SUCTION PUMP FOR INTRACORPOREAL ULTRASOUND LITHOTRIPTER AND ACCESSORIES, MODEL 2207.XXX

K011911 · Richard Wolf Medical Instruments Corp. · FFK · Sep 17, 2001 · Gastroenterology, Urology

Device Facts

• Record ID: K011911
• Device Name: SUCTION PUMP FOR INTRACORPOREAL ULTRASOUND LITHOTRIPTER AND ACCESSORIES, MODEL 2207.XXX
• Applicant: Richard Wolf Medical Instruments Corp.
• Product Code: FFK · Gastroenterology, Urology
• Decision Date: Sep 17, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.4480
• Device Class: Class 2

Intended Use

Suction pump 2207 with its accessories is used to aspirate liquids in ultrasound lithotripsy. It is designed for combined use with the ultrasound generator 2271 for aspiration of disintegrated kidney stones, bladder stones and ureter stones and the liquid involved.

Device Story

Roller pump generates continuous vacuum for aspiration of liquids and stone fragments during ultrasound lithotripsy. Device integrates with ultrasound generator 2271; suction rate increases automatically during ultrasound activation. Vacuum level and suction rate are continuously monitored and feedback-controlled by software. Flow detector monitors suction performance. Safety circuit interrupts suction if pump housing cover is opened. Used in clinical settings by medical professionals. Output allows for clear surgical field by removing debris and irrigation fluid, facilitating stone removal and potentially reducing procedure time.

Clinical Evidence

No clinical tests performed. Bench testing only.

Technological Characteristics

Roller pump mechanism; software-controlled vacuum feedback; flow detector; safety interlock for housing cover; interface for ultrasound generator 2271; electrical safety per UL 2601 and IEC 601-1.

Indications for Use

Indicated for aspiration of liquids and disintegrated kidney, bladder, and ureter stones during ultrasound lithotripsy. No specific contraindications; physician to determine suitability based on patient's general condition.

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

• Suction pump 2017.00 (pre-enact.)
• Ultrasound Lithotriptor 2271 (K011065)

Submission Summary (Full Text)

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SEP 1 7 2001

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Image /page/0/Picture/2 description: The image shows the logo for Richard Wolf Medical Instruments Corporation. The logo features the words "RICHARD WOLF" in bold, black letters, with "RICHARD" stacked above "WOLF". Below the company name is the text "Medical Instruments Corporation" in a smaller font. To the right of the company name is a square graphic with a black border, containing an abstract image of a wolf.

353 Corporate Woods Parkway Vernon Hills, IL 60061 Phone: [phone] Customer Service: 800-323-WOLF www.richard-wolf.com

| | | <b>12.0 510(k) Summary of Safety and Effectiveness</b> | | | |
|---------------------------------------------------------------------|-------------------------------------------------------------------------|--------------------------------------------------------|----------|----------------------------------------|------------------------------------|
| Submitter: | | | | Date of Preparation: | |
| Company / Institution name: | RICHARD WOLF MEDICAL INSTRUMENTS CORP. | | | June 18, 2001 | |
| Division name (if applicable): | N.A. | | | FDA establishment registration number: | |
| | | | | 14 184 79 | |
| Street address: | 353 Corporate Woods Parkway | | | Phone number (include area code): | |
| | | | | ( 847 ) 913 1113 | |
| City: | Vernon Hills | State/Province: | Illinois | FAX number (include area code): | |
| | | | | ( 847 ) 913 0924 | |
| Country: | USA | ZIP / Postal Code: | IL 60061 | | |
| Contact name: | Mr. Robert L. Casarsa | | | | |
| Contact title: | Quality Assurance Manager | | | | |
| Product Information: | | | | | |
| Trade name: | Suction pump for Intracorporeal Ultrasound Lithotripter and accessories | | | Model number: | 2207.xxx |
| Common name: | Suction Pump | | | Classification name: | Gastroenterology-urology evacuator |
| Information on devices to which substantial equivalence is claimed: | | | | | |
| 510(k) Number | Trade or proprietary or model name | | | Manufacturer | |
| 1 pre-enact. | 1 Suction pump 2017.00 | | | 1 Richard Wolf | |
| 2 K011065 | 2 Ultrasound Lithotriptor 2271 | | | 2 Richard Wolf | |

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#### 1.0 Description

The Suction pump 2207 is a roller pump that generates a continuous vacuum for aspirating the particles and liquids during ultrasound lithotripsy into a fluid trap (bottle).

