(81 days)
No
The summary describes a purely electromechanical device for lithotripsy, focusing on ultrasonic fragmentation and aspiration. There is no mention of AI, ML, image processing, or any data-driven decision-making components. The performance studies described relate to package integrity and shelf life, not algorithmic performance.
Yes.
The device is intended for the fragmentation of urinary tract calculi, addressing a medical condition.
No
The device is described as a system for the fragmentation and aspiration of calculi, which is a treatment function, not a diagnostic one.
No
The device description explicitly states it is an "electromechanical device" with a "hand piece" containing an "ultrasonic transducer" and "probes," indicating it is a hardware device, not software-only.
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 kidneys, ureter, and bladder." This is a therapeutic procedure performed directly on the patient's body.
- Device Description: The description details an electromechanical device that uses ultrasonic waves to break up stones and aspirate them. 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.
IVD devices are designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device performs a therapeutic action within the body.
N/A
Intended Use / Indications for Use
The CyberWand Sterile Probe Set is designed to be used only with the CyberWand Dual Action Ultrasonic Lithotripsy System for the fragmentation of urinary tract calculi in the kidneys, ureter, and bladder.
Product codes
FFK
Device Description
The CyberWand Dual Action Ultrasonic Lithotripsy System includes a Generator, Transducer, Footswitch, Power Cord, Wrench, and Cleaning Stylet. The CyberWand Sterile Probe Set is sold 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
kidneys, ureter, and bladder (urinary tract calculi)
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)
To verify that CyberWand Sterile Probe Set met the validation requirements to support the five year shelf life claim, representative samples of the device underwent package integrity testing in accordance with Cybersonics design change control process and risk management activities.
Expiration dating is supported based upon acceptable test results (2ACMI-07P1-O/2013-GMP-028) obtained from the following series of package integrity tests.
- Accelerated Aging of Packaging .
- Real Time Aging of Packaging
- Simulated Ship Test & Inspection .
- Dye Penetration Testing for Single Barrier Packages
- Burst Package Testing for Packages .
- Peel Strength Test for Package Seals .
Testing was conducted on non-aged, one (1) and three (3) year accelerated, and one (1) and five (5) year real time aged tyvek/film pouches used for the CyberWand Sterile Probe Set.
Based on the results, it has been determined that a five (5) year expiration date may be applied to the CyberWand Sterile Probe Set.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
CyberWand Dual Action Ultrasonic Lithotripsy System (K120303), CyberWand Probe Lithotripter with Sterile Probes (K072422)
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.”
0
CYBERSONICS SPECIAL 510(k) SUBMISSION CyberWand Sterile Probe Set
Contact Information
Lori A. Colvin, C.Q.A. Director, Requlatory Affairs Cybersonics, Inc. 5325 Kuhl Road Erie, Pennsylvania 16510 Phone: 814-898-4734 Fax: 814-898-4737
Trade Name
Proprietary: CyberWand® Sterile Probe Set Common: Lithotriptor, Ultrasonic Intracorporeal
Classification
Product Code FFK, Class II, 21 CFR 876.4880 - Electrohydraulic lithotripter
Predicate Device
The CyberWand Sterile Probe Set described in this Special 510(k) submission is, in our opinion, substantially equivalent with the predicate devices, CyberWand Dual Action Ultrasonic Lithotripsy System (K120303) and CyberWand Probe Lithotripter with Sterile Probes (K072422).
Product Description
The CyberWand Dual Action Ultrasonic Lithotripsy System includes a Generator, Transducer, Footswitch, Power Cord, Wrench, and Cleaning Stylet. The CyberWand Sterile Probe Set is sold 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 Sterile Probe Set is designed to be used only with the CyberWand Dual Action Ultrasonic Lithotripsy System for the fragmentation of urinary tract calculi in the kidneys, ureter, and bladder.
1
Basis for Substantial Equivalence
The CyberWand Sterile Probe Set is substantially equivalent to the:
- CyberWand Dual Probe Lithotripter with Sterile Probes (K072422) .
- CyberWand Dual Action Ultrasonic Lithotripsy System (K120303) .
which were previously cleared for the fragmentation and removal of urinary tract calculi in the kidney, ureter and bladder.
The CyberWand Sterile Probe Set has the following similarities to the abovereferenced devices:
- Same indications for use .
- . Same ultrasonic technology
- . Same operating principle
- . Same basic configuration
- . Same materials
Performance Data
To verify that CyberWand Sterile Probe Set met the validation requirements to support the five year shelf life claim, representative samples of the device underwent package integrity testing in accordance with Cybersonics design change control process and risk management activities.
Package Integrity Validation
Expiration dating is supported based upon acceptable test results (2ACMI-07P1-O/2013-GMP-028) obtained from the following series of package integrity tests.
- Accelerated Aging of Packaging .
- Real Time Aging of Packaging t
- Simulated Ship Test & Inspection .
- Dye Penetration Testing for Single Barrier Packages �
- Burst Package Testing for Packages .
- Peel Strength Test for Package Seals .
Testing was conducted on non-aged, one (1) and three (3) year accelerated, and one (1) and five (5) year real time aged tyvek/film pouches used for the CyberWand Sterile Probe Set.
Based on the results, it has been determined that a five (5) year expiration date may be applied to the CyberWand Sterile Probe Set.
2
Conclusion
.
Cybersonics through its distributor conducts training of the sales representatives. and users about the appropriate and proper use of the CyberWand Sterile Probe Set with 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.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus symbol. The logo is black and white.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 26, 2013
Cybersonics, Inc. Lori a. Colvin. C.O.A. Director of Regulatory Affairs 5325 Kuhl Road Erie, PA 16510
Re: K132795
Trade/Device Name: Cyber Wand Sterile Probe Set Regulation Number: 21 CFR§ 876.4480 Regulation Name: Electrohydraulic lithotriptor Regulatory Class: II Product Code: FFK Dated: October 29, 2013 Received: October 30, 2013
Dear Lori A. 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
4
Page 2 - Lori A. Colvin, C.Q.A.
medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
HerbertP.Lerner-S
for
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal. and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
INDICATIONS FOR USE STATEMENT
510(k) Document Control Number: K132795
Device Name:
CyberWand Sterile Probe Set
Indications for Use:
The CyberWand Sterile Probe Set is designed to be used only with the CyberWand Dual Action Ultrasonic Lithotripsy System for the fragmentation of urinary tract calculi in the kidneys, ureter, and bladder.
(Please do not write below this line - continue on another page if needed.)
Concurrence of CDRH, Office of Device Evaluation
Prescription Use X (21 CFR 801 Subpart D) Or
Over-The-Counter Use (21 CFR 801 Subpart C)
Herbert P. Lerner-S
2013.11.26 15:11:06 -05'00'
September 4, 2013