GETTIG STYRL-JECT DELIVERY SYSTEM

K972285 · Gettig Pharmaceutical Instrument Co. · EJI · Sep 11, 1997 · Dental

Device Facts

• Record ID: K972285
• Device Name: GETTIG STYRL-JECT DELIVERY SYSTEM
• Applicant: Gettig Pharmaceutical Instrument Co.
• Product Code: EJI · Dental
• Decision Date: Sep 11, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6770
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Indications for Use

The intended use of the device is to inject medicaments subcutaneously, intramuscularly, or via I.V. access ports. This device is intended for all adult patient populations based upon the appropriate needle size selection by the physician or clinician, and is governed by the specific drug being administered. Any pediatric applications is at the discretion of the physician and governed by the specific drug being administered.

Device Story

Gettig Styrl-Ject® Delivery System is a sterile, single-use hypodermic syringe cartridge; consists of pre-filled glass carpule and plastic syringe. Carpule features plastic retainer with frangible button to maintain sterility of needle path until use; eliminates need for alcohol swab. User snaps off button, inserts carpule into plastic syringe; syringe needle rear extension punctures rubber diaphragm to create fluid path. Plunger rod engages plunger for aspiration and injection. Configurable for various needle sizes; supports subcutaneous, intramuscular, and I.V. applications via butyl and needleless access ports. Used by physicians or clinicians in clinical settings to administer prescribed medicaments.

Clinical Evidence

Bench testing only. Performance evaluations included carpule leak testing (vacuum dye), button snap-off force, glass neck integrity, plunger extrusion force, needle sharpness/penetration drag, needle retention, and cover pull-off force. No clinical data provided.

Technological Characteristics

Sterile, single-use hypodermic syringe cartridge. Components: glass carpule, plastic syringe. Materials utilize USP class VI designations with established history in medical manufacturing. Connectivity: none. Energy source: manual. Sterilization: not specified (implied sterile).

Indications for Use

Indicated for subcutaneous, intramuscular, or I.V. administration of medicaments in adult patients; pediatric use at physician discretion. Contraindications governed by specific drug administered.

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 (K851903)
• Terumo Hypodermic Syringe (K771205)
• Wyeth Tubex® (Pre-amendment)
• Monoject® Prefilled Syringe (K812934)

Submission Summary (Full Text)

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SEP 11 1997

K972285

# Section A

ﺎ ﻣﺴ

# 510 (k) Summary

## Submitted By:

Gettig Pharmaceutical Instrument Company A Division of Gettig Technologies, Inc. One Streamside Place West P.O. Box 85 Spring Mills, PA 16875

# Establishment Registration Number - #2511670

Telephone Number - 814-422-8892 Fax Number - 814-422-8011 email - [e-mail]

Contact Person: Kevin Fee

Date of Application - June 17, 1997

#### Device Name:

| • Proprietary Name -- | Gettig Styrl-Ject® Delivery System |
|-----------------------------------|--------------------------------------------|
| • Common Name -- | Hypodermic Syringe Cartridge |
| • Proposed Classification Name -- | Syringe, Cartridge<br>21 CFR Sec. 872.6770 |
| • Class II | |
| • Product Code -- | 76 E J I |

#### Predicate Device - Substantial Equivalence

The Gettig Stryl-Ject® Delivery System is similar to various predicate and preamendment devices currently and previously marketed having the same intended use for medicament administration. The device has attributes similar to the Astra Aspirating Syringe (K851903), the Terumo Hypodermic Syringe (K771205), the Wyeth Tubex® (Pre-amendment), and the Monoject® Prefilled Syringe (K812934).

