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 solutions or diagnostic contrast agents.

Device Description

All models have 3 radiopaque markers spaced equally along the distal shaft to aid in estimating geometry within the vascular system. The most 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. Predicate devices of this type with similar intended uses have been classified into Class II. The support catheters are single-use and provided in sterile packaging.

AI/ML Overview

Acceptance Criteria and Study for Spectranetics Cross-Pilot™ Turbo Elite® Support Catheter

This document describes the acceptance criteria and the study performed to demonstrate the substantial equivalence of the Spectranetics Cross-Pilot™ Turbo Elite® Support Catheter to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary focuses on "substantial equivalence" rather than specific numerical acceptance criteria. The performance is assessed through comparative laboratory testing against identified predicate devices.

Acceptance Criteria (Implicit)	Reported Device Performance (Summary)
Equivalence in Physical Dimensions	Test results show equivalence to predicate devices.
Equivalence in Infusion Rates	Test results show equivalence to predicate devices.
Equivalence in Burst Pressure	Test results show equivalence to predicate devices.
Biocompatibility	Confirmed in conformance with ISO 10993-1:2003 (utilizing identical component materials as already-marketed products).
Sterilization	Protocol executed in conformance with ANSI/AAMI/ISO 11135:1994.
Package Integrity	Initially validated in conjunction with sterilization studies.
Device Integrity and Functionality	Qualified and/or validated using samples produced under routine manufacturing conditions.
Compliance with Catheter Standards	Meets or exceeds Spectranetics in-house requirements and ISO 10555-1.
Technical Characteristics (e.g., braided shaft, tapered tip)	Same as predicate devices (Terumo 5Fr Radifocus Optitorque, Asahi Angiographic Catheters).

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: The document does not explicitly state the specific number of units tested for each physical dimension, infusion rate, or burst pressure test. It refers to "samples produced under routine manufacturing conditions" for device integrity and functionality.
Data Provenance: All testing appears to be retrospective and conducted in-house by Spectranetics Corporation, Inc. The country of origin for the data is implicitly the United States, given the company's location.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. This submission is for a medical device (support catheter) based on physical and functional equivalence to predicate devices, not on diagnostic or prognostic performance requiring expert interpretation of results. The "ground truth" is defined by the technical specifications and performance of the predicate devices and relevant industry standards.

4. Adjudication Method for the Test Set

Not applicable, as there is no subjective interpretation of results requiring adjudication. The assessment is based on objective measurements and comparison to established specifications or predicate device performance.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. This device is a support catheter, not an imaging or diagnostic device requiring human reader interpretation or comparative effectiveness studies of human performance with and without AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable. This device is a physical medical instrument, not software or an algorithm.

7. Type of Ground Truth Used

The "ground truth" for this submission is based on:

Predicate Device Performance: The established physical dimensions, infusion rates, burst pressure, and technical characteristics of the legally marketed predicate devices (Terumo 5Fr Radifocus Optitorque and Asahi Angiographic Catheters).
Industry Standards: Compliance with relevant ISO and ANSI/AAMI standards for biocompatibility (ISO 10993-1:2003), sterilization (ANSI/AAMI/ISO 11135:1994), and intravascular catheters (ISO 10555-1).
In-house Requirements: Spectranetics' own established internal requirements for device integrity and functionality.

8. Sample Size for the Training Set

Not applicable. This device is a physical medical instrument, not a machine learning model requiring a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this device.

Summary

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510(k) Summary

SUBMITTER INFORMATION

DEC 11 2008

A. Company Name: Spectranetics Corporation, Inc.
B. Company Address: 96 Talamine Court

Colorado Springs, Colorado 80907

C. Company Phone: 719-633-8333 / 1-800-633-0960
D. Company Facsimile: 719-447-2040
E. Contact Person: Michael K. Handley

Vice President, Global Regulatory Affairs & Compliance

DEVICE IDENTIFICATION

A. Device Trade Name: Spectranetics Cross-Pilot™ Turbo Elite® Support Catheter
B. Device Common Name: Support Cathete
C. Classification Name: Catheter, Percutaneous
D. Device Class: Class II (per 21 CFR 870.1330)
E. Device Code: DQY

