The SCDG -AS, SCDG -BS, and SCDG CS are sterile, single-use electrohydraulic lithotripsy (EHL) probes. These probes are designed to be used with the Electrohydraulic Lithotripter (TCS-B3-II) for the fragmentation of biliary calculi. The probes deliver low-energy electrical pulses through a dedicated connection to the generator, generating hydraulic shock waves in a saline medium to fragment stones in the biliary tract.

AI/ML Overview

The provided text is a 510(k) summary for a medical device (EHL probe) seeking FDA clearance. It describes the device, its intended use, comparison to a predicate device, and performance data from bench testing. However, it does not contain information about a clinical study involving human subjects or AI algorithms, which is typically where the concepts of "acceptance criteria," "human readers improve with AI vs without AI assistance," "standalone performance," "training set," and "ground truth establishment" would be relevant.

The document primarily focuses on bench testing to demonstrate substantial equivalence to a legally marketed predicate device. This type of submission relies on the device meeting certain engineering specifications and performance characteristics, rather than a clinical trial with specific diagnostic accuracy metrics.

Therefore, many of the requested details about acceptance criteria and study design are not applicable (N/A) based on the provided text.

Here's a breakdown of the information that can be extracted from the document, along with an explanation for the N/A sections:

Acceptance Criteria and Device Performance (Based on Bench Testing)

The document does not present a formal table of "acceptance criteria" and "reported device performance" in the way one would establish for, say, an AI-powered diagnostic device. Instead, it describes various bench tests conducted to ensure the device meets safety and performance standards comparable to the predicate device. The implicit acceptance criterion for each test is that the probe performs as expected and similarly to the predicate device, demonstrating substantial equivalence.

Acceptance Criteria (Implied from Bench Testing Objectives)	Reported Device Performance (Summary from Text)
Endoscope Compatibility: Smooth insertion and operation without damaging endoscope or probe.	Probes were rigorously tested for compatibility with standard endoscopes, ensuring smooth insertion and operation.
Visual Inspection: No defects or deviations from design specifications.	Each probe underwent a meticulous visual inspection to identify any defects or deviations from the design specifications.
Dimensional Verification: Critical measurements within specified tight tolerance limits.	Critical measurements of the probes were taken to check that all dimensions fell within the tight tolerance limits specified in the design. Dimensions are smaller than the predicate device but core functionality is unaffected.
Shockwave Efficacy: Generation of controlled and effective shockwaves.	The ability of the probes to generate controlled and effective shockwaves was evaluated.
Electrode Durability: Acceptable rate of electrode material consumption under normal usage.	Monitoring the rate of electrode material consumption was pivotal in assessing the durability and longevity of the probes under normal usage conditions.
Stone Fragmentation: Ability to fragment biliary stones consistently.	Validated the system's ability to generate consistent high-voltage pulses and hydraulic shock waves capable of fragmenting biliary stones.
Shockwave Pressure Attenuation: Comparable profile to predicate device, compliant with IEC 61846.	Comparative analysis of maximum shock wave propagation distance and pressure attenuation profile between TCS-B3-II and predicate device EL27-Compact (K230488). The system was tested for compliance with IEC 61846. (Implicitly, the results were comparable and compliant as part of the overall substantial equivalence claim).
Acoustic Characterization: Comparable key electrohydraulic shock wave parameters to predicate, compliant with IEC 61846.	Comparative testing of key electrohydraulic shock wave parameters between TCS-B3-II and predicate device. The system was tested for compliance with IEC 61846. (Implicitly, the results were comparable and compliant).
Tissue Perforation: Comparable performance to predicate device using porcine bile duct.	Comparative tissue perforation testing between TCS-B3-II and EL27-Compact using porcine bile duct. (Implicitly, the results showed comparable safety characteristics).
Aging Tests: Consistent performance throughout intended lifespan; compliant with ASTM F1980.	Testing demonstrated that the probes maintain consistent performance throughout their intended lifespan. The test is compliant with ASTM F1980.
Electrical Safety: Compliance with IEC 60601-1.	The probes were tested for compliance with IEC 60601-1 (general safety). (Implicitly, compliance was achieved).
EMC Testing: Compliance with IEC 60601-1-2.	The probes were tested for compliance with IEC 60601-1-2 (EMC requirements) to ensure safety and electromagnetic compatibility when used with the TCS-B3-II Electrohydraulic Lithotripter. (Implicitly, compliance was achieved).
Biocompatibility: No adverse issues; compliance with ISO 10993 series.	Biocompatibility evaluations, including cytotoxicity, sensitization Testing, irritation, acute systemic toxicity testing & material mediated pyrogenicity testing, were conducted according to ISO 10993-1/ ISO 10993-5/ISO 10993-10/ISO 10993-11. No adverse biocompatibility issues were identified.

