The Shockwave Medical Intravascular Lithotripsy (IVL) System is intended for lithotripsy-enhanced balloon dilatation of lesions, including calcified lesions, in the peripheral vasculature, including the ilia-femoral, popliteal, infrapopliteal, and renal arteries. Not for use in the coronary or cerebral vasculature.

Device Description

The IVL Catheter is a proprietary lithotripsy device delivered through the peripheral arterial system of the lower extremities to the site of an otherwise difficult to treat calcified stenosis. Energizing the lithotripsy device will generate pulsatile mechanical energy within the target treatment site, disrupting calcium within the lesion and allowing subsequent dilation of a peripheral artery stenosis using low balloon pressure. The IVL Catheter is comprised of an integrated balloon with an array of integrated lithotripsy emitters for the localized delivery of pulsatile mechanical energy. The system consists of an IVL Catheter, an IVL Connector Cable and an IVL Generator.

The Shockwave L Peripheral IVL Catheter shaft contains an inflation lumen, a guidewire lumen. and the lithotripsy emitters. The emitters are positioned along the length of the balloon working length for delivery of pulsatile mechanical energy. The balloon is located near the distal tip of the catheter. Two radiopaque marker bands within the balloon denote the length of the balloon to aid in positioning of the balloon during treatment. The balloon is designed to provide an expandable segment of known length and diameter at a specific pressure.

The IVL Generator and Connector Cable are used with a Shockwave Medical IVL Catheter to deliver localized, lithotripsy-enhanced, balloon dilatation of calcified, stenotic arteries. The IVL Generator, IVL Connector Cable and IVL Catheters are designed to exchange data during patient treatment.

AI/ML Overview

This document describes the premarket notification (510(k)) for the Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave L6 Peripheral IVL Catheter. It is important to note that this document pertains to a medical device for physical intervention, not an AI/Software as a Medical Device (SaMD). As such, many of the requested criteria, particularly those related to AI model development, ground truth establishment, expert review, and MRMC studies, are not applicable to this device.

The document details the device's design, intended use, and the engineering tests conducted to demonstrate its safety and effectiveness.

Here’s a breakdown of the information provided, addressing the questions where applicable to this medical device:

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

The document does not present a formal table of "acceptance criteria" in terms of specific numerical thresholds for clinical performance or diagnostic accuracy (as would be seen for a SaMD). Instead, it lists extensive engineering and design verification and validation tests whose successful completion serves as the "acceptance criteria" for demonstrating substantial equivalence. The "reported device performance" is that the device met all these specifications.

Acceptance Criteria (Type of Test)	Reported Device Performance (Outcome)
IVL Catheter Design Verification & Validation Testing:
Guidewire compatibility	Met design specifications
Introducer sheath compatibility	Met design specifications
Nominal balloon diameter	Met design specifications
Balloon diameter at Rated Burst Pressure (RBP)	Met design specifications
Balloon length	Met design specifications
Balloon inflation time	Met design specifications
Balloon deflation time	Met design specifications
Usable catheter length	Met design specifications
Balloon crossing profile	Met design specifications
Catheter distal tip	Met design specifications
Distal tip durability	Met design specifications
Catheter bonds tensile strength	Met design specifications
Catheter torsional strength	Met design specifications
Emitter and marker band integrity	Met design specifications
System leakage	Met design specifications
Minimum balloon RBP	Met design specifications
Balloon fatigue (multiple inflations)	Met design specifications
Sonic output	Met design specifications
Catheter pulse count and pulse rate	Met design specifications
Temperature rise	Met design specifications
Catheter particle count	Met design specifications
Catheter connector length	Met design specifications
Catheter connection	Met design specifications
Catheter identification	Met design specifications
Catheter sterility (visual inspection)	Met design specifications
Cable sleeve packaging	Met design specifications
Catheter compatibility with materials and accessories commonly used in OTW peripheral balloon angioplasty procedures	Met design specifications
Simulated use testing	Performance met design specifications
Confirmatory chronic GLP animal testing	Performance met design specifications
Overall conclusion:	The performance of the IVL System meets its design specifications and demonstrates substantial equivalence for its intended use.

