CIRCON AEH-4 ELECTROHYDRAULIC LITHOTRIPSY PROBE

K011848 · Circon Video · FFK · Sep 11, 2001 · Gastroenterology, Urology

Device Facts

• Record ID: K011848
• Device Name: CIRCON AEH-4 ELECTROHYDRAULIC LITHOTRIPSY PROBE
• Applicant: Circon Video
• Product Code: FFK · Gastroenterology, Urology
• Decision Date: Sep 11, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.4480
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Circon AEH-4 Electrohydraulic Lithotripter (EHL) Probes are to be used with the Circon AEH-4 Electrohydraulic Lithotripter to fragment stones (calculi) in the urinary and biliary tracts.

Device Story

Circon AEH-4 Electrohydraulic Lithotripter Probes are accessory devices used with the Circon AEH-4 Electrohydraulic Lithotripter system. The system functions by generating an electrical spark at the probe tip, creating a hydraulic shock wave that fragments urinary and biliary stones. The device is intended for use by physicians in clinical settings. The probe delivers the energy required for lithotripsy, facilitating stone removal or passage. The device is a mechanical accessory to the lithotripter unit.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Electrohydraulic lithotripter probe; functions via electrical spark-induced hydraulic shock wave generation. Designed for compatibility with the Circon AEH-4 Electrohydraulic Lithotripter system. Mechanical device; no software or electronic processing components.

Indications for Use

Indicated for fragmentation of urinary and biliary tract calculi 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.”

Submission Summary (Full Text)

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

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/11 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the department's name around the perimeter. Inside the circle is an image of an eagle.

SEP 1 1 2001

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Jerry Crouthers Circon Corporation 6500 Hollister Ave. SANTA BARBARA CA 93117-3019

Re: K011848 Trade/Device Name: CIRCON AEH-4 Electrohydraulic Lithotripter Probes Regulation Number: 21 CFR 876.4480 Regulation Name: Electrohydraulic Lithotriptor Regulatory Class: Class II Product Code: 78 FFK Dated: June 12, 2001 Received: June 13, 2001

Dear Mr. Crouthers:

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.

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); 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.

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

Page 2

This letter will allow you to begin marketing your device as described in your 510(k) premarket I his letter will and on your substantial equivalence of your device to a legally marketed predication. The results in a classification for 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 IT you desire spooline action of the following numbers, based on the regulation number at the top of this letter:

| 8xx.1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on of folcrence to promained the Act may be obtained from the Division of Small Manufacturers, your responsibilities and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.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

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

## CIRCON CORPORATION Circon AEH-4 Electrohydraulic Lithotripter Probes FDA Premarket Notification 510(k)

## INDICATIONS FOR USE STATEMENT

## K011848 510(k) Number (if known):_

Device Name: Circon AEH-4 Electrohydraulic Lithotripter Probes

The Circon AEH-4 Electrohydraulic Lithotripter (EHL) Probes are to be used with the Circon AEH-4 Electrohydraulic Lithotripter to fragment stones (calculi) in the urinary and biliary tracts.

## (PLEASE NO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CRDH, Office of Device Evaluation (ODE)

David R. Ligman

(Division Sign-Om)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number. K6118

**Prescription Use**

1-5