MINIJECT

K991888 · Spartan Ultrasonics, Inc. · EJI · Aug 25, 1999 · Dental

Device Facts

• Record ID: K991888
• Device Name: MINIJECT
• Applicant: Spartan Ultrasonics, Inc.
• Product Code: EJI · Dental
• Decision Date: Aug 25, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6770
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

This product is intended to be used to administer intraligamental injections of anaesthetic product, through a two-ended needle.

Device Story

Miniject Syringe is a manual cartridge syringe used for intraligamental anesthetic delivery. Device features a metal barrel accommodating a 1.8cc anesthetic cartridge and a plunger that engages the cartridge's rubber piston. A two-ended needle is threaded onto the metal or plastic hub. Operated by dental professionals in a clinical setting to provide local anesthesia. The device functions as a standard manual delivery system for anesthetic cartridges; no electronic or automated components.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Manual cartridge syringe; metal barrel construction; accommodates 1.8cc anesthetic cartridges; threaded needle hub (metal or plastic); manual plunger actuation.

Indications for Use

Indicated for the administration of intraligamental anesthetic injections in patients requiring local anesthesia.

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

• Intralig (K823536)
• Ligmaject (K802483)

Submission Summary (Full Text)

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AUG 25 1999

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# 510(k) Summary

Submitted By: Spartan Marketing Group 1663 Fenton Business Park Ct. Fenton, MO 63026 USA

## Establishment Registration Number - #1926480

Telephone Number - 314.343.8733 FAX Number - 949.203.2122 Email - [e-mail]

Contact Person: Aldo Eagle Title: Director of International Business Development

Date of Application - May 28, 1999

#### Device Name:

- Miniject Syringe Proprietary Name -Cartridge Syringe or Intraligamental Syringe Common Name -Proposed Classification Name - Syringe, Cartridge
Class II ס

- Product Code -76 E J I ם
### Predicate Device - Substantial Equivalence

The Miniject Syringe is substantially equivalent in terms of safety and effectiveness to the marketed injection devices of (K823536) Intralig and (K802483) Ligmaject

### Device Description

The Miniiect Syringe is a cartridge syringe with a metal syringe barrel to which the metal or plastic hub of the injection needle is threaded. The barrel accommodates a 1.8cc anesthetic cartridge. The syringe has a plunger on one end, which engages the rubber piston of the anesthetic cartridge. These characteristics are the same or similar for the "Intralig", by Miltex, (K823536) and Ligmaject, (K802483).

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo consists of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA". Inside the circle is a symbol of three stylized human profiles facing right, with flowing lines above them that resemble a bird in flight.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 25 1999

Mr. Aldo Eagle Director Spartan Ultrasonics, Incorporated 1663 Fenton Business Park Court Fenton, Missouri 63026

Re : K991888 Trade Name: Miniject Regulatory Class: II Product Code: EJI May 28, 1999 Dated: Received: June 2, 1999

Dear Mr. Eagle

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 The general controls provisions of the Act 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 (Premarket Approval), 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 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 regulation may result in regulatory 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

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Page 2 - Mr. Eagle

the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510 (k) premarket notification. The FDA dinding 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 ene regarderen endtification" (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.fdaygov/cdrh/dsmamain.html".

Sincerely yours,

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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K 99/888/A'

Image /page/3/Picture/1 description: The image is a logo for Obtura Spartan, a company that specializes in endodontic success. The logo features a stylized image of a tooth with the company name written below it. The slogan "Enhancing Endodontic Success" is written below the company name. The logo is black and white.

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510(k) Number (if known): K991888

Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications For Use:

This product is intended to be used to administer intraligamental injections of anaesthetic product, through a two-ended needle.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER P. NEGOED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Bank

(Division Sign-Off)

Division of Dental, Infection Control, and General Hospital Devices

| 510(k) Number | K991885 |
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|---------------|---------|

| Prescription Use | <div style="display:inline-block;">✓</div> (Per 21 CFR 801.109) | OR | Over-The-Counter Us (Optional Form) |
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1663 FENTON BUSINESS PARK COURT • FENTON, MISSOURI 63026 USA [phone] • [phone] • FAX [phone]