AEU-425 TRANSPORT II PORTABLE DENTAL SYSTEM

K022217 · Aseptico, Inc. · EIA · Oct 24, 2002 · Dental

Device Facts

• Record ID: K022217
• Device Name: AEU-425 TRANSPORT II PORTABLE DENTAL SYSTEM
• Applicant: Aseptico, Inc.
• Product Code: EIA · Dental
• Decision Date: Oct 24, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6640
• Device Class: Class 1
• Attributes: Therapeutic

Indications for Use

Transport II offers the dental professional the capability of carrying a complete dental operative system in one transportable case. The system is ideally suited for performing general dental procedures anywhere there is a suitable power source.

Device Story

Transport II (AEU-425) is a portable electronic dental operative system housed in a single carrying case. It integrates an autoclavable micro motor, dental irrigation, high/low volume suction, and an optional ultrasonic scaler. The system is operated by dental professionals in various clinical settings. The electric handpiece motor provides torque and speed control; the irrigation and suction systems manage fluids and waste. The device is powered by an external source. The healthcare provider uses the integrated tools to perform general dental procedures, facilitating mobile dental care. Safety is verified via UL 2601.1 compliance.

Clinical Evidence

Bench testing only. The device was evaluated for electrical and mechanical safety according to IEC 601.1 and UL 2601.1 standards. No clinical data was required or provided.

Technological Characteristics

Portable dental operative unit. Materials: polyethylene/polyurethane (fluid lines), PET/polypropylene (containers). Components: autoclavable electric micro motor, irrigation system, suction system, optional ultrasonic scaler. Power: external electrical source. Safety: UL 2601.1 and IEC 601.1 compliant. Sterilization: steam autoclave for handpiece motor exterior.

Indications for Use

Indicated for dental professionals performing general dental procedures in locations with a suitable power source.

Regulatory Classification

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.

Predicate Devices

• Aseptico dental handpiece system (K882526/A)
• Asepti-mini ADU-10 (K905401)

Submission Summary (Full Text)

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022217

# OCT 2 4 2002

# 510(k) Summary

Contact: Grant Ramaley

Date Prepared: May 23, 2002

| Trade or Proprietary Name: | Transport II - Model Number: AEU-425 |
|----------------------------|---------------------------------------------|
| | Portable Electronic Dental Operative System |

Classification Name: D Dental Operative Unit (872.6640)

### Description of Transport II's characteristics

Portable Electrical Dental System that combine an autoclavable micro motor, dental irrigation, high and low volume suction and *Ultrasonic scaler into a single transportable carrying case into which all features have been integrated.

#### Features

- 1) Low voltage electric handpiece motor with forward, reverse and speed control.
- a. More powerful electric Handpiece motor offers more torque and runs cooler than previous models.
- b. Uses the same methods for powering and connecting contra angles used in the previously marketed devices covered by Aseptico's previous approval under K882526/A
- c. The electrical and mechanical safety of the handpiece drive system complies with IEC 601.1 and is to be Classified under the U.S. version of Underwriters Laboratories UL 2601.1 - This product is tested and listed under UL File number E208087.
- d. The motor is designed so that the exterior surface can be sterilized in a steam autoclave between each patient use.
- 2) Irrigation and suction.
- a. The irrigation and suction systems employed by the AEU-425 are substantially equivalent to the previously marketed device "Asepti-mini" ADU-10 covered by 510(k) K905401.
- b. All water, waste water lines are made of polyethylene or polyurethane. Containers are made form either PET or Polyproplyene. All materials are commonly used in similar dental applications and are able to be disinfected using common bleach/water rinsing without suffering deterioration.
- 3) *Can be provided with an Ultrasonic Scaler.

*The optional ultrasonic Scaler is provided with all accompanying labels and instructions for use that are part of the original manufacturer's packaging . Any scaler sold with the Transport II is additionally evaluated along with the entire system by Underwriter's Laboratories to internationally recognized safety standards for medical devices (ref UL 2601.1).

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name arranged in a circular fashion around a symbol. The symbol consists of three stylized human profiles facing right, stacked on top of each other. The profiles are rendered in black and have a flowing, ribbon-like appearance.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# OCT 2 4 2002

Mr. Grant Ramaley Quality Assurance and Regulatory Affairs Aseptico, Incorporated 833 216th Street S.E. Woodinville, Washington 98072

Re: K022217

Trade/Device Name: Transport II Model Number AEU-425 Portable Electronic Dental Operative System Regulation Number: 872.6640 and 872.4200 Regulation Name: Dental Operative Unit and Accessories and Dental Handpiece and Accessories Regulatory Class: I Product Code: EIA and EKX Dated: October 10, 2002 Received: October 10, 2002

Dear Mr. Ramsey:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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### Page 2 - Mr. Ramsey

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 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 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.qov/cdrh/dsma/dsmamain.html

Sincerely vou

Timothy A. Ulatowski Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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KC22217

Page

## 510(k) Number (if known)

Device Name:

### Transport II Model Number AEU-425 Portable Electronic Dental Operative System

Indications For Use:

Transport II offers the dental professional the capability of carrying a complete dental operative system in one transportable case. The system is ideally suited for performing general dental procedures anywhere there is a suitable power source.

Kshetz DDS for Dr Susan Renner

eneral Hospital.

510(k) Number: K022217

### (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per CFR 801.109) OR

Over-The-Countern Use_

(Optional Format 1-2-96)