Use	Identical to predicate device (Caries Finder): "A visual aid for the identification of infected carious dentin."
Mechanism of Action	Identical to predicate: "Visible staining of carious dentin."
Material Composition	- Red & Green Dyes: 99% propylene glycol, 1% dye (acid red 52 or FD&C green). Identical to predicate.- Blue Dye: 99% distilled water, 1% methylene blue dye. Differs from primary predicate (which uses propylene glycol) but is equivalent to reference device (Pulpdent Snoop).
Physical Properties	Colored aqueous liquid. Identical to predicate.
Chemical Properties	1% dye concentration. Identical to predicate.
Intended Use	Same target population and anatomical site. Identical to predicate.
Packaging Configuration	- Dropper bottles: Identical to predicate.- Prefilled 1.2mL syringes: Additional configuration, deemed not to raise new concerns as it simplifies application and is common in dentistry.
Sterility	Non-sterile. Identical to predicate.
Shelf-Life	3 years. Based on accelerated testing and ongoing real-time aging. Identical to predicate.
Prescription/OTC Use	Prescription use only. Identical to predicate.
Biocompatibility	Confirmed via literature review, LD50 analysis of constituents, existing FDA data, and longstanding use of predicate without significant adverse events (MAUDE database).
Safety and Effectiveness	Demonstrated through substantial equivalence to legally marketed predicate devices, with no new questions of safety or effectiveness raised by minor differences.

In essence, the "study" for Vista Dyes was a substantial equivalence comparison demonstrating that its characteristics are similar enough to existing, legally marketed devices that it does not require new clinical performance data.

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, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font below.

March 11, 2020

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

Re: K193447

Trade/Device Name: Vista Dyes Regulation Number: 21 CFR 872.1740 Regulation Name: Caries Detection Device Regulatory Class: Class II Product Code: LFC Dated: December 10, 2019 Received: December 13, 2019

Dear Mr. 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

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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 https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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) K193447

Device Name Vista Dyes

Indications for Use (Describe)

A visual aid for the identification of carious dentin.

Type of Use (Select one or both, as applicable)
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Remediation Use (Part 21 CFR 201 Subpart D)	Own-Use Exception (21 CFR 201 Subpart C)
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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 INC. The word "intermed" is written in blue, with a black line underneath. 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/3/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 blue sans-serif font. Below "VISTA" are the words "Dental Products" in a smaller, sans-serif font. There is a horizontal line below the word "VISTA".

K193447 510(k) Summary for Vista Dyes

1. Applicant

Submitter's Name:	Alex Johnson, MSc	Date Summary Prepared:	March 10, 2020
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. Devce Name

Proprietary Name: Vista Dyes Common Name: Device, Caries Detection Product Code: LFC Device Class: Class II

3. Primary Predicate

Caries Finder (K955445) by Danville Engineering, Inc.

Common Name: Device, Caries Detection o
Product Code: LFC O
Device Class: Class II O

Reference Device:

Pulpdent Snoop (K964430) by Pulpdent Corp.

O Common Name: Device, Caries Detection
Product Code: LFC O
Device Class: Class II O

4. Device Description

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

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Image /page/4/Picture/0 description: The image features the logos of two companies, Intermed Inc. and Vista Dental Products. The Intermed Inc. logo is on the left and includes the word "intermed" in blue, followed by a blue globe graphic and the letters "INC." in black. The Vista Dental Products logo is on the right and includes a stylized mountain range above the word "VISTA" in blue, with the words "Dental Products" in smaller font below.

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

ട. Intended Use / Indications for Use

A visual aid for the identification of infected carious dentin.

Technological Characteristics and Substantial Equivalence 6.

	Subject Device:Vista Dyes	Primary Predicate: CariesFinder	Reference Device:Pulpdent Snoop
Manufacturer	Inter-Med / VistaDental Products	Danville Engineering, Inc.	Pulpdent Corp.
510(k) Number	Pending(subject device for this510(k) submission)	K955445	K964430
Common Name	Device, CariesDetection	Device, Caries Detection	Device, Caries Detection
DeviceClassification	Class II	Class II	Class II
Product Code	LFC	LFC	LFC
Indicationsfor Use	A visual aid for theidentification ofinfected carious dentin.	A visual aid for theidentification of infectedcarious dentin.	A visual aid for theidentification of infectedcarious dentin.
Where used	Dental offices	Dental offices	Dental offices
Targetpopulation	Patients undergoingdental procedures	Patients undergoing dentalprocedures	Patients undergoing dentalprocedures
Anatomical site	Oral cavity	Oral cavity	Oral cavity
PhysicalProperties	Colored aqueous liquid	Colored aqueous liquid	Colored aqueous liquid
ChemicalProperties	Red & Green Color:99% propylene glycol1% dye(red = acid red 52;green = FD&C green)	Red & Green Color:99% propylene glycol1% dye(red = acid red 52; green =FD&C green)	Not applicable (no red orgreen dye)

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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 black line underneath. 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/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 blue, with a trademark symbol next to it. Below "VISTA" are the words "Dental Products" in a smaller font size.

