(79 days)
The BluTube@Dental Unit Water Purification Cartridge is for use on dental unit water lines attached to the dynamic dental instruments, i.e., high-speed handpiece, three-way airwater syringe and ultrasonic scaler. This cartridge in conjunction with currently recommended practices regarding sterilization and flushing of dental instruments reduces bacteria from the water supplied to the instruments to less than 200 CFU/mL, a level that will meet or exceed the current American Dental Association (ADA) recommendations for water quality.
BluTube® is a dental unit waterline purification cartridge intended for use at dental offices to reduce microbial bioburden in dental unit waterlines (DUWLs). BluTube® is placed in-line with the pick-up tube of the water supply bottle of a dental operative unit (DOU). Once installed, water flows into the device and through the iodinated resin chamber. Bacterial populations in the treated water are reduced through the antimicrobial action of iodine, which is released from the iodinated resin and into the treated water. Treated water expelled from BluTube® can be used as an irrigant/coolant for nonsurgical dental procedures and is appropriate for use in dental instruments like air/water syringes or high-speed handpieces.
The FDA 510(k) summary for the BluTube® Dental Unit Water Purification Cartridge (K232393) describes the acceptance criteria and the study that proves the device meets them. This device is intended to reduce bacterial populations in dental unit waterlines (DUWLs).
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Antimicrobial Efficacy: Reduce bacteria from the water supplied to dental instruments to less than 200 CFU/mL, meeting or exceeding current American Dental Association (ADA) recommendations for water quality. | Under simulated use conditions (≥ 120 L of water treated), bacterial concentrations in DUWL water treated by BluTube® and the predicate device (Dentapure DP365B) were < 200 CFU/mL. |
| Minimum Iodine Concentration: Maintain iodine concentrations ≥ 0.5 ppm. | Under simulated use conditions (≥ 120 L of water treated), both BluTube® and the predicate device (Dentapure DP365B) maintained iodine concentrations ≥ 0.5 ppm. |
| Maximum Iodine Concentration: Have a maximum concentration of iodine in treated water substantially equivalent to the predicate device. | Under simulated use conditions (≥ 120 L of water treated), the maximum concentration of iodine in water treated by BluTube® was substantially equivalent to the maximum concentration of iodine in water treated by Dentapure DP365B. |
| Biocompatibility: No new risks to biocompatibility from iodine released or materials used. | The evaluation indicated no new risks to biocompatibility have been found for the BluTube® device due to iodine released or device materials. Manufacturing processes and packaging materials were also evaluated with no biocompatibility risks identified. |
2. Sample size used for the test set and data provenance
The document mentions "simulated use conditions (≥ 120 L of water treated)" for the performance tests. This implies that the tests were conducted in a laboratory setting simulating dental unit water flow, rather than using patient data. The specific number of BluTube® cartridges or test runs that constitute the "test set" is not explicitly stated, only the minimum water volume treated.
The data provenance is from simulated use conditions within a laboratory setting. There is no indication of country of origin for the data or whether it was retrospective or prospective, though simulated use studies are typically prospective.
3. Number of experts used to establish the ground truth for the test set and their qualifications
This device does not involve expert interpretation or image analysis. The "ground truth" for its performance is objective microbiological and chemical measurements (bacterial count, iodine concentration) determined by laboratory testing, not by human expert consensus or interpretation. Therefore, this question is not applicable in the context of this device.
4. Adjudication method for the test set
Not applicable, as the "test set" involves objective laboratory measurements rather than subjective human assessment requiring adjudication.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. The BluTube® is a water purification cartridge and does not involve AI, human readers, or case interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The BluTube® is a physical device, not an algorithm. The performance tests evaluate the device's ability to purify water.
7. The type of ground truth used
The ground truth used for performance evaluation was based on objective laboratory measurements of:
- Bacterial count: Colony Forming Units per milliliter (CFU/mL) in the treated water.
- Iodine concentration: Parts per million (ppm) of iodine in the treated water.
