V-Mix is a two-part, dual-action root canal cleanser. V-Mix A is an aqueous solution that contains carboxylic acid chelating agents and surfactants. V-Mix B is an aqueous solution that contains sodium hypochlorite. Once the two solutions are mixed, the mixed solution cleanses and debrides the root canal system by removing the organic and inorganic debris during and after endodontic instrumentation.

AI/ML Overview

The provided document is a 510(k) K193357 Premarket Notification for the V-Mix device. It includes a general statement that "Clinical performance is not deemed necessary" and states that non-clinical tests were conducted to evaluate functionality, performance, safety, and substantial equivalence.

Therefore, the document does not report on acceptance criteria or a study proving the device meets acceptance criteria in a clinical setting.

It lists several non-clinical tests that were performed, but no details of these tests (such as specific methods, results, or acceptance criteria) are provided.

Hence, I cannot extract the requested information as it is not present in the provided text.

Summary

{0}------------------------------------------------

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

October 23, 2020

Inter-Med/ Vista Dental Products Katherine Barry Product Development Engineer 2220 South Street Suite A Racine. Wisconsin 53404

Re: K193357

Trade/Device Name: V-Mix Regulatory Class: Unclassified Product Code: KJJ Dated: September 22, 2020 Received: September 23, 2020

Dear Katherine Barry:

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 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-reporting

{1}------------------------------------------------

combination-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

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K193357

Device Name V-Mix

Indications for Use (Describe)

V-Mix is used for debridement, removing the smear layer, and cleansing the root canal system.

Type of Use (Select one or both, as applicable)

区 Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

Image /page/3/Picture/0 description: The image shows the logo for Intermed INC. The word "intermed" is written in blue, with a horizontal 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/3/Picture/1 description: The image shows the logo for Vista Dental Products. The logo features the word "VISTA" in a stylized blue font, with a mountain range graphic above it. Below the word "VISTA" are the words "Dental Products" in a smaller, sans-serif font. The overall design is clean and professional, suggesting a company that specializes in dental-related products.

K193357 510(k) Summary for V-Mix

1. Applicant

Submitter's Name:	Katherine Barry, MSc	Date Summary Prepared:	September 21, 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

2. Device Name

Fax:

Proprietary Name: V-Mix Common Name: Cleanser, Root Canal Product Code: KJJ Device Class: Unclassified

(262) 636-9760

3. Predicate Devices

Chlor-Xtra (K082470) by Inter-Med / Vista Dental Products

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

Biopure MTAD Root Canal Cleanser (K053167) by Dentsply

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

Vista Rinse Plus (K193409) by Inter-Med / Vista Dental Products

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

4. Device Description

{4}------------------------------------------------

Image /page/4/Picture/0 description: The image shows the logos for Intermed INC. and Vista Dental Products. The Intermed INC. logo is in blue and features the word "intermed" in a sans-serif font, followed by a globe graphic and the letters "INC." in a smaller font. The Vista Dental Products logo is also in blue and features a stylized mountain range above the word "VISTA" and the words "Dental Products" in a smaller font below.

ನ. Intended Use / Indication for Use

V-Mix is used for debridement, removing the smear layer, and cleansing the root canal system.

6. Technological Characteristics and Substantial Equivalence

Technological Characteristics

Most all the components found in V-Mix have been used in legally marketed devices or were found safe for dental use. We believe that the prior use of components in legally marketed devices, the performance data provided, and the biocompatibility data provided support the safety and effectiveness of V-Mix for the indicated uses.

	Subject Device:V-Mix	Primary PredicateDevice:Chlor-XTRA™	Predicate Device:BioPure MTAD RootCanal Cleanser	Predicate Device: VistaRinse Plus
Manufacturer	Inter-Med / VistaDental Products	Inter-Med / VistaDental Products	DENTSPLY INTL	Inter-Med / Vista DentalProducts
510(k) Number	K193357	K082470	K053167	K193409
Common Name	Cleanser, Root Canal	Cleanser, Root Canal	Cleanser, Root Canal	Cleanser, Root Canal
DeviceClassification	Unclassified	Unclassified	Unclassified	Unclassified
Product Code	KJJ	KJJ	KJJ	KJJ
Indication forUse	V-Mix is used fordebridement,removing the smearlayer, and cleansingthe root canal system.	Chlor-XTRA™ is asolution used fordebridement and theinstrumentation of rootcanal.	BioPure MTAD is usedto chemically clean thecanal and disinfect theroot canal system afterendodonticinstrumentation.	Vista Rinse Plus is anendodontic irrigatingsolution that cleanses theroot canal system byremoving the smear layerafter endodonticinstrumentation.
Where used	Dental offices andhealth care offices	Dental offices andhealth care offices	Dental offices andhealth care offices	Dental offices and healthcare offices
Targetpopulation	Patients undergoingendodontic therapy	Patients undergoingendodontic therapy	Patients undergoingendodontic therapy	Patients undergoingendodontic therapy
Anatomical site	Oral cavity	Oral cavity	Oral cavity	Oral cavity

Substantial Equivalence

{5}------------------------------------------------

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

Image /page/5/Picture/1 description: The image shows the logo for Vista Dental Products. The logo features the word "VISTA" in a stylized font, with a mountain range graphic above it. Below the word "VISTA" is the text "Dental Products".

