Lithoplasty Peripheral Balloon Dilatation Catheter; Lithoplasty Generator And Connector Cable; Lithoplasty Connector Cable

K163306 · Shockwave Medical, Inc. · PPN · Dec 22, 2016 · Cardiovascular

Device Facts

• Record ID: K163306
• Device Name: Lithoplasty Peripheral Balloon Dilatation Catheter; Lithoplasty Generator And Connector Cable; Lithoplasty Connector Cable
• Applicant: Shockwave Medical, Inc.
• Product Code: PPN · Cardiovascular
• Decision Date: Dec 22, 2016
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1250
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Shockwave Medical Lithoplasty 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.

Device Story

System comprises balloon catheter with integrated lithotripsy emitters, generator, and connector cable. Used in peripheral arterial system to treat calcified lesions. Catheter delivered to lesion site; balloon partially inflated. Generator delivers energy through cable to emitters, creating pulsatile mechanical energy within balloon to disrupt calcium deposits. Allows subsequent low-pressure balloon dilation of stenosis to facilitate blood flow. Used in clinical settings by physicians. Generator and cable are reusable; catheter is single-use and sterile. Updates include generator enclosure, display, IV pole mount, packaging, catheter hub dimensions, and magnetic electrical connectors for improved usability.

Clinical Evidence

Bench testing only. Included hardware, electrical performance, electromagnetic compatibility, and software verification/validation. Component testing per ISO 594-1:1986 and ISO 594-2:1998. Safety testing per ANSI/AAMI ES60601-1:2005/(R)2012 and EMC testing per IEC 60601-1-2:2007/A:2010. Packaging and transit testing performed for updated cases.

Technological Characteristics

System includes balloon catheter, generator, and connector cable. Energy source: electrical energy converted to pulsatile mechanical energy. Connectivity: magnetic electrical connectors. Standards: ISO 594-1/2 (hub), ANSI/AAMI ES60601-1 (safety), IEC 60601-1-2 (EMC). Sterilization: catheter supplied sterile; generator/cable non-sterile reusable.

Indications for Use

Indicated for lithotripsy-enhanced balloon dilatation of calcified and non-calcified lesions in peripheral vasculature (iliac, femoral, popliteal, infra-popliteal, and renal arteries). Contraindicated for coronary or cerebral vasculature use.

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 Lithoplasty System (K161384)

Submission Summary (Full Text)

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

December 22, 2016

Shockwave Medical, Inc. Ms. Plessy Paul Senior Regulatory Affairs Specialist 48501 Warm Springs Blvd., Suite 108 Fremont, CA 94539

Re: K163306

Trade/Device Name: Shockwave Medical Lithoplasty System Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: PPN Dated: November 22, 2016 Received: November 23, 2016

Dear Ms. Paul:

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. 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 801); medical device reporting (reporting of medical devicerelated 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.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

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

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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

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

Sincerely.

Brian D. Pullin -S

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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# Indications for Use

510(k) Number (if known) K163306

#### Device Name

Shockwave Medical Lithoplasty System

#### Indications for Use (Describe)

The Shockwave Medical Lithoplasty 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) | |
|-------------------------------------------------|--|
| | |

|X Prescription Use (Part 21 CFR 801 Subpart D)

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

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

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## 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, Phone, and Fax Number of Applicant

Shockwave Medical, Inc. 48501 Warm Springs Blvd., Suite 108 Fremont, CA 94539 Phone: [phone] Fax: [phone]

## Contact Person

Plessy Paul

## Date Prepared

November 22, 2016

### Device Name and Classification

| Trade Name: | Shockwave Medical Lithoplasty® System |
|----------------------|-------------------------------------------------|
| Common Name: | Catheter, angioplasty, peripheral, transluminal |
| CFR Classification: | 21 CFR § 870.1250 |
| Classification Name: | Percutaneous catheter |
| Product Code: | PPN |

## Predicate Device

The predicate device is the Shockwave Medical Lithoplasty System, K161384, cleared by FDA on September 14, 2016.

