PROCEDUR-10

K052075 · Avanca Medical Devices, Inc. · FMF · Nov 9, 2005 · General Hospital

Device Facts

• Record ID: K052075
• Device Name: PROCEDUR-10
• Applicant: Avanca Medical Devices, Inc.
• Product Code: FMF · General Hospital
• Decision Date: Nov 9, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.5860
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Procedur-10 device is used to inject fluids into, or withdraw fluids from, the body.

Device Story

Procedur-10 is a piston syringe device. It consists of two syringe components assembled within a plastic holder, with plungers connected by a pulley mechanism. The device is used to inject or withdraw fluids from the body. It is a manual device operated by a clinician.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Piston syringe; two syringe components; plastic holder; pulley-connected plungers.

Indications for Use

Indicated for the injection of fluids into, or withdrawal of fluids from, the human body.

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

• Procedur-10 device (K042486)

Submission Summary (Full Text)

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NOV - 9 2005

K052075

## 510(K) SUMMARY

| Sponsor: | Avanca Medical Devices, Inc.<br>801 University Blvd SE - Suite 307<br>Albuquerque, NM 87106 |
|--------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitted By: | Frank Ferguson<br>Vice President |
| Contact Information: | Phone: [phone]<br>FAX: [phone] |
| Classification Name: | Piston Syringe |
| Common/Usual Name: | Syringe, injection syringe, aspiration syringe<br>and others |
| Proprietary Name: | Procedur-10 |
| Classification Number: | 21 CFR 880.5860/Procode 80 FMF |
| Substantial Equivalence: | Avanca Medical Devices Procedur-10 device<br>(K042486) |
| Device Description: | The Procedur-10 device is a piston syringe |
| Intended Use: | The Procedur-10 device is intended to be used<br>to inject fluids into, or withdraw fluids from,<br>the body |
| Technological Characteristics: | The Procedur-10 device utilizes two syringe<br>components assembled in a plastic holder.<br>The syringe plungers are connected by a<br>pulley. |

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Image /page/1/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular in shape, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. In the center of the circle is a stylized symbol that resembles a caduceus, a traditional symbol of medicine, but with three wavy lines instead of snakes.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV - 9 2005

Mr. Frank Ferguson Vice President Avanca Medical Devices, Incorporated 801 University Boulevard SE, Suite 307 Albuquerque, New Mexico 87106

Re: K052075

Trade/Device Name: Procedur-10 Regulation Number: 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: FMF Dated: October 28, 2005 Received: October 31, 2005

Dear Mr. Ferguson:

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. Ferguson

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.

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): หุ บรว 2075

Device Name: Procedur-10

Indications For Use:

... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

The Procedur-10 device is used to inject fluids into, or withdraw fluids from, the body.

Prescription Use __ XX (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)

Apten D.m

Con Sinn-Off) is on ot Anesthesiology, General Hospital, Intection Control, Dental Devices

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