(256 days)
No
The description focuses on a software-controlled motor-driven pump for controlled contrast delivery, with no mention of AI or ML capabilities.
No
The device is used for controlled administration of contrast media during angiographic procedures, which are diagnostic imaging procedures, not therapeutic treatments.
No
The device is a contrast delivery system used for administering contrast media during angiographic procedures, not for diagnosing conditions.
No
The device description explicitly states it contains a "software controlled motor-driven pump" and is used in conjunction with "ACIST provided consumable kits," indicating it is a hardware device with integrated software, not a software-only device.
Based on the provided text, the ACIST|CVi® Contrast Delivery System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states the device is for "controlled administration of radiopaque contrast media and saline to human subjects while undergoing angiographic procedures." This involves administering substances into the human body for imaging purposes, not testing samples outside the body.
- Device Description: The description details a "software controlled motor-driven pump that delivers contrast media" and its use in "interventional cardiology, radiology, and vascular surgical procedures." This aligns with a device used for administering substances during medical procedures, not for analyzing biological samples.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD device, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening based on sample analysis
Therefore, the ACIST|CVi® Contrast Delivery System is a medical device used for administering contrast media during imaging procedures, not an in vitro diagnostic device.
N/A
Intended Use / 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 six (6) 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.
Product codes
DXT
Device Description
The ACIST CVi® Contrast Delivery System is designed to aid the physician in the controlled infusion of radiopaque contrast media. The CVi Contrast Delivery System contains a software controlled motor-driven pump that delivers contrast media at a user-determined flow rate and volume. The CVi Contrast Delivery System is used in conjunction with ACIST provided consumable kits: A2000 Syringe Kit, BT2000 Manifold Kit, and the AT-P AngioTouch Hand Controller Kit, and a hospital provided angiographic patient catheter. The CVi Contrast Delivery System is used in interventional cardiology, radiology, and vascular surgical procedures. The operating environments for the CVi Contrast Delivery System are catheterization or radiological laboratories.
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
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.
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)
The CVi Contrast Delivery System was subjected to bench and biocompatibility testing, software validation, system level testing, and human factors testing. Bench testing included burst, functional, life, pressure, bond pull, flow, durability. microbial ingress, and cross contamination. Test results demonstrate that the CVi Contrast Delivery System meets specification and performs as intended. No new safety or performance issues were raised during the testing. The CVi Contrast Delivery System is substantially equivalent to the predicate devices.
The following biocompatibility tests were completed on the CVi Contrast Delivery System:
Cytotoxicity
Sensitization
Irritation
Acute Systemic Toxicity
Material Mediated Pyrogenicity
Hemolysis
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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 shows the logo of the U.S. Food and 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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
February 16, 2018
ACIST Medical Systems, Inc. Melissa Sommerfeld Principal Regulatory Affairs Specialist 7905 Fuller Road Eden Prairie, Minnesota 55344
Re: K171646
Trade/Device Name: ACIST | CVi® Contrast Delivery System Regulation Number: 21 CFR 870.1650 Regulation Name: Angiographic Injector And Syringe Regulatory Class: Class II Product Code: DXT Dated: January 16, 2018 Received: January 18, 2018
Dear Melissa Sommerfeld:
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. 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 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
1
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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Kenneth J. Cavanaugh -S
for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K171646
Device Name ACIST|CVi® Contrast Delivery System
Indications for Use (Describe)
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 ACISTICVi® Contrast Delivery System is specifically indicated for use in angiographic procedures for the delivery of ISOVUE (lopamidol 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 six (6) 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.
| 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
K171646
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 | Melissa Sommerfeld
Principal Regulatory Affairs Specialist
Phone: 952.656.2409
Fax: 952.941.4648
E-mail: melissa.sommerfeld@acistmedical.com | |
| Date Prepared | 15 February 2018 | |
| Proprietary
Name(s) | ACIST CVi® Contrast Delivery System | |
| Common Name | Contrast Delivery System | |
| Product Code | DXT | |
| Classification | Class II, 21 CFR Part 870.1650, Angiographic injector and syringe | |
| Primary
Predicate
Device | K991103 | ACIST Angiographic Contrast Management Injector
System, Model CMS2000 |
| Secondary
Predicate
Device | K984231 | ACIST Angiographic Contrast Management System |
| Reference
Predicate
Devices | K010390 | ACIST Angiographic Contrast Management Injector
System, Model R2000 CMS |
| | K040298 | ACIST Angiographic Contrast Management System |
| | K151048 | CT Expres 3D Contrast Media Delivery System, Bottle
Spike Type B, Day Set III HP, Patient Set |
| Device
Description | The ACIST CVi® Contrast Delivery System is designed to aid the
physician in the controlled infusion of radiopaque contrast media. The CVi
Contrast Delivery System contains a software controlled motor-driven pump
