QL LOCKING SYRINGE

K060643 · Atrion Medical Products, Inc. · MAV · Jul 12, 2006 · Cardiovascular

Device Facts

• Record ID: K060643
• Device Name: QL LOCKING SYRINGE
• Applicant: Atrion Medical Products, Inc.
• Product Code: MAV · Cardiovascular
• Decision Date: Jul 12, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1650
• Device Class: Class 2

Intended Use

The Atrion Medical QL® Locking Syringe Device is intended for single use to inject fluid into and aspirate fluid from a balloon interventional device having a recommended balloon inflation volume.

Device Story

The Atrion Medical QL® Locking Syringe Device is a manual, single-use plastic syringe featuring a screw-type plunger and a locking mechanism. It is designed for use by clinicians to inject fluid into or aspirate fluid from balloon interventional devices. The device facilitates controlled inflation and deflation of interventional balloons during procedures. It operates mechanically without electronic components or software.

Clinical Evidence

Bench testing only. Materials contacting the solution were tested using USP guidelines, confirming safety for the intended use.

Technological Characteristics

Plastic syringe with screw-type plunger and locking mechanism; 25ml capacity; manual operation; single-use; biocompatibility tested per USP guidelines.

Indications for Use

Indicated for single use to inject and aspirate fluid from balloon interventional devices with recommended inflation volumes.

Regulatory Classification

Special Controls

*Classification.* Class II (special controls). The device, when it is a non-patient contacting balloon inflation syringe intended only to inflate/deflate balloon catheters and monitor pressure within the balloon, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.

Predicate Devices

• Atrion Medical Products, Inc. QL® Inflation Device (K032840)
• Merit Medical Systems, Inc. Viceroy™ Inflation device (K040138)

Submission Summary (Full Text)

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

K060643
p. 1 of 1

#### SECTION 5

Atrion Medical Products, Inc. 1426 Curt Francis Road Post Office Box 564 Arab, AL 35016 Tel [phone] Fax [phone]

# JUL 1 2 2006

Image /page/0/Picture/4 description: The image shows the logo for Atrion Medical. The logo is in black and features a stylized "A" with a swoosh extending from the left side. The word "Atrion" is written in a bold, sans-serif font, with "Medical" written in a smaller font below and to the right of "Atrion". The logo is simple and modern.

## SUMMARY OF SAFETY AND EFFECTIVENESS

July 7, 2006 Date of Preparation:

Atrion Medical QL® Locking Syringe Device Device Name:

Classification Name: Angiographic Injector and Syringe

Manufacturer: Atrion Medical Products, Inc. PO Box 564, 1426 Curt Francis Road Arab, AL 35016

Contact:

Mr. Dan Clark. Atrion Medical Products, Inc. 1426 Curt Francis Road Arab, AL 35016 Telephone: [phone] Fax: [phone] Email: [e-mail]

#### Predicates:

Atrion Medical Products, Inc. QL® Inflation Device, K032840. Merit Medical Systems, Inc. Viceroy™ Inflation device, K040138

#### Device Description:

The Atrion Medical QL® Locking Syringe Device consists of a plastic syringe with a screw-type plunger and a locking mechanism.

Intended Use: The Atrion Medical QL® Locking Syringe Device is intended for single use to inject fluid into and aspirate fluid from a balloon interventional device having a recommended balloon inflation volume.

## Technological Characteristics:

The Atrion Medical QL® Locking Syringe Device has a capacity of 25ml, while the predicate devices have a range of 10ml or 60ml, depending on the predicate. There are no other significant technological characteristics that distinquish the two devices, and no differences that should pose a risk to patient safety.

## Testing:

The materials of the device which contact the solution in use have been tested using USP guidelines and the results of these studies indicate that the product is safe for its intended use.

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

Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird-like figure, composed of three curved lines that suggest the head and wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular pattern around the bird-like figure.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 1 2 2006

Atrion Medical Products, Inc. c/o Mr. Dan Clark Vice President 1426 Curt Francis Road Arab. AL 35016

Re: K060643

> Atrion Medical QL® Locking Syringe Device Regulation Number: 21 CFR 870.1650 Regulation Name: Angiographic Injector and Syringe Regulatory Class: II Product Code: MAV Dated: June 9, 2006 Received: June 9, 2006

Dear Mr. Clark:

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.

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

Page 2 - Mr. Dan Clark

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,

QSRN

For Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

Attachment for: Item 4

# SECTION 4

Kobob43

## INDICATIONS FOR USE

510(k) Number (if known): K060643

Device Name: Atrion Medical QL® Locking Syringe Device

Indications For Use: The Atrion Medical QL® Locking Syringe Device is intended for single use to inject fluid into and aspirate fluid from a balloon interventional device having a recommended balloon inflation volume.

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

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

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

> Office of Device Evaluation (ODE) Concurrence) of CDRH,

(Division Sign-Off)
Division of Cardiovascular Devices

510(k) Numb

10