#### 2.0 Intended Use

Suction pump 2207 with its accessories is used to aspirate liquids in ultrasound lithotripsy. It is designed for combined use with the ultrasound generator 2271 for aspiration of disintegrated kidney stones, bladder stones and ureter stones and the liquid involved.

#### 3.0 Technological Characteristics

The vacuum applied to the fluid trap (and with it the suction rate) is continuously measured and feedback-controlled by software.

The suction is monitored by a flow detector.

A safety circuit interrupts the suction if the cover of the pump housing is opened. The suction pump has an interface to our Intracorporeal Ultrasound Lithotripter 2271 for increasing the suction rate during activation of ultrasound.

#### 4.0 Substantial Equivalence

The submitted devices pose the same type of questions about safety or effectiveness as the predicate devices and the new technological characteristics have not diminished safety or effectiveness. The submitted devices are substantially equivalent to existing 510(k)-devices sold by Richard Wolf and competitors.

#### 5.0 Performance Data

The Suction pump 2207 is conforming to standards UL 2601 and IEC 601-1.

#### 6.0 Clinical Tests

No clinical tests performed.

#### 7.0 Conclusions Drawn

These devices are designed and tested to guarantee the safety and effectiveness, when used according to the instructions manual.

By: ....

Robert L. Casarsa Quality Assurance Manager

Date: June 18, 2001

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles three stylized human profiles or birds in flight.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

### DEC 2 0 2001

Mr. Robert L. Casarsa Quality Assurance Manager Richard Wolf Medical Instruments Corp. 353 Corporate Woods Parkway VERNON HILLS IL 60061

Re: K011911

Trade/Device Name: Model 2270.011 Suction Pump for Intracorporeal Ultrasound Lithotriptor and Accessories Regulation Number: 21 CFR \$876.4480 Regulation Name: Electrohydraulic Lithotriptor Regulatory Class: II Product Code: 78 FFK Dated: June 18, 2001 Received: June 19, 2001

Dear Mr. Casarsa:

This letter corrects our substantially equivalent letter of September 17, 2001, regarding the Model 2270 Suction Pump for Intracorporeal Ultrasound Lithotriptor and Accessories which was listed as a model 2270 Ultrasound Generator.

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). You may, therefore, market the device, subject to the general controls provisions of the Act. The gencral 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.

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Page 2 - Mr. Robert Casarsa

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.

This letter will allow you to continue market your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to legally marketed predicate device 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 and additionally Part 809.10 for in vitro diagnostic devices), Please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at their toll free number [phone] or at [phone] or at its Internet address http://www.fda.gov/cdrl/dsma/dsmanain.html.

Sincerely yours,

Yurid le. deponon

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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## 5.0 Indications for Use

# 510(k) Number (if known): —

Device Name: Suction pump for Intracorporeal Ultrasound Lithotripter and accessories

- Intended use: Suction pump 2207 with its accessories is used to aspirate liquids in ultrasound lithotripsy. It has been designed for combined use with the ultrasound ultrasound litholipsy. It nas in with ultrasound generator 2271 the suction pump is generator 22711. In ochance of disintegrated kidney stones, bladder stones and ureter stones and the liquid involved.
- Contraindications: Contraindications directly related to the product are presently rannown. On the basis of the patient's general condition the doctor in charge must anklown. On the basianed use is possible or not. For further information see the latest medical literature.
- Combinations: The R.Wolf "Suction Pump 2207" is specially designed for use with an ultrasound lithotriptor. It is specially designed for combined use with the WOLF US-LITHO 2271.

If the suction pump is to be used in conjunction with other ultrasound lithotriptors if the buoten pamp to the user must check whether the device combination can (other maintain the required functions on a continuous basis.

Nancy C brogdon

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K011911

*Prescription Use* ✓