The Turbo-Elite Atherectomy Catheter is a laser atherectomy catheter constructed of multiple optical fibers arranged circumferentially around a guidewire lumen (0.014 and 0.018, presently). Turbo Elite Laser Catheters are available in Over the Wire (OTW) and Rapid Exchange (RX) configurations. The proposed catalog additions are over-the-wire (OTW) 0.035" guidewire compatible with crossing profiles of 2.3mm and 2.5mm.

The laser catheter is connected to the Spectranetics CVX-300 Excimer Laser System by means of an optical coupler and tail-tubing.

The Turbo Elite, OTW catheters include a luer adapter located at the proximal end of the usable length facilitates the use of the laser catheter over the appropriate sized guidewire.

AI/ML Overview

The provided document is a 510(k) summary for the Spectranetics 0.035" compatible, 2.3mm and 2.5mm TurboElite Atherectomy Catheters. It is not a study report that details specific acceptance criteria and the results of a clinical or analytical study in the way typically expected for AI/ML device evaluations.

Instead, this document focuses on demonstrating substantial equivalence to a previously cleared predicate device (K071227) by showing that the new devices have comparable intended use, patient population, mode of operation, materials, packaging, biocompatibility, sterilization, and shelf-life. The "studies" mentioned are primarily device integrity testing to support this claim of substantial equivalence.

Therefore, many of the requested items (e.g., sample sizes for test and training sets, number of experts, adjudication methods, MRMC studies, ground truth types) are not applicable or cannot be extracted from this specific document, as it describes a different type of regulatory submission.

Here's an analysis based on the information provided, highlighting what is available and what is not:

1. Table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
Preamble: The primary acceptance criterion for this 510(k) submission is to demonstrate substantial equivalence to the predicate device (K071227). This means showing that the new devices are as safe, as effective, and perform substantially equivalent to the predicate.	The document concludes that the 0.035" compatible 2.3mm and 2.5mm Turbo Elite Laser Atherectomy Catheters "are as safe, as effective, and perform substantially equivalent to the predicate device" based on the summary of studies.
Specific Performance Requirements (Inferred from "Summary of Studies"): These are not explicit quantitative "acceptance criteria" with numerical thresholds, but rather categories of testing performed to support substantial equivalence.
Visual Inspection and Dimensional Testing met specified requirements.	Met specified requirements.
In vitro Liquid Leak Pressure Testing met specified requirements.	Met specified requirements.
Tensile Strength met specified requirements.	Met specified requirements.
In vitro Track Testing met specified requirements.	Met specified requirements.
Laser testing met specified requirements.	Met specified requirements.
Accelerated age testing met specified requirements.	Met specified requirements.

Study Proving Device Meets Acceptance Criteria:

The "study" proving the device meets the acceptance criteria is the device integrity testing (listed above) performed by Spectranetics. The purpose of these tests was to support the claim of substantial equivalence to the predicate device (K071227). The conclusion states that "All device integrity tests...met the specified requirements," leading to the determination of substantial equivalence.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size for Test Set: This document does not provide specific sample sizes (e.g., number of catheters, number of tests for each category) for the device integrity testing. This information is typically found in detailed test reports, not a 510(k) summary.
Data Provenance: Not specified. The studies are described as "device integrity testing" and "in vitro," implying laboratory-based testing rather than clinical data from human subjects or specific geographical regions.

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)

Not Applicable. This submission is for a medical device (catheter) and relies on engineering and performance testing, not on expert adjudication of diagnostic images or clinical assessments to establish "ground truth" in the context of an AI/ML device.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not Applicable. As above, this type of adjudication is relevant for studies involving human interpretation (e.g., radiology reads) and is not part of the device integrity testing described here.

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

No. An MRMC study was not done. This study is focused on the physical and performance characteristics of a catheter, not the comparative effectiveness of human readers, with or without AI assistance, in a diagnostic context.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not Applicable. This is a hardware device (catheter), not an algorithm or AI system. Therefore, standalone algorithm performance is not relevant.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" in this context refers to the specified requirements or design specifications for the device's physical and functional performance (e.g., dimensional tolerances, leak pressure limits, tensile strength minimums, laser output parameters). The device integrity tests were conducted to verify that the manufactured devices met these engineering specifications.

8. The sample size for the training set

Not Applicable. There is no "training set" in the context of this device's regulatory submission. This is not an AI/ML device.

9. How the ground truth for the training set was established

Not Applicable. As there is no training set, this question is not applicable.

