The ViperCross™ Support Catheter is intended to be used in conjunction with steerable guidewires to access discrete regions of the peripheral and/or coronary vasculature. It may be used to facilitate placement and exchange of guidewires and other interventional devices and to sub-selectively infuse/deliver diagnostic and therapeutic agents.

0.018" & 0.035"

The ViperCross™ Support Catheter is intended to be used in conjunction with steerable guidewires to access discrete regions of the peripheral vasculature. It may be used to facilitate placement and exchange of guidewires and other interventional devices and to sub-selectively infuse / deliver diagnostic and therapeutic agents.

Device Description

014: The ViperCross™ Support Catheter is a single lumen catheter designed for use in the peripheral and/or coronary vasculature. The ViperCross™ Support Catheter provides guidewire support during interventional procedures and allows for the exchange of one distally located guidewire for another while maintaining access to distal vasculature. The ViperCross™ Support Catheters have a hydrophilic coating on the distal 90cm or 70cm dependent on model length to enhance deliverability to the target vasculature.

The ViperCross™ Support Catheters have a single radiopaque marker band located 0.040" / 1.02mm from the distal tip. The catheters have white positioning marks located at 100cm and 110cm from the distal tip. The proximal end of the catheter incorporates a strain relief and a luer-lock adapter for flushing.

018/035: The ViperCross™ Support Catheter is a single lumen catheter designed for use in the peripheral vasculature. The ViperCross™ Support Catheter provides guidewire support during interventional procedures and allows for the exchange of one distally located guidewire for another while maintaining access to distal vasculature. The ViperCross™ Support Catheters have a hydrophilic coating on the distal 90cm, 70cm, or 40cm dependent on model length to enhance deliverability to the target vasculature.

The ViperCross™ Support Catheters have a single radiopaque marker band located 0.040" / 1.02mm from the distal tip. The 135cm catheters have white positioning marks located at 100cm and 110cm from the distal tip. The proximal end of the catheter incorporates a strain relief and a luer-lock adapter for flushing.

The ViperCross™ Support Catheters have been sterilized with ethylene oxide.

AI/ML Overview

The acceptance criteria and study proving the device meets them are:

1. Table of Acceptance Criteria and Reported Device Performance:

The document primarily states that "All testing met the requirements and passed." Specific quantitative acceptance criteria or numerical performance results are not detailed in the provided text. The performance testing categories are listed below:

Acceptance Criteria Category	Reported Device Performance
Working length	Met requirements and passed
Overall length	Met requirements and passed
Distal shaft outer diameter	Met requirements and passed
Proximal shaft outer diameter	Met requirements and passed
Inner diameter	Met requirements and passed
Radiopacity of tip	Met requirements and passed
Contrast injection	Met requirements and passed
Leak test air aspiration	Met requirements and passed
Liquid leak resistance	Met requirements and passed
High pressure leak test	Met requirements and passed
Surface finish	Met requirements and passed
Particulate	Met requirements and passed
Corrosion resistance	Met requirements and passed
Trackability / simulated use	Met requirements and passed
Torque transmission	Met requirements and passed
Kink resistance	Met requirements and passed
Tip flexibility	Met requirements and passed
Tensile strength	Met requirements and passed
Luer hub fitting	Met requirements and passed
035 only Tip Angle	Met requirements and passed
Biocompatibility (ISO 10993-1)	Met requirements and passed (specific tests listed below)
- ASTM Hemolysis assay	Met requirements and passed
- Heparinized blood platelet and leukocyte count assay	Met requirements and passed
- Partial thromboplastin Time (PTT) assay	Met requirements and passed
- Complement activation assay	Met requirements and passed
- MEM Elution cytotoxicity assay	Met requirements and passed
- Material mediated pyrogenicity test	Met requirements and passed
- Acute systemic toxicity test	Met requirements and passed
- Intracutaneous reactivity test	Met requirements and passed
- Guinea pig maximization test	Met requirements and passed
- In-vitro blood loop assay with comparison article	Met requirements and passed

2. Sample size used for the test set and the data provenance:

The document does not specify the sample size for individual tests. It also does not explicitly state the provenance of the test data (e.g., country of origin, retrospective or prospective). The testing appears to be primarily bench testing and materials characterization rather than clinical studies with patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not applicable and not provided in the document as the testing described is not clinical and does not involve establishing ground truth from expert interpretations.

4. Adjudication method for the test set:

This information is not applicable and not provided in the document, as no human adjudication is mentioned for the described performance testing.

