(97 days)
No
The summary describes a lithotripsy device with pneumatic and ultrasound modes, controlled by a console and foot pedal. There is no mention of AI, ML, image processing, or any data-driven decision-making processes. The performance studies focus on physical and electrical safety, biocompatibility, and sterilization, not AI/ML performance metrics.
Yes
The device is indicated for "fragmentation and removal of urinary tract calculi," which is a treatment for a medical condition.
No
This device is indicated for fragmentation and removal of urinary tract calculi, which is a therapeutic function, not a diagnostic one.
No
The device description clearly outlines hardware components including a console, handpiece, probes, foot pedal, and optional pump/valve and stone catcher. While software verification and validation are mentioned, the device is fundamentally a hardware system with software control.
Based on the provided information, the Swiss LithoClast Trilogy is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for the fragmentation and removal of urinary tract calculi within the body (in the kidney, ureter, and bladder). IVD devices are used to examine specimens outside the body to provide information for diagnosis, monitoring, or screening.
- Device Description: The device is a system that generates energy (pneumatic and ultrasound) and uses probes to physically break down stones. This is an interventional procedure performed on the patient, not a test performed on a sample.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or providing diagnostic information based on laboratory testing.
The Swiss LithoClast Trilogy is a therapeutic device used for lithotripsy (stone fragmentation).
N/A
Intended Use / Indications for Use
The Swiss LithoClast® Trilogy is indicated for fragmentation and removal of urinary tract calculi in the kidney, ureter, and bladder.
Product codes
FEO, FFK
Device Description
The Swiss LithoClast® Trilogy is a modified version of the Swiss LithoClast® Master, previously cleared under K012445. As with the predicate device, three possible modes of operation are available: 1) pneumatic lithotripsy alone; 2) ultrasound lithotripsy alone; and 3) and combined pneumatic and ultrasound lithotripsy.
The LithoClast Trilogy system consists of the console used to set the treatment parameters and generate the treatment energy, a reusable handpiece, and a variety of probe sizes to enable use of the system with a wide range of commercially available endoscopes. Delivery of energy is controlled using a twostep foot pedal.
Two models of the LithoClast Trilogy are available: one with a peristaltic pump and one with a pinch valve. Both versions can be used to suction stone fragments into the optional Stone Catcher. An external vacuum system is required to enable suction with the pinch valve model of the console.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
kidney, ureter, and bladder
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Bench Testing:
- Fragmentation and stone clearance time using the dual energy Trilogy handpiece and probes and artificial Begostones
- Tissue perforation testing on pig bladder tissue
- Reusable handpiece qualification testing
- Reusable probe qualification testing
- Electrical safety testing to IEC 60601-1:2005 +A1:2012 (ed. 3.1)
- Electromagnetic compatibility testing to IEC 60601-1-2:2014 (ed. 4.0)
- Biocompatibility testing to ISO 10993-1 including:
- Cytotoxicity: ISO 10993-5:2009
- Sensitization: ISO 10993-10:2010
- Intracutaneous reactivity in rabbits: ISO 10993-10:2010
- Acute Systemic Toxicity in Mice: ISO 10993-11:2006
- Endotoxin (LAL) test: USP39 2016, USP39 2016
- Material-mediated Pyrogenicity: ISO 10993-11:2006, USP o Pyrogen Test
- Sterilization validation to ISO 11135:2014
- Shipping and handling testing to ISTA 1E and ISTA 2A
- Package and sterility testing after 2X EtO sterilization and accelerated aging including:
- Visual inspection to ASTM F1886:2016
- Seal peel and seal tensile strength tests to EN 868-5:2009
- Seal integrity test to ASTM F1929:2015
- Dye penetration test for pinholes to EN 868-5:2009
- Sterility tests to ISO 11737-2:2009
- Functional tests of the Trilogy probes after aging
- Software verification and validation to IEC 62304:2006
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.”
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January 10, 2018
E.M.S. Electro Medical Systems SA % Sheila Hemeon-Heyer President Heyer Regulatory Solutions LLC 125 Cherry Lane Amherst. MA 01002
Re: K173234
Trade/Device Name: Swiss LithoClast Trilogy Regulation Number: 21 CFR§ 876.4480 Regulation Name: Electrohydraulic Lithotripter Regulatory Class: II Product Code: FEO, FFK Dated: October 4, 2017 Received: October 5, 2017
Dear Sheila Hemeon-Heyer:
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.
1
You must 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 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.
