The ViperCath XC Peripheral Exchange Catheter is intended to guide and support a guide wire during access of the vasculature, allow for wire exchanges and provide a conduit for the delivery of saline or diagnostic contrast agents.

Device Description

The ViperCath XC Exchange Catheter (ViperCath XC) is intended to be used to facilitate vascular access and guidewire exchanges during peripheral vascular intervention procedures. It is provided in a 200 cm length, to facilitate the radial access approach, with either a straight or angled tip. There are no accessories for this device. The catheter shaft has radiopaque marker bands at distances of 1 cm and 5 cm from the distal tip. Two additional printed markers are located 120 cm and 150 cm from the distal tip and are provided to aid with placement.

AI/ML Overview

The provided document is a 510(k) premarket notification for a medical device called the ViperCath XC Peripheral Exchange Catheter. It outlines the device's intended use, comparison to a predicate device, and the testing performed to demonstrate substantial equivalence.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a quantitative performance metric sense (e.g., sensitivity, specificity, accuracy) because the device being reviewed is a physical medical instrument (catheter), not an AI/software device. Instead, the "acceptance criteria" for this type of device are met through demonstrating functional equivalence and safety to a legally marketed predicate device via a series of performance and safety tests.

The table below summarizes the comparison to the predicate device and the types of testing performed on the ViperCath XC, which effectively serve as the criteria for its acceptance by the FDA for substantial equivalence.

Acceptance Criteria (Implied by Equivalence to Predicate and Performance Testing)	Reported Device Performance / Evidence
Functional and Physical Characteristics:

Effective Length(s): 200 cm compatible with specified use. | 200 cm (Specific to the subject device for radial access).
Recommended Guide Catheter Compatibility: 5 Fr | 5 Fr
Shaft Design: Braid-reinforced for support and pushability. | Braid-reinforced
Tip Shape: Straight, Angled for navigation. | Straight, Angled
Maximum Injection Pressure: Ability to withstand pressure during fluid delivery. | 600 psi
Guidewire Compatibility: 0.035" | 0.035"
Hydrophilic Coating: Presence/absence as per design. | No (Differentiator from predicate, but not identified as a safety/effectiveness concern).
Sterility: Sterilized for single use. | Yes
Single Use: Disposable after one use. | Yes
Biocompatibility (Safety): |
Non-toxic to biological systems. | Passed Cytotoxicity, Sensitization, Irritation/Intracutaneous Reactivity, Acute Systemic Toxicity, Hemocompatibility, Thrombogenicity, Pyrogenicity tests.
Bench Testing (Performance & Safety): |
Dimensional Verification: Conformance to specified dimensions (luer, shaft, tip). | Performed
Bond Strengths: Structural integrity of device components. | Performed
Tracking: Ability to navigate through vasculature. | Performed
Guidewire Exchange: Facilitates smooth guidewire exchange. | Performed
Radiopacity: Visibility under fluoroscopy. | Performed
Wrap/Kink Resistance: Resists kinking or wrapping. | Performed
Torque Transfer: Efficient transfer of torque from hub to tip. | Performed
Torque to Failure: Ability to withstand twisting forces. | Performed
Fluid Flow: Adequate flow rate for injectates. | Performed
Burst Pressure: Withstands internal pressure without rupture. | Performed
Leakage: Prevents leakage of fluids. | Performed
Overall Safety and Effectiveness: |
No new questions of safety or effectiveness identified compared to the predicate device. | Conclusion: "The ViperCath XC Exchange Catheter data supports that no new questions of safety or effectiveness were identified compared to the predicate device."

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify a "sample size" in terms of patients or a test set, as this is a 510(k) submission for a physical medical device based primarily on bench testing and biocompatibility studies, not a clinical study involving a patient test set for performance metrics like sensitivity or specificity.

Test Set: Not applicable in the context of a clinical test set. The "test set" here refers to the actual ViperCath XC devices that underwent the various bench and biocompatibility tests. The exact number of devices tested for each parameter is not provided in this summary.
Data Provenance: The testing was conducted by Cardiovascular Systems, Inc. in accordance with applicable standards and guidance (e.g., FDA Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters (September 2010)). This testing is typically performed in a laboratory setting, not derived from patient data from a specific country or as retrospective/prospective data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Not applicable. For this type of device submission, "ground truth" is established through engineering specifications, material science, and established laboratory testing protocols and standards, rather than expert consensus on diagnostic interpretations. The "experts" involved would be engineers, material scientists, and toxicologists who design and conduct these tests and interpret the results against predefined safety and performance criteria. Their qualifications are inherent in their roles in a medical device company and adherence to regulatory standards.

4. Adjudication Method for the Test Set

Not applicable. As there is no clinical test set requiring expert interpretation, there is no need for an adjudication method like 2+1 or 3+1. Performance is based on direct measurement and observation during physical and chemical testing.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, What was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance?

