← Product Code KJJ · K193409 # Vista Rinse, Vista Rinse Plus (K193409) _Inter-Med/Vista Dental Products · KJJ · Sep 9, 2020 · DE · SESE_ **Canonical URL:** https://fda.innolitics.com/device/K193409 ## Device Facts - **Applicant:** Inter-Med/Vista Dental Products - **Product Code:** KJJ - **Decision Date:** Sep 9, 2020 - **Decision:** SESE - **Submission Type:** Traditional - **Device Class:** Class U - **Review Panel:** DE ## Intended Use 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 Story Vista Rinse and Vista Rinse Plus are aqueous endodontic irrigating solutions used in dental offices by clinicians. Vista Rinse contains EDTA; Vista Rinse Plus contains EDTA and chlorhexidine digluconate. Solutions are supplied in bottles and expelled from syringes through irrigation tips into the root canal system. Mechanical action of the solution facilitates removal of debris, bacteria, and necrotic pulp tissue. EDTA acts as a chelating agent to remove the smear layer from canal walls. Clinical use involves irrigation during endodontic procedures to prepare the canal for obturation. The device provides a chemical-mechanical cleaning benefit, aiding in the disinfection and preparation of the root canal. ## Clinical Evidence No clinical data. Evidence consists of bench testing: analytical testing, 24-hour cytotoxicity testing (ISO 10993-5), accelerated shelf-life testing, and SEM evaluation of calcium chelation/smear layer removal performance compared to Q-Mix. ## Technological Characteristics Aqueous solutions containing EDTA (Vista Rinse) or EDTA and chlorhexidine digluconate (Vista Rinse Plus). pH range 7.0-8.5. Non-sterile. Packaged in 120mL and 480mL bottles. Complies with ISO 10993-5 (cytotoxicity) and ISO 14971 (risk management). ## Predicate Devices - Q-Mix 2in1 Endodontic Irrigation Solution ([K103244](/device/K103244.md)) - PacEndo EDTA ([K153528](/device/K153528.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ 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 {1}------------------------------------------------ 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 {2}------------------------------------------------ ## 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) | |-------------------------------------------------| |-------------------------------------------------| X 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 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 Products
2200 South St. Ste A
Racine, 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 {4}------------------------------------------------ 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. 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. #### 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 Rinse
Plus | Primary Predicate Device:
Q-Mix 2in1 Endodontic
Irrigation Solution | Reference Predicate Device:
PacEndo™ EDTA | |--------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------| | Manufacturer | Inter-Med / Vista Dental
Products | Dentsply | Pac-Dent | | 510(k) Number | K193409 | K103244 | K153528 | | Common Name | Cleanser, Root Canal | Cleanser, Root Canal | Cleanser, Root Canal | | Device
Classification | Unclassified | Unclassified | Unclassified | | Product Code | KJJ | KJJ | KJJ | | Indication for
Use | Vista Rinse and Vista Rinse Plus
are endodontic irrigating
solutions that cleanse the root
canal system by removing the
smear layer after endodontic
instrumentation. | Q-Mix 2in1 Irrigation Solution
is a premixed dual-action device
that cleanses and disinfects the
root canal system by removing
the smear layer after endodontic
instrumentation. | PacEndo™ EDTA is intended to
facilitate removal of dentinal
debris from the walls of root
canals prior to obturation. | | Where used | Dental offices and health care
offices | Dental offices and health care
offices | Dental offices and health care
offices | | Target
population | Patients undergoing endodontic
therapy | Patients undergoing endodontic
therapy | Patients undergoing endodontic
therapy | | Anatomical site | Oral cavity | Oral cavity | Oral cavity | | Physical
Properties | Vista Rinse and Vista Rinse Plus
are both clear, colorless,.
odorless aqueous solutions | Clear, colorless, odorless
aqueous solution | Clear, colorless, odorless
aqueous solution | #### 6. Technological Characteristics and 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 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 Rinse
Plus | Primary Predicate Device:
Q-Mix 2in1 Endodontic
Irrigation Solution | Reference Predicate Device:
PacEndoTM EDTA | |------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Chemical
Properties | pH 7.0 - 8.5 | pH 7.5 - 8.51 | pH 7.5 | | Mechanism of
Action | The mechanical action of the
solution moving in the root canal
facilitates ease in the removal of
debris, bacteria, and necrotic
pulp tissue from the root canal. | The mechanical action of the
solution moving in the root canal
facilitates ease in the removal of
debris and necrotic pulp tissue
from the root canal. The mode of
action for the solution is that it
disrupts the bacterial cell
membrane, killing the cell to
ensure that it cannot reproduce
or grow. | The mechanical action of the
solution moving in the root canal
facilitates ease in the removal of
debris, bacteria, and necrotic
pulp tissue from the root canal. | | Packaging
Configuration | Both Vista Rinse and Vista
Rinse Plus are packaged in the
following configurations:
120mL and 480mL bottles | 60mL and 480mL bottle | 480 mL bottle | | Sterility | Non-sterile | Non-sterile | Non-sterile | | Active
Ingredients | 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 | | Biocompatibility
Testing
Performed | 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. {6}------------------------------------------------ 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. {7}------------------------------------------------ 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 {8}------------------------------------------------ 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 {9}------------------------------------------------ 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. --- **Source:** [https://fda.innolitics.com/device/K193409](https://fda.innolitics.com/device/K193409) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com