(29 days)
Not Found
Not Found
No
The summary describes a mechanical injection system with user-controlled flow rate and does not mention any AI/ML terms or functionalities.
No.
The device injects contrast media for angiographic procedures, which is a diagnostic aid, not a therapeutic treatment.
No
The device is used to inject contrast media for angiographic procedures, not to diagnose a condition. Angiography is an imaging technique that may be used for diagnosis, but the injection system itself is an accessory for the procedure.
No
The device description explicitly lists hardware components such as Injector Head, Control Panel, Power Supply, AC Power, and Interconnect Cables, in addition to disposable components.
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 device used in vivo (within the body) to deliver a substance for imaging purposes.
- Device Description: The description details a system for delivering contrast media to a catheter connected to a patient. This is consistent with an in vivo procedure.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.) in vitro (outside the body) to provide diagnostic information.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is to deliver a substance into the body for imaging, which is not the role of an IVD.
N/A
Intended Use / Indications for Use
The Acist Angiographic Injection System is intended to be used for the controlled infusion of radiopaque contrast media for angiographic procedures.
Product codes (comma separated list FDA assigned to the subject device)
IZO, DXT
Device Description
The Acist® Angiographic Injection System delivers contrast media to a catheter at a userdetermined variable flow rate that can be instantaneously and continuously varied. The system is comprised of the following elements: - Injector Head - Control Panel . - Power Supply - AC Power and Interconnect Cables ● Not affected by this change, but provided with the system are the sterile disposable components. These are contained in two separate kits (D-1000 and H-1000) and include the Hand Controller, Contrast Syringe, and the valving to provide the interface between the system and the angiographic patient catheter
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
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Acist® Angiographic Injection System, Model CL100H without the "RESUME" feature.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
DEC - 7 1999
Image /page/0/Picture/2 description: The image shows the logo for Acist Medical Systems. The logo features the word "acist" in bold, black letters, with a stylized design above the "i" that resembles a small circle with a line extending from it. Below "acist" are the words "MEDICAL SYSTEMS" in a smaller, sans-serif font. A curved line is above the word "acist".
510(k) SUMMARY
Applicant's Name and Address:
Acist Medical Systems, Inc. 7450 Flying Cloud Drive Suite 150 Eden Prairie, MN 55344
Name of Contact Person:
Carl M. Beaurline Vice President, Quality Assurance / Regulatory Affairs
Telephone and Fax Numbers:
Telephone - (612) 995-9319 Fax - (612) 941-4648
Address of Manufacturing and Sterilization Site:
Manufacturing: Acist Medical Systems, Inc. 7450 Flying Cloud Drive Suite 150 Eden Prairie, MN 55344
Sterilization: Not applicable to this product.
1
Acist® Angiographic Injection System, Model CL100H Proprietary Name:
Common Name: Contrast Injector
Classification Name: Injector, Contrast Medium, Automatic
Classification Number: 870.1650
Class: II
Classification Panel: Cardiovascular
Product Code: IZO
Description:
The Acist® Angiographic Injection System delivers contrast media to a catheter at a userdetermined variable flow rate that can be instantaneously and continuously varied.
The system is comprised of the following elements:
- Injector Head
- Control Panel .
- Power Supply
- AC Power and Interconnect Cables ●
Not affected by this change, but provided with the system are the sterile disposable components. These are contained in two separate kits (D-1000 and H-1000) and include the Hand Controller, Contrast Syringe, and the valving to provide the interface between the system and the angiographic patient catheter
Predicate Device: Acist® Angiographic Injection System, Model CL100H without the "RESUME" feature.
Indications for Use:
The Acist Angiographic Injection System is intended to be used for the controlled infusion of radiopaque contrast media for angiographic procedures.
2
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of three stylized human profiles facing to the right, with flowing lines suggesting movement or connection.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC - 7 1999
Mr. Carl M. Beaurline Vice President, Quality Assurance/Regulatory Affairs Acist Medical Systems, Inc. 7450 Flying Cloud Drive Eden Prairie, MN 55344
K993774 Re: Trade Name: Acist Angiographic Injection System Regulatory Class: II Product Code: DXT Dated: November 4, 1999 November 8, 1999 Received:
Dear Mr. Beaurline:
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 leqally 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 Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with 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 requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to
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Page 2 - Mr. Carl M. Beaurline
your premarket notification submission does not affect any obliqation 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) 594-4586. 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" (21CFR 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,
Chistopher M. Heaton
Celia M. Witten, Ph.D., M.D. Acting Director Division of Cardiovascular, Respiratory and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
SECTION 6 - STATEMENT OF INDICATIONS FOR USE / LABELING
PART A - INDICATIONS FOR USE FORM
Page _________________________________________________________________________________________________________________________________________________________________________ of
510(k) Number:
Device Name: Acist Angiographic Injection System
Indications for Use:
The Acist Angiographic Injection System is intended to be used for the controlled infusion of radiopaque contrast media for angiographic procedures.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of I
Christopher tu White
510(k) Number
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use (Optional Format 1-2-96)