(245 days)
To isolate water delivery lines in the dental operatory unit and reduce the contamination due to biofilm to improve the quality of water supplied to dental handpieces and other dental instruments.
Accessory to dental unit, dental line-cleaner.
The provided text is a 510(k) summary for the Eradic-All™ device, a dental line cleaner. It establishes substantial equivalence to previously cleared devices. However, it does not contain any information about acceptance criteria or a study proving device performance against such criteria.
The document focuses solely on:
- Identifying the device and its classification.
- Stating its intended use.
- Listing predicate devices.
- Asserting substantial equivalence based on intended use, technological characteristics (with stated differences in methods of use but same intent), and material composition of the delivery unit.
- Mentioning that the product does not contact patients and operating instructions require adequate flushing.
Therefore, I cannot provide the requested information from the given text. The text does not describe:
- A table of acceptance criteria and reported device performance.
- Sample size used for the test set and data provenance.
- Number of experts used to establish ground truth or their qualifications.
- Adjudication method.
- MRMC comparative effectiveness study or effect size.
- Standalone (algorithm only) performance.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
The summary states that the manufacturer has "not been able to locate specific guidance documents applying to biofilm removal from dental lines," suggesting that formal performance testing against specific criteria related to efficacy might not have been a requirement or was addressed through the substantial equivalence argument rather than a direct performance study.
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DEC 2 1998
SAFE MEDICAL DEVICES ACT OF 1990 SUMMARY OF SAFETY AND XI. EFFECTIVENESS, March 12, 1998 [Separate Pages]
- Andre de Villers, Theratechnologies Inc., 630 Boul. Rene-Levesque Ouest, Se étage, I. Montreal H3B 1S6, Quebec, Canada. Phone: 514-877-0077.
- II. Classification Names and numbers: Dental Operative unit, accessory 76EIA.
- Common/Usual Name: Accessory to dental unit, dental line-cleaner. III.
- Proprietary Names: Eradic-All™ IV.
- V. Establishment Registration Number: In process
- Classification: Dental operative unit and accessories, Class I, reserved, Described in CFR VI. 872.6640.
- Substantial Equivalence: Eradic-All™ is substantially equivalent to the classified device VII. and those cleared for marketing by the 510(k) process under K-971278 (Pure Company, K-963548 (MRLB Int'l.) and K-930144 (SciTech Dental) and K-882491 (Micryllum Labs.)
The "510(k) Substantial Equivalence" Decision Making Process (Detailed) from ODE Guidance Memorandum # 36-3 was followed as described below:
These products have the same intended use to provide a cleaner water supply for use with ﻟﺴﻴ dental operative units, including devices cleared for marketing by K-963548 and K-882491, K-930144 and K-971278.
- The technological characteristics for this product are similar to those for the predicate devices and those currently on the market except for differences in methods of use. The technological features of the chemical solution used, although distinct, have the same intended use of reducing contaminants. The methods used with these equivalent products also vary widely including daily or weekly change, overnight soak or elution of traces of bactericide and filtering or non-filtering.
Descriptive information provided shows that the materials from which the delivery unit of 3. Eradio-All™ is made are substantially equivalent to (identical with those of K-971278) those of similar products, used for identical purposes, currently on the market.
This product does not contact patients. Operating instructions clearly indicate the necessity 4. for adequate flushing so the cleaning solution is removed from the water lines. Products from which the cleaning agent are prepared are accepted in food processing applications.
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We have not been able to locate specific guidance documents applying to biofilm removal from dental lines. However, we believe we have complied fully with general guidance documents and usual practices in preparing premarket notifications. If additional information or explanation is needed, please call me at 514-877-0077 or fax me at 514-877-3177. Alternately, you may contact Dr. H. N. Dunning at 301-229-2138, 8309 Bryant Dr., Bethesda, MD 20817, who is acting on my behalf, for a local response.
Sincerely yours
du addresses of
Andre de Villers President
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Image /page/2/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, and a circle of text around the symbol. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
2 1998 DEC
Mr. Andre de Villers Theratechnologies, Incorporated 630, boul.René-Lévesque Quest 5€ étage Montréal (Québec) H3B IS6
K981171 Re : Eradic-All Trade Name: Requlatory Class: I Product Code: EIA October 20, 1998 Dated: October 22, 1998 Received:
Dear Mr. de Villers:
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 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 (Act). provible therefore, market the device, subject to the general The general controls controls provisions of the Act. provisions of the Act include requirements for annual reqistration, 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 requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਉ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation 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 not affect any obligation you might have under sections 531
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Page 2 - Mr. de Villers
through 542 of the Act for devices under the Electronic enroduct Radiation Control 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 finding of substantial equivalence 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) 594-4692. 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" (21CFR 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.fda.gov/cdrh/dsma/dsmamaif/.html".
Sincerely yours
Timothy A. Ulatowski
Ulatowski Timot 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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| 510(k) Number (if known): | NA K981171 |
|---|---|
| Device Name: | Eradic-All™ |
Page ___ of ___
Indications For Use:
ﺑﺘﺠﺎﺑﺮ
To isolate water delivery lines in the dental operatory unit and reduce the contamination due to biofilm to improve the quality of water supplied to dental handpieces and other dental instruments.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Myra Browne for S. Renner
(Division Sign-Off) Division of Deall, Infecture and General Hospital L
ﺍﻟﻤﺮﺍﺟﻊ ﺍﻟﻤﻮﺍﻗﻊ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤ 510(k) Number
Prescription Use √
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-9
મ્દ્રો (
§ 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.