(189 days)
Not Found
No
The device description and performance studies focus on the physical mechanism of stone fragmentation using electrical pulses and shockwaves. There is no mention of AI, ML, image processing, or data-driven decision making.
Yes
The device is described as disintegrating "concernments in the upper and lower urinary tract and in gastroenterology, particularly in the bile duct" and directly fragments "hard stones," indicating a therapeutic purpose.
No
Explanation: The device is described as being used for the "disintegration of concrements" (stone fragmentation) using shockwaves, which is a therapeutic function, not a diagnostic one. It does not mention any capability for identifying, analyzing, or assessing a medical condition.
No
The device description clearly states it is a "table-top device" consisting of a generator, power cord, footswitch, and probe cable, all of which are hardware components.
Based on the provided information, the EL27-Compact is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the device is used for the "disintegration of concernments in the upper and lower urinary tract and in gastroenterology, particularly in the bile duct." This describes a procedure performed within the patient's body (in vivo) to break up stones.
- Device Description: The description details how the device generates shockwaves to fragment stones inside the body. It involves inserting a probe through an endoscope and applying energy directly to the stone.
- Lack of In Vitro Activities: There is no mention of the device being used to examine or analyze samples (like blood, urine, tissue) outside the body (in vitro) to provide diagnostic information.
IVD devices are specifically designed to be used in vitro for the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The EL27-Compact's function is therapeutic (breaking up stones), not diagnostic.
N/A
Intended Use / Indications for Use
The EL27-Compact is a device to be used together with EHL-probes from Walz Elektronik GmbH for disintegration of concernments in the upper and lower urinary tract and in gastroenterology, particularly in the bile duct.
Product codes (comma separated list FDA assigned to the subject device)
FFK
Device Description
The EL27-Compact is a device, designed to be used with Walz Elektronik GmbH disposable EHL-Probes for the fragmentation of concrements in the gastroenterology and urology.
A physician inserts and pushes the disposable EHL probe through the working channel of an endoscope and places the tip of the probe in front of the stone surrounded with saline solution. With pressing the footswitch, the device provides electric pulse energy in form of a high-voltage pulse. This pulse generates high pressure shockwaves that fragment hard stones.
The EL27-Compact is a table-top device and consists of the generator itself, the power cord, the footswitch, a probe cable for connection between the device and the EHL-probes.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
upper and lower urinary tract and in gastroenterology, particularly in the bile duct.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
hospital environment
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)
The following performance testing was conducted in substantial equivalence determination.
Biocompatibility Evaluation
The EL27-Compact does not contain components that come directly or indirectly in patient contact. Biocompatibility testing according to ISO 10993-1 for these components is not required. Biocompatibility evaluation of the patient contacting EHL-Probes were successfully conducted previously according to ISO 10993-1 Biological Evaluation of Medical Devices-Part 1: Evaluation and Testing. There have been no changes that have impacted the established biocompatibility.
-
- Biological Safety Evaluation of EHL Probes
-
- In vitro Cytotoxicity testing
-
- Testing for contact allergens
-
- Testing for tissue compatibility
Bench Testing
These comprehensive validation bench tests support equivalence to the predicate device. Testing confirmed that comparable effects could be achieved for applicable modes of operation.
For the EHL-Probe, the following tests were performed:
- -Visual inspection of the appearance of the probes
- -Measuring the dimensions to check if tolerances are okay
- -Insertion (not P4,5/3000/f) of probes into an Endoscope
- -Measuring the shockwaves
- Measuring withdrawing force of the tip of the probes -
- -Measuring the electrode consumption.
For the EL27, the following test was performed:
The Test performed was to set up the 3 devices and connect them to 3Fr. Probes. Choosing the different intensities on the devices, pulses have been emitted on a piece of plasterboard. The distance of the probe to the plasterboard have been kept the same overall tests. The resulting holes in the plasterboard, which vary in depth caused by the chosen intensity, can be compared to another.
Electrical safety and electromagnetic compatibility (EMC)
Electrical safety and EMC performance testing have been confirmed to be in compliance with the relevant requirements as noted below.
- IEC60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance
- IEC 60601-1:2005+AMD1:2012 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
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.
K130368, K914514, K914515, K914516, K913955
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.”
0
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August 31, 2023
Walz Elektronik GmbH Bernd Vollmer CEO Walddorfer Strasse 40 Rohrdorf, Baden-Wuertemberg 72229 Germany
Re: K230488 Trade/Device Name: EL27-Compact Regulation Number: 21 CFR§ 876.4480 Regulation Name: Electrohydraulic Lithotriptor Regulatory Class: II Product Code: FFK Dated: August 3, 2023 Received: August 3, 2023
Dear Bernd Vollmer:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatoryinformation/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Mark J. Antonino -S
Mark J. Antonino, M.S. Assistant Director DHT3B: Division of Reproductive, Gynecology and Urology Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K230488
Device Name EL27-Compact
Indications for Use (Describe)
The EL27-Compact is a device to be used together with EHL-probes from Walz Elektronik GmbH for disintegration of concernments in the upper and lower urinary tract and in gastroenterology, particularly in the bile duct.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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3
| Image: @ logo | 5 - 510(k) Summary | K230488
Date.:23.05.2022
Rev:1.0
Page: 5-3 of 5-7 |
|-------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------|
| General | | |
| 510(k) Submitter: | Walz Elektronik GmbH
Walddorfer Straße 40
72229 Rohrdorf, Germany
Phone: (+49) 7452 2020 | |
| Contact Person: | Bernd Vollmer, CEO
Walz Elektronik GmbH
Walddorfer Straße 40
72229 Rohrdorf, Germany
E-Mail Address: vollmer@walz-el.de | |
| Official Correspondent: | German American Chamber of Commerce, Inc.
