(106 days)
CLEARLINE PLUS™ is a disposable, combined 0.22 micron filter and anti-retraction check valve for use in dental unit water lines. It is intended to be used, in line, as a means of controlling bacteriological contaminants in the dental water and preventing the retraction of orally contaminated fluids into the dental line. It is to be used for all patients and changed every week, or 5 working days.
Clearline Plus is a disposable microfiltration cartridge with approximately 10 sq. cms. of polyethersulfone membrane with 0.2 micron pores and a normally closed check valve at the exit port. The check valve has a silastic rubber membrane which operates with a cracking pressure of 1.5 psi.
This document describes the performance testing for the CLEARLINE® PLUS dental waterline filter, which combines a microfiltration cartridge and an anti-retraction check valve.
1. Acceptance Criteria and Reported Device Performance:
The device has two primary functions: bacterial retention and backflow prevention.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Bacterial Retention: To provide filter sterilized water and prevent bacterial contaminants in the dental water system from entering the water flow downstream of the device for a period of five working days, when subjected to a typical on/off use pattern. (Equivalent to predicate device claim of "commonly reduce bacterial levels to less than one cfu/milliliter" downstream of the filter.) | In two modes of pulsatile flow (20-second pulses for 50 cycles/day, and 3-second pulses for 250 cycles/day), no Serratia contamination of the filtrate was detected after passing more than 8 liters of a ~100,000 cfu/mL challenge bacterial suspension and over 1,000,000,000 cfu of bacteria over the 5-day test period. This demonstrates effective bacterial retention for at least 5 working days. |
| Backflow Prevention (Anti-Retraction): To prevent backflow (or "suckback") of patient-derived microorganisms into a dental line, even when there is negative pressure applied upstream, over a five-day working period. (Equivalent to predicate device claim of "reduces the chance of cross-contamination by introducing the germicide iodine into the water system, downstream of the filter.") | After 1250 on/off cycles over 5 consecutive 8-hour sessions (mimicking a heavy use pattern for a working week), three of six tested check valves showed zero bacteria on culturing the downstream tube contents after a Chromobacterium backflow test. The other three showed an average of 0.11 microliters of suspension drawn into the tubing. Since approximately 45 microliters of retraction is allowed before material reaches the dental waterline upstream of the coupler according to A.D.A./A.N.S.I. specification #47, this level of backflow control is deemed compatible with preventing contamination of the dental water line for 5 working days. |
2. Sample Size Used for the Test Set and Data Provenance:
- Bacterial Retention Test: 6 Clearline® Plus cartridges were tested in the first mode (20-second pulses) and an unspecified number (but implies 6 based on overall context) in the second mode (3-second pulses). The entire study appears to use 12 devices in total, suggesting 6 per mode.
- Backflow Prevention Test: 6 Clearline® Plus devices (with integrated BacStop™ valves) were tested.
- Data Provenance: The study was conducted retrospectively as part of a 510(k) submission, implied to be conducted by the submitter (SciTech Dental, Inc.) in a laboratory setting. There is no mention of country of origin for the data itself, but the submitter is based in Seattle, WA, USA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
Not applicable. This study involves performance testing against quantifiable metrics (bacterial count, liquid volume) rather than subjective expert assessment of images or clinical outcomes.
4. Adjudication Method for the Test Set:
Not applicable. Ground truth was established by direct measurement and culturing, not expert adjudication.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This is a performance study for a physical medical device, not an AI or imaging diagnostic tool that would involve human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a physical device, not an algorithm. The device's performance was assessed directly.
7. The Type of Ground Truth Used:
- Bacterial Retention: Absence of cultivable Serratia contamination in filtrate. This is based on laboratory culturing of samples.
- Backflow Prevention: Absence of cultivable Chromobacterium violaceum (marker bacterium) in the downstream tubing, and measured volume of backflow. This is based on laboratory culturing and volumetric measurement.
8. The Sample Size for the Training Set:
Not applicable. This device is not an AI algorithm; there is no "training set."
