The CyberWand Dual Action Ultrasonic Lithotripsy System is intended to be used for the fragmentation of urinary tract calculi in the kidney, ureter and bladder.

Device Description

The CyberWand Dual Action Ultrasonic Lithotripsy System includes a Generator, Transducer (2), Footswitch, Power Cord, Wrench, and Cleaning Stylet. The disposable probe set is sold separately either sterile or non-sterile. The Cybersonics CyberWand Dual Probe Ultrasonic Lithotripsy System is an electromechanical device capable of fragmenting and aspirating calculi. The hand piece consists of an ultrasonic transducer containing the piezoelectric elements, which are driven by a generator operating at 20400 - 22200 Hz. The resulting longitudinal waves are propagated along the ultrasonic dual probe to the target stone. The ultrasonic transducer probes are hollow, permitting simultaneous suction.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the CyberWand Dual Action Ultrasonic Lithotripsy System:

Summary of Device and Context:

The CyberWand Dual Action Ultrasonic Lithotripsy System is an electromechanical device designed for the fragmentation and aspiration of urinary tract calculi (kidney, ureter, and bladder stones). This submission is an Abbreviated 510(k), indicating a reliance on substantial equivalence to previously cleared predicate devices.

Acceptance Criteria and Reported Device Performance:

Based on the provided text, the acceptance criteria are primarily focused on safety, performance standards compliance, and equivalence to predicate devices, rather than specific clinical efficacy metrics like sensitivity or specificity.

Acceptance Criteria Category	Specific Criteria	Reported Device Performance (`CyberWand Dual Action Ultrasonic Lithotripsy System`)
Substantial Equivalence	Equivalency in: Indications for Use, ultrasonic technology, operating principle, basic configuration, materials.	"Substantially equivalent with the predicate device, CyberWand Dual Probe Lithotripter (K052135)." Also compared to CyberWand Hollow Semi-Flexible Ureteral Probe Lithotripter (K102169). Stated similarities: "Same indications for use, Same ultrasonic technology, Same operating principle, Same basic configuration, Same materials."
International Standards Compliance (Performance)	Compliance with IEC 61847:1998 - Ultrasonics, Surgical Systems - Measurement and Declaration of the Basic Output Characteristics.	"Cybersonics prepared an evaluation report which provides a declaration of output characteristics."
Verification and Validation (Device Performance)	Performance tests for the Advanced Transducer, including pre-sterilization and post-sterilization performance: Drill Rate, Laser Vibrometer, Surface Temperature Profile, Interface and Compatibility, Steam Sterilization, and Endurance Durability.	"Verification and Validation studies for the Advanced Transducer were performed and documented in a formal report which included results for pre-sterilization and post-sterilization performance tests (Drill Rate Study, Laser Vibrometer Study, Surface Temperature Profile Study, Interface and Compatibility Study, Steam Sterilization and Endurance Durability Study)." (Specific numerical results are not provided in this summary, only that they were performed and documented).
Electrical Safety Standards Compliance	Compliance with IEC 60601-1:2005 3rd Edition (Class I equipment with Type BF applied part).	"The CyberWand Dual Action Ultrasonic Lithotripsy System is classified as Class I equipment with a Type BF applied part that complies with IEC 60601-1.2005 3rd Edition."
Electromagnetic Compatibility (EMC)	Compliance with: EN 60601-1-2:2007 (emission and immunity), IECES-003, Issue 4:2004, FCC Part 15, Subpart B, EN55011:2007 (emissions), EN61000-3-2:2006 (harmonic current emissions), EN61000-3-3:2008 (voltage changes, fluctuations, flicker).	"The evaluation... illustrates that the unit meets the emission requirements of the EN 60601-1-2:2007... and with the requirements of IECES-003, Issue 4:2004, FCC Part 15, Subpart B and European Standard EN55011:2007... including Amendment A1:2010." "The evaluation... illustrates that the unit meets the immunity requirements of EN60601-1-2:2007..." "The evaluation... illustrates that the unit meets the requirements of EN61000-3-2:2006... and with EN61000-3-3:2008..."
Software Validation	Compliance with FDA's "Moderate Level of Concern" recommendations for software contained in medical devices ("Guidance for the Content for Premarket Submissions for Software Contained in Medical Devices (5/29/98)").	"Software validation for the cycle operation has been performed according to the FDA's Moderate Level of Concern recommendations..."
Sterilization Validation (Steam - Advanced Transducer)	Sterilization of Advanced Transducer to achieve an SAL minimum of 10^-6^ against ISO 17665-1:2006. Effective sterilization at 132C for a 2-minute Prevac half cycle. Thermocouple verification calibration passed. All controls satisfactory.	"Prevacuum steam sterilization technique has been qualified against the ISO 17665-:2006... The results of the biological indicators and inoculated device indicated no spore survivors for three consecutive half cycles... judged to be effectively sterilized at 132C for a 2 minute Prevac half cycle and zero minute dry time... considered adequate to achieve an SAL minimum of 10^-6^ at twice the stated exposure time. The thermocouples passed the verification calibration. All positive and negative controls were satisfactory."
Sterilization Validation (Steam - Probes)	Sterilization of CyberWand probes to achieve 10^-6^ sterility assurance level (SAL) using the overkill method, as defined in AAMI-TIR:2004. Effective sterilization at 132C for a 2-minute Prevac half cycle (double wrapped probes).	"A steam sterilization study with the CyberWand probes was conducted to determine if exposure of the double wrapped probes would produce the required 10^-6^ sterility assurance level using the overkill method... The CyberWand probes, doubled wrapped, was judged to be effectively sterilized at 132C for a 2 minute Prevac half cycle and zero minute dry time."
Sterilization Validation (ETO - Advanced Transducer)	Sterilization of Advanced Transducer using 100% ethylene oxide at 55C for 50 minutes with 12-hour aeration, against ISO 10993-7:2008 (residuals) and achieving an SAL of 10^-6^ using biological indicator overkill method. Allowable limits for ETO, ECH, and EG.	"The Advanced Transducer was also validated in a 100% ethylene oxide sterilization cycle at 55C for 50 minutes sterilize with twelve (12) hour aeration against the ISO 10993-7:2008... The study demonstrated that ethylene oxide (ETO), and its common degradants ethylene chlorohydrin (ECH) and ethylene glycol (EG), are within the allowable limits. The Advanced Transducer also demonstrated a sterility assurance level (SAL) of 10^-6^ using the biological indicator... overkill method."
Sterilization Validation (ETO - Sterile Probe Sets)	Requalification of sterilization process for CyberWand Sterile Probe Sets to confirm 10^-6^ SAL, in accordance with ANSI/AAMI/ISO 11135-1:2007. Bioburden testing and EO residual testing to verify aeration hold time.	"A study was conducted to validate the sterilization process for the CyberWand Sterile Probe Sets to confirm that the sterility assurance level (SAL) of 10^-6^ is obtained. This requalification was performed by Ethox and done in accordance with ANSI/AAMI/ISO 11135-1:2007... This study also included bioburden testing and EO residual testing to verify the previously validated EO aeration hold time."

