(33 days)
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.
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.
The provided document (K090913) is a Special 510(k) Premarket Notification for the Cross-Pilot™ Turbo elite® Support Catheter. This type of submission focuses on documenting that modifications to an already cleared device do not affect its safety or effectiveness, or alter its intended use. Therefore, the "study" described is a revalidation of the device's functional equivalence to its predicate, rather than a clinical trial with acceptance criteria for new performance metrics.
Here's an analysis based on the provided text, addressing your specific points:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state a table of acceptance criteria with specific numerical targets for performance metrics. Instead, it refers to "specified requirements" and implicitly relies on the predicate device's performance as the benchmark.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Equivalence to predicate device for functional testing. | "All device functional test results for the Cross-Pilot™ Turbo elite Support Catheter met specified requirements." |
| No change in labeling, packaging, materials, and sterilization from the predicate. | "Labeling, packaging, materials and sterilization of the Cross-Pilot™ Turbo elite Support Catheter has not changed from that of the predicate devices listed above." |
| Continued ability to guide and support Spectranetics laser catheters during access of vasculature. | Indication for Use remains the same, implying continued performance in this regard. |
| Continued ability to provide a conduit for the delivery of saline solution or diagnostic contrast agents. | Indication for Use remains the same, implying continued performance in this regard. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify general "test set" sample sizes, data provenance, or whether the testing was retrospective or prospective. It only mentions "device functional testing." In the context of a Special 510(k) for minor changes, functional testing typically involves in-vitro and bench testing, performed in a controlled laboratory environment. The "data provenance" would therefore be the manufacturer's internal testing facilities, likely in the US (Colorado Springs, CO, as per the contact information).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This is not applicable to the described study. The study involves functional testing of a physical medical device (a catheter), not a diagnostic algorithm or image analysis requiring expert ground truth for interpretation. The "ground truth" for functional testing is typically established by engineering specifications and predicate device performance.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. As noted above, this study is about functional testing of a physical device against engineering specifications and predicate performance, not about clinical outcomes or interpretations that would require an adjudication method.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is not a study involving human readers, AI, or comparative effectiveness. It is a submission for a modification to a medical device and relies on functional equivalence to a predicate.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device is a physical catheter, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" in this context is the established performance and specifications of the predicate device (K082559) and engineering design specifications for the modified device. The functional testing aims to show that the modified device performs equivalently to the predicate and meets its own internal design requirements.
8. The sample size for the training set
Not applicable. This is not a machine learning or AI algorithm, and therefore there is no "training set."
9. How the ground truth for the training set was established
Not applicable, as there is no training set.
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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 HansenRegulatory AffairsSpectranetics Corporation9965 Federal DriveColorado Springs, CO 80921Telephone: (719) 447-2385Facsimile: (719) 447-2040E-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.
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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
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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.
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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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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
§ 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).