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set for this type of device.
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Food and Drug Administration Center for Devices and Radiological Health Office of Device Evaluation, (ODE) HFZ-400 Document Mail Center HFZ-401 9200 Corporate Boulevard Rockville, MD 20850
510 (k) Submission
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Device Proprietary name:
전국:
CLEARLINE® PLUS, dental waterline filter
Device common name:
Membrane filter with combined anti-retraction check valve
Establishment Registration Number:
3027751
Class in which device has been put under Section 513:
Class I: Predicate device was on interstate market prior to 1976. Other comparable devices have received 510 (k) clearance since the Device Amendment. SciTech's one day filter (K.930144) was given regulatory clearance on December 3, 1993. SciTech's anti-retraction check valve (K.960556) was given clearance on February 9, 1996. MLRB International, Inc. received clearance for a similar device (K.963548) on January 22, 1997.
Action taken by party to register to comply with Section 514: Not applicable.
Proposed labels, labeling and advertisements, sufficient to describe the device, its intended use and directions for use:
The device is not currently marketed for this application. No promotional materials have been finalized and packaging is not yet available; it will be forwarded for review, once finalized, and will be based on allowable claims.
510 (k) Summary:
See attached 510 (k) Summary of efficacy and safety data on separate numbered sheets (Summary pages 1-3).
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Photographs of the Device:
See attached print photograph of the device at Exhibit 1 (page 10). The device incorporates the membrane filter which has already been cleared for five working days of use (K.963548) together with the anti-retraction check valve (K.960556) attached on the outlet port by use of an adapter.
Engineering Drawings of the device:
The engineering drawings of the individual components of the device are attached as the following exhibits:
Exhibit LA - filter cartidge (page 11) : Exhibit 2B - check valve (page 12) Exhibit 3C - adapter for check valve (page 13)
Identification of the marketed device to which equivalence is claimed:
- Dentapure cartridge (K.963548), MLRB International Inc. Filter - Clearline® cartridge (K.930144), SciTech Dental Inc. Checkvalve - BacStop™ (K.960556), SciTech Dental Inc.
Statement of Similarities and differences between CLEARLINE® PLUS and the predicate, marketed device:
Clearline Plus is a disposable microfiltration cartridge with approximately 10 sq. cms. of polyethersulfone membrane with 0.2 micron pores and a normally closed check valve at the exit port. The check valve has a silastic rubber membrane which operates with a cracking pressure of 1.5 psi. The predicate device (Dentapure) is a disposable micro filtration cartridge which contains the same area of filter membrane, the same type of housing and is made by the same manufacturer (Millipore Corporation). It has been FDA cleared for five working days of filtration use in dental unit water lines. Dentapure, however, is filled with an iodinated resin in the cartridge space, upstream of the filter membrane, so that any viral particles, which may be sucked back from a patient's mouth and pass through the pores of the membrane, are subject to the antiviral action of the iodine.
The iodine also leaches out of the iodinated resin reserve and enters the water stream, so that several parts per million of iodine are present in the water exiting from the device; this provides a decontaminating effect on any bacteria or viruses that are sucked back into the waterline down stream from the device. By comparison Clearline® Plus accomplishes this function by the use of a check valve on the exit. This normally closed valve prevents back
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flow and thereby avoids contamination of the water line downstream of the device, throughout the five day working life of the unit. Both Clearline® Plus and Dentapure are designed to fit in the dental line close to the coupling point for the hand piece, air/water syringe and ultra-sonic scaler.
Data to show consequences of modified device:
Not applicable.
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Submitter's name and address:
Simon Johnston SciTech Dental, Inc. 562 First Avenue South, Suite 700 and and seattle, WA 9810 and 112 2810 and 2000 100 2000 100 100 100 100 10 FDA establishment registration number: 3027751 Owner/Operator I.D. 9011186 TEL # 800 524 6984 or 206 382 0880 FAX # 206 382 0823
Contact person, telephone #, fax #:
Clive Defty TEL # 206 382 0880 FAX # 206 382 0823
Representative/consultant:
Not applicable.
