(110 days)
The SWISS LITHOBREAKER is intended to be used for the fragmentation of urinary tract calculi in the kidney, ureter, and bladder.
The EMS SWISS LITHOBREAKER is a handheld, standalone, battery operated intracorporeal lithotripter which uses a mechanical impact drive to fragment urinary tract calculi in the kidney, ureter, and bladder. The device generates around 3 impacts in continuous mode per second which are transmitted through the probes on the stones or a lower frequency by "single-pulse" mode, depending on the activation time of the button. The probes are introduced into the working channels of suitable endoscopes. The energy is sustained and stable throughout the life of the battery and the frequency drops only at the end of the battery life. An optional suction handpiece allows extraction of fragmented stones.
The proposed device consists of the following:
- Handpiece including powerpack .
- LithoClast probes, non-sterile reusable and sterile single use .
- LithoVac lv3 suction system with suction tubes .
The SWISS LITHOBREAKER is also supplied with accessories for cleaning (endcap), periodic maintenance (O-rings), probe accessories (interface and probe guide), AAA batteries and sterile drapes.
The provided 510(k) summary for the E.M.S. Electro Medical Systems SA SWISS LITHOBREAKER outlines the device's technical specifications and a summary of non-clinical performance testing. However, it does not include a table of specific acceptance criteria and detailed reported device performance for each criterion, nor does it describe a study that explicitly "proves the device meets the acceptance criteria" in a typical clinical study format.
Based on the provided document, here's an analysis of the requested information:
1. A table of acceptance criteria and the reported device performance
The document describes performance specifications that the device fulfills, but does not provide a quantitative table of acceptance criteria with corresponding performance metrics. It generally states that the device "fulfills the prospectively defined performance specifications" and that testing "demonstrated that the SWISS LITHOBREAKER fulfills the prospectively defined performance specifications."
The performance aspects tested and considered in comparison to predicate devices were:
- Probe Tip Displacement
- Probe Tip Velocity
- Stone Breakage/Clearance
- Stone Displacement (Retropulsion)
- Energy Output
Without specific numbers or target ranges, a formal table cannot be created from the provided text. The document asserts that the results of this testing confirm that the SWISS LITHOBREAKER is substantially equivalent to the predicates based on these parameters.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document does not specify the sample size used for the non-clinical performance testing. It also does not specify the data provenance in terms of country of origin or whether the testing was retrospective or prospective, although the statement "prospectively defined performance specifications" implies the criteria were set before testing. The testing appears to be laboratory-based rather than involving human subjects.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
This information is not applicable as the described testing is non-clinical (laboratory-based performance testing of mechanical characteristics) and does not involve establishing ground truth from expert assessments of medical images or patient outcomes.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not applicable as the described testing is non-clinical and does not involve expert review or adjudication of results.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No MRMC comparative effectiveness study was done as the device is a medical instrument (lithotripter) and not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device itself is a standalone medical instrument. The performance testing described (Probe Tip Displacement, Probe Tip Velocity, Stone Breakage/Clearance, Stone Displacement (Retropulsion), Energy Output) inherently evaluates the device's standalone mechanical performance. There is no "algorithm" in the context of AI being evaluated here; it's a mechanical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the non-clinical performance testing, the "ground truth" would be established by physical measurements and standardized testing methodologies using calibrated equipment and reference materials (e.g., artificial stones for stone breakage/clearance tests). It would not involve expert consensus, pathology, or outcomes data, as these are clinical measures.
8. The sample size for the training set
This information is not applicable as the SWISS LITHOBREAKER is a mechanical medical device, not an AI model that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable as the SWISS LITHOBREAKER is a mechanical medical device, not an AI model that requires a training set.
In summary:
The 510(k) summary primarily relies on non-clinical performance testing to demonstrate substantial equivalence to predicate devices, rather than clinical studies with human subjects or AI-specific evaluation metrics. The "acceptability criteria" are implied through the fulfillment of "prospectively defined performance specifications" and comparison to known predicate devices on specific mechanical performance characteristics (probe tip displacement, velocity, stone breakage, retropulsion, energy output), without providing granular data or specific numerical targets. The basis for clearance is demonstrating that the new device performs comparably to already cleared devices.
