MICROVASIVE LIPTHOTRIPSY PROBES

K973788 · Boston Scientific Corp · FFK · Jan 21, 1998 · Gastroenterology, Urology

Device Facts

• Record ID: K973788
• Device Name: MICROVASIVE LIPTHOTRIPSY PROBES
• Applicant: Boston Scientific Corp
• Product Code: FFK · Gastroenterology, Urology
• Decision Date: Jan 21, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.4480
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

An endoscopic intracorporeal pneumatic lithotripter probe for use in fragmenting urinary calculi, including renal, ureteral and bladder stones through rigid, semi-rigid and flexible endoscopes.

Device Story

Microvasive Lithotripsy Probes are endoscopic accessories used for mechanical fragmentation of urinary calculi. The device functions as a pneumatic lithotripter probe, transmitting energy to fragment stones within the urinary tract. It is intended for use by physicians in clinical settings during endoscopic procedures (rigid, semi-rigid, or flexible). The probe is inserted through the endoscope to contact the stone; pneumatic energy is applied to break the calculus into smaller pieces for easier removal or passage. This facilitates minimally invasive treatment of renal, ureteral, and bladder stones, potentially reducing the need for more invasive surgical interventions.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Pneumatic lithotripsy probe designed for use with endoscopic systems. Mechanical energy transmission principle. Compatible with rigid, semi-rigid, and flexible endoscopes.

Indications for Use

Indicated for the fragmentation of urinary calculi, including renal, ureteral, and bladder stones, in patients requiring endoscopic lithotripsy via rigid, semi-rigid, or flexible endoscopes.

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

• Lithoclast Lithotripsy Probes

Submission Summary (Full Text)

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510(k) Premarket Notification
Lithotripsy Probe October 1, 1997

Boston Scientific Corporation Doctor Scientific Place
Natick, MA 01760-1537

## SECTION X 510(K) SUMMARY

.

| Sponsor: | Boston Scientific Corporation<br>One Scientific Place<br>Natick, MA 01760-1537 | K973788 |
|------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| | | P171 |
| | | JAN 21 1998 |
| Contact Person: | Lorraine M. Hanley Manager,<br>Regulatory Affairs or<br><br>Carol J. Holloway<br>Regulatory Affairs Specialist | |
| Submission Date: | October 1, 1997 | |
| Common/Usual Names:<br>Trade/Proprietary Name: | Endoscopic Intracorporeal Pneumatic Lithotripter Probe<br>To Be Determined | |
| Device Classification<br>and Name: | Boston Scientific Corporation believes that while the proposed device is<br>classified as Class III, a Class II classification is appropriate for this device<br>proposed by the EMS 515(i) submission currently under review.<br>• CFR 876-4480; Lithotripter, Electro-hydraulic<br>Product Code: 78FFK | |
| Substantial Equivalence: | The proposed Microvasive® Lithotripsy Probes are <i>Substantially</i><br><i>Equivalent</i> to the currently marketed Lithoclast Lithotripsy Probes used<br>for fragmenting urinary calculi, including renal, ureteral and bladder<br>stones, through rigid, semi-rigid and flexible endoscopes. | |
| Product Testing: | The proposed Microvasive® Lithotripsy Probes are <i>Substantiaily</i><br><i>Equivalent</i> to the currently marketed Lithotripsy Probes in terms of<br>performance characteristics tested. | |

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 2 | 1998

Ms. Carol J. Holloway Regulatory Affairs Specialist Boston Scientific Corporation One Boston Scientific Place Natick, Massachusetts 01760-1537 Re: K973788

Endoscopic Intracorporeal Pneumatic Lithotripter Probe Dated: October 1, 1997 Received: October 6, 1997 Regulatory class: III 21 CFR §876.4480/Product code: 78 FFK

Dear Ms. Holloway:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent for the indications for use stated in interstate commerce prior to May 28, 1976, the enactment date of the Medical Devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, 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 misbraning and adulteration.

If your device is classified (see above) into either class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification does not affect any obligation you might have under sections 531 through 542 of the Act for devices under Radiation Control provisions, or . other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a 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 (2) CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for question 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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone]-or-[phone] or at its Internet address http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours.

W.Lilian Yin

Lillian Yin, Ph.D. Director, Division of Reproductive. Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

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Page _________________________________________________________________________________________________________________________________________________________________________

510(k) Number (if known): K973788

Device Name:

MLP

Indications For Use:

An endoscopic intracorporeal pneumatic lithotripter probe for use in fragmenting urinary calculi, including renal, ureteral and bladder stones through rigid, semi-rigid and flexible endoscopes.

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

Prescription Use
(Per 21 CFR 801.109)

イ

or

Over-The-Counter Use_

Robert R. Sothman

(Optional Format 1-2-96)

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 97 388 510(k) Number _