Table of Contents:
ないと思います。 (1)
See cover sheet.
Name and address of manufacturing and packaging facilities:
SciTech Dental, Inc. 562 First Avenue South, Suite 700 Seattle, WA 98104 FDA reg. #3027751
Millipore Corporation 80 Ashby Road Bedford, MA 01730 FDA reg. #2647612
B. Braun Medical, Inc. 824 Twelfth Avenue Bethelehem, PA 18018 FDA reg. #2523676
Filter manufacturer
Check Valve manufacturer, assembly and packaging
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Comparison Table of the new device to marketed devices:
:
.
:
:
| CLEARLINE® PLUSIn-line membrane filterand check valve | DENTAPUREIn-line disposablemembrane filter | BACSTOP™Anti-retractionCheck Valve | |
|---|---|---|---|
| Intended use | In-line control ofbacterial contaminationand water retraction indental hoses | In-line control ofbacterial contamin-ation and water retrac-tion in dental hoses | In-line control ofwater retraction indental hoses |
| Size-length | 9.0 cm | 6.5 cm | 2.4 cms |
| Size-width | 1.5 cm | 1.5 cm | 1.3 cms |
| Composition-Housing | Ektar DN003 andLexan polycarbonate | Ektar DN003 | Lexan polycarbonate |
| Filter membrane | 0.22 micron polyether-sulfone | 0.22 micron poly-ethersulfone | N/A |
| Vent membrane | Polyvinylidene fluoride | Polyvinylidene fluoride | N/A |
| Anti-retractionComponent | Silastic rubber disc | 2.5 cc iodinatedIon exchange resin | Silastic rubber disc |
| ReplacementSchedule | Weekly (five workingdays) | Weekly (five workingdays) | Daily |
| Fittings-inlet | Female luer | Female luer | Female luer |
| Fittings-outlet | Male luer | Male luer | Male luer |
| Cracking pres-sure of checkvalve | 1.5 psi | N/A | 1.5 psi |
| Max. workingpressure | 70 psi | 70 psi | 70 psi |
:
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Action taken to comply with voluntary standards:
Not applicable.
Performance data on the device:
Twelve Clearline® Plus devices were performance-tested for their potential utility as bacterial retention filters in dental waterlines by placement in-line in a standard (Proma Dental Equipment Co.) dental unit hose with luer mounts, close to the coupling connection for a handpiece, syringe or scaler. The unit was supplied with a water source through a "bottled water" or "clean water" delivery system, manufactured by Ampco Dental Co., pressurized to 35 psi with Nitrogen gas from a cylinder. The bottled water system was charged daily with a challenge bacterial suspension, containing ~100,000 cfi/mL of test organisms (Sartates mo versas). Approximately 11.5 liters of this suspension was passed 1 - 1 through the Clearline® Plus each day for 5 days, over a period of about 8 hours. In between the test periods the units were left stagnant, just as they would be under normal working conditions, with the Clearline® Plus cartridges still in place.
The challenge suspension was delivered in two modes, so as to mimic the pulsatile flow usually associated with use of dental handpieces or syringes. In the first mode (Exhibit 3 A), six sterile Clearline® Plus cartridges were each put in-line and tested with intermittent pulses of water flow of 20 seconds duration, with a period of stasis in between, so as to ensure that over the 8 hour test period between 1 and 1.5 liters of the bacterial suspension passed through the device during 50 operating cycles. Intermittent pulses were delivered with precision by use of a programmed microprocessor-controlled solenoid valve.
In the second mode (Exhibit 3B), delivery of the test volume was accomplished over the 8 hour period in a series of intermittent 3 second pulses and 250 operating cycles per day. At the end of each mimicked "working day" a 100 mL sample of the filtrate was collected through each Clearline Plus into a sterile container and subjected to the Milliflex (Millipore Corporation), bacterial counting test system, so as to be able to detect contaminating Serratia with a high sensitivity (<1/100 mL of filtrate). In this way it was possible to assess the daily performance in terms of the bacterial retention efficacy and to define, over the course of the 5 days, what the total capacity would be.
