(79 days)
Not Found
No
The device description and performance studies focus on the chemical and physical properties of the water purification cartridge, with no mention of AI or ML.
No
The device purifies water for dental instruments and does not directly treat or diagnose a medical condition in a patient.
No
The device is a water purification cartridge for dental unit waterlines, designed to reduce bacteria in the water supplied to dental instruments. It does not diagnose any condition or disease.
No
The device description clearly states that BluTube® is a physical cartridge containing iodinated resin, which is a hardware component used for water purification. It is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to purify water used in dental unit water lines to reduce bacterial contamination. It is used on the dental equipment to treat the water supply, not to perform a diagnostic test on a biological sample from a patient.
- Device Description: The description clearly states it's a water purification cartridge that uses iodinated resin to reduce microbial bioburden in dental unit waterlines. It treats the water itself.
- Lack of Diagnostic Function: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing information for the diagnosis, monitoring, or treatment of a disease or condition based on such analysis.
- Performance Studies: The performance studies focus on water quality metrics (iodine concentration, bacterial reduction in water), not on diagnostic accuracy or clinical outcomes related to patient samples.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for medical purposes. This device's function is to improve the quality of water used in dental procedures, which is a different category of medical device.
N/A
Intended Use / Indications for Use
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.
Product codes
QYJ, EIA
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
dental offices
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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
§ 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.
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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).
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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
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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)
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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 Usage
Records are Kept | If No Water Usage Records
are Kept | If Iodine Concentration is
Monitored |
|---------|------------------------------------|---------------------------------------|---------------------------------------------------------|
| BT180 | 120 liters (L) | 6 months (180 days) | Change when iodine output
falls 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®:
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"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 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 DentaPure® DP90 and
DP365 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 through the
instruments to a level that will
meet or exceed the current
ADA recommendations for
water quality having a
maximum of 200 cfu/ml. | The DentaPure® DP40
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 through the
instruments to a level that
will meet or exceed the
current ADA
recommendations for water
quality having a maximum of
200 cfu/ml. |
| Installation Location | Connected to pickup tube
of bottle water system | DP365M is connected to
municipal water supply
junction; model DP365B is
connected to pickup tube | Connected to pickup tube of
bottle water system |
Table 5-2: Summary Substantial Equivalence Comparison
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| Parameter | BluTube® Cartridge | DentaPure® DP365
(Primary Predicate) | DentaPure® DP40 |
|----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Replacement Schedule | If iodine is monitored,
when iodine output falls to
less than 0.5 ppm. If water
usage records kept, when
60 L (BT90) or 120 L
(BT180) are treated. If
water usage records are not
kept, at 90 (BT90) or 180
(BT180) calendar days | If iodine is monitored, when
iodine output falls to less than
0.5 ppm. If water usage
records kept, when 240 L are
treated. If water usage
records are not kept, at 365
calendar days | If iodine is monitored, when
iodine output falls to less
than 0.5 ppm. If water usage
records kept, when 40 L are
treated. If water usage
records are not kept, at 60
calendar 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 to
anion exchange resin | 46% iodine bound to anion
exchange resin | 46% iodine bound to anion
exchange 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