(139 days)
Clearline™ Cartridge, (K930144)
Clearline™ Cartridge, (K930144)
No
The device description and performance studies focus on the physical filtration and chemical properties of the iodinated resin, with no mention of AI or ML.
No
The device is described as an "in-line filter assembly" that reduces bacteria and prevents cross-contamination in dental water systems, rather than directly treating a disease or condition in a patient.
No
The device is an in-line filter assembly designed to reduce bacteria and cross-contamination in dental water systems by releasing iodine, not to diagnose medical conditions.
No
The device description clearly states it is an "in-line filter assembly incorporating iodinated resin and a .22 micron filter," which are physical components, not software.
Based on the provided text, the DentaPure™ Cartridge is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to filter and treat water in dental water systems to reduce bacteria and prevent cross-contamination. This is a treatment/prevention function, not a diagnostic one.
- Device Description: The device description focuses on the physical components (iodinated resin, filter) and their function in treating the water. There is no mention of analyzing biological samples or providing diagnostic information.
- Performance Studies: The performance studies evaluate the effectiveness of the device in reducing bacteria in the water and maintaining an iodine residual. These are performance metrics related to water quality and contamination control, not diagnostic accuracy.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for the diagnosis, treatment, or prevention of disease. The DentaPure™ Cartridge does not perform this function.
N/A
Intended Use / Indications for Use
The DentaPure™ Cartridge is an in-line filter assembly Incorporating iodinated resin and a .22 micron filter. The filter incorporating fournated roshe connection to the handpiece.
The filter portion is of a sufficiently small porosity to be bacterially retentive, and would thereby reduce the amount of bacteria that would reach the patient from the dental water system. The iodine that is released reduces the chance of cross contamination by introducing the germicide, iodine, into the water system downstream of the filter.
The DentaPure™ Cartridge is a disposable unit, retrofittable to all modern dental operatory units. The filter is installed in each dynamic instrument water tubing with quick connect fittings for ease of changing on a weekly basis.
The instructions for use of the DentaPure™ Cartridge require that the dental instruments be sterilized in conformity with current recommendations for sterilization and flushing. When used in conjunction with these normal practices, the DentaPure™ Cartridges commonly reduce bacteria levels to less than 1 cfu/ml. Current recommendations of the ADA recommend having less than 200 cfu/ml in dental unit water lines, so this device exceeds those recommendations.
Product codes (comma separated list FDA assigned to the subject device)
Not Found
Device Description
The DentaPure™ Cartridge is an in-line filter assembly Incorporating iodinated resin and a .22 micron filter. The filter incorporating an iodide resin is designed for connection to the handpiece. It consists of an outer chamber filled with a film of an iodophor type in image resin that imparts 2-4 ppm of iodine into the water as it flows through. The resin is registered with EPA. The filter portion is of a sufficiently small porosity to be bacterially retentive. The iodine that is released reduces the chance of cross contamination by introducing the germicide, iodine, into the water system downstream of the filter. The DentaPure™ Cartridge is a disposable unit, retrofittable to all modern dental operatory units.
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 office
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)
Two tests have been conducted to show the efficacy of the DentaPure™ Cartridge and its substantial equivalence to the Clearline™ filter.
- Tests of the effectiveness of the iodine residual in cross contamination were conducted. Results showed an iodine residual in the tubing of .5 ppm in the first 5 ml, and less than 1 cfu/ml. Samples of the first 5 ml taken the next day showed little or no recontamination after 43 days.
- The second set of tests to show equivalence and effectiveness were performed in a dental office, under actual conditions. Tests showed that inclusion of a 0.45 micron filter in conjunction with iodinated resin reduced the number of colony forming units from 10 cfu/100ml to less than 10cfu/100ml.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- Iodine residual in tubing: 0.5 ppm in the first 5 ml
- Bacterial levels: less than 1 cfu/ml (after 43 days, little or no recontamination)
- Reduction of colony forming units: from 10 cfu/100ml to less than 10cfu/100ml
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Clearline™ Cartridge, (K930144)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
JAN 2 2 1997
Image /page/0/Picture/1 description: The image is a black and white logo for Global Ventures International Inc. The logo is circular and contains the letters "MRLB" in a rectangular box in the center. The words "GLOBAL VENTURES" are written along the top of the circle, and the words "INTERNATIONAL INC." are written along the bottom of the circle. The logo has a simple, classic design.
