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510(k) Data Aggregation
(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.
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