(87 days)
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 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.
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.
The provided text does not contain information about acceptance criteria or a study proving that the device meets those criteria, as typically found in submissions for AI/ML devices. The document is a 510(k) premarket notification for a medical device (ACIST | CVi®1 Contrast Delivery System) which is an angiographic injector and syringe. This type of device does not involve AI or algorithms in the way that would necessitate the kind of performance study you're asking about (e.g., diagnostic accuracy studies, reader studies).
The content describes:
- Device Name: ACIST | CVi®1 Contrast Delivery System
- Intended Use: Controlled administration of radiopaque contrast media and saline to human subjects during angiographic procedures.
- Key Change: The new device (CVi1) is a modification of a predicate device (K171646 ACIST CVi® Contrast Delivery System). The primary change is the removal of functionality that allowed the administration of contrast media from the same syringe to multiple patients. The CVi1 system is designed for single-patient use for the syringe and contrast media.
- Substantial Equivalence: The submission argues for substantial equivalence to the predicate device because the fundamental technological characteristics and principle of operation are unchanged, and the modifications do not introduce different questions of safety or effectiveness.
Regarding performance data, the document states:
"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."
And for the new component:
"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."
Given this information, it's not possible to populate the requested table or answer most of the questions about AI/ML device study parameters, as they are not relevant to this type of device submission.
Here’s what can be extracted based on the document:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (General) | Reported Device Performance |
|---|---|
| Safety | No new safety issues raised during testing. |
| Effectiveness | No new effectiveness issues raised during testing. |
| Bench Performance (Burst, Functional, Life, Pressure, Bond Pull, Flow, Durability) | "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." |
| Biocompatibility (for new component) | "Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity, Material Mediated Pyrogenicity" were conducted and presumably met acceptance criteria as the conclusion states substantial equivalence. |
| Software Verification | Conducted. |
| System Level Testing | Conducted. |
| Human Factors | No new critical tasks identified with the proposed CVi1 when compared with the CVi, thus no additional human factors validation testing is necessary. |
| Sterility | Assessed. |
Regarding the other questions:
- 2. Sample size used for the test set and the data provenance: Not applicable in the context of an AI/ML diagnostic or prognostic device. This refers to bench testing of mechanical properties and biocompatibility, not patient data sets. The document doesn't specify test sample sizes for these bench tests.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as understood for AI/ML performance is not relevant here.
- 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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 device is not an AI-assisted diagnostic tool.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. The "ground truth" for this device relates to engineering specifications and biological material compatibility, not clinical diagnostic accuracy.
- 8. The sample size for the training set: Not applicable. This is not an AI/ML algorithm.
- 9. How the ground truth for the training set was established: Not applicable.
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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
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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
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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)
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K191060
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 | Matthew D. StepanekManager, Global Regulatory AffairsPhone: 952-253-4519Fax: 952-941-4648E-mail: matt.stepanek@acistmedical.com |
| Date Prepared | 19 April 2019 |
| ProprietaryName(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 |
| DeviceDescription | The ACIST CVi1 Contrast Delivery System is designed to aid the physicianin the controlled infusion of radiopaque contrast media. The CVi1® ContrastDelivery System contains a software controlled motor-driven pump thatdelivers contrast media at a user-determined flow rate and volume. The CVi1Contrast Delivery System is used in conjunction with ACIST providedconsumable kits: A1000/A1000V Syringe Kit, BT2000 Manifold Kit, and theAT-P AngioTouch Hand Controller Kit. The current submission introduces theA1000/A1000V Syringe Kit provided in the consumable kits. Changes arealso introduced into software and labeling to address single patient use forthe consumable kit. The CVi1 Contrast Delivery System is used ininterventional cardiology, radiology, and vascular surgical procedures. Theoperating environments for the CVi1 Contrast Delivery System arecatheterization or radiological laboratories. The CVi1 system is used ininterventional cardiology, radiology, and vascular surgical procedures. Likethe predicate CVi system, the CVi1 system is used in adults and pediatricspatient populations. |
| Indications forUse | The 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 Controller Kitmust be discarded after each patient procedure. The CVi1 Syringe Kits arealso indicated for single patient use with ACIST CVI® Contrast DeliverySystems.The ACIST CVi®1 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 for radiologicalprocedures that involve intravascular administration of a contrast agent |
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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.
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| Characteristic | Predicate DeviceA2000 SyringeK171646 | Proposed DeviceA1000 and A1000V SyringeThis 510(k) | Comparison Analysis |
|---|---|---|---|
| Indicationsfor Use | The ACIST CVi® ContrastDelivery System is indicated forcontrolled administration ofradiopaque contrast media andsaline to human subjects whileundergoing angiographicprocedures.The ACIST CVi® ContrastDelivery System is specificallyindicated for use in angiographicprocedures for the delivery ofISOVUE (Iopamidol Injection)contrast media as supplied in anImaging Bulk Package (IBP), fora maximum of ten (10) hours.The Syringe Kit must bediscarded after five (5) patientprocedures. The Manifold Kit andAngioTouch Hand Controller Kitmust be discarded after eachpatient procedure.The ACIST CVi® ContrastDelivery System is to be usedonly by and under quasi-continuous supervision of trainedhealth care professionals in anappropriate licensed health carefacility, in a room designated forradiological procedures thatinvolve intravascularadministration of a contrastagent. | The ACIST CVi®1 ContrastDelivery System is indicated forcontrolled administration ofradiopaque contrast media andsaline to human subjects whileundergoing angiographicprocedures.The CVi1 Syringe Kits, ManifoldKit and AngioTouch® HandController Kit must be discardedafter each patient procedure.The CVi1 Syringe Kits are alsoindicated for single patient usewith ACIST CVi® ContrastDelivery Systems.The ACIST CVi®1 ContrastDelivery System is to be usedonly by and under quasi-continuous supervision oftrained health care professionalsin an appropriate licensed healthcare facility, in a roomdesignated for radiologicalprocedures that involveintravascular administration of acontrast agent. | Different |
| Usability | Up to 5 patient cases | Single Patient Use | Different |
| Syringe KitComponentS | WiperWiper SupportRotatorContrast TubingContrast O-RingContrast Valve Check Ball | WiperWiper SupportRotatorContrast TubingContrast O-RingContrast Valve CheckBall(A1000) or Scepter(A1000V) | Different |
| DisinfectingCaps andSlide Clamp | Yes | No | Different |
| SterilizationMethod | Gamma Irradiation | Gamma Irradiation | Same |
Consumable Kit Comparison-Syringe
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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.
§ 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.