STERIPACK STERILE DISPOSABLE SYRINGE & STERILE DISPOSABLE INSULIN SYRINGE

K023108 · Atlantic Products, Inc. · FMF · Dec 3, 2002 · General Hospital

Device Facts

• Record ID: K023108
• Device Name: STERIPACK STERILE DISPOSABLE SYRINGE & STERILE DISPOSABLE INSULIN SYRINGE
• Applicant: Atlantic Products, Inc.
• Product Code: FMF · General Hospital
• Decision Date: Dec 3, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5860
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The STERIPACK Sterile Disposable Syringe is intended to be used for injecting fluids into, or for withdrawing fluids from, the body. The STERIPACK Sterile Disposable Insulin Syringe is intended to be used for the subcutaneous injection of insulin.

Device Story

STERIPACK sterile disposable syringes are manual, single-use piston syringes. General syringes (3-50 ml) feature luer lock, slip tip, or eccentric configurations for fluid injection or withdrawal. Insulin syringes (0.5-1.0 ml) include permanently affixed needles and markings for U-100 insulin delivery. Devices are used by clinicians or patients for manual fluid administration or withdrawal. No electronic or automated components.

Clinical Evidence

Bench testing only. Compliance with ISO 7886-1 (hypodermic syringes), ISO 8537 (insulin syringes), ISO 594-1 (conical fittings), and ISO 7864 (sterile hypodermic needles).

Technological Characteristics

Manual piston syringe; sterile, single-use. Available in 3-50 ml (general) and 0.5-1.0 ml (insulin) volumes. Materials and performance comply with ISO 7886-1, ISO 8537, ISO 594-1, and ISO 7864. No energy source, software, or connectivity.

Indications for Use

Indicated for patients requiring fluid injection or withdrawal (general syringe) or subcutaneous insulin administration (insulin syringe).

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

• Becton Dickinson Syringes
• Exel Intl Syringes
• Nipro Disposable Syringes and Insulin Syringes
• Monoject Piston Syringes

Submission Summary (Full Text)

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DEC 0 3 2002

# 510(k) Summary of Safety and Effectiveness

## Atlantic Products, Inc. STERIPACK™ Sterile Disposable Syringes and STERIPACK™ Sterile Disposable Insulin Syringes

| Contact Person: | Mr. Mahbubur Rahman<br>Chief Executive Officer<br>Atlantic Products, Inc.<br>24 Center Street<br>Hicksville, NY 11801<br>Tel: [phone]<br>Fax: [phone] |
|--------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date Prepared: | December 1, 2002 |
| Device Names: | Brand Names: STERIPACK™ Sterile Disposable Syringe<br>STERIPACK™ Sterile Disposable Insulin Syringe |
| | Common or Usual Names: Sterile Disposable Syringe<br>Sterile Disposable Insulin Syringe |
| | FDA Classification Names: Piston Syringe<br>Piston (Insulin) Syringe |
| Predicate Devices: | The STERIPACK Syringes are similar to the following devices:<br>Becton Dickinson Syringes<br>Exel Intl Syringes<br>Nipro Disposable Syringes and Insulin Syringes<br>Monoject Piston Syringes |

All of the devices listed above are either, used for injecting fluids into, or withdraw fluids from, the body, or used for the subcutaneous injection of insulin, and are considered substantially equivalent to the STERIPACK Sterile Disposable Syringe and the STERIPACK Sterile Disposable Insulin Syringe.

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#### Product Description:

The STERIPACK Sterile Disposable Syringe, with or without a hypodermic needle, is a sterile, single use, piston syringe, designed for manual use. The STERIPACK Sterile Disposable Syringe is available in 3, 5, 10 and 50 ml volume sizes with luer lock, slip tip, and eccentric configurations.

The STERIPACK Sterile Disposable Insulin Syringe with permanently affixed hypodermic needle, is a sterile, single use, insulin syringe, designed for manual use. The STERIPACK Sterile Disposable Insulin Syringe is available in 0.5 and 1.0 ml volume sizes, color coded with markings for delivery of 100 units of insulin/ml (U-100).

#### Intended Use:

The STERIPACK Sterile Disposable Syringe is intended to be used for injecting fluids into, or withdraw fluids from, the body. The STERIPACK Sterile Disposable Insulin Syringe is intended to be used for the subcutaneous injection of insulin.

#### Technology Characteristics:

The STERIPACK Sterile Disposable Syringe and Insulin Syringe submitted in this 510(k) Notification are substantially equivalent in intended use, technology/principles of operation, materials and performance to the predicate devices listed above. Any differences that do exist do not significantly affect the safety and effectiveness of the STERIPACK Sterile Disposable Syringe and Insulin Syringe.

#### Performance Characteristics:

The STERIPACK Sterile Disposable Syringe and Insulin Syringe comply with ISO 7886-1 (1993) for Hypodermic Syringes, ISO 8537-1991 for Insulin Syringes, ISO 594-1 (1986) for Conical Fittings, and ISO 7864 for Sterile Hypodermic Needles for Single Use.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the caduceus symbol. The image is in black and white.

DEC 03 2002

0 Corporate Boulevaro ckville MD 20850

Mr. Mahbubur Rahman Chief Executive Officer Atlantic Products, Incorporated 24 Center Street . Hicksville, New York 11801

Re: K023108

Trade/Device Name: STERIPACK Sterile Disposable Syringe. STERIPACK Sterile Disposable Insulin Syringe Regulation Number: 880.5860 and 880.5570 Regulation Name: Piston Syringe and Hypodermic Single lumen Needle Regulatory Class: II Product Code: FMF and FMI Dated: September 10, 2002 Received: September 18, 2002

Dear Mr. Rahman:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into cither class II (Special Controls) or class III (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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#### Page 2 - Mr. Rahman

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 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), 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 Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrl/dsma/dsmamain.html

Sincerely yours,

Timothy Ullatowski

Timothy A. Ulatowski Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### 510(k) Premarket Notification Indications Enclosure

Page

510(k) Number (if known): KO23108

Device Name:

STERIPACK Sterile Disposable Syringe STERIPACK Sterile Disposable Insulin Syringe

Indications for Use:

The STERIPACK Sterile Disposable Syringe is intended to be used for injecting fluids into, or for withdrawing fluids from, the body.

The STERIPACK Sterile Disposable Insulin Syringe is intended to be used for the subcutaneous injection of insulin.

### (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 Inselin (Optional Format 1-2-96) Syrings

Astoria Guerrero
(Division Sign or

of Anesthesiology General Hospital. e Molon of Anesthesiology Gene Infection Control, Dental Devices

510(k) Number: K023126