(429 days)
Not Found
No
The description focuses on a mechanical and electronic system for controlled contrast infusion, with no mention of AI or ML capabilities.
No
The device infuses contrast media for diagnostic imaging (angiography) and does not directly treat a disease or condition.
No
The device is an angiographic injector system that delivers contrast media during angiographic procedures, which are interventional rather than diagnostic. It does not analyze patient data or provide diagnostic information.
No
The device description explicitly details hardware components such as a motorized syringe pump, tubing, catheter, hand actuated proportional controller, and a disposable kit including a syringe and valve assembly, injection manifold assembly, high pressure assembly, tubing assembly, and associated caps and connectors. Performance studies also include physical and electrical safety testing, indicating hardware is a significant part of the device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "controlled infusion of radiopaque contrast media for angiographic procedures." This describes a procedure performed on a patient, not a test performed on a sample taken from a patient.
- Device Description: The description details a system for delivering contrast material into a patient's body during an angiographic procedure. It involves a syringe pump, tubing, and a catheter connected to the patient.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on in vitro testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is used to facilitate an imaging procedure performed directly on the patient.
N/A
Intended Use / Indications for Use
The ACIST System from Invasatec is intended to be used for the controlled infusion of radiopaque contrast media for angiographic procedures.
Product codes
DXT
Device Description
The ACIST is an angiographic injector system which supplies radiographic contrast material to a catheter at a clinician determined variable flow rate which can be remotely and continuously varied by the user. The system includes a motorized syringe pump which delivers radiographic contrast material to tubing which is connected to a angiographic catheter. The clinician controls the flow rate of radiographic contrast material from the pump to the catheter with a hand actuated proportional controller. By operating the hand control, the user can vary a command signal in order to adjust the flow rate of radiographic contrast material from the pump to the outlet during the operation of the pump. The remote hand control allows the clinician to interactively adjust flow rate (and thus volume of material delivered to the patient) while observing the angiographic procedure (for example on a fluoroscope monitor).
The system includes a remote hand controller which is responsive to the command signal from the clinician. Based upon that command signal, the controller controls flow rate of the radiographic contrast material from the pump to the outlet.
The system also includes a specifically designed disposable kit. The kit includes a syringe and valve assembly, injection manifold assembly, high pressure assembly, tubing assembly and associated caps and connectors. The kit is intended to provide all components necessary to perform an angiographic study.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
clinician
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)
Physical testing of the system included: dimensional inspection, bond strength testing, burst pressure, flow rate capability, and performance under simulated conditions. Electrical safety testing was performed per IEC 601-1 and electromagnetic compatibility testing per IEC 601-1-2. All testing of the product vielded acceptable results.
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.
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Attachment G
abilining
DEC - 5 1997
510(k) Summary
1
510(k) Summary
ACIST Angiographic Injector System
General Information
Classification
Class II
ACIST Angiographic Injector System
Submitter
Trade Name
Invasatec Corporation 10180 Viking Drive Eden Prairie, MN 55344 (612) 941-3507
Contact
Doug Duchon Vice President
Predicate Devices
from Medrad, Inc. K822536. Mark V Mark V+ from Medrad, Inc.
Device Description
The ACIST is an angiographic injector system which supplies radiographic contrast material to a catheter at a clinician determined variable flow rate which can be remotely and continuously varied by the user. The system includes a motorized syringe pump which delivers radiographic contrast material to tubing which is connected to a angiographic catheter. The clinician controls the flow rate of radiographic contrast material from the pump to the catheter with a hand actuated proportional controller. By operating the hand control, the user can vary a command signal in order to adjust the flow rate of radiographic contrast material from the pump to the outlet during the operation of the pump. The remote hand control allows the clinician to interactively adjust flow rate (and thus volume of material delivered to the patient) while observing the angiographic procedure (for example on a fluoroscope monitor) .
system includes a remote hand controller which is The responsive to the command signal from the clinician. Based upon that command signal, the controller controls flow rate of the radiographic contrast material from the pump to the outlet.
2
The system also includes a specifically designed disposable kit. The kit includes a syringe and valve assembly, injection manifold assembly, high pressure assembly, tubing assembly and associated caps and connectors. The kit is intended to provide all components necessary to perform an angiographic study.
Intended Use
The ACIST System from Invasatec is intended to be used for the controlled infusion of radiopaque contrast media for angiographic procedures.
Testing
The materials used in the construction of the ACIST disposable angiographic kit are well known materials widely used in the medical industry. All materials are certified from the vendor as biocompatible based on compliance with USP Class VI and/or ISO 10993. All materials are biocompatible and are suitable for this application.
Physical testing of the system included: dimensional inspection, bond strength testing, burst pressure, flow rate capability, and performance under simulated conditions. Electrical safety testing was performed per IEC 601-1 and electromagnetic compatibility testing per IEC 601-1-2. All testing of the product vielded acceptable results.
Summary of Substantial Equivalence
The ACIST System components are constructed of the same or substantially equivalent materials as the predicate products. The sizes and configurations available along with the packaging and sterilization methods are also equivalent.
The clinical indications for use are identical to the predicate devices.
due to the similarity of materials Therefore, to other angiographic injection systems, the test results and the identical indications for use to other angiographic injectors, Invasatec believes this product does not raise any new safety or effectiveness issues.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle with three curved lines representing its wings and body. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.
Rockville MD 20857
DEC - 5 1997
Mr. Doug Duchon V.P. Product Development Invasatec, Inc. 10180 Viking Lane Eden Prairie, Minnesota 55344
Re: K963982 Invasatec ACIST Angiographic Injector Regulatory Class: II (two) Product Code: DXT Dated: September 9, 1997 Received: September 10, 1997
Dear Mr. Duchon:
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 (for the indications for use stated in the enclosure) to 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 Please note: this response to your premarket the Federal Register. notification submission does not affect any 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.
4
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) 594-4648. 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/dsmamain.html".
Sincerely yours,
Thomas J. Callahon
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Page_
510(k) Number (if known): K963982 Angiogr Device Name: Invosatec_ACIST Indications For Use: asatec The for the be int a que l (1 for procer (Division Sign-Off) Division of Cardiovascular, Ke and Neurological Devices 510(k) Number
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use_ (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)