(256 days)
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.
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.
This document is a 510(k) premarket notification for a medical device, the ACIST|CVi® Contrast Delivery System. It primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices through a comparison of technological characteristics and performance data from bench and biocompatibility testing. The information provided does not detail an AI/ML-based device or a clinical study that would typically establish accuracy metrics like sensitivity, specificity, or AUC based on expert review.
Therefore, many of the requested elements for an AI/ML device's acceptance criteria and study proving its performance (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, ground truth types for AI/ML models) are not applicable or extractable from this document.
However, I can extract the general "acceptance criteria" through the lens of device performance for this type of non-AI device, which is primarily demonstrating fundamental functional safety and equivalence.
Here's a breakdown of what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
For a traditional medical device like this, "acceptance criteria" are defined by meeting specifications for physical performance (e.g., flow rate, pressure, durability) and safety (biocompatibility, microbial ingress, cross-contamination). The qualitative reported performance against these criteria is that the device "meets specification and performs as intended." No specific quantitative performance metrics are provided in the summarized data.
| Acceptance Criteria (Implied by Testing) | Reported Device Performance (Qualitative) |
|---|---|
| Functional performance (flow, pressure, life, burst, bond pull, durability) | "meets specification and performs as intended" |
| Biocompatibility (Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity, Material Mediated Pyrogenicity, Hemolysis) | All tests "completed" and "no new safety or performance issues were raised" |
| Microbial ingress & Cross contamination | "meets specification and performs as intended" for microbial ingress and cross-contamination (implied by "no new safety or performance issues") |
| Software validation | Software validation was performed. |
| System level testing | Performed. |
| Human factors testing | Performed. |
2. Sample sized used for the test set and the data provenance
The document refers to "bench and biocompatibility testing, software validation, system level testing, and human factors testing." It does not specify sample sizes for these tests, nor does it mention country of origin or whether the data was retrospective or prospective, as these are typically not relevant for this type of device's 510(k) submission focused on physical and functional safety.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This device is not an AI/ML device requiring expert ground truth for classification or prediction tasks. The "ground truth" for this device's performance would be established through engineering specifications and standardized test methods.
4. Adjudication method for the test set
Not applicable. No expert adjudication for a test set is relevant for this device.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done
No. This is not an AI/ML diagnostic or assistive device that would undergo an MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a contrast delivery system, not an algorithm.
7. The type of ground truth used
For this device, the "ground truth" for performance is based on engineering specifications, standardized bench testing protocols, and established biocompatibility testing methods. There's no clinical "ground truth" in the sense of pathology, outcomes data, or expert consensus on image interpretation, as it's not a diagnostic AI.
8. The sample size for the training set
Not applicable. As this is not an AI/ML product, there is no "training set."
9. How the ground truth for the training set was established
Not applicable. No training set for an AI/ML model.
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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);
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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
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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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K171646
510(k) Summary [21 CFR 807.92]
| Submitter'sName andAddress | ACIST Medical Systems, Inc.7905 Fuller RoadEden Prairie, MN 55344Phone: 952.995.9300Fax: 952.941.4648 | |
|---|---|---|
| Contact Nameand Information | Melissa SommerfeldPrincipal Regulatory Affairs SpecialistPhone: 952.656.2409Fax: 952.941.4648E-mail: melissa.sommerfeld@acistmedical.com | |
| Date Prepared | 15 February 2018 | |
| ProprietaryName(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 | |