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# Device Description

The Gettig Styrl-Ject® Delivery System is a sterile, single use hypodermic syringe cartridge device designed to be similar to current single use products. The device consists of two basic constituents - a previously filled glass carpule, and plastic syringe. The carpule features a plastic retainer with a frangible button. When ready to use, the carpule retainer button is snapped off, exposing the rubber diaphragm insert. Until, the button is snapped the carpule needle path remains sterile, thus eliminating the need for an alcohol swab. The plastic syringe is also sterile until ready for use via the plunger rod encapsulating the needle rear extension. After removal of the threaded plunger rod, the carpule is then inserted into the clear plastic syringe allowing the syringe needle rear extension to puncture the rubber diaphragm creating a path for medicament administration. Then the syringe plunger rod is engaged with the plunger and the cover (needle or luer) is removed, to allow aspiration and injection. The syringe can be configured for a variety of needle sizes for subcutaneous injection as well as for I.V. applications via butyl and needleless access ports.

## Biocompatibility

Reasonable assurance of biocompatibility of the materials comprising the device is provided by their established history in medical product manufacturing, USP class VI designations, and DMF file information for the materials (see Section H - Appendix).

#### Materials

See Section F for materials description and Section H Appendix for material specifications.

## Physical Properties

See Section H Appendix for physical properties

## Statement of Intended Use

The intended use of the device is to inject medicaments subcutaneously, intramuscularly, or via I.V. access ports. This device is intended for all adult patient populations based upon the appropriate needle size selection by the physician or clinician, and is governed by the specific drug being administered. Any pediatric applications is at the discretion of the physician and governed by the specific drug being administered.

## Indication Statement Differences

There are no differences for indications with the predicate device(s).

## Comparison of Technologies, Materials, and Design with Predicate Device(s).

See Section E, Tables 11 & 12 for comparison data.

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## Performance Bench Tests and Data to Show Safety and Effectiveness

The non-clinical bench tests performed on the Gettig Styrl-Ject® Delivery System are the same protocols and standards used for the evaluation of our standard syringe products. See Section C for performance data and Section H Appendix for performance test summary.

#### Listing of Performance Bench Tests

Carpule Leak Test Vacuum Dye Air Gauge - Federal DimensionAire Button Snap Tests Before Sterilization After Sterilization Glass Neck Snap-Off Schott revision 1 & 2 Plunger Extrusion Force

Using O-Ring Universal Plunger Chattilon Gauge

Needle Sharpness - 22 ga & 25 ga Penetration Drag

Needle Rear Extension Penetration

Needle Retention - Instron Pull

22 ga & 25 ga

Cover Pull-off Force - Instron Pull 22 ga & 25 ga

22 ga & 23 ga
N. H. P. Fastener Corp.

Needle Rear Extension Coring 22 ga & 25 ga Rear Beveled

22 ga Blunt w/Rear Blunt

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Image /page/3/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services USA. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The text is in all caps and is evenly spaced around the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP | | 1997

Mr. Kevin Fee Gettig Pharmaceutical Instrument Company 1 Stream Side Place West Spring Mills, Pennsylvania 16875-0085

K972285 Re: Trade Name: Gettig Styrl-Ject Delivery System Requlatory Class: II Product Code: EJI Dated: June 17, 1997 Received: June 19, 1997

Dear Mr. Fee:

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 of the Act. The general controls provisions of the Act include requirements for annual reqistration, listing of devices, qood 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 requlations 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 current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug

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Page 2 - Mr. Fee

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 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 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 and additionally 809.10 for in vitro diaqnostic 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" (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.f.a.gov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

Timot Ulatowski Direct or Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radioloqical Health

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Page of

510(k) Number (if known):

Device Name: Gettig Styrl-Ject® Delivery System

Indications For Use:

The indications for use of the device is to inject medicaments subcutaneously, intramuscularly, or via I.V. access ports. This device is subedules for all adult patient populations based upon the appropriate needle size selection by the physician or clinician, and is governed by the specific drug being administered. Any pediatric applications is at the discretion of the physician and governed by the specific drug being administered.

There are no differences for indications with the predicate device(s).

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Division of Dental, Infection Contr and General Hospital D 5 i O(k) Number

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use.

(Optional Format 1-2-96)

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