	Subject Device:V-Mix	Primary PredicateDevice:Chlor-XTRATM	Predicate Device:BioPure MTAD RootCanal Cleanser	Predicate Device: VistaRinse Plus
PhysicalProperties	Clear, pale yellow,aqueous solution witha chlorine-like odor	Clear, pale yellow,aqueous solution witha chlorine-like odor	Clear, colorless,odorless liquid	Clear, colorless, odorlessaqueous solution
ChemicalProperties	Carboxylic acidchelating agents andsodium hypochlorite	Sodium hypochloritesolution	Carboxylic acidchelating agent	Carboxylic acid chelatingagent
Mechanism ofAction	The mechanical actionof the solution movingin the root canalfacilitates ease in theremoval of debris andnecrotic pulp tissuefrom the root canal.	Used for debridementand in theinstrumentation of theroot canal.	The mixed solutioncleanses the root canal,removes the smearlayer, and kills thebacteria in aninstrumented root canalwithout harming thetooth structure or softtissue.	The mechanical action ofthe solution moving in theroot canal facilitates ease inthe removal of debris andnecrotic pulp tissue fromthe root canal.
PackagingConfiguration	10mL pre-filled dualcartridge syringe withapplicator tip	3mL and 12mL pre-filled syringe and480mL bottle	Pre-filled 5mL syringepaired with a pre-filled150mg bottle and a pre-filled 20mL syringewith a pre-filled 600mgbottle	120mL and 480mL bottlesand 6mL syringe
Sterility	Non-sterile	Non-sterile	Non-sterile	Non-sterile
ActiveIngredients	2-phophonobutane-1,2,4-Tricarboxylicacid (PBTC), Citricacid, and SodiumHypochlorite (NaOCl)	Sodium Hypochlorite(NaOCl)	Citric acidand DoxycyclineHyclate	Ethylenediaminetetraaceticacid (EDTA) andChlorhexidine digluconate(CHX)
Shelf-Life	18 months	24 months	Unknown	24 months
Prescription /OTC	Prescription	Prescription	Prescription	Prescription

Similarities between the subject device (V-Mix) and the predicate devices (Chlor-XTRA™, Biopure MTAD Root Canal Cleanser, and Vista Rinse Plus)

V-Mix has similar indications for use as the predicate devices. ●
V-Mix is classified under product code KJJ and shares the identical common name "Cleanser, Root ● Canal" as the predicate devices.
Identical to the predicate devices, V-Mix is a non-sterile device.
V-Mix and all the predicate devices contain surfactants. ●
V-Mix and the primary predicate device, Chlor-XTRA™ (K082470), contain sodium hypochlorite . as the active ingredient.
V-Mix and the predicate device, Biopure MTAD Root Canal Cleanser (K053167), both contain ● citric acid, a carboxylic acid chelating agent.

{6}------------------------------------------------

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. 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 sans-serif font. Below "VISTA" is the text "Dental Products" in a smaller font. There is a horizontal line below the text.

. V-Mix and the predicate device, Vista Rinse Plus (K193409), both contain a carboxylic acid chelating agent.
V-Mix and the predicate device, Biopure MTAD Root Canal Cleanser (K053167), are both two-● part products, that when mixed, cleanse the root canal and remove smear layer in the instrumented root canal.
V-Mix and Chlor-XTRA have identical physical properties, a clear, pale yellow, aqueous solution ● with a chlorine-like odor.
V-Mix is identical to the predicate devices as all products are aqueous, endodontic irrigants. ●
V-Mix is used in the same target population and anatomical site as the predicate devices (i.e. oral ● cavity).
Identical to the predicate devices, V-Mix is for prescription use only by healthcare professionals. ●
V-Mix is administered identically to the predicate devices. All irrigants are delivered via a syringe ● and endodontic irrigating needle tip.
Identical to Chlor-XTRA, V-Mix is similar in biocompatibility for its intended use, as evident by ● the biocompatibility testing.

V-Mix shares similar intended uses, technical characteristics, and method of application to the predicate devices Chlor-XTRA™, Biopure MTAD Root Canal Cleanser, and Vista Rinse Plus.

