(33 days)
No
The summary describes a physical catheter device and its intended use for guiding other catheters and delivering fluids. There is no mention of software, algorithms, image processing, or any terms related to AI or ML. The performance studies focus on functional testing of the physical device.
No
The device is described as a "Support Catheter" intended to "guide and support" other catheters and provide a conduit for delivery of solutions, not to treat a medical condition itself.
No
The device is described as a "Support Catheter" which is intended to guide and support other catheters and deliver substances. While it can deliver diagnostic contrast agents, its primary stated purpose is support and delivery, not diagnosis itself. The description focuses on its physical characteristics as an intravascular catheter rather than any diagnostic capabilities.
No
The device description clearly states it is an "intravascular catheter" and describes physical components like radiopaque markers, a luer connector, and a hydrophilic coating, indicating it is a physical medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for guiding and supporting laser catheters during vascular access and delivering saline or contrast agents. This is a therapeutic or interventional use, not a diagnostic test performed on samples outside the body.
- Device Description: The description details an intravascular catheter designed for physical manipulation within the vasculature. This aligns with an interventional device, not a diagnostic one.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or performing any kind of diagnostic test to determine a disease state or condition.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device operates in vivo (within the body) for procedural support.
N/A
Intended Use / Indications for Use
Cross-Pilot™ Turbo elite® Support Catheters are intended to guide and support Spectranetics laser catheters during access of the vasculature and provide a conduit for the delivery of saline solution or diagnostic contrast agents.
Product codes
DQY
Device Description
The Spectranetics Cross-Pilot™ Turbo Elite® Support Catheters are intravascular catheters. These catheters are available in a variety of lengths 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.
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
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
Spectranetics performed device functional testing to support that the Cross-Pilot Turbo elite Support Catheter is equivalent to the predicate device. All device functional test results for the Cross-Pilot™ Turbo elite Support Catheter met specified requirements.
Key Metrics
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
Special 510(k) Premarket Notification 510(k) Summary of Substantial Equivalence Cross-Pilot™ Turbo elite® Support Catheter
i690913
510(k) SUMMARY OF SUBSTANTIAL EQUIVALENCE
MAY - 4 2009
| Proprietary Name: | Cross-Pilot™ Turbo elite® Support Catheter |
|---|---|
| Common Name: | Support Catheter |
| Classification Name: | Percutaneous Catheter |
| Device Classification: | Class II |
| Product Classification and Code: | 21 CFR 870.1250, DQY |
| Classification Panel: | Cardiovascular Devices |
| Establishment Registration Number: | 3007284006 |
| Contact Person: | Brandon Hansen |
| Regulatory Affairs | |
| Spectranetics Corporation | |
| 9965 Federal Drive | |
| Colorado Springs, CO 80921 | |
| Telephone: (719) 447-2385 | |
| Facsimile: (719) 447-2040 | |
| E-mail: brandon.hansen@spnc.com |
Performance Standards
Performance standards do not currently exist for these devices. None established under Section 514.
Image /page/0/Picture/9 description: The image shows the word "Spectranetics" in a stylized, bold, italicized font. The word is written in black ink and appears to be the name of a company or product. The font is distinctive and easily recognizable.
1
Special 510(k) Premarket Notification 510(k) Summary of Substantial Equivalence Cross-Pilot™ Turbo elite® Support Catheter
page lot 1
Device Description
The Spectranetics Cross-Pilot™ Turbo Elite® Support Catheters are intravascular catheters. These catheters are available in a variety of lengths 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.
Indication for Use
Cross-Pilot™ Turbo elite® Support Catheters are intended to guide and support Spectranetics laser catheters during access of the vasculature and provide a conduit for the delivery of saline solution or diagnostic contrast agents.
Substantially Equivalent Devices
In Spectranetics' opinion, the Cross-Pilot™ Turbo elite "Support Catheter is believed to be substantially equivalent to the following predicate device currently in interstate commerce with respect to comparable features, materials of construction and intended use.
- Cross-Pilot" Turbo elite Support Catheter (Spectranetics Corp., Colorado . Springs, CO) - K082559
Labeling, packaging, materials and sterilization of the Cross-Pilot" Turbo elite Support Catheter has not changed from that of the predicate devices listed above.
Summary of Studies
Spectranetics performed device functional testing to support that the Cross-Pilot Turbo elite Support Catheter is equivalent to the predicate device. All device functional test results for the Cross-Pilot™ Turbo elite Support Catheter met specified requirements.
Conclusion (Statement of Equivalence)
Through data and information presented, numerous similarities support a determination of substantial equivalence, and therefore market clearance of the Spectranetics Cross-Pilot" Turbo elite "Support Catheter through this Special 510(k) Premarket Notification.
Spectranetics
2
Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features an abstract eagle design with three stylized wing segments. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The seal is black and white and appears to be a scanned image.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY - 4 2009
Spectranetics Corporation c/o Mr. Brandon Hansen Manager, Global Regulatory Affairs 9965 Federal Drive Colorado Springs, CO 80921
Re: K090913
Cross-Pilot Turbo Elite Support Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: March 31, 2009 Received: April 1, 2009
Dear Mr. Hansen:
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.
3
Page 2 - Mr. Brandon Hansen
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 (OS) 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 contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120 Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adversc events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Prem D. Zukerman, M.D.
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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page 1 ot 1
INDICATION FOR USE
510(k) Number (if known):
5090913
Device Name:
Cross-Pilot" Turbo elite® Support Catheter
Indication For Use:
Cross-Pilot" Turbo elite Support Catheters are intended to guide and support Spectranetics laser catheters during access of the vasculature and provide a conduit for the delivery of saline solution or diagnostic contrast agents.
| Prescription Use | 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 IF NEEDED)
Concurrence of CDRH, Office of Dovice Evaluation (ODE)
Jtittlestar for B Zuckerman
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510(k) Number K690913
Spectranetics Confidential