ULTRASAFE DENTAL INJECTION SYSTEM

K013801 · Safety Syringes, Inc. · MEG · Dec 13, 2001 · General Hospital

Device Facts

• Record ID: K013801
• Device Name: ULTRASAFE DENTAL INJECTION SYSTEM
• Applicant: Safety Syringes, Inc.
• Product Code: MEG · General Hospital
• Decision Date: Dec 13, 2001
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.5860
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The UltraSafe Dental™ Injection System is a sterile, single use Needle Guard assembly and a reusable Syringe Plunger assembly that is indicated for use with pre-filled, 1.8mL, anesthetic cartridges for injection of anesthetic solution for profound anesthesia of oral tissues. The Needle Guard sheath manually slides forward over the needle in between injections and after injection(s) have been completed. The Needle Guard helps protect dental healthcare professionals from accidental needlesticks. The intended patient population is unrestricted and includes children and adults of all ages.

Device Story

System comprises sterile, single-use needle guard assembly and reusable syringe plunger assembly. Used by dental healthcare professionals in clinical settings (dental offices, clinics, oral surgery) to administer local anesthetic via pre-filled 1.8mL cartridges. Needle guard sheath manually slides forward over needle between and after injections to prevent accidental needlesticks. Device provides physical barrier protection for clinician; used syringe disposed of in sharps container post-procedure. Benefits include reduced risk of occupational needlestick injuries during dental anesthetic delivery.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

System consists of a sterile, single-use needle guard assembly and a reusable syringe plunger assembly. Designed for use with standard 1.8mL anesthetic cartridges. Manual operation for needle shielding. No electronic components, software, or energy sources.

Indications for Use

Indicated for use with pre-filled 1.8mL anesthetic cartridges for injection of anesthetic solution for profound anesthesia of oral tissues in patients of all ages.

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

• UltraSafe Aspirating Syringe

Submission Summary (Full Text)

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K 013801

# DEC 1 3 2001

## 510(k) Summary

# Special 510(k) summary of safety and effectiveness

#### Company Information

Safety Syringes, Inc. 1939 Palomar Oaks Way, Suite A Carlsbad. CA 92009

#### Device Information

Trade Name - UltraSafe Dental™ Injection System - Model TBD Classification Name - Syringe, Antistick Classification - Class II Product Code - 80 MEG

#### Predicate Device

UltraSafe Aspirating Syringe

#### Device Description

The UltraSafe Dental™ Injection System is a sterile, single use Needle Guard assembly to help prevent needlestick and a reusable Syringe Plunger assembly that is used to administer local anesthetic solutions.

#### Intended Use Purpose and Function

The UltraSafe Dental™ Injection System is intended for use by dental healthcare professionals for injecting anesthetic into oral tissues with a syringe that provides a needlestick prevention mechanism. The anti-needlestick feature of this syringe system may be activated in between injections and at the conclusion of injections. When the Needle Guard is activated, it provides added protection to the dental healthcare professional from an accidental needlestick.

At the conclusion of iniections, the dental healthcare professional disposes of the used syringe into a sharps disposal container.

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### Intended Patient Population

The intended patient population is unrestricted and includes children and adults of all ages.

#### Intended Environment of Use

The intended environment of use is where dental healthcare professionals inject anesthetic into oral tissues by means of a syringe system (e.g., dental offices, dental clinics, oral surgery).

#### Indications for Use

The UltraSafe Dental™ Injection System is a sterile, single use Needle Guard assembly and a reusable Syringe Plunger assembly that is indicated for use with pre-filled, 1.8mL, anesthetic cartridges for injection of anesthetic solution for profound anesthesia of oral tissues.

The Needle Guard sheath manually slides forward over the needle in between injections and after injection(s) have been completed. The Needle Guard helps protect dental healthcare professionals from accidental needlesticks.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its body and wing. The eagle's head is facing left. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# DEC 1 3 2001

Ms. Thomas L. Hall Director, Regulatory Affairs & Quality Assurance Safety Syringes, Incorporated 1939 Palomar Oaks Way, Suite A Carlsbad, California 92009

Re: K013801

Trade/Device Name: UltraSafe Dental Injection System Regulation Number: 880.5860 Regulation Name: Syringe, Antistick Regulatory Class: II Product Code: MEG Dated: November 15, 2001 Received: November 15, 2001

Dear Mr. Hall :

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.

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.

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You must comply with all the Act's requirements, including, but not limited to: registration I ou inust comply with and are labeling (21 CFR Part 801); good manufacturing practice alle fisting (21 OF Real vor), and ity systems (QS) regulation (21 CFR Part 820); and if requirences as bet form nroduct 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 This teller will and w you to cognification. 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 11 you desire operine we are 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 the receinal of to toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

1. Ulatowski Timothy 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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# KO13801

## Indications for Use Statement

510(k) Number (if known): ___

Device Name:

UltraSafe Dental™ Injection System (Syringe, Antistick)

Indications for Use:

The UltraSafe Dental™ Injection System is a sterile, single use Needle Guard assembly and a reusable Syringe Plunger assembly that is indicated for use with pre-filled, 1.8mL, anesthetic cartridges for injection of anesthetic solution for profound anesthesia of oral tissues.

The Needle Guard sheath manually slides forward over the needle in between injections and after injection(s) have been completed. The Needle Guard helps protect dental healthcare professionals from accidental needlesticks.

The intended patient population is unrestricted and includes children and adults of all ages.

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Concurrence of CDRH, Office of Device Evaluation

Prescription Use
(Per 21 CFR 801.109

OR

Over the Counter_

Susan Runov

(Division Sign-Offi (Division Sign of Division Control, and General Hospital Da 510(k) Number ________________________________________________________________________________________________________________________________________________________________