FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

The Endovenous Radiofrequency Catheter is intended to be used with CuraWay's JM-S40 Endovenous RF Generator indicated for endovascular coagulation of blood vessels in patients with superficial vein reflux.

Device Description

The JM-S40 Endovenous Radiofrequency Generator includes a host and a power cord. The JM-S40 Endovenous Radiofrequency Generator is intended to be used with the Endovenous Radiofrequency Catheter for vessel and tissue coagulation. The JM-S40 Endovenous Radiofrequency Generator outputs RF energy and the Endovenous Radiofrequency Catheter is the applied part. The JM-S40 Endovenous Radiofrequency Generator has simple operation and simple interface, and can accurately provide real-time monitoring of temperature, power and time during RF output.

The generator generates high frequency alternating current and transfers to the catheter. When the cable of the catheter or its connection