(77 days)
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.
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 Hand Controller.
The provided text is a 510(k) summary for the ACIST CVi®1 Contrast Delivery System, focusing on a modification to its AngioTouch Hand Controller. This document primarily addresses the substantial equivalence of the modified device to a predicate device and includes information about the types of testing performed to support this claim, but it does not contain the level of detail typically found in a clinical study report or a publication detailing specific acceptance criteria and detailed performance data for a diagnostic algorithm.
Therefore, many of the requested sections about acceptance criteria, sample sizes, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, and ground truth for training sets cannot be extracted from this document.
However, I can extract the following information:
1. A table of acceptance criteria and the reported device performance:
The document describes "bench testing" and "biocompatibility testing" to demonstrate that the modified device meets specifications and performs as intended. Specific numerical acceptance criteria and precise performance values are not given, but the summary states the device met specifications.
| Test Type | Reported Device Performance |
|---|---|
| Bench Testing (Burst) | Test results demonstrate that the modified device meets specification and performs as intended. |
| Bench Testing (Functional) | Test results demonstrate that the modified device meets specification and performs as intended. |
| Bench Testing (Life) | Test results demonstrate that the modified device meets specification and performs as intended. |
| Bench Testing (Pressure) | Test results demonstrate that the modified device meets specification and performs as intended. |
| Bench Testing (Bond Pull) | Test results demonstrate that the modified device meets specification and performs as intended. |
| Bench Testing (Flow) | Test results demonstrate that the modified device meets specification and performs as intended. |
| Bench Testing (Durability) | Test results demonstrate that the modified device meets specification and performs as intended. |
| Biocompatibility (Cytotoxicity) | Completed (Implies passed relevant criteria) |
| Biocompatibility (Sensitization) | Completed (Implies passed relevant criteria) |
| Biocompatibility (Irritation) | Completed (Implies passed relevant criteria) |
| Biocompatibility (Acute Systemic Toxicity) | Completed (Implies passed relevant criteria) |
| Biocompatibility (Material Mediated Pyrogenicity) | Completed (Implies passed relevant criteria) |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified. The document refers to "bench and biocompatibility testing" without enumerating the number of samples or tests.
- Data Provenance: Not specified. Bench and biocompatibility testing are typically laboratory-based and do not involve patient data provenance in the same way clinical studies do.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. This is a medical device (contrast delivery system) modification, not an AI/diagnostic software. Ground truth in this context refers to engineering specifications and biological safety standards, not expert consensus on medical images.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is a medical device (contrast delivery system) modification.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is a medical device (contrast delivery system) modification, not an AI/diagnostic software.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a medical device (contrast delivery system) modification.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For the bench testing, "ground truth" would be established by engineering specifications and industry standards for device performance (e.g., burst pressure limits, flow rate accuracy). For biocompatibility, "ground truth" is established by recognized standards for biological safety (e.g., ISO 10993 series). The document states the modified device "meets specification and performs as intended," implying conformity to these established engineering and biological safety standards.
8. The sample size for the training set
Not applicable. This is a medical device (contrast delivery system) modification, not an AI/diagnostic software that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This is a medical device (contrast delivery system) modification.
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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 (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
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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'sName andAddress | ACIST Medical Systems, Inc.7905 Fuller RoadEden Prairie, MN 55344Phone: 952.656.2409Fax: 952.941.4648 |
|---|---|
| Contact Nameand Information | Jeffrey L. KollSr. Principal Regulatory Affairs SpecialistPhone: 952.656.2409Fax: 952-941-4648E-mail: jeff.koll@acistmedical.com |
| Date Prepared | 29 September 2020 |
| ProprietaryName(s) | ACIST CVi®1 Contrast Delivery SystemACIST 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) |
| DeviceDescription | The CVi/CVi1 System is designed to aid the physician in the controlledinfusion of radiopaque contrast media. Radiographic imaging devices areused in conjunction with the delivery of contrast media to produceangiograms. Operating environments for the CVi/CVi1 System arecatheterization and radiological laboratories. The CVi/CVi1 Systemcontains a software-controlled motor-driven pump that delivers contrastmedia at a user-determined flow rate and volume via the ACIST providedconsumable kits and a hospital provided angiographic patient catheter. TheCVi/CVi1 System is also equipped to synchronize with commerciallyavailable X-ray imaging systems. The CVi/CVi1 System is used ininterventional cardiology, radiology, and vascular surgical procedures. TheCVi/CVi1 System device modification that is the subject of this 510kpremarket notification is a material component change to the AngioTouch |
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| Indicationsfor Use | ACIST CVi®1 Contrast Delivery SystemThe ACIST CVi®1 Contrast Delivery System is indicated for controlledadministration of radiopaque contrast media and saline to human subjectswhile undergoing angiographic procedures.The CVi1 Syringe Kits, Manifold Kit and AngioTouch® Hand ControllerKit must be discarded after each patient procedure. The CVi1 Syringe Kitsare also indicated for single patient use with ACIST CVi® ContrastDelivery Systems.The ACIST CVi®1 Contrast Delivery System is to be used only by andunder quasi-continuous supervision of trained health care professionals inan appropriate licensed health care facility, in a room designated forradiological procedures that involve intravascular administration of acontrast agent |
|---|---|
| ACIST CVi® Contrast Delivery SystemThe ACIST CVi® Contrast Delivery System is indicated for controlledadministration of radiopaque contrast media and saline to humansubjects while undergoing angiographic procedures.The ACIST CVi® Contrast Delivery System is specifically indicatedfor use in angiographic procedures for the delivery of ISOVUE(Iopamidol Injection) contrast media as supplied in an Imaging BulkPackage (IBP), for a maximum of ten (10) hours. The Syringe Kit mustbe discarded after six (6) patient procedures. The Manifold Kit andAngioTouch Hand Controller Kit must be discarded after each patientprocedure.The ACIST CVi® Contrast Delivery System is to be used only by andunder quasi-continuous supervision of trained health care professionals inan appropriate licensed health care facility, in a room designated forradiological procedures that involve intravascular administration of acontrast agent. | |
| SubstantialEquivalence /Comparison ofTechnologicalCharacteristics | The proposed AngioTouch Hand Controller modifications to the CVi/CVi1system includes:Replacing current braided polyurethane high-pressure tubing withcoextruded 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 regardingthe safety or effectiveness of the device. The fundamental technologicalcharacteristics and principle of operation of the modified device areunchanged from the predicate device. The CVi/CVi1 system with modifiedAngioTouch Hand Controller is substantially equivalent to the predicatedevice in intended use, design, performance, and technologicalcharacteristics. |
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| Characteristic | Predicate DeviceAngioTouch Hand ControllerK191060 | Proposed DeviceAngioTouch Hand Controller (modified)This 510(k) |
|---|---|---|
| Intended Use | For controlled administration ofradiopaque contrast media and saline tohuman subjects while undergoingangiographic procedures. | Same |
| Usability | Single Use | Same |
| AngioTouchHand ControllerKit Components | Housings (2)Bladders (2)Twin TubingHigh Pressure Tubing | Same |
| High PressureTubing Length | 54 inches65 inches | 65 inches |
| High PressureTubing Function | Deliver contrast to patientDeliver saline to patientProvides a hemodynamic pathway fromthe patient to the hospital's hemodynamicmonitoring system | Same |
| High PressureTubing Material | Polyurethane | Polyurethane/Polyamide |
| SterilizationMethod | 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.
§ 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.