ShockPulse-SE Lithotripsy System

K171024 · Cybersonics, Inc. · FEO · Aug 21, 2017 · Gastroenterology, Urology

Device Facts

• Record ID: K171024
• Device Name: ShockPulse-SE Lithotripsy System
• Applicant: Cybersonics, Inc.
• Product Code: FEO · Gastroenterology, Urology
• Decision Date: Aug 21, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.4480
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

ShockPulse-SE Lithotripsy System is intended to be used for the fragmentation of urinary tract calculi in the kidney, ureter and bladder.

Device Story

Electromechanical device for fragmentation and aspiration of urinary tract calculi. System comprises generator, probes, transducer, cleaning stylet, wrench, power cord, nosecone, and optional footswitch. Operates via ultrasonic technology: transducer converts electrical energy into ultrasonic frequency vibrations (19,500–21,500 Hz) transmitted through a probe to mechanically break stones. Used in clinical settings by physicians. Output is physical fragmentation of calculi; healthcare providers use this to clear urinary tract obstructions. Benefits include effective stone removal.

Clinical Evidence

Bench testing only. Performance metrics included electrical safety, EMC/EMI, biocompatibility, bioburden, EO residuals, mass removal rate, drill rate, displacement, and frequency. All tests passed.

Technological Characteristics

Ultrasonic lithotriptor; 100W max output; 19,500–21,500 Hz frequency. Materials: 304 Stainless Steel, with diamond-like carbon coating on select probes. Applied part type: BF. Sterilization: Ethylene Oxide (disposable probes), Prevac Cycle/Prevac Flash Cycle (reusable probes).

Indications for Use

Indicated for fragmentation of urinary tract calculi in the kidney, ureter, and bladder in patients requiring lithotripsy.

Regulatory Classification

Identification

An electrohydraulic lithotriptor is an AC-powered device used to fragment urinary bladder stones. It consists of a high voltage source connected by a cable to a bipolar electrode that is introduced into the urinary bladder through a cystoscope. The electrode is held against the stone in a water-filled bladder and repeated electrical discharges between the two poles of the electrode cause electrohydraulic shock waves which disintegrate the stone.

Special Controls

The special control for this device is FDA's “Guidance for the Content of Premarket Notifications for Intracorporeal Lithotripters.”

Predicate Devices

• ShockPulse-SE Lithotripsy System (K142428)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

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

August 21, 2017

Cybersonics, Inc. Samradni Patil Regulatory Affairs Manager Knowledge Park, 5340 Fryling Road, Suite 101 Erie. PA 16510

Re: K171024

Trade/Device Name: ShockPulse-SE Lithotripsy System Regulation Number: 21 CFR§ 876.4480 Regulation Name: Electrohydraulic Lithotriptor Regulatory Class: II Product Code: FEO Dated: July 24, 2017 Received: July 25, 2017

Dear Samradni Patil:

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.

{1}------------------------------------------------

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 device-related 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 contact the Division of Industry and Consumer Education (DICE) 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 (DICE) at its toll-free number [phone] or [phone] or at its Internet address

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

Sincerely.

Image /page/1/Picture/9 description: The image shows the name "Benjamin R. Fisher -S" in a large, bold font. The text is black and appears to be centered on a white background. The letters are clearly legible and well-defined.

Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

# Indications for Use

510(k) Number (if known) K171024

Device Name ShockPulse-SE Lithotripsy System

Indications for Use (Describe)

ShockPulse-SE Lithotripsy System is intended to be used for the fragmentation of urinary tract calculi in the kidney, ureter and bladder.

| 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.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

#### Cybersonics Inc.

### 510(k) Summary of Safety and Effectiveness Cybersonics Inc. ShockPulse-SE Lithotripsy System

## General Information

| Manufacturer: | Cybersonics, Inc.<br>Knowledge Park<br>5340 Fryling Road, Suite 101<br>Erie, Pennsylvania 16510 USA<br>Phone: [phone]<br>Fax: [phone] |
|------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|
| Establishment Registration Number: | 3004216443 |
| Contact Person: | Samradni Patil<br>Manager, Regulatory Affairs |
| Date Prepared: | April 3, 2017 |