Since this is an Abbreviated 510(k) submission for a device built on established technology with predicate devices, the "study that proves the device meets the acceptance criteria" primarily consists of:

Engineering bench testing and verification studies: These confirm that the new device adheres to specific design specifications, performance parameters (like drill rate, vibration, temperature profiles), compatibility, and durability, replicating or exceeding previous results.
Compliance with recognized national and international consensus standards: This is a key component of demonstrating safety and fundamental performance for such devices.
Validation of manufacturing processes: Especially sterilization and software.

The document does not describe a clinical study comparing human readers with AI assistance, or any clinical performance metrics like sensitivity, specificity, or clinical outcomes (e.g., stone fragmentation rates in patients). This is typical for devices cleared via substantial equivalence where safety and basic performance are demonstrated through non-clinical means and equivalence to a device with a known safety and efficacy profile.

Here's a breakdown of the other requested information based on the provided text:

Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not applicable in the context of a typical clinical test set for AI performance. The "test sets" here refer to batches of devices/components used for engineering verification (e.g., advanced transducers, probes) and sterility validation (e.g., biological indicators, inoculated devices, double wrapped probes). Specific numerical sample sizes for these tests are not provided in the summary but are generally defined by the relevant standards and protocols.
- Data Provenance: The studies are internal company verification and validation studies conducted by Cybersonics, and external validation performed by Ethox for sterilization. The data is prospective, generated specifically for this submission.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as there is no mention of a "ground truth" derived from expert consensus interpretation of medical images or clinical cases. The "ground truth" for the engineering and sterilization studies is established by the specifications in the standards themselves, physical measurements, and biological indicator results.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable, as no expert adjudication process is described.
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, an MRMC comparative effectiveness study was not done. This device is a physical, invasive surgical tool (lithotripter), not an AI-powered diagnostic or interpretive device. Therefore, the concept of "human readers improve with AI assistance" is not relevant to this submission.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This device is a physical instrument, not an algorithm. Its operation inherently involves a human surgeon.
The type of ground truth used (expert concensus, pathology, outcomes data, etc):
- Engineering/Performance Tests: The ground truth for these tests is defined by the technical specifications, design requirements, and performance parameters outlined in relevant international standards (e.g., IEC 61847) and internal company specifications. This involves objective physical measurements (e.g., drill rate, vibration frequency, temperature).
- Sterilization Validation: The ground truth is the achievement of a specific Sterility Assurance Level (SAL, typically 10^-6^) as measured by biological indicators and validated against standards like ISO 17665-1, AAMI-TIR, ISO 10993-7, and ANSI/AAMI/ISO 11135-1. EO residuals are compared to allowable limits.
The sample size for the training set:
- Not applicable. This submission does not describe an AI model with a training set. The "training" mentioned refers to the training of sales representatives and users on the device's proper use.
How the ground truth for the training set was established:
- Not applicable. (See #8)