- Biocompatibility testing: According to established international standards (ISO 10993-1:2018, ISO 7405:2018) and FDA guidance, which involves evaluating material compatibility with biological systems.
8. The sample size for the training set
Not applicable. This is a physical device, not a machine learning algorithm, and therefore does not have a "training set" in the context of AI development.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this device.
{0}------------------------------------------------
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, 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 27, 2023
ProEdge Dental Products, Inc. % Ian Trump Principal Scientist Exponent, Inc. 980 9th Street, 16th Floor Sacramento, California 95814
Re: K232393
Trade/Device Name: BluTube® Dental Unit Water Purification Cartridge (BluTube®) Regulation Number: 21 CFR 872.6640 Regulation Name: Dental Operative Unit And Accessories Regulatory Class: Class I. reserved Product Code: QYJ, EIA Dated: August 9, 2023 Received: August 9, 2023
Dear Ian Trump:
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 (the 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 available 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.
{1}------------------------------------------------
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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).
{2}------------------------------------------------
Sincerely,
Michael E. Adjodha -S
Michael Adjodha, MChE, RAC, CQIA Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
{3}------------------------------------------------
Indications for Use
510(k) Number (if known) K232393
Device Name BluTube® Dental Unit Water Purification Cartridge
Indications for Use (Describe)
The BluTube@Dental Unit Water Purification Cartridge is for use on dental unit water lines attached to the dynamic dental instruments, i.e., high-speed handpiece, three-way airwater syringe and ultrasonic scaler. This cartridge in conjunction with currently recommended practices regarding sterilization and flushing of dental instruments reduces bacteria from the water supplied to the instruments to less than 200 CFU/mL, a level that will meet or exceed the current American Dental Association (ADA) recommendations for water quality.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) | Over The Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
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."
{4}------------------------------------------------
5 510(k) Summary K232393
Traditional 510(k) Summary for BluTube® Dental Unit Water Purification Cartridge
5.1 Submitter
Mark Frampton President and CEO ProEdge Dental Products, Inc. 7042 South Revere Parkway, Suite 400 Centennial, CO 80112
Phone: 888.843.3343 Date Prepared: February 18th, 2020
Primary Contact 5.2
J. Ian Van Trump Principal Scientist Exponent Inc. 980 9th Street, 16th Floor Sacramento, CA 95814
Phone: 916.306.2684 Email: ivantrump@exponent.com
5.3 Device Name
Name of Device: BluTube® Dental Unit Water Purification Cartridge Common or Usual Name: Dental Unit Waterline Purification Cartridge Classification Name: Dental operative unit accessory (21 CFR 872.6640) Regulatory Class: Class I Product Code: QYJ, EIA
5.4 Predicates
Primary Predicate: DentaPure® DP90 Cartridge; DentaPure® DP365 Cartridge (K992893) Common or Usual Name: Dental Unit Waterline Treatment Cartridge and Dental Unit Purification Cartridge Classification Name: Dental operative unit accessory (21 CFR 872.6640) Regulatory Class: Class I Product Code: EIA
Additional Predicate: DentaPure® DP40 Cartridge (K992868) Common or Usual Name: Dental Unit Waterline Purification Cartridge Classification Name: Dental operative unit accessory (21 CFR 872.6640) Regulatory Class: Class I
{5}------------------------------------------------
Product Code: EIA
ર્ રંડ Device Description
BluTube® is a dental unit waterline purification cartridge intended for use at dental offices to reduce microbial bioburden in dental unit waterlines (DUWLs). BluTube® is placed in-line with the pick-up tube of the water supply bottle of a dental operative unit (DOU). Once installed, water flows into the device and through the iodinated resin chamber. Bacterial populations in the treated water are reduced through the antimicrobial action of iodine, which is released from the iodinated resin and into the treated water. Treated water expelled from BluTube® can be used as an irrigant/coolant for nonsurgical dental procedures and is appropriate for use in dental instruments like air/water syringes or high-speed handpieces.