| PrimaryPredicateDevice | K991103 | ACIST Angiographic Contrast Management InjectorSystem, Model CMS2000 |
| SecondaryPredicateDevice | K984231 | ACIST Angiographic Contrast Management System |
| ReferencePredicateDevices | K010390 | ACIST Angiographic Contrast Management InjectorSystem, Model R2000 CMS |
| K040298 | ACIST Angiographic Contrast Management System | |
| K151048 | CT Expres 3D Contrast Media Delivery System, BottleSpike Type B, Day Set III HP, Patient Set | |
| DeviceDescription | The ACIST CVi® Contrast Delivery System is designed to aid thephysician in the controlled infusion of radiopaque contrast media. The CViContrast Delivery System contains a software controlled motor-driven pumpthat delivers contrast media at a user-determined flow rate and volume. TheCVi Contrast Delivery System is used in conjunction with ACIST providedconsumable kits: A2000 Syringe Kit, BT2000 Manifold Kit, and the AT-PAngioTouch Hand Controller Kit, and a hospital provided angiographicpatient catheter. The CVi Contrast Delivery System is used in interventionalcardiology, radiology, and vascular surgical procedures. The operatingenvironments for the CVi Contrast Delivery System are catheterization orradiological laboratories. | |
| Indicationsfor Use | The ACIST CVi® Contrast Delivery System is indicated for controlledadministration of radiopaque contrast media and saline to human subjectswhile undergoing angiographic procedures.The ACIST CVi® Contrast Delivery System is specifically indicated for usein angiographic procedures for the delivery of ISOVUE (Iopamidol Injection)contrast media as supplied in an Imaging Bulk Package (IBP), for amaximum of ten (10) hours. The Syringe Kit must be discarded after six (6)patient procedures. The Manifold Kit and AngioTouch Hand Controller Kitmust be discarded after each patient procedure.The ACIST CVi® Contrast Delivery System is to be used only by and underquasi-continuous supervision of trained health care professionals in anappropriate licensed health care facility, in a room designated forradiological procedures that involve intravascular administration of acontrast agent. | |
| SubstantialEquivalence /Comparison ofTechnologicalCharacteristics | The fundamental technological characteristics and principal of operation ofthe CVi Contrast Delivery System are unchanged from the predicatedevices. The CVi Contrast Delivery System contains enhanced safetyfeatures for administering contrast media to multiple patients from a singlecontainer. The CVi system is substantially equivalent in design,performance, and technological characteristics to the predicate devices forits intended purpose. No new or different questions of safety oreffectiveness were raised with the enhancements. A comparison of thepredicate and subject devices is provided in Table 1 and 2. | |
| Table 1: Injection System Comparison | ||
| Characteristic | Predicate DeviceInjection System CMS2000K991103 | Proposed DeviceInjection System- CVIThis 510(k) |
| Indications forUse | The ACISTTM CMS-2000Angiographic InjectionSystem with ContrastManagement is intended tobe used for the controlledinfusion of radiopaquecontrast media forangiographic procedures. | The ACIST CVi® Contrast Delivery System isindicated for controlled administration of radiopaquecontrast media and saline to human subjects whileundergoing angiographic procedures.The ACIST CVi® Contrast Delivery System isspecifically indicated for use in angiographicprocedures for the delivery of ISOVUE (IopamidolInjection) contrast media as supplied in an ImagingBulk Package (IBP), for a maximum of ten (10)hours. The Syringe Kit must be discarded after six(6) patient procedures. The Manifold Kit andAngioTouch Hand Controller Kit must be discardedafter each patient procedure.The ACIST CVi® Contrast Delivery System is to beused only by and under quasi-continuoussupervision of trained health care professionals inan appropriate licensed health care facility, in aroom designated for radiological procedures thatinvolve intravascular administration of a contrastagent. |
| Primary SystemComponents | •Injector Head•Power Supply•Control Panel | •Injector Head•Power Supply•Control Panel |
| ContrastInjectionParameters | •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 |
| CompatibleConsumableKits | •Syringe Kit•Manifold Kit•Hand Controller Kit | •Syringe Kit•Manifold Kit•Hand Controller Kit |
| Saline Flush | Yes | Yes |
| SoftwareControlledRequiredSyringe Change | No | Yes |
| InjectionDelivery | Variable or Fixed Rate | Variable or Fixed Rate |
| Equipped withAir ColumnDetect Sensor | Yes | Yes |
| X-Ray ImagingFunctionality | No | Yes1 |
| Characteristic | Predicate DeviceA2000 SyringeK984231 | Proposed DeviceA2000 SyringeThis 510(k) |