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.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Image /page/1/Picture/6 description: The image shows the name "Benjamin R. Fisher -S" in a large, bold font. The text is black and appears to be centered on a white background. The letters are clearly legible and well-defined.
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
510(k) Number (if known) K173234
Device Name
Swiss LithoClast Trilogy
Indications for Use (Describe)
The Swiss LithoClast Trilogy is indicated for fragmentation and removal of urinary tract calculi in the kidney, ureter, and bladder.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| × Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted per the requirements of 21 CFR 807.92.
| A. | 510(k) Applicant: | EMS Electro Medical Systems SA |
|---|---|---|
| Ch. De la Vuarpillière 31 | ||
| 1260 Nyon, Switzerland | ||
| c/o Sonia Callegaro | ||
| Regulatory Affairs Group Leader - Medica | ||
| T: +41 22 994 26 11 | ||
| Email: scallegaro@ems-ch.com |
- B. Date Prepared: January 9, 2018
D. Device Name and Classification Information:
| Trade Name: | Swiss LithoClast® Trilogy |
|---|---|
| Classification Name: | Electrohydraulic Lithotripter |
| Regulation: | 21 CFR 876.4480 |
| Product Code: | FEO, FFK |
| Review Panel: | 78 Gastroenterology / Urology |
| Class: | II |
- E. K012445, Swiss LithoClast® Master Predicate Device(s):
F. Summary Device Description:
The Swiss LithoClast® Trilogy is a modified version of the Swiss LithoClast® Master, previously cleared under K012445. As with the predicate device, three possible modes of operation are available: 1) pneumatic lithotripsy alone; 2) ultrasound lithotripsy alone; and 3) and combined pneumatic and ultrasound lithotripsy.
The LithoClast Trilogy system consists of the console used to set the treatment parameters and generate the treatment energy, a reusable handpiece, and a variety of probe sizes to enable use of the system with a wide range of commercially available endoscopes. Delivery of energy is controlled using a twostep foot pedal.
Two models of the LithoClast Trilogy are available: one with a peristaltic pump and one with a pinch valve. Both versions can be used to suction stone fragments into the optional Stone Catcher. An external vacuum system is required to enable suction with the pinch valve model of the console.
4
G. Intended Use / Indication for Use:
The Swiss LithoClast® Trilogy is indicated for fragmentation and removal of urinary tract calculi in the kidney, ureter, and bladder.
H. Technical Comparison with Predicate Device
The table below provides a side-by-side comparison of the modified device to the predicate device.
| Characteristic | Ems Swiss Lithoclast
Master (K012445) | Ems Swiss Lithoclast
Trilogy | Basis for SE |
|----------------------------------|------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------|
| Indications for use | Fragmentation of urinary
tract calculi in the kidney,
ureter and bladder | Fragmentation and removal
of urinary tract calculi in the
kidney, ureter and bladder | Substantially
equivalent |
| DEVICE COMPONENTS | | | |
| CONSOLE | | | |
| Microprocessor control | Yes | Yes | Same |
| I/O | Rotary knobs/switches
LCD display | Touchscreen input
LCD display | Substantially
equivalent |
| Dimensions | 135 mm (H) x 371 mm (W)
x 432 mm (D) | 135 mm (H) x 360 mm (W)
x 420 mm (D) | Substantially
equivalent |
| Weight | 10.5 kg | 13.5 kg | Substantially
equivalent |
| Power supply | 100-240 VAC, 50-60 Hz | 100-240 VAC, 50-60 Hz | Same |
| HANDPIECE | | | |
| Handpiece types | Separate handpieces for
ultrasound and pneumatic | Single handpiece | Single handpiece
delivers both
energy types |
| Handpiece housing
material | PEEK | PEEK | Same |
| Sterilization | Re-usable, pre-vacuum,
steam | Re-usable, pre-vacuum,
steam | Same |
| PROBES | | | |
| Probe types | Separate probes for
ultrasound (vibration) and
ballistic (shock wave) | Single probe provides both
ultrasound (vibration) and
ballistic (shock wave) | Single probe
delivers both
energy types |
| Probe material | Ultrasound: 316L stainless
steel
Ballistic: 304 stainless
steel | Ultrasound: 316L stainless
steel | Same as for
ultrasound probe |
| Characteristic | Ems Swiss Lithoclast
Master (K012445) | Ems Swiss Lithoclast
Trilogy | Basis for SE |
