SAFETYWAND DISPOSABLE HANDPIECE

K023722 · Spintech, Inc. · EJI · Sep 2, 2003 · Dental

Device Facts

• Record ID: K023722
• Device Name: SAFETYWAND DISPOSABLE HANDPIECE
• Applicant: Spintech, Inc.
• Product Code: EJI · Dental
• Decision Date: Sep 2, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6770
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The SafetyWand™ is intended to inject local anesthetic agents subcutaneously or intramuscularly for dental applications. It is a sterile single use handpiece assembly for use with the Milestone Compudent™ computer controlled injection system. The SafetyWand™ incorporates safety engineering sharps protection features to aid in the prevention of needlesticks.

Device Story

SafetyWand™ is a disposable, safety-engineered handpiece for the CompuDent™ computer-controlled anesthetic delivery system. It consists of a rigid PVC handpiece, flexible vinyl tubing, and an anesthetic cartridge holder. The device features a protective barrel with a retractable needle hub assembly; the needle can be extended and locked for injection or retracted into the barrel to prevent needlesticks. Used in dental clinics by practitioners, it functions as a manual syringe component integrated with the CompuDent™ system, which provides audible status indicators and optional voice announcements regarding injection rate and volume. The device is supplied sterile for single-use, reducing the risk of needlestick injuries during anesthetic administration.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Materials: Rigid PVC handpiece, flexible vinyl tubing. Principle: Piston and cartridge syringe mechanism. Form factor: Disposable handpiece assembly with retractable needle hub. Connectivity: Integrates with CompuDent™ system for audible status/voice feedback. Sterilization: Sterile, single-use.

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® handpiece (K992819)
• IntegriTech Safety Injection System (K962999)

Reference Devices

• CompuDent™ computer controlled injection system (K992819)

Submission Summary (Full Text)

{0}------------------------------------------------

## 3722

SEP - 2 2003

## 510(k) Summary

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

Phone: [phone]

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

SafetyWand™ disposable handpiece for CompuDent™ 510(k) Submission: anesthetic delivery system

Date:August 13, 2003

The SafetyWand™ disposable handpiece is a safety engineered syringe Description: component designed for use with the CompuDent™ computer controlled injection system (K992819). The CompuDent® 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 hanbdpiece is made of rigid PVC. The anesthetic cartridge holder, 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 svringes. The device provides audible status indicators, including optional voice announcement of injection rate, and volume of anesthetic dispensed.

> The SafetyWand™ handpiece incorporates a protective barrel inside of which a movable needle hub assembly can be extended and locked in place for use in performing iniections. When not in use, or for disposal, the needle can be retracted within the barrel to aid in the prevention of needlesticks. The SafetyWand™ is substantially equivalent to the company's Wand® handpiece (K992819) and to the IntegriTech Safety Injection System (K962999).

Indications for use:

To iniect local anesthetic aqents subcutaneously or intramuscularly for dental applications.

{1}------------------------------------------------

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the department's name around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP - 2 2003

Spintech. Incorporated Mr. Daniel J. Manelli Attorney 2000 M Street NW (Suite 700) Washington, DC 20036

Re: K023722

Trade/Device Name: SafetyWand™ Disposable Handpiece Regulation Number: 872.6770 Regulation Name: Cartridge Syringe Regulatory Class: II Product Code: EJI Dated: June 20, 2003 Received: June 20, 2003

Dear Mr. Manelli:

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.

{2}------------------------------------------------

Page 2 -Mr. Manelli

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 (OS) 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), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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.gov/cdrh/dsma/dsmamain.html

Sincerely vours.

Susan Runoir

Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{3}------------------------------------------------

Exhibit H Page 1 of 1

510(k) Number (if known): K023722

Device Name: SafetyWand™ disposable handpiece

Indications for Use:

The SafetyWand™ is intended to inject local anesthetic agents subcutaneously or intramuscularly for dental applications. It is a sterile single use handpiece assembly for use with the Milestone Compudent™ computer controlled injection system. The SafetyWand™ incorporates safety engineering sharps protection features to aid in the prevention of needlesticks.

Susan Runne

(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices

510(k) Number: K023722

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

Prescription Use J (Per 21 CFR 801.109)

OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)