CYBERWAND LITHOTRIPTER

K102169 · Cybersonics, Inc. · FFK · Aug 30, 2010 · Gastroenterology, Urology

Device Facts

• Record ID: K102169
• Device Name: CYBERWAND LITHOTRIPTER
• Applicant: Cybersonics, Inc.
• Product Code: FFK · Gastroenterology, Urology
• Decision Date: Aug 30, 2010
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 876.4480
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The CyberWand Hollow Semi-Flexible Ureteral probe is designed to be used only with the CyberWand System for the fragmentation of urinary tract calculi in the kidneys, ureter, and bladder.

Device Story

The CyberWand Hollow Semi-Flexible Ureteral Probe is an accessory to the CyberWand Dual Ultrasonic Lithotripsy System. The system uses ultrasonic energy to fragment and aspirate urinary calculi. The probe is a stainless steel, semi-flexible instrument (58.5 cm length, 1.65 mm diameter) designed for use with semi-rigid or rigid scopes (cystoscopes, nephroscopes, ureteroscopes) having 5-7 French working channels. Operated by a physician in a clinical setting, the probe facilitates stone fragmentation within the urinary tract. The device is provided non-sterile for single-patient use.

Clinical Evidence

Bench testing only. Representative samples underwent durability and stone breakage testing in accordance with Cybersonics Design Control processes and risk assessment to verify functional and performance requirements.

Technological Characteristics

Stainless steel construction; semi-flexible form factor; 58.5 cm working length; 1.65 mm outer diameter; compatible with 5-7 French scope working channels; ultrasonic energy source; single-patient use.

Indications for Use

Indicated for fragmentation of urinary tract calculi in the kidneys, 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

• Cyberwand Dual Probe Set (K052135)

Submission Summary (Full Text)

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

K102169

AUG 3 0 2010

## 510(K) SUMMARY 6.

- 'ঊ

| Submitter: | Cybersonics, Inc.<br>5325 Kuhl Road<br>Erie, PA 16510<br>Phone: [phone]<br>Fax: [phone]<br>Contact: Jeff Vaitekunas |
|-----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date Prepared: | July 30, 2010 |
| Trade Name: | CyberWand® Lithotripter |
| Classification: | Class II, 21 CFR 876.4880, FFK<br>Electrohydraulic lithotripter |
| Predicate Device(s): | The CyberWand Hollow Semi-Flexible Ureteral probe is equivalent to<br>the Cyberwand Dual Probe Set (K052135). |
| Device Description: | The CyberWand Dual Ultrasonic Lithotripsy System is an<br>electromechanical device used to fragment and aspirate calculi. The<br>system consists of the generator unit, transducer handpiece,<br>footswitch, probe sets and cleaning stylets.<br><br>The Semi-Flexible Probe is constructed entirely of stainless steel and<br>is packaged with a stainless steel cleaning stylet. The probe has a<br>working length of 58.5 cm and an outer diameter of 1.65 mm; it is is<br>intended to be used primarily with semi-rigid or ridged scopes<br>(cystoscopes, nephroscopes and ureteroscopes) which have a working<br>channel between 5 and 7 French in diameter.<br><br>The probe is for provided non-sterile and is for single-patient use. |
| Intended Use: | The CyberWand Hollow Semi-Flexible Ureteral probes are designed<br>to be used only with the CyberWand Dual Ultrasonic Lithotripsy<br>System for the fragmentation of urinary tract calculi in the kidneys,<br>ureter, and bladder. |
| Functional and Safety<br>Testing: | To verify that device design met its functional and performance<br>requirements, representative samples of the device underwent<br>durability and stone breakage testing in accordance with Cybersonics<br>Design Control processes and the risk assessment. |
| Conclusion: | Cybersonics considers the modified probes to be equivalent to the<br>predicate device listed above. This conclusion is based upon the<br>devices' similarities in principles of operation, technology, materials<br>and indications for use. |

.

:

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

Image /page/1/Picture/0 description: The image shows the logo for the Department of Health & Human Services in the USA. The logo features a stylized eagle with its wings spread, facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

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

Mr. Jeff Vaitekunas Vice-President Regulatory Cybersonics, Inc. 5325 Kuhl Road ERIE PA 16510

AUG 3'0 2010

Re: K102169

Trade/Device Name: Cybersonics CyberWand® Hollow Semi-Flexible Ureteral Probe Regulation Number: 21 CFR§ 876.4480 Regulation Name: Electrohydraulic Lithotriptor Regulatory Class: II Product Code: FFK Dated: July 30, 2010 Received: August 2, 2010

Dear Mr. Vaitekunas:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your betermined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate 101 use stated in the encreations of the Medical Device Americal Device Americans, or to conninered phor to may 20, 1978, me except ance with the provisions of the Federal Food, Drug, devices that have been require approval of a premarket approval application (PMA). and Cosmetic Treefore, market the device, subject to the general controls provisions of the Act. The I ou may, merelore, mains of the Act include requirements for annual registration, listing of general controls provisioning practice, labeling, and prohibitions against misbranding and devices, good manufacturing praction, accomment related to contract liability addition. Thease note. SDATE ver, 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 If your device is classified (boo above) axisting major regulations affecting your device can be filly be subject to additional controlly institute and to 898. In addition, FDA may in 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 Please be advised that I DPT 3 issuation of a station of the requirements of the Act
that FDA has made a determination that your device complies with other comple that FDA has made a decernmanon that your conserved by other Federal agences. You must comply
or any Federal statutes and regulations administered by other Federal and listi of any Federal Statutes and regulations administered of to: registration and listing (21 CFR Patter with all the Act s requirements, medical device reporting of medical device-related

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

Page 2

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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Stuker Lemur MD

Herbert P. Lerner, M.D., Director (Acting) Division of Reproductive, Gastro-Renal and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health.

Enclosure

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

## 5. INDICATIONS FOR USE STATEMENT

510(k) Number (if known): KJO2169

Device Name: Cybersonics CyberWand® Hollow Semi-Flexible Ureteral Probe

## Indications for Use:

The CyberWand Hollow Semi-Flexible Ureteral probe is designed to be used only with the CyberWand System for the fragmentation of urinary tract calculi in the kidneys, ureter, and bladder.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

## Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)-
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number. K102169

Special 510(k) - CyberWand Hollow Semi-Flexible Ureteral Probe

Page 19 of 70