(77 days)
Not Found
No
The summary describes a software-controlled pump for contrast delivery and a material component change to a hand controller. There is no mention of AI, ML, or any features that would suggest the use of such technologies for image analysis, decision support, or automated control beyond user-determined parameters.
Yes
The device is used for the controlled administration of contrast media during angiographic procedures, which aids in diagnostic imaging to assess health conditions or guide medical interventions. This direct involvement in medical procedures to improve or maintain health (even if indirectly through improved diagnostics) classifies it as a therapeutic device.
No
Explanation: The device is described as a "Contrast Delivery System" that aids in the "controlled infusion of radiopaque contrast media." Its function is to deliver contrast for better imaging, not to diagnose. The text repeatedly emphasizes "administration" and "delivery" of contrast, working in conjunction with "radiographic imaging devices" to "produce angiograms." It does not interpret or analyze data to provide a diagnosis.
No
The device description explicitly states it contains a "software-controlled motor-driven pump" and utilizes "consumable kits," indicating the presence of significant hardware components beyond just software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for the "controlled administration of radiopaque contrast media and saline to human subjects while undergoing angiographic procedures." This describes a device used in vivo (within the living body) for imaging purposes, not for testing samples in vitro (outside the living body).
- Device Description: The description reinforces this by stating the system is designed to "aid the physician in the controlled infusion of radiopaque contrast media" and is used in conjunction with "Radiographic imaging devices." This is consistent with an in vivo procedure.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on in vitro testing.
Therefore, the ACIST CVi®/CVi®1 Contrast Delivery System is a medical device used for administering substances during imaging procedures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
ACIST CVi®1 Contrast Delivery System
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 CVi®1 Syringe Kits, Manifold Kit and AngioTouch® Hand Controller Kit must be discarded after each patient procedure. The CVi@1 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.
ACIST CVi® Contrast Delivery System
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 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 CVi/CVi1 System is designed to aid the physician in the controlled infusion of radiopaque contrast media. Radiographic imaging devices are used in conjunction with the delivery of contrast media to produce angiograms. Operating environments for the CVi/CVi1 System are catheterization and radiological laboratories. The CVi/CVi1 System contains a software-controlled motor-driven pump that delivers contrast media at a user-determined flow rate and volume via the ACIST provided consumable kits and a hospital provided angiographic patient catheter. The CVi/CVi1 System is also equipped to synchronize with commercially available X-ray imaging systems. The CVi/CVi1 System is used in interventional cardiology, radiology, and vascular surgical procedures. The CVi/CVi1 System device modification that is the subject of this 510k premarket notification is a material component change to the AngioTouch
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
human subjects
Intended User / Care Setting
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 modified device was subjected to bench and biocompatibility testing. Bench testing Data included burst, functional, life, pressure, bond pull, flow, and durability. Test results demonstrate that the modified device meets specification and performs as intended. No new safety or performance issues were raised during the testing. The modified device is substantially equivalent to the predicate device.
The following biocompatibility tests were completed:
- ·Cytotoxicity
- ·Sensitization
- •Irritation
- Acute Systemic Toxicity
- •Material Mediated Pyrogenicity
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.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a stacked format.
December 17, 2020 ACIST Medical Systems, Inc. Jeff Koll Sr. Principal Regulatory Affairs Specialist 7905 Fuller Rd Eden Prairie, Minnesota 55344
Re: K203004
Trade/Device Name: ACIST CVi1 Contrast Delivery System, 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: November 23, 2020 Received: November 24, 2020
Dear Jeff Koll:
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 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
1
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 medical devices and radiation-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,
Rumi Young Acting 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) K203004
Device Name
ACIST CVi®1 Contrast Delivery System ACIST CVi® Contrast Delivery System
Indications for Use (Describe)
ACIST CVi®1 Contrast Delivery System
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 CVi®1 Syringe Kits, Manifold Kit and AngioTouch® Hand Controller Kit must be discarded after each patient procedure. The CVi@1 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.
