The ShockPulse-SE Lithotripsy System (CYBERWAND II) is the next generation of the CyberWand System. The ShockPulse-SE is an electromechanical device, whose intended purpose is to fragment and aspirate calculi. The hand piece consists of an ultrasonic transducer containing piezoelectric elements which are driven by a generator operating at approximately 21,000 Hz. The transducer is lightweight and incorporates two contact switches that activate Standard Power and High Power generator output. Activation will either require continuous pushing of the button or a double click to latch activation on; a single click of either button would then turn activation off. There are markings near the buttons to indicate function. Suction control is integrated into the transducer housing. With a thumb wheel that can rotate approximately 20 degrees, the flow can be varied from "full" on to "off." There are markings on the transducer to indicate which direction increases and decreases suction flow through the transducer lumen. There are families of probes that function similar to the probes of the current CyberWand System (K120303) by transmitting stress-waves from the transducer to the calculi to break up kidney-stones. Hollow probes permit simultaneous suction. The direct patient-contact material is stainless steel, which is the same material used in the predicate system.

AI/ML Overview

The provided document is a 510(k) Summary for the ShockPulse-SE Lithotripsy System (CYBERWAND II). It details the device's technical specifications, indications for use, and a comparison to its predicate device, the CyberWand Dual Action Ultrasonic Lithotripsy System (K120303). The document primarily focuses on demonstrating substantial equivalence through performance data, safety considerations, and compliance with various standards.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria / Performance Goal	Reported Device Performance
Stone Breakage Performance
CyberWand II 3.76 probe drills through a stone at least 10% faster than CyberWand I 3.76 Dual Probe.	The CyberWand II 3.76 probe drills through a stone at least 10% faster than the CyberWand I 3.76 Dual Probe. (Met)
CyberWand II 3.76 probe removes mass at least 20% faster than CyberWand I 3.76 Dual Probe.	The CyberWand II 3.76 probe removes mass at least 20% faster than the CyberWand I 3.76 Dual Probe. (Met)
CyberWand II 1.65 probe has less impact force than LithoClast pneumatic ureteral probe.	The CyberWand II 1.65 probe has less impact force than the LithoClast pneumatic ureteral probe. (Met)
Smallest probe size (0.97 mm) equivalent stone breakage.	Supported by stone breakage measurements and identification of a reference device (K111058, Med-Sonics Corp. UreTron Multi Probe Lithotripter) with an 0.8 mm ultrasonic probe. (Met by comparison to a cleared device)
Transducer and Torque Wrench Life Cycle (50 Cycles)
Performance (Mass Removal, Drill Rate, Probe Tip Displacement) does not degrade.	Evaluated, implied to be met as it states performance does not degrade over 50 simulated use cycles.
Functionality (Suction Control, Button Activation Switches) remains.	Evaluated, implied to be met as it states every aspect of the transducer is functional after 50 simulated use cycles.
Safety (Electrical Safety - Patient Leakage Current) remains.	Evaluated, implied to be met as it states every aspect of the transducer is functional after 50 simulated use cycles.
Appearance Quality (Black Anodize, Laser Etching) does not degrade.	Evaluated, implied to be met as it states every aspect of the transducer is functional after 50 simulated use cycles.
Probe Reliability and Reusability
Probes are functional after a single simulated use (5x typical use time).	Probes are functional after a single simulated use, capable of 5x typical use time. (Met - Note: Probes are to be labeled single use)
IEC 61847 Evaluation
Output characteristics of CyberWand II system compared to CyberWand I 3.76 mm dual probe.	Demonstrated.
Less probe tip displacement than predicate (safe and substantially equivalent).	Less probe tip displacement (101 microns peak-to-peak) compared to the predicate CyberWand I (102 microns peak-to-peak). (Met)
Tissue Perforation Testing (Safety)