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:

This information is not applicable and not provided in the document. The device is a physical medical device (ViperCross Support Catheters), not an AI-powered diagnostic tool, and therefore MRMC studies are not relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

This information is not applicable and not provided in the document, as the device is not an algorithm or AI system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

For the performance testing mentioned, the "ground truth" would be established by engineering specifications, recognized industry standards (e.g., ISO 10993-1 for biocompatibility), and established test methodologies designed to assess the physical and mechanical properties of the device.

8. The sample size for the training set:

This information is not applicable and not provided in the document, as this is a physical medical device and does not involve a "training set" in the context of machine learning or AI.

9. How the ground truth for the training set was established:

This information is not applicable and not provided in the document, as this is a physical medical device and does not involve a "training set" in the context of machine learning or AI.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters.

August 26, 2021

Cardiovascular Systems, Inc. Jonathan Holmes Regulatory Affairs Manager 6030 W. Harold Gatty Dr. Salt Lake City, Utah 84116

Re: K211240

Trade/Device Name: ViperCross Support Catheters Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: July 28, 2021 Received: July 29, 2021

Dear Jonathan Holmes:

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/cdrl-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.

for Lydia Glaw Assistant Director DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular 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) K211240

Device Name ViperCross™ Support Catheters

Indications for Use (Describe)

0.014"

0.018" & 0.035"

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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Image /page/3/Picture/0 description: The image shows the logo for Cardiovascular Systems, Inc. The logo consists of the letters "CSI" in a stylized font, with a green arc underneath. The address "1225 Old Highway 8 NW, Saint Paul, MN 55112" is printed below the logo.

------------------------------------------------------------------------------------------------------------------------------------------------------------------------------510(k) K211240

Submitter:

Cardiovascular Systems, Inc. 1225 Old Highway 8 NW Saint Paul, MN 55112

Correspondent:

Jonathan Holmes 6030 W Harold Gatty Dr. Salt Lake City, UT 84116 Phone: (801) 503-9065 Email: jholmes(@biomerics.com

Manufacturer:

Cardiovascular Systems, Inc. 1225 Old Highway 8 NW Saint Paul, MN 55112

DATE PREPARED: 22 April 2021

NAME OF MEDICAL DEVICE:

ViperCross™ Support Catheters Proprietary Name: Common/Usual Name: Percutaneous Catheter Classification Name: Catheter, Percutaneous

DEVICE CLASSIFICATION:

Classification Panel:	Cardiovascular
Regulatory Class:	2
Product Code:	DQY
Regulation Number:	21 CFR 870.1250

PREDICATE DEVICE 1 (014):

Proprietary Name:	SuperCross Microcatheter
Common/Usual Name:	Percutaneous Catheter
Classification Name:	Catheter, Percutaneous
510(k) Number:	K101659

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Image /page/4/Picture/0 description: The image shows the logo for Cardiovascular Systems, Inc. The logo consists of the letters "CSI" in a stylized, sans-serif font, with a green arc underneath. To the right of the letters is a vertical line, followed by the words "CARDIOVASCULAR SYSTEMS, INC." in a smaller, sans-serif font. The overall design is clean and modern.

PREDICATE DEVICE 2 (018 & 035):

Proprietary Name:	Quick-Cross Extreme & Quick-Cross Select
Common/Usual Name:	Percutaneous Catheter
Classification Name:	Catheter, Percutaneous
510(k) Number:	K082561

DEVICE DESCRIPTION:

The ViperCross™ Support Catheters have been sterilized with ethylene oxide.

INTENDED USE/INDICATION FOR USE:

Intended Use: The ViperCross™ Support Catheters may be used to facilitate placement and exchange of guidewires and other interventional devices and to selectively infuse/deliver diagnostic and therapeutic agents.

014 Indications for Use: The ViperCross™ Support Catheter is intended to be used in conjunction with steerable guidewires to access discrete regions of the peripheral and/or coronary vasculature. It may be used to facilitate placement and exchange of guidewires and other interventional devices and to sub-selectively infuse/deliver diagnostic and therapeutic agents.

018/035 Indications for Use: The ViperCross™ Support Catheter is intended to be used in conjunction with steerable guidewires to access discrete regions of the peripheral vasculature. It may be used to facilitate placement and exchange of guidewires and other

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Image /page/5/Picture/0 description: The image shows the logo for Cardiovascular Systems, Inc. The logo consists of the letters "CSI" in a gray, rounded font, with a green arc underneath. To the right of the letters is a vertical line, followed by the words "CARDIOVASCULAR SYSTEMS, INC." in a smaller, gray font.

interventional devices and to sub-selectively infuse/deliver diagnostic and therapeutic agents.

