(30 days)
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.
The ViperCath XC Exchange Catheter is intended to be used to facilitate vascular access and guidewire exchanges during peripheral vascular intervention procedures. It is available in the following lengths with a straight tip: 65, 90, 135, and 150 cm as described in this submission. A 200 cm length is also available and was previously cleared under K183000 with a straight tip and an angled tip. There are no accessories for this device. The catheter is compatible with .035" guidewires and has radiopaque marker bands at distances of 1 cm and 5 cm from the distal tip. The ViperCath XC is supplied sterile with one catheter per box.
The provided text is a 510(k) summary for the ViperCath™ XC Peripheral Exchange Catheter. It describes the device, its intended use, and compares it to a predicate device. However, this document does not contain information on acceptance criteria for device performance, nor does it describe a study that proves the device meets such criteria in terms of clinical performance or diagnostic accuracy.
The "Functional and Safety Testing" section briefly mentions: "Dimensional checks and torque to failure testing were performed to verify the modifications are acceptable and meet specifications over the life of the device." This indicates engineering and mechanical testing, not a clinical study involving human patients or a diagnostic accuracy study.
Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving the device meets those criteria, specifically concerning the elements like sample size, data provenance, ground truth, expert qualifications, or MRMC studies, as these types of studies are not described in the provided document.
The document mainly focuses on establishing substantial equivalence to a predicate device based on similar intended use, technological characteristics, and material properties, and basic functional/safety testing of the device itself rather than its performance in a diagnostic or clinical scenario.
{0}------------------------------------------------
May 26, 2021
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there 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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Cardiovascular Systems, Inc. Erika Huffman Manager, Regulatory Affairs 1225 Old Hwy 8 NW St. Paul, Minnesota 55112
Re: K211251
Trade/Device Name: ViperCath™ XC Peripheral Exchange Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: April 23, 2021 Received: April 26, 2021
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 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 (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.
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) K211251
Device Name
ViperCath™ XC Peripheral Exchange Catheter
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)
|--|--|
X Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
510(K) SUMMARY
| 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: | April 23, 2021 |
| Trade Name: | ViperCath™ XC Peripheral Exchange Catheter |
| Common Name: | Percutaneous Catheter, 21 CFR 870.1250 |
| Classification: | Class II |
| Product Code: | DQY |
| Predicate Device: | ViperCath XC Peripheral Exchange Catheter - K183000 |
| Device Description: | The ViperCath XC Exchange Catheter is intended to be used tofacilitate vascular access and guidewire exchanges duringperipheral vascular intervention procedures. It is available in thefollowing lengths with a straight tip: 65, 90, 135, and 150 cm asdescribed in this submission. A 200 cm length is also availableand was previously cleared under K183000 with a straight tipand an angled tip. There are no accessories for this device. Thecatheter is compatible with .035" guidewires and has radiopaquemarker bands at distances of 1 cm and 5 cm from the distal tip.The ViperCath XC is supplied sterile with one catheter per box. |
| 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. |
{4}------------------------------------------------
| Comparison toPredicate: | ViperCath™ XCPeripheralExchangeCatheter(Subject Device) | ViperCath™ XCPeripheralExchangeCatheter K183000(Predicate Device) | |
|---|---|---|---|
| EffectiveLength(s) | 65, 90, 135, 150 cm | 200 cm | |
| RecommendedGuide Catheter | 5 Fr | 5 Fr | |
| Shaft Design | Braid-reinforced | Braid-reinforced | |
| Tip Shape | Straight | Straight, Angled | |
| MaximumInjectionPressure | 600 psi | 600 psi | |
| GuidewireCompatibility | 0.035" | 0.035" | |
| HydrophilicCoating | No | No | |
| Sterile | Yes | Yes | |
| Single Use | Yes | Yes | |
| Functional andSafety Testing: | Dimensional checks and torque to failure testing were performedto verify the modifications are acceptable and meetspecifications over the life of the device. | ||
| Conclusion: | The ViperCath XC Exchange Catheter (femoral lengths) issubstantially equivalent to the predicate device and themodifications do not introduce new questions of safety oreffectiveness. |
§ 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).