ACIST CVI1 Contrast Delivery System, A1000 Syringe Kit, A1000V Syringe Kit, BT2000 Manifold Kit, BT2000 Manifold Kit, AngioToiuch Hand Controller Kit

Q: Who is the manufacturer of ACIST CVI1 Contrast Delivery System, A1000 Syringe Kit, A1000V Syringe Kit, BT2000 Manifold Kit, BT2000 Manifold Kit, AngioToiuch Hand Controller Kit?

Acist Medical Systems, Inc. filed the 510(k) submission for ACIST CVI1 Contrast Delivery System, A1000 Syringe Kit, A1000V Syringe Kit, BT2000 Manifold Kit, BT2000 Manifold Kit, AngioToiuch Hand Controller Kit (K191060).

Q: What is the FDA product code for ACIST CVI1 Contrast Delivery System, A1000 Syringe Kit, A1000V Syringe Kit, BT2000 Manifold Kit, BT2000 Manifold Kit, AngioToiuch Hand Controller Kit?

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

Q: What is the regulatory pathway for ACIST CVI1 Contrast Delivery System, A1000 Syringe Kit, A1000V Syringe Kit, BT2000 Manifold Kit, BT2000 Manifold Kit, AngioToiuch Hand Controller Kit?

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

Q: What are the predicate devices for ACIST CVI1 Contrast Delivery System, A1000 Syringe Kit, A1000V Syringe Kit, BT2000 Manifold Kit, BT2000 Manifold Kit, AngioToiuch Hand Controller Kit?

ACIST CVi® Contrast Delivery System (K171646).

Q: Who can help prepare an FDA 510(k) submission like ACIST CVI1 Contrast Delivery System, A1000 Syringe Kit, A1000V Syringe Kit, BT2000 Manifold Kit, BT2000 Manifold Kit, AngioToiuch Hand Controller Kit?

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.

K191060 · Acist Medical Systems, Inc. · DXT · Jul 18, 2019 · Cardiovascular

Device Facts

Record ID	K191060
Device Name	ACIST CVI1 Contrast Delivery System, A1000 Syringe Kit, A1000V Syringe Kit, BT2000 Manifold Kit, BT2000 Manifold Kit, AngioToiuch Hand Controller Kit
Applicant	Acist Medical Systems, Inc.
Product Code	DXT · Cardiovascular
Decision Date	Jul 18, 2019
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 870.1650
Device Class	Class 2
Attributes	Pediatric

Intended 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.

Device Story

ACIST CVi®1 is a motor-driven, software-controlled pump system for controlled infusion of radiopaque contrast media and saline during angiographic procedures. Used in interventional cardiology, radiology, and vascular surgery labs. Operated by trained healthcare professionals. System inputs include user-determined flow rate and volume settings via the AngioTouch® Hand Controller. The pump delivers contrast media through a single-patient-use syringe kit (A1000/A1000V) and manifold. Output is the precise intravascular delivery of contrast agent to the patient. The system aids physicians in visualizing vasculature during procedures. Modifications from the predicate include restricting the system to single-patient use, removing the need for disinfecting caps/slide clamps, and updating software to enforce single-use protocols. Benefits include controlled, consistent contrast delivery and reduced risk of cross-contamination compared to multi-patient systems.

Clinical Evidence

Bench testing only. Evaluations included burst, functional, life, pressure, bond pull, flow, and durability testing. Biocompatibility testing for the A1000V syringe kit included cytotoxicity, sensitization, irritation, acute systemic toxicity, and material-mediated pyrogenicity. Human factors and sterility assessments were performed. Results demonstrated the device met all pre-defined endpoints and performance criteria equivalent to the predicate.

Technological Characteristics

Motor-driven pump; software-controlled flow rate and volume. Consumables: A1000/A1000V Syringe Kits, BT2000 Manifold, AT-P AngioTouch Hand Controller. Materials: Contrast valve check scepter (A1000V) or ball (A1000). Sterilization: Gamma irradiation. Connectivity: Standalone system for use in radiological labs.

Indications for Use

Indicated for controlled administration of radiopaque contrast media and saline to human subjects (adults and pediatrics) undergoing angiographic procedures in licensed healthcare 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 CVi® Contrast Delivery System (K171646)

Related Devices

K203004 — ACIST CVi1 Contrast Delivery System, ACIST CVi Contrast Delivery System · Acist Medical Systems, Inc. · Dec 17, 2020
K171646 — ACISTCVi® Contrast Delivery System · Acist Medical Systems, Inc. · Feb 16, 2018
K963982 — ACIST ANGIOGRAPHIC INJECTOR · Invasatec · Dec 5, 1997
K040298 — ACIST ANTIOGRAPHIC INJECTION SYSTEM CONTRAST MANAGEMENT DISPOSABLE KITS · Acist Medical Systems, Inc. · Mar 15, 2004
K984058 — ACIST INJECTOR SYSTEM, MODEL CL100 H · Acist Medical Systems · Feb 11, 1999

Submission Summary (Full Text)

{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) ### 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}------------------------------------------------ # 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.