MIRAMATIC SAFE SYRINGE SYSTEM

K043322 · Hager Worldwide, Inc. · EJI · Jul 21, 2005 · Dental

Device Facts

• Record ID: K043322
• Device Name: MIRAMATIC SAFE SYRINGE SYSTEM
• Applicant: Hager Worldwide, Inc.
• Product Code: EJI · Dental
• Decision Date: Jul 21, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6770
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Indicated for use with pre-filled anesthetic cartridges and press fit dental needles for the manual injection of local dental anesthetics into the oral tissues. The cartridge syringe may aid in the reduction of needle stick injuries.

Device Story

Manual dental cartridge syringe system; designed for use with pre-filled anesthetic cartridges and specific press-fit dental needles. Features compression-fit needle hub mechanism; replaces traditional threaded connections. Syringe hub includes locked and unlocked positions to secure needle. Used by dental professionals in clinical settings for local anesthetic delivery. Primary benefit is reduction of needle stick injuries through integrated safety design.

Clinical Evidence

Bench testing only. Included mechanical testing, cleaning and sterilization efficacy validation, and simulated clinical evaluation.

Technological Characteristics

Manual cartridge syringe system; compression-fit needle hub mechanism; designed for use with MIRAJECT needles. Hub features locked and unlocked positions. Non-powered, manual operation.

Indications for Use

Indicated for patients requiring local dental anesthesia via manual injection into oral tissues.

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

• SafeStep™ Safety Dental Cartridge Injector (K022959)

Submission Summary (Full Text)

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K043322

JUL 2 1 2005 (As Required by 21 C.F.R. §807.92)

| Submitted by: | Hager Worldwide, Inc.<br>13322 Byrd Drive<br>Odessa, FL 33556 | |
|----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------|
| Date of summary: | This summary was prepared on June 30, 2005. | |
| Device name: | Hager MIRAMATIC Safety Syringe System | |
| Common name: | Dental cartridge syringe system with antistick feature, needle re-capper,<br>and sharps container. | |
| Classification names: | Regulation Number and ProCode | Classification Name |
| | 872.6770, EJI | Cartridge Syringe |
| | 872.4730, DZM | Dental Needle |
| Predicate Devices | SafeStep™ Safety Dental Cartridge Injector K022959 ("1-Shot™ Safety<br>Syringe."). Dental needles are 510(k) exempt. | |
| Modifications | The device employs a compression fit loading and ejecting needle hub<br>rather than threaded connection. | |
| Intended Use | Indicated for use with pre-filled anesthetic cartridges and press fit dental<br>needles for the manual injection of local dental anesthetics into the oral<br>tissues. | |
| | The cartridge syringe may aid in the reduction of needle stick injuries. | |
| Technological<br>Characteristics | The Hagar MIRAMATIC System consists of a cartridge syringe (the<br>MIRAMATIC) and dental needles (MIRAJECT). | |
| | The MIRAMATIC System is a manual system designed exclusively for<br>use with MIRAJECT needles. The hub of the syringe is designed to<br>receive the needle using a compression fit mechanism rather than a<br>threaded screw-on motion or slip-fit. The needles have a corresponding<br>specially designed cone to allow seating by push fit on to the hub. The<br>syringe hub has locked and unlocked positions. | |
| Testing | Testing activities were conducted to establish the performance and<br>reliability characteristics of the new device with respect to the predicates.<br>Testing involved mechanical testing, cleaning and sterilization efficacy<br>and simulated clinical evaluation. | |

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Public Health Service

JUL 2 1 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Hager Worldwide, Incorporated c/o Mr. James Delaney 4 Lincoln Street Andover, Massachusetts 01810

Re: K043322

Trade/Device Name: Miramatic Safe Syringe System Regulation Number: 21 CFR 872.6770 Regulation Name: Cartridge syringe Regulatory Class: II Product Code: EJI Dated: July 1, 2005 Received: July 5, 2005

Dear Mr. Delaney:

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.

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Page 2 - Mr. Delaney

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 (QS) 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/industry/support/index.html.

Sincerely yours,

Davers

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K013322

## Indications for Use

510(k) Number (if known): K043322

Device Name: Hagar MIRAMATIC Safe Svringe System

Indications for Use:

Indicated for use with pre-filled anesthetic cartridges and press fit dental needles for the manual injection of local dental anesthetics into the oral tissues.

The cartridge syringe may aid in the reduction of needle stick injuries.

Prescription Use 关 (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mhe Udshle for MSR

(Division Sign Division of Anesthesiolo Infection Control, De

510(k) Number:

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(Posted November 13, 2003)