CLAIMED EQUIVALENCE

Terumo 5Fr RadiFocus Optitorque (marketed as Glidecath) - K992051 Asahi Angiographic Catheters (marketed as Cook Slip-Cath XL) - K051561

DEVICE DESCRIPTION

Model(Ref.)	Size	Max. (OD)OuterDiameter	WorkingLength	*MaxPressurepsi (kPa)	Tip Shape
518-068	5 Fr	0.071" / 1.80 mm	100 cm	500 (3447)	Straight
518-070	5 Fr	0.071" / 1.80 mm	125 cm	500 (3447)	Straight
518-069	5 Fr	0.071" / 1.80 mm	100 cm	500 (3447)	Angled
518-071	5 Fr	0.071" / 1.80 mm	125 cm	500 (3447)	Angled

Specifications:

75/25 Optiray 320 Contrast Sterile Saline

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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 solutions or diagnostic contrast agents.

KO82959

BELGO, do

IDENTIFICATION OF PREDICATE DEVICES

Spectranetics Cross-Pilot Turbo Elite Support Catheters are equivalent to the Terumo 5Fr Radifocus Optitorque Angiographic Catheter (K992051), marketed at the 5Fr Radifocus Glidecath, and the Asahi Angiographic Catheters (K051561), marketed as Cook Slip-Cath XL, with regard to materials, basic design principles, construction, specifications, intended use and performance. Both are examples of a support catheter for guide wires, a common and familiar tool of cardiovascular interventionist.

COMPARISON TO PREDICATE DEVICES

Comparative laboratory testing was conducted to assess physical dimensions, infusion rates and burst pressure. Test results show that the Spectranetics Cross-Pilot Turbo Elite Support Catheters are equivalent to the predicate devices with regard to safety, effectiveness, indication and performance.

BIOCOMPATIBILITY, STERILIZATION, PACKAGING, AND BENCH TESTING

Cross-Pilot Turbo Elite Support Catheters are built from the same components and materials of construction as the predicate devices, already-marketed products. Biocompatibility of the finished Cross-Pilot Turbo Elite Support Catheters utilizing identical component materials have been confirmed in conformance with ISO 10993-1:2003, Biological Evaluation of Medical Devices. Device integrity and functionality were qualified and/or validated using samples produced under routine manufacturing conditions. An internal company protocol was prepared and executed in conformance with ANSI/AAMI/ISO 11135:1994, Medical Devices - Validation and Routine Control of Ethylene Oxide Sterilization. All Cross-Pilot Turbo Elite Support Catheters models meet or exceed both Spectranetics in-house requirements, and requirements listed in ISO 10555-1, Sterile, Single-use Intravascular Catheters - Part 1: General Requirements. Package integrity was initially validated in conjunction with sterilization studies.

TECHNILOGICAL CHARACTERISTICS

The Spectranetics Cross-Pilot Turbo Elite Support Catheters have the same technical characteristics as the Terumo 5Fr Radifocus Optitorque (GlideCath) and the Asahi Angiographic Catheters (Slip-Cath XL), the predicate devices. Both devices feature a stainless steel braided shaft for aided support and torque response and a tapered tip.

CONCLUSION

The Spectranetics Cross-Pilot Turbo Elite Support Catheters are substantially equivalent to the predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, clutching a caduceus in its talons. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

Public Health Service

Food and Drug Administration 200 Corporate Boulevard Rockville MD 20850

Spectranetics Corporation, Inc. c/o Mr. Michael K. Handley Vice President Global Regulatory Affairs & Compliance 9965 Federal Drive Colorado Springs, CO 80921

DEC 1 1 2008

Re: K082559

Spectranetics Cross-Pilot™ Turbo Elite® Support Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: November 18, 2008 Received: November 19, 2008

Dear Mr. Handley:

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 such 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. Michael K. Handley

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); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

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 postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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,

Duna D. Vanes

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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Spectranetics

.spectranetics.com

570(k) #: K08 2559

Statement of Indication for Use

Device Name: Spectranetics Cross-Pilot™ Turbo Elite® Support Catheters

Indications for Use

Prescription Use XXXX

AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

ina R. V. Ahmer

(Division Sian-Off) Division of Cardiovascular Devices

510(k) Number_K082559

Regulation Number and Section

§ 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).