OZ POWER SYRINGE

K973334 · Cardiovascular Innovations · DXT · Apr 3, 1998 · Cardiovascular

Device Facts

• Record ID: K973334
• Device Name: OZ POWER SYRINGE
• Applicant: Cardiovascular Innovations
• Product Code: DXT · Cardiovascular
• Decision Date: Apr 3, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1650
• Device Class: Class 2

Intended Use

Injection of contrast media into the heart, great vessels, and coronary arteries, to study the heart and vessels by x-ray photography.

Device Story

Oz Power Syringe is a manually operated angiographic injector; consists of 35cc syringe, base, and lever arm. Operator loads contrast media by pulling plunger; removes air; delivers contrast by pressing down on lever handle. Lever mechanism provides mechanical advantage, allowing operator to achieve 200-350 psi delivery pressure via 80-70 lbs of manual force. Used in clinical settings during x-ray/fluoroscopic imaging; operated by physician or trained clinician. Device provides controlled delivery of contrast media; allows real-time pressure adjustment based on imaging feedback or patient comfort. Benefits include sufficient pressure for contrast delivery with smaller footprint than electric injectors; disposable design.

Clinical Evidence

No clinical data. Substantial equivalence established via non-clinical bench testing, including pressure delivery (closed and open systems), luer suction, high-pressure leakage, high-pressure burst, luer testing, break testing, and packaging integrity.

Technological Characteristics

Manual lever-actuated syringe injector. Materials: Polypropylene (syringe/plunger), Rubber (plunger tip), Clear ABS (handle/base). Dimensions: 12" x 4" x 4". Weight: 13 oz. Volume: 35cc. Pressure range: 1-800 psi (operator controlled). Sterile, non-pyrogenic, disposable. No electronic components or software.

Indications for Use

Indicated for the injection of contrast media into the heart, great vessels, and coronary arteries for x-ray imaging studies in patients requiring such diagnostic procedures.

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

• MedRad Mark V Angiographic Injector (K822536)
• Sherwood Medical Monoject 35cc Syringe (K852640)

Submission Summary (Full Text)

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

#### MIKE BOYKIN

K97334
PAGE 83

APR - 3 1998

## Oz Power Syringe 510 (k) Summary of Safety and Effectiveness

### Device Information:

| Trade Name: | Oz Power Syringe |
|----------------------|----------------------------------------|
| Common Name: | Angiographic Injector and Syringe |
| Classification Name: | DXT Injector and Syringe, Angiographic |

#### Predicate Devices:

MedRad Mark V Angiographic Injector (Ref. 510 (k) # K822536) Sherwood Medical Monoject 35cc Syringe (Ref. 510 (k) # K852640)

#### Device Description:

The Oz Power Syringe consists of a 35cc syringe that is manually powered by a lever arm which attaches to a base. As the lever arm is raised, the synnge is titled with the distal tip plyoting on a pin while the plunger filts to a higher angle. The mechanism is designed to stop the plunger as the lever arm is raised to pull the plunger back in the synnge barrel to 35cc. At this position, the lever arm is approximately at a 45 degree angle from the base and the syringe is titled to help produce power as the lever arm will be pushed downward to deliver the contrast media in the syringe.

The operator loads the syringe by pulling back on the plunger to draw in the contrast, then pushes the plunger forward to remove air, as is done with a traditional manual syringe. To deliver contrast media, the operator presses down on the lever handle. The operator can easily adjust the delivery pressure in response to fluoroscope or x-ray imaging, or in response to patient comfort levels, by simply adjusting the manual force applied to the lever.

The Oz Power Syringe allows the operator to produce more pounds per square inch pressure than normal synnge use. By applying 80-70 pounds of downward pressure on the lever, the operator can easily achieve a 200-350 psl delivery prossure. It is easy to load and inject. It is easy to control and requires much less space than electrically driven power injector equipment.

This device enables the operator to produce sufficient pressures to achieve proper contrast delivery, while maintaining control throughout the delivery process. It is very important that the proper amount of contrast media, as well as the pressure and rate at which it is delivered, be controlled for safe and desirable results to both the operator and the patient.

