THE WAND

K992404 · Spintech, Inc. · FMF · Jun 6, 2000 · General Hospital

Device Facts

• Record ID: K992404
• Device Name: THE WAND
• Applicant: Spintech, Inc.
• Product Code: FMF · General Hospital
• Decision Date: Jun 6, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5860
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

For injection of lidocaine subcutaneously or intramuscularly for infiltration and nerve block.

Device Story

The Wand™ is a computer-controlled syringe system for anesthetic delivery. It consists of a stationary motor housing, a metal piston, flexible vinyl tubing, and a rigid PVC handpiece. The device accepts standard 1.8mm pre-filled anesthetic carpules and hypodermic needles. Operation is controlled via a foot switch, which regulates the motor-driven piston speed to manage the anesthetic flow rate. The handpiece, tubing, and carpule holster are provided as a sterile, single-use disposable assembly. The device is intended for use by clinicians to perform local anesthesia via infiltration or nerve block. By providing controlled, motorized delivery, it aims to improve the consistency of anesthetic administration compared to manual syringes.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and intended use compared to legally marketed predicate devices.

Technological Characteristics

Stationary motor housing with metal piston; rigid PVC handpiece; flexible vinyl tubing; accepts standard 1.8mm pre-filled anesthetic carpules; foot-switch controlled flow rate; sterile disposable assembly.

Indications for Use

Indicated for subcutaneous or intramuscular injection of lidocaine for infiltration and nerve block.

Regulatory Classification

Identification

A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.

Predicate Devices

• The Wand™ (Spintech, K961648)
• Shifa syringe (Alshifa Medical, K962614)
• CCS Computer Controlled Syringe (CATCO, K983105)

Submission Summary (Full Text)

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## JUN - 6 2000

K992404

## Summary of Safety and Effectiveness

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™ Syringe Date: May 25, 2000

## Description:

The Wand™ is a computer controlled syringe consisting of 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 is substantially equivalent to the Wand™ (Spintech, K961648); the Shifa syringe (Alshifa Medical; K962614); and the CCS Computer Controlled Syringe (CATCO; K983105).

Indications for use:

For injection of lidocaine subcutaneously or intramuscularly for infiltration and nerve block.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of three wavy lines, which are meant to represent the human form.

JUN - 6 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 NW, Suite 700 Washington, DC 20036

Re : K992404 Trade Name: The Wand Regulatory Class: II Product Code: FMF Dated: May 1, 2000 Received: May 2, 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 aqainst 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 Good Manufacturing Practice for Medical Devices: 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 requlation 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 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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## Page 2 - Mr. Manelli

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.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

for Susan Runser

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): _______K992404

Device Name: The Wand™ Computer Controlled Anesthetic Delivery System

Indications for Use:

For injection of lidocaine subcutaneously or intramuscularly for infiltration and nerve block.

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

Patroca Cucenete

Histon 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)