(463 days)
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).
ESWL, model CS-2012A-3, is an mobile electromagnetic lithotripter with a focal zone to treat patients, the shock wave generator has a high voltage power supply, a closed circuit water supply system with a tank, an spherical concave electromagnetic coil, a membrane and a water cushion (rubber membrane) for the acoustic conductivity of the shock waves to the patient.
It is intended to be used properly by trained and qualified medical personnel for use in noninvasive fragmentation of urinary calculi in the kidney (renal pelvis and renal calyces) and ureter (upper, middle, and lower ureter).
The shock waves are generated by the high voltage discharge through the electromagnetic coil which repels the membrane creating a shockwave. The shockwave is then focused to the focal point. 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 device includes following parts:
- 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. - 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.
The provided document describes the acceptance criteria and study data for the Extracorporeal Shock Wave Lithotripter, model CS-2012A-3.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the device are implicitly demonstrated through its compliance with various standards and the outcome of the clinical study, particularly the success rate. The specific "acceptance criteria" for the clinical study's success rate are not explicitly stated as a numerical threshold in isolation but are presented as the achieved performance which is deemed satisfactory for substantial equivalence.
| Acceptance Criteria (Implicit) | Reported Device Performance (Clinical Study) |
|---|---|
| Device operates safely and effectively | Overall success rate of 80% |
| Device is as safe and effective as predicate devices | Confirmatory clinical study demonstrates substantial equivalence |
| User manual is adequate for operation | User's manual evaluated as adequate |
| Low incidence of device malfunction | No device malfunction reported |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size (Clinical Test Set): 144 patients (105 male, 39 female).
- Data Provenance: The document states that "clinical investigations were performed at 2 sites." The country of origin is not explicitly stated for these clinical sites, but the manufacturer is Suzhou Xixin Medical Instruments Co., Ltd. from China, suggesting the studies likely took place in China. The studies were prospective in nature, described as "clinical investigations were performed... to support this application."
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The document does not specify the "number of experts" or their "qualifications" involved in establishing the ground truth for the clinical test set. It mentions that the device is "intended for use by attending physician" and that "experiences of physicians have shown that patients treated by the CS-2012A-3 are safe and having high evaluations". This suggests that the clinical outcomes (e.g., stone fragmentation, removal) assessed by the attending physicians served as the ground truth, but the details of their roles in data adjudication are not provided.
4. Adjudication Method for the Test Set
The document does not explicitly describe an adjudication method (e.g., 2+1, 3+1). The "overall success rate" was measured, implying a clinical assessment of treatment efficacy by the medical professionals involved in the study.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. The clinical study focused on the performance of the CS-2012A-3 device itself, not on comparing human readers with and without AI assistance.
6. Standalone (Algorithm Only) Performance
This device is an Extracorporeal Shock Wave Lithotripter, a physical medical device, not an AI algorithm. Therefore, a standalone (algorithm only) performance study is not applicable and was not performed.
7. Type of Ground Truth Used (Clinical Test Set)
The ground truth for the clinical test set was based on clinical outcomes. Specifically, the "overall success rate" of the treatment was measured, with success presumably defined by the fragmentation and/or removal of kidney and ureteral calculi. The document mentions "patients with stones were treated" and the evaluation of the "device function."
8. Sample Size for the Training Set
The document does not refer to a "training set" as this device is a physical medical instrument, not a machine learning or AI model that requires a data training set. The development and validation of the device would have involved engineering tests and potentially pre-clinical studies, but not a data training set in the context of AI.
9. How the Ground Truth for the Training Set Was Established
As there is no "training set" in the context of an AI/machine learning device, the concept of establishing ground truth for a training set is not applicable to this device.
