ULTRASAFE INJECTION SYSTEM MODEL C200 INJECTOR WITH NEEDLE GUARD

K972877 · Safety Syringes, Inc. · FMF · Feb 26, 1998 · General Hospital

Device Facts

• Record ID: K972877
• Device Name: ULTRASAFE INJECTION SYSTEM MODEL C200 INJECTOR WITH NEEDLE GUARD
• Applicant: Safety Syringes, Inc.
• Product Code: FMF · General Hospital
• Decision Date: Feb 26, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5860
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The UltraSafe® Model C200 Injector with Needle Guard is designed to hold a sterile medication cartridge with needle in place while administering an injection. The guard is intended to protect the user from needle sticks after injection and during disposal of the needle cartridge unit. The UltraSafe® Model C200 Injector is used with a standard Sanofi-Winthrop Carpuject® 2.0ml medication cartridge to deliver medication from the cartridge to the tissue of a patient, and is equipped with a shield that covers the needle during disposal. This device is used for a wide range of patients from children to adults and for a wide range of clinical conditions.

Device Story

Manual injection system; holds sterile medication cartridge with needle; delivers medication to patient tissue. Features integrated needle shield/guard; manually snapped into place post-injection to cover needle point; eliminates need for recapping; minimizes accidental needle stick injuries during disposal. Used by clinicians in healthcare settings. Device provides same usable needle length as unguarded needles; allows standard hypodermic procedures. Benefits patient and caregiver by reducing risk of sharps injury.

Clinical Evidence

Bench testing only. No clinical data provided. Testing focused on biocompatibility and mechanical strength of the needle guard.

Technological Characteristics

Materials: K-Resin KR01, KR03, and ABS Resin. Mechanical needle guard/shield system. Manual operation. Disposable. No energy source. No software.

Indications for Use

Indicated for patients ranging from children to adults requiring medication delivery via sterile cartridge and needle; used for various clinical conditions requiring hypodermic injection.

Regulatory Classification

Identification

A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.

Predicate Devices

• Safety Syringes UltraSafe® Aspirating Syringe (K944425)
• Sanofi-Winthrop Injector (Pre-amendment)

Submission Summary (Full Text)

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K972877

FEB 26 1998

## 510(k) Premarket Notification UltraSafe® Injection System Model C200 Injector with Needle Guard

# 9.0 Summary of Safety and Effectiveness

## Safety Syringes Contact Person .1

David Mitchell Safety Syringes, Inc. 250 West Colorado Blvd. Suite # 101 Arcadia, CA 91007 [phone] Phone [phone] Fax

### 9.2 Device Name

UltraSafe® Injection System, Model C200 Injector with Needle Guard

#### 9.3 Predicate Devices

Safety Syringes UltraSafe® Aspirating Syringe - K944425 Sanofi-Winthrop Injector - Pre-amendment

## Product Description and Function 9.4

The UltraSafe® Model C200 Injector with Needle Guard is a product which is intended to be used with a sterile medication cartridge with needle to deliver medication from the cartridge into the tissues of the patient. The device is totally disposable and is equipped with a needle shield which consists of a safety guard that can be snapped into place after use of a syringe, thus protecting the caregiver by eliminating the need to recap the needle, and minimizing accidental needle stick injuries during disposal of the syringe/needle

#### 9.5 Comparison to Predicate Devices/Equivalence

Descriptive Comparison to Legally Marketed Devices Model C200 Injectors with Needle Guard are intended to be used to deliver medication from a cartridge. The guard

Safety Syringes, Inc. UltraSafe C200 Injector 510(k) Submission

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requires a two-handed action in order to cover the needle point after use.

The Model ( 200 needle guard has been tested and found to have considerably greater strength than the predicate device. The C200 Injector is as easy to assemble and use as the Sanofi-Winthrop Injector.

With the Mode! C200 needle guard in the "ready-to-use" position, it provides the same useable needle length as an unquarded needle. The user can perform typical hypodermic procedures equivalently to standard, unguarded needles.

### 9.6 Comparison of Materials

The UltraSate® Injection System, Model C200 Injector is made of K-Resin KR01, KR03, and ABS Resin which are the same materials as the Safety Syringes predicate device.

## Safety and Efficacy Information 9.7

Biocompatibility:

The UltraSafe® Injection System, Model C200 Injector uses the same materials as the Safety Syringes predicate device. The materials have passed biocompatibility tests.

Labeled Warning Statements:

Hands must remain behind the needle at all times during use and disposal.

Safety Syringes, Inc. UltraSafe C200 Injector 510(k) Submission

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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 stylized eagle with three lines representing its body and wings. The eagle's head is facing to the left. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 26 1998

Mr. Anthony R. Perez CEO & President Safety Syringes, Incorporated 250 West Colorado Boulevard, Suite 101 Arcadia, California 91007

K972877 Re : UltraSafe® Injection System Model C200 Trade Name: Injector with Needle Guard Regulatory Class: II Product Code: FMF Dated: January 6, 1998 Received: January 7, 1998

Dear Mr. Perez:

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 qeneral 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 requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. And ----------substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical General requlation (21 CFR Part 820) and that, Devices: through periodic (QS) inspections, the Food and Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does

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Page 2 - Mr. Perez

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 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 requlation (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 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.gov/cdrh/dsmamain.html".

Sincerely yours,

K. Whitworth

Ohy 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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1 Page 1 of

510(k) Number (if known): K972877

UltraSafe® Injection System Model C200 Injector With Needle Guard Device Name:

Indications For Use:

The UltraSafe® Model C200 Injector with Needle Guard is designed to hold a sterile medication cartridge with needle in place while administering an injection. The guard is intended to protect the user from needle sticks after injection and during disposal of the needle cartridge unit.

The UltraSafe® Model C200 Injector is used with a standard Sanofi-Winthrop Carpuject® 2.0ml medication cartridge to deliver medication from the cartridge to the tissue of a patient, and is equipped with a shield that covers the needle during disposal. This device is used for a wide range of patients from children to adults and for a wide range of clinical conditions.

Patricio Cucumita

(Division Sign-Off) (Division of Dinal, Infection Control, and General Trospital Devices 510(k) Number .

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)