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510(k) Summary for the E.M.S. Electro Medical Systems SA SWISS LITHOBREAKER
JAN 1 6 2013
1. SUBMITTER/510(K) HOLDER
E.M.S. Electro Medical Systems SA Ch. de la Vuarpillière 31 CH - 1260 Nyon Switzerland
Sonia Callegaro Contact Person: 41 22 994 26 11 Telephone:
September 27, 2012 Date Prepared:
2. DEVICE NAME
| Proprietary Name: | SWISS LITHOBREAKER |
|---|---|
| Common/Usual Name: | Endoscopic intracorporeal lithotripsy |
| Classification Name: | Electrohydraulic lithotripsy |
3. PREDICATE DEVICES
The proposed SWISS LITHOBREAKER is substantially equivalent to the following legally marketed medical devices:
- E.M.S. Electro Medical Systems S.A., Swiss LithoClast Master (aka Swiss ● LithoClast Ultra) (K012445)
- . The Laryngial Mask Company Limited, LMA StoneBreaker (K062475)
The probes used by the SWISS LITHOBREAKER were previously cleared by FDA in K012445, and K973788. The LithoVac lv3 suction system was previously cleared in K012445. The sterile drape was previously cleared in K110724.
4. DEVICE DESCRIPTION
The EMS SWISS LITHOBREAKER is a handheld, standalone, battery operated intracorporeal lithotripter which uses a mechanical impact drive to fragment urinary tract calculi in the kidney, ureter, and bladder. The device generates around 3 impacts in continuous mode per second which are transmitted through the probes on
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the stones or a lower frequency by "single-pulse" mode, depending on the activation time of the button. The probes are introduced into the working channels of suitable endoscopes. The energy is sustained and stable throughout the life of the battery and the frequency drops only at the end of the battery life. An optional suction handpiece allows extraction of fragmented stones.
The proposed device consists of the following:
- Handpiece including powerpack .
- LithoClast probes, non-sterile reusable and sterile single use .
- LithoVac lv3 suction system with suction tubes .
The SWISS LITHOBREAKER is also supplied with accessories for cleaning (endcap), periodic maintenance (O-rings), probe accessories (interface and probe guide), AAA batteries and sterile drapes.
5. INTENDED USE
.
The SWISS LITHOBREAKER is intended to be used for the fragmentation of urinary tract calculi in the kidney, ureter, and bladder.
PRINCIPLES OF OPERATION 6.
The proposed SWISS LITHOBREAKER can be used as a lithotripter only or in combination with a suction device LithoVac lv3. The probes mounted on the handpiece transmit impact generated waves of sufficient strength to fragment urinary tract calculi of any composition. LithoVac lv3 suction system can be combined with the lithotripsy device to provide simultaneous suction to remove calculi fragments.
The SWISS LITHOBREAKER handpiece is a battery operated lithotripter which uses a mechanical impact drive to fragment urinary tract calculi in the kidney, ureter, and bladder. The device works at an impact frequency of approximately 3Hz in either a continuous mode or "single-pulse" mode, depending on the time the activation button is depressed and probes are used through the working channels of suitable endoscopes.
Probes are mounted on the handpiece and the probes are inserted into the working channel of an endoscope. The LithoVac lv3 suction system may be used in conjunction with the SWISS LITHOBREAKER handpiece and probe to allow for suctioning during procedures. The probe is brought into contact with the calculi, and the LithoBreaker is activated.
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K123038 Page 3 of 4
7. SUMMARY OF TECHNOLOGICAL CHARACTERISTICS COMPARED TO THE PREDICATE DEVICES
The proposed SWISS LITHOBREAKER is substantially equivalent to the previously cleared Swiss LithoClast Master (K012445) and the handheld LMA StoneBreaker (K062475).
Differences between the proposed SWISS LITHOBREAKER and the predicate Swiss LithoClast Master (K012445) and the handheld LMA StoneBreaker (K062475) are limited to the power sources used and the mechanism used to translate the power into impacts which are transmitted through the probes, resulting in non-significant variations in performance. The design and function of the lithotripsy probes of the proposed SWISS LITHOBREAKER are identical to the EMS LithoClast probes.