TECNOLOGICAL COMPARISION TO PREDICATE DEVICE:

Technologically the ViperCross™ Support Catheter is substantially equivalent to the SuperCross Microcatheter, (K101659) and Quick-Cross Extreme & Quick-Cross Select, (K082561) in terms of design, materials, technology and performance.

The ViperCross™ Support Catheter uses the same technology and has a similar intended use, fundamental technology and performance as the predicate device.

Characteristic	ViperCross™Support Catheters(Subject Device)	SuperCross™Microcatheter(Predicate for 014Straight Model)	Quick-CrossExtreme & Quick-Cross Select(Predicate for 018Straight & 035Straight/AngledModels)
Intended Use	The ViperCross™Support Catheter maybe used to facilitateplacement and exchangeof guidewires and otherinterventional devicesand to selectivelyinfuse/deliver diagnosticand therapeutic agents.	The SuperCrossMicrocatheter isintended to be used inconjunction withsteerable guidewires toaccess discrete regionsof the coronary and/orperipheral vasculature.It may be used tofacilitate placement andexchange of guidewiresand other interventionaldevices and tosubselectivelyinfuse/deliver diagnosticand therapeutic agents.	Quick-Cross Extremeand Quick-Cross Selectsupport catheters areintended to guide andsupport a guidewireduring access of thecoronary or peripheralvasculature, allow forwire exchanges andprovide a conduit forthe delivery of salinesolutions or diagnosticcontrast agents.
Indications foruse	014The ViperCross™Support Catheter isintended to be used inconjunction withsteerable guidewires toaccess discrete regionsof the peripheral and/orcoronary vasculature. Itmay be used to facilitateplacement and exchangeof guidewires and other	The SuperCrossMicrocatheter isintended to be used inconjunction withsteerable guidewires toaccess discrete regionsof the coronary and/orperipheral vasculature.It may be used tofacilitate placement andexchange of guidewiresand other interventional	Quick-Cross Extremeand Quick-Cross Selectsupport catheters areintended to guide andsupport a guidewireduring access of thecoronary or peripheralvasculature, allow forwire exchanges andprovide a conduit forthe delivery of saline
Characteristic	ViperCross™™Support Catheters(Subject Device)	SuperCross™Microcatheter(Predicate for 014Straight Model)	Quick-CrossExtreme & Quick-Cross Select(Predicate for 018Straight & 035Straight/AngledModels)
	interventional devicesand to sub-selectivelyinfuse/deliver diagnosticand therapeutic agents.	devices and tosubselectivelyinfuse/deliver diagnosticand therapeutic agents.	solutions or diagnosticcontrast agents.
	018/035The ViperCross™™Support Catheter isintended to be used inconjunction withsteerable guidewires toaccess discrete regionsof the peripheralvasculature. It may beused to facilitateplacement and exchangeof guidewires and otherinterventional devicesand to sub-selectivelyinfuse/deliver diagnosticand therapeutic agents.
Technology
	Max. GuidewireDiameter:	Max. GuidewireDiameter:	Max. GuidewireDiameter:
Dimensions	014: 0.014" / 0.36mm	0.014" / 0.36mm	Extreme 018: 0.018" /0.46mm
	018: 0.018" / 0.46mm	Working Length:130cm & 150cm	Extreme 035 Straight:0.035" / 0.89mm
	035 Straight & Angled:0.035" / 0.89mm	Distal Tip OD:0.024" / 0.61mm	Select 035 Angled:0.035" / 0.89mm
	Working Length:014: 135cm & 150cm	Proximal Shaft OD:0.033" / 0.84mm	Working Length:
	018: 135cm	Min. Guide CatheterID:0.042" / 1.07mm	Extreme 018: 135cm
	035 Straight & Angled:90cm & 135cm		Extreme 035 Straight:90cm & 135cm
Characteristic	ViperCross™™Support Catheters(Subject Device)	SuperCross™Microcatheter(Predicate for 014Straight Model)	Quick-CrossExtreme & Quick-Cross Select(Predicate for 018Straight & 035Straight/AngledModels)
	Distal Tip OD:		Select 035 Angled:90cm & 135cm
	014: 0.021" / 0.53mm		Distal Tip OD:
	018: 0.025" / 0.63mm		Extreme 018: 0.038"
	035 Straight & Angled:0.45" / 1.14mm		Extreme 035 Straight:0.052"
	Proximal Shaft OD:		Select 035 Angled:0.052"
	014: 0.375" / 0.95mm		Proximal Shaft OD:
	018: 0.0375" / 0.95mm		Extreme 018: 0.044"
	035 Straight & Angled:0.056" / 1.42mm		Extreme 035 Straight:0.059"
	Min Guide CatheterID:		Select 035 Angled:0.059"
	014: 0.042" / 1.07mm		Min. Guide CatheterID:
	018: 0.042" / 1.07mm		Extreme 018: 0.049" /1.24mm
	035 Straight & Angled:0.061" / 1.55mm		Extreme 035 Straight:0.064" / 1.63mm
			Select 035 Angled:0.064" / 1.63mm
Distal TipAngulation	014: N/A	N/A	Extreme 018: N/A
	018: N/A		Extreme 035 Straight:N/A
	035 Straight: N/A		Select 035 Angled: 45°
	035 Angled: 30°
Angled TipLength	014: N/A	N/A	Extreme 018: N/A
	018: N/A		Extreme 035 Straight:N/A
	035 Straight: N/A
Characteristic	ViperCross™Support Catheters(Subject Device)	SuperCross™Microcatheter(Predicate for 014Straight Model)	Quick-CrossExtreme & Quick-Cross Select(Predicate for 018Straight & 035Straight/AngledModels)
	035 Angled: 1.2cm		Select 035 Angled:7mm
ShaftConstruction	Coiled	Coiled	Coiled
Packaging	Mylar / Tyvek Pouch	Tyvek Pouch	Tyvek Pouch
Sterilization	Ethylene Oxide	Ethylene Oxide	Ethylene Oxide

