EXTRACORPOREAL SHOCK WAVE LITHOTRIPTER
Device Facts
| Record ID | K131817 |
|---|---|
| Device Name | EXTRACORPOREAL SHOCK WAVE LITHOTRIPTER |
| Applicant | Osmunda Medical Device Consulting Co., Ltd. |
| Product Code | LNS · Gastroenterology, Urology |
| Decision Date | Sep 26, 2014 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 876.5990 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
CS-2012A-3 is intended for use by attending physician in the treatment of all kinds of calculi in the kidney (renal pelvis and renal calyces) and ureter (upper, middle, and lower ureter).
Device Story
CS-2012A-3 is a mobile electromagnetic extracorporeal shock wave lithotripter (ESWL). It utilizes a high-voltage power supply to discharge through a spherical concave electromagnetic coil, repelling a metallic membrane to generate acoustic shock waves. These waves are transmitted to the patient via a water cushion. The device includes a motorized 3-axis patient table for precise positioning of stones at the focal point. Localization is achieved using external, commercially available mobile fluoroscopic X-ray or ultrasound equipment. Operated by trained medical personnel in a clinical setting, the device fragments urinary calculi noninvasively. The physician monitors the procedure via external imaging and controls the device via a control panel and foot pedal. Successful fragmentation reduces the need for invasive surgical intervention, benefiting patients by providing a noninvasive treatment option for urolithiasis.
Clinical Evidence
Clinical investigation conducted at 2 sites with 144 patients (105 male, 39 female) with stone sizes ≤ 20 mm. Follow-up at 1 and 2 weeks. Primary endpoint was treatment success, with an overall success rate of 80%. No general anesthesia was used. No device malfunctions reported. Results support safety and effectiveness comparable to predicate devices.
Technological Characteristics
Mobile electromagnetic lithotripter; spherical concave coil and metallic membrane shock wave generator. 3-axis motorized patient table. Energy source: high-voltage electrical discharge. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-36, ISO 10993-1, ISO 10993-5, ISO 10993-10. Acoustic characteristics measured per IEC 61846.
Indications for Use
Indicated for patients with renal or ureteral calculi (kidney/ureter stones) up to 20 mm in size requiring noninvasive fragmentation.
Regulatory Classification
Identification
An extracorporeal shock wave lithotripter is a device that focuses ultrasonic shock waves into the body to noninvasively fragment urinary calculi within the kidney or ureter. The primary components of the device are a shock wave generator, high voltage generator, control console, imaging/localization system, and patient table. Prior to treatment, the urinary stone is targeted using either an integral or stand-alone localization/imaging system. Shock waves are typically generated using electrostatic spark discharge (spark gap), electromagnetically repelled membranes, or piezoelectric crystal arrays, and focused onto the stone with either a specially designed reflector, dish, or acoustic lens. The shock waves are created under water within the shock wave generator, and are transferred to the patient's body using an appropriate acoustic interface. After the stone has been fragmented by the focused shock waves, the fragments pass out of the body with the patient's urine.
Special Controls
*Classification.* Class II (special controls) (FDA guidance document: “Guidance for the Content of Premarket Notifications (510(k)'s) for Extracorporeal Shock Wave Lithotripters Indicated for the Fragmentation of Kidney and Ureteral Calculi.”)
Predicate Devices
Submission Summary (Full Text)
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The caduceus is depicted in a simple, black and white design, with the snakes forming a continuous line. The text is written in a sans-serif font and is also in black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 26, 2014
Suzhou Xixin Medical Instruments Co., Ltd. % Mike Gu Regulatory Manager Osmunda Medical Device Consulting Co., Ltd. No. 982 Cogyun Road 7th F1. Jinggui Business Bldg Baiyun District Guangzhou, Guangdong, 510420 CN
Re: K131817
Trade/Device Name: Extracorporeal Shock Wave Lithotripter Regulation Number: 21 CFR§ 876.5990 Regulation Name: Extracorporeal Shock Wave Lithotripter Regulatory Class: II Product Code: LNS Dated: June 18, 2013 Received: June 25, 2013
Dear Mike Gu,
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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
{1}------------------------------------------------
with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
## Benjamin R. Fisher -S
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
510(k) Number (if known): K131817
Device Name: Extracorporeal Shock Wave Lithotripter
Indications for Use: CS-2012A-3 is intended for use by attending physician in the treatment of all kinds of calculi in the kidney (renal pelvis and renal calyces) and ureter (upper, middle, and lower ureter).