Testing demonstrated that the SWISS LITHOBREAKER fulfills the prospectively defined performance specifications. The similarities in intended use, operational characteristics, and technological characteristics between the proposed SWISS LITHOBREAKER and the predicate Swiss LithoClast Master (K012445) and LMA StoneBreaker (K062475) lead to a conclusion of substantial equivalence between the proposed and predicate devices. A side-by-side comparison of the predicate devices and the proposed device is provided in Table 5-1 at the end of this section.
8. SUMMARY OF NON-CLINICAL PERFORMANCE TESTING AS BASIS FOR SUBSTANTIAL EQUIVALENCE
Testing was performed to verify compliance of the SWISS LITHOBREAKER with the following standards:
- · ANSI/AAMI ST79:2006, "Comprehensive guide to steam sterilization and sterility assurance in health care facilities"
- · ISO 17664 (2004), "Sterilization of Medical Devices Information to be provided by the Manufacturer for the Processing of Resterilizable Medical Devices"
- · ANSI/AAMI/ISO 17665-1:2006 "Sterilization of health care products -- Moist heat -- Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices"
- · IEC 60601-1:1988 +A1: 1991 + A2: 1995, "Medical electrical equipment, Partl : General requirements for safety"
- IEC 60601-1-2, "Medical electrical equipment. Part 1 General requirements for . safety - Part 2 Collateral standard: Electromagnetic compatibility: Requirements and Tests" (2007).
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- · ISTA 2A (2008), "ISTA Preshipment Testing Procedures- Combination Tests for Packaged-Products 150 lb (68 kg) or Less"
The results of this testing confirm that the SWISS LITHOBREAKER is safe and effective for the intended use described in Section 5.
In addition, the SWISS LITHOBREAKER was tested as compared to the predicates with respect to the following:
- · Probe Tip Displacement
- · Probe Tip Velocity
- · Stone Breakage/Clearance
- · Stone Displacement (Retropulsion)
- · Energy Output
The results of this testing confirm that the SWISS LITHOBREAKER is substantially equivalent to the predicates.
9. SUMMARY OF CLINICAL TESTING AS BASIS FOR SUBSTANTIAL EQUIVALENCE
No clinical testing was conducted for this submission.
10. SUMMARY OF OTHER INFORMATION
No other information is available.
11. CONCLUSIONS DRAWN FROM NON-CLINICAL AND CLINICAL TESTS
Based on the information and supporting documentation provided in the premarket notification, the SWISS LITHOBREAKER is substantially equivalent to the cited predicate devices. Testing demonstrates that the SWISS LITHOBREAKER fulfills prospectively defined design and performance specifications.
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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its wing, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the eagle. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 16, 2013
EMS Electro Medical Systems SA % Ms. Suzanne Goodman, BSE, RAC Regulatory Project Manager, Medical Devices Aptiv Solutions 225 Turnpike Road SOUTHBOROUGH MA 01772
Re: K123038
Trade/Device Name: SWISS LITHOBREAKER Regulation Number: 21 CFR § 876.4480 Regulation Name: Electrohydraulic lithotriptor Regulatory Class: Class II Product Code: FFK Dated: November 30, 2012 Received: December 6, 2012
Dear Ms. Goodman:
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
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comply 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 device-related 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Herbert R. Lerner
for 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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Indications for Use
K123038 510(k) Number (if known):
Device Name: SWISS LITHOBREAKER
Indications for Use:
The SWISS LITHOBREAKER is intended to be used for the fragmentation of urinary tract calculi in the kidney, ureter, and bladder.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Herbert R. Lerner
| (Division Sign-Off) | |
|---|---|
| Division of Reproductive, Gastro-Renal, and | |
| Urological Devices | |
| 510(k) Number | K123038 |
§ 876.4480 Electrohydraulic lithotriptor.
(a)
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.(b)
Classification. Class II. The special control for this device is FDA's “Guidance for the Content of Premarket Notifications for Intracorporeal Lithotripters.”