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.

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.

AI/ML Overview

This document describes the EL27-Compact, an electrohydraulic lithotriptor (EHL) device used for fragmenting concretions in the urinary tract and bile duct.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly present a table of acceptance criteria with numerical targets. Instead, it describes performance testing conducted to demonstrate "equivalence to the predicate device" and "comparable effects." The acceptance criterion generally appears to be meeting relevant standards, achieving comparable performance to the predicate device in bench tests, and ensuring biocompatibility and electrical/EMC safety.

Feature/Test	Acceptance Criteria (Implicit)	Reported Device Performance
EHL-Probes
Visual Inspection	Appearance within acceptable limits.	(Not explicitly stated, but implied as "successfully conducted" for other EHL-probe tests.)
Dimensions	Tolerances met.	(Not explicitly stated, but implied as "successfully conducted" for other EHL-probe tests.)
Insertion into Endoscope	Compatible with endoscopes.	(Not explicitly stated, but implied as "successfully conducted" for other EHL-probe tests.)
Shockwave Measurement	Comparable shockwave characteristics to predicate.	"Measuring the shockwaves" was performed. Conclusion is that "comparable effects could be achieved."
Withdrawing Force of Tip	Within acceptable limits for safe and effective use.	"Measuring withdrawing force of the tip of the probes" was performed. Conclusion is that "comparable effects could be achieved."
Electrode Consumption	Comparable electrode consumption.	"Measuring the electrode consumption" was performed. Conclusion is that "comparable effects could be achieved."
Biocompatibility	Compliance with ISO 10993-1.	"Successfully conducted previously according to ISO 10993-1 Biological Evaluation of Medical Devices-Part 1: Evaluation and Testing" for patient-contacting EHL-Probes. Confirmed "no changes that have impacted the established biocompatibility."
EL27-Compact (Generator)
Performance (Intensity Output)	Comparable performance across different intensity settings (Low, Medium, High) to the predicate device.	"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." Conclusion: "comparable effects could be achieved for applicable modes of operation."
Electrical Safety & Electromagnetic Compatibility (EMC)	Compliance with IEC 60601-1-2:2014 and IEC 60601-1:2005+AMD1:2012.	"Electrical safety and EMC performance testing have been confirmed to be in compliance with the relevant requirements."
Software Verification and Validation	Compliance with FDA Guidance Document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."	"Software testing has been performed and documented accordingly to the FDA Guidance Document."
Overall Substantial Equivalence	Indications for use, principles of operation, fundamental technology, patient population, and procedures are identical to predicate.	"Indications for use, principles of operation, fundamental technology of the generator are identical to the predicate device... The indicated patient population and procedures are also identical to the predicate devices."

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: The document does not specify the exact sample sizes (number of probes, number of plasterboards, etc.) for each bench test. For the EL27-Compact intensity test, it mentions "the 3 devices" (presumably 3 EL27-Compact units) and "3Fr. Probes" (number of probes not specified per device).
Data Provenance: The document implies that the data is from prospective bench testing conducted by Walz Elektronik GmbH ("The following performance testing was conducted..."). There is no information about the country of origin of the data beyond the manufacturer being in Germany.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This type of information is not applicable as the study described is primarily bench testing against engineering specifications and predicate device performance, not a clinical study involving human assessment of ground truth.

4. Adjudication Method for the Test Set

This is not applicable as the study described is primarily bench testing, not a study requiring adjudication of expert interpretations.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not mentioned or conducted. The submission focuses on demonstrating substantial equivalence through bench testing to a predicate device.

6. Standalone Performance (Algorithm Only Without Human-in-the-Loop Performance)

This is not applicable. The EL27-Compact is a medical device that requires a human operator (physician) to operate. It is not an AI algorithm with standalone performance metrics.

7. Type of Ground Truth Used

The "ground truth" for the bench tests was based on:

Engineering specifications and tolerances: For visual inspection, dimensions, insertion compatibility, and withdrawing force.
Established biological safety standards (ISO 10993-1): For biocompatibility.
Comparative physical effects: For shockwave measurement, electrode consumption, and the plasterboard penetration test (comparing the "resulting holes" to another, implicitly the predicate, or expected performance).
Compliance with recognized electrical safety and EMC standards (IEC 60601-1, IEC 60601-1-2).
Compliance with regulatory guidance for software verification and validation.

8. Sample Size for the Training Set

This is not applicable. The EL27-Compact is a physical medical device, not an AI/ML algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established

This is not applicable as there is no training set for this device.

Summary

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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.

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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

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Indications for Use

510(k) Number (if known) K230488

Device Name EL27-Compact

Indications for Use (Describe)

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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Image: @ logo	5 - 510(k) Summary	K230488Date.:23.05.2022Rev:1.0Page: 5-3 of 5-7
General
510(k) Submitter:	Walz Elektronik GmbHWalddorfer Straße 4072229 Rohrdorf, GermanyPhone: (+49) 7452 2020
Contact Person:	Bernd Vollmer, CEOWalz Elektronik GmbHWalddorfer Straße 4072229 Rohrdorf, GermanyE-Mail Address: vollmer@walz-el.de
Official Correspondent:	German American Chamber of Commerce, Inc.United States80 Pine Street, 24st FloorNew York, 10005Phone Number: (212) 974-8830Emergency Phone: (212) 974-8830Fax Number: (212) 974-8867E-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

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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.

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

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Indications for use

Comparison of Technological Characteristics

Generator

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-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

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Summary of Performance Testing

The following performance testing was conducted in substantial equivalence determination.

Biocompatibility Evaluation

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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.

1. Biological Safety Evaluation of EHL Probes
1. In vitro Cytotoxicity testing
1. Testing for contact allergens
1. 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.

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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.

Regulation Number and Section

§ 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.”