Device Information

| Classification Name: | Device Classification Name:<br>Electrohydraulic lithotriptor,<br>Regulation / CFR Citation Number: 21<br>CFR 876.4480<br>Product Code: FEO<br>Class: II |
|----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name: | ShockPulse-SE Lithotripsy System |
| Generic/Common Name: | Lithotripter, Ultrasonic Intracorporeal |

Predicate Devices

| Predicate Device | ShockPulse-SE Lithotripsy<br>System (K142428) |
|------------------|-----------------------------------------------|
|------------------|-----------------------------------------------|

{4}------------------------------------------------

Special 510(k) Notification

#### Device Description

The ShockPulse-SE Lithotripsy System is an electromechanical device capable of fragmenting calculi and aspirating stone debris. The ShockPulse-SE Lithotripsy System consists of generator, probes, transducer, cleaning stylet, wrench, power cord and nosecone. Footswitch is optional.

#### Intended Use/Indication for Use

ShockPulse-SE Lithotripsy System is intended to be used for the fragmentation of urinary tract calculi in the kidney, ureter and bladder.

#### Comparison of Technological Characteristics with the Predicate Devices

| | Predicate Device | Proposed Device |
|------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | ShockPulse-SE Lithotripsy System | ShockPulse-SE Lithotripsy System |
| 510(k) Number(s) | K142428 | To be Assigned |
| Product Code | FEO | FEO |
| Intended<br>Use/Indication for<br>Use | ShockPulse-SE Lithotripsy System is<br>intended to be used for the fragmentation<br>of urinary tract calculi in the kidney,<br>ureter and bladder. | ShockPulse-SE Lithotripsy System is<br>intended to be used for the fragmentation<br>of urinary tract calculi in the kidney,<br>ureter and bladder. |
| Principle of<br>operation | Ultrasonic technology that uses a<br>transducer to convert electrical energy to<br>ultrasonic frequency vibrations that travel<br>down the probe and break up stones. | Ultrasonic technology that uses a<br>transducer to convert electrical energy to<br>ultrasonic frequency vibrations that travel<br>down the probe and break up stones. |
| Applied Part Type | Type BF | Type BF |
| Ultrasonic<br>Maximum Output<br>to Transducer | 100 Watts | 100 Watts |
| Ultrasonic<br>Frequency | 19,500 Hz – 21,500 Hz | 19,500 Hz – 21,500 Hz |
| Sterilization<br>Method for<br>disposable probes | Ethylene Oxide | Ethylene Oxide |
| Sterilization<br>Method of<br>reusable probes | Prevac Cycle (USA), Prevac Flash Cycle | Prevac Cycle (USA), Prevac Flash Cycle |
| Material<br>for 3.76mm and<br>3.40mm probe<br>tube | 304 Stainless Steel | 304 Stainless Steel coated with diamond<br>like carbon |
| Material for<br>1.83mm, 1.50mm<br>and 0.97mm<br>probe tube | 304 Stainless Steel | 304 Stainless Steel |

{5}------------------------------------------------

Device modifications described in the submission do not affect the intended use or the technological characteristics of the ShockPulse-SE Lithotripsy System.

### Performance Data

Testing has confirmed that the proposed ShockPulse-SE Lithotripsy System functions as intended and is substantially equivalent to the predicate device.

| Performance Testing Performed | |
|-------------------------------|------|
| Electrical Safety | Pass |
| EMC/EMI | Pass |
| Biocompatibility | Pass |
| Bioburden | Pass |
| EO Residuals | Pass |
| Mass removal rate | Pass |
| Drill rate | Pass |
| Displacement | Pass |
| Frequency | Pass |

#### Conclusions

The proposed ShockPulse-SE Lithotripsy System is substantially equivalent to the predicate device. The modifications in the device do not affect the intended use or the technological characteristics for the system and do not raise different questions of safety or effectiveness.