Differences between the subject device (V-Mix) and predicate devices (Chlor-XTRA™, Biopure MTAD Root Canal Cleanser, and Vista Rinse Plus)

Minor differences in indications for use between the subject device and the predicate devices ● (Chlor-XTRA™, Biopure MTAD Root Canal Cleanser, and Vista Rinse Plus). Based on V-Mix's dual action, V-Mix's indications for use are aligned with all the predicate devices.
V-Mix and the predicate devices Biopure MTAD Root Canal Cleanser and Vista Rinse Plus all . contain a chelating agent as an active ingredient. However, V-Mix contains PBTC and citric acid whereas the predicate devices, Biopure MTAD Root Canal Cleanser and Vista Rinse Plus, contain citric acid and EDTA, respectively.
- Nevertheless, this difference does not raise any safety or efficacy concerns as PBTC, citric o acid, and EDTA are all carboxylic acid chelating agents with a high affinity for calcium and all effectively remove the inorganic portion of smear layer.
V-Mix is a standalone endodontic irrigant, whereas the primary predicate, Chlor-XTRA requires ● additional endodontic irrigants to thoroughly clean the root canal system.
- Sodium hypochlorite (Chlor-XTRA™) is used for debridement but cannot be used as a O standalone endodontic irrigant as it is not effective at removing smear layer.
- V-Mix is used for debridement, cleansing, and removing the smear laver. O
- However, this difference does not raise any safety or efficacy concerns as the primary O predicate device, Chlor-XTRA requires the subsequent use of a carboxylic acid chelating agent to remove the smear layer.

{7}------------------------------------------------

Image /page/7/Picture/0 description: The image shows the logo for Intermed INC. The word "intermed" is in blue, with a horizontal 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/7/Picture/1 description: The image shows the logo for Vista Dental Products. The logo features the word "VISTA" in a light blue sans-serif font, with a stylized mountain range above it. Below the word "VISTA" is the text "Dental Products" in a smaller, darker font. There is a horizontal line below the word "VISTA".

. V-Mix is a standalone endodontic irrigant, whereas the predicate devices, Biopure MTAD Root Canal Cleanser and Vista Rinse Plus require additional endodontic irrigants to thoroughly clean the root canal system.
- Biopure MTAD Root Canal Cleanser and Vista Rinse Plus are used for cleansing and O removing the smear layer but cannot be used as standalone endodontic irrigants.
- V-Mix is used for debridement, cleansing, and removing the smear layer. O
- However, this difference does not raise any safety or efficacy concerns as the predicate O devices. Biopure MTAD Root Canal Cleanser and Vista Rinse Plus, require the prior use of sodium hypochlorite-based solutions to debride the root canal.
V-Mix has a shelf-life of 18 months, whereas the predicate devices (Chlor-XTRA™ and Vista ● Rinse Plus) have a shelf-life of 24 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 has labeling which adequately communicates shelf-life to the user.

Applicable Standards

ISO 7405:2018 Dentistry Evaluation of Biocompatibility of Medical Devices Used In Dentistry ●
ISO 10993-5:2009 Biological Evaluation of Medical Devices Part 5: Tests for In Vitro ● Cytotoxicity
ISO 10993-10:2010 Biological Evaluation of Medical Devices Part 10: Tests for irritation and ● skin sensitization
ISO 10993-11:2017 - Biological Evaluation of Medical Devices - Part 11: Tests for systemic toxicity
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 V-Mix:

Analytical Testing ●
Cytotoxicity Testing ●
Shelf-Life Testing ●
Bacteriostatic Testing ●
Transit Testing
SEM Evaluation
Working Time ●
Antimicrobial Performance ●
Sensitization ●

{8}------------------------------------------------

Image /page/8/Picture/0 description: The image shows the logo for Intermed INC. The word "intermed" is written in blue, with the "i" and "d" being slightly larger than the other letters. To the right of the word "intermed" is a blue globe. To the right of the globe is the word "INC." in black.

Image /page/8/Picture/1 description: The image shows the logo for Vista Dental Products. The logo features the word "VISTA" in a large, sans-serif font, with a stylized mountain range above the letters. Below the word "VISTA" are the words "Dental Products" in a smaller font. The logo is primarily blue and black.

Intracutaneous Reactivity
Acute Systemic Toxicity

8. Clinical Performance Testing and Compliance

Clinical performance is not deemed necessary.

9. Conclusion

V-Mix is to be marketed by Inter-Med / Vista Dental Products, 2200 South St. Ste. A., Racine, WI 53404, and is substantially equivalent to Chlor-XTRA™ (K082470), Biopure MTAD Root Canal Cleanser (K053167), and Vista Rinse Plus (K193409). The subject medical device has nearly identical intended use and technological characteristics as the predicate device is substantially equivalent to the predicate devices.

Regulation Number and Section

N/A