Summary

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510(k) Summary (As Required By 21 CFR 807.92)

JAN 2 5 2013

This 510(k) Summary for the Spectranetics 0.035" compatible, 2.3mm TurboElite Atherectorny Catheters is submitted in accordance with the requirements of the SMDA 1990 and following guidance concerning the organization and content of a 510(k) summary.

Submitter Information

Company name:	Spectranetics Corporation
Company address:	9965 Federal Drive
	Colorado Springs, CO 80921
Company phone:	(719) 477-2000
	(800) 633-0960
Company fax:	(719) 447-2040

Device Identification

Device trade name:	2.3mm and 2.5mm TurboElite 0.035" Atherectomy Catheters
Device common name:	Laser atherectomy catheter
Classification:	Intraluminal Artery Stripper
Device class:	Class II (per 21 CFR 870.4875)
Device code:	MCW
Establishment Registration number:	3007284006

Performance Standards

There are no performance standards applicable to this device.

Device Description

The laser catheter is connected to the Spectranetics CVX-300 Excimer Laser System by means of an optical coupler and tail-tubing.

The Turbo Elite, OTW catheters include a luer adapter located at the proximal end of the usable length facilitates the use of the laser catheter over the appropriate sized guidewire.

Indication for Use

The Turbo Elite is intended for use in the treatment, including atherectomy, of infrainguinal stenoses and occlusions.

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Substantially Equivalent Device

The Turbo Elite (previously referred to as CLiRpath Excimer Laser Catheter) was originally cleared by the FDA through a Premarket Notification in the US in 2004. Between 2005 and 2007, Spectranetics filed various 510(k) applications to modify features and indications. The most recently cleared 510(k) application (K071227) serves as our predicate for this 510(k) application.

The intended use, intended patient population, and mode of operation are comparable to the predicate device. The materials of construction, packaging, biocompatibility, sterilization, and shelf-life are identical to the predicate device.

Summary of Studies

Spectranetics performed device integrity testing to support the claim that the substantially equivalent to the predicate device. All device integrity tests for the over-the-wire (OTW) 0.035" guidewire compatible 2.3mm and 2.5mm Turbo Elite Atherectory Catheters met the specified requirements, which consisted of:

Visual Inspection and Dimensional . Testing
In vitro Liquid Leak Pressure Testing .
Tensile Strength .
In vitro Track Testing .
Laser testing .
Accelerated age testing �

Conclusion

Numerous similarities support a determination of substantial equivalence of the 0.035" compatible 2.3mm and 2.5mm Turbo Elite to the currently cleared 0.018" compatible 2.3mm and 2.5mm TurboElite devices. Based on data and information presented, it can be concluded that the 0.035" compatible 2.3mm and 2.5mm Turbo Elite Laser Atherectomy Catheters are as safe, as effective, and perform substantially equivalent to the predicate device.

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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 or bird-like symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the bird symbol.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

JAN 2 5 2013

Spectranetics Corp. c/o Ms. Christine Godleski Senior Regulatory Affairs Specialist 9665 Federal Drive Colorado Springs, CO 80921

Re: K123632

Trade/Device Name: 2.3mm and 2.5mm Turbo Elite 0.035" Atherectomy Catheters Regulation Number: 21 CFR 870.4875 Regulation Name: Intraluminal artery stripper Regulatory Class: Class II Product Code: MCW Dated: November 15, 2012 Received: November 23, 2012

Dear Ms. Godleski:

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. Please note: CDRH does not evaluate information related to contract liability warranties. However, we remind you that device labeling must be truthful and not misleading.

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.

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

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or any Federal statutes and regulations administered by other Federal agencies. You must or uny 1 vith 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 Or ice rated 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 11 Jou 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 (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Matthew G. Hillebrenner

for

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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K1236.32

Indications for Use 510(k) Number (if known): TBD Device Name: Turbo Elite 035 Indications For Use:

The Turbo Elite is intended for use in the treatment, including atherectomy, of infrainguinal stenoses and occlusions.

AND/OR Over-The-Counter Use _ x Prescription Use (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE) Page 1

M.J. Hellek

(Division Sign-Off) Division of Cardiovascular Devices

11-12-3632 510(k) Number

Regulation Number and Section

§ 870.4875 Intraluminal artery stripper.

(a)
Identification. An intraluminal artery stripper is a device used to perform an endarterectomy (removal of plaque deposits from arterisclerotic arteries.)(b)
Classification. Class II (performance standards).