	Subject Device:Vista Dyes	Primary Predicate Device:Caries Finder	Reference Device:Pulpdent Snoop
	99% distilled water1% methylene blue dye	Not applicable (no blue dye)	49.5% propylene glycol49.5% distilled water1% methylene blue dye
Mechanism ofAction	Visible staining ofcarious dentin	Visible staining of cariousdentin	Visible staining of cariousdentin
PackagingConfiguration	Prefilled dropper bottlePrefilled 1.2mL syringe	Prefilled dropper bottle	Prefilled dropper bottle
Sterility	Non-sterile	Non-sterile	Non-sterile
ActiveIngredients	1% dye(red = acid red 52;green = FD&C green)	1% dye(red = acid red 52; green =FD&C green)	Not applicable (no red orgreen dye)
	1% methylene blue dye	Not applicable (no blue dye)	1% methylene blue dye
Shelf-Life	3 years	3 years	Unknown
Prescription /OTC	Prescription use only	Prescription use only	Prescription use only

Similarities between the subject device (Vista Dyes) and primary predicate (Caries Finder):

Vista Dyes and Caries Finder have identical indications for use. ●
. Vista Dyes are classified under product code LFC and shares the identical common name "Device, Caries Detection" as the predicate device, Caries Finder.
Vista Dyes are identical to the primary predicate as all products are liquid medical devices composed of propylene glycol and/or water and a colored dye.
Vista Dyes are used in the same target population and anatomical site as the primary predicate. ●
Identical to the primary predicate, Vista Dyes are for prescription use only by healthcare ● professionals.
Vista Dyes is offered in the same configurations as the primary predicate (i.e. filled dropper bottles).
Vista Dyes have identical shelf-life to the primary predicate (36 months). ●
Vista Dyes have identical technological characteristics to the primary predicate: ●
- O All medical devices contain a colored dye in a liquid media.
- O The colored dye in Vista Dyes is identical to the colored dye found in the primary predicate and reference device.
- The colored dye in Vista Dyes is incorporated at identical concentrations to that of the O primary predicate and reference device.

Vista Dyes share identical intended uses, technical characteristics, and methods of application to the primary predicate (Caries Finder).

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

Image /page/6/Picture/1 description: The image is a logo for Vista Dental Products. The logo features a stylized mountain range above the word "VISTA" in blue, with a small "TM" symbol next to it. Below "VISTA" are the words "Dental Products" in a smaller, sans-serif font. A horizontal black line is located on the bottom left of the logo.

Differences between the subject device (Vista Dyes) and predicate device (Caries Finder)

The blue-colored device of Vista Dyes is 1% dye in 99% water whereas the predicate device, Caries Finder, uses propylene glycol as the liquid media instead of water.
- This difference does not raise concerns or risks as reference is made to the a previously o 510(k) cleared reference device, Pulpdent Snoop (K964430), which is 1% dye in 99% water.
- Therefore, the subject devices remain substantially equivalent to the predicate device, in O light of the reference device.
Vista Dyes are packaged in 10mL dropper bottles and 1.2mL prefilled syringes, whereas the predicate device is only packaged in 10mL dropper bottles.
- o This difference does not raise concerns or risks as the additional packaging configuration (i.e. 1.2mL prefilled syringe) is very common in the dental field for application of dental materials. Additionally, this packaging configuration helps to simplify the application of Vista Dyes, as material can be expressed directly from the syringe onto the tooth in a controlled fashion using an applicator tip.

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 and support the substantial equivalence of Vista Dyes:

Shelf-Life Testing
- o Based on accelerated testing, a shelf life of three years is supported for Vista Dyes. Real time aging is being performed on Vista Dyes to support shelf life during typical storage conditions.

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Image /page/7/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 features the word "intermed" in blue, followed by a blue globe and the letters "INC." in black. The Vista Dental Products logo is on the right side of the image and features a blue mountain range above the word "VISTA" in blue, followed by the words "Dental Products" in black.

Additionally, given the long history of use of similar devices, and the fact the proposed device features identical constituents as the predicate and reference devices, the biocompatibility of Vista Dyes was confirmed via a literature review, LD50 analysis of product constituents, existing FDA data, and longstanding use of the predicate device in commerce without significant reportable events (MAUDE database).

8. Clinical Performance Testing and Compliance

Clinical performance is not deemed necessary to support the substantial equivalence of the proposed device.

9. Conclusion

Vista Dyes are to be marketed by Inter-Med / Vista Dental Products, 2200 South St. Ste. A., Racine, WI 53404, and is deemed to be substantially equivalent to primary predicate Caries Finder (K955445). The proposed device and its primary predicate have identical intended use and technological characteristics as the predicate device, and both devices are suitable for their described indications. Any differences between the subject device and primary predicate device do not significantly alter the product's use and do not result in unacceptable or unnecessary concerns for the patients or users. Further, any differences between the subject and predicate devices are substantiated from and addressed in the reference device (Pulpdent Snoop, K964430). Therefore, Inter-Med / Vista Dental Products concludes that Vista Dyes are substantially equivalent to the predicate device, Caries Finder.

Regulation Number and Section

§ 872.1740 Caries detection device.

(a)
Identification. The caries detection device is a device intended to show the existence of decay in a patient's tooth by use of electrical current.(b)
Classification. Class II.