The results are shown in the Exhibits for each of the two modes of delivery. In no instance was Serratia contamination of the filtrate detected even after passage of more than 8 liters of the test suspension, and over 1,000,000,000 cfu of bacteria over the course of the 5 day test period. These conditions represent extremes which are very unlikely to be faced as a routine in the dental operatory, and the results justify the conclusion that, under normal working conditions, Clearline Plus has sufficient retention capacity to ensure passage of filter sterilized water for at least 5 working days in the dental operatory into the tubing downstream of the device.
In the initial installation of Clearline® Plus, the downstream tubing section is replaced with a sterile section, connecting the exit luer of the device to the coupler. This section of tubing is subject to contamination by organisms sucked back from the patient's mouth
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unless protected by a check valve. BacStop™ (K.960556) disposable check valves have been shown to be effective in achieving this protection when used in conjunction with daily disposable Clearline® Microfiltration cartridges (K.930144). For the development of Clearline Plus it was necessary to establish the performance capacity of this normallyclosed check valve when used as an integral component part of the microfiltration/check valve device.
BacStop is a normally-closed backflow prevention check valve that consists of a flat silastic rubber disc valve in a housing, sealed by sonic welding, that provides for luer connection to in line fittings. The housing parts are made of clear 124 polycarbonate. It is used in infusion I/V sets to control backflow. When placed in line in dental water hoses, it opens only when sufficient pressure is applied, usually about 1.5 psi. When the pressure falls, the valve snay's closed and thus prevents any fluid from golig hack up the line.
BacStop was cleared for daily use as a disposable check valve for dental water lines (K#960556) and is the only FDA cleared device for this purpose. Clearance came after data was submitted to the FDA for this device. The data confirmed that after 250 on/off cycles representing a "worst case scenario" for the use pattern in a dental unit during one day's work, the check valve was able to completely prevent any suckback of either bacteria or viruses, when a negative pressure was applied upstream of the check valve. In order for the test to be more sensitive, no handpiece or air/water syringe was used. Pursuant to A.D.A/A.N.S.I. specification #47, promulgated by the American Dental Association, approximately 45 microlitres of retraction is allowed into a handpiece, because this is insufficient to reach the dental water lines upstream of the coupling. Accordingly, any retraction of less than this amount will not be drawn into the tubing, but will be retained within the instrument and sterilized by routine autoclaving.
A suspension of a marker bacterium, Chromobacterium violaceum (ATCC 553), was used to show that no organisms were able to get up into the tubing even when the tubing tip, six inches downstream of the valve, was inserted into a heavy suspension of this organism. The same conclusion was reached with a suspension of viruses. In these tests, less than 0.1 microliters would have been detected if there had been any passage into the six inch length of tubing (between the valve and the tip of the tubing) after applying the negative pressure upstream. This sensitivity was achieved by culturing the entire contents of the tubing, between the valve and the tip, after the test conditions had been applied.
In order to evaluate the potential for this valve to be useful for 5 days, as a component part of Clearline® Plus, the number of on/off cycles experienced by the valve was extended to 1,250 cycles over 5 consecutive 8 hour sessions, with stasis of flow in between, in conditions comparable to those described above for retention capacity testing of the Clearline Plus filter membrane. The intention was to mimic a heavy use pattern of the valve for a working week (5 days) in a dental line. Over the course of the testing, approximately 5 liters of water passed through each of 6 Clearline® Plus devices (in which the BacStop™ valves are integrated), with a pressure of 35 psi, and a pulse length of 3 seconds each.