CyberWand consistently induces less kidney tissue damage than LithoClast Ultra.	The CyberWand consistently induced less kidney tissue damage than the LithoClast Ultra using a visual assessment methodology (on predicate device). ShockPulse SE system designed and tested to have equal or less maximum tip amplitude than CyberWand I, and tested in porcine model with no significant tissue damage. (Met by lineage and animal study)
Smallest probe (0.97 mm) equivalent tissue perforation potential.	Supported by identification of a reference device (K111058, Med-Sonics Corp. UreTron Multi Probe Lithotripter) with an 0.8 mm ultrasonic probe. (Met by comparison to a cleared device)
Torque Wrench Performance
Consistent torque specification of 35-40 inch pounds.	Demonstrated a consistent torque specification of 35-40 inch pounds. (Met)
Generator and Footswitch Life Cycle
Generator useful life of 7 years.	Demonstrated a useful life of 7 years for the generator. (Met)
Footswitch durability and IPX6 rating.	Demonstrated footswitch durability and IPX6 rating. (Met)
Shipping and Handling Durability
System functionality after rigorous simulated shipping and handling.	Demonstrated system functionality after being run through rigorous simulated shipping and handling. (Met)
Noise Evaluation
Less noise output compared to CyberWand I.	Demonstrated less noise output of the CyberWand II compared to the CyberWand I. (Met)
Surface Temperature Profile
Surface temperature stabilizes at an acceptable level (IEC 60601-1) with aspiration.	Demonstrated that the surface temperature of the transducer stabilizes at an acceptable level while running with aspiration. (Met)
Surface temperature stabilizes at a lower temperature than CyberWand I (with and without aspiration).	Demonstrated that the surface temperature of the CyberWand II transducer stabilizes at a lower temperature than the CyberWand I while running with and without aspiration. (Met)
Setup Steps
Fewer setup steps for CyberWand II compared to CyberWand I (37.5% fewer).	Demonstrated the number of setup steps is less for the CyberWand II as compared to the CyberWand I (37.5% fewer steps). (Met)
Usability Verification and Validation
Ability to fragment simulated urinary tract calculi (3.76, 1.65, 0.97 probes).	Demonstrated the ability for the CyberWand II 3.76, 1.65, and 0.97 to fragment simulated urinary tract calculi. (Met)
Usability of IFU and labeling.	Demonstrated the usability of the CyberWand II IFU and labeling. (Met)
Meets customer needs.	Demonstrated the CyberWand II meets customer needs. (Met)
Electrical Safety (IEC 60601-1:2005 3rd Ed.)	Complies with IEC 60601-1:2005 3rd Edition. All testing conducted by Intertek. (Met)
EMC (IEC 60601-1-2 ed3.0 and CISPR 11:2009+A1:2010)	Complies with IEC 60601-1-2 ed3.0 and CISPR 11:2009+A1:2010. All testing conducted by Intertek. (Met)
Risk Management (ISO 14971)	Compliance with ISO 14971 established by inspection (desktop audit) of the Risk Management File. (Met)
Software Validation (FDA Moderate Level of Concern)	Performed according to FDA's Moderate Level of Concern recommendations. (Met)
Sterilization Validation
SPL-PD376 probe (EO sterilization)	Packaging and sterilization validations apply to SPL-PD376 probes, confirmed by MOOG Medical Device Group. (Met by comparison to predicate data K120303)
5-year shelf life sterile packaging (SPL-PD376 probe)	Assured with accelerated and real-time aging and subsequent testing; supported by data in K132795. (Met)
Cleaning efficacy for non-sterile components	Validated manual cleaning method demonstrated. (Met)
Steam efficacy (US steam sterilization cycle)	Demonstrated efficacy at the US steam sterilization cycle (4 minutes at 132 degrees C, 20 minute dry time) for various components. (Met)
Dry time validation (20 minute dry time for US steam sterilization)	Demonstrated adequate 20 minute dry time for a US steam sterilization cycle for various components. (Met)

The document describes several performance tests and validations to demonstrate the ShockPulse-SE Lithotripsy System (CYBERWAND II)'s safety and effectiveness and its substantial equivalence to the predicate device (CyberWand Dual Action Ultrasonic Lithotripsy System, K120303).