that delivers contrast media at a user-determined flow rate and volume. The
CVi Contrast Delivery System is used in conjunction with ACIST provided
consumable kits: A2000 Syringe Kit, BT2000 Manifold Kit, and the AT-P
AngioTouch Hand Controller Kit, and a hospital provided angiographic
patient catheter. The CVi Contrast Delivery System is used in interventional
cardiology, radiology, and vascular surgical procedures. The operating
environments for the CVi Contrast Delivery System are catheterization or
radiological laboratories. | |
| 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 six (6)
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. | |
| Substantial
Equivalence /
Comparison of
Technological
Characteristics | The fundamental technological characteristics and principal of operation of
the CVi Contrast Delivery System are unchanged from the predicate
devices. The CVi Contrast Delivery System contains enhanced safety
features for administering contrast media to multiple patients from a single
container. The CVi system is substantially equivalent in design,
performance, and technological characteristics to the predicate devices for
its intended purpose. No new or different questions of safety or
effectiveness were raised with the enhancements. A comparison of the
predicate and subject devices is provided in Table 1 and 2. | |
| Table 1: Injection System Comparison | | |
| Characteristic | Predicate Device
Injection System CMS2000
K991103 | Proposed Device
Injection System- CVI
This 510(k) |
| Indications for
Use | The ACISTTM CMS-2000
Angiographic Injection
System with Contrast
Management is intended to
be used for the controlled
infusion of radiopaque
contrast media for
angiographic procedures. | 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 six
(6) 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. |
| Primary System
Components | •Injector Head
•Power Supply
•Control Panel | •Injector Head
•Power Supply
•Control Panel |
| Contrast
Injection
Parameters | •Flow (ml/s): 0.8-40.0
•Volume (ml): 0.8-99.9
•Pressure (psi): 200-1200
•Rise Time (s): 0.0-1.0 | •Flow (ml/s): 0.8-40.0
•Volume (ml): 0.8-99.9
•Pressure (psi): 200-1200
•Rise Time (s): 0.0-1.0 |
| Compatible
Consumable
Kits | •Syringe Kit
•Manifold Kit
•Hand Controller Kit | •Syringe Kit
•Manifold Kit
•Hand Controller Kit |
| Saline Flush | Yes | Yes |
| Software
Controlled
Required
Syringe Change | No | Yes |
| Injection
Delivery | Variable or Fixed Rate | Variable or Fixed Rate |
| Equipped with
Air Column
Detect Sensor | Yes | Yes |
| X-Ray Imaging
Functionality | No | Yes1 |
| Characteristic | Predicate Device
A2000 Syringe
K984231 | Proposed Device
A2000 Syringe
This 510(k) |
| Indications for
Use | The ACIST CMS-2000
Angiographic Injection System
with Contrast Management is
intended to be used for the
controlled infusion of
radiopaque contrast media for
angiographic procedures. | 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
specifically indicated for use in
is
angiographic procedures for the delivery of
ISOVUE (lopamidol 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 six (6) 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. |
| Usability | Up to 5 patient cases | Up to 6 patient cases |
| Syringe Kit
Components | 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 |
| Disinfecting Cap | No | Yes |
| Sterilization
Method | Gamma Irradiation | Gamma Irradiation |
| Characteristic | Predicate Device
BT2000 Manifold
K984231 | Proposed Device
BT2000 Manifold
This 510(k) |
| Indications for Use | The ACIST CMS-2000
Angiographic Injection System
with Contrast Management is
intended to be used for the
controlled infusion of
radiopaque contrast media for
angiographic procedures. | 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
(lopamidol 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 six (6) 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. | | |
| Usability | Single Use | Single Use |
| Syringe Kit
Components | Manifold Shaft
Manifold Cap
Spring
Sealing O-ring
Pressure Transducer
Valve Trigger | Manifold Shaft
Manifold Cap
Spring
Sealing O-ring
Pressure Transducer
Valve Trigger |
| Sterilization
Method | Gamma Irradiation | Gamma Irradiation |
| Characteristic | Predicate Device
AT-P Hand Controller
K040298 | Proposed Device
AT-P Hand Controller
This 510(k) |
| Indications for Use | The ACIST CMS-2000 Angiographic
Injection System with Contrast
Management is intended to be used
for the controlled infusion of
radiopaque contrast media for
angiographic procedures. | 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
(lopamidol 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 six (6) 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. |
| Usability | Single Use | Single Use |
| AT-P Hand
Controller Kit
Components | Housings (2)
Bladders (2)
Twin Tubing
High Pressure Tubing | Housings (2)
Bladders (2)
Twin Tubing
High Pressure Tubing |
| High Pressure
Tubing Length | 54 inches
65 inches | 54 inches
65 inches |
| Sterilization Method | Ethylene Oxide | Ethylene Oxide |
4
.
5
6
Table 2: Consumable Kit Comparion- A2000 Syringe
7
Consumable Kit Comparion- BT2000 Manifold
8
Consumable Kit Comparion- AT-P Hand Controller
9
| Performance
| Data | The CVi Contrast Delivery System was subjected to bench and biocompatibility testing, software validation, system level testing, and human factors testing. Bench testing included burst, functional, life, pressure, bond pull, flow, durability. microbial ingress, and cross contamination. Test results demonstrate that the CVi Contrast Delivery System meets specification and performs as intended. No new safety or performance issues were raised during the testing. The CVi Contrast Delivery System is substantially equivalent to the predicate devices. |
|---|---|
| The following biocompatibility tests were completed on the CVi Contrast Delivery System: | |
| Cytotoxicity | |
| Sensitization | |
| Irritation | |
| Acute Systemic Toxicity | |
| Material Mediated Pyrogenicity | |
| Hemolysis | |
| The CVi Contrast Delivery System is substantially equivalent in design, performance, and |
- The CVi Contrast Delivery System is substantially equivalent in design, performance, and
technological characteristics to the predicate devices for its intended purpose. Conclusion