2. Sample size used for the test set and the data provenance
The document does not specify exact sample sizes for each engineering test. These tests typically involve a defined number of units tested to statistical confidence levels based on accepted engineering practices and standards (e.g., ISO, ASTM). The "data provenance" is controlled laboratory testing and animal studies, not patient data in the typical sense of a clinical trial for diagnostic performance. The document states "Confirmatory chronic GLP animal testing" was performed, indicating a controlled laboratory environment. No country of origin for such data is explicitly mentioned, but it's generated by Shockwave Medical, Inc. in Santa Clara, California, USA. The studies are not described as retrospective or prospective in the clinical trial sense.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This question is not applicable. For a physical medical device like this, "ground truth" is established by engineering specifications, physical measurements, and established physiological responses in animal models, not by expert human interpretation of images or other clinical data.

4. Adjudication method for the test set
This question is not applicable. Adjudication is relevant for subjective assessments, particularly in clinical or diagnostic contexts where human interpretation can vary. Engineering tests have objective pass/fail criteria or measurements against specifications.

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
This question is not applicable. An MRMC study is relevant for evaluating the performance of AI/SaMD devices, particularly in diagnostic imaging. This submission is for a physical medical device (catheter system), not an AI. The document states: "Results demonstrated that the performance of the IVL System meets its design specifications and demonstrates substantial equivalence for its intended use; therefore, additional clinical data were not required."

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable as there is no algorithm or AI component to this device.

7. The type of ground truth used
The "ground truth" for this device's performance validation is based on engineering design specifications, physical measurements, and performance in controlled in vitro (bench) and in vivo (animal) studies. This is standard for demonstrating the safety and effectiveness of a physical medical device and its substantial equivalence to a predicate.

8. The sample size for the training set
This question is not applicable. There is no AI model or "training set" for this physical device.

9. How the ground truth for the training set was established
This question is not applicable. There is no AI model or "training set" for this physical device.

Summary

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August 16, 2022

Shockwave Medical, Inc. Danica Van Principal Regulatory Affairs Specialist 5403 Betsy Ross Dr Santa Clara, California 95054

Re: K221852

Trade/Device Name: Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave L6 Peripheral IVL Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: PPN Dated: June 24, 2022 Received: June 27, 2022

Dear Danica Van:

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

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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) 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,

for

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

Enclosure

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Indications for Use

510(k) Number (if known) K221852

Device Name

Shockwave Intravascular Lithotripsy System with the Shockwave L6 Peripheral IVL Catheter

Indications for Use (Describe)

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

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Image /page/3/Picture/0 description: The image shows the logo for Shockwave Medical Inc. The logo consists of the word "SHOCKWAVE" in a sans-serif font, with three concentric circles to the left of the word. Below the word "SHOCKWAVE" is the phrase "MEDICAL INC" in a smaller font. The logo is simple and modern, and the use of the concentric circles suggests the idea of waves or vibrations.

510(k) Summary

This 510(k) Summary is submitted in accordance with the requirements of the Safe Medical Devices Act (SMDA) of 1990 and 21 CFR 807.92.

Name, Address, and Phone Number of Applicant

Shockwave Medical, Inc. 5403 Betsy Ross Drive Santa Clara, CA 95054 Phone: (510) 279-4262

Contact Person

Danica Van

Date Prepared

June 23, 2022

Trade Name:	Shockwave Intravascular Lithotripsy (IVL) System with theShockwave L6 Peripheral IVL Catheter
Common Name:	Catheter, lithotripsy, peripheral, transluminal
CFR Classification:	21 CFR 870.1250
Classification Name:	Percutaneous catheter
Product Code:	PPN

Device Name and Classification

Predicate Device

The predicate device is the Shockwave Medical Intravascular Lithotripsy System, K180958, cleared by FDA on July 26, 2018.