Study Details (Applicable to Clinical/AI Performance Studies)

As stated, this document describes a 510(k) submission based on bench testing for substantial equivalence, not a clinical study involving human performance or an AI algorithm. Therefore, the following information is not present or applicable:

Sample size used for the test set and the data provenance: N/A (No clinical test set described). The testing was bench-based.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: N/A (No ground truth for a test set of clinical data was established).
Adjudication method (e.g. 2+1, 3+1, none) for the test set: N/A (No test set of clinical data requiring adjudication).
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: N/A (No MRMC study or AI component described).
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: N/A (No algorithm or standalone performance described).
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): N/A (Ground truth in a clinical sense is not applicable here; performance was demonstrated through engineering and material testing against established standards and predicate device performance).
The sample size for the training set: N/A (No training set for an AI algorithm described).
How the ground truth for the training set was established: N/A (No training set for an AI algorithm described).

Summary

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March 21, 2025

Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd. Zhengzhou Li General Manager Room 208, Building C, No. 3, Juquan Road, Huangpu District Guangzhou, Guangdong 510000 China

Re: K243032

Trade/Device Name: EHL Probe (SCDG-AS); EHL Probe (SCDG-BS); EHL Probe (SCDG-CS) Regulation Number: 21 CFR 876.4480 Regulation Name: Electrohydraulic Lithotriptor Regulatory Class: Class II Product Code: FFK Dated: February 24, 2025 Received: February 25, 2025

Dear Zhengzhou Li:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.

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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,

Anthony Lee -S

Anthony Lee, Ph.D., M.B.A. Assistant Director DHT3A: Division of Renal, Gastrointestinal, Obesity, and Transplant 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) K243032

Device Name EHL probe (SCDG-AS); EHL probe (SCDG-BS); EHL probe (SCDG-CS)

Indications for Use (Describe)

The EHL probe is designed for use with Potent Medical Electrohydraulic Lithotripter (TCS-B3-II) for disintegration of concernments in the bile duct.

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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510(k) Summary

510(k) Number: K243032

Date Prepared: March 10, 2024

Device Name: EHL probe (SCDG -AS); EHL probe (SCDG -BS); EHL probe (SCDG -CS)

I. Submitter Information

Submitter: Guangzhou Potent Medical Equipment Joint-Stock Co. Ltd.

Address: Room 208, Building C, No. 3, Juquan Road, Huangpu District, Guangzhou, Guangdong Province, China.

Manufacture Address: Area C, 4th Floor, Xinyin Industrial Village, Xintang Industrial Processing Zone, Xintang

Town, Zengcheng District, Guangzhou, Guangdong Province, China

Contact Person: Zhengzhou Li, General Manager

Room 5002-5003, A01 Building, Ping'an Technology Guigu Industrial Park, No.74 Chuangyu Road, Ningxi Street,

Zengcheng District, Guangzhou, Guangdong Province, China.

E-Mail Address: potent medical public@potent-medical.com

Phone: +86 20-37396970

Fax: +86 20-37376979

II. Device Information

i Regulation Name: Electrohydraulic lithotriptor
. Regulation Number:21 CFR. 876.4480
. Regulatory Class: Class II
Product Codes: FFK i
. Device Panel: Gastroenterology/Urology
Trade Name: EHL probe (SCDG -AS); EHL probe (SCDG -BS); EHL probe (SCDG -CS) .
. Model: SCDG -AS/ SCDG -BS/ SCDG -CS

III. Predicate Device

: Predicate Device 510(k) Number: K230488
Trade Name: EL27-Compact; Sterile EHL -Probes
Regulation Name: Electrohydraulic lithotriptor .
Regulation Number:21 CFR. 876.4480 .
Regulatory Class: Class II i

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Product Codes: FFK
. Device Panel: Gastroenterology/Urology
Manufacturer: Walz Elektronik GmbH .

IV. Device Description

Key materials

stainless steel, Polycarbonate (PC)
Polytetrafluoroethylene (PTFE)
Fluorinated Ethylene Propylene (FEP)
Silver-plated Copper Wire
Polyimide (PI)
Perfluoroalkoxy (PFA)

The tip of each probe is the indirect-contacting patient component, designed for precise energy delivery.

V. Indications for use

The EHL probe is designed for use with Potent Medical Electrohydraulic Lithotripter (TCS-B3-II) for disintegration of concernments in the bile duct.

