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.

AI/ML Overview

The Oz Power Syringe is a manually powered syringe system intended for injecting contrast media into the heart, great vessels, and coronary arteries for x-ray photography. The summary of safety and effectiveness indicates that the device's performance was established by comparing it to predicate devices through a series of non-clinical tests.

1. Table of Acceptance Criteria and Reported Device Performance:

The document implicitly defines acceptance criteria by conducting comparative non-clinical tests against predicate devices. The "reported device performance" is essentially that the Oz Power Syringe passed these tests, demonstrating substantial equivalence. The document does not provide specific quantitative acceptance criteria values (e.g., "pressure must be X psi +/- Y") or direct quantitative performance results for the Oz Power Syringe for each test. Instead, it lists the types of tests performed.

Acceptance Criteria (Inferred from Test Types)	Reported Device Performance
Ability to generate and withstand pressure (closed system)	"Pressure through system directly into pressure gauge (closed)" passed.
Ability to deliver pressure through catheters (open system)	"Pressure through system flowing through catheters (open)" passed.
Compatibility with existing power injector systems (open system)	"Pressure through present power injector system (open)" passed.
Ability to maintain Luer suction	"Luer suction test" passed.
Resistance to high-pressure leakage	"High pressure leakage" test passed.
Resistance to high-pressure burst	"High pressure burst" test passed.
Functionality of Luer connections	"Luer test" passed.
Mechanical strength/durability	"Break testing" passed.
Integrity of product packaging	"Packaging Integrity" passed.
Comparable performance to predicate devices (MedRad Mark V Angiographic Injector & Sherwood Medical Monoject 35cc Syringe) across various parameters (intended use, operating principle, materials, dimensions, weight, volume, flow rate, injection pressure, packaging, labeling, expiration date).	The device was found "substantially equivalent" to predicate devices based on the comparison and non-clinical testing.

2. Sample Size for the Test Set and Data Provenance:

The document describes non-clinical laboratory testing. Therefore, there is no "test set" in the sense of patient data. The sample size for the physical devices tested (e.g., number of syringes subjected to burst pressure) is not specified. The data provenance is from non-clinical bench testing. Specific country of origin for the testing is not mentioned, but the submission is to the U.S. FDA.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:

This information is not applicable. For non-clinical bench testing of a physical device like a syringe, "ground truth" is established by measurements against specified engineering and performance criteria, not by expert interpretation of medical images or data.

4. Adjudication Method for the Test Set:

This information is not applicable as the study involved non-clinical bench testing, not human-based assessment requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No. This is a 510(k) submission for a physical medical device (syringe/injector) based on non-clinical testing and substantial equivalence to predicate devices. It is not an AI-assisted diagnostic tool, so an MRMC comparative effectiveness study is not relevant or included.

6. Standalone Performance Study:

Yes, in a way. The "Non-Clinical Testing" detailed in the document serves as the standalone performance study for the Oz Power Syringe. These tests were conducted on the device itself to verify its functional and safety characteristics, confirming its ability to perform its intended use and withstand operational stresses. The comparison to predicate devices also implicitly supports its standalone performance by demonstrating it behaves similarly to currently marketed devices.

7. Type of Ground Truth Used:

The ground truth for this device's performance is based on engineering specifications and measurements from physical testing. For example, a pressure gauge provides the "ground truth" for pressure output, and direct observation or measurement determines leakage or burst points. The "ground truth" for proving safety relies on meeting established industry standards for such devices and demonstrating equivalence to legally marketed predicates.

8. Sample Size for the Training Set:

This information is not applicable. The development and testing of this device do not involve machine learning or AI models with "training sets."

9. How the Ground Truth for the Training Set was Established:

This information is not applicable as there is no training set for an AI model.

Summary

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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 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(Subject Device)	MedRad Mark VAngiographic Injector510(k) # K822536	Sherwood MedicalMonoject 36cc Syringe510(k) # K862640
Intended Use:	Injection of contrastmedia into the heart,great vessels, andcoronary arteries, tostudy the heart andvessels by x-rayphotography	Same	Same
Operating Principle:	Manual delivery throughsyringe with force appliedto syringe plungerthrough lever action	Automated deliverythrough syringe usingelectronic screw drivedelivery control	Manual delivery throughsyringe with force appliedto syringe plunger byhand
Design Features:	Clear plastic handle,base, and syringeManually controlled	Metal body, clearplastic syringeAutomated screw	Clear plastic syringeManually controlledLightweight design

Comparison to Predicate Device:

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PAGE	84
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	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

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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

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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 (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597,

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

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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)

Over-The-Counter Use ___

Regulation Number and Section

§ 870.1650 Angiographic injector and syringe.

(a)
Identification. An angiographic injector and syringe is a device that consists of a syringe and a high-pressure injector which are used to inject contrast material into the heart, great vessels, and coronary arteries to study the heart and vessels by x-ray photography.(b)
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.