Summary of Studies and Information:

2. Sample Size Used for the Test Set and Data Provenance:

CyberWand II Performance Analysis for Stone Breakage:
- No specific sample size (number of stones, trials) is mentioned for the quantitative stone drilling and mass removal tests. The comparison states "at least 10% faster" and "at least 20% faster," implying a statistically significant difference was observed, but the underlying data points are not provided.
- Data Provenance: Not specified, but generally in vitro (bench-top) or ex vivo (simulated use) given the nature of the tests (drilling into stones, mass removal).
Retropulsion Study:
- No specific sample size is mentioned. It compares the CyberWand II 1.65 probe to a "competitively marketed lithotripter" (LithoClast pneumatic).
- Data Provenance: Implied in vitro or bench-top measurement, as it quantifies "impact force."
Tissue Perforation Testing (Dr. Evans' Pig Kidney Test):
- No specific sample size (number of kidneys or trials) is explicitly stated for the "Pig Kidney Test." It mentions "The CyberWand consistently induced less kidney tissue damage..." The ShockPulse SE system was "tested in simulated use conditions by several physicians in the porcine model."
- Data Provenance: Ex vivo (freshly harvested porcine kidney) for the initial comparison with the predicate device. The subsequent test for ShockPulse SE was ex vivo in a porcine model.
Life Cycle Analyses (Transducer, Torque Wrench, Generator, Footswitch):
- Sample size: "50 simulated use cycles" for transducer and torque wrench. No specific number of units tested is provided for generator (7 years) or footswitch (durability).
- Data Provenance: Bench-top, simulated use testing.
Probe Reliability and Reusability Analysis:
- Sample size: Refers to "functional after a single simulated use" for "5x typical use time," but the number of actual probes tested is not stated.
- Data Provenance: Bench-top, simulated use testing.
IEC 61847 Evaluation:
- No specific sample size (number of probes or trials) for output characteristics or probe tip displacement.
- Data Provenance: Bench-top measurements.
Usability Verification and Validation:
- Sample size: Not specified for stone fragmentation (simulated calculi), IFU usability, or customer needs. "Several physicians" were involved in the porcine model for tissue perforation, which might feed into "customer needs" indirectly.
- Data Provenance: Bench-top for stone fragmentation; likely qualitative assessment for IFU and customer needs validation, possibly involving real users/physicians.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

Tissue Perforation Testing: "Dr. Evans' Pig Kidney Test" and "several physicians" were involved in the porcine model for the ShockPulse SE.
- Qualifications: "Dr. Evans" implies a qualified expert, and "physicians" indicates medical professionals. Specific specializations (e.g., urologists) and years of experience are not provided.
For other performance tests like stone breakage, retropulsion, life cycle, EMC, electrical safety, usability, the "ground truth" is typically objective measurement against engineering specifications and validated test methods rather than expert consensus on a subjective finding.

4. Adjudication Method for the Test Set:

Given that most tests are objective engineering or bench-top measurements (e.g., drill rate, mass removal, impact force, displacement, temperature, electrical safety, noise levels, torque, cycle counts), adjudication methods like 2+1 or 3+1 (common for subjective image interpretation) are not applicable.
For the "Dr. Evans' Pig Kidney Test," a "visual assessment methodology" was used to compare tissue damage. The document doesn't specify if multiple observers were used or an adjudication process.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, a "multi-reader multi-case (MRMC) comparative effectiveness study" focusing on human readers improving with AI vs. without AI assistance was not conducted. This is an electrohydraulic lithotripter for physical stone fragmentation, not an AI-assisted diagnostic or image interpretation device. The studies focus on device performance, safety, and functionality.

6. Standalone (Algorithm Only Without Human-in-the Loop Performance) Study:

This question is not applicable as the device is a medical instrument (lithotripter), not an algorithm or AI software for diagnosis or image analysis. The device's "standalone" performance is evaluated through the bench-top and simulated use tests described (e.g., stone breakage, life cycle, safety, EMC).