#### Intended Use:

Injection of contrast media into the heart, great vessels, and coronary artenes, to study the heart and vessels by x-ray photography.

| | Oz Power Syringe<br>(Subject Device) | MedRad Mark V<br>Angiographic Injector<br>510(k) # K822536 | Sherwood Medical<br>Monoject 36cc Syringe<br>510(k) # K862640 |
|----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------|
| Intended Use: | Injection of contrast<br>media into the heart,<br>great vessels, and<br>coronary arteries, to<br>study the heart and<br>vessels by x-ray<br>photography | Same | Same |
| Operating Principle: | Manual delivery through<br>syringe with force applied<br>to syringe plunger<br>through lever action | Automated delivery<br>through syringe using<br>electronic screw drive<br>delivery control | Manual delivery through<br>syringe with force applied<br>to syringe plunger by<br>hand |
| Design Features: | Clear plastic handle,<br>base, and syringe<br>Manually controlled | Metal body, clear<br>plastic syringe<br>Automated screw | Clear plastic syringe<br>Manually controlled<br>Lightweight design |

#### Comparison to Predicate Device:

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

| PAGE | 84 |
|------|----|
|------|----|

| | Lightweight design Female luer connection Completely disposable | drive operation Heavier, larger design Female luer connection Reusable equipment/ disposable syringe | Female luer connection Completely disposable |
|---------------------|-----------------------------------------------------------------|------------------------------------------------------------------------------------------------------|----------------------------------------------|
| Materials: | | | |
| Syringe | Polypropylene | Polypropylene | Polypropylene |
| Plunger | Polypropylene | Polypropylene | Polypropylene |
| Plunger Tip | Rubber | Rubber | Rubber |
| Handle/Base | Clear ABS | N/A | N/A |
| Dimensions: | | | |
| Length | 12" | 24" | 9" |
| Width | 4" | 4" | 1" |
| Height: | 4" | 9" | 1" |
| Weight: | 13 oz. | 40 lbs. | 3 oz. |
| Volume: | 100-35cc | 65cc-260cc | 100-35cc |
| Flow Rate: | Operator controlled | Machine controlled | Operator controlled |
| Injection Pressure: | 1-800 psi (appx based on operator control) | 150 - 1200 psi | 1-450 psi (appx based on operator control) |
| Packaging: | Tyvek pouch | Form-fill tray w/ Tyvek lid | Form-fill tray w/ Tyvek lid |
| Labeling: | Sterile, non-pyrogenic prescription | Same | Same |
| Expiration Date: | 1 year | 3 years | 3 years |

## Non-Clinical Testing:

Non-Clinical Testing:
The following tests were conducted to establish substantially equivalent performance between the subject and predicate devices:

- Ject and predicate devices.
Pressure through system directly into pressure gauge (closed) .
- Pressure through system flowing through catheters (open) .
- Pressure through present power injector system (open) ●
- . Luer suction test
- High pressure leakage .
- High pressure burst ●
- . Luer test
- Break testing .
- . Packaging Integrity

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

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR - 3 1998

Dr. Azam Anwar President Cardiovascular Innovations 4331 Arcady Dallas, TX 75205

K973334 Re: Trade Name: Oz Power Syringe Requlatory Class: II Product Code: DXT Dated: August 22, 1997 September 4, 1997 Received:

Dear Dr. Anwar:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to A substantially equivalent determination assumes compliance with 895. the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any

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

Page 2 - Dr. Anwar

obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

This letter will allow you to begin marketing your device as described in your 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 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone],

or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Thomas J. Callahan

Thomas J. Calla Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

{4}------------------------------------------------

# STATEMENT OF INTENDED USE FORM

Page 1 of 1

510 (k) #: K97334

#### Oz Power Syringe Device Name:

## Indications for Use:

Injection of contrast media into the heart, great vessels, and coronary arteries, to study the heart and vessels by x-ray photography

ThAR

(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Device

510(k) Number .

Concurrence of CDRH, Office of Device Evaluations (ODE)

V Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use ___