B-D AUTO-INJECTOR

K974678 · Bd Becton Dickinson Vacutainer Systems Preanalytic · KZH · May 29, 1998 · General Hospital

Device Facts

• Record ID: K974678
• Device Name: B-D AUTO-INJECTOR
• Applicant: Bd Becton Dickinson Vacutainer Systems Preanalytic
• Product Code: KZH · General Hospital
• Decision Date: May 29, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6920
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The intended use is to provide to patients a safe, simple and easy subcutaneous injection system in order to self-administer injectable drugs or biologics. The B-D® Auto-Injector is a syringe needle introducer. Syringe needle introducers are devices that use a spring-loaded mechanism to perform an injection at a predetermined depth with an hypodermic needle. The B-D® Auto-Iniector is intended to be used exclusively with drugs or biologics packaged in the HYPAK® cartridge system which contains a HYPAK® prefilled syringe. It is intended for use only with FDA approved drugs or biologics in dosages indicated in their labeling.

Device Story

B-D® Auto-Injector; spring-loaded syringe needle introducer; facilitates subcutaneous self-administration of drugs/biologics. Input: HYPAK® cartridge system containing prefilled syringe. Operation: spring-loaded mechanism performs injection at predetermined depth. Output: delivered dose of medication. Used by patients in home or clinical settings. Benefits: provides safe, simple, easy injection system for patients requiring regular medication administration.

Clinical Evidence

Bench testing only. Device conforms to ISO 10993-1 for biocompatibility.

Technological Characteristics

Molded plastic parts and springs. Spring-loaded mechanism for hypodermic needle depth control. Biocompatibility conforms to ISO 10993-1. Designed for use with HYPAK® cartridge system.

Indications for Use

Indicated for assisting the subcutaneous injection of a fixed dose of an FDA-approved drug or biologic packaged in a HYPAK® cartridge system containing a prefilled syringe.

Regulatory Classification

Identification

A syringe needle introducer is a device that uses a spring-loaded mechanism to drive a hypodermic needle into a patient to a predetermined depth below the skin surface.

Predicate Devices

• Diamatic autoinjector (K860284)

Submission Summary (Full Text)

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K974678

Page 25 of 34

# BECTON DICKINSON PHARMACEUTICAL SYSTEMS

MAY 2 9 1998

## 510(k) SUMMARY

Date of preparation: December 11, 1997

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirement of SMDA 1990 and 21 CFR 807.92.

- REASON FOR 510(k): Introduction of a new product. A.
- B. NAME OF DEVICE:
- B-D® Auto-Injector · Proprietary name :
- Syringe needle introducer · Classification name :
- · Common or usual name : auto-injector
- Class II · Class :

General Hospital, Panel 80; Classification panel: Regulation Number 21 C.F.R § 880.6920

#### ESTABLISHMENT REGISTRATION NUMBER: D. 8023072

### E. SUBMITTER'S NAME AND ADDRESS:

Becton Dickinson and Company Pharmaceutical Systems Division 1 Becton Drive Franklin Lakes, New Jersey 07417-1886

| Contact person: | Michael Gross, Ph.D. | |
|-----------------|----------------------|--------------|
| | Tel : | 201-847-5930 |
| | Fax : | 201-847-4854 |

### に MANUFACTURING FACILITIES:

Becton Dickinson France SA Pharmaceutical Systems Division BP4 38800 Le Pont-de-Claix, France Tel : [phone] 76 68 37 88 Fax : FDA Device Establishment Registration Number: 8023072

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## BECTON DICKINSON PHARMACEUTICAL SYSTEMS

## Page 26 of 34

### G. PERFORMANCE STANDARD(S) :

No performance standards applicable to syringe needle introducers or similar products have been promulgated under Section 514 of the Food, Drug and Cosmetic Act. The product has been tested in terms of biocompatibility and conforms to ISO standard 10993-1.

### DEVICE DESCRIPTION AND INTENDED USE : H.

The intended use is to provide to patients a safe, simple and easy subcutaneous injection system in order to self-administer injectable drugs or biologics.

The B-D® Auto-Injector is a syringe needle introducer. Syringe needle introducers are devices that use a spring-loaded mechanism to perform an injection at a predetermined depth with an hypodermic needle.

The B-D® Auto-Iniector is intended to be used exclusively with drugs or biologics packaged in the HYPAK® cartridge system which contains a HYPAK® prefilled syringe. It is intended for use only with FDA approved drugs or biologics in dosages indicated in their labeling.

The B-D® Auto-Injector is made of molded plastic parts and springs. Similar technology characteristics are found in various commercially marketed auto-injectors which operate on the same principle.

### ﻨﮯ ﺳﮯ SUBSTANTIAL EQUIVALENCE

The BD Auto-Injector is substantially equivalent to Ulster Scientific Inc.'s Diamatic "" autoinjector, (K860284) which was cleared by FDA in April 1986.

The term " substantial equivalence " as used in this 510(k) notification is limited to the definition of substantial equivalence as found in the Federal Food, Druq, and Cosmetic Act, as amended and as supplied under 21 CFR 807, Subpart E under which a device can be marketed without pre-market approval or reclassification. A determination of substantial equivalency under this notification is not intended to have any bearing whatsoever on the resolution of patent infringement suits or any other patent matters. No statement related to, or in support of substantial equivalence herein shall be construed as an admission against interest under the US Patent Laws or their application by the court.

## [END OF SUMMARY]

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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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with outstretched wings, composed of several curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 2 9 1998

Dr. Michael Gross, Ph.D. · Director, Corporate Regulatory Affairs Becton Dickinson and Company Pharmaceutical Systems Division One Becton Drive Franklin Lakes, New Jersey 07417-1886

Re : K974678 B-D® Auto-Injector Trade Name: Requlatory Class: II Product Code: KZH Dated: April 8, 1998 Received: April 9, 1998

Dear Dr. Gross:

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 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). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls com 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 (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. ਰੇ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS 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

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Page 2 - Dr. Gross

through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

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 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 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.fda.qov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

Time thy 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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510(k) Number (if known):

Device Name:

Indications for Use:

The B-D® Auto-Injector is indicated for assisting the injection of a fixed dose of an approved drug or biologic packaged in a HYPAK® Cartridge component which contains a HYPAK® syringe prefilled with the drug or biologic.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use _____________________________________________________________________________________________________________________________________________________________

OR

Over-The-Counter Use

(Per 21 CRF 801.109)

(Optional Format 1-2-96)
Palacio Queceritz

(Division Sign-Off) (Division of Dental, Infection Control, Divisioneral Hospital Devices 510(k) Number _