← Product Code [FFK](/submissions/GU/subpart-e%E2%80%94surgical-devices/FFK) · K974164 # SWISS LITHOCLAST MASTER HANDPIECE AND 3.2 MM PROBE (K974164) _Medical Device Consultants, Inc. · FFK · Dec 18, 1997 · Gastroenterology, Urology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/FFK/K974164 ## Device Facts - **Applicant:** Medical Device Consultants, Inc. - **Product Code:** [FFK](/submissions/GU/subpart-e%E2%80%94surgical-devices/FFK.md) - **Decision Date:** Dec 18, 1997 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 876.4480 - **Device Class:** Class 2 - **Review Panel:** Gastroenterology, Urology - **Attributes:** Therapeutic ## Intended Use The LITHOCLAST® MASTER Handpiece and the 3.2 mm probe have the same intended use as their predicate accessories, that is, for the fragmentation of urinary tract calculi, including renal, ureteral and bladder stones, through rigid or semirigid endoscopes. The 3.2 mm probe is specifically indicated for use in fragmenting large stones in the bladder and kidney. ## Device Story Pneumatic lithotripsy accessory system; includes MASTER Handpiece and 3.2 mm probe. Handpiece (aluminum alloy) connects to pressure regulator; internal metal projectile driven by pneumatic pressure; energy transmitted to probe via shock transmitter. Probe (304 stainless steel) couples shockwave to target stone for fragmentation. Used in clinical settings by physicians during endoscopic procedures. Sealed handpiece design prevents contamination and allows probe changes without breaking sterility. Benefits include efficient stone disintegration and improved device longevity compared to open-design predecessors. ## Clinical Evidence Bench testing only. Performance supported by life time testing, probe displacement tests, impact pressure measurements, disintegration efficiency analysis, and in-vitro tissue impact studies. ## Technological Characteristics Handpiece: Aluminum alloy, 18 mm diameter, 228 mm length, sealed design. Probe: Type 304 surgical grade stainless steel, rigid rod. Energy source: Pneumatic pressure. Sterilization: Steam sterilization for reusable probes. ## Regulatory 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 Standard Handpiece ([K951531](/device/K951531.md)) - EMS Standard Handpiece ([K963285](/device/K963285.md)) - EMS probes (0.8, 1.0, 1.6, 2.0 mm) ([K951531](/device/K951531.md)) - EMS probes (0.8, 1.0, 1.6, 2.0 mm) ([K963285](/device/K963285.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ K 974164 Jor i ok #### 510(k) Summary DEC 18 1997 # ELECTRO MEDICAL SYSTEMS SA LITHOCLAST® MASTER Handpiece and ### 3.2 mm Probe - Sponsor 1. ELECTRO MEDICAL SYSTEMS SA Chemin de la Vaurpilliere 31 CH-1260 Nyon Switzerland Manfred Schulz Contact Person: General Manager Date Prepared: October 31, 1997 - 2. Device Name | Trade/Proprietary Name: | LITHOCLAST® MASTER Handpiece and 3.2 mm Probe | |-------------------------|-----------------------------------------------------------------| | Common/Usual Name: | Accessories to endoscopic intracorporeal pneumatic lithotripter | | Classification Name: | Accessories to electrohydraulic lithotripter (Class III) | #### 3. Intended Use The LITHOCLAST® MASTER Handpiece and the 3.2 mm probe have the same intended use as their predicate accessories, that is, for the fragmentation of urinary tract calculi, including renal, ureteral and bladder stones, through rigid or The 3.2 mm probe is specifically indicated for use in semirigid endoscopes. fragmenting large stones in the bladder and kidney. {1}------------------------------------------------ K974164 fg 2 of 3 #### Device Description 4. #### MASTER Handpiece The MASTER Handpiece is 18 mm in diameter, 228 mm long, and is constructed of aluminum alloy. The proximal end of the handpiece is connected to the LITHOCLAST pressure regulator. The chosen treatment probe is attached to the distal end of the handpiece using a screw cap. The metal projectile inside the handpiece is driven forward by the pressure from the pressure regulator. The energy from the projectile is transmitted to the probe by a shock transmitter at the distal end of the handpiece. The handpiece is sealed at both the distal and proximal ends, which: (1) prolongs the life time of the handpiece by preventing dirt, moisture and other particles from entering the handpiece; and (2) allows for the changing of probes during a treatment without the risk of breaking sterility. #### 3.2 mm Probe The 3.2 mm probe is a rigid Type 304 surgical grade stainless steel rod that acts to couple the shockwave from the handpiece to the target stone. The probe is reusable and may be sterilized by steam sterilization according to standard hospital procedures. #### 5. Basis For Substantial Equivalence ### MASTER Handpiece The MASTER Handpiece is substantially equivalent to the EMS Standard Handpiece that was cleared for marketing under K951531 and K963285. The main difference between the two devices is that the MASTER Handpiece is sealed at both the distal and proximal ends, while the Standard Handpiece is open and requires the use of a silicone sleeve to provide a watertight seal between the probe and the handpiece. Life time and probe displacement tests were performed to support the substantial equivalence of the MASTER Handpiece. {2}------------------------------------------------ ### 3.2 mm Probe K 974/64 rg3 q3 The EMS 3.2 mm probe is substantially equivalent to the EMS probes with smaller diameters (0.8, 1.0, 1.6, 2.0 mm). These predicate devices were cleared for marketing under K951531 and K963285. The main difference between these devices is the probe diameter. The larger 3.2 mm probe is specifically intended for use in fragmenting large stones in the bladder and kidney. Probe velocity and displacement tests, impact pressure, disintegration efficiency, and in-vitro tissue impact studies were performed to support the substantial equivalence of the 3.2 mm probe. {3}------------------------------------------------ #### DEPARTMENT OF HEALTH & HUMAN SERVICES - ...... Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 ## DEC 18 1997 Re: K974164 ELECTRO MEDICAL SYSTEMS SA c/o Ms. Rosina Robinson Senior Staff Consultant Medical Device Consultants, Inc. 49 Plain Street North Attleboro, Massachusetts 02760 EMS Swiss LITHOCLAST® MASTER Handpiece and 3.2mm Probe Dated: October 31, 1997 Received: November 5, 1997 Regulatory class: III 21 CFR §876.4480/Product code: 78 FFK Dear Ms. Robinson: 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 the enclosure) to 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, subject to the general controls provisions of 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 (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 submission does not affect any obligation you might have under sections 531 the Act for devices under the Electronic Product 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 predication 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsmamain.html". Sincerely yours, W.Liau Yu 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 {4}------------------------------------------------ Swiss LITHOCLAST® MASTER HANDPIECE and 3.2 MM Device Name: PROBE Indications For Use: The Swiss LITHOCLAST® MASTER HANDPIECE and the 3.2 MM PROBE are intended to be used as accessories to the EMS Swiss LITHOCLAST® Lithotripter for the fragmentation of urinary tract calculi, including renal, ureteral and bladder stones, through rigid or semirigid endoscopes. The 3.2 mm Probe is specifically indicated for use in fragmenting large stones in the bladder and kidney. (Please do not write below this line - Continue on another page if necessary) anaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaa Concurrence of CDRH, Office of Device Evaluation (ODE) Robert P. Satting (Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices K974164 510(k) Number **Prescription Use** (Per 21 CFR 801.109) OR Over-the-Counter Use_ (Optional Format 1-2-96) --- **Source:** [https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/FFK/K974164](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/FFK/K974164) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com