Summary

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CYBERSONICS ABBREVIATED 510/k) SUBMISSION . CyberWand Dual Action Ultrasonic Lithotripsy System K120303/S001

510(k) Summary

Contact Information

Lori A. Colvin, C.Q.A. Director, Regulatory Affairs Cybersonics, Inc. 5325 Kuhl Road Erie, Pennsylvania 16510 Phone: 814-898-4734 Fax: 814-898-4737

Trade Name

CyberWand® Dual Action Ultrasonic Lithotripsy System Proprietary: Common: Lithotriptor, Ultrasonic Intracorporeal

Classification

Product Code FFK, Class II, 21 CFR 876.4880 - Electrohydraulic lithotripter

Predicate Device

The CyberWand Dual Action Ultrasonic Lithotripsy System described in this Abbreviated 510(k) submission is, in our opinion, substantially equivalent with the predicate device, CyberWand Dual Probe Lithotripter (K052135).

Product Description

The Cybersonics CyberWand Dual Probe Ultrasonic Lithotripsy System is an electromechanical device capable of fragmenting and aspirating calculi. The hand piece consists of an ultrasonic transducer containing the piezoelectric elements, which are driven by a generator operating at 20400 - 22200 Hz. The resulting longitudinal waves are propagated along the ultrasonic dual probe to the target stone. The ultrasonic transducer probes are hollow, permitting simultaneous suction.

Indications for Use Statement

The CyberWand Dual Action Ultrasonic Lithotripsy System is intended to be used for the fragmentation of urinary tract calculi in the kidney, ureter and bladder.

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Basis for Substantial Equivalence

The Cybersonics CyberWand Dual Action Ultrasonic Lithotripsy System is substantially equivalent to the:

CyberWand Dual Probe Lithotripter (K052135) ●
CyberWand Hollow Semi-Flexible Ureteral Probe Lithotripter (K102169) .

which were previously cleared for the fragmentation and removal of urinary tract calculi in the kidney, ureter and bladder.

The CyberWand Dual Action Lithotripsy System has the following similarities to the above-referenced devices:

Same indications for use ◆
Same ultrasonic technology .
. Same operating principle
Same basic configuration .
Same materials .

Performance Data

The safety and effectiveness of the CyberWand Dual Action Ultrasonic Lithotripsy System is determined primarily by confirming that its design and performances conform to the established national and international standards and protocols applicable to lithotripters. The CyberWand Dual Action Ultrasonic Lithotripsy System complies with the requirements of each the standards and protocols discussed below.

Performance Considerations

IEC 61847:1998 - Ultrasonics, Surgical Systems - Measurement and Declaration of the Basic Output Characteristics. This international standard defines the parameters which characterize the output and performance of open and closed site ultrasonic surgical systems, and indicates which parameters should be declared. Cybersonics prepared an evaluation report which provides a declaration of output characteristics.

Verification and Validation studies for the Advanced Transducer were performed and documented in a formal report which included results for pre-sterilization and post-sterilization performance tests (Drill Rate Study, Laser Vibrometer Study, Surface Temperature Profile Study, Interface and Compatibility Study, Steam Sterilization and Endurance Durability Study).

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The CyberWand Dual Action Ultrasonic Lithotripsy System is classified as Class I equipment with a Type BF applied part that complies with IEC 60601-1.2005 31° Edition.

The purpose of the 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 will not transmit electro-magnetic surges back into the power grid at frequencies and amplitudes that are above the values listed in the standard.

The evaluation of the CyberWand Dual Action Ultrasonic Lithotripsy System illustrates that the unit meets the emission requirements of the EN 60601-1-2:2007 "Medical Electric Equipment - Part 1, Section 1.2 Collateral Standard: Electromagnetic Compatibility - Requirements and Tests" and with the requirements of IECES-003, Issue 4:2004, FCC Part 15, Subpart B and European Standard EN55011:2007 "Limits and Methods of Measurement of Radio Interference Characteristics of Industrial, Scientific and Medical (ISM) Equipment" including Amendment A1:2010.

The evaluation of the CyberWand Dual Action Ultrasonic Lithotripsy System illustrates that the unit meets the immunity requirements of EN60601-1-2:2007 "Medical Electrical Equipment, Part 1-2: General Requirements for Basic Safety - Collateral Standard: Electromagnetic Compatibility - Requirements and Tests".