ProEdge intends to market two models of the BluTube® device. The two BluTube® models are identical in terms of design and performance characteristics. The only difference is in the labeling and respective replacement schedules to fit requirements of dental offices. The two models and respective replacement schedules are described in Table 5-1 below. The purpose of providing two models with different replacement schedules is to give dental offices the option of choosing the frequency of change-out schedule for the DUWL treatment products.
| Model # | If Water UsageRecords are Kept | If No Water Usage Recordsare Kept | If Iodine Concentration isMonitored |
|---|---|---|---|
| BT180 | 120 liters (L) | 6 months (180 days) | Change when iodine outputfalls to less than 0.5 ppm |
| BT90 | 60 L | 3 months (90 days) |
Table 5-1: BluTube Models and Replacement Schedules
Principal of Operation ર્ રહ
Bacterial populations in the treated water are reduced through the antimicrobial action of iodine from the iodinated resin present in the device. The use pattern for the iodinated resin as present in BluTube® is consistent with the United States Environmental Production Agency (USEPA)-registered label for the iodinated resin. The mechanism of action for BluTube® is the same as its cited predicates, which also employ iodinated resin for this purpose.
5.7 Indications for Use
BluTube® is intended for use at dental offices and is compatible with DOUs utilizing bottle-type water supply systems with water pressures ≤ 45 pounds per square inch (psi). BluTube® is not intended for the treatment of water for dental surgery applications where the utilization of sterile water is required. The following Indications for Use statement is proposed for BluTube®:
{6}------------------------------------------------
"The BluTube® Dental Unit Water Purification Cartridge is for use on dental unit water lines attached to the dynamic dental instruments, i.e., high-speed handpiece, three-way air/water syringe and ultrasonic scaler. This cartridge in conjunction with currently recommended practices regarding sterilization and flushing of dental instruments reduces bacteria from the water supplied to the instruments to less than 200 CFU/mL, a level that will meet or exceed the current American Dental Association (ADA) recommendations for water quality."
The Indications for Use statement for BluTube® is not identical to the predicate devices, with the main difference being citation of the revised ADA microbiological water quality recommendation. These differences do not alter the intended therapeutic use of the device and do not raise any new questions of safety or effectiveness relative to the predicate devices.
5.8 Description of Substantial Equivalence
Technological Characteristics ર જતા
BluTube® has similar physical and technical characteristics to the predicate devices, as illustrated in Table 5-2 below.
| Parameter | BluTube® Cartridge | DentaPure® DP365(Primary Predicate) | DentaPure® DP40 |
|---|---|---|---|
| 510(k)# | K232393 | K992893 | K992868 |
| Product Code | QYJ, EIA | EIA | EIA |
| Device Class | Class I | Class I | Class I |
| Regulation Number | 21 CFR 872.6640 | 21 CFR 872.6640 | 21 CFR 872.6640 |
| Indication | The BluTube® Dental UnitWater PurificationCartridge is for use ondental unit water linesattached to the dynamicdental instruments, i.e.,high-speed handpiece,three-way air/water syringeand ultrasonic scaler. Thiscartridge in conjunctionwith currentlyrecommended practicesregarding sterilization andflushing of dentalinstruments reducesbacteria from the watersupplied to the instrumentsto less than 200 CFU/mL, alevel that will meet orexceed the currentAmerican DentalAssociation (ADA)recommendations for waterquality. | The DentaPure® DP90 andDP365 Cartridge is for use ondental unit water linesattached to the dynamic dentalinstruments, i.e., high-speedhandpiece, three-wayair/water syringe andultrasonic scaler. Thiscartridge in conjunction withcurrently recommendedpractices regardingsterilization and flushing ofdental instruments reducesbacteria from the watersupplied through theinstruments to a level that willmeet or exceed the currentADA recommendations forwater quality having amaximum of 200 cfu/ml. | The DentaPure® DP40Cartridge is for use on dentalunit water lines attached tothe dynamic dentalinstruments, i.e., high-speedhandpiece, three-wayair/water syringe andultrasonic scaler. Thiscartridge in conjunction withcurrently recommendedpractices regardingsterilization and flushing ofdental instruments reducesbacteria from the watersupplied through theinstruments to a level thatwill meet or exceed thecurrent ADArecommendations for waterquality having a maximum of200 cfu/ml. |
