Vista Rinse and Vista Rinse Plus are endodontic irrigating solutions that cleanse the root canal system by removing the smear layer after endodontic instrumentation.

Device Description

Vista Rinse and Vista Rinse Plus are endodontic irrigating solutions that cleanse the root canal system by removing the smear layer after endodontic instrumentation. Both medical devices are packaged in bottles. Clinical use of the medical devices requires the irrigant to be expelled from syringes through irrigation tips, which are class I medical devices per EIC product code (syringe, periodontic, endodontic, irrigating) and CFR regulation number 872.4565 and are 510(k) exempt.

AI/ML Overview

The provided document is a 510(k) summary for the Vista Rinse and Vista Rinse Plus endodontic irrigating solutions. This type of document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed clinical study with specific acceptance criteria as one might find for a novel medical device. Therefore, much of the requested information regarding a study proving acceptance criteria and specific performance metrics in a clinical context is not explicitly available in this document.

However, I can extract information related to the non-clinical performance testing which served as the basis for demonstrating substantial equivalence.

Here's the breakdown based on the provided text:

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

The document does not define explicit "acceptance criteria" in a quantitative sense as might be found in a clinical trial protocol. Instead, it relies on demonstrating comparable performance to predicate devices through non-clinical testing. The reported device performance is presented as being "commensurate with" or "identical to or better than" the predicate devices.

Acceptance Criteria (Implied)	Reported Device Performance (Vista Rinse / Vista Rinse Plus)
Manufacturing verification for composition	Analytical Testing: Verified manufacturing; results commensurate with the predicate device.
Cytotoxicity (at 24 hours)	Cytotoxicity Testing: Exhibited the same cytotoxicity results at 24 hours as the primary predicate device (Q-Mix). For Vista Rinse Plus, it was even "less cytotoxic than Q-Mix at dilutions of 1:16 and 1:64" at 72 hours, which "does not raise any concerns of safety or efficacy."
Shelf-life	Shelf-Life Testing: 24 months supported based on accelerated testing. Real-time aging is being performed to support shelf life during typical storage conditions (identical to the predicate device Q-Mix).
Root canal cleansing via smear layer removal (calcium chelation)	SEM Evaluation & Calcium Chelation Testing: Satisfactorily performed as root canal cleansers via SEM imaging. Calcium chelation characteristics equal to or better than the predicate device Q-Mix. (The predicate, 17% EDTA, is noted as the "gold standard irrigant for the removal of smear layer" and the subject device's lack of surfactants in Vista Rinse or different blend in Rinse Plus had "no impact on safety or efficacy.")

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

The document does not specify the sample sizes (e.g., number of test specimens, number of wells for cytotoxicity) used for the non-clinical tests.

Cytotoxicity Testing: No specific sample size is mentioned.
SEM Evaluation & Calcium Chelation Testing: No specific sample size is mentioned for the SEM evaluations or calcium chelation.
Data Provenance: The testing was conducted by Inter-Med/Vista Dental Products, the submitter, as part of their 510(k) submission. The exact country of origin or whether the data was retrospective or prospective (for non-clinical lab studies) is not detailed.

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

This information is not applicable. For non-clinical performance testing like cytotoxicity and smear layer removal, the "ground truth" is established by scientific methodologies and laboratory measurements, not by expert consensus. There were no human experts adjudicating test results in this context.

4. Adjudication method for the test set

Not applicable, as there was no human expert adjudication of test results for these laboratory studies.

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 an endodontic irrigating solution, not an AI-assisted diagnostic or therapeutic device that would involve human readers or MRMC studies.

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

Not applicable. This device is a medical solution, not a software algorithm.

7. The type of ground truth used

The "ground truth" for the non-clinical performance testing was based on:

Laboratory measurements and analytical chemistry: For composition verification (analytical testing), pH, and chelation characteristics.
Standardized biological assays: For cytotoxicity testing (ISO 10993-5:2009).
Microscopic imaging and qualitative assessment: For smear layer removal (SEM evaluation). The effectiveness was compared to the known performance of predicate devices, which utilize 17% EDTA, considered the "gold standard."