Not applicable. This device is a physical catheter, not an AI or software device. Therefore, no MRMC study involving human readers or AI assistance was conducted.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This device is a physical catheter, not an algorithm or AI system.

7. The Type of Ground Truth Used

The "ground truth" for the ViperCath XC Peripheral Exchange Catheter is established by:

Engineering Specifications: The design and manufacturing specifications of the device itself (e.g., dimensions, material properties, bond strengths).
Industry Standards and Regulatory Guidance: Adherence to recognized national and international standards for medical devices (e.g., ISO standards for biocompatibility, FDA guidance documents for catheters).
Direct Measurement and Observation: Results from bench tests are directly measured (e.g., burst pressure, fluid flow) or observed to meet established pass/fail criteria (e.g., no leakage, successful guidewire exchange).
Chemical and Biological Analysis: Results from biocompatibility tests are analyzed against established criteria for toxicity, sensitization, etc.

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device, not an AI/machine learning model, so there is no concept of a "training set" in this context. The engineering design and manufacturing processes are refined through iterative development, but this is distinct from training an algorithm.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As there is no training set, this question is not relevant.

Summary

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December 29, 2018

Cardiovascular Systems, Inc. Erika Huffman Regulatory Affairs Manager 1225 Old Highway 8 NW St. Paul, Minnesota 55112

Re: K183000

Trade/Device Name: ViperCath XC Peripheral Exchange Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DOY Dated: October 29, 2018 Received: October 30, 2018

Dear Erika Huffman:

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

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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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

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.

Michael John -S 2018.12.29 19:57:01 -05'00'

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) K183000

Device Name

ViperCath XC Exchange Catheter, 035-XC-200-0; ViperCath XC Exchange Catheter, 035-XC-200-1

Indications for Use (Describe)

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)

Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary / Statement

Submitter:	Cardiovascular Systems, Inc.1225 Old Highway 8 NWSaint Paul, MN 55112
Contact Person:	Erika Huffman, MS, RACRegulatory Affairs ManagerCardiovascular Systems, Inc.1225 Old Highway 8 NWSt. Paul, MN 55112Ph: 651-259-1608ehuffman@csi360.com
Date Prepared:	October 30, 2018
Trade Name:	ViperCath™ XC Peripheral Exchange Catheter
Common Name:	Percutaneous Catheter, 21 CFR 870.1250
Classification:	Class II
Product Code:	DQY
Predicate Device(s):	K110540 - NaviCross™ Support Catheter
Device Description:	The ViperCath XC Exchange Catheter (ViperCath XC) isintended to be used to facilitate vascular access and guidewireexchanges during peripheral vascular intervention procedures. Itis provided in a 200 cm length, to facilitate the radial accessapproach, with either a straight or angled tip. There are noaccessories for this device.The catheter shaft has radiopaque marker bands at distances of 1cm and 5 cm from the distal tip. Two additional printed markersare located 120 cm and 150 cm from the distal tip and areprovided to aid with placement.
Intended Use:	The ViperCath™ XC Peripheral Exchange Catheter is intendedto guide and support a guide wire during access of thevasculature, allow for wire exchanges and provide a conduit forthe delivery of saline or diagnostic contrast agents.

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Comparison toPredicate:		ViperCath™ XCPeripheralExchange Catheter(subject device)	TerumoNaviCross™Support Catheter(predicate device)
	EffectiveLength(s)	200 cm	65, 90, 135, 150 cm
	RecommendedGuide Catheter	5 Fr	4 Fr
	Shaft Design	Braid-reinforced	Braid-reinforced
	Tip Shape	Straight, Angled	Straight, Angled
	MaximumInjection Pressure	600 psi	750 psi
	GuidewireCompatibility	0.035"	0.035"
	HydrophilicCoating	No	Yes
	Sterile	Yes	Yes
	Single Use	Yes	Yes
Functional andSafety Testing:		Testing was performed in accordance with applicable standardsand guidance, including FDA Class II Special ControlsGuidance Document for Certain Percutaneous TransluminalCoronary Angioplasty (PTCA) Catheters (September 2010).
		Biocompatibility Testing:
		● Cytotoxicity
		● Sensitization
		● Irritation/Intracutaneous Reactivity
		● Acute Systemic Toxicity
		● Hemocompatibility
		● Thrombogenicity
		● Pyrogenicity
		Bench Testing
		● Dimensional verification – luer, shaft, tip
		● Bond strengths
		● Tracking
		● Guidewire Exchange
		● Radiopacity
		● Wrap/Kink
		● Torque Transfer
		● Torque to Failure
		● Fluid flow
		● Burst Pressure
		● Leakage

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Conclusion:	The ViperCath XC Exchange Catheter data supports that no new questions of safety or effectiveness were identified compared to the predicate device.
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Regulation Number and Section

§ 870.1250 Percutaneous catheter.

(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).