ATRION MEDICAL QL FLUID DISPENSING SYRINGE

K020333 · Atrion Medical Products, Inc. · DXT · Apr 25, 2002 · Cardiovascular

Device Facts

• Record ID: K020333
• Device Name: ATRION MEDICAL QL FLUID DISPENSING SYRINGE
• Applicant: Atrion Medical Products, Inc.
• Product Code: DXT · Cardiovascular
• Decision Date: Apr 25, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1650
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The syringe is intended for single use by healthcare professionals to dispense fluids to the body and monitor the pressure of those fluids.

Device Story

Atrion Medical QL™ Fluid Dispensing Syringe is a manual device consisting of a plastic syringe, screw-type plunger, locking lever, rotating palm grip, manometer, and connecting tube. Operated by healthcare professionals in a clinical setting, the device is used to dispense fluids into the body while simultaneously monitoring fluid pressure via the integrated manometer. The screw-type mechanism allows for controlled fluid delivery. The device is intended for single use.

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, locking lever, rotating palm grip, manometer, and connecting tube. Operating pressure range varies by manometer (vacuum to gauge capacity). Single-use device.

Indications for Use

Indicated for single use by healthcare professionals to dispense fluids to the body and monitor fluid pressure.

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 Balloon Catheter Inflation Device (K972964)
• Monarch (IN 2125)/Intellisystem (IN 1125) (K973230)

Submission Summary (Full Text)

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

APR 2 5 2002

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**Atrion**
*Medical*

### 12. SUMMARY OF SAFETY AND EFFECTIVENESS

| Date of Preparation: | January 28, 2002 |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | Atrion Medical QL™ Fluid Dispensing Syringe |
| Classification Name: | Piston Syringe |
| Manufacturer: | Atrion Medical Products, Inc.<br>PO Box 564, 1426 Curt Francis Road<br>Arab, AL 35016 |
| Contact: | Mr. Dan Clark, Atrion Medical Products, Inc.<br>PO Box 564, 1426 Curt Francis Road<br>Arab, AL 35016<br>Telephone: [phone], ext. 220, Fax: [phone]<br>Email: [e-mail] |

#### Predicate:

Atrion Medical Products Balloon Catheter Inflation Device, cleared for market on October 10, 1997 under 510(k) submission K972964. The new device will have the same intended use as the Monarch (IN 2125)/Intellisystem (IN 1125), which was cleared for market on November 25, 1997 under 510(k) submission K973230.

#### Device Description/Intended Use:

The Atrion Medical QL™ Fluid Dispensing Syringe consists of a plastic syringe with a screw-type plunger and a locking lever and rotating palm grip that control the plunger, a manometer to measure pressure and a connecting tube.

The svringe is intended for single use by healthcare professionals to dispense fluids to the body and monitor the pressure of those fluids.

#### Technological Characteristics:

The Atrion Medical QL™ Fluid Dispensing Syringe has an operating pressure range of vacuum to gauge capacity, depending on the manometer attached, while the predicate device has a range of vacuum to 10 or 20 atm, depending on the manometer attached. There are no other significant technological characteristics that distinguish the two devices, and no differences that should pose a risk to patient safety.

#### Summary of 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.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# APR 2 5 2002

Mr. Dan Clark

Vice President Regulatory and Quality Atrion Medical Products, Inc. P.O. Box 564, 1426 Curt Francis Road Arab, AL 35016

Re: K020333

Atrion Medical QL™ Fluid Dispensing Syringe Regulation Number: 870.1650 Regulation Name: Angiographic injector and syringe Regulatory Class: II (two) Product Code: 74 DXT Dated: January 28, 2002 Received: January 31, 2002

Dear Mr. Clark:

We have reviewed your Section 510(k) premarket notification of intent to market the device w o no re ro rowed you 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 for the enaverior 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.

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.

Image /page/1/Picture/12 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the top half of the circle. Inside the circle is an abstract symbol that resembles an eagle or bird-like figure.

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Page 2 - Mr. Dan Clark

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html

Sincerely yours,

Dada Tuh

Donna-Bea Tillman, Ph.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## 13. INDICATIONS FOR USE STATEMENT

510(k) Number (if known): K

Device Name: Atrion Medical QL TM Fluid Dispensing Syringe

Indications For Use:

:

The syringe is intended for single use by healthcare professionals to dispense fluids to the body and monitor the pressure of those fluids.

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| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
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Prescription Use

OR Over-The- Counter Use

(Per 21 CFR 801.109)

| 510(k) Number | K020333 |
|---------------|---------|
|---------------|---------|

(Optional Format 1-2-96)