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Image /page/6/Picture/0 description: The image shows the logo for CSI, which is a company that provides software and technology solutions for the financial industry. The logo consists of the letters "CSI" in a stylized font, with a green arc underneath. The letters are gray, and the arc is green. The logo is simple and modern, and it conveys a sense of innovation and technology.

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Image /page/7/Picture/0 description: The image shows the logo for CSI. The logo consists of the letters "CSI" in a sans-serif font, with the letters in gray. Underneath the letters is a green curved line. To the right of the letter "I" is a registered trademark symbol.

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Image /page/8/Picture/0 description: The image shows the logo for Cardiovascular Systems, Inc. The logo consists of the letters "CSI" in a gray sans-serif font, with a green arc underneath. To the right of the letters is a vertical line, followed by the words "CARDIOVASCULAR SYSTEMS, INC." in a smaller, gray sans-serif font. The logo is simple and modern, and the use of green suggests a connection to health and wellness.

The ViperCross™ Support Catheter is substantially equivalent to the predicate device, SuperCross Microcatheter, (K101659) and Quick-Cross Extreme Support Catheter, (K082561). The ViperCross™ Support Catheter, SuperCross Microcatheter, and the Quick-Cross Extreme Support Catheter provide in conjunction with a steerable guidewire, provide access to discrete regions of the coronary and/or peripheral vasculature.

PERFORMANCE TESTING

The ViperCross™ Support Catheter was thoroughly tested and verifies that it performs as designed and is suitable for it intended use.

Performance Testing included the following:

· Working length
· Overall length
Distal shaft outer diameter
Proximal shaft outer diameter
Inner diameter
Radiopacity of tip
· Contrast injection
Leak test air aspiration
· Liquid leak resistance
· High pressure leak test
· Surface finish
· Particulate
· Corrosion resistance
Trackability / simulated use
· Torque transmission
Kink resistance
· Tip flexibility

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Image /page/9/Picture/0 description: The image shows the logo for Cardiovascular Systems, Inc. The logo consists of the letters "CSI" in a gray, sans-serif font, with a green arc underneath. To the right of the letters, separated by a vertical line, is the text "CARDIOVASCULAR SYSTEMS, INC." also in gray.

· Tensile strength
Luer hub fitting
035 only Tip Angle

Biocompatibility per ISO 10993-1 for an external communicating device, limited (<24 hour) blood contacting device.

· ASTM Hemolysis assay
· Heparinized blood platelet and leukocyte count assay
· Partial thromboplastin Time (PTT) assay
· Complement activation assay
· MEM Elution cytotoxicity assay
· Material meditated pyrogenicity test
· Acute systemic toxicity test
· Intracutaneous reactivity test
· Guinea pig maximization test
· In-vitro blood loop assay with comparison article

All testing met the requirements and passed. There are no new questions raised regarding safety or efficacy of the ViperCross™ Support Catheter.

CONCLUSION:

The ViperCross™ Support Catheter is substantially equivalent in design, materials, sterilization, principles of operation, performance and indications for use to the cited predicate.

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).