8. The sample size for the training set

Not applicable. This document describes a traditional medical device (chemical solution), not a machine learning or AI-driven device that requires a training set.

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

Not applicable, as no training set was used.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym along with the full name of the agency on the right. The FDA acronym is in blue, and the full name of the agency, "U.S. Food & Drug Administration," is in a smaller font size below the acronym.

September 9, 2020

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

Re: K193409

Trade/Device Name: Vista Rinse, Vista Rinse Plus Regulatory Class: Unclassified Product Code: KJJ Dated: June 9, 2020 Received: June 12, 2020

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/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 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) K193409

Device Name Vista Rinse and Vista Rinse Plus

Indications for Use (Describe)

Vista Rinse and Vista Rinse Plus are endodontic irrigating solutions that cleanse the root canal system by removing the smear layer after endodontic instrumentation.

Type of Use (Select one or both, as applicable)
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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 INC. The word "intermed" is in blue, with a black 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/3/Picture/1 description: The image shows the logo for Vista Dental Products. The logo features the word "VISTA" in a sans-serif font, with a stylized mountain range above it. Below the word "VISTA" are the words "Dental Products" in a smaller font. The logo is primarily blue and white.

510(k) Summary for Vista Rinse & Vista Rinse Plus

K193409

1. Applicant

Submitter's Name:	Katherine Barry, MSc	Date Summary Prepared:	April 20, 2020
Address:	Inter-Med / Vista Dental Products2200 South St. Ste ARacine, WI, USA 53404	Contact Person:	Katherine Barry, MSc
Phone:	(262) 635-8956	Email:	kbarry@vista-dental.com
Fax:	(262) 636-9760

2. Device Name

Proprietary Name: Vista Rinse & Vista Rinse Plus Common Name: Cleanser, Root Canal Product Code: KJJ Device Class: Unclassified

3. Predicate Devices

O-Mix 2in1 Endodontic Irrigation Solution (K103244) by Dentsply Sirona

O Common Name: Cleanser, Root Canal
Product Code: KJJ O
Device Class: Unclassified O

PacEndo EDTA (K153528) by Pac-Dent International, Inc.

Common Name: Cleanser, Root Canal O
O Product Code: KJJ
Device Class: Unclassified O

4. Device Description

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Image /page/4/Picture/0 description: The image features the logos of two companies. On the left is the "intermed INC." logo, with "intermed" in blue and a blue globe next to it. To the right is the "VISTA Dental Products" logo, which includes a stylized mountain range above the word "VISTA" and the words "Dental Products" below.

Intended Use / Indication for Use ડ.

Vista Rinse and Vista Rinse Plus are endodontic irrigating solutions that cleanse the root canal system by removing the smear layer after endodontic instrumentation.

	Subject Device:Vista Rinse and Vista RinsePlus	Primary Predicate Device:Q-Mix 2in1 EndodonticIrrigation Solution	Reference Predicate Device:PacEndo™ EDTA
Manufacturer	Inter-Med / Vista DentalProducts	Dentsply	Pac-Dent
510(k) Number	K193409	K103244	K153528
Common Name	Cleanser, Root Canal	Cleanser, Root Canal	Cleanser, Root Canal
DeviceClassification	Unclassified	Unclassified	Unclassified
Product Code	KJJ	KJJ	KJJ
Indication forUse	Vista Rinse and Vista Rinse Plusare endodontic irrigatingsolutions that cleanse the rootcanal system by removing thesmear layer after endodonticinstrumentation.	Q-Mix 2in1 Irrigation Solutionis a premixed dual-action devicethat cleanses and disinfects theroot canal system by removingthe smear layer after endodonticinstrumentation.	PacEndo™ EDTA is intended tofacilitate removal of dentinaldebris from the walls of rootcanals prior to obturation.
Where used	Dental offices and health careoffices	Dental offices and health careoffices	Dental offices and health careoffices
Targetpopulation	Patients undergoing endodontictherapy	Patients undergoing endodontictherapy	Patients undergoing endodontictherapy
Anatomical site	Oral cavity	Oral cavity	Oral cavity
PhysicalProperties	Vista Rinse and Vista Rinse Plusare both clear, colorless,.odorless aqueous solutions	Clear, colorless, odorlessaqueous solution	Clear, colorless, odorlessaqueous solution

