Turbo-Power is indicated for laser atherectomy of de novo or restenotic lesions in native infrainguinal atteries and for the treatment of femoropopliteal artery in-stent restenosis (ISR) in bare nitinol stents, with adjunctive Percutaneous Transluminal Angioplasty (PTA).

Device Description

The Turbo-Power (2.0mm, 2.3mm) Laser Atherectomy Catheter are laser atherectomy devices designed for use with the CVX-300™ Excimer Laser System and Philips Laser System. The Turbo-Power (2.0mm) and (2.3mm) Laser Atherectomy Catheters are sterile, single use, prescription only devices used for peripheral atherectomy. The Turbo-Power (2.0mm) and (2.3mm) are used to ablate lesions with reference vessel diameters of ≥3.0mm. Turbo-Power (2.0mm) and (2.3mm) Laser Atherectomy Catheters are comprised of 2 subassemblies:

1. Catheter Subassembly
1. Motor Drive Unit (MDU) Subassembly
  The working length of the Turbo Power Laser Atherectomy Catheter is constructed of multiple optical fibers arranged eccentrically around a 0.018" (0.46 mm) quidewirecompatible lumen. The PTFE quidewire lumen tip is attached to a stainless steel torque wire which is connected to the MDU at the proximal end of the working length. The multifiber laser catheter transmits ultraviolet energy from the Spectranetics CVX-300 Excimer Laser System or Philips Laser System through the tip of the laser to an obstruction in the patient's artery. The outer surface of the laser catheter working length is hydrophilic-coated, and the distal tip of the catheter contains a radiopaque marker band for in situ visibility. The ultraviolet energy transmitted from the CVX-300 laser system or Philips Laser System is used to photoablate multiple morphology lesions which may be comprised of atheroma, fibrosis, calcium, and thrombus, thus recanalizing diseased vessels. Photoablation is the process by which energy photons cause molecular bond disruption at the cellular level without thermal damage to surrounding tissue.

AI/ML Overview

This document is a 510(k) premarket notification for the Turbo-Power (2.0mm and 2.3mm) Laser Atherectomy Catheters. It describes a modification to an existing device (a new Printed Circuit Board Assembly and firmware) and aims to demonstrate substantial equivalence to a predicate device.

Therefore, the study design described is a design verification and validation testing for the modified device, rather than a clinical trial or large-scale comparative effectiveness study typical for new medical device approvals. The acceptance criteria and the study performed are focused on confirming that the modified device functions as intended and meets the safety and performance requirements established for the original device.

Here's an analysis based on the provided text:

1. A table of acceptance criteria and the reported device performance:

The document broadly states that "Functional testing was performed to confirm the devices with the new PCBA meet the relevant product requirements." and "The following testing was conducted to verify that the subject device met all acceptance criteria as required by the risk analysis that was performed." However, a specific table detailing individual acceptance criteria and corresponding reported device performance values (e.g., pass/fail for specific tests, quantitative measurements within certain tolerances) is not provided in this summary. The categories of testing performed are listed:

Acceptance Criteria (General Categories)	Reported Device Performance
Functional Performance (relevant product requirements)	Confirmed to meet relevant product requirements (Pass)
Software Performance	Software testing was performed (Pass)
Medical Electrical Safety	Medical Electrical Safety Testing was performed (Pass)
Sterilization	Assessment concluded additional sterilization testing not required (Deemed Acceptable)
Risk Analysis Requirements	Met all acceptance criteria as required by risk analysis (Pass)

2. Sample size used for the test set and the data provenance:

Sample Size: The document does not specify the exact sample size (number of modified devices) used for the functional, software, and medical electrical safety testing. It mentions "devices with the new PCBA" in plural, implying more than one unit, but no specific number.
Data Provenance: The testing was conducted by The Spectranetics Corporation, based in Colorado Springs, Colorado, USA. The data is prospective as it involves new testing on the modified device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This type of information (number and qualifications of experts for ground truth) is typically relevant for studies involving subjective human interpretation, such as image reading in AI/diagnostic device studies. For this submission, which focuses on engineering verification of a physical device modification, the "ground truth" is established by the device's technical specifications and engineering requirements. Therefore, no external experts (like radiologists) were used to establish a "ground truth" in the diagnostic sense. The "experts" would be the internal engineers and quality personnel responsible for defining and executing the test protocols and assessing compliance. Their qualifications are implicitly assumed to be appropriate for device testing and validation.

4. Adjudication method for the test set:

Not applicable in the context of this device modification verification. Adjudication methods (like 2+1 or 3+1) are used to resolve disagreements among multiple human readers when establishing ground truth for diagnostic studies. For engineering and safety testing, passing or failing a test is typically based on predefined objective criteria, not subjective interpretation requiring adjudication.

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 comparative effectiveness study was not done. This document is for a medical device modification (a laser atherectomy catheter) and not an AI/CADe device where human reader improvement with AI assistance would be relevant. The submission aimed to demonstrate substantial equivalence of the modified device to its predicate, focusing on maintaining existing performance and safety.

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

Not applicable. This is not an algorithmic device. The "performance" here refers to the physical and electrical function of the catheter and its associated components, not the output of a diagnostic algorithm.

7. The type of ground truth used:

The "ground truth" for this device modification is based on engineering specifications, functional requirements, and safety standards. The tests performed verify that the modified device continues to meet these objective, predefined criteria. It does not involve "expert consensus, pathology, or outcomes data" in the traditional sense of validating a diagnostic or AI-based device.

