(106 days)
K.963548, K.930144, K.960556
Not Found
No
The device description and performance studies focus on the physical properties and mechanical function of a filter and check valve. There is no mention of AI, ML, or any computational analysis of data.
No.
The device is intended to control bacteriological contaminants in dental unit water lines and prevent retraction of fluids, rather than directly treating a disease or condition in a patient.
No
The device is a filter and anti-retraction check valve designed to control bacteriological contaminants and prevent fluid retraction in dental unit water lines. It does not perform any diagnostic function.
No
The device description clearly indicates it is a physical, disposable microfiltration cartridge with a membrane and check valve, not software.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is to control bacteriological contaminants in dental unit water lines and prevent backflow of fluids into the lines. This is a function related to maintaining the quality and safety of the water delivered to the patient during dental procedures.
- Device Description: The device is a filter and check valve designed to be installed in the water line itself.
- Performance Studies: The performance studies evaluate the device's ability to filter bacteria from water and prevent backflow, not to analyze a biological sample from a patient to provide diagnostic information.
IVDs are devices intended for use in vitro for the examination of specimens, including blood, tissues, and urine, from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not perform such a function.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
EIA
Device Description
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.
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 unit water lines
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
Description of the test set for bacterial retention efficacy: Twelve Clearline® Plus devices were tested in-line in a standard (Proma Dental Equipment Co.) dental unit hose. The unit was supplied with a water source through a "bottled water" or "clean water" delivery system (Ampco Dental Co.), pressurized to 35 psi with Nitrogen gas. The bottled water system was charged daily with a challenge bacterial suspension, approximately 100,000 cfi/mL of test organisms (Sartates mo versas). Approximately 11.5 liters of this suspension was passed through each Clearline® Plus each day for 5 days, over a period of about 8 hours. Testing was performed in two modes:
- Six sterile Clearline® Plus cartridges were tested with intermittent pulses of water flow of 20 seconds duration, with stasis in between, to ensure between 1 and 1.5 liters of bacterial suspension passed through the device during 50 operating cycles over the 8-hour test period.
- The remaining devices were tested with 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 to detect contaminating Serratia with a high sensitivity (
§ 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
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
JMMART
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
2
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.
. ... ... ... .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
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
3
Comparison Table of the new device to marketed devices:
:
.
:
:
| | CLEARLINE® PLUS
In-line membrane filter
and check valve | DENTAPURE
In-line disposable
membrane filter | BACSTOP™
Anti-retraction
Check Valve |
|------------------------------------------|------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|-----------------------------------------------------------|
| Intended use | In-line control of
bacterial contamination
and water retraction in
dental hoses | In-line control of
bacterial contamin-
ation and water retrac-
tion in dental hoses | In-line control of
water retraction in
dental 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 and
Lexan 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-retraction
Component | Silastic rubber disc | 2.5 cc iodinated
Ion exchange resin | Silastic rubber disc |
| Replacement
Schedule | Weekly (five working
days) | Weekly (five working
days) | Daily |
| Fittings-inlet | Female luer | Female luer | Female luer |
| Fittings-outlet | Male luer | Male luer | Male luer |
| Cracking pres-
sure of check
valve | 1.5 psi | N/A | 1.5 psi |
| Max. working
pressure | 70 psi | 70 psi | 70 psi |
:
4
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 ( 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
8
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
9
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.
(PLEASE DO NOT WRITE BBLOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
| 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)