Prescription Use X AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (Part 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health
510(k)_
{3}------------------------------------------------
## 510(k) Summary
In accordance with 21 CFR 807.92 the following summary of information is provided:
| Date: | June 15, 2013 |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | Suzhou Xixin Medical Instruments Co. Ltd |
| Primary Contact Person: | Mike Gu<br>Regulatory Affairs Manager<br>Guangzhou Osmunda Medical Device Consulting Co., Ltd<br>Tel: +86-20-62321333<br>Fax: +86-20-86330253 |
| Secondary Contact Person: | Du JunYuan<br>General Manager<br>Suzhou Xixin Medical Instruments Co. Ltd<br>Tel: +86-512-65270692/ 65287789<br>Fax:+86-512-65278410<br>Add: No.28, Fengjin Road, Wuzhong District, Suzhou, 215128,<br>P.R. China |
| Device: Trade Name: | Extracorporeal Shock Wave Lithotripter |
| Common/Usual Name: | Extracorporeal Shock Wave Lithotripter |
| Classification Names: | According to 21 CFR §876.5990, FDA has classified<br>extracorporeal shock wave lithotripter as Class II device with<br>special controls. The Product Code for this lithotripter is 78 LNS. |
| Product Code: | 78 LNS |
| Predicate Device(s): | P840008/S065; K103217 |
| Device Description: | ESWL, model CS-2012A-3, is an mobile electromagnetic<br>lithotripter with a focal zone to treat patients, the shock wave<br>generator has a high voltage power supply, a closed circuit water<br>supply system with a tank, an spherical concave electromagnetic<br>coil, a membrane and a water cushion (rubber membrane) for<br>the acoustic conductivity of the shock waves to the patient.<br><br>It is intended to be used properly by trained and qualified<br>medical personnel for use in noninvasive fragmentation of<br>urinary calculi in the kidney (renal pelvis and renal calyces) and<br>ureter (upper, middle, and lower ureter).<br><br>The shock waves are generated by the high voltage discharge<br>through the electromagnetic coil which repels the membrane<br>creating a shockwave. The shockwave is then focused to the<br>focal point. The stones to be fragmented are positioned at this<br>focal point by moving the motorized patient table in 3 axis. The<br>localization is performed with a separate and commercially |
{4}------------------------------------------------
| | available mobile fluoroscopic x-ray unit and/or US equipment. | | |
|---------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|
| | The device includes following parts: | | |
| | 1. ESWL device | | |
| | The ESWL device contains therapy head, main switch, control panel, target indicator and foot pedal. It also provides patient with treatment, controls functions of CS-2012A-3. | | |
| | 2. Therapy table | | |
| | Therapy table consists of table (For personal hygiene, the table should be covered by disposable medical nonwoven fabrics in treatment), table supporter and 3-dimension movement. | | |
| | Patient is positioned on therapy table. Table cutout area allows positioning of therapy table near patient, table can be moved as required. Table motion is completely independent of ESWL device. It has its own 3 dimension movement, not to link CS-2012A-3. | | |
| Intended Use: | CS-2012A-3 is intended for use by attending physician in the treatment of all kinds of calculi in the kidney (renal pelvis and renal calyces) and ureter (upper, middle, and lower ureter). | | |
{5}------------------------------------------------
| Technology: ESWL model CS-2012A-3 is a mobile electromagnetic lithotripter, it generates shock waves by means of electromagnetic shock wave generator which consists of a spherical concave coil and metallic membrane, invented by Prof. Eisenmenger. The predicate device from Dornier uses the same technology from the design and energy source. | | | | |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------|-----------|---------|
| The shock waves are generated by the high voltage discharge through the electromagnetic coil which repels the membrane creating a shockwave. The shock wave focuses automatically via the structure of spherical concave of coil during its propagation. The stones to be fragmented are positioned at this focal point by moving the motorized patient table in 3 axis. The localization is performed with a separate and commercially available mobile fluoroscopic x-ray unit and/or US equipment. | | | | |
| The calculus to be treated is positioned and fragmented in the focal point of the shock wave. The shock wave characteristics are reported below by taking the guideline described in the consensus standard IEC 61846 "Ultrasonics - Pressure pulse lithotripters - Characteristics of fields" (1998) into consideration. The hydrophones are used in the measurements. The details of the measurements/calculations are given in relevant part of 510(k) application. | | | | |