Reference Device

The reference device is the Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave M5+ Peripheral IVL Catheter, K203365, cleared by FDA on April 22, 2021.

Indications for Use / Intended Use

The Shockwave Medical IVL System is intended for lithotripsy-enhanced balloon dilatation of lesions, including calcified lesions, in the peripheral vasculature, including the iliac, femoral, iliofemoral, popliteal, infra-popliteal, and renal arteries. Not for use in the coronary or cerebral vasculature.

Device Description

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Image /page/4/Picture/0 description: The image shows the logo for Shockwave Medical Inc. The word "SHOCKWAVE" is written in a gray sans-serif font, with three blue concentric circles to the left of the "O" in "SHOCKWAVE". Below the word "SHOCKWAVE" is the text "MEDICAL INC" in a smaller, gray sans-serif font.

the lithotripsy device will generate pulsatile mechanical energy within the target treatment site, disrupting calcium within the lesion and allowing subsequent dilation of a peripheral artery stenosis using low balloon pressure. The IVL Catheter is comprised of an integrated balloon with an array of integrated lithotripsy emitters for the localized delivery of pulsatile mechanical energy. The system consists of an IVL Catheter, an IVL Connector Cable and an IVL Generator.

Technological Comparison

This Traditional 510(k) Premarket Notification describes dimensional modifications to the Shockwave Mr IVL Catheter, including increased sheath and guidewire compatibility, larger balloon diameters and a shorter balloon length.

The catheter labeling was updated to reference the name of the modified device, Shockwave L Peripheral IVL Catheter. Additionally, the Shockwave L 1abeling includes a sterile cable sleeve in the packaging to form a convenience kit.

The IVL System has the same intended use, principles of operation and has substantially equivalent technological characteristics including same fundamental scientific technology, design, energy source, shelf life, and sterilization as the 510(k) cleared IVL System.

Summary of Performance Data

Objective evidence demonstrating that the IVL System design output meets the product design input requirements as well as that device performance characteristics conform to user needs and intended uses as defined in the product specification was provided. Testing was conducted in accordance with Shockwave Medical's Risk Analysis procedures, applicable FDA guidance documents and relevant international standards. Testing included:

IVL Catheter design verification and validation testing: ●
- o Guidewire compatibility
- o Introducer sheath compatibility
- Nominal balloon diameter O
- Balloon diameter at Rated Burst Pressure (RBP) о
- Balloon length O

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Image /page/5/Picture/0 description: The image shows the logo for Shockwave Medical Inc. The word "SHOCKWAVE" is written in a gray sans-serif font, with three blue curved lines emanating from the "O" in "SHOCKWAVE". Below "SHOCKWAVE" is the text "MEDICAL INC" in a smaller, gray sans-serif font.

Balloon inflation time O
Balloon deflation time O
Useable catheter length O
Balloon crossing profile O
Catheter distal tip O
Distal tip durability O
Catheter bonds tensile strength O
O Catheter torsional strength
Emitter and marker band integrity O
System leakage O
O Minimum balloon RBP
Balloon fatigue (multiple inflations) O
Sonic output O
Catheter pulse count and pulse rate O
Temperature rise O
Catheter particle count O
Catheter connector length O
Catheter connection O
Catheter identification O
Catheter sterility (visual inspection) O
Cable sleeve packaging O
Catheter compatibility with materials and accessories commonly used in Over-the- O Wire (OTW) peripheral balloon angioplasty procedures
о Simulated use testing
Confirmatory chronic GLP animal testing ●

Results demonstrated that the performance of the IVL System meets its design specifications and demonstrates substantial equivalence for its intended use; therefore, additional clinical data were not required.

Basis for Substantial Equivalence

The IVL Catheter with dimensional modifications shares the same intended use, principles of operation, overall technical and functional capabilities, and similar design and materials as the identified predicate device. Any differences between the IVL Systems were evaluated through design verification and validation testing which demonstrated device performance and confirmed that there are no new questions of safety or effectiveness. The modified IVL Catheter is therefore substantially equivalent to the predicate device.

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).