| Indications forUse | The ACIST CMS-2000Angiographic Injection Systemwith Contrast Management isintended to be used for thecontrolled infusion ofradiopaque contrast media forangiographic procedures. | The ACIST CVi® Contrast Delivery Systemis indicated for controlled administration ofradiopaque contrast media and saline tohumansubjectswhileundergoingangiographic procedures.The ACIST CVi® Contrast Delivery Systemspecifically indicated for use inisangiographic procedures for the delivery ofISOVUE (lopamidol Injection) contrastmedia as supplied in an Imaging BulkPackage (IBP), for a maximum of ten (10)hours. The Syringe Kit must be discardedafter six (6) patient procedures. TheManifold Kitand AngioTouch HandController Kit must be discarded after eachpatient procedure.The ACIST CVi® Contrast Delivery Systemis to be used only by and under quasi-continuous supervision of trained healthcare professionals in an appropriatelicensed health care facility, in a roomdesignated for radiological procedures thatinvolve intravascular administration of acontrast agent. |
| Usability | Up to 5 patient cases | Up to 6 patient cases |
| Syringe KitComponents | WiperWiper SupportRotatorContrast TubingContrast O-RingContrast Valve Check Ball | WiperWiper SupportRotatorContrast TubingContrast O-RingContrast Valve Check Ball |
| Disinfecting Cap | No | Yes |
| SterilizationMethod | Gamma Irradiation | Gamma Irradiation |
| Characteristic | Predicate DeviceBT2000 ManifoldK984231 | Proposed DeviceBT2000 ManifoldThis 510(k) |
| Indications for Use | The ACIST CMS-2000Angiographic Injection Systemwith Contrast Management isintended to be used for thecontrolled infusion ofradiopaque contrast media forangiographic procedures. | The ACIST CVi® Contrast Delivery System isindicated for controlled administrationofradiopaque contrast media and salinetohuman subjects while undergoing angiographicprocedures. |
| The ACIST CVi® Contrast Delivery System isspecifically indicated for use in angiographicproceduresfor the delivery of ISOVUE(lopamidol Injection) contrast media assupplied in an Imaging Bulk Package (IBP), fora maximum of ten (10) hours. The Syringe Kitmust be discarded after six (6) patientprocedures. The Manifold Kit and AngioTouchHand Controller Kit must be discarded aftereach patient procedure. | ||
| The ACIST CVi® Contrast Delivery System isto be used only by and under quasi-continuoussupervision of trained health care professionalsin an appropriate licensed health care facility,in a room designated for radiologicalprocedures that involve intravascularadministration of a contrast agent. | ||
| Usability | Single Use | Single Use |
| Syringe KitComponents | Manifold ShaftManifold CapSpringSealing O-ringPressure TransducerValve Trigger | Manifold ShaftManifold CapSpringSealing O-ringPressure TransducerValve Trigger |
| SterilizationMethod | Gamma Irradiation | Gamma Irradiation |
| Characteristic | Predicate DeviceAT-P Hand ControllerK040298 | Proposed DeviceAT-P Hand ControllerThis 510(k) |
| Indications for Use | The ACIST CMS-2000 AngiographicInjection System with ContrastManagement is intended to be usedfor the controlled infusion ofradiopaque contrast media forangiographic procedures. | The ACIST CVi® Contrast Delivery System isindicated for controlled administration ofradiopaque contrast media and saline tohuman subjects while undergoingangiographic procedures.The ACIST CVi® Contrast Delivery System isspecifically indicated for use in angiographicprocedures for the delivery of ISOVUE(lopamidol Injection) contrast media assupplied in an Imaging Bulk Package (IBP), fora maximum of ten (10) hours. The Syringe Kitmust be discarded after six (6) patientprocedures. The Manifold Kit and AngioTouchHand Controller Kit must be discarded aftereach patient procedure.The ACIST CVi® Contrast Delivery System isto be used only by and under quasi-continuoussupervision of trained health careprofessionals in an appropriate licensed healthcare facility, in a room designated forradiological procedures that involveintravascular administration of a contrastagent. |
| Usability | Single Use | Single Use |
| AT-P HandController KitComponents | Housings (2)Bladders (2)Twin TubingHigh Pressure Tubing | Housings (2)Bladders (2)Twin TubingHigh Pressure Tubing |
| High PressureTubing Length | 54 inches65 inches | 54 inches65 inches |
| Sterilization Method | Ethylene Oxide | Ethylene Oxide |
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.
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Table 2: Consumable Kit Comparion- A2000 Syringe
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Consumable Kit Comparion- BT2000 Manifold
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Consumable Kit Comparion- AT-P Hand Controller
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| PerformanceData | 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:CytotoxicitySensitizationIrritationAcute Systemic ToxicityMaterial Mediated PyrogenicityHemolysis | |
| 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
§ 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.