VI. Comparison of Technological Characteristics

Energy Delivery Mechanism
Both the SCDG -AS, SCDG -BS, SCDG -CS probes and the predicate device use an electrohydraulic lithotripsy mechanism to generate hydraulic shock waves for bile duct stone fragmentation. These shock waves are produced by high-voltage pulses transmitted through the probe and directed at the target stones.
Materials
Both devices use biocompatible materials, ensuring safety during patient contact.

SCDG - AS, SCDG -BS, SCDG -CS: Made from stainless steel, Polycarbonate (PC)

Polytetrafluoroethylene (PTFF)

Fluorinated Ethylene Propylene (FEP)

Silver-plated Copper Wire

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K243032 Page 3 of 5

Polyimide (PI)

Perfluoroalkoxy (PFA)

Predicative Device: Uses similar materials, with a focus on epoxy and metals, ensuring high durability and biocompatibility.

● Dimension

Although probe of potent medical is smaller than the probe of EL27-Compact in terms of total length, energy output line, therapeutic electrode length, and probe diameter, the core functionality remains unaffected due to identical structural composition, use of similar materials, the same energy delivery mechanism, and validated performance data. This confirms that dimensional change has not compromised its performance.

Sterilization and Single-Use
Both sets of probes are sterile and intended for single-use, reducing contamination risks. They are sterilized using ethylene oxide (EO), ensuring effective sterility while maintaining material integrity.

● Biocompatibility

Both devices have undergone rigorous biocompatibility testing in compliance with ISO 10993-1. Testing includes cytotoxicity, sensitization Testing, irritation, acute systemic toxicity testing & material mediated pyrogenicity testing, ensuring that the probes are safe for patient contact.

VII. Performance Data

● Bench Testing:

In the process of validating the Electrohydraulic Lithotripsy (EHL) Probe, a comprehensive sequence of bench tests was conducted to verify the probe's compliance with design specifications and its clinical efficacy. The tests prioritized safety, performance, and compatibility, structured as follows:

Endoscope Compatibility Test: Probes were rigorously tested for compatibility with standard endoscopes, ensuring smooth insertion and operation without damaging the endoscope or the probe itself.
Visual Inspection: Each probe underwent a meticulous visual inspection to identify any defects or deviations from the design specifications.
Dimensional Verification: Critical measurements of the probes were taken to check that all dimensions fell within the tight tolerance limits specified in the design.
Shockwave Efficacy: The ability of the probes to generate controlled and effective shockwaves was

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K243032 Page 4 of 5

evaluated.

Electrode Durability Test: Monitoring the rate of electrode material consumption was pivotal in assessing the durability and longevity of the probes under normal usage conditions.
Stone Fragmentation Test: Validated the system's ability to generate consistent high-voltage pulses and hydraulic shock waves capable of fragmenting biliary stones.
Shock wave pressure attenuation test. Comparative analysis of maximum shock wave propagation distance and pressure attenuation profile between TCS-B3-II and predicate device EL27-Compact (K230488). The system was tested for compliance with IEC 61846.
Acoustic characterization test: Comparative testing of key electrohydraulic shock wave parameters between TCS-B3-II and predicate device. The system was tested for compliance with IEC 61846.
Tissue perforation test: Comparative tissue perforation testing between TCS-B3-II and EL27-Compact . using porcine bile duct.

These bench tests were not only fundamental in ensuring that the EHL Probe met all required regulatory standards but also in certifying its readiness for effective and safe clinical application. Each step of the testing process was carefully designed to challenge the probes under realistic conditions, thereby validating their performance and safety.

Aging tests was conducted to validate the durability and service life of the probes under simulated use conditions. Testing demonstrated that the probes maintain consistent performance throughout their intended lifespan. The test is compliant with ASTM F1980.
Electrical Safety and EMC Testing: The probes were tested for compliance with IEC 60601-1 (general safety) and IEC 60601-1-2 (EMC requirements) to ensure safety and electromagnetic compatibility when used with the TCS-B3-II Electrohydraulic Lithotripter.
Biocompatibility Testing: biocompatibility evaluations, including cytotoxicity, sensitization Testing, irritation, acute systemic toxicity testing & material mediated pyrogenicity testing, were conducted according to ISO 10993-1/ ISO 10993-5/ISO 10993-10/ISO 10993-11. No adverse biocompatibility issues were identified.

The EHL probe was tested with its compatible Electrohydraulic Lithotriptor (TCS-B3-II) in the relevant test items ; and is provided "For prescription use only."

VIII. Conclusion

Based on the nonclinical testing results, device comparisons, and functional similarities, the SCDG

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-BS, and SCDG -CS probes are substantially equivalent to the EL27-Compact(K230488). The minor differences in design and interface with energy generator source do not raise new questions of safety or effectiveness. Therefore, the probes are as safe and effective as the predicate device and are suitable for use in its intended clinical applications.

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.”