(125 days)
No
The description focuses on electromechanical fragmentation and aspiration using ultrasonic waves, with no mention of AI/ML terms or functionalities.
Yes
The device is intended for the fragmentation of urinary tract calculi, indicating a direct medical intervention to treat a condition.
No
The device is intended for fragmentation and aspiration of urinary tract calculi, which is a therapeutic action, not a diagnostic one.
No
The device description explicitly lists multiple hardware components including a Generator, Transducer, Footswitch, Power Cord, Wrench, and Cleaning Stylet, and describes it as an electromechanical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "fragmentation of urinary tract calculi in the kidney, ureter and bladder." This describes a therapeutic procedure performed directly on the patient's body to break up stones.
- Device Description: The description details an electromechanical system that uses ultrasonic waves to fragment and aspirate calculi. This is a physical intervention, not a test performed on a sample taken from the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis. IVDs are designed to diagnose diseases or conditions by examining samples in vitro (outside the body).
This device is a therapeutic medical device used for lithotripsy, a procedure to break up stones within the urinary tract.
N/A
Intended Use / 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.
Product codes
FFK
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.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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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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 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.
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.
1
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).
2
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 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
6
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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)