(28 days)
The CyberWand Hollow Semi-Flexible Ureteral probe is designed to be used only with the CyberWand System for the fragmentation of urinary tract calculi in the kidneys, ureter, and bladder.
The CyberWand Dual Ultrasonic Lithotripsy System is an electromechanical device used to fragment and aspirate calculi. The system consists of the generator unit, transducer handpiece, footswitch, probe sets and cleaning stylets.
The Semi-Flexible Probe is constructed entirely of stainless steel and is packaged with a stainless steel cleaning stylet. The probe has a working length of 58.5 cm and an outer diameter of 1.65 mm; it is is intended to be used primarily with semi-rigid or ridged scopes (cystoscopes, nephroscopes and ureteroscopes) which have a working channel between 5 and 7 French in diameter.
The probe is for provided non-sterile and is for single-patient use.
The provided text is related to a 510(k) submission for the Cybersonics CyberWand® Lithotripter and its Hollow Semi-Flexible Ureteral Probe. This type of regulatory submission focuses on demonstrating substantial equivalence to a predicate device, rather than conducting extensive clinical studies to establish new safety and effectiveness criteria as would be typical for novel devices.
Therefore, many of the requested items (e.g., acceptance criteria for clinical performance, sample size for test sets with ground truth, MRMC studies, training set details) are not applicable or not present in the provided 510(k) summary because the device is a modified version of an already cleared predicate device. The focus is on demonstrating that the modifications do not raise new questions of safety and effectiveness and that the modified device performs as intended.
Here's an analysis based on the provided text, addressing the points where information is available:
1. Table of Acceptance Criteria and Reported Device Performance
The 510(k) summary does not provide specific quantitative acceptance criteria or detailed reported device performance in a table format for clinical efficacy. The device is a "modified probe" intended to be equivalent to a predicate. The "acceptance criteria" here refer more to meeting functional and performance requirements for a medical device rather than clinical outcome measures as you might find for a diagnostic AI.
| Acceptance Criteria Type | Details from Submission |
|---|---|
| Functional & Performance Requirements | "To verify that device design met its functional and performance requirements, representative samples of the device underwent durability and stone breakage testing in accordance with Cybersonics Design Control processes and the risk assessment." (Specific metrics are not provided in this summary.) |
| Substantial Equivalence | "Cybersonics considers the modified probes to be equivalent to the predicate device listed above. This conclusion is based upon the devices' similarities in principles of operation, technology, materials and indications for use." |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not specified for clinical efficacy. The summary mentions "representative samples of the device" for durability and stone breakage testing, implying in-vitro or bench testing, not a clinical test set with patient data.
- Data Provenance: Not applicable for a clinical test set. The functional and performance testing would have been conducted internally by Cybersonics.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This is not applicable as the provided summary discusses a physical medical device (lithotripter probe) and its functional performance, not an AI or diagnostic device that requires expert-established ground truth on a test set of patient data.
4. Adjudication method for the test set
- This is not applicable for the same reasons as point 3.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
- No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices, especially those incorporating AI, where human readers interpret patient cases. This submission is for a surgical instrument.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- This is not applicable. The device is a human-operated surgical instrument, not an algorithm.
7. The type of ground truth used
- For the functional and performance testing, the "ground truth" would be the engineering specifications and performance standards established by Cybersonics for durability and stone breakage. This is not clinical ground truth like pathology or outcome data.
- For the overall submission, the "ground truth" for substantial equivalence is the predicate device's established safety and effectiveness.
8. The sample size for the training set
- This is not applicable as there is no AI algorithm being developed or trained for this device.
9. How the ground truth for the training set was established
- This is not applicable as there is no AI algorithm or training set discussed.
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AUG 3 0 2010
510(K) SUMMARY 6.
