SAFETY INJECTION SYSTEM

K962999 · Integritech, Inc. · EJI · Jan 22, 1997 · Dental

Device Facts

• Record ID: K962999
• Device Name: SAFETY INJECTION SYSTEM
• Applicant: Integritech, Inc.
• Product Code: EJI · Dental
• Decision Date: Jan 22, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6770
• Device Class: Class 2

Intended Use

The IntegriTech Safety Injection System is intended to be used for the injection of local anesthetic solutions in dental procedures. The device is designed to allow for aspiration of fluid during the injection to determine if the needle has entered a blood vessel and to provide a protective cover for the needle to prevent needlestick injuries.

Device Story

Plated brass dental aspirating syringe; accommodates 1.8 cc anesthetic carpule; features harpoon plunger for aspiration to verify needle placement outside blood vessels. Includes integrated, autoclavable polycarbonate protective cover; cover locks in extended position to shield contaminated needle; facilitates safe recapping by allowing needle cap placement into cover end before retraction. Used in dental clinics by dentists/auxiliary staff. Protects operator and patient from needlestick injuries during procedure and recapping.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Materials: chrome-plated brass syringe barrel, polycarbonate protective cover. Dimensions: accommodates 1.8 cc anesthetic carpule. Mechanism: threaded needle hub, harpoon plunger for aspiration. Sterilization: autoclavable components.

Indications for Use

Indicated for use by dental professionals for the administration of local anesthetic solutions in patients requiring dental procedures.

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

• Astra Aspirating Syringe (K85-1903)
• UltraSafe Aspirating Syringe (K944425)

Submission Summary (Full Text)

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K962999
Page 13

# SUMMARY
JAN 22 1997

| Submitter’s Name: | IntegriTech, Inc.
6020 Bayou Road
Mobile, Alabama 36605
Phone: [phone]
Fax: [phone] |
| --- | --- |
| Contact Persons: | Jerry A. Smith
Phone: [phone]

Joseph M. Gerlecz, D.D.S.
Phone: [phone] |
| Date of Preparation: | June 24, 1996 |
| Device Name: | |
| Proprietary Name: | Safety Injection System |
| Common Name: | Dental Aspirating Antistick Syringe |
| Classification Name: | Cartridge Syringe |
| Equivalent Device: | Astra Aspirating Syringe
510K Number - K85-1903
Astra Pharmaceutical Products, Inc.
50 Otis Street
Westborough, MA 01581
Phone: [phone]
UltraSafe Aspirating Syringe |

Device Description: The IntegriTech Safety Injection System is a plated brass syringe with a threaded male on the end of the syringe barrel to which the metal or plastic hub of the injection needle is threaded. The barrel accommodates a 1.8 cc anesthetic carpule. The syringe has a plunger with a harpoon on one end which engages the rubber piston of the anesthetic carpule to allow aspiration of fluid during the injection to determine if the needle has entered a blood vessel. These characteristics are the same for the “Astra” syringe (K85-1903) to which we are claiming equivalence. In addition, the Safety Injection System includes a polycarbonate protective cover which in the extended position locks and completely covers the uncapped needle. This allows the syringe to be set aside during the procedure with the contaminated needle covered thereby protecting the operator, auxiliary and patient from a needlestick injury. The protective cover in the extended locked position also allows for the safe placement of the needle cap into the end of the cover which can then be retracted. This action simultaneously recaps the needle thus preventing a needlestick injury during the recapping process. The protective cover is equivalent to the polycarbonate cover on the disposable UltraSafe Aspirating Syringe by Safety Syringes, Inc. (510K #K944425, January 26, 1995). The difference is that the protective cover on the Safety Injection System (IntegriTech) is a solid autoclavable polycarbonate tube attached to an autoclavable chrome plated brass syringe barrel. This cover can be replaced as needed.