(138 days)
Not Found
No
The summary describes a purely electromechanical device for stone fragmentation and aspiration, with no mention of AI, ML, image processing, or data-driven performance metrics typically associated with AI/ML systems.
Yes
The device is used for the fragmentation of urinary tract calculi, addressing a medical condition (kidney stones, etc.) within the body, which is a therapeutic action.
No
The device is described as a lithotripsy system, which is used for the fragmentation and aspiration of urinary tract calculi (treatment), not for diagnosing medical conditions.
No
The device description explicitly lists multiple hardware components (generator, probes, transducer, etc.), indicating it is not a software-only device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Function: The ShockPulse-SE Lithotripsy System is an electromechanical device that fragments and aspirates urinary tract calculi (stones) within the body. It is a therapeutic device, not a diagnostic one.
- Intended Use: The intended use clearly states it's for the fragmentation of calculi, which is a treatment, not a diagnostic test.
- Device Description: The description details the components of a system used for physical intervention within the body.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples, image processing for diagnosis, or any other activity typically associated with IVDs.
Therefore, based on the provided information, the ShockPulse-SE Lithotripsy System is a therapeutic medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
ShockPulse-SE Lithotripsy System is intended to be used for the fragmentation of urinary tract calculi in the kidney, ureter and bladder.
Product codes (comma separated list FDA assigned to the subject device)
FEO
Device Description
The ShockPulse-SE Lithotripsy System is an electromechanical device capable of fragmenting cacti and aspirating stone debris. The ShockPulse-SE Lithotripsy System consists of generator, probes, transducer, cleaning stylet, wrench, power cord and nosecone. Footswitch is optional.
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)
Performance Testing Performed: Electrical Safety (Pass), EMC/EMI (Pass), Biocompatibility (Pass), Bioburden (Pass), EO Residuals (Pass), Mass removal rate (Pass), Drill rate (Pass), Displacement (Pass), Frequency (Pass).
Testing has confirmed that the proposed ShockPulse-SE Lithotripsy System functions as intended and is substantially equivalent to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 21, 2017
Cybersonics, Inc. Samradni Patil Regulatory Affairs Manager Knowledge Park, 5340 Fryling Road, Suite 101 Erie. PA 16510
Re: K171024
Trade/Device Name: ShockPulse-SE Lithotripsy System Regulation Number: 21 CFR§ 876.4480 Regulation Name: Electrohydraulic Lithotriptor Regulatory Class: II Product Code: FEO Dated: July 24, 2017 Received: July 25, 2017
Dear Samradni Patil:
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.
1
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 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 contact the Division of Industry and Consumer Education (DICE) 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 (DICE) 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.
Image /page/1/Picture/9 description: The image shows the name "Benjamin R. Fisher -S" in a large, bold font. The text is black and appears to be centered on a white background. The letters are clearly legible and well-defined.
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) K171024
Device Name ShockPulse-SE Lithotripsy System
Indications for Use (Describe)
ShockPulse-SE Lithotripsy System is intended to be used for the fragmentation of urinary tract calculi in the kidney, ureter and bladder.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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Cybersonics Inc.
510(k) Summary of Safety and Effectiveness Cybersonics Inc. ShockPulse-SE Lithotripsy System
General Information
| Manufacturer: | Cybersonics, Inc.
Knowledge Park
5340 Fryling Road, Suite 101
Erie, Pennsylvania 16510 USA
Phone: 814 898 4734
Fax: 814 898 4737 |
|------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|
| Establishment Registration Number: | 3004216443 |
| Contact Person: | Samradni Patil
Manager, Regulatory Affairs |
| Date Prepared: | April 3, 2017 |
Device Information
| Classification Name: | Device Classification Name:
Electrohydraulic lithotriptor,
Regulation / CFR Citation Number: 21
CFR 876.4480
Product Code: FEO
Class: II |
|----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name: | ShockPulse-SE Lithotripsy System |
| Generic/Common Name: | Lithotripter, Ultrasonic Intracorporeal |
Predicate Devices
| Predicate Device | ShockPulse-SE Lithotripsy
System (K142428) |
| ------------------ | ----------------------------------------------- |
|---|
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Special 510(k) Notification
Device Description
The ShockPulse-SE Lithotripsy System is an electromechanical device capable of fragmenting calculi and aspirating stone debris. The ShockPulse-SE Lithotripsy System consists of generator, probes, transducer, cleaning stylet, wrench, power cord and nosecone. Footswitch is optional.
Intended Use/Indication for Use
ShockPulse-SE Lithotripsy System is intended to be used for the fragmentation of urinary tract calculi in the kidney, ureter and bladder.
Comparison of Technological Characteristics with the Predicate Devices
| Predicate Device | Proposed Device | |
|---|---|---|
| Device Name | ShockPulse-SE Lithotripsy System | ShockPulse-SE Lithotripsy System |
| 510(k) Number(s) | K142428 | To be Assigned |
| Product Code | FEO | FEO |
| Intended | ||
| Use/Indication for | ||
| Use | ShockPulse-SE Lithotripsy System is | |
| intended to be used for the fragmentation | ||
| of urinary tract calculi in the kidney, | ||
| ureter and bladder. | ShockPulse-SE Lithotripsy System is | |
| intended to be used for the fragmentation | ||
| of urinary tract calculi in the kidney, | ||
| ureter and bladder. | ||
| Principle of | ||
| operation | Ultrasonic technology that uses a | |
| transducer to convert electrical energy to | ||
| ultrasonic frequency vibrations that travel | ||
| down the probe and break up stones. | Ultrasonic technology that uses a | |
| transducer to convert electrical energy to | ||
| ultrasonic frequency vibrations that travel | ||
| down the probe and break up stones. | ||
| Applied Part Type | Type BF | Type BF |
| Ultrasonic | ||
| Maximum Output | ||
| to Transducer | 100 Watts | 100 Watts |
| Ultrasonic | ||
| Frequency | 19,500 Hz – 21,500 Hz | 19,500 Hz – 21,500 Hz |
| Sterilization | ||
| Method for | ||
| disposable probes | Ethylene Oxide | Ethylene Oxide |
| Sterilization | ||
| Method of | ||
| reusable probes | Prevac Cycle (USA), Prevac Flash Cycle | Prevac Cycle (USA), Prevac Flash Cycle |
| Material | ||
| for 3.76mm and | ||
| 3.40mm probe | ||
| tube | 304 Stainless Steel | 304 Stainless Steel coated with diamond |
| like carbon | ||
| Material for | ||
| 1.83mm, 1.50mm | ||
| and 0.97mm | ||
| probe tube | 304 Stainless Steel | 304 Stainless Steel |
5
Device modifications described in the submission do not affect the intended use or the technological characteristics of the ShockPulse-SE Lithotripsy System.
Performance Data
Testing has confirmed that the proposed ShockPulse-SE Lithotripsy System functions as intended and is substantially equivalent to the predicate device.
| Performance Testing Performed | |
|---|---|
| Electrical Safety | Pass |
| EMC/EMI | Pass |
| Biocompatibility | Pass |
| Bioburden | Pass |
| EO Residuals | Pass |
| Mass removal rate | Pass |
| Drill rate | Pass |
| Displacement | Pass |
| Frequency | Pass |
Conclusions
The proposed ShockPulse-SE Lithotripsy System is substantially equivalent to the predicate device. The modifications in the device do not affect the intended use or the technological characteristics for the system and do not raise different questions of safety or effectiveness.