| Probe diameters | Pneumatic: 0.8, 1.0, 1.6,
2.0 and 3.2 mm
Ultrasound: 3.3 and 3.8
mm | 1.1, 1.5, 1.9, 3.4 and 3.9
mm | Equivalent range |
| RFID tag | None | Yes | Enables console
to track probe
type and use
history |
| Sterilization | Provided EtO sterilized,
Multiple-use probes
validated for 4x steam
sterilization after first use | Provided EtO sterilized,
Multiple-use probes
validated for 4x steam
sterilization after first use | Same |
| FOOT PEDAL | Dual side-by-side
Two-step for suction and
ultrasound | Single pedal
Two-step for suction and
energy | Only one pedal
needed due to
integrated
energy |
| SUCTION | Pinch valve on console,
compatible with EMS
LithoVac | Options of pinch valve or
peristaltic pump on console | Substantially
equivalent |
| STONE CATCHER | Optional component | Optional component | Same product |
| OPERATING MODES | | | |
| ULTRASOUND MODE | Yes | Yes | Same |
| Transducer frequency | 24 kHz | 24 Hz | Same |
| Max. amplitude
Peak to peak | 60 μm | 60 μm | Same |
| Output power
adjustment | Adjustable from 0%-100%
(10% increments) | Adjustable from 10%-100%
(10% increments) | Substantially
equivalent |
| BALLISTIC MODE | Yes | Yes | Same |
| Energy Type | Ballistic, generated by
compressed air | Ballistic, generated by
electromagnetic field | Different energy
source |
| Output power
adjustment | Adjustable from 0%-100%
(10% increments) | Adjustable from 10%-100%
(10% increments) | Substantially
equivalent |
| Operating modes | Single shot or multiple shot
modes | Multiple shot mode only | Single shot
mode eliminated
as rarely used |
| Multiple shot repetition
rate | 1 to 12 Hz in 1 Hz
increments | 1 to 12 Hz in 1 Hz
increments | Same |
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l. Basis for Substantial Equivalence - Bench Testing
The following FDA guidance documents were followed for this 510(k):
- . "Guidance for the Content of Premarket Notifications for Intracorporeal Lithotripters," Nov. 30, 1998
- . "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices," May 11, 2005
- "Off-The-Shelf Software Use in Medical Devices," Sept. 9, 1999
- "Radio Frequency Wireless Technology in Medical Devices," August 14, ● 2013
- . "Use of International Standard ISO 10993-1, 'Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process,"" June 16, 2016
- . "Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile," January 21, 2016
Testing submitted in this 510(k) to support substantial equivalence included the following:
- Fragmentation and stone clearance time using the dual energy Trilogy handpiece and probes and artificial Begostones
- Tissue perforation testing on pig bladder tissue ●
- Reusable handpiece qualification testing .
- Reusable probe qualification testing
- Electrical safety testing to IEC 60601-1:2005 +A1:2012 (ed. 3.1) ●
- Electromagnetic compatibility testing to IEC 60601-1-2:2014 (ed. 4.0) ●
- Biocompatibility testing to ISO 10993-1 including: .
- Cytotoxicity: ISO 10993-5:2009 o
- Sensitization: ISO 10993-10:2010 o
- Intracutaneous reactivity in rabbits: ISO 10993-10:2010 O
- Acute Systemic Toxicity in Mice: ISO 10993-11:2006 O
- Endotoxin (LAL) test: USP39 2016, USP39 2016 o
- Material-mediated Pyrogenicity: ISO 10993-11:2006, USP o Pyrogen Test
- . Sterilization validation to ISO 11135:2014
- Shipping and handling testing to ISTA 1E and ISTA 2A ●
- Package and sterility testing after 2X EtO sterilization and accelerated ● aqing including:
- o Visual inspection to ASTM F1886:2016
- Seal peel and seal tensile strength tests to EN 868-5:2009 O
- Seal integrity test to ASTM F1929:2015 O
- Dye penetration test for pinholes to EN 868-5:2009 o
7
- Sterility tests to ISO 11737-2:2009 o
- Functional tests of the Trilogy probes after aging .
- Software verification and validation to IEC 62304:2006
J. Conclusion
The information and testing presented in this 510(k) demonstrate that the modified Swiss LithoClast device, called the Trilogy, is substantially equivalent to the predicate Swiss LithoClast device, called the Master. The modified device has the same intended use, equivalent indications for use, and same fundamental scientific technology as compared to the predicate device. The test data submitted in the 510(k) demonstrate that the modified device is as safe and as effective as the predicate device and, therefore, can be found substantially equivalent.