## Indications for Use / Intended Use

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

### Device Description

The Shockwave Medical Lithoplasty System has three components: a proprietary balloon catheter, a generator, and a connector cable. The balloon 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 the structure of an occlusive vascular deposit (stenosis) prior to low-pressure balloon dilation of the stenosis and facilitates the passage of blood.

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The Lithoplasty 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 Shockwave Medical Lithoplasty Generator delivers energy through the Connector Cable to the pulse emitters located inside the balloon in the Lithoplasty Catheter. The Lithoplasty Catheter is a single-use device supplied sterile to the customer. The Generator and Connector Cable are non-sterile reusable devices.

## Technological Comparison

The proposed Shockwave Medical Lithoplasty System described in this 510(k) Premarket Notification has the same feature set and technological characteristics and is similar tothe predicate device. Updates are being made to the Generator enclosure, display, IV pole mounting mechanism and packaging. In addition, a minor update to dimensions is being made to the Lithoplasty Catheter hub. Lastly, the connectors between the Lithoplasty Catheter, Connector Cable, and Generator are being updated from a mechanical locking to a magnetic electrical connector. The changes are being made to enhance usability and manufacturability.

The proposed device is identical and substantially equivalent to the predicate device Shockwave Medical Lithoplasty System, K161384, in terms of its intended use/ indications for use, as well as fundamental technological characteristics and principles of operation. All technological characteristics of the Shockwave Medical Lithoplasty System are substantially equivalent to the predicate device including scientific technology, design, blood-tissue and patient contacting materials, energy source, shelf life, manufacturing processes, biocompatibility and sterilization.

## Summary of Performance Data

Testing of the Lithoplasty Catheter hub update as well as the connections between the Lithoplasty Catheter, Connector Cable, and Generator was performed. To support the Generator enclosure and display updates, hardware, electrical performance, electromagnetic compatibility, and software verification and validation tests were conducted. Objective evidence demonstrating that the Lithoplasty 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 and all applicable FDA guidance documents and relevant international standards. Component level testing included ISO 594-1:1986 and ISO 594-2: second edition 1998-09-01 testing for the tri-port hub. Generator and Connector Cable safety testing was completed successfully per ANSI/AAMI ES60601-1:2005/(R)2012 and electromagnetic compatibility testing requirements for medical electrical equipment were met per IEC 60601-1-2:2007/A:2010.

Results demonstrate that the performance of the Shockwave Medical Lithoplasty System meets its design specifications and is suducpycm "gs wxcrgpv"for its intended use.

### Summary of Biocompatibility Testing

There have been no changes to the blood tissue or patient contacting components or materials for the Shockwave Medical Lithoplasty System; they are similar to the predicate device. Minor dimensional updates were made to the Triport hub, considered indirect patient contacting, with

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no change to the material. Since the component changes were minor, no new biocompatibility testing was warranted.

## Sterilization, Shelf life and Packaging

There is no change to the sterilization or shelf life of the Shockwave Medical Lithoplasty System.

Lithoplasty Catheters are individually packaged in a Tyvek/Nylon pouch. There is no change to the packaging of the Shockwave Medical Lithoplasty Catheter requiring additional testing.

The Shockwave Medical Lithoplasty System Generator Cable are re-usable medical equipment and are provided non-sterile. For ease of user convenience, the packaging of the Lithoplasty Generator, Connector Cable and accessories was updated from Pelican Model 1620 (Pelican Products US) to Pelican Model 1610. Packaging and Simulated Transit testing was completed for the Shockwave Medical Lithoplasty Generator, Connector Cable and accessories packaged in 1610 Pelican case. There is no change to the packaging materials of the replacement Connector Cable sold separately.

## Basis for Substantial Equivalence

The Lithoplasty System shares the same intended use, principles of operation, overall technical and functional capabilities, and similar design and blood tissue contacting materials as the identified predicate device. Any differences between the Lithoplasty System and predicate device 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 Lithoplasty System is therefore substantially equivalent to the predicate device.