WAND PLUS

K992819 · Spintech, Inc. · EJI · May 11, 2000 · Dental

Device Facts

• Record ID: K992819
• Device Name: WAND PLUS
• Applicant: Spintech, Inc.
• Product Code: EJI · Dental
• Decision Date: May 11, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6770
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

To inject local anesthetic agents subcutaneously or intramuscularly for dental applications.

Device Story

Computer-controlled syringe for dental anesthesia; consists of stationary motor housing, metal piston, foot switch, flexible vinyl tubing, and handpiece. Uses standard 1.8mm pre-filled anesthetic carpules and hypodermic needles. Disposable assembly includes holster, tubing, and handpiece. Motor speed regulates anesthetic flow rate. Provides audible status indicators and optional voice announcements for injection rate and volume. Operated by dental professionals in clinical settings. Enhances control over anesthetic delivery compared to manual syringes.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and intended use compared to the predicate device.

Technological Characteristics

Stationary motor housing with metal piston; handpiece constructed of rigid PVC; flexible vinyl tubing. Energy source: electric (motor-driven). Connectivity: audible status indicators and voice announcement system. Disposable sterile assembly for one-time use. Compatible with standard 1.8mm pre-filled anesthetic carpules.

Indications for Use

Indicated for subcutaneous or intramuscular injection of local anesthetic agents in dental applications.

Regulatory Classification

Identification

A cartridge syringe is a device intended to inject anesthetic agents subcutaneously or intramuscularly. The device consists of a metal syringe body into which a disposable, previously filled, glass carpule (a cylindrical cartridge) containing anesthetic is placed. After attaching a needle to the syringe body and activating the carpule by partially inserting the plunger on the syringe, the device is used to administer an injection to the patient.

Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.

Predicate Devices

• Wand™ computer controlled syringe

Submission Summary (Full Text)

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## MAY 1 1 2000

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510(k) Summary

Daniel J. Manelli Submitted by: Farkas & Manelli, P.L.L.C. 2000 M Street NW (Suite 700) Washington, DC 20036

> On behalf of Spintech, Inc. 220 South Orange Avenue Livingston, NJ 07039

510(k) Submission: The Wand Plus™ Syringe Date: December 10th, 1999

The Wand Plus™ is a computer controlled syringe consisting of Description: a stationary motor housing which includes a metal piston whose speed of advance is regulated by a foot switch thus controlling the flow rate of anesthetic being injected. The device utilizes hypodermic needles and standard 1.8mm pre-filled carpules manufactured by various third parties. The anesthetic agent reaches the needle by means of a length of flexible vinyl tubing. The handpiece is made of rigid PVC. The holster containing the anesthetic carpule, the tubing and the handpiece are sold in a sterile condition as a disposable assembly for one-time use. The materials, principal of operation and intended use are the same as other marketed piston and cartridge syringes. The device provides audible status indicators, including optional voice announcement, of injection rate, and volume of anesthetic dispensed. It is substantially equivalent to the company's currently marketed Wand™ computer controlled syringe.

Indications for use:

To inject local anesthetic agents subcutaneously or intramuscularly for dental applications.

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Public Health Service

MAY 11 2000

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Spintech, Incorporated C/O Mr. Daniel J. Manelli Farkas & Manelli, P.L.L.C. 2000 M street, N.W., Suite 700 Washington, DC 20036

Re : K992819 Trade Name: Wand Plus Regulatory Class: II Product Code: EJI April 4, 2000 Dated: Received: April 4, 2000

Dear Mr. Manelli

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 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 Good Manufacturing Practice for Medical Devices: a General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory 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 seations 531 through 542 of

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Page 2 - Mr. Manelli

the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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 [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" (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 [phone] or [phone] or at its internet address "http://www.fde.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

510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________

Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications for Use:

To inject local anesthetic agents subcutaneously or intramuscularly for dental applications.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED Concurrence of CDRH, Office of Device Evaluation (ODE)

Suon Runoe

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

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)