"510 (K) SUMMARY" [As required by 807.92(c)]
Submitter:
MRLB INTERNATIONAL, INC. 305 DeMers Avenue East Grand Forks, Minnesota 56721
Telephone: Fax:
Date:
(218) 773-6841 (218) 773-2845
Rex Hammarback, President
August 27,1996
Trade Name:
Contact Person:
DentaPure™ Cartridge
Common Name:
Inline Water Filter
Classification Name: Accessory for "Unit, Dental Operative" per CFR 872.6640) Class I.
Equivalent Device:
Clearline™ Cartridge, (K930144) Manufactured by: SciTech Dental 562 First Avenue South, Suite 700 Seattle, Washington 98104 [per 807.92(a) (3)]
Device Description and Intended Use:
The DentaPure™ Cartridge is an in-line filter assembly Incorporating iodinated resin and a .22 micron filter. The filter incorporating fournated roshe connection to the handpiece. This is illustrated in Figure 1.
A schematic of the cartridge is shown in Figure 2. It consists of A schematic of the cartings is vith the outer chamber filled with a lichiorane type in mage resin that imparts 2-4 ppm of iodine
I-1
1
into the water as it flows through. The resin is registered with EPA. The filter portion is of a sufficiently small porosity to be bacterially retentive, and would thereby reduce the amount of bacteria that would reach the patient from the dental water system. The iodine that is released reduces the chance of cross contamination by introducing the germicide, iodine, into the water system downstream of the filter.
The DentaPure™ Cartridge is a disposable unit, retrofittable to all modern dental operatory units. The filter is installed in each dynamic instrument water tubing with quick connect fittings for ease of changing on a weekly basis.
The instructions for use of the DentaPure™ Cartridge require that the dental instruments be sterilized in conformity with current recommendations for sterilization and flushing. When used in conjunction with these normal practices, the DentaPure™ Cartridges commonly reduce bacteria levels to less than 1 cfu/ml. Current recommendations of the ADA recommend having less than 200 cfu/ml in dental unit water lines, so this device exceeds those recommendations.
Two tests have been conducted to show the efficacy of the Performance Data: DentaPure™ Cartridge and its substantial equivalence to the Clearline™ filter. Tests of the effectiveness of the iodine residual in cross contamination were conducted. Results showed an iodine residual in the tubing of .5 ppm in the first 5 ml, and less than 1 cfu/ml. Samples of the first 5 ml taken the next day showed little or no recontamination after 43 days.
The second set of tests to show equivalence and effectiveness were performed in a dental office, under actual conditions. Tests showed that inclusion of a 0.45 micron filter in conjunction with iodinated resin reduced the number of colony forming units from 10 cfu/100ml to less than 10cfu/100ml.
| Comparative Technological Characteristics: | ||
|---|---|---|
| Parameter | DentaPure™ | Clearline™ |
| Filter Type | In-line | |
| Disposable | In-line | |
| Disposable |
2
| Parameter | DentaPure™ | Clearline™™ |
|---|---|---|
| Installation | ||
| Fittings | Luer-loc | Luer-loc |
| Components | Membrane Filter | |
| 0.22 micron | ||
| Column Type | ||
| 10.0cm² Area | ||
| 2.5cc Iodinated | ||
| Ion Exchange | ||
| Resin | Membrane Filter | |
| 0.22 micron | ||
| Disc Type | ||
| 4.2cm² Area | ||
| Chlorhexidine | ||
| overnight soak | ||
| Maintenance | Weekly Change | Daily Change, |
| connectingtubing | ||
| between dynamic | ||
| instrument and | ||
| filter requires an | ||
| overnight soak | ||
| in Chlorhexidine. | ||
| Air-Lock Potential | Vented | Non-vented |
| Pressure Rating | 70 PSI | 75 PSI |
| Dimensions | 1.5cm Diameter | |
| 4.5cm Length | 2.8cm Diameter | |
| 2.3cm Length | ||
| Biosafe | USP Class VI | USP Class VI |
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