ACIST CVi® Contrast Delivery System
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 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) | |
|---|---|
| > Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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Section 2.4
510(k) Summary [21 CFR 807.92]
| Submitter's
Name and
Address | ACIST Medical Systems, Inc.
7905 Fuller Road
Eden Prairie, MN 55344
Phone: 952.656.2409
Fax: 952.941.4648 |
|------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Name
and Information | Jeffrey L. Koll
Sr. Principal Regulatory Affairs Specialist
Phone: 952.656.2409
Fax: 952-941-4648
E-mail: jeff.koll@acistmedical.com |
| Date Prepared | 29 September 2020 |
| Proprietary
Name(s) | ACIST CVi®1 Contrast Delivery System
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 |
| Predicate Device | ACIST CVi®/CVi®1 Contrast Delivery System (K191060) |
| Device
Description | The CVi/CVi1 System is designed to aid the physician in the controlled
infusion of radiopaque contrast media. Radiographic imaging devices are
used in conjunction with the delivery of contrast media to produce
angiograms. Operating environments for the CVi/CVi1 System are
catheterization and radiological laboratories. The CVi/CVi1 System
contains a software-controlled motor-driven pump that delivers contrast
media at a user-determined flow rate and volume via the ACIST provided
consumable kits and a hospital provided angiographic patient catheter. The
CVi/CVi1 System is also equipped to synchronize with commercially
available X-ray imaging systems. The CVi/CVi1 System is used in
interventional cardiology, radiology, and vascular surgical procedures. The
CVi/CVi1 System device modification that is the subject of this 510k
premarket notification is a material component change to the AngioTouch |
4
| Indications
for Use | ACIST CVi®1 Contrast Delivery System
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 |
|-----------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | ACIST CVi® Contrast Delivery System
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 proposed AngioTouch Hand Controller modifications to the CVi/CVi1
system includes:
Replacing current braided polyurethane high-pressure tubing with
coextruded polyamide/ polyurethane high-pressure tubing. Replace fixed luers with rotating luers on the high-pressure tubing Extend shelf life of the modified AngioTouch Hand Controller Kit These modifications do not introduce or raise different questions regarding
the safety or effectiveness of the device. The fundamental technological
characteristics and principle of operation of the modified device are
unchanged from the predicate device. The CVi/CVi1 system with modified
AngioTouch Hand Controller is substantially equivalent to the predicate
device in intended use, design, performance, and technological
characteristics. |
5
| Characteristic | Predicate Device
AngioTouch Hand Controller
K191060 | Proposed Device
AngioTouch Hand Controller (modified)
This 510(k) |
|-------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------|
| Intended Use | For controlled administration of
radiopaque contrast media and saline to
human subjects while undergoing
angiographic procedures. | Same |
| Usability | Single Use | Same |
| AngioTouch
Hand Controller
Kit Components | Housings (2)
Bladders (2)
Twin Tubing
High Pressure Tubing | Same |
| High Pressure
Tubing Length | 54 inches
65 inches | 65 inches |
| High Pressure
Tubing Function | Deliver contrast to patient
Deliver saline to patient
Provides a hemodynamic pathway from
the patient to the hospital's hemodynamic
monitoring system | Same |
| High Pressure
Tubing Material | Polyurethane | Polyurethane/Polyamide |
| Sterilization
Method | Ethylene Oxide | Same |
Consumable Kit Comparison- AT-P Hand Controller
Performance The modified device was subjected to bench and biocompatibility testing. Bench testing Data included burst, functional, life, pressure, bond pull, flow, and durability. Test results demonstrate that the modified device meets specification and performs as intended. No new safety or performance issues were raised during the testing. The modified device is substantially equivalent to the predicate device.
The following biocompatibility tests were completed:
- ·Cytotoxicity
- ·Sensitization
- •Irritation
- Acute Systemic Toxicity
- •Material Mediated Pyrogenicity
Conclusion
The CVi/CVi1 Contrast Delivery System with modified AngioTouch Hand Controller Kit (AT X) is substantially equivalent in design, performance, and technological characteristics to the predicate device for its intended purpose.