(122 days)
Not Found
No
The device description and intended use focus on the mechanical function of a support catheter for guidewire manipulation and delivery of agents, with no mention of AI or ML capabilities.
No
The device is described as facilitating placement and exchange of guidewires and other interventional devices, and enabling sub-selective infusion/delivery of diagnostic and therapeutic agents, but it is not itself a therapeutic device. It is a support catheter.
No
The device is described as a support catheter used to facilitate placement and exchange of guidewires and other interventional devices, and to sub-selectively infuse/deliver diagnostic and therapeutic agents. It does not perform diagnostic functions itself but can deliver diagnostic agents.
No
The device description clearly describes a physical catheter with a lumen, coating, marker band, positioning marks, strain relief, and luer-lock adapter. It also mentions sterilization with ethylene oxide, which is a process applied to physical devices. There is no mention of software as the primary component or function.
Based on the provided text, the ViperCross™ Support Catheter is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The description of the ViperCross™ Support Catheter clearly states its intended use is to be used in conjunction with steerable guidewires to access discrete regions of the peripheral and/or coronary vasculature. This is an in vivo (within the living body) procedure, not an in vitro (in glass/outside the body) diagnostic test.
- The device description focuses on its physical characteristics and function within the body (providing guidewire support, facilitating exchange, infusing/delivering agents). There is no mention of analyzing biological samples.
- The intended use involves direct interaction with the patient's circulatory system, which is characteristic of interventional medical devices, not IVDs.
Therefore, the ViperCross™ Support Catheter is a medical device used for interventional procedures within the body, not an IVD.
N/A
Intended Use / Indications for Use
0.014"
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.
Product codes (comma separated list FDA assigned to the subject device)
DQY
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Peripheral and/or coronary vasculature
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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
- · Tensile strength
- Luer hub fitting
- 035 only Tip Angle
Biocompatibility per ISO 10993-1 for an external communicating device, limited (
§ 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).
0
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
1
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
2
Indications for Use
510(k) Number (if known) K211240
Device Name ViperCross™ Support Catheters
Indications for Use (Describe)
0.014"
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.
| 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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3
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 |
4
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:
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.
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
5
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 014
Straight Model) | Quick-Cross
Extreme & Quick-
Cross Select
(Predicate for 018
Straight & 035
Straight/Angled
Models) |
|--------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The ViperCross™
Support Catheter may
be used to facilitate
placement and exchange
of guidewires and other
interventional devices
and to selectively
infuse/deliver diagnostic
and therapeutic agents. | The SuperCross
Microcatheter is
intended to be used in
conjunction with
steerable guidewires to
access discrete regions
of the coronary and/or
peripheral vasculature.
It may be used to
facilitate placement and
exchange of guidewires
and other interventional
devices and to
subselectively
infuse/deliver diagnostic
and therapeutic agents. | Quick-Cross Extreme
and Quick-Cross Select
support catheters are
intended to guide and
support a guidewire
during access of the
coronary or peripheral
vasculature, allow for
wire exchanges and
provide a conduit for
the delivery of saline
solutions or diagnostic
contrast agents. |
| Indications for
use | 014
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 | The SuperCross
Microcatheter is
intended to be used in
conjunction with
steerable guidewires to
access discrete regions
of the coronary and/or
peripheral vasculature.
It may be used to
facilitate placement and
exchange of guidewires
and other interventional | Quick-Cross Extreme
and Quick-Cross Select
support catheters are
intended to guide and
support a guidewire
during access of the
coronary or peripheral
vasculature, allow for
wire exchanges and
provide a conduit for
the delivery of saline |
| Characteristic | ViperCross™™
Support Catheters
(Subject Device) | SuperCross™
Microcatheter
(Predicate for 014
Straight Model) | Quick-Cross
Extreme & Quick-
Cross Select
(Predicate for 018
Straight & 035
Straight/Angled
Models) |
| | interventional devices
and to sub-selectively
infuse/deliver diagnostic
and therapeutic agents. | devices and to
subselectively
infuse/deliver diagnostic
and therapeutic agents. | solutions or diagnostic
contrast agents. |
| | 018/035
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. | | |
| Technology | | | |
| | Max. Guidewire
Diameter: | Max. Guidewire
Diameter: | Max. Guidewire
Diameter: |
| 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 Catheter
ID:
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 014
Straight Model) | Quick-Cross
Extreme & Quick-
Cross Select
(Predicate for 018
Straight & 035
Straight/Angled
Models) |
| | 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 Catheter
ID: | | Select 035 Angled:
0.059" |
| | 014: 0.042" / 1.07mm | | Min. Guide Catheter
ID: |
| | 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 Tip
Angulation | 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 Tip
Length | 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 014
Straight Model) | Quick-Cross
Extreme & Quick-
Cross Select
(Predicate for 018
Straight & 035
Straight/Angled
Models) |
| | 035 Angled: 1.2cm | | Select 035 Angled:
7mm |
| Shaft
Construction | Coiled | Coiled | Coiled |
| Packaging | Mylar / Tyvek Pouch | Tyvek Pouch | Tyvek Pouch |
| Sterilization | Ethylene Oxide | Ethylene Oxide | Ethylene Oxide |
6
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.
8
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
9
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 (