(211 days)
Not Found
No
The device description details a purely mechanical, manually operated syringe system. There is no mention of any computational processing, algorithms, or learning capabilities.
No.
The device injects contrast media to facilitate diagnosis via x-ray photography, but it does not directly treat a disease or medical condition.
No
The device is described as a power syringe for injecting contrast media, which is used to enhance images during diagnostic procedures but is not itself a diagnostic device. Its function is to deliver a substance, not to perform a diagnosis.
No
The device description clearly details a physical syringe with a lever arm and base, indicating it is a hardware device, not software-only. The performance studies also focus on physical properties like pressure, leakage, and burst strength.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Function: The Oz Power Syringe is used to inject contrast media directly into the patient's body (heart, great vessels, and coronary arteries) for imaging purposes (x-ray photography). It is a delivery system for a substance used in a diagnostic procedure, but it does not analyze a specimen taken from the body.
- Intended Use: The intended use is to "study the heart and vessels by x-ray photography" through the injection of contrast media. This is an in vivo procedure (performed within a living organism), not an in vitro procedure (performed outside of a living organism).
Therefore, the Oz Power Syringe is a medical device used in an in vivo diagnostic imaging procedure, but it is not an In Vitro Diagnostic device itself.
N/A
Intended Use / 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
Product codes
DXT
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
x-ray photography
fluoroscope
Anatomical Site
heart, great vessels, and coronary arteries
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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
(Subject Device) | MedRad Mark V
Angiographic Injector
510(k) # K822536 | Sherwood Medical
Monoject 36cc Syringe
510(k) # K862640 |
|----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------|
| Intended Use: | Injection of contrast
media into the heart,
great vessels, and
coronary arteries, to
study the heart and
vessels by x-ray
photography | Same | Same |
| Operating Principle: | Manual delivery through
syringe with force applied
to syringe plunger
through lever action | Automated delivery
through syringe using
electronic screw drive
delivery control | Manual delivery through
syringe with force applied
to syringe plunger by
hand |
| Design Features: | Clear plastic handle,
base, and syringe
Manually controlled | Metal body, clear
plastic syringe
Automated screw | Clear plastic syringe
Manually controlled
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 (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
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 ___