The evaluation of the CyberWand Dual Action Ultrasonic Lithotripsy System illustrates that the unit meets the requirements of EN61000-3-2:2006: "Electromagnetic Compatibility - Part 3-2: Limits for Harmonic Current Emissions (Equipment Input Current < 16 Amps Per Phase)" including Amendments A1:2009 and A2:2009, and with EN61000-3-3:2008: "Electromagnetic Compatibility - Part 3-3: Limits - Limitation of Voltage Changes, Voltage Fluctuations and Flicker in Public Low-Voltage Supply Systems for Equipment with Rated Current < 16 Amps Per Phase and not Subject to Conditional Connection".

Software Validation Considerations

Software validation for the 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)."

K 120303

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Sterilization Validation Considerations

Steam Sterilization

Prevacuum steam sterilization technique has been qualified against the ISO 17665-:2006 "Sterilization of Healthcare Products - Moist-Heat - Part 1: Requirements for the Development, Validation and Routine Control of a Sterilization Process for Medical Devices" standard for the Advanced Transducer (USLTA). The results of the biological indicators and inoculated device indicated no spore survivors for three consecutive half cycles. The Cybersonics Advanced Transducer was judged to be effectively sterilized at 132C for a 2 minute Prevac half cycle and zero minute dry time. The cycle conditions are considered adequate to achieve an SAL minimum of 106 at twice the stated exposure time. The thermocouples passed the verification calibration. All positive and negative controls were satisfactory. A dry time of fifteen (15) minutes was successfully validated for the four (4) minute Prevac cycle at 132C for 4 minutes sterilize for the double wrapped transducer.

A steam sterilization study with the CyberWand probes was conducted to determine if exposure of the double wrapped probes would produce the required 10° sterility assurance level using the overkill method as defined in the AAMI-TIR:2004 "Designing, Testing, and Labeling Reusable Medical Devices for Reprocessing in Health Care Facilities: A Guide for Medical Device Manufacturers". The CyberWand probes, doubled wrapped, was judged to be effectively sterilized at 132C for a 2 minute Prevac half cycle and zero minute dry time.

Ethylene Oxide Sterilization

The Advanced Transducer was also validated in a 100% ethylene oxide sterilization cycle at 55C for 50 minutes sterilize with twelve (12) hour aeration against the ISO 10993-7:2008 "Biological Evaluation of Medical Devices – Part 7: Ethylene Oxide Sterilization Residuals" standard. The study demonstrated that ethylene oxide (ETO), and its common degradants ethylene chlorohydrin (ECH) and ethylene glycol (EG), are within the allowable limits. The Advanced Transducer also demonstrated a sterility assurance level (SAL) of 10° using the biological indicator (Bacillus atrophaeus ATCC #9372) overkill method.

A study was conducted to validate the sterilization process for the CyberWand Sterile Probe Sets to confirm that the sterility assurance level (SAL) of 10° is obtained. This requalification was performed by Ethox and done in accordance with ANSI/AAMI/ISO 11135-1:2007 Sterilization of healthcare products -Ethylene Oxide - Part 1: Requirements for Development, Validation and Routine Control of Sterilization Process for Medical Devices. This study also included

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bioburden testing and EO residual testing to verify the previously validated EO aeration hold time.

Conclusion

Cybersonics through its distributor conducts training of the sales representatives and users about the appropriate and proper use of the CyberWand Dual Action Ultrasonic Lithotripsy System. Cybersonics further provides information to the user that is intended to ensure safe and effective use of lithotripsy procedures in its Instructions for Use Manual and other labeling.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and features an abstract image of an eagle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the eagle.

Public Health Service

Food and Drug Administration . 10903 New Hampshire Avenue Document Control Room -W066-G609 Silver Spring, MD 20993-0002

Ms. Lori Colvin Director of Regulatory Affairs Cybersonics. Inc. 5325 Kuhl Road ERIE PA 16510

JUN - 5 2012

Re: K120303

Trade/Device Name: Cyber Wand Dual Action Ultrasonic Lithotripsy System Regulation Number: 21 CFR§ 876.4480 Regulation Name: Electrohydraulic lithotriptor Regulatory Class: II Product Code: FFK Dated: May 25, 2012 Received: May 30, 2012

Dear Ms. Colvin:

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

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Page 2-

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,

and an 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 STATEMENT

510(k) Document Control Number:

120303

Device Name:

CyberWand Dual Action Ultrasonic Lithotripsy System

Indications for Use:

The CyberWand Dual Action Ultrasonic Lithotripsy System is intended to be used for the fragmentation of urinary tract calculi in the kidney, ureter and bladder.

(Please do not write below this line - continue on another page if needed.)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use X or Over-The-Counter Use
(21 CFR 801 Subpart D) (21 CFR 801 Subpart C)

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.”