| Installation Location | Connected to pickup tubeof bottle water system | DP365M is connected tomunicipal water supplyjunction; model DP365B isconnected to pickup tube | Connected to pickup tube ofbottle water system |
Table 5-2: Summary Substantial Equivalence Comparison
{7}------------------------------------------------
| Parameter | BluTube® Cartridge | DentaPure® DP365(Primary Predicate) | DentaPure® DP40 |
|---|---|---|---|
| Replacement Schedule | If iodine is monitored,when iodine output falls toless than 0.5 ppm. If waterusage records kept, when60 L (BT90) or 120 L(BT180) are treated. Ifwater usage records are notkept, at 90 (BT90) or 180(BT180) calendar days | If iodine is monitored, wheniodine output falls to less than0.5 ppm. If water usagerecords kept, when 240 L aretreated. If water usagerecords are not kept, at 365calendar days | If iodine is monitored, wheniodine output falls to lessthan 0.5 ppm. If water usagerecords kept, when 40 L aretreated. If water usagerecords are not kept, at 60calendar days |
| Maximum Pressure Rating(psi) | 45 | 45 | 45 |
| Antimicrobial Active | Iodine(CAS No. 7553-56-2) | Iodine(CAS No. 7553-56-2) | Iodine(CAS No. 7553-56-2) |
| Resin Composition | 47.5% iodine bound toanion exchange resin | 46% iodine bound to anionexchange resin | 46% iodine bound to anionexchange resin |
Performance Testing 5.8.2
The following performance data were provided in support of the substantial equivalence determination.
- Maximum Iodine Concentration: Under simulated use conditions (≥ 120 L of water treated), the maximum concentration of iodine in water treated by BluTube® was substantially equivalent to the maximum concentration of iodine in water treated by Dentapure DP365B (K992893).
- Minimum Iodine Concentration: Under simulated use conditions (≥ 120 L of water treated), both BluTube® and the Dentapure DP365B (K992893) predicate maintained iodine concentrations ≥ 0.5 ppm.
- Antimicrobial Efficacy: Under simulated use conditions (≥ 120 L of water treated), bacterial ● concentrations in DUWL water treated by BluTube® and the Dentapure DP365B predicate (K992893) were < 200 CFU/mL.
Biocompatibility 5.8.3
Iodine released from the iodinated resin is the only direct patient-contacting component of BluTube®. The maximum concentration of iodine in BluTube®-treated DUWL water was substantially equivalent to the maximum concentration of iodine in water treated with the predicate devices.
The maximum concentration of iodine in BluTube®-treated DUWL water, as well as the materials used to manufacture the BluTube device that could indirectly contact patients, were evaluated according to ISO 10993-1:2018, ISO 7405:2018, and FDA's 2020 guidance: Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management
{8}------------------------------------------------
process". The evaluation indicated no new risks to biocompatibility have been found for the BluTube® device.
The manufacturing processes and the packaging materials were also evaluated, as these directly contact the device, and no biocompatibility risks were identified due to manufacturing process materials or device-contacting packaging materials.
5.8.4 Substantial Equivalent Conclusion
BluTube® and its cited predicates (K992893 and K992868) were compared based on their intended use, indications, technological characteristics, principle of operation, and performance in bench testing intended to evaluate safety and effectiveness. On the basis of these comparisons, BluTube® is determined to be substantially equivalent to the cited predicates.
§ 872.6640 Dental operative unit and accessories.
(a)
Identification. A dental operative unit and accessories is an AC-powered device that is intended to supply power to and serve as a base for other dental devices, such as a dental handpiece, a dental operating light, an air or water syringe unit, and oral cavity evacuator, a suction operative unit, and other dental devices and accessories. The device may be attached to a dental chair.(b)
Classification. Class I (general controls). Except for dental operative unit, accessories are exempt from premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9.