PISTON SYRINGE & HYPODERMIC NEEDLE

K022159 · International Medsurg Connection · FMF · Nov 7, 2002 · General Hospital

Device Facts

• Record ID: K022159
• Device Name: PISTON SYRINGE & HYPODERMIC NEEDLE
• Applicant: International Medsurg Connection
• Product Code: FMF · General Hospital
• Decision Date: Nov 7, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5860
• Device Class: Class 2

Intended Use

This device is intended for inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe consisting of a calibrated hollow barrel and a movable plunger.

Device Story

Device consists of piston syringe with calibrated hollow barrel and movable plunger, paired with sharpened metal hypodermic needle. Needle features female hub connector for mating with syringe male nozzle. Used by clinicians to inject or withdraw fluids subcutaneously or intramuscularly. Manual operation; provides fluid delivery or aspiration. Benefits include precise fluid volume administration and access to body tissues for therapeutic or diagnostic purposes.

Clinical Evidence

Bench testing only. Evaluated syringe column sealing (300 Kpa positive/88 Kpa negative pressure), volume accuracy (±4%), tip sealing, ruler accuracy, tip draw strength (25N), residue contents (<0.075 mL), sliding force (<10N), appearance, sterility, pyrogenicity, and toxicity.

Technological Characteristics

Piston syringe with calibrated hollow barrel and movable plunger; metal hypodermic needle with female hub. Materials evaluated for toxicity and biocompatibility. Performance specs: 300 Kpa positive pressure sealing, 88 Kpa negative pressure sealing, ±4% volume accuracy, <10N sliding force, 25N tip draw strength. Sterile, single-use.

Indications for Use

Indicated for the injection of fluids into, or withdrawal of fluids from, parts of the body below the surface of the skin.

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 Piston Syringes
• Nipro needles

Submission Summary (Full Text)

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K022159

# Attachment 3

#### 9.0 SUMMARY OF SAFETY AND EFFECTIVENESS

#### NOV 7 2002 INTERNATIONAL MEDSURG CONNECTIONS SYRINGE AND NEEDLES

| Manufacturer: | International Medsurg Connections, Inc.<br>935 N. Plum Grove Road, Suite F<br>Schaumburg, Illinois 60173-4770 |
|-----------------------------|---------------------------------------------------------------------------------------------------------------|
| Regulatory Affairs Contact: | Michele Vovolka<br>P.O. Box 848<br>Grayslake, Illinois 60030 |
| Telephone: | [phone] |
| Date Summary Prepared: | October 11, 2002 |
| Product Trade Name: | International Medsurg Connections Equipment Covers |
| Common Name: | Piston Syringe and Needles |
| Classification: | Class II |
| Predicate Devices: | |

The International Medsurg Connections piston syringe and hypodermic needle. Description: The covers are offered sterile, single use.

This device is intended for inject fluids into, or withdraw fluids from, parts of the Intended Use: body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe consisting of a calibrated hollow barrel and a movable plunger

Substantial Equivalence:

The International Medsurg Connections piston syringe and hypodermic needles are substantially equivalent to the Becton Dickinson Piston Syringes and the Nipro needles in that they provide the following characteristics:

- Intended use is the same
- Size, configuration, color are similar
- Materials
- Physical properties are similar

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# Attachment 3

Summary of Testing: All materials used in the fabrication of the International Medsurg Connections O.R. piston syringe and hypodermic needles were evaluated for:

| Testing Items | Code Requirement |
|------------------------------------|---------------------------------------------------------------------------------------|
| Syringe Column<br>Sealing | 300 Kpa Positive Pressure - No<br>leakage<br>88 Kpa Negative Pressure - No<br>leakage |
| Volume | $\pm 4\%$ |
| Tip Sealing Property | No Leakage |
| Indicating Ruler - 0<br>level line | Within ¼ range |
| Tip size, Draw<br>Strength | No separation at 25N |
| Residue Contents | < 0.075 mL |
| Sliding Property | Average <10N |
| Appearance | Clean, Smooth |
| Non-Bacteria | Non-Bacteria |
| Pyrogen | Pyrogen-Free |
| Toxicity | Non-toxic, no toxicity reaction for<br>human body |

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

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 arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA". Inside the circle is a stylized symbol that resembles three human profiles facing to the right, stacked on top of each other. The profiles are connected by curved lines, creating a flowing, abstract design.

#### Public Health Service

7 2002 NOV

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

International Medsurg Connection C/O Ms. Michele H. Vovolka Vantage Consulting International, Limited P.O. Box 848 Grayslake, Illinois 60030

Re: K022159

Trade/Device Name: International Medsurg Connections Syringe and Needles 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: October 11, 2002 Received: October 15, 2002

Dear Ms. Vovolka:

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 either 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 - Ms. Vovolka

. . . . . .

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 and additionally 21 CFR Part 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 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/cdrh/dsma/dsmamain.html

Sincerely vours.

Susan Runyon

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

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# Attachment 4

# 510(k) Number (if known): K022159

International Medsurg Connections Syringe and Needles Device Name:

### Indications For Use:

This device is intended for inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe consisting of a calibrated hollow barrel and a movable plunger.

. .

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

### Concurrence of CDRH, Office of Device Evaluation (ODE)

Patricia Cucchi

vision of Anesthesiology, General Hospital. Infection Control, Dental Devices

510(k) Number: K022159

(Optional Format 3/10/98)