(60 days)
Not Found
No
The description focuses on the physical characteristics and intended use of a catheter for vascular procedures. There is no mention of AI, ML, image processing, or any software-driven analytical capabilities.
No.
The device is used to facilitate vascular access and guidewire exchanges, and to deliver saline or contrast agents, which are procedural support functions rather than direct therapeutic actions.
No
The device is intended to guide and support a guide wire, allow for wire exchanges, and provide a conduit for the delivery of substances, including diagnostic contrast agents. While it facilitates the delivery of a diagnostic agent, the device itself does not perform a diagnostic function (e.g., analyze data, provide a diagnosis, or capture diagnostic images).
No
The device description clearly describes a physical catheter with a shaft, tip, and marker bands, indicating it is a hardware medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device as being used to guide and support a guide wire, allow for wire exchanges, and provide a conduit for delivering saline or diagnostic contrast agents within the vasculature. This is an interventional procedure performed directly on the patient's body.
- Device Description: The description details a catheter used for facilitating vascular access and guidewire exchanges during peripheral vascular intervention procedures. This is consistent with a device used in vivo (within a living organism).
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening. IVDs are typically used in a laboratory setting or at the point of care to analyze these specimens.
The device described is a medical device used for interventional procedures within the body, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
DQY
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Functional and Safety Testing:
Testing was performed in accordance with applicable standards and guidance, including FDA Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary 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
Conclusion: The ViperCath XC Exchange Catheter data supports that no new questions of safety or effectiveness were identified compared to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K110540 - NaviCross™ Support Catheter
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left and features a stylized human figure. The FDA logo is on the right and includes the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
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
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/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
2
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)
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.
| 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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3
510(k) Summary / Statement
| Submitter: | Cardiovascular Systems, Inc.
1225 Old Highway 8 NW
Saint Paul, MN 55112 |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Erika Huffman, MS, RAC
Regulatory Affairs Manager
Cardiovascular Systems, Inc.
1225 Old Highway 8 NW
St. Paul, MN 55112
Ph: 651-259-1608
ehuffman@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) 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. |
| Intended Use: | 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. |
4
| Comparison to
Predicate: | | ViperCath™ XC
Peripheral
Exchange Catheter
(subject device) | Terumo
NaviCross™
Support Catheter
(predicate device) |
|-----------------------------------|-------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------|
| | Effective
Length(s) | 200 cm | 65, 90, 135, 150 cm |
| | Recommended
Guide Catheter | 5 Fr | 4 Fr |
| | Shaft Design | Braid-reinforced | Braid-reinforced |
| | Tip Shape | Straight, Angled | Straight, Angled |
| | Maximum
Injection Pressure | 600 psi | 750 psi |
| | Guidewire
Compatibility | 0.035" | 0.035" |
| | Hydrophilic
Coating | No | Yes |
| | Sterile | Yes | Yes |
| | Single Use | Yes | Yes |
| Functional and
Safety Testing: | | Testing was performed in accordance with applicable standards
and guidance, including FDA Class II Special Controls
Guidance Document for Certain Percutaneous Transluminal
Coronary 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 | |
5
| Conclusion: | The ViperCath XC Exchange Catheter data supports that no new questions of safety or effectiveness were identified compared to the predicate device. |
|---|---|
| -------------------- | ----------------------------------------------------------------------------------------------------------------------------------------------------- |