ULTRASAFE INJECTION SYSTEM NEEDLE GUARD, MODELS B50,B100L,B150,B225, AND B300

K972878 · Safety Syringes, Inc. · FMF · Oct 30, 1997 · General Hospital

Device Facts

• Record ID: K972878
• Device Name: ULTRASAFE INJECTION SYSTEM NEEDLE GUARD, MODELS B50,B100L,B150,B225, AND B300
• Applicant: Safety Syringes, Inc.
• Product Code: FMF · General Hospital
• Decision Date: Oct 30, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5860
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

Each UltraSafe® Injection System Needle Guard is attached to an ISO standard glass syringe that is pre-filled and equipped with a shield that covers the needle during disposal intending to reduce the occurrence of accidental needle sticks to users. This device is used for a wide range of patients from children to adults and parenteral methods of administration.

Device Story

UltraSafe® Injection System Needle Guard is a disposable accessory for ISO 11040-4 standard pre-filled glass syringes. Device functions as a safety guard; after injection, user manually activates guard to cover needle. Eliminates need for recapping; minimizes accidental needle stick injuries during disposal. Used in clinical settings by healthcare providers performing hypodermic procedures. Provides same usable needle length as unguarded needles; allows equivalent performance of standard procedures. Benefits patient and caregiver by enhancing safety during syringe disposal.

Clinical Evidence

Bench testing only. No clinical data provided. Testing demonstrated that the needle guard provides greater strength than the predicate device and allows for equivalent performance of hypodermic procedures.

Technological Characteristics

Disposable needle guard for ISO 11040-4 standard glass syringes. Materials: K-Resin KR03 and KR01. Mechanical activation; two-handed operation. No energy source. Non-sterile/sterile (implied by disposable nature).

Indications for Use

Indicated for children and adults requiring parenteral administration of medication via pre-filled ISO standard glass syringes to reduce accidental needle stick injuries during disposal.

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)

Submission Summary (Full Text)

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K972878

## UltraSafe® Injection System 510(k) Premarket Notification Models B50, B100, B100L, B150, B225 and B300 Needle Guard

OCT 3 0 1997

### 9.0 Summary of Safety and Effectiveness

#### Safety Syringes Contact Person 9.1

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 Needle Guard

#### 9.3 Predicate Devices

Safety Syringes UltraSafe® Aspirating Syringe - K944425

#### 9.4 Product Description and Function

The UltraSafe® Needle Guerd is an accessory to the ISO 11040-4 standard glass syringe that is pre-filled. The device is totally disposable. It is a safety guard that can be mated with a pre-filled syringe of the same size. After use of the syringe, the guard is activated covering the needle and thus protecting the caregiver by eliminating the need to recap the needle and minimizing accidental needle stick injuries during disposal of the syringe/needle.

Safety Syringes, Inc. UltraSafe® B Series Needle Guard 510/k) Submission

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### Comparison to Predicate Devices/Equivalence 9.5

Descriptive Comparison to Legally Marketed Devices The Needle Guard requires a two-handed action in order to cover the needle point after use.

The Needle Guards have been tested and found to have considerably greater strength than the predicate device. The Guard is easy to assemble and use with a prefilled syringe.

With the Needle Guards in the "ready-to-use" position, they provide the same useable needle length as an unguarded needle. The user can perform typical hypodermic procedures equivalently to standard, unguarded needles.

#### 9.6 Comparison of Materials

The UltraSafe® Injection System Needle Guards are made of K-Resin KR03 and KR01, which are the same materials as the Safety Syringes predicate device.

#### 9.7 Safety and Efficacy Information

Biocompatibility:

The UltraSafe® Injection System uses the same material as the Safety Syringes predicate device. The material has passed biocompatibility tests.

Labeled Warning Statements: Hands must remain behind the needle at all times during use and disposal.

Safety Syringes, Inc. UltraSafe B Series Needle Guard 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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines beneath them, possibly representing water or movement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# OCT 3.0 1997

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

Re : K972878 Ultrasafe® Injection System Needle Guard, Trade Name: Models B50,B100,B100L,B150,B225 & B300 Regulatory Class: II Product Code: FMF Dated: July 31, 1997 Received: August 4, 1997

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 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 Requlations, Title 21, Parts 800 to 895. ਜ 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 regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does

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Paqe 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 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" (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.fda.qov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

Timothy A. Diredtor 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): K972878

Device Name: UltraSafe® Injection System Needle Guard Models B50, B100, B100L, B150, B225 & B300

Indications For Use:

Each UltraSafe® Injection System Needle Guard is attached to an ISO standard glass syringe that is pre-filled and equipped with a shield that covers the needle during disposal intending to reduce the occurrence of accidental needle sticks to users. This device is used for a wide range of patients from children to adults and parenteral methods of administration.

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

Patricie Croate

Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices
510(k) Number K972878
Prescription Use ✓
(Per 21 CFR 801.109)
OR

Over-The-Counter Use

(Optional Format 1-2-96)