IGN 500 TM WATER CLEANING UNIT WITH CALBENIUM LIQUID by AIREL-WEST

This document is a 510(k) clearance letter for the IGN 500 Waterline Unit. It indicates that the device has been found substantially equivalent to a predicate device marketed before May 28, 1976. This type of document does not contain acceptance criteria for device performance or any studies demonstrating that the device meets such criteria.

The core purpose of a 510(k) submission and the resulting clearance letter is to demonstrate "substantial equivalence" to a legally marketed predicate device, not necessarily to provide detailed performance data and acceptance criteria in the format you requested.

Therefore, I cannot extract the requested information from the provided text. The document states:

Trade Name: IGN 500 Waterline Unit
Regulatory Class: I
Product Code: EIA (which typically refers to a water purification, unit, dental)
Indications For Use: Intended to help prevent gross contamination of the dental operatory unit.

To answer your questions, one would need access to the actual 510(k) submission document (K964271), specifically the sections pertaining to performance testing, if any were submitted beyond basic safety and substantial equivalence comparisons. For Class I devices, extensive clinical studies or detailed performance trials with specific acceptance criteria are often not a prerequisite for 510(k) clearance, as the focus is on demonstrating equivalence to an existing device rather than proving novel clinical effectiveness.

Summary

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Airiel-West C/O Daniel A. Kracov Patton Boggs, L.L.P. 2550 M Street, N.W. 6th Floor Washington, DC 20037

DEC 19 1997

K964271 Re : IGN 500 Waterline Unit Trade Name: Requlatory Class: I Product Code: EIA September 19, 1997 Dated: Received: September 22, 1997

Dear Mr. Kracov:

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 of the Act. The general controls 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 regulations affecting your device can be found in the Code of Federal Requlations, 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 Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: through periodic (QS) inspections, the Food and Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory action. In addition, FDA may publish further announcements 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. Kracov

through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

This letter will allow you to beqin 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) 594-4618. 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.fda.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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. ・・・

510(k) Number (if known): _ K964271

IGN 500TM WATER CLEANING UNIT WITH CALBENIUM LIQUIDTM Device Name:__________________________________________________________________________________________________________________________________________________________________

Indications For Use:

Intended to help prevent gross contamination of the dental operatory unit.

(PLEASE DO NOT WRITI: BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

	Concurrence of CDRH, Office of Device Evaluation (ODE)
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Susan Runne

(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices
510(k) Number	K964271

Prescription Use(Per 21 CFR 801.109)	OR	Over-The-Counter Use
O()		(Optional Format 1-2-96)

Regulation Number and Section

§ 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.