8. The sample size for the training set:

Not applicable. This is a medical device modification, not a machine learning or AI algorithm development. Therefore, there is no "training set" in the context of AI.

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

Not applicable, as there is no training set for an AI algorithm.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the seal of the Department of Health & Human Services. To the right of the seal is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font size below.

December 8, 2022

Spectranetics Inc. Taylor Olen Regulatory Affairs Specialist 9965 Federal Drive Colorado Springs, Colorado 80921

Re: K222837

Trade/Device Name: Turbo-Power™ (2.0mm and 2.3mm) Laser Atherectomy Catheters Regulation Number: 21 CFR 870.4875 Regulation Name: Intraluminal Artery Stripper Regulatory Class: Class II Product Code: MCW Dated: November 15, 2022 Received: November 16, 2022

Dear Taylor Olen:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. We remind you, however, 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 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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Gregory W. Digitally signed by Gregory W. O'connell -S O'connell -S Date: 2022.12.08
10:28:02 -05'00'28:02 -05'00'

Gregory O'Connell Assistant Director DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K222837

Device Name

Turbo-Power (2.0mm and 2.3mm) Laser Atherectomy Catheters

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart G)

Prescription Use (Part 21 CFR 801 Subpart D)

| | Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

This 510(k) summary was prepared in accordance with 21 CFR 807.92(c) Prepared on November 22, 2022

510(k) Submitter / Holder:	The Spectranetics Corporation9965 Federal DriveColorado Springs, CO 80921.3617Establishment Registration No: 3007284006
Contact:	Ms. Taylor OlenRegulatory Affairs SpecialistMobile: 719-437-4129Fax: 719.447.2070Email: taylor.olen@philips.com

Subiect Device

Device Trade Name:

Device Common Name: Device Class: Classification Requlation: Regulation Description: Product Code: 510(k) Number: 510(k) Type: Model Numbers:

Turbo-Power™ (2.0mm, 2.3mm) Laser Atherectomy Catheters Laser Atherectomy Catheter . 21 CFR 870.4875, Intraluminal Artery Stripper Cardiovascular MCW K222837 Special 420-050, 423-050

Predicate Device

The Turbo-Power™ (2.0mm and 2.3mm) Laser Atherectomy Catheters are being compared to the following legally marketed predicate device:

510(k) Number: Manufacturer: Trade Name: Device Common Name: Model Number:

K180694 (cleared April 5,2018) The Spectranetics Corporation Turbo-Power Laser Atherectomy Catheter Laser Atherectomy Catheter 420-050, 423-050

Intended and Indications for Use

Turbo-Power is indicated for laser atherectomy of de novo or restenotic lesions in native infrainguinal arteries and for the treatment of femoropopliteal artery in-stent restenosis (ISR) in bare nitinol stents, with adjunctive Percutaneous Transluminal Angioplasty (PTA).

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Device Description

1. Catheter Subassembly
1. Motor Drive Unit (MDU) Subassembly

The working length of the Turbo Power Laser Atherectomy Catheter is constructed of multiple optical fibers arranged eccentrically around a 0.018" (0.46 mm) quidewirecompatible lumen. The PTFE quidewire lumen tip is attached to a stainless steel torque wire which is connected to the MDU at the proximal end of the working length. The multifiber laser catheter transmits ultraviolet energy from the Spectranetics CVX-300 Excimer Laser System or Philips Laser System through the tip of the laser to an obstruction in the patient's artery. The outer surface of the laser catheter working length is hydrophilic-coated, and the distal tip of the catheter contains a radiopaque marker band for in situ visibility. The ultraviolet energy transmitted from the CVX-300 laser system or Philips Laser System is used to photoablate multiple morphology lesions which may be comprised of atheroma, fibrosis, calcium, and thrombus, thus recanalizing diseased vessels. Photoablation is the process by which energy photons cause molecular bond disruption at the cellular level without thermal damage to surrounding tissue.

Technological Characteristics

This submission introduces a new Printed Circuit Board Assembly (PCBA) and firmware; however, it does not affect the fundamental scientific technology used in the Turbo-Power family of devices. The mechanism of action, and intended use, remain unchanged from the predicate Turbo- Power (2.0mm, 2.3mm). Functional testing was performed to confirm the devices with the new PCBA meet the relevant product requirements. Additionally, Software testing and Medical Electrical Safety Testing was performed on devices with the new PCBA.

Performance Data

The following testing was conducted to verify that the subject device met all acceptance criteria as required by the risk analysis that was performed.

Design Verification and Validation Testing

Functional Testing .
. Software Testing
Medical Electrical Safety Testing ●

Sterilization

An assessment was conducted and concluded that additional sterilization testing was not required for the subject device to demonstrate substantial equivalence.

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K222837

Pre-clinical and Clinical Data

No new pre-clinical or clinical data was required to demonstrate substantial equivalence.

Substantial Equivalence

Based on the similarities in design between the subject and predicate devices currently in use, and the performance and pre-clinical data, the use of the Turbo-Power (2.0mm and 2.3mm) Laser Atherectomy Catheter for the new PCBA and firmware does not raise new questions related to safety and effectiveness compared with the predicate. Therefore Turbo-Power (2.0mm and 2.3mm) are substantially equivalent to Turbo-Power (2.3mm) and Turbo-Power (2.0mm) (K180694).

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).