(77 days)
Not Found
No
The summary describes a mechanical injection system and disposable tubing, with no mention of AI or ML capabilities.
No
The device is used for controlled infusion of contrast media and pressure monitoring, which are diagnostic procedures, not therapeutic ones.
No
The device is described as an "Angiographic Injection System" for controlled infusion of contrast media and for measuring hemodynamic waveform. These functions are therapeutic or procedural, not diagnostic. While it interfaces with "pressure monitoring equipment" for "measure[ing] hemodynamic waveform," the device itself is a component in the procedure, not primarily diagnosing a condition.
No
The device description explicitly details physical components like tubing, manifold, stopcock, and lines, indicating it is a hardware device with disposable components, not software only.
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 is a procedure performed in vivo (within the living body) to visualize blood vessels.
- Device Description: The device is described as "disposable patient contact intravenous tubing" and is used to "measure homodynamic waveform." This involves interacting directly with the patient's circulatory system.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information about a patient's health. The provided description does not mention any analysis of biological samples.
Therefore, the ACIST Angiographic Injection System, as described, is a medical device used for in vivo procedures, not 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
DXT
Device Description
The C2000 Automated Manifold Assembly Kit is the disposable patient contact intravenous tubing that attaches to Part A via a connector. This kit is contains the patient manifold, saline spike, 3-way pressure stopcock, high pressure line, and a syringe cap. This kit is designed to be connected to the users own pressure monitoring equipment to measure homodynamic waveform.
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
Not Found
Key Metrics
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
0EC 1 6 2005
510(k) Summary
..
:
| Submitter: | ACIST Medical Systems, Inc
7450 Flying Cloud Drive, Suite 150
Eden Prairie, MN 55344 USA |
|---------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Mr. Al Saalabi
Vice President of Quality and Regulatory Affairs
Phone: (952) 995-9360 FAX: (952) 941-4648
Al.saalabi@acistmedical.com |
| Date Prepared: | September 28, 2005 |
| Trade Name: | C2000 Automated Kit Assembly |
| Classification
Name and
Number: | Angiographic contrast media injection systems, and its accessories, have
been classifieds as Class II devices per 21 CFR 870.1650. No
performance standards have been established under Section 514 of the
Food, Drug and Cosmetic Act for these devices. |
| Product Code: | DXT |
| Predicate Device | The ACIST Angiographic Contrast Management System cleared under
K984231. |
| Device Description: | The C2000 Automated Manifold Assembly Kit is the disposable patient
contact intravenous tubing that attaches to Part A via a connector. This
kit is contains the patient manifold, saline spike, 3-way pressure
stopcock, high pressure line, and a syringe cap. This kit is designed to
be connected to the users own pressure monitoring equipment to
measure homodynamic waveform. |
| Intended Use: | The ACIST Angiographic Injection System is intended to be used for
the controlled infusion of radiopaque contrast media for angiographic
procedures. |
| Statement of
Technological
Comparison | The subject device and predicate device have the following similarities.
The same indication for use; The same operating principle; The same basic design; materials; The same manufacturing environment; The same sterilization process; and The same packaging configurations. |
| Conclusion: | In summary, the subject device, as described in this submission is, in the
opinion of ACIST Medical, substantially equivalent to the predicate
device.
The subject device, as modified in this submission, is substantially
equivalent to the predicate device, ACIST Angiographic Contrast Management
System (cleared under K984231.) This conclusion is based upon the
similarities of the devices in terms of functional design, indication for
use, principles of operation, materials, and performance characteristics. |
C2000 Disposable Kit Special 510(k) ACIST Medical Systems, Inc.
Appendix F, Page 2
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract image of an eagle.
OEC 16 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Acist Medical Systems, Inc. c/o Mr. Al Saalabi Vice President of Quality and Regulatory Affairs 7450 Flying Cloud Drive, Suite 150 Eden Prairie, MN 55344
K052744 Re: C2000 Automated Manifold Kit Regulation Number: 21 CFR 870.1650 Regulation Name: Angiographic injector & syringe Regulatory Class: II Product Code: DXT Dated: November 18, 2005 Received: November 21, 2005
Dear Mr. Saalabi:
We have reviewed your Section 510(k) premarket notification of intent to market the indication We have reviewed your Section 910(x) premainer is substantially equivalent (for the indications
referenced above and have determined the device is substant in interstate referenced above and have decimined the devices marketed in interstate
for use stated in the enclosure) to legally marketed predicate devices Amendments for use stated in the encrosulty to regally manced promises of the Medical Device Amendments, or to commerce prior to May 20, 1970, the chance with the provisions of the Federal Food. Drug, devices that have been reclassince in accordance what approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a provisions of the Act . The and Cosmetic Act (Act) that do not require approval controls provisions of the Act. The
You may, therefore, market the device, subject to the general registration, liging o You may, therefore, market the devreet, seeject of the storest for annual registration, listing of
general controls provisions of the Act include requirements misbranding and general controls provisions of the 7tet merade requirements of the mastern misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (see above) in to existing major regulations affecting your device can
may be subject to such additional controls. This as a see may be subject to such additional controls. Existing major of Sep In addition, FDA may
be found in the Code of Federal Regulations, Title 21, Parts 800 designer be found in the Code of Peacharting your device in the Federal Register.
2
Page 2 - Mr. Al Saalabi
Please be advised that FDA's issuance of a substantial equivalence determination and mean Please be advised that FDA 3 issualted or a bevice complies with other requirements of the Act that FDA has made a decormination that Jour atered by other Federal agencies. You must of ally Federal statutes and regulations and limited to: registration and listing (21 comply with an the Act stequirements, morealing, which and acturing practice requirements as set CFR Part 807), labeling (21 CFR Part 820); and 820); and if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR Part 820); and 11 app 1000 1060 forum in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control provisions (Declines our device as described in your Section 510(k) I his letter will anow you to begin manieting your and equivalence of your device to a legally premarket nothleadon: "The PDF intemsgsification 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), please If you desire specific davis at (240) 276-0120. Also, please note the regulation entitled, Connact the Office of Oremarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general miormational on your respender Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Dmna R. Vochner
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use Page
510(k) Number (if known): K052744
C2000 Automated Manifold Kit Device Name:
Indications for Use:
The ACIST Angiographic Injection System is intended to be used for the controlled infusion
ing the same of the Samesia procedures The ACIST Anglographic injoction byoma
of radiopaque contrast media for angiographic procedures.
Prescription Use __ X (Per 21 CFR 801 Subpart D) AND/OR
Over-the-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Dona R. VoLuner
sic Sign-Off) ... Jarsion Ji Cardiovascular Devices
510(k) Number K052744