The Turbo-Tandern™ System (Laser Guide Catheter with Laser Ablation Catheter) is a laser ablation catheter constrained within a guiding catheter to facilitate the offset (biased position) of the laser ablation catheter. The guiding catheter portion of the Turbo-Tandem System is used to offset the distal end of the incorporated laser catheter from the central plane of the vessel lumen allowing for circumferential guidance and positioning of the laser catheter within the vessel. The Turbo-Tandem System is 7F sheath compatible with a maximum crossing profile of 0.160" (4.0mm) with the laser catheter extended or offset position. The incorporated laser catheter is constructed of multiple optical fibers arranged circumferentially around a guidewire lumen and has a fiber optic surface area similar to a 2.0mm laser catheter.

AI/ML Overview

The information primarily describes a 510(k) premarket notification for a medical device (Spectranetics Turbo-Tandem™ System). This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with acceptance criteria in the typical sense of a clinical trial for an AI/ML-based diagnostic device.

Therefore, many of the requested elements for an AI/ML device study (e.g., sample sizes for test/training sets, experts for ground truth, MRMC studies, standalone performance) are not applicable to this document. The provided text details the device, its intended use, and its comparison to predicate devices through device integrity testing.

Here's a breakdown of the available information based on your request, highlighting where information is absent or not applicable:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria: The document states, "Performance standards do not currently exist for these devices. None established under Section 514." Instead of formal acceptance criteria, the study aimed to demonstrate substantial equivalence to predicate devices. The implicit acceptance criterion for the premarket notification was that the device integrity test results met "specified requirements," which implies internal company specifications.
Reported Device Performance: "All device integrity test results for the Spectranetics Turbo-Tandem System met specified requirements."

Acceptance Criteria (Implicit)	Reported Device Performance
Device integrity test results meet specified requirements.	All device integrity test results for the Spectranetics Turbo-Tandem System met specified requirements.
Substantially equivalent to predicate devices (Spectranetics Turbo Elite™ and Spectranetics Turbo Booster™) in features, materials, and intended use.	Through data and information presented, numerous similarities support a determination of substantial equivalence.

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

Not Applicable: This document describes device integrity testing, not a clinical study involving a "test set" of patient data for an AI/ML diagnostic device. The "test set" here refers to the device itself being subjected to various integrity tests. The sample size for these engineering tests is not specified, but it would typically involve a certain number of manufactured units.
Data Provenance: The data provenance is from internal Spectranetics Corporation testing in the USA. The study is retrospective in the sense that the testing was performed, and the results were then compiled for the submission.

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

Not Applicable: This type of information is relevant for AI/ML diagnostic devices where expert review is needed to establish ground truth from medical images or clinical data. For device integrity testing, the "ground truth" is established by engineering specifications and objective measurements, not expert consensus on diagnostic interpretations.

4. Adjudication Method for the Test Set

Not Applicable: Adjudication methods (like 2+1, 3+1) are used to resolve disagreements among human reviewers (experts) in establishing ground truth for diagnostic studies. This is not relevant for basic device integrity testing.

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

Not Performed: An MRMC study is designed to assess the performance of human readers, often with and without AI assistance, on a set of cases. This study is about confirming the physical and functional equivalence of a medical device (catheter system), not evaluating human reader performance or AI's impact on it.

6. Standalone (Algorithm Only) Performance Study

Not Performed: This is not an AI/ML algorithm. Therefore, a standalone algorithm performance study is not applicable. The performance evaluated here is that of the physical device.

7. Type of Ground Truth Used

Engineering Specifications and Objective Measurements: For device integrity testing, the "ground truth" refers to established engineering standards, design specifications, and objective measurements (e.g., tensile strength, dimensional accuracy, sterilization efficacy).

8. Sample Size for the Training Set

Not Applicable: This type of study does not involve a "training set" in the context of machine learning.

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

Not Applicable: There is no training set for an AI/ML algorithm in this context.

Summary

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K091299 page 1 of 2

STED Summary of Substantial Equivalence

SUBMITTER INFORMATION

A. Company Name: Spectranetics Corporation, Inc.
B. Company Address: 9965 Federal Blvd Colorado Springs, CO 80921

JUL - 1 2009

். Company Phone: 719-633-8333/ 1-800-633-0960
Company Facsimile: 719-447-2040 D.

DEVICE IDENTIFICATION

A. Device Trade Name: Spectranetics Turbo-Tandem™ System
B. Device Common Name: Percutaneous Laser Ablation Catheter
C. Classification: Catheter, Percutaneous
D. Device Class: Class II (per 21 CFR 870.1250)
E. Device Code: DQY
F. Establishment Registration Number: 3007284006

PERFORMANCE STANDARDS

Performance standards do no currently exist for these devices. None established under Section 514.

DEVICE DESCRIPTION

INDICATION FOR USE

Indicated for atherectomy of infrainguinal arteries.

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K091279 page 2 of 2

SUBSTANTIALLY EQUIVALENT DEVICES

In Spectranetics' opinion, the Turbo-Tandem System is believed to be substantially equivalent to the following predicate devices currently in interstate commerce with respect to comparable features, materials of construction and intended use.

. Spectranetics Turbo Elite™ - K071227
Spectranetics Turbo Booster™ K071226 ●

Labeling, packaging, and sterilization of the Spectranetics Turbo-Tandem System has not changed from the predicate devices listed above.

SUMMARY OF STUDIES

Spectranetics performed device integrity testing to support that the Turbo-Tandem System is equivalent to the predicate devices. All device integrity test results for the Spectranetics Turbo-Tandem System 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 Turbo-Tandem™ System through this STED Premarket Notification.

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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 circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" around the perimeter. Inside the circle is an abstract image of an eagle.

Public Health Service

JUL -- 1 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Gracie Murguia Regulatory Affairs and Compliance Supervisor Spectranetics Corp. 9965 Federal Drive Colorado Springs, CO 80921

Re: K091299

Turbo-Tandem System Regulation Number: 21 CFR 870.1250 Regulation Name: Catheter, Percutaneous Regulatory Class: Class II Product Code: DQY Dated: May 1, 2009 Received: May 4, 2009

Dear Ms. Murguia:

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 - Ms. Gracie Murguia

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); 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/CDRH/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 (240) 276-3150 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

R. Lochner

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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Statement of Indication for Use

Premarket Notification Number: IBD

Device Name: Turbo-Tandem™ System

Indication for Use

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Turbo-Tandem™ System is indicated for atherectomy of infrainguinal arteries.

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510(k) Number K091271

Prescription Use: V (Part 21 CFR 801 Subpart D)

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Over the Counter Use: 21 CFR 807 Subpart C

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).