(28 days)
Not Found
No
The device description and performance testing focus on the physical characteristics and mechanical performance of a support catheter, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No.
The primary purpose of the device is to facilitate placement and exchange of guidewires and other interventional devices and to sub-selectively infuse/deliver diagnostic and therapeutic agents, not to provide therapy itself. While it can deliver therapeutic agents, it is a delivery device, not a therapeutic one.
Yes
The "Intended Use / Indications for Use" section states that the device "may be used to ... sub-selectively infuse / deliver diagnostic and therapeutic agents." The inclusion of "diagnostic agents" indicates that the device has a diagnostic function.
No
The device description clearly details a physical catheter with specific dimensions, materials (hydrophilic coating, radiopaque markers), and physical properties (trackability, kink resistance, tensile strength). The performance studies also focus on physical characteristics and mechanical performance, not software functionality.
Based on the provided information, the ViperCross™ Support Catheter is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used within the body (in the peripheral vasculature) to facilitate procedures and deliver agents. IVDs are used to examine specimens from the body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The description details a physical catheter designed for insertion into blood vessels. This is consistent with an interventional medical device, not a diagnostic test performed on samples outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or providing diagnostic information based on laboratory testing.
The ViperCross™ Support Catheter is an interventional medical device used in procedures within the peripheral vasculature.
N/A
Intended Use / 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 interventional devices and to sub-selectively infuse / deliver diagnostic and therapeutic agents.
Product codes
DQY
Device Description
The ViperCross™ Support Catheters are single lumen catheters designed for use in the peripheral vasculature. The ViperCross™ Support Catheters provide 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 30cm, 40cm, 70cm, or 90cm dependent on model length to enhance deliverability to the target vasculature.
The ViperCross™ Support Catheters have three (3) radiopaque marker bands located 0.040" / 1.01mm, 1.968" / 50mm, and 3.937" / 100mm from the distal tip, respectively. The 135cm and 150cm 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 014 or 018 ViperCross™ Support Catheter can be placed through the 035 ViperCross™ Support Catheter for extended reach and pushability.
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 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
- Contrast injection
- Leak test air aspiration
- Liquid leak resistance
- High pressure leak test
- Surface finish
- Particulate
- Trackability / simulated use
- Hydrophilic Coating
- Torque transmission
- Kink resistance
- Tip flexibility
- Tensile strength
- 035 only Tip Angle
All testing met the requirements and passed. There are no new questions raised regarding safety or efficacy of the ViperCross™ Support Catheter.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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 contains the logo of the U.S. Food and 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 square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
September 24, 2021
Cardiovascular Systems, Inc. % Jonathan Holmes Regulatory Affairs Manager Biomerics 6030 W. Harold Gatty Dr. Salt Lake City, Utah 84116
Re: K212725
Trade/Device Name: ViperCross Support Catheters Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: August 26, 2021 Received: August 27, 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
1
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 (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 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,
Image /page/1/Picture/5 description: The image shows the name "Lydia S. Glaw -S" in a large, sans-serif font. The text is arranged in two lines, with "Lydia" and "Glaw" stacked vertically on the left, and "S." and "-S" stacked vertically on the right. The background is plain white.
Digitally signed by Lydia S. Glaw -S Date: 2021.09.24 17:29:17 -04'00'
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) K212725
Device Name ViperCross™ Support Catheters
Indications for Use (Describe)
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) | |
|---|---|
| X 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 includes the letters CSI in a stylized font, with a green arc underneath. Below the logo is the address 1225 Old Highway 8 NW, Saint Paul, MN 55112.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------============================================================================================================================================================================== 510(k) K212725
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: 26 August 2021
NAME OF MEDICAL DEVICE:
Proprietary Name: ViperCross™ Support Catheters Percutaneous Catheter Common/Usual Name: Classification Name: Catheter, Percutaneous
DEVICE CLASSIFICATION:
| Classification Panel: | Cardiovascular |
|---|---|
| Regulatory Class: | 2 |
| Product Code: | DQY |
| Regulation Number: | 21 CFR 870.1250 |
PREDICATE DEVICE:
| Proprietary Name: | ViperCross™ Support Catheters |
|---|---|
| Common/Usual Name: | Percutaneous Catheter |
| Classification Name: | Catheter, Percutaneous |
| 510(k) Number: | K211240 |
Cardiovascular Systems Inc.
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 bold, sans-serif font, with a green arc underneath. To the right of the letters is the company name, "CARDIOVASCULAR SYSTEMS, INC.", in a smaller, sans-serif font. The logo is simple and modern, and the use of green suggests a focus on health and wellness.
DEVICE DESCRIPTION:
The ViperCross™ Support Catheters are single lumen catheters designed for use in the peripheral vasculature. The ViperCross™ Support Catheters provide 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 30cm, 40cm, 70cm, or 90cm dependent on model length to enhance deliverability to the target vasculature.