7. Type of Ground Truth Used:

Objective Measurements: For most tests (stone breakage, retropulsion, displacement, life cycle, noise, temperature, torque, electrical safety, EMC), the ground truth is established by objective, quantitative measurements against predefined engineering specifications, national/international standards (e.g., IEC 60601-1, CISPR 11), and internal performance targets derived from the predicate device.
Comparisons to Predicate/Reference Devices: Performance (e.g., stone breakage, displacement, tissue damage, noise) is often compared directly to the predicate device (CyberWand I) or other legally marketed devices (LithoClast, Med-Sonics Corp. UreTron Multi Probe Lithotripter K111058), which serve as a benchmark for substantial equivalence.
Expert Visual Assessment: For tissue perforation (Dr. Evans' Pig Kidney Test), ground truth was based on a "visual assessment methodology" of kidney tissue damage.
Compliance with Standards: For regulatory aspects (electrical safety, EMC, risk management, software validation, sterilization validation), ground truth is compliance with specified regulatory standards and guidance documents.

8. Sample Size for the Training Set:

This question is not applicable. The ShockPulse-SE Lithotripsy System is a mechanical/electronic medical device, not a machine learning or AI algorithm that requires a "training set" in the conventional sense. The device's design is based on engineering principles and iterative development, not data-driven machine learning.

9. How the Ground Truth for the Training Set Was Established:

This question is not applicable as there is no "training set" for this type of device. The design and performance validation rely on engineering specifications, physical testing, and comparison with predicate devices and established standards.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

November 13, 2014

Cybersonics, Inc. Jeff Vaitekunas Vice President of R&D 5340 Fryling Road Erie. PA 16510

Re: K142428

Trade/Device Name: Shock Pulse-SE Lithotripsy System CyberWand II Regulation Number: 21 CFR 876.4480 Regulation Name: Electrohydraulic Lithotriptor Regulatory Class: Class II Product Code: FEO Dated: August 27, 2014 Received: August 29, 2014

Dear Jeff Vaitekunas,

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 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

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the quality systems (OS) 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 -A

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) K142428

Device Name ShockPulse-SE Lithotripsy System

CYBERWAND II

Indications for Use (Describe)

The ShockPulse-SE Lithotripsy System is intended to be used for the fragmentation of urinary tract calcul 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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CYBERSONICS TRADITIONAL 510(k) SUBMISSION ShockPulse-SE Lithotripsy System (CYBERWAND II) K142428

510(k) Summary for ShockPulse-SE Lithotripsy System (CYBERWAND II)

Contact Information for Cybersonics, Inc.

Jeff Vaitekunas

Vice President of Regulatory Affairs

Cybersonics, Inc.

5340 Fryling Road

Erie, Pennsylvania 16510

Phone: 814-920-1521

Fax: 814-898-4737

jvaitekunas@cybersonics-inc.com

This Summary was prepared on June 20, 2014. This Summary was revised on November 12, 2014.

Trade Name

Proprietary: ShockPulse-SE Lithotripsy System CYBERWAND II
Common: Lithotripter, Ultrasonic Intracorporeal

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Classification

Product Code FEO (lithotripter, ultrasonic) Class II, 21 CFR 876.4480 - Electrohydraulic lithotripter

Predicate Device

The ShockPulse-SE Lithotripsy System (CYBERWAND II) described in this Traditional 510(k) Submission is, in our opinion, substantially equivalent to the predicate device, CyberWand Dual Action Ultrasonic Lithotripsy System (K120303).

Product Description

Suction control is integrated into the transducer housing. With a thumb wheel that can rotate approximately 20 degrees, the flow can be varied from "full" on to "off." There are markings on the transducer to indicate which direction increases and decreases suction flow through the transducer lumen.

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CYBERSONICS TRADITIONAL 510(k) SUBMISSION ShockPulse-SE Lithotripsy System (CYBERWAND II) K142428

There are families of probes that function similar to the probes of the current CyberWand System (K120303) by transmitting stress-waves from the transducer to the calculi to break up kidney-stones. Hollow probes permit simultaneous suction. The direct patient-contact material is stainless steel, which is the same material used in the predicate system.