By daily testing, it was established that there was no failure of any single valve tested on days 1-4 after experiencing this use pattern. At the end of the fifth day of pulsing through
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the 6 Clearline® Plus test devices, the Chromobacterium backflow test was again performed. Three valves of the units subjected to this "working week" of pulses showed zero bacteria on culturing the downstream tube contents, indicating that no backflow of the test suspension at all had occurred. The other three check valves showed that an average of 0.11 microliters of the suspension had been drawn into the tubing when tested at the end of the fifth day. As mentioned earlier, since no handpiece or syringe tip was used on the line, it would take approximately 45 microlitres of retraction for material to reach the dental water line upstream of the coupler. These results demonstrate, that there will be no contamination of the dental water line. This level of control of backflow is entirely compatible with our claim of utility of the check valve in Clearline", even after experiencing 5 working days of on/off cycling. In the absence of the valve, the tubing yielded approximately 170,000 bacteria in a total volume of about 200 microliters, when the sight negative pressure (3-5 persifialition) was applied upstream of the Clearliale "Plcs.
The conclusions drawn constitute the claims we make for the Clearline® Plus device and its substantial equivalence to Dentapure: a) that, when placed in-line in dental unit waterlines, Clearline" Plus will provide filter sterilized water and prevent bacterial contaminants in the dental water system from entering the water flow downstream of the device for a period of five working days, when subjected to a pattern of on/off use typical of that experienced in a dental operatory; and b) that over this working period, the device will prevent backflow (or "suckback") of patient-derived microorganisms into a dental line, even when there is negative pressure applied upstream.
These claims are equivalent to those for Dentapure (K 963548), where it is stated that the device will "commonly reduce bacterial levels to less than one cfulmilliliter" downstream of the filter, and that use of Dentapure will "reduce the amount of bacteria that would reach the patient from the dental water system", and that, in addition, the device "reduces the chance of cross-contamination by introducing the germicide iodine into the water system, downstream of the filter." Use of both devices requires that current recommendations on instrument sterilization be followed by the practitioner.
Sterilization, Software and Hardware information:
It is intended that the device will be marketed in a sterile packaging. The final attachment of the check valve, packaging and sterilization (ETO) will be done at the following facility:
B. Braun Medical, Inc. 824 Twelfth Avenue Bethlehem, PA 18018 FDA reg. #2523676
Information requested in specific guidance documents:
Not applicable.
Kit Certification Statement:
Not applicable.
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Image /page/7/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 4 1998
Mr. Clive Defty President Scitech Dental, Incorporated 562 1st Avenue South #700 Seattle, Washington 98104
Re: K973996 Clearline Plus, Dental Waterline Filter Trade Name: Regulatory Class: I EIA Product Code: December 30, 1997 Dated: Received: January 5, 1998
Dear Mr. Defty:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does
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Page 2 - Mr. Defty
not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic chrough Siz or on inotrol provisions, or other Federal laws or requlations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA deberison in your in your device of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding-by-reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fdp.gov/cdrh/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page of
510 (k) Number (if known): K973996
Device Name: CLEARLINE PLUSTM Dental waterline filter and check valve
Indications For Use:
CLEARLINE PLUS™ is a disposable, combined 0.22 micron filter and anti-retraction check valve for use in dental unit water lines. It is intended to be used, in line, as a means of controlling bacteriological contaminants in the dental water and preventing the retraction of orally contaminated fluids into the dental line. It is to be used for all patients and changed every week, or 5 working days ... ................................................................................................................................
CLEARLINE PLUS™ is to be installed within the last several inches of tubing, before the dental handpiece, air/water syringe or ultrasonic scaler. The filter comprises a 0.2 micron bacterial retentive membrane to reduce bacteriological contaminants in the dental water. The check valve opens only when sufficient pressure is applied (1.5 psi) and snaps closed when the pressure drops below this point, thereby sealing the line against any backflow. The device is inserted by connection to luer mounts placed permanently in line.
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| Concurrence of CDRH, Office of Device Evaluation (ODE) |
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| Susan Rudy | |
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(Division Sign Division of Dental, Infection Control, and General Hospital Devic agglo (V) 510(k) Number
Prescription Use (Per 21 CFR 801.109)
OR Over-The-Counter Use
(Optional Format 1-2-96)
§ 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.