CYBERSONICS CYBERWAND DUAL PROBE LITHOTRIPTER

K052135 · Cybersonics, Inc. · FFK · Dec 20, 2005 · Gastroenterology, Urology

Device Facts

• Record ID: K052135
• Device Name: CYBERSONICS CYBERWAND DUAL PROBE LITHOTRIPTER
• Applicant: Cybersonics, Inc.
• Product Code: FFK · Gastroenterology, Urology
• Decision Date: Dec 20, 2005
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 876.4480
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Cybersonics, Cyberwand Dual Probe Lithotripter is intended to be used for the percutaneous fragmentation and removal of kidney stones.

Device Story

Electromechanical device for percutaneous fragmentation and aspiration of urinary calculi. System comprises handpiece with ultrasonic transducer (piezo-electronic elements) and generator operating at 21 ± 1 kHz. Longitudinal waves propagate along hollow dual probe to target stone; hollow design enables simultaneous suction. Used by physicians in clinical settings. Output is mechanical ultrasonic energy for stone disintegration. Benefits include efficient stone fragmentation and removal. Device performance validated via bench testing comparing drill rates against multiple predicate lithotripters.

Clinical Evidence

Bench testing only. Drill rate performance compared against six predicate/reference devices using artificial stone models. Cyberwand demonstrated a mean drill rate of 8.7 ± 0.9 seconds, outperforming the EMS LithoClast Ultra (10.9 ± 1.0 seconds) and other reference devices (ranging from 28.8 to 103.7 seconds).

Technological Characteristics

Electromechanical ultrasonic lithotripter. Piezo-electric transducer; titanium horn. Operating frequency 20–22 kHz. Hollow probes (OD ≤ 3.75mm, length 400mm). Table-top generator (120–240 Vac). Applied part type BF. Autoclavable handpiece and probes. Threaded probe assembly. Detachable footswitch.

Indications for Use

Indicated for the fragmentation of urinary tract calculi in the kidney and bladder.

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

• EMS Swiss Lithoclast Ultra (K012445)
• Karl Storz Electro Medical Systems Calcuson (K973251)

Reference Devices

• Olympus LUS-2
• Circon-ACMI USL-2000
• Olympus LUS-1
• Richard Wolf Model 2271-004

Submission Summary (Full Text)

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K052135

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DEC 2 0 2005

## 510(k) Summary per 807.92(c) for Cybersonics, Inc.

## CYBERWAND DUAL PROBE LITHOTRIPTER

#### SPONSOR

#### CYBERSONICS, INC.

5368 Kuhl Road Erie, Pennsylvania 16510-4703 USA Phone: [phone] Fax: [phone] Contact Person: William A. Stoll Date Prepared: August 01, 2005

#### DEVICE NAME

Trade/Proprictary Name: Cybersonics, Cyberwand Dual Probe Lithotripter Common/Usual Name: Intracorporeal ultrasonic lithotripter Classification Name: Lithotripter, Ultrasonic Class: 11 (876.4480) 78 FFK

### DEVICE EQUIVALENCE

Substantially equivalent to the legally marketed EMS Swiss Lithoclast Ultra.

#### DEVICE DESCRIPTION

The Cybersonics, Cyberwand Dual Probe Ultrasonic Lithotripsy system is an electromechanical device capable of fragmenting and aspirating calculi. The hand piece consists of an ultrasonic transducer containing the piezo-electronic elements, which are driven by a generator operating at 21 ± 1 kHz. The resulting longitudinal waves are propagated along the ultrasonic dual probe to the target stone. The ultrasonic transducer probes are hollow, permitting simultaneous suction.

#### INTENDED USE

The Cybersonics, Cyberwand Dual Probe Lithotripter is intended to be used for the percutaneous fragmentation and removal of kidney stones.

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## BASIS FOR SUBSTANTIAL EQUIVALENCE

Cybersonics Cyberwand Dual Probe Lithotripter is substantially equivalent to the Electro Medical Systems SA Swiss LithoClast Ultra (K012445), and Karl Storz Electro Medical Systems oripter (K973251) which have been cleared for the Calcuson Oftrasonic Ention por (emoval of kidney stones. Information on these perculancous fragmentation and removal of this submission. The Cyberwand Dual Probe systems can be found in section 11 or this succifications as compared with the predicate devices. Substantial equivalence has also been demonstrated by stone predicate devices. Duostantal equivalention of that the Cybersonics, Cyberwand Dual Probe Lithotripter results in fragmentation of a variety of standard artificial stone I 1000 Enthoulpter results in 1988
materials (ranging from soft to hard) when tested against predicate ultrasound lithotripters.

