(87 days)
Not Found
No
The description focuses on a software-controlled motor-driven pump for controlled contrast delivery, with no mention of AI or ML capabilities for analysis, decision-making, or image processing.
No.
The device is used for controlled administration of contrast media during diagnostic imaging procedures, not for treating a disease or condition.
No
The device is indicated for the "controlled administration of radiopaque contrast media and saline to human subjects while undergoing angiographic procedures." It is a delivery system, not a diagnostic one.
No
The device description explicitly states it contains a "software controlled motor-driven pump" and is used in conjunction with "consumable kits" (syringe kits, manifold kit, hand controller kit), indicating it is a hardware device with integrated software, not a software-only device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the controlled administration of radiopaque contrast media and saline to human subjects while undergoing angiographic procedures. This is an in-vivo procedure, meaning it's performed within the living body.
- Device Description: The device is described as a "software controlled motor-driven pump that delivers contrast media". This is a delivery system for substances administered to the patient, not a device used to examine specimens taken from the body.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples (blood, urine, tissue, etc.) or the detection of specific analytes or markers. IVDs are designed to provide information about a patient's health status based on the examination of such samples.
The device is clearly designed for direct administration of substances into the patient's body during a medical procedure, which falls outside the scope of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The ACIST|CVi®1 Contrast Delivery System is indicated for controlled administration of radiopaque contrast media and saline to human subjects while undergoing angiographic procedures.
The CVil Syringe Kits, Manifold Kit and AngioTouch® Hand Controller Kit must be discarded after each patient procedure. The CV1 Syringe Kits are also indicated for single patient use with ACISTCVi® Contrast Delivery Systems.
The ACIST|CVi®1 Contrast Delivery System is to be used only by and under quasi-continuous supervision of trained health care professionals in an appropriate licensed health care facility, in a room designated for radiological procedures that involve intravascular administration of a contrast agent.
Product codes
DXT
Device Description
The ACIST CVi1 Contrast Delivery System is designed to aid the physician in the controlled infusion of radiopaque contrast media. The CVi1® Contrast Delivery System contains a software controlled motor-driven pump that delivers contrast media at a user-determined flow rate and volume. The CVi1 Contrast Delivery System is used in conjunction with ACIST provided consumable kits: A1000/A1000V Syringe Kit, BT2000 Manifold Kit, and the AT-P AngioTouch Hand Controller Kit. The current submission introduces the A1000/A1000V Syringe Kit provided in the consumable kits. Changes are also introduced into software and labeling to address single patient use for the consumable kit. The CVi1 Contrast Delivery System is used in interventional cardiology, radiology, and vascular surgical procedures. The operating environments for the CVi1 Contrast Delivery System are catheterization or radiological laboratories. The CVi1 system is used in interventional cardiology, radiology, and vascular surgical procedures. Like the predicate CVi system, the CVi1 system is used in adults and pediatrics patient populations.
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
The CVi1 system is used in adults and pediatrics patient populations.
Intended User / Care Setting
used only by and under quasi-continuous supervision of trained health care professionals in an appropriate licensed health care facility, in a room designated for radiological procedures that involve intravascular administration of a contrast agent.
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
The CVi1 Contrast Delivery System was subjected to bench and biocompatibility testing, human factors and sterility assessment, software verification, and system level testing. Bench testing included burst, functional, life, pressure, bond pull, flow, and durability, Bench performance testing was repeated from the predicate device. The subject device met the same endpoints and criteria as the predicate. Test results demonstrate that the CVi1 Contrast Delivery System meets specification and performs as intended. No new safety or performance issues were raised during the testing. No new critical tasks were identified with the proposed CVi1 when compared with the CVi, thus no additional human factors validation testing is necessary for the CVi1 Contrast Delivery System is substantially equivalent to the predicate device.
