GLOBAL MEDI PRODUCTS RETRACTABLE SAFETY SYRINGE

K120641 · Global Medi Products · MEG · Oct 17, 2012 · General Hospital

Device Facts

• Record ID: K120641
• Device Name: GLOBAL MEDI PRODUCTS RETRACTABLE SAFETY SYRINGE
• Applicant: Global Medi Products
• Product Code: MEG · General Hospital
• Decision Date: Oct 17, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5860
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Global Medi Products Retractable Safety Syringe is a sterile, single use, disposable and non-reusable manual retractable safety syringe intended for medical purposes for injection of fluids into the body, while reducing the risks of sharps injuries and the potential for syringe reuse.

Device Story

Manual retractable safety syringe; used for injection of fluids into body. Device features two-part plunger; distal part holds hypodermic needle; proximal part contains projection spike. Operation: user performs injection; manually retracts needle-plunger into syringe barrel; breaks off plunger rod; discards components. Designed to prevent accidental needle sticks and syringe reuse. Used in clinical settings by healthcare professionals. Benefits include reduced risk of sharps injuries to clinicians and prevention of syringe reuse.

Clinical Evidence

Bench testing only. Testing included biocompatibility (ISO 10993-4, -5, -10, -11), syringe performance (ISO 7886-1, ISO 7886-4), conical fittings (ISO 594), sterilization validation (ISO 11135, ISO 10993-7), and hypodermic needle standards (ISO 7864, ISO 594-1/2).

Technological Characteristics

Manual retractable piston syringe. Materials: unspecified. Standards: ISO 7886-1/4 (syringe performance), ISO 594 (luer taper), ISO 10993 (biocompatibility), ISO 11135 (ETO sterilization), ISO 7864 (needles). Features: two-part plunger with locking projection spike, male luer lock connector. Sterile, single-use, disposable.

Indications for Use

Indicated for medical injection of fluids into the body for patients requiring such administration, while providing a mechanism to reduce sharps injuries and prevent 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

• DuoProSS Retractable Safety Syringe (K022806)

Submission Summary (Full Text)

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K120641
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# Sec. 6: 510(k) Summary - Global Medi Products Retractable Safety Syrin

Image /page/0/Picture/2 description: This document is a 510(k) summary for the Global Medi Products Retractable Safety Syringe, dated October 17, 2012. The submitter and primary contact is Mr. Graeme Walton, President of Global Medi products, located in Queensland, Australia, and his email and phone number are listed. The device is classified as a piston syringe and a hypodermic single lumen needle, and it is designed to retract the contaminated needle after injection to prevent accidental needle sticks.

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| Intended Use | Indications for Use: The Global Medi Products Retractable Safety Syringe is a sterile, single<br>use, disposable and non-reusable manual retractable safety syringe intended for medical<br>purposes for injection of fluids into the body, while reducing the risks of sharps injuries<br>and the potential for syringe reuse. |
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| Technological<br>Characteristics | Global Medi Products makes the claim of substantial equivalence of the GMP Retractable Safety Syringe to the<br>Meditech Co, DuoProSS Retractable Safety Syringe based on similarities in intended use, design,<br>technological, and operational characteristics. Both are indicated for injecting fluids into the body, while helping<br>to reduce risks of sharps injuries. The GMP Retractable Safety Syringe are always provided with preassembled<br>needs whereas the DuoProSS can be ordered with and without needles. GMP Retractable Safety Syringe<br>currently uses a male luer lock needle connector design where the DuoProSS uses a luer slip ne connector<br>design. Both syringes are provided sterile, single use, and disposable. There are minor differences between<br>the GMP Retractable Safety Syringe and DuoProSS which is syringe volume (and associated dimensions).<br>This difference does not affect the performance of the syringe, since syringe size is typically determined by<br>drug volume to be administered and user preferences. Both syringes have two part plungers. The distal part<br>holds the hypodermic needle and the proximal part has a projection spike that mates with the distal part,<br>thereby locking the needle to the plunger. Both syringes require the user to manually retract the needle-plunger<br>into the syringe barrel, break of the plunger rod, and discard the pieces. Global Medi Products believes that the<br>differences between the GMP Retractable Safety Syringe and the predicate device are minor and they raise no<br>new issues of safety or effectiveness. |
| Summary of<br>Testing | Global Medi Products Retractable Safety Syringe is substantially equivalent and meets the same acceptance<br>criteria as the predicate device in K022806. Non-clinical performance testing includes:<br>Biocompatibility (cytotoxicity, irritation, sensitization, systemic toxicity, interactions with blood) in<br>compliance with the methods of ISO 10993-4, -5, -10, -11, Syringe performance per ISO 7886-1 Sterile<br>hypodermic syringes for single use -- Part 1: Syringes for manual use; ISO7886-4; Sterile hypodermic<br>syringes for single use -- Part 4: Syringes with re-use prevention feature, ISO 594, Conical fittings with a 6<br>% (Luer) taper for syringes; ISO 11135; Sterilization Validation ETO, GB/T14233.1 (GB / T 14233.1- 1998<br>Infusion, transfusion, injection equipment for test methods - Part 1 Methods for chemical analysis, (EO<br>Residuals), ISO 10993-7, Biological evaluation of medical devices -- Part 7: Ethylene oxide sterilization<br>residuals. ISO 10993-7:2008 specifies allowable limits for residual ethylene chlorohydrin (ECH) in<br>individual EO-sterilized medical devices, procedures for the measurement of EO and ECH. Hypodermic<br>needles have been tested in accordance with ISO 7864: 1993; Sterile hypodermic needles for single use<br>and ISO 594-1:1986 ISO594-2:1998 Conical fittings with a 6 % (Luer) taper. |
| Substantial<br>Equivalence | The Retractable Safety Syringe described in this 510(k) submission is substantially equivalent in all<br>specifications and performance compared to the predicate device identified in K022806 |

队|20641

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure, with three curved lines forming its body and wings. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room-WO66-G609 Silver Spring, MD 20993-0002

OCT 17 2012

Global Medi Products C/O Robert O. Dean President Compliance Systems International, Limited Liability Company 1083 Delaware Avenue Buffalo, New York 14209

Re: K120641

Trade/Device Name: Global Medi Products Retractable Safety Syringe Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: MEG Dated: October 10, 2012 Received: October 16, 2012

Dear Mr. Dean:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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. Dean

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

0,5Wa Introna

Anthony D. Watson. B.S., M.S., M.B.A. 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 Form

### Indications for Use:

510(k) Number (if known): K120641

Device Name: Global Medi Products Retractable Safety Syringe

Indications for Use: The Global Medi Products Retractable Safety Syringe is a sterile, single use, disposable and non-reusable manual retractable safety svringe intended for medical purposes for injection of fluids into the body, while reducing the risks of sharps injuries and the potential for syringe reuse.

Prescription Use × (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C) . રજકુ

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

Rhal Chyn 10/18/12
(Division Sign-Off)

Division of Anesthestology, General Hospital Infection Control. Dental Devices

510(k) Number: K120641