| | Storz<br>Calcuson | Olympus<br>LUS-2 | EMS<br>LithoClast<br>Ultra | Cybersonics<br>Cyberwand |
|----------------------------------------------|-------------------|------------------|----------------------------|--------------------------|
| Comparison of Technological Characteristics | | | | |
| Operating<br>Frequency | 25--26kHz | 23.5kHz | 24--26kHz | 20--22kHz |
| Utilities | 120--240 Vac | 120--240 Vac | 120--240 Vac | 120--240Vac |
| Autoclavable<br>probes and hand<br>piece | Yes | Yes | Yes | Yes |
| Probes threaded<br>for assembly | Yes | Yes | Yes | Yes |
| Probe length<br>( standard ) | 400 mm | 400 mm | 400 mm | 400 mm |
| Probe OD ≤<br>3.75mm | Yes | Yes | Yes | Yes |
| Ultrasonic Probe<br>tip excursion<br>≤100 µm | Yes | Yes | Yes | Yes |
| Detachable hand<br>piece | Yes | Yes | Yes | Yes |
| Handpiece with<br>rear suction<br>connection | Yes | Yes | Yes | Yes |
| Piezo stack with<br>Titanium horn | Yes | Yes | Yes | Yes |
| Detachable<br>footswitch | Yes | Yes | Yes | Yes |
| Table Top<br>Generator | Yes | Yes | Yes | Yes |
| Applied Part BF | Yes | Yes | Yes | Yes |

5368 Kuhl Road • Erie, Pennsylvania 16510-4703 • TEL [phone] • FAX [phone]

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| Drill Rate Comparisons<br>Drill rate data supplied by Indiana University School of Medicine | | | | | |
|---------------------------------------------------------------------------------------------|----------------|----------------------------------------|--|--|--|
| Instrument | Stones Treated | Drill Rate in Seconds<br>(Mean +/- SD) | | | |
| Cyberwand | 10 | 8.7 +/- 0.9 | | | |
| Litho Clast Ultra | 10 | 10.9 +/- 1.0 | | | |
| Olympus LUS-2 | 25 | 28.8 +/- 2.7 | | | |
| Circon-ACMI USL-2000 | 25 | 31.7 +/- 8.1 | | | |
| Karl Storz Calcuson | 15 | 40.3 +/- 8.1 | | | |
| Olympus LUS-1 | 12 | 60.5 +/- 13.5 | | | |
| Richard Wolf Model 2271-004 | 10 | 103.7 +/- 21.6 | | | |

## CONCLUSION

Cybersonics Cyberwand Dual Probe Lithotripter is substantially equivalent to the legally Cybersonics Cyberwand Daal Proov wand is as safe, as effective and performs as well or better than the predicate devices.

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Image /page/3/Picture/1 description: The image shows a circular seal with the words "Department of Health & Human Services" around the edge. Inside the circle is a stylized image of a bird or other winged creature. The image is in black and white and appears to be a scan or photocopy.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 2 0 2005

Mr. William A. Stoll Manager of Quality Assurance & Regulatory Affairs Cybersonics, Inc. 5368 Kuhl Road ERIE PA 16510

Re: K052135

Trade/Device Name: Cyberwand Dual Probe Lithotripter Regulation Number: 21 CFR §876.4480 Regulation Name: Electrohydraulic lithotriptor Regulatory Class: II Product Code: FFK Dated: November 29, 2005 Received: November 30, 2005

Dear Mr. Stoll

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced we have levewed your socurer 5 retty prehentially equivalent (for the indications for use stated in above and nave decomments ad predicate devices marketed in interstate commerce prior to the enclosure) to tegany manectod production of the Medical Devices that have been May 20, 1770, the chanance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that reciassified in accordation while pro noval application (PMA). You may, therefore, market the do not require approval of a promation approvisions of the Act. The general controls provisions of the Act device, subject to the general volual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket If your device is classified (300 as 10) hitting major regulations affecting your Approval), it thay of subject to secured Regulations, Title 21, Parts 800 to 898. In addition, FDA uevice can be round in the concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that Please be advisou mai 1 DA s 135dailed of a see complies with other requirements of the Act of the Act of the FDA has made a decemination mad your as router Federal agencies. You must comply with all the Federal statues and regulations administration and listing (21 CFR Part 807); labeling Act s requirements, metading but hot minted to reguirements as set forth in the quality systems (QS) (21 CFR Part 801); good manufacturing product radiation control product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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This letter will allow you to begin marketing your device as described in your Section 5 I (k) This letter will allow you lo begin matketing your actives of your device of your device of your device to a legally
premarket notification. The FDA finding of substantial e premarket notification. The IDA finding of substantial equildine of your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire specific advice for your device on our laboring regulation () ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( the top of this letter:

| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|-----------------|----------------------------------|--------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Also, please note the regulation entitled, "Misoration on your responsibilities under the Act from the 807.97). You may obtain other general intonnation on your respections and its toll-free number (800) Division of Binan National of Street address 056-2041 of (2019/01/2019/2017/industry/support/index.html.

Sincerely yours,

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known): K052135

Device Name: Cybersonics – Cyberwand Dual Probe Lithotripter

Indications for Use:

The Cyberwand Dual Probe Lithotripter is intended to be used for the fragmentation of urinary The Cyberwand Daily and bladder.

Prescription Use
(Part 21 CFR 801 Subpart D)

AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Jennie A. Symm

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

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(Posted November 13, 2003)