The A1000V Syringe Kit contains a new contrast valve check scepter compared to the predicate device. To evaluate this change, the following biocompatibility tests were completed on the A1000V Syringe Kit of the CVi1 Contrast Delivery System:
Cytotoxicity
Sensitization
Irritation
Acute Systemic Toxicity
Material Mediated Pyrogenicity
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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
July 18, 2019
ACIST Medical Systems, Inc. Matthew Stepanek Manager, Global Regulatory Affairs 7905 Fuller Road Eden Prairie, Minnesota 35344
Re: K191060
Trade/Device Name: ACIST | CVi®1 Contrast Delivery System Regulation Number: 21 CFR 870.1650 Regulation Name: Angiographic Injector And Syringe Regulatory Class: Class II Product Code: DXT Dated: April 19, 2019 Received: April 22, 2019
Dear Matthew Stepanek:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) 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) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Alan Stevens Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices, and Human Factors OHT3: Office of Gastrorenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name
ACIST|CVi®1 Contrast Delivery System
Indications for Use (Describe)
The ACIST|CVi®1 Contrast Delivery System is indicated for controlled administration of radiopaque contrast media and saline to human subjects while undergoing angiographic procedures.
The CVil Syringe Kits, Manifold Kit and AngioTouch® Hand Controller Kit must be discarded after each patient procedure. The CV1 Syringe Kits are also indicated for single patient use with ACISTCVi® Contrast Delivery Systems.
The ACIST|CVi®1 Contrast Delivery System is to be used only by and under quasi-continuous supervision of trained health care professionals in an appropriate licensed health care facility, in a room designated for radiological procedures that involve intravascular administration of a contrast agent.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
K191060
510(k) Summary [21 CFR 807.92]
| Submitter's
Name and
Address | ACIST Medical Systems, Inc.
7905 Fuller Road
Eden Prairie, MN 55344
Phone: 952.995.9300
Fax: 952.941.4648 |
|------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Name
and Information | Matthew D. Stepanek
Manager, Global Regulatory Affairs
Phone: 952-253-4519
Fax: 952-941-4648
E-mail: matt.stepanek@acistmedical.com |
| Date Prepared | 19 April 2019 |
| Proprietary
Name(s) | ACIST CVi®1 Contrast Delivery System |
| Common Name | Contrast Delivery System |
| Product Code | DXT |
| Classification | Class II, 21 CFR Part 870.1650, Angiographic injector and syringe |
| Predicate Device | K171646 ACIST CVi® Contrast Delivery System |
| Device
Description | The ACIST CVi1 Contrast Delivery System is designed to aid the physician
in the controlled infusion of radiopaque contrast media. The CVi1® Contrast
Delivery System contains a software controlled motor-driven pump that
delivers contrast media at a user-determined flow rate and volume. The CVi1
Contrast Delivery System is used in conjunction with ACIST provided
consumable kits: A1000/A1000V Syringe Kit, BT2000 Manifold Kit, and the
AT-P AngioTouch Hand Controller Kit. The current submission introduces the
A1000/A1000V Syringe Kit provided in the consumable kits. Changes are
also introduced into software and labeling to address single patient use for
the consumable kit. The CVi1 Contrast Delivery System is used in
interventional cardiology, radiology, and vascular surgical procedures. The
operating environments for the CVi1 Contrast Delivery System are
catheterization or radiological laboratories. The CVi1 system is used in
interventional cardiology, radiology, and vascular surgical procedures. Like
the predicate CVi system, the CVi1 system is used in adults and pediatrics
patient populations. |
| Indications for
Use | The ACIST CVi®1 Contrast Delivery System is indicated for controlled
administration of radiopaque contrast media and saline to human subjects
while undergoing angiographic procedures.
The CVi1 Syringe Kits, Manifold Kit and AngioTouch® Hand Controller Kit
must be discarded after each patient procedure. The CVi1 Syringe Kits are
also indicated for single patient use with ACIST CVI® Contrast Delivery
Systems.
The ACIST CVi®1 Contrast Delivery System is to be used only by and under
quasi-continuous supervision of trained health care professionals in an
appropriate licensed health care facility, in a room designated for radiological
procedures that involve intravascular administration of a contrast agent |
4
Substantial Equivalence / Comparison of Technological Characteristics
The CVi1 system includes modifications to remove functionality for administration of contrast media from the same syringe and imaging bulk pack(IBP) contrast container to multiple patients. This will result in a modified system that will only allow for single patient use of the syringe and contrast media. These modifications do not introduce or raise different questions to the safety or effectiveness of the device. The fundamental technological characteristics and principle of operation of the CVi1 system are unchanged from the predicate device. The CVi1 system is substantially equivalent to the predicate device in intended use, design, performance, and technological characteristics.
5
| Characteristic | Predicate Device
A2000 Syringe
K171646 | Proposed Device
A1000 and A1000V Syringe
This 510(k) | Comparison Analysis |
|-----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------|
| Indications
for Use | The ACIST CVi® Contrast
Delivery System is indicated for
controlled administration of
radiopaque contrast media and
saline to human subjects while
undergoing angiographic
procedures.