The ViperCross™ Support Catheters have three (3) radiopaque marker bands located 0.040" / 1.01mm, 1.968" / 50mm, and 3.937" / 100mm from the distal tip, respectively. The 135cm and 150cm 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 014 or 018 ViperCross™ Support Catheter can be placed through the 035 ViperCross™ Support Catheter for extended reach and pushability.
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.
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 interventional devices and to sub-selectively infuse/deliver diagnostic and therapeutic agents.
TECNOLOGICAL COMPARISION TO PREDICATE DEVICE:
The ViperCross™ Support Catheter uses the same technology, intended use, fundamental technology and performance as the predicate device (ViperCross™ Support Catheter K211240).
| Characteristic | ViperCross™ Support
Catheters
(Subject Device) | ViperCross™ Support
Catheters
(K211240 Predicate Device
018 / 035) |
|--------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The ViperCross™ Support
Catheter may be used to facilitate
placement and exchange of
guidewires and other
interventional devices and to | The ViperCross™ Support
Catheter may be used to facilitate
placement and exchange of
guidewires and other
interventional devices and to |
| Characteristic | ViperCross™ Support
Catheters
(Subject Device) | ViperCross™ Support
Catheters
(K211240 Predicate Device
018 / 035) |
| | selectively infuse/deliver
diagnostic and therapeutic agents. | selectively infuse/deliver
diagnostic and therapeutic agents. |
| 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
interventional devices and to sub-
selectively infuse/deliver
diagnostic and therapeutic agents. | 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. |
| | Max. Guidewire Diameter: | Max. Guidewire Diameter: |
| | 018: 0.018" / 0.46mm | 018: 0.018" / 0.46mm |
| | 035 Straight & Angled: 0.035" /
0.89mm | 035 Straight & Angled: 0.035" /
0.89mm |
| | Working Length: | Working Length: |
| | 018: 65cm, 90cm, & 150cm | 018: 135cm |
| | 035 Straight & Angled: 65cm &
150cm | 035 Straight & Angled: 90cm &
135cm |
| | Distal Tip OD: | Distal Tip OD: |
| Dimensions | 018: 0.025" / 0.63mm | 018: 0.025" / 0.63mm |
| | 035 Straight & Angled: 0.45" /
1.14mm | 035 Straight & Angled: 0.45" /
1.14mm |
| | Proximal Shaft OD: | Proximal Shaft OD: |
| | 018: 0.0375" / 0.95mm | 018: 0.0375" / 0.95mm |
| | 035 Straight & Angled: 0.056" /
1.42mm | 035 Straight & Angled: 0.056" /
1.42mm |
| | Min Guide Catheter ID: | Min Guide Catheter ID: |
| | 018: 0.042" / 1.07mm | 018: 0.042" / 1.07mm |
| | 035 Straight & Angled: 0.061" /
1.55mm | 035 Straight & Angled: 0.061" /
1.55mm |
| Characteristic | ViperCross™ Support
Catheters
(Subject Device) | ViperCross™ Support
Catheters
(K211240 Predicate Device
018 / 035) |
| Distal Tip
Angulation | 018: N/A
035 Straight: N/A
035 Angled: 30° | 018: N/A
035 Straight: N/A
035 Angled: 30° |
| Angled Tip
Length | 018: N/A
035 Straight: N/A
035 Angled: 1.2cm | 018: N/A
035 Straight: N/A
035 Angled: 1.2cm |
| Shaft
Construction | Coiled | Coiled |
| Packaging | Mylar / Tyvek Pouch | Mylar / Tyvek Pouch |
| Sterilization | Ethylene Oxide | Ethylene Oxide |
5
Image /page/5/Picture/0 description: The image shows the logo for CSI. The logo consists of the letters "CSI" in a rounded, sans-serif font. The letters are gray. Below the letters is a curved, green line. To the right of the letters is a small circle with an R inside, indicating a registered trademark.
6
Image /page/6/Picture/0 description: The image shows the logo for CSI. The letters "CSI" are in a gray, sans-serif font. There is a green arc below the letters. To the right of the letters is a vertical line, also in gray. There is a registered trademark symbol to the right of the "I".
The ViperCross™ Support Catheter is substantially equivalent to the predicate device, ViperCross Support Catheter (K211240).
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
- Contrast injection
- Leak test air aspiration
- Liquid leak resistance
- · High pressure leak test
- Surface finish
- Particulate
- Trackability / simulated use
- Hydrophilic Coating
- · Torque transmission
- Kink resistance
Cardiovascular Systems Inc.
7
Image /page/7/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.
- Tip flexibility
- Tensile strength
- 035 only Tip Angle
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 identical in general design, materials, sterilization, principles of operation, performance, intended use and indications for use to the cited predicate.