| The results are found similar to the predicate device characteristics. | | | | |
| | Parameter | Min | Typical | Maximum |
| | Parameter | 7.0kV | 9.3Kv | 10.5Kv |
| | Peak-positive acoustic pressure p+: | 7.6MPa | 27.4MPa | 39.8MPa |
| | Peak-negative acoustic pressure p_: | -3MPa | -4.1MPa | -4MPa |
| | Compressional pulse duration tFWHMp+: | 1.305 $\mu$ s | 428.8ns | 409.5ns |
| | Rise time (10%-90%) | 1.14 $\mu$ s | 452ns | 216ns |
| tr: | | | | |
| Total derived pulse-<br>intensity integral PIIT: | 45.8J/m2 | 196.4J/m2 | 494.4J/m2 | |
| Positive derived pulse-<br>intensity integral PIIP: | 33.0J/m2 | 177.3J/m2 | 469.3J/m2 | |
| Distance focus position<br>- target location in z-<br>direction: | -16mm | -9.5mm | +7mm | |
| Z1 | 76 mm | 57 mm | 69 mm | |
| Z2 | 44 mm | 38 mm | 55 mm | |
| Z3 | 16 mm | 9.5 mm | 7 mm | |
| Distance focus position<br>- target location in x-<br>direction: | 0mm | 0mm | 0mm | |
| Distance focus position<br>- target location in y-<br>direction: | 0mm | 0mm | 0mm | |
| Focal extent (in z-<br>direction) fz: | 120mm | 95mm | 124mm | |
| Maximum focal width<br>(in x-direction) fx: | 15mm | 9.5mm | 10mm | |
| Orthogonal focal width<br>(in y-direction) fy: | 14mm | 8.5mm | 8.5mm | |
| Focal cross-sectional<br>area Af: | 1.65cm2 | 0.63cm2 | 0.67cm2 | |
| Focal volume Vf: | 13.2cm3 | 4.0cm3 | 5.5cm3 | |
| Total derived focal<br>acoustic pulse energy | 5.7mJ | 10.0mJ | 22.7mJ | |
| | EfT: | | | |
| | Total derived acoustic<br>pulse energy ERT<br>(R=5mm): | 3.1mJ | 12.1mJ | 27.1mJ |
| | Positive derived focal<br>acoustic pulse energy<br>EfP: | 4.1mJ | 8.9mJ | 21.1mJ |
| | Positive derived<br>acoustic pulse energy<br>ERP (R=5mm): | 2.2mJ | 10.9mJ | 25.5mJ |
| Determination of<br>Substantial Equivalence: | Summary of non-Clinical Tests: | | | |
| | The Extracorporeal Shock Wave Lithotripter was designed and<br>tested for compliance to the following standards: | | | |
| | a. IEC 60601-2-36, "Medical electrical equipment - Part 2:<br>Particular requirements for the safety of equipment for<br>extracorporeally induced lithotripsy" (1997); | | | |
| | b. IEC 60601-1 Medical Electrical Equipment - Part 1:<br>General Requirements for Safety, 1988; Amendment 1,<br>1991-11, Amendment 2, 1995; | | | |
| | c. IEC 60601-1-2 Medical Electrical Equipment - Part 1-2:<br>General Requirements for Safety - Collateral standard:<br>Electromagnetic Compatibility - Requirements and Tests; | | | |
| | d. ISO 10993-1, Biological evaluation of medical devices -<br>Part 1: Evaluation and testing within a risk management<br>process; | | | |
| | e. ISO 10993-5, Biological evaluation of medical devices --<br>Part 5: Tests for In Vitro cytotoxicity | | | |
| | f. ISO 10993-10, Biological evaluation of medical devices -<br>Part 10: Tests for irritation and skin sensitization. | | | |
| | The product specifications had been tested as attachment 1:<br>Attachment 1:<br>Voltage/Frequency ESWL Module 110V, 60Hz<br>Power Supply ESWL Module 1.0 kVA | | | |
{6}------------------------------------------------
{7}------------------------------------------------
{8}------------------------------------------------
| Therapy Table | patient |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Physical Parameters of Shock Wave in Focus Area. | Pmax: 5~50MPa |
| | P_:-2~-8MPa |
| | DX, DY: -2~+2mm |
| | DZ: -20~+20mm |
| | Tw:0.2~2 μ s |
| | Tr:0.1~2 μ s |
| | $\phi$ focus≈15mm |
| Lifetime of coil | ≥10° shots |
| Summary of Clinical Tests:<br>According to the "Guidance for the Content of Premarket<br>Notifications for Extracorporeal Shock Wave Lithotripters<br>Indicated for the Fragmentation of Kidney and Ureteral Calculi"<br>section 8.D clinical performance testing, the clinical<br>investigations were performed at 2 sites with 1 and 2 weeks<br>follow-up to support this application. Totally 144 (105 male, and<br>39 female) patients with stones were treated. The stones sizes<br>treated were not more than 20 mm. None of the patients<br>received general anesthesia. The overall success rate of the<br>investigations is measured as 80%.<br>The experiences of physicians have shown that patients treated<br>by the CS-2012A-3 are safe and having high evaluations for the<br>device function. And the user's manual is adequate for the<br>operation of CS-2012A-3. The incidence of device malfunction<br>does not happen in these clinical investigations.<br>ESWL demonstrates with a confirmatory clinical study that it is<br>performed as the substantial equivalence, please see appendix<br>C1, appendix C2, appendix C3, appendix C4 and appendix C5. | |
| Conclusion: | The conclusions drawn from the nonclinical and clinical tests that<br>demonstrate that the extracorporeal shock wave lithotripter,<br>model CS-2012A-3 from Suzhou Xixin Medical Instruments Co.<br>Ltd is as safe, as effective, and performs at least as safely and<br>effectively as the legally marketed device identified in<br>paragraph(3) of this section. |