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| Submitter: | Cybersonics, Inc.5325 Kuhl RoadErie, PA 16510Phone: (814) 898-4734Fax: (814)898-4737Contact: Jeff Vaitekunas |
|---|---|
| Date Prepared: | July 30, 2010 |
| Trade Name: | CyberWand® Lithotripter |
| Classification: | Class II, 21 CFR 876.4880, FFKElectrohydraulic lithotripter |
| Predicate Device(s): | The CyberWand Hollow Semi-Flexible Ureteral probe is equivalent tothe Cyberwand Dual Probe Set (K052135). |
| Device Description: | The CyberWand Dual Ultrasonic Lithotripsy System is anelectromechanical device used to fragment and aspirate calculi. Thesystem consists of the generator unit, transducer handpiece,footswitch, probe sets and cleaning stylets.The Semi-Flexible Probe is constructed entirely of stainless steel andis packaged with a stainless steel cleaning stylet. The probe has aworking length of 58.5 cm and an outer diameter of 1.65 mm; it is isintended to be used primarily with semi-rigid or ridged scopes(cystoscopes, nephroscopes and ureteroscopes) which have a workingchannel between 5 and 7 French in diameter.The probe is for provided non-sterile and is for single-patient use. |
| Intended Use: | The CyberWand Hollow Semi-Flexible Ureteral probes are designedto be used only with the CyberWand Dual Ultrasonic LithotripsySystem for the fragmentation of urinary tract calculi in the kidneys,ureter, and bladder. |
| Functional and SafetyTesting: | To verify that device design met its functional and performancerequirements, representative samples of the device underwentdurability and stone breakage testing in accordance with CybersonicsDesign Control processes and the risk assessment. |
| Conclusion: | Cybersonics considers the modified probes to be equivalent to thepredicate device listed above. This conclusion is based upon thedevices' similarities in principles of operation, technology, materialsand indications for use. |
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Image /page/1/Picture/0 description: The image shows the logo for the Department of Health & Human Services in the USA. The logo features a stylized eagle with its wings spread, facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Mr. Jeff Vaitekunas Vice-President Regulatory Cybersonics, Inc. 5325 Kuhl Road ERIE PA 16510
AUG 3'0 2010
Re: K102169
Trade/Device Name: Cybersonics CyberWand® Hollow Semi-Flexible Ureteral Probe Regulation Number: 21 CFR§ 876.4480 Regulation Name: Electrohydraulic Lithotriptor Regulatory Class: II Product Code: FFK Dated: July 30, 2010 Received: August 2, 2010
Dear Mr. Vaitekunas:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your betermined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate 101 use stated in the encreations of the Medical Device Americal Device Americans, or to conninered phor to may 20, 1978, me except ance with the provisions of the Federal Food, Drug, devices that have been require approval of a premarket approval application (PMA). and Cosmetic Treefore, market the device, subject to the general controls provisions of the Act. The I ou may, merelore, mains of the Act include requirements for annual registration, listing of general controls provisioning practice, labeling, and prohibitions against misbranding and devices, good manufacturing praction, accomment related to contract liability addition. Thease note. SDATE ver, 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 If your device is classified (boo above) axisting major regulations affecting your device can be filly be subject to additional controlly institute and to 898. In addition, FDA may in 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 Please be advised that I DPT 3 issuation of a station of the requirements of the Act
that FDA has made a determination that your device complies with other comple that FDA has made a decernmanon that your conserved by other Federal agences. You must comply
or any Federal statutes and regulations administered by other Federal and listi of any Federal Statutes and regulations administered of to: registration and listing (21 CFR Patter with all the Act s requirements, medical device reporting of medical device-related
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Page 2
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/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,
Stuker Lemur MD
Herbert P. Lerner, M.D., Director (Acting) Division of Reproductive, Gastro-Renal and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health.
Enclosure
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5. INDICATIONS FOR USE STATEMENT
510(k) Number (if known): KJO2169
Device Name: Cybersonics CyberWand® Hollow Semi-Flexible Ureteral Probe
Indications for Use:
The CyberWand Hollow Semi-Flexible Ureteral probe is designed to be used only with the CyberWand System for the fragmentation of urinary tract calculi in the kidneys, ureter, and bladder.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)-
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number. K102169
Special 510(k) - CyberWand Hollow Semi-Flexible Ureteral Probe
Page 19 of 70
§ 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.”