6. Technological Characteristics and Substantial Equivalence

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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 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/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 sans-serif font. Below "VISTA" are the words "Dental Products" in a smaller font. The logo is simple and clean, with a focus on the company name and the mountain imagery.

	Subject Device:Vista Rinse and Vista RinsePlus	Primary Predicate Device:Q-Mix 2in1 EndodonticIrrigation Solution	Reference Predicate Device:PacEndoTM EDTA
ChemicalProperties	pH 7.0 - 8.5	pH 7.5 - 8.51	pH 7.5
Mechanism ofAction	The mechanical action of thesolution moving in the root canalfacilitates ease in the removal ofdebris, bacteria, and necroticpulp tissue from the root canal.	The mechanical action of thesolution moving in the root canalfacilitates ease in the removal ofdebris and necrotic pulp tissuefrom the root canal. The mode ofaction for the solution is that itdisrupts the bacterial cellmembrane, killing the cell toensure that it cannot reproduceor grow.	The mechanical action of thesolution moving in the root canalfacilitates ease in the removal ofdebris, bacteria, and necroticpulp tissue from the root canal.
PackagingConfiguration	Both Vista Rinse and VistaRinse Plus are packaged in thefollowing configurations:120mL and 480mL bottles	60mL and 480mL bottle	480 mL bottle
Sterility	Non-sterile	Non-sterile	Non-sterile
ActiveIngredients	Vista Rinse:Ethylenediaminetetraacetic acid(EDTA)Vista Rinse Plus:Ethylenediaminetetraacetic acid(EDTA)Chlorhexidine digluconate(CHX)	Ethylenediaminetetraacetic acid(EDTA)Chlorhexidine digluconate(CHX)Cetrimonium bromide (CB)	Ethylenediaminetetraacetic acid(EDTA)
Shelf-Life	24 months	24 months	Unknown
BiocompatibilityTestingPerformed	Cytotoxicity	Cytotoxicity	Unknown
Prescription /OTC	Prescription	Prescription	Prescription

Similarities between the subject device (Vista Rinse) and predicate devices (Q-Mix and PacEndo EDTA)

Besides tradenames, Vista Rinse has nearly identical indications for use as the primary predicate ● device, Q-Mix, and identical indications for use as the reference predicate device, PacEndo EDTA.
1 The Q-Mix 510(k) (K103244) Executive Summary states "slightly basic" as a Chemical Property. In the cover letter and in the SDS for Q-Mix the pH is listed at 7.5 and 8.0, respectively. Furthermore, an additional lot of Q-Mix was evaluated by Inter-Med / Vista Dental and the pH was measured to be 8.5.

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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 the "i" in "intermed" being replaced by a blue globe. The letters "INC." are written in black to the right of the globe.

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 a light blue sans-serif font. Below "VISTA" are the words "Dental Products" in a smaller, darker font. There is a horizontal line under the word "VISTA".