The ACIST CVi® Contrast
Delivery System is specifically
indicated for use in angiographic
procedures for the delivery of
ISOVUE (Iopamidol Injection)
contrast media as supplied in an
Imaging Bulk Package (IBP), for
a maximum of ten (10) hours.
The Syringe Kit must be
discarded after five (5) patient
procedures. The Manifold Kit and
AngioTouch Hand Controller Kit
must be discarded after each
patient procedure.
The ACIST CVi® Contrast
Delivery System is to be used
only by and under quasi-
continuous supervision of trained
health care professionals in an
appropriate licensed health care
facility, in a room designated for
radiological procedures that
involve intravascular
administration of a contrast
agent. | The ACIST CVi®1 Contrast
Delivery System is indicated for
controlled administration of
radiopaque contrast media and
saline to human subjects while
undergoing angiographic
procedures.
The CVi1 Syringe Kits, Manifold
Kit and AngioTouch® Hand
Controller Kit must be discarded
after each patient procedure.
The CVi1 Syringe Kits are also
indicated for single patient use
with ACIST CVi® Contrast
Delivery Systems.
The ACIST CVi®1 Contrast
Delivery System is to be used
only by and under quasi-
continuous supervision of
trained health care professionals
in an appropriate licensed health
care facility, in a room
designated for radiological
procedures that involve
intravascular administration of a
contrast agent. | Different |
| Usability | Up to 5 patient cases | Single Patient Use | Different |
| Syringe Kit
Component
S | Wiper
Wiper Support
Rotator
Contrast Tubing
Contrast O-Ring
Contrast Valve Check Ball | Wiper
Wiper Support
Rotator
Contrast Tubing
Contrast O-Ring
Contrast Valve Check
Ball(A1000) or Scepter(A1000V) | Different |
| Disinfecting
Caps and
Slide Clamp | Yes | No | Different |
| Sterilization
Method | Gamma Irradiation | Gamma Irradiation | Same |
Consumable Kit Comparison-Syringe
6
Discussion of similarities and differences:
Similarities: The ACIST|CVi®1 Contrast Delivery System A1000/A1000V Syringes, have the same intended use and fundamental scientific technology as the predicate device. The A1000V Syringe uses a Contrast Valve Check Scepter which is similar to the Contrast Valve Check Ball as found in the A1000 Syringe and predicate device. The purpose and function of the Contrast Valve Check Scepter and Contrast Valve Check Ball are the same. The software for the pump has been updated to remove the ability to reuse the syringe, requiring the user to change syringe after each patient case. The ACIST|CVi®1 System indications for use are similar to the predicate device and result in a modified system that will only allow for single patient use of the syringe with contrast media. These device modifications do not raise any new issues of safety and effectiveness of the device.
Differences: The ACIST|CVi®1 Contrast Delivery System includes modifications to remove functionality for administration of contrast media from the same syringe and IBP contrast container to multiple patients. Specifically, this means the syringe will be indicated for single use and will not require the predicate device's disinfecting caps and slide clamp, as it will be disposed of after each patient use. These modifications do not introduce or raise different questions of safety or effectiveness of the device.
Performance Data
The CVi1 Contrast Delivery System was subjected to bench and biocompatibility testing, human factors and sterility assessment, software verification, and system level testing. Bench testing included burst, functional, life, pressure, bond pull, flow, and durability, Bench performance testing was repeated from the predicate device. The subject device met the same endpoints and criteria as the predicate. Test results demonstrate that the CVi1 Contrast Delivery System meets specification and performs as intended. No new safety or performance issues were raised during the testing. No new critical tasks were identified with the proposed CVi1 when compared with the CVi, thus no additional human factors validation testing is necessary for the CVi1 Contrast Delivery System is substantially equivalent to the predicate device.
The A1000V Syringe Kit contains a new contrast valve check scepter compared to the predicate device. To evaluate this change, the following biocompatibility tests were completed on the A1000V Syringe Kit of the CVi1 Contrast Delivery System:
Cytotoxicity Sensitization Irritation Acute Systemic Toxicity Material Mediated Pyrogenicity
Conclusion
The CVi1 Contrast Delivery System is substantially equivalent in design, performance, and technological characteristics to the predicate devices for its intended purpose.