Indications for Use Statement

The ShockPulse-SE Lithotripsy System (CYBERWAND II) is intended to be used for the fragmentation of urinary tract calculi in the kidney, ureter and bladder.

Substantial Equivalence Rationale

The ShockPulse Lithotripsy System (CYBERWAND II) is substantially equivalent to the:

CyberWand Dual Action Ultrasonic Lithotripsy System (CYBERWAND) . (K120303)
The ShockPulse-SE Lithotripsy System (CYBERWAND II) has the following similarities to the predicate device CyberWand Dual Action Ultrasonic Lithotripsy System that previously received 510(k) clearance (K120303):
Indications for use
Free mass enhanced ultrasonic technology
Basic design
. Patient contact materials

The ShockPulse-SE Lithotripsy System (CYBERWAND II) is the next generation of the CyberWand System. Key differences between the ShockPulse-SE Lithotripsy System and predicate device are:

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. Generator:
- o addition of an auto-tune feature (versus manual tuning to match the transducer's resonant frequency),
- o addition of circuitry to provide probe constant probe displacement under various loading conditions, and
- o a redesigned housing to be more ergonomic.
. Transducer:
- o addition of power activation buttons (providing an option to using the footswitch),
- o addition of a suction control knob, and
- o a redesigned housing to be more ergonomic.
. Probes:
- o change from a dual tube probe design to a single tube design, and
- o expanding the previous range of probe sizes (3.76 and 1.65 mm OD) to include four new models (3.40, 1.83, 1.50, and 0.97 mm OD).
. Wrench:
- o the standard wrench was modified to limit the applied torque when attaching the probe to the transducer.

The remaining system components are similar or unchanged: footswitch, nosecone, and cleaning stylets.

Performance Data

The safety and effectiveness of the ShockPulse SE Lithotripsy System (CYBERWAND II) is determined primarily by confirming that its design and performances conform to the established national and international standards, protocols applicable to lithotripters and the FDA document, "Guidance for the Content of Premarket Notifications for Intracorporeal Lithotripters". The ShockPulse-SE Lithotripsy System (CYBERWAND II) performs as well as or

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CYBERSONICS TRADITIONAL 510(k) SUBMISSION ShockPulse-SE Lithotripsy System (CYBERWAND II) K142428

better than the predicate device. The ShockPulse-SE Lithotripsy System (CYBERWAND II) complies with the requirements of each the standards and protocols discussed below.

Performance Considerations

The ShockPulse-SE Lithotripsy System (also known as the CyberWand II) was evaluated extensively for performance using bench-top tests and a series of simulated-use animal labs. Below are outlines of the individual tests performed:

CyberWand II Performance Analysis for Stone Breakage

Demonstrating the performance (mass removal and . stone drilling) of the CyberWand II compared to the predicate CyberWand I.
- o The CyberWand II 3.76 probe drills through a stone at least 10% faster than the CyberWand I 3.76 Dual Probe.
- o The CyberWand II 3.76 probe removes mass at least 20% faster than the CyberWand I 3.76 Dual Probe.
Demonstrating the retropulsion of the CyberWand II . ureteral probe compared to the LithoClast pneumatic. The LithoClast is a competitively marketed lithotripter.
- The CyberWand II 1.65 probe has less impact ● force than the LithoClast pneumatic ureteral probe.

Equivalent stone breakage for the smallest probe size (0.97 mm solid probe) is supported by stone breakage measurements and identification of

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a reference device with an 0.8 mm ultrasonic probe (K111058, Med-Sonics Corp. UreTron Multi Probe Lithotripter).

