RITRACT SAFETY SYRINGE

K060002 · Ritract , Ltd. · MEG · Jun 2, 2006 · General Hospital

Device Facts

• Record ID: K060002
• Device Name: RITRACT SAFETY SYRINGE
• Applicant: Ritract , Ltd.
• Product Code: MEG · General Hospital
• Decision Date: Jun 2, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5860
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Ritract Safety Syringe is a sterile, single-use, disposable, nonreusable, auto-retracting safety syringe which is intended for injection of fluids into the body, while reducing the risk of sharps injury and the potential for syringe reuse.

Device Story

Ritract Safety Syringe is a sterile, single-use, auto-retracting piston syringe (3mL, 5mL, 10mL) with luer lock needle connection. Device operates via manual plunger depression; when plunger bottoms out, internal collar system releases compressed spring, retracting needle into barrel to prevent reuse and sharps injury. Used in clinical settings by healthcare professionals. Output is delivery of injectable fluids. Benefit is reduced risk of accidental needlestick injuries and prevention of syringe reuse.

Clinical Evidence

No clinical data provided; substantial equivalence based on bench testing and design comparison to predicate devices.

Technological Characteristics

Sterile, single-use, disposable piston syringe. Features auto-retracting spring mechanism activated by plunger-collar interaction. Standard luer lock needle connection. Available in 3mL, 5mL, 10mL sizes. Materials and manufacturing processes are consistent with predicate devices.

Indications for Use

Indicated for injection of fluids into the body for patients requiring parenteral administration; intended for use by healthcare professionals to reduce risk of sharps injury and syringe reuse.

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

• BD Integra Spring Based Syringe (K011103)
• Nipro Disposable Syringe (K030683)

Submission Summary (Full Text)

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K060002

JUN - 2 2006

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www.ritract.com

# 510(k) PREMARKET NOTIFICATION SUMMARY

Submitter Details: Ritract Limited 1. ABN 28 106 353 253 Level 17, 201 Miller Street North Sydney, NSW 2060 [phone] Phone:

Mr. Rupert Northcott 2. Contact Person: Managing Director, Ritract Limited Level 17, 201 Miler Street North Sydney, NSW 2060 Australia

> [phone] Phone: [phone] Fax: Email : [e-mail]

### Name of the device: 3.

Ritract Safety Syringe Proprietary Name: Common/Usual Name: Syringe Hypodermic Piston Syringe Classification Name:

### Predicate Device(s): 4.

- BD Integra Spring Based Syringe K011103 .
- Nipro Disposable Syringe K030683 .

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## 5. Device Description

The Ritract Safety Syringe is a sterile, single-use, disposable, nonreusable, 3mL, 5mL, 10ml, auto-retracting safety syringe with a standard luer lock needle connection.

### 6. Indications for Use:

The Ritract Safety Syringe is a sterile, single-use, disposable, nonreusable, auto-retracting safety syringe which is intended for injection of fluids into the body, while reducing the risk of sharps injury and the potential for syringe reuse.

## Summary of the technological characteristics of our 7. device compared to the predicate device:

The Ritract Safety Syringe operates in the same fashion as the BD Integra 3ml Syringe. The needle is assembled by the user onto the syringe, the user draws the required fluid into the barrel as indicated by the graduation marks by drawing back the plunger, and the user injects the fluid by pushing the plunger forward till it bottoms out in the barrel. In both devices when the plunger bottoms out in the barrel this action activates a simple mechanism which releases the compressed spring and draws the needle back up into the barrel of the syringe with no protrusion of the syringe tip from the device.

In the case of the BD Integra Syringe the mechanism which releases the compressed spring is as follows: The plunger contains a tool which as it bottoms out in the barrel travels through the piston seal and pierces a hub on the dedicated BD Integra Needle which releases the spring drawing the needle fully up inside the plunger.

The Ritract Safety Syringe also uses the action of the plunger bottoming out to release the compressed spring. In the case of the Ritract Syringe the spring is held in compression by a collar system which as the plunger bottoms out the interaction of the plunger profile and the collar activates the release of the spring and draws the needle into the barrel of the syringe with no protrusion of the needle tip from the device.

### 8. Equivalence

The Ritract Safety Syringe is substantially equivalent to the BD Integra Syringe in terms of the mode of operation, function, materials used, packaging, manufacturing processes and performance.

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Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health and Human Services, USA. The seal features a stylized eagle with three lines forming its body and wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged in a circular pattern around the eagle.

## Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN - 2 2006

Mr. Rupert Northcott Managing Director Ritract, Limited Level 17, 201 Miller Street North Sydney, NSW 2060 AUSTRALIA

Re: K060002

Trade/Device Name: Ritract Safety Syringe Regulation Number: 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: MEG Dated: May 12, 2006 Received: May 16, 2006

Dear Mr. Northcott:

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 - Mr. Northcott

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]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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/industry/support/index.html.

Sincerely yours.

Chiu Lin, Ph.D.

Chiu Lin, Ph.D. 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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# Indications for Use Statement

# 510(k) Number (if known):

K060002

# Device Name:

Ritract Safety Syringe

# Indications for Use:

The Ritract Safety Syringe is a sterile, single-use, disposable, nonreusable, auto-retracting safety syringe which is intended for injection of fluids into the body, while reducing the risk of sharps injury and the potential for syringe reuse.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use X (Per 21 CFR 801.109) OR

Over-The-Counter Use_ (Optional Format 1-2-96)

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-(-11) of Anasthesiology, General Hospital, on Control, Dental Devices

Number: K460042