(89 days)
No
The device description and performance studies indicate a chemical staining agent, not a software or image processing technology that would typically incorporate AI/ML.
No
The device is a visual aid for identifying carious dentin, which means it helps in diagnosis and detection rather than directly treating a condition.
Yes
This device is used for the identification of carious dentin, which is a diagnostic purpose.
No
The device description clearly states it is a colored agent (dye) applied to the tooth, which is a physical substance, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The Vista Dyes device is a visual aid applied directly to the tooth (an anatomical site within the oral cavity) to stain carious dentin. It is used during a dental procedure to help the dentist identify and remove the affected tissue. It does not analyze a sample taken from the body.
- Intended Use: The intended use is for the "identification of carious dentin" in situ during a dental procedure, not for a diagnostic test performed on a sample in a lab.
- Device Description: The description clearly states the dye is applied to the suspected carious areas of the tooth.
- Lack of IVD Characteristics: There is no mention of analyzing bodily fluids or tissues in a laboratory setting, which is a hallmark of IVDs.
Therefore, while it is a diagnostic aid used in a clinical setting, it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
A visual aid for the identification of carious dentin.
Product codes
LFC
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Oral cavity
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Dental offices
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
The following non-clinical tests were conducted to evaluate the functionality, performance and support the substantial equivalence of Vista Dyes:
- Shelf-Life Testing
- 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.
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).
Clinical performance is not deemed necessary to support the substantial equivalence of the proposed device.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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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
1
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
2
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) |
|---|
| ------------------------------------------------- |
| Remediation Use (Part 21 CFR 201 Subpart D) | Own-Use Exception (21 CFR 201 Subpart C) |
|---|---|
| ------------------------------------------------------------------------------------- | ------------------------------------------------------------------- |
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 Products | ||
| 2200 South St. Ste A | |||
| Racine, | |||
| 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.
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.
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: Caries
Finder | Reference Device:
Pulpdent Snoop |
|--------------------------|----------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------|
| Manufacturer | Inter-Med / Vista
Dental Products | Danville Engineering, Inc. | Pulpdent Corp. |
| 510(k) Number | Pending
(subject device for this
510(k) submission) | K955445 | K964430 |
| Common Name | Device, Caries
Detection | Device, Caries Detection | Device, Caries Detection |
| Device
Classification | Class II | Class II | Class II |
| Product Code | LFC | LFC | LFC |
| Indications
for Use | A visual aid for the
identification of
infected carious dentin. | A visual aid for the
identification of infected
carious dentin. | A visual aid for the
identification of infected
carious dentin. |
| Where used | Dental offices | Dental offices | Dental offices |
| Target
population | Patients undergoing
dental procedures | Patients undergoing dental
procedures | Patients undergoing dental
procedures |
| Anatomical site | Oral cavity | Oral cavity | Oral cavity |
| Physical
Properties | Colored aqueous liquid | Colored aqueous liquid | Colored aqueous liquid |
| Chemical
Properties | Red & Green Color:
99% propylene glycol
1% dye
(red = acid red 52;
green = FD&C green) | Red & Green Color:
99% propylene glycol
1% dye
(red = acid red 52; green =
FD&C green) | Not applicable (no red or
green 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 water
1% methylene blue dye | Not applicable (no blue dye) | 49.5% propylene glycol
49.5% distilled water
1% methylene blue dye |
| Mechanism of
Action | Visible staining of
carious dentin | Visible staining of carious
dentin | Visible staining of carious
dentin |
| Packaging
Configuration | Prefilled dropper bottle
Prefilled 1.2mL syringe | Prefilled dropper bottle | Prefilled dropper bottle |
| Sterility | Non-sterile | Non-sterile | Non-sterile |
| Active
Ingredients | 1% dye
(red = acid red 52;
green = FD&C green) | 1% dye
(red = acid red 52; green =
FD&C green) | Not applicable (no red or
green 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.
7
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.