Shockwave Medical Peripheral Intravascular Lithotripsy (IVL) System

K221041 · Shockwave Medical, Inc. · PPN · Apr 25, 2022 · Cardiovascular

Device Facts

• Record ID: K221041
• Device Name: Shockwave Medical Peripheral Intravascular Lithotripsy (IVL) System
• Applicant: Shockwave Medical, Inc.
• Product Code: PPN · Cardiovascular
• Decision Date: Apr 25, 2022
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1250
• Device Class: Class 2
• Attributes: Therapeutic

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 Story

System comprises IVL catheter, generator, and connector cable. Catheter delivered to peripheral arterial lesion site; balloon partially inflated. Generator delivers energy via cable to emitters inside balloon, creating pulsatile mechanical energy to disrupt vascular calcium deposits. Facilitates low-pressure balloon dilation of stenosis to improve blood flow. Used in clinical settings by physicians. Modifications include alternate energy storage, software updates for features/servicing, and enhanced diagnostic event logging/retrieval. System remains single-use catheter with reusable generator/cable.

Clinical Evidence

Bench testing only. Verification and validation included electronic hardware design, software unit/integration/system/regression testing, extended life testing, 60601-1 safety/EMC testing, and transit testing. No clinical data required.

Technological Characteristics

System includes IVL catheter (single-use, sterile), IVL generator (reusable), and connector cable. Energy source: electrical energy converted to pulsatile mechanical energy. Connectivity: includes system event record storage and non-invasive retrieval for diagnostics. Software: updated for customer features, manufacturability, and servicing.

Indications for Use

Indicated for patients with calcified lesions in peripheral vasculature (iliac, femoral, iliofemoral, popliteal, infra-popliteal, and renal arteries) requiring lithotripsy-enhanced balloon dilatation. Not for use in coronary or cerebral vasculature.

Regulatory Classification

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.

Predicate Devices

• Shockwave Medical Intravascular Lithotripsy System (K203365)

Submission Summary (Full Text)

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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 Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. Next to that is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

April 25, 2022

Shockwave Medical, Inc. Soraya Hori Principal Regulatory Affairs Specialist 5403 Betsy Ross Drive Santa Clara, California 95054

Re: K221041

Trade/Device Name: Shockwave Medical Peripheral Intravascular Lithotripsy (IVL) System Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: PPN Dated: April 4, 2022 Received: April 8, 2022

Dear Soraya Hori:

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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

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) K221041

Device Name

Shockwave Medical Peripheral Intravascular Lithotripsy (IVL) System

Indications for Use (Describe)

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, popliteal, infra-popliteal, and renal arteries. Not for use in the coronary or cerebral vasculature.

Type of Use (Select one or both, as applicable)

| <span style="font-family: Arial;"> <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) </span> |
|----------------------------------------------------------------------------------------------------------------------------------|
| <span style="font-family: Arial;"> <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) </span> |

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Image /page/3/Picture/0 description: The image shows the logo for Shockwave Medical Inc. The logo has the word "SHOCKWAVE" in gray, with three blue curved lines emanating from the "O" in Shockwave. Below the word "SHOCKWAVE" is the text "MEDICAL INC" in a smaller, gray font.

# 510(k) Summary - K221041

## Name, Address, and Phone Number of Applicant

Shockwave Medical, Inc. 5403 Betsy Ross Drive Santa Clara, CA 95054 Phone: [phone]

## Contact Person

Soraya L. Hori

#### Date Prepared

April 20, 2022

#### Device Name and Classification

| Trade Name: | Shockwave Medical Peripheral Intravascular Lithotripsy<br>(IVL) System |
|----------------------|------------------------------------------------------------------------|
| Common Name: | Catheter, lithotripsy, peripheral, transluminal |
| CFR Classification: | 21 CFR 870.1250 |
| Classification Name: | Percutaneous catheter |
| Product Code: | PPN |

#### Predicate Device

The predicate device is the Shockwave Medical Intravascular Lithotripsy System, 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

The Shockwave Medical Peripheral Intravascular Lithotripsy (IVL) System has three components: a proprietary IVL Catheter, an IVL Generator, and an IVL Connector Cable. The IVL Catheter has integrated lithotripsy emitters and is designed to enhance percutaneous transluminal angioplasty by enabling delivery of the calcium disrupting capability of lithotripsy prior to full balloon dilatation at low pressures. The application of lithotripsy mechanical pulse waves alters

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Image /page/4/Picture/1 description: The image shows the logo for Shockwave Medical Inc. The word "SHOCKWAVE" is in large, gray, sans-serif font, with blue concentric circles emanating from the "O". Below "SHOCKWAVE" is the phrase "MEDICAL INC" in a smaller, gray, sans-serif font.

the structure of an occlusive vascular deposit (stenosis) prior to low-pressure balloon dilation of the stenosis and facilitates the passage of blood.

The IVL Catheter is delivered through the peripheral arterial system of the lower extremities to the site of an otherwise difficult to treat lesion. The balloon is partially inflated and the lithotripsy emitters are energized thereby generating pulsatile mechanical energy within the balloon at the target treatment site and allowing subsequent dilation of a peripheral artery stenosis using low balloon pressure. The IVL Generator delivers energy through the IVL Connector Cable to the pulse emitters located inside the balloon in the IVL Catheter. The IVL Catheter is a single-use device supplied sterile to the customer. The IVL Generator and IVL Connector Cable are nonsterile reusable devices.

# Technological Comparison

This Special 510(k) Premarket Notification describes the addition of an alternate energy storage component, software updates consisting of both customer facing features and updates for manufacturability and servicing, and the inclusion of additional data for storage of system event records and the means for non-invasive retrieval of system event records to facilitate enhanced diagnostics and troubleshooting.

The Generator labeling was updated to reference the catalog model number of the modified device, Shockwave 825Dx Generator.

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.

# Summarv 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:

- Electronic Hardware Design Verification Testing: ●
- User interface O
- Battery system O
- Battery charging system
- I Battery management system
- System power supplies o
- Internal system verification O
- Control system O
- Catheter management system O

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Image /page/5/Picture/1 description: The image shows the logo for Shockwave Medical Inc. The word "SHOCKWAVE" is in large, gray, sans-serif font. To the left of the "O" in "SHOCKWAVE" are three curved blue lines, resembling sound waves. Below the word "SHOCKWAVE" is the text "MEDICAL INC" in a smaller, gray, sans-serif font.

- o Pulse delivery system
- Software Verification and Validation Testing: ●
- Unit Test о
- Integration Test O
- System Test o
- Regression Test O
- Extended Life Testing .
- 60601-1 Type Testing for Safety and Electromagnetic Compatibility
- . Transit Testing

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

# Basis for Substantial Equivalence

The IVL System with modified hardware and software 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 IVL System with modified hardware and software is therefore substantially equivalent to the predicate device.