Who is the manufacturer of ACISTCVi® Contrast Delivery System?

Acist Medical Systems, Inc. filed the 510(k) submission for ACISTCVi® Contrast Delivery System (K171646).

What is the FDA product code for ACISTCVi® Contrast Delivery System?

DXT. It is classified under 21 CFR 870.1650 as a Class 2 device in the Cardiovascular panel.

What is the regulatory pathway for ACISTCVi® Contrast Delivery System?

510(k) clearance (submission type: Traditional).

What are the predicate devices for ACISTCVi® Contrast Delivery System?

ACIST Angiographic Contrast Management Injector System, Model CMS2000 (K991103); ACIST Angiographic Contrast Management System (K984231).

Who can help prepare an FDA 510(k) submission like ACISTCVi® Contrast Delivery System?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

ACISTCVi® Contrast Delivery System

K171646 · Acist Medical Systems, Inc. · DXT · Feb 16, 2018 · Cardiovascular

Device Facts

Record ID	K171646
Device Name	ACISTCVi® Contrast Delivery System
Applicant	Acist Medical Systems, Inc.
Product Code	DXT · Cardiovascular
Decision Date	Feb 16, 2018
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 870.1650
Device Class	Class 2

Intended 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 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.

Device Story

Software-controlled, motor-driven pump for controlled infusion of radiopaque contrast media and saline; used in interventional cardiology, radiology, and vascular surgery. Operates in catheterization or radiological labs; used by trained healthcare professionals. System utilizes consumable kits (A2000 Syringe, BT2000 Manifold, AT-P AngioTouch Hand Controller) and hospital-provided patient catheter. Physician controls flow rate and volume via hand controller; system provides automated delivery. Includes air column detect sensor and software-required syringe change protocols for multi-patient use from single container. Enhances safety for multi-patient contrast administration; provides precise, user-determined delivery parameters.

Clinical Evidence

Bench testing only. Testing included burst, functional, life, pressure, bond pull, flow, durability, microbial ingress, and cross-contamination. Biocompatibility testing included cytotoxicity, sensitization, irritation, acute systemic toxicity, material-mediated pyrogenicity, and hemolysis. Software validation, system-level testing, and human factors testing were also performed. Results demonstrate device meets specifications and performs as intended.

Technological Characteristics

Motor-driven pump system; software-controlled. Components: injector head, power supply, control panel. Consumables: A2000 Syringe Kit, BT2000 Manifold Kit, AT-P Hand Controller Kit. Sterilization: Gamma irradiation (syringes/manifolds), Ethylene Oxide (hand controller). Connectivity: Standalone. Flow: 0.8-40.0 ml/s; Volume: 0.8-99.9 ml; Pressure: 200-1200 psi. Includes air column detect sensor.

Indications for Use

Indicated for controlled administration of radiopaque contrast media and saline to human subjects undergoing angiographic procedures. Specifically for delivery of ISOVUE (Iopamidol) from Imaging Bulk Package (IBP) for max 10 hours. Syringe kit discarded after 6 procedures; manifold/hand controller kits discarded after each procedure. For use by trained healthcare professionals in licensed facilities.

Regulatory Classification

Special Controls

*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.

Predicate Devices

ACIST Angiographic Contrast Management Injector System, Model CMS2000 (K991103)
ACIST Angiographic Contrast Management System (K984231)

Reference Devices

ACIST Angiographic Contrast Management Injector System, Model R2000 CMS (K010390)
ACIST Angiographic Contrast Management System (K040298)
CT Expres 3D Contrast Media Delivery System (K151048)

Related Devices

K963982 — ACIST ANGIOGRAPHIC INJECTOR · Invasatec · Dec 5, 1997
K040298 — ACIST ANTIOGRAPHIC INJECTION SYSTEM CONTRAST MANAGEMENT DISPOSABLE KITS · Acist Medical Systems, Inc. · Mar 15, 2004
K171392 — ulrichINJECT CT motion · Ulrich GmbH & Co. KG · Nov 9, 2017
K113133 — MEDRAD MARK 7 ARTERION (PEDESTAL SYSTEM), (TABLE MOUNT SYSTEM), MEDRAD MARK 7 ARTERION ARTERION SYRINGE · Medrad, Inc. · Dec 15, 2011
K192872 — ulrichINJECT CT Motion · Ulrich GmbH & Co. KG · Jul 2, 2020

Submission Summary (Full Text)

{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) ### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {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…