CyberWand II Transducer and Torque Wrench Life Cycle Analysis (50 Cycles)

Demonstrating the transducer and torque wrench performance . does not degrade over 50 simulated use cycles and that every aspect of the transducer is functional after 50 simulated use cycles. The following characteristics were evaluated:
- · Performance
  - o Mass Removal
  - o Drill Rate
  - o Probe Tip Displacement
- . Functionality
  - o Suction Control
  - o Transducer Button Activation Switches
- . Safety
  - o Electrical Safety (Patient Leakage Current)
- Appearance Quality ●
  - o Black Anodize
  - o Laser Etching

CyberWand II Probe Reliability and Reusability Analysis

. Demonstrating probes are functional after a single simulated use. This tested for the probes to be capable of 5x typical use time.
Note: The probes are to be labeled single use.

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CyberWand II IEC 61847 Evaluation

Demonstrating the output characteristics of the CyberWand II . system including all probe sizes compared to the CyberWand I 3.76 mm dual probe.
Demonstrating less probe tip displacement (101 microns peak-. to-peak) compared to the predicate CyberWand I (102 microns peak-to-peak) as evidence for a safe and substantially equivalent next generation lithotripter.

Tissue Perforation Testing (Performed on the predicate CyberWand I)

Dr. Evans' Pig Kidney Test

The Pig Kidney Test supported the safety of the largest probe size (3.76 mm).
In vitro testing was performed to determine the type of tissue . damage induced by the CyberWand Dual Action Ultrasonic Lithotripsy System and LithoClast Ultra when placed in contact with the surface of a freshly harvested porcine kidney. The CyberWand consistently induced less kidney tissue damage than the LithoClast Ultra using a visual assessment methodology.
The ShockPulse SE system was designed and tested to have ● equal or less maximum tip amplitude than the CyberWand Dual Action Ultrasonic Lithotripsy System. Further, the CyberWand ShockPulse SE system was tested in simulated use conditions by several physicians in the porcine model; and no significant tissue damage occurred.

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Equivalent tissue perforation potential for the smallest probe . size (0.97 mm) is supported by identification of a reference device with an 0.8 mm ultrasonic probe (K111058, Med-Sonics Corp. UreTron Multi Probe Lithotripter).

CyberWand II Torque Wrench Performance

Demonstrating a consistent torque specification of 35-40 inch . pounds.

CyberWand II Generator and Footswitch Life Cycle Analysis

Demonstrating a useful life of 7 years for the generator. ●
. Demonstrating footswitch durability and IPX6 rating.

CyberWand II Shipping and Handling Durability Verification and Validation

Demonstrating system functionality after being run through . rigorous simulated shipping and handling.

Noise Evaluation of CyberWand II Transducer

Demonstrating less noise output of the CyberWand II compared . to the CyberWand I.

Surface Temperature Profile of the CyberWand II Aluminum Transducer

Demonstrating that the surface temperature of the transducer ● stabilizes at an acceptable level while running with aspiration. The acceptable level is defined by IEC 60601-1.
. Demonstrating that the surface temperature of the CyberWand II transducer stabilizes at a lower temperature than the CyberWand I while running with and without aspiration.

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Setup Steps - CyberWand and CyberWand II ShockPulse SE

Demonstrating the number of setup steps is less for the ● CyberWand II as compared to the CyberWand I.
- o The CyberWand II has 37.5% fewer steps which saves time in the Operating Room and reduces the probability of improper setup and a delay in procedure

Cybersonics' ShockPulse SE Usability Verification and Validation

Demonstrating the ability for the CyberWand II 3.76, 1.65, and 0.97 to fragment simulated urinary tract calculi.
Demonstrating the usability of the CyberWand II IFU and labeling. ●
Demonstrating the CyberWand II meets customer needs. .

Electrical Safety Considerations

The ShockPulse-SE Lithotripsy System (CYBERWAND II) is classified as IEC Electrical Safety Class I equipment, with a Type BF applied part that complies with IEC 60601-1:2005 30 Edition. The following is a list of testing related to the evaluation of the ShockPulse-SE Lithotripsy System for Electromagnetic Compatibility and Electrical Safety. All testing was conducted by Intertek.

IEC 60601-1, Medical electrical equipment, Part 1: General requirements for basic safety and essential performance.