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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
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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
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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)_
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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 GuRegulatory Affairs ManagerGuangzhou Osmunda Medical Device Consulting Co., LtdTel: +86-20-62321333Fax: +86-20-86330253 |
| Secondary Contact Person: | Du JunYuanGeneral ManagerSuzhou Xixin Medical Instruments Co. LtdTel: +86-512-65270692/ 65287789Fax:+86-512-65278410Add: No.28, Fengjin Road, Wuzhong District, Suzhou, 215128,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 classifiedextracorporeal shock wave lithotripter as Class II device withspecial 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 electromagneticlithotripter with a focal zone to treat patients, the shock wavegenerator has a high voltage power supply, a closed circuit watersupply system with a tank, an spherical concave electromagneticcoil, a membrane and a water cushion (rubber membrane) forthe acoustic conductivity of the shock waves to the patient.It is intended to be used properly by trained and qualifiedmedical personnel for use in noninvasive fragmentation ofurinary calculi in the kidney (renal pelvis and renal calyces) andureter (upper, middle, and lower ureter).The shock waves are generated by the high voltage dischargethrough the electromagnetic coil which repels the membranecreating a shockwave. The shockwave is then focused to thefocal point. The stones to be fragmented are positioned at thisfocal point by moving the motorized patient table in 3 axis. Thelocalization is performed with a separate and commercially |
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| 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). |
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| 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-intensity integral PIIT: | 45.8J/m2 | 196.4J/m2 | 494.4J/m2 | |
| Positive derived pulse-intensity integral PIIP: | 33.0J/m2 | 177.3J/m2 | 469.3J/m2 | |
| Distance focus position- target location in z-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- target location in x-direction: | 0mm | 0mm | 0mm | |
| Distance focus position- target location in y-direction: | 0mm | 0mm | 0mm | |
| Focal extent (in z-direction) fz: | 120mm | 95mm | 124mm | |
| Maximum focal width(in x-direction) fx: | 15mm | 9.5mm | 10mm | |
| Orthogonal focal width(in y-direction) fy: | 14mm | 8.5mm | 8.5mm | |
| Focal cross-sectionalarea Af: | 1.65cm2 | 0.63cm2 | 0.67cm2 | |
| Focal volume Vf: | 13.2cm3 | 4.0cm3 | 5.5cm3 | |
| Total derived focalacoustic pulse energy | 5.7mJ | 10.0mJ | 22.7mJ | |
| EfT: | ||||
| Total derived acousticpulse energy ERT(R=5mm): | 3.1mJ | 12.1mJ | 27.1mJ | |
| Positive derived focalacoustic pulse energyEfP: | 4.1mJ | 8.9mJ | 21.1mJ | |
| Positive derivedacoustic pulse energyERP (R=5mm): | 2.2mJ | 10.9mJ | 25.5mJ | |
| Determination ofSubstantial Equivalence: | Summary of non-Clinical Tests: | |||
| The Extracorporeal Shock Wave Lithotripter was designed andtested for compliance to the following standards: | ||||
| a. IEC 60601-2-36, "Medical electrical equipment - Part 2:Particular requirements for the safety of equipment forextracorporeally induced lithotripsy" (1997); | ||||
| b. IEC 60601-1 Medical Electrical Equipment - Part 1:General Requirements for Safety, 1988; Amendment 1,1991-11, Amendment 2, 1995; | ||||
| c. IEC 60601-1-2 Medical Electrical Equipment - Part 1-2:General Requirements for Safety - Collateral standard:Electromagnetic Compatibility - Requirements and Tests; | ||||
| d. ISO 10993-1, Biological evaluation of medical devices -Part 1: Evaluation and testing within a risk managementprocess; | ||||
| e. ISO 10993-5, Biological evaluation of medical devices --Part 5: Tests for In Vitro cytotoxicity | ||||
| f. ISO 10993-10, Biological evaluation of medical devices -Part 10: Tests for irritation and skin sensitization. | ||||
| The product specifications had been tested as attachment 1:Attachment 1:Voltage/Frequency ESWL Module 110V, 60HzPower Supply ESWL Module 1.0 kVA |
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| 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:According to the "Guidance for the Content of PremarketNotifications for Extracorporeal Shock Wave LithotriptersIndicated for the Fragmentation of Kidney and Ureteral Calculi"section 8.D clinical performance testing, the clinicalinvestigations were performed at 2 sites with 1 and 2 weeksfollow-up to support this application. Totally 144 (105 male, and39 female) patients with stones were treated. The stones sizestreated were not more than 20 mm. None of the patientsreceived general anesthesia. The overall success rate of theinvestigations is measured as 80%.The experiences of physicians have shown that patients treatedby the CS-2012A-3 are safe and having high evaluations for thedevice function. And the user's manual is adequate for theoperation of CS-2012A-3. The incidence of device malfunctiondoes not happen in these clinical investigations.ESWL demonstrates with a confirmatory clinical study that it isperformed as the substantial equivalence, please see appendixC1, appendix C2, appendix C3, appendix C4 and appendix C5. | |
| Conclusion: | The conclusions drawn from the nonclinical and clinical tests thatdemonstrate that the extracorporeal shock wave lithotripter,model CS-2012A-3 from Suzhou Xixin Medical Instruments Co.Ltd is as safe, as effective, and performs at least as safely andeffectively as the legally marketed device identified inparagraph(3) of this section. |
§ 876.5990 Extracorporeal shock wave lithotripter.
(a)
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.(b)
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.”)