United States
80 Pine Street, 24st Floor
New York, 10005
Phone Number: (212) 974-8830
Emergency Phone: (212) 974-8830
Fax Number: (212) 974-8867
E-Mail Address: legalservices@gaccny.com | |
| Date Prepared: | 21.02.2023 | |
Predicate Devices
| Predicate Device | 510(k) No. |
|---|---|
| AUTOLITH TOUCH | K130368 |
| AUTOLITH URO-TOUCH | K130368 |
| 1.9 FRENCH LITHOTRIPTER ELECTRODE, MODIFICATION | K914514 |
| 3 FRENCH LITHOTRIPTER ELECTRODE, MODIFICATION | K914515 |
| 9 FRENCH LITHOTRIPTER ELECTRODE, MODIFICATION | K914516 |
| 1.9 FRENCH LITHOTRIPTER ELECTRODE, MODIFICATION | K913955 |
4
Device Description
(a
The EL27-Compact is a device, designed to be used with Walz Elektronik GmbH disposable EHL-Probes for the fragmentation of concrements in the gastroenterology and urology.
A physician inserts and pushes the disposable EHL probe through the working channel of an endoscope and places the tip of the probe in front of the stone surrounded with saline solution. With pressing the footswitch, the device provides electric pulse energy in form of a high-voltage pulse. This pulse generates high pressure shockwaves that fragment hard stones.
The EL27-Compact is a table-top device and consists of the generator itself, the power cord, the footswitch, a probe cable for connection between the device and the EHL-probes.
Regulation Name: Regulation Number: Regulatory Class: Product Codes: Review Panel: Trade Name: Generic/Common Name: Lithotripter, Electro-Hydraulic 21 CFR. 876.4480 Class II FFK Gastroenterology/Urology EL27-Compact Lithotripter
5
Indications for use
The EL27-Compact is a device to be used together with EHL-probes from Walz Elektronik GmbH for disintegration of concernments in the upper and lower urinary tract and in gastroenterology, particularly in the bile duct.
Comparison of Technological Characteristics
Generator
ರ
- -Both devices, the predicate and the subject of this 510(k) submission, are used in the field of urology and gastroenterology for fragmentation of concrements.
- -Both devices are table-top units that connect over a probe connecting cable to a disposable probe that, is used in the working channel of an endoscope. The physician inserts and pushes the disposable EHL probe through the working channel of a compatible endoscope and places the tip of the probe in front of the stone surrounded with saline solution (0,9% isotonic saline solution). With pressing the footswitch, the device provides electric pulse energy in form of a high-voltage pulse. This pulse generates high pressure shockwaves that fragment hard stones.
- Both devices have a selection of 3 intensities (Low, Medium, High) -
- -Both devices' outputs are controlled over a footswitch
- -Both devices are used in hospital environment
- -Both devices are made of commonly used materials for building electronic devices
Disposable EHL Probes
- -Both probe types have a proprietary connection to the generator
- -Both probe types are sterile and for single-use
- Both probe types are made of similar materials like epoxy, stainless steel, copper, -Polyimid, Polyvinylidenfluorid or Polyolefin
- -Both probe types have the tip of the probe as the patient contacting part
- -Both probe types are sterilized with ethylene oxide
6
Summary of Performance Testing
The following performance testing was conducted in substantial equivalence determination.
Biocompatibility Evaluation
ರ
The EL27-Compact does not contain components that come directly or indirectly in patient contact. Biocompatibility testing according to ISO 10993-1 for these components is not required. Biocompatibility evaluation of the patient contacting EHL-Probes were successfully conducted previously according to ISO 10993-1 Biological Evaluation of Medical Devices-Part 1: Evaluation and Testing. There have been no changes that have impacted the established biocompatibility.
-
- Biological Safety Evaluation of EHL Probes
-
- In vitro Cytotoxicity testing
-
- Testing for contact allergens
-
- Testing for tissue compatibility
Bench Testing
These comprehensive validation bench tests support equivalence to the predicate device. Testing confirmed that comparable effects could be achieved for applicable modes of operation.
For the EHL-Probe, the following tests were performed:
- -Visual inspection of the appearance of the probes
- -Measuring the dimensions to check if tolerances are okay
- -Insertion (not P4,5/3000/f) of probes into an Endoscope
- -Measuring the shockwaves
- Measuring withdrawing force of the tip of the probes -
- -Measuring the electrode consumption.
For the EL27, the following test was performed:
The Test performed was to set up the 3 devices and connect them to 3Fr. Probes. Choosing the different intensities on the devices, pulses have been emitted on a piece of plasterboard. The distance of the probe to the plasterboard have been kept the same overall tests. The resulting holes in the plasterboard, which vary in depth caused by the chosen intensity, can be compared to another.
Electrical safety and electromagnetic compatibility (EMC)
Electrical safety and EMC performance testing have been confirmed to be in compliance with the relevant requirements as noted below.
7
- IEC60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance
- IEC 60601-1:2005+AMD1:2012 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
Software Verification and Validation Testing
Software testing has been performed and documented accordingly to the FDA Guidance Document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices".
Substantial Equivalence
The predicate device is composed of a generator, a probe cable, a foot switch and a power cable. The indications for use, principles of operation, fundamental technology of the generator are identical to the predicate device. It has full compatibility with the existing device and so that users can select from the entire instrument line-up. The indicated patient population and procedures are also identical to the predicate devices. However, functions and principles of operation are identical to the predicate device.
Conclusion
In summary, the EHL-Probes, the EL27-Compact and its accessories are at least substantially equivalent to the predicate devices and present no new questions of safety or effectiveness.