Standards: IEC 60601-1: 2005 + CORR. 1 (2006) + CORR. 2 (2007)

EMC Test Report

Standards: IEC 60601-1-2 ed3.0 (2007-03) With Voltage Deviations for Japan.

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EMC Emissions Report

Standards: Radiated Emissions, CISPR 11:2009+A1:2010 per IEC 60601-1-2 ed3.0 (2007-03).

Classification Constructional Data Report (CDR)

Standards: Medical electrical equipment, Part 1: General Requirements for Basic Safety and Essential Performance, AAMI ES60601-1:2005, lssued: 2006/03/09: 2005 Version (R2012): with AMD C1: 2009, AMD 2: 2010

Medical Electrical Equipment - Part 1: General Req. for Basic Safety & Essential Performance, CSA C22.2#60601-1, Issued: 2008/02/01 Ed: 2; Cor. 2: 2011.

IEC Certificate US/5130/ITS

CB Test Certificate - Compliance with ISO 14971, as required by subclause 4.2, has been established by performing an inspection (desktop audit) of the Risk Management File.

Standards: ISO 14971, IEC 60601-1-6(ed.3), IEC 60601-1(ed.3), IEC 62366(ed.1).

The purpose of the Electromagnetic Compatibility (EMC) Directive is to ensure the customer that all standards for manufacturing and operating the electronics of the device safely have been adhered to and followed. The EMC Directive also stipulates that the device will not emit radiation at levels that will interfere with other devices located nearby. Additionally, the EMC Directive ensures the device will not transmit electro-magnetic surges back into the power grid at frequencies and amplitudes that are above the values listed in the standard.

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Software Validation Considerations

Software validation for the life cycle operation has been performed according to the FDA's Moderate Level of Concern recommendations provided in the document "Guidance for the Content for Premarket Submissions for Software Contained in Medical Devices (5/29/98)."

Sterilization Validation Considerations

All probes except the SPL-PD376 are provided single patient use, nonsterile, and are cleaned and sterilized prior to use by the user in accordance with the directions provided in the system IFU. The SPL-PD376 probe is packaged sterile, single patient use, and is sterilized using the EO process outlined below.

EO Sterilization for 3.76 mm single probe

MOOG Medical Device Group analyzed the differences between the predicate CyberWand I 3.76 Dual Probe (CW-RBP) and the present SPL-PD376 and has determined that the packaging and sterilization validations apply to the SPL-PD376 probes. The packaging and sterilization for the Shock Pulse SE Lithotripsy System probes are the same as described in K120303.

5 year shelf life sterile packaging

The SPL-PD376 probe is packaged sterile, single patient use, with a 5 year sterility shelf-life. It is sterilized using the EO process outlined above. 5-year shelf life has been assured with both accelerated and real-time ageing and subsequent testing. The 5 year shelf life of the SPL-PD376

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probe is also supported by data submitted in reference device K132795. Subsequently real-time ageing was performed.

Cleaning and Steam Sterilization

The ShockPulse SE Lithotripsy System (CYBERWAND II) probes, nose-cone, torque wrench, stylets and transducer are all provided non-sterile to the user, and are to be cleaned and sterilized in accordance with the instructions provided in the system IFU. Cleaning and sterilization validations were performed by MicroTest, and the reports are summarized below.

Cleaning Efficacy

Demonstrating a validated manual cleaning method for all components that are used in the sterile field.

MicroTest Steam Efficacy

Demonstrating efficacy at the US steam sterilization cycle (4 minutes at 132 degrees C, 20 minute dry time).

4 double wrapped packs per load:

Transducer and Nosecone ●
Ultem Nose-cone .
Torque Wrench .
Probes and Stylets .

Dry Time Validation

Demonstrating adequate 20 minute dry time for a US steam sterilization cycle.

4 double wrapped packs per load:

Transducer and Nosecone ●
Ultem Nose-cone .

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Torque Wrench .
Probes and Stylets .

Conclusion

The performance testing summarized above demonstrates that the ShockPulse-SE Lithotripsy System (CYBERWAND II) is substantially equivalent to the predicate device.

Regulation Number and Section

§ 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.”