OMI RETRACTABLE SAFTEY SYRINGE, VARIOUS

K060971 · Omi Manufacturing Pty., Ltd. · MEG · Oct 24, 2006 · General Hospital

Device Facts

• Record ID: K060971
• Device Name: OMI RETRACTABLE SAFTEY SYRINGE, VARIOUS
• Applicant: Omi Manufacturing Pty., Ltd.
• Product Code: MEG · General Hospital
• Decision Date: Oct 24, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5860
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The OMI Safety Insulin Syringes are intended for the subcutaneous injection of insulin. In addition, the syringe is designed to aid in prevention of needlestick injuries. This device is a safety hypodermic syringe for intramuscular and subcutaneous injection of medication to patients. This device aids in prevention of needlestick injuries. EO sterilized, non-pyrogenic, and latex free. The function of the OMI Retractable Safety Syringe is to provide a safe, accurate and reliable method of injecting medication into a patient.

Device Story

OMI Retractable Safety Syringe is a sterile, single-use, latex-free, non-pyrogenic piston syringe with an integral needle. Available in 1ml, 3ml, and 10ml sizes. Operates like a conventional hypodermic syringe; features a user-activated spring-loaded mechanism that retracts the contaminated needle into the plunger immediately following injection. Used by healthcare professionals for subcutaneous and intramuscular medication administration. Retraction mechanism serves to contain the needle, reducing risk of accidental needlestick injuries to the operator.

Clinical Evidence

Bench testing only. Compliance with ISO 6009, ISO 7864, ISO 7886-1, ISO 7886-4, and ISO 10993 standards demonstrated performance and safety.

Technological Characteristics

Piston syringe with integral needle; spring-loaded retraction mechanism. Materials: Latex-free. Sterilization: Ethylene Oxide (ISO 11135). Standards: ISO 6009 (color coding), ISO 7864 (needles), ISO 7886-1/4 (syringes), ISO 10993 (biocompatibility).

Indications for Use

Indicated for intramuscular and subcutaneous injection of medication (including insulin) to patients. Aids in the prevention of needlestick injuries.

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

• Vanishpoint Syringe (K946219)

Submission Summary (Full Text)

{0}------------------------------------------------

K060971

001 2 4 2006

### EXHIBIT 2 510(k) Summary

- 1. Submitter Name: OMI Manufacturing Pty Ltd
- 2. Address: 1/12 Booran Dr.

Slacks Creek, Queensland,

- Australia 4127
- 3. Phone:
- 4. Fax: [phone]
- 5. Email: projects(@omiltd.com
- 6. Contact: Graham McNicol Project Manager

61 7 34517000

- 7. Establishment Registration Number: 3003462738
- 8. Date summary prepared: March 1, 2006
- 9. Device Trade or Proprietary Name: OMI Retractable Safety Syringe
- 10. Device Common or usual name: Safety Syringe
- 11. Device Classification Name: Piston Syringe/Syringe Anti-stick
- 12. Device Classification Code: MEG
- 13. Device Class: class 11 as per regulation 21 CFR 880.5860
- 14. Compliance (performance Standard): None established under section 513-514 Complies with voluntary standards and FDA guidance documents: ISO6009: Hypodermic needles for single use color coding for identification. ISO7864 Sterile hypodermic needles for single use
-
- ISO7886-1 Sterile Hypodermic syringes for single use
- ISO7886-4 Syringes with reuse Prevention Features
- ISO10993: Biological evaluation of medical devices
- EN550/ISO11135 Sterilization of Medical Devices- Validation and routine control Of Ethylene Oxide Sterilization
- 15: Predicate Device: Vanishpoint Syringe (K946219) from Retractable Technologies Inc.
- 16: Device Description: The OMI Retractable Safety Syringe is a Sterile, Non Toxic, Non Pyrogenic, Latex Free, Single Use, automatically activated anti-stick piston syringe with integral needle. Available in 1ml, 3ml and 10ml sizes with various needle sizes.

The OMI Retractable Safety Syringe works like a conventional hypodermic syringe except for its ability to retract the contaminated needle inside the plunger immediately after patient injection. Needle retraction is activated by the syringe user.

The primary intended use is to administer safe and accurate subcutaneous and intramuscular injections. The secondary intended use is to retract and contain the contaminated needle after injection for the purpose of aiding in the prevention of accidental needle stick injuries.

{1}------------------------------------------------

KCC9.71

- 17. Indications for Use: This device is a safety hypodermic syringe for intramuscular and subcutaneous injection of medication to patients. This device aids in prevention of needlestick injuries. EO sterilized, non-pyrogenic, and latex free. The function of the OMI Retractable Safety Syringe is to provide a safe, accurate and reliable method of injecting medication into a patient.
### 18. Summary Comparing Technological Characteristics With Predicate Devices:

The OMI Manufacturing Pty Ltd makes a Substantial Equivalence claim of the OMI Retractable Safety Syringe to Retractable Technologies, Inc., Pop-n-Lock Syringe (currently marketed as the Vanishpoint syringe), 510(k) # k946219. Both syringes are similar and in some cases the same, with regards to parts, design, material, operating procedure and intended use. Both the OMI and Vanishpoint syringes consist of a syringe barrel, syringe plunger, single lumen hypodermic needle, needle hub and stem. Both have a spring retracting mechanism which is user activated once medication has been injected. Both are plunger syringes which are supplied with permanently attached needles. Both are supplied sterile, single-use and disposable.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" are arranged in a circular pattern around the eagle.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## OCT 2 4 2006

OMI Manufacturing Pty., Limited C/O Mr. Daniel Kamm Kamm & Associates P.O. Box 7007 Deerfield, Illinois 60015

Re: K060971

Trade/Device Name: OMI Retractable Safety Syringe and OMI Insulin Safety Syringe Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: MEG Dated: October 16, 2006 Received: October 19, 2006

Dear Mr. Kamm:

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.

{3}------------------------------------------------

Page 2 -- Mr. Kamm

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,

Susi Runne
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

{4}------------------------------------------------

# Indications for Use

510(k) Number (if known): K060971

Device Name: OMI Insulin Safety Syringe

Indications For Use:

The OMI Safety Insulin Syringes are intended for the subcutaneous injection of insulin. In addition, the syringe is designed to aid in prevention of needlestick injuries.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use _ (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Antar Ume

n of Anesthesiology, General Hospital, on Control, Dental Devices

K46971

Page 1 of 2

{5}------------------------------------------------

## Indications for Use

510(k) Number (if known): צו 609 7/

Device Name: OMI Retractable Safety Syringe

Indications For Use:

This device is a safety hypodermic syringe for intramuscular and subcutaneous injection of medication to patients. This device aids in prevention of needlestick injuries. EO sterilized, non-pyrogenic, and latex free.

Prescription Use _ X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

ell for ADK 10/25/2022

in of Anesthesiology, General Hospital, con Control, Dental Devices

Page 1 of 1

1124

Page 7 of 323