. Vista Rinse is classified under product code KJJ and shares the identical common name "Cleanser. Root Canal" as the predicate devices.
Vista Rinse is nearly identical to the predicate devices, Q-Mix and PacEndo EDTA, as all products . are EDTA-based aqueous liquids which aid in the cleansing of root canals during endodontic therapy.
Vista Rinse is used in the same target population and anatomical site as the predicate devices. ●
Identical to the predicate devices, Vista Rinse is for prescription use only by healthcare ● professionals.
Vista Rinse is offered in the same configurations as the predicate devices (i.e. filled bottles). ●
Vista Rinse has the same shelf-life as the predicate device Q-Mix 2in1 Endodontic Irrigation ● Solution (i.e. 24 months).
Vista Rinse has identical technological characteristics to the predicate device (Q-Mix): ●
- o All medical devices contain an aqueous solution of EDTA.
- o All medical devices have similar pH values (i.e. slightly basic, 7.0 8.5).
- o Identical results to the primary predicate device, Q-Mix, within cytotoxicity testing at 24 hours and smear layer removal.

Similarities between the subject device (Vista Rinse Plus) and predicate devices (Q-Mix and PacEndo EDTA)

Besides tradenames. Vista Rinse Plus has nearly identical indications for use as the predicate . devices. O-Mix and PacEndo EDTA.
Vista Rinse Plus is classified under product code KJJ and shares the identical common name "Cleanser, Root Canal" as the predicate devices.
Vista Rinse Plus is nearly identical to the predicate devices Q-Mix and PacEndo EDTA, as all ● products are EDTA-based aqueous liquids containing surfactants which aid in the cleansing of root canals during endodontic therapy.
Vista Rinse Plus is used in the same target population and anatomical site as the predicate devices. ●
Identical to the predicate devices, Vista Rinse Plus is for prescription use only by healthcare ● professionals.
Vista Rinse Plus is offered in the same configurations as the predicate devices (i.e. filled bottles). ●
Vista Rinse Plus has the same shelf-life as the predicate device Q-Mix 2in1 Endodontic Irrigation ● Solution (i.e. 24 months).
Vista Rinse Plus has identical technological characteristics to the predicate device: ●
- Vista Rinse Plus and Q-Mix contain an aqueous solution of EDTA and chlorhexidine O digluconate.
- All medical devices have similar pH values (i.e. slightly basic, 7.0 8.5). O
- Identical results to the primary predicate device, Q-Mix, within cytotoxicity testing at 24 O hours and smear layer removal.

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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 black line underneath. To the right of the word is a blue globe with white lines. 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 the word "VISTA" in a sans-serif font, with a stylized mountain range above it. Below the word "VISTA" is the text "Dental Products" in a smaller font. There is a horizontal line below the word "VISTA".

Vista Rinse & Vista Rinse Plus share similar intended uses, technical characteristics, and methods of application to the predicate devices (Q-Mix and PacEndo EDTA). Therefore, Vista Rinse & Vista Rinse Plus pose no additional safety risks or efficacy concerns.

Differences between the subject device (Vista Rinse) and predicate devices (Q-Mix and PacEndo EDTA)

Vista Rinse is packaged in 120mL and 480mL bottles, whereas the predicate devices, Q-Mix and . PacEndo EDTA are packaged in 60mL and 480mL bottles and 480mL bottles, respectively.
- The difference of 120mL vs 60mL bottles does not raise any safety or efficacy risks as this о is simply user preference and has no implications on risk or efficacy. A clinical user of the predicate device could use two 60mL bottles in place of one 120mL bottle of the subject device.
While the predicate devices, Q-Mix and PacEndo EDTA, have a pH of 7.5 8.5 and 7.5, ● respectively, Vista Rinse has a pH range of 8.0 to 8.5. This has no impact on safety or efficacy as the pH ranges of the subject device and predicate devices overlap. Furthermore, according to Nikiforuk and Sreebny2 at a pH above 6, calcium is strongly chelated by EDTA.
While the predicate devices, Q-Mix and PacEndo EDTA, contain an aqueous solution of EDTA . and surfactants. Vista Rinse contains an aqueous solution of EDTA without the addition of surfactants. The lack of surfactants has no impact on safety or efficacy, as 17% EDTA has been used for over 60 years as the gold standard irrigant for the removal of smear layer.

Differences between the subject device (Vista Rinse Plus) and predicate devices (Q-Mix and PacEndo EDTA)

. Vista Rinse Plus is packaged in 120mL and 480mL bottles, whereas the predicate devices. O-Mix and PacEndo EDTA are packaged in 60mL and 480mL bottles and 480mL bottles, respectively.
- The difference of 120mL vs 60mL bottles does not raise any safety or efficacy risks as this o is simply user preference and has no implications on risk or efficacy. A clinical user of the predicate device could use two 60mL bottles in place of one 120mL bottle of the subject device.
While the predicate devices, Q-Mix and PacEndo EDTA, have a pH of 7.5 8.5 and 7.5, . respectively, Vista Rinse Plus has a pH range of 7.0 to 8.0. This has no impact on safety or efficacy as the pH ranges of the subject device and predicate devices overlap. Furthermore, according to Nikiforuk and Sreebny2 at a pH above 6, calcium is strongly chelated by EDTA.
While the predicate devices. O-Mix and PacEndo EDTA, contain an aqueous solution of EDTA ● and surfactants, Vista Rinse Plus contains an aqueous solution of EDTA with a different blend of surfactants. The different blend of surfactants has no implications on safety or efficacy, as all surfactants have been used in previously cleared 510(k)s.

2 Nikiforuk G, Sreenby L. Demineralization of hard tissues by organic chelating agents at neutral pH. J Dent Res. 1953;32(6):859-867. doi:10.1177/00220345530320061401

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Image /page/8/Picture/0 description: The image shows the logos for two companies, 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, with a blue globe to the right of the word. The Vista Dental Products logo is on the right side of the image and features a blue mountain range above the word "VISTA".

At 72 hours, Vista Rinse Plus proved to be less cytotoxic than O-Mix at dilutions of 1:16 and 1:64. . This does not raise any concerns of safety or efficacy.
Applicable Standards
ISO 10993-5:2009 Biological evaluation of medical devices Part 5: Tests for in vitro ● cytotoxicity
ISO 14971:2019 Application of Risk Management to Medical Devices ●

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 Rinse Plus to the primary predicate device, 0-Mix:

Analytical Testing ●
- Testing verified manufacturing of Vista Rinse & Vista Rinse Plus. Results from testing o are commensurate with the predicate device, supporting substantial equivalence of the subject device to an existing commercialized device.
Cytotoxicity Testing ●
- Vista Rinse & Vista Rinse Plus exhibited the same cytotoxicity results at 24 hours as o the predicate device (Q-Mix) sold for the same intended use.
- This testing confirms that the subject device is substantially equivalent to the predicate O device. Combined with DHF-10008-BS, Inter-Med concludes that no further biocompatibility testing or clinical evaluation is needed before release of this product to the market.
Shelf-Life Testing ●
- Based on accelerated testing, a shelf life of two years is supported for Vista Rinse & o Vista Rinse Plus. Real time aging is being performed on Vista Rinse & Vista Rinse Plus to support shelf life during typical storage conditions.
SEM Evaluation & Calcium Chelation Testing ●
- Testing verified that Vista Rinse & Vista Rinse Plus satisfactorily performed as root o canal cleansers via SEM imaging. Substantial equivalence to the predicate device, Q-Mix, is supported as the subject medical devices have calcium chelation characteristics equal to or better than the predicate device.

8. Clinical Performance Testing and Compliance

Clinical performance is not deemed necessary.

9. Conclusion

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Image /page/9/Picture/0 description: The image shows the logos for two companies, 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, with a blue globe next to it. The Vista Dental Products logo is on the right side of the image and features a blue mountain range above the word "VISTA" and the words "Dental Products" below it.

Vista Rinse & Vista Rinse Plus have similar intended uses and technological characteristics as the predicate devices, and all devices are suitable when used for their described indications. Therefore, Inter-Med concludes that Vista Rinse & Vista Rinse Plus are substantially equivalent to the predicate devices, Q-Mix and PacEndo EDTA.

Regulation Number and Section

N/A