(30 days)
Not Found
No
The device description and intended use focus on the physical characteristics and function of a catheter, with no mention of AI or ML capabilities.
No
The device is a support catheter used to guide other devices and deliver solutions; it does not directly treat a medical condition.
No
The device is primarily intended for guiding and supporting a guidewire, allowing wire exchanges, and delivering solutions or contrast agents, which are procedural rather than diagnostic functions. While it can deliver diagnostic contrast agents, its primary role is not to perform diagnosis itself, but to facilitate other procedures.
No
The device description clearly describes a physical, intravascular catheter with various lengths, diameters, tip configurations, radiopaque markers, and a luer connector. This is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used within the body to guide and support a guidewire, allow for wire exchanges, and deliver solutions. This is an in vivo application, meaning it's used directly on or within a living organism.
- Device Description: The description details an intravascular catheter, which is a device designed to be inserted into blood vessels. This further supports its use within the body.
- Anatomical Site: The specified anatomical site is the "vasculature," which refers to the system of blood vessels in the body.
- IVD Definition: In vitro diagnostics (IVDs) are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, outside of the body.
The Quick-Cross® Extreme Support Catheters are designed for direct use within the patient's vascular system, making them an in vivo device, not an IVD.
N/A
Intended Use / Indications for Use
Quick-Cross® Extreme Support Catheters are intended to guide and support a guidewire during access of the vasculature, allow for wire exchanges and provide a conduit for the delivery of saline solutions or diagnostic contrast agents.
Product codes (comma separated list FDA assigned to the subject device)
DOY
Device Description
The Spectranetics Quick-Cross® Extreme Support Catheters are intravascular catheters. These catheters are available in a variety of lengths, diameters and tip configurations. All models have 3 radiopaque markers spaced equally along the distal shaft to aid in estimating geometry within the vascular system. The distal radiopaque marker is positioned within 3 mm of the distal catheter tip. A standard female luer is placed on the proximal end of each model. The catheter is coated with a lubricious, hydrophilic coating on the distal 100cm for catheters with a working length greater than 100cm and 60cm for those with a working length less than 100cm
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vasculature
Indicated Patient Age Range
Not Found
Intended User / Care Setting
The primary customers are those physicians that perform endovascular treatment of vascular disease, namely Interventional Cardiologists, Interventional Radiologists and Vascular Surgeons who are trained in endovascular procedures.
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)
Not Found
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.
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
K092396 SECTION 5 - 1
Quick-Cross Extreme Support Catheter Special 510(k) Submission
Spectranetics Corporation requests that the attached "Summary" for the Quick-Cross® Extreme Support Catheters be distributed upon request under the Freedom of Information Act. This report is a summary of the information presented in this 510(k) submission.
| Owner/Manufacturer: | Spectranetics Corporation
96 Talamine Court
Colorado Springs, CO 80907 |
| --------------------- | ------------------------------------------------------------------------------ |
|---|
Contact Person:
Name Title Office Phone: BlackBerry Fax
Cheryl Hastings Regulatory Affairs & Compliance Manager 719-447-2482 719-659-1848 719-447-2040
Date of Summary Preparation: July 31, 2009
Establishment Registration Number: 1721279
Trade Name of Device: Spectranetics Quick Cross® Extreme Support Catheters
Common Name: Support Catheters
Classification Name: Catheters Percutaneous
Class: II
Product Code: DOY
Predicate Devices: Spectranetics Quick Cross® Extreme Support Catheters K082561 and the Spectranetics Quick Cross Support 2 Catheters K072750
Device Description: The Spectranetics Quick-Cross® Extreme Support Catheters are intravascular catheters. These catheters are available in a variety of lengths, diameters and tip configurations. All models have 3 radiopaque markers spaced equally along the distal shaft to aid in estimating geometry within the vascular system. The distal radiopaque marker is positioned within 3 mm of the distal catheter tip. A standard female luer is placed on the proximal end of each model. The catheter is coated with a lubricious, hydrophilic coating on the distal 100cm for catheters with a working length greater than 100cm and 60cm for those with a working length less than 100cm
Confidential
9/2/2009
1
Quick-Cross Extreme Support Catheter Special 510(k) Submission
Indications for Use: Quick-Cross® Extreme Support Catheters are intended to guide and support a guidewire during access of the vasculature, allow for wire exchanges and provide a conduit for the delivery of saline solutions or diagnostic contrast agents.
Intended Use:
Intended Customers
The primary customers are those physicians that perform endovascular treatment of vascular disease, namely Interventional Cardiologists, Interventional Radiologists and Vascular Surgeons who are trained in endovascular procedures.
Intended Patient Population
The intended patient population is those suffering from vascular disease, both coronary and peripheral.
Technological Comparison:
The 0.014" and the 0.018" Quick Cross® Extreme is a smaller lumen version of the previously approved 0.035" Spectranetics Quick-Cross® Extreme (K082561). The products are substantially equivalent with regards to materials, design principles and construction. The 0.014" and the 0.018" Quick Cross® Extreme is also substantially equivalent to the 0.014" and the 0.018" Ouick Cross® (K072750) with regards to dimensions, specifications and intended use.
Conclusion:
The0.014" and the 0.018" Quick Cross® Extreme catheters are substantially equivalent to the predicate device the 0.035" Spectranetics Quick-Cross® Extreme (K082561) and substantially equivalent to the Quick Cross® (K072750).
2
Confidential
:
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3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
SEP 0 4 2009
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Ms. Cheryl Hastings Regulatory Affairs & Compliance Manager Spectranetics Corporation 9965 Federal Drive Colorado Springs, CO 80921
Re: K092396
Trade/Device Name: Quick-Cross Extreme Support Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: July 30, 2009 Received: August 5, 2009
Dear Ms. Hastings:
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. 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.
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.
4
Page 2 - Ms. Cheryl Hastings
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part.820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Dunia D. Lachner
Bram Zuckerman, M.D.
Director
Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
SECTION 4 - 1 Quick-Cross Extreme Support Catheter Special 510(k) Submission
Indications for Use
510(k) Number:
KO92396
Device Name: Quick-Cross® Extreme Support Catheter
Indications for Use:
Quick-Cross® Extreme Support Catheters are intended to guide and support a guidewire during access of the vasculature, allow for wire exchanges and provide a conduit for the delivery of saline solutions or diagnostic contrast agents.
Prescription Use only X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Duner R. Vachner
Page / of
(Division Sign-Off) (Division Olgh Jign of Cardiovascular Devices
510(k) Number_Ko9239 (6