ACIST CVi1 Contrast Delivery System, ACIST CVi Contrast Delivery System

K203004 · Acist Medical Systems, Inc. · DXT · Dec 17, 2020 · Cardiovascular

Device Facts

• Record ID: K203004
• Device Name: ACIST CVi1 Contrast Delivery System, ACIST CVi Contrast Delivery System
• Applicant: Acist Medical Systems, Inc.
• Product Code: DXT · Cardiovascular
• Decision Date: Dec 17, 2020
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1650
• Device Class: Class 2

Intended 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.

Device Story

The ACIST CVi/CVi1 Contrast Delivery System is a software-controlled, motor-driven pump used in interventional cardiology, radiology, and vascular surgery. It delivers radiopaque contrast media and saline at user-determined flow rates and volumes to patients via hospital-provided catheters and ACIST-supplied consumable kits (including the AngioTouch Hand Controller). The system synchronizes with X-ray imaging equipment to assist physicians in producing angiograms. The device is operated by trained healthcare professionals in catheterization and radiological laboratories. The current modification involves the AngioTouch Hand Controller, specifically replacing braided polyurethane high-pressure tubing with coextruded polyamide/polyurethane tubing and adding rotating luers. The system provides a hemodynamic pathway from the patient to the hospital's monitoring system. The device benefits patients by enabling precise, controlled contrast delivery during diagnostic and interventional procedures.

Clinical Evidence

Bench testing only. Testing included burst, functional, life, pressure, bond pull, flow, and durability. Biocompatibility testing included cytotoxicity, sensitization, irritation, acute systemic toxicity, and material-mediated pyrogenicity. Results demonstrate the modified device meets specifications and performs as intended.

Technological Characteristics

Motor-driven pump system; software-controlled. AngioTouch Hand Controller components: housings, bladders, twin tubing, and high-pressure tubing (coextruded polyamide/polyurethane). Connectivity: synchronizes with X-ray imaging systems. Sterilization: Ethylene Oxide. Single-use consumables.

Indications for Use

Indicated for controlled administration of radiopaque contrast media and saline to human subjects undergoing angiographic procedures. Used by trained healthcare professionals in licensed facilities for radiological procedures involving intravascular contrast administration.

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®/CVi®1 Contrast Delivery System (K191060)

Submission Summary (Full Text)

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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

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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 ([e-mail]) or phone [phone] 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

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# 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<br>Name and<br>Address | ACIST Medical Systems, Inc.<br>7905 Fuller Road<br>Eden Prairie, MN 55344<br>Phone: [phone]<br>Fax: [phone] |
|------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Name<br>and Information | Jeffrey L. Koll<br>Sr. Principal Regulatory Affairs Specialist<br>Phone: [phone]<br>Fax: [phone]<br>E-mail: [e-mail] |
| Date Prepared | 29 September 2020 |
| Proprietary<br>Name(s) | ACIST CVi®1 Contrast Delivery System<br>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<br>Description | The CVi/CVi1 System is designed to aid the physician in the controlled<br>infusion of radiopaque contrast media. Radiographic imaging devices are<br>used in conjunction with the delivery of contrast media to produce<br>angiograms. Operating environments for the CVi/CVi1 System are<br>catheterization and radiological laboratories. The CVi/CVi1 System<br>contains a software-controlled motor-driven pump that delivers contrast<br>media at a user-determined flow rate and volume via the ACIST provided<br>consumable kits and a hospital provided angiographic patient catheter. The<br>CVi/CVi1 System is also equipped to synchronize with commercially<br>available X-ray imaging systems. The CVi/CVi1 System is used in<br>interventional cardiology, radiology, and vascular surgical procedures. The<br>CVi/CVi1 System device modification that is the subject of this 510k<br>premarket notification is a material component change to the AngioTouch |

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| Indications<br>for Use | ACIST CVi®1 Contrast Delivery System<br>The ACIST CVi®1 Contrast Delivery System is indicated for controlled<br>administration of radiopaque contrast media and saline to human subjects<br>while undergoing angiographic procedures.<br>The CVi1 Syringe Kits, Manifold Kit and AngioTouch® Hand Controller<br>Kit must be discarded after each patient procedure. The CVi1 Syringe Kits<br>are also indicated for single patient use with ACIST CVi® Contrast<br>Delivery Systems.<br>The ACIST CVi®1 Contrast Delivery System is to be used only by and<br>under quasi-continuous supervision of trained health care professionals in<br>an appropriate licensed health care facility, in a room designated for<br>radiological procedures that involve intravascular administration of a<br>contrast agent |
|-----------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | ACIST CVi® Contrast Delivery System<br>The ACIST CVi® Contrast Delivery System is indicated for controlled<br>administration of radiopaque contrast media and saline to human<br>subjects while undergoing angiographic procedures.<br>The ACIST CVi® Contrast Delivery System is specifically indicated<br>for use in angiographic procedures for the delivery of ISOVUE<br>(Iopamidol Injection) contrast media as supplied in an Imaging Bulk<br>Package (IBP), for a maximum of ten (10) hours. The Syringe Kit must<br>be discarded after six (6) patient procedures. The Manifold Kit and<br>AngioTouch Hand Controller Kit must be discarded after each patient<br>procedure.<br>The ACIST CVi® Contrast Delivery System is to be used only by and<br>under quasi-continuous supervision of trained health care professionals in<br>an appropriate licensed health care facility, in a room designated for<br>radiological procedures that involve intravascular administration of a<br>contrast agent. |
| Substantial<br>Equivalence /<br>Comparison of<br>Technological<br>Characteristics | The proposed AngioTouch Hand Controller modifications to the CVi/CVi1<br>system includes:<br>Replacing current braided polyurethane high-pressure tubing with<br>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<br>the safety or effectiveness of the device. The fundamental technological<br>characteristics and principle of operation of the modified device are<br>unchanged from the predicate device. The CVi/CVi1 system with modified<br>AngioTouch Hand Controller is substantially equivalent to the predicate<br>device in intended use, design, performance, and technological<br>characteristics. |

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| Characteristic | Predicate Device<br>AngioTouch Hand Controller<br>K191060 | Proposed Device<br>AngioTouch Hand Controller (modified)<br>This 510(k) |
|-------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------|
| Intended Use | For controlled administration of<br>radiopaque contrast media and saline to<br>human subjects while undergoing<br>angiographic procedures. | Same |
| Usability | Single Use | Same |
| AngioTouch<br>Hand Controller<br>Kit Components | Housings (2)<br>Bladders (2)<br>Twin Tubing<br>High Pressure Tubing | Same |
| High Pressure<br>Tubing Length | 54 inches<br>65 inches | 65 inches |
| High Pressure<br>Tubing Function | Deliver contrast to patient<br>Deliver saline to patient<br>Provides a hemodynamic pathway from<br>the patient to the hospital's hemodynamic<br>monitoring system | Same |
| High Pressure<br>Tubing Material | Polyurethane | Polyurethane/Polyamide |
| Sterilization<br>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.