PROCEDUR SF SAFETY SYRINGE DEVICE

K042487 · Avanca Medical Devices, Inc. · MEG · Jan 21, 2005 · General Hospital

Device Facts

• Record ID: K042487
• Device Name: PROCEDUR SF SAFETY SYRINGE DEVICE
• Applicant: Avanca Medical Devices, Inc.
• Product Code: MEG · General Hospital
• Decision Date: Jan 21, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5860
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Procedur-SF device is intended to be used to inject fluids into, or withdraw fluids from, the body, while reducing the risk of sharps injuries and potential for syringe reuse.

Device Story

Procedur-SF is a piston safety syringe designed to inject or withdraw fluids. Device consists of two syringes assembled within a plastic holder; plungers are connected by a pulley mechanism. Used by clinicians to mitigate sharps injuries and prevent syringe reuse. Operates as a manual medical instrument.

Technological Characteristics

Piston safety syringe; two syringes assembled in a plastic holder; plunger mechanism connected by a pulley.

Indications for Use

Indicated for injection of fluids into or withdrawal of fluids from the body, while reducing sharps injury risk and potential for 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

• Becton Dickinson Single Use Hypodermic Syringes (K980987)
• Retractable Technologies, Inc. VanishPoint Safety Syringe (K980069)

Submission Summary (Full Text)

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K042487

## JAN 2 1 2005

## 510(K) SUMMARY

| Sponsor: | Avanca Medical Devices, Inc.<br>800 Bradbury SE<br>Albuquerque, NM 87106 |
|--------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitted By: | Ferguson Medical<br>Consultant to Avanca Medical Devices, Inc. |
| Contact Information: | Phone: [phone]<br>FAX: [phone] |
| Classification Name: | Piston syringe, antistick |
| Common/Usual Name: | Syringe, safety syringe, injection syringe,<br>aspiration syringe and others |
| Proprietary Name: | Procedur-SF |
| Classification Number: | 21 CFR 880.5860/Procode $_{90}$ FMF/ $_{90}$ MEG |
| Substantial Equivalence: | Becton Dickinson Single Use Hypodermic<br>Syringes (K980987) and Retractable<br>Technologies, Inc. VanishPoint Safety Syringe<br>(K980069) |
| Device Description: | The Procedur-SF device is a piston safety<br>syringe |
| Intended Use: | The Procedur-SF device is intended to be used<br>to inject fluids into, or withdraw fluids from,<br>the body, while reducing the risk of sharps<br>injuries and potential for syringe reuse |
| Technological Characteristics: | The Procedur-SF device utilizes two syringes<br>assembled in a plastic holder. The syringe<br>plungers are connected by a pulley |

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Image /page/1/Picture/11 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized graphic of three wavy lines that appear to be emanating from a central point.

JAN 2 1 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Avanca Medical Devices, Incorporated C/O Mr. Frank Ferguson Official Correspondent Ferguson Medical 12200 Academy Road, NE #931 Albuquerque, New Mexico 87111

Re: K042487

Trade/Device Name: Procedur SF Safety Syringe Device Regulation Number: 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: MEG Dated: December 12, 2004 Received: December 27, 2004

Dear Mr. Ferguson:

We have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed your becatermined the device is substantially equivalent (for the referenced above and have acternines re) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Interstate comments, or to that have been reclassified in accordance with the provisions of Amendinens, of to devroes mar na ris of the that do not require approval of a premarket the rederal I ood, Drug, and Ocenimay, therefore, market the device, subject to the general approval approvisions of the Act. The general controls provisions of the Act include controls provisions of the First - 1110 Jisting of devices, good manufacturing practice, requirements for aibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III If your device is clubstired (200 as a dditional controls. Existing major regulations affecting (PMA), it may of subject to Sach adatof Federal Regulations, Title 21, Parts 800 to 898. In your device can be found in the Seas nouncements concerning your device in the Federal Register.

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## Page 2 - Mr. Ferguson

Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that I DA s issualles of a base your device complies with other requirements mean that IDA has muce a doceminations administered by other Federal agencies. of the Act of ally I ederal statutes and rightenents, including, but not limited to: registration You must comply with an the Here Progations (21 CFR Part 801); good manufacturing practice allu listing (21 CFR Part 067), labelity systems (QS) regulation (21 CFR Part 820); and if requirents as set forth in the quality sion 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) This letter will anon your be began mading of substantial equivalence of your device to a premarket notification. - The PDF mailis 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), If you desire specific at 110 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 may obtain 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,

Ching-Lin Liu, 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

510(k) Number (If known): K042487

Device Name: Procedur-SF

Indications For Use:

The Procedur-SF device is used to inject fluids into, or withdraw fluids from, the body, while reducing the risk of sharps injuries and the potential for syringe reuse.

Prescription Use __ ర్ల (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

from link

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Division of Anesthesiology, General Hospital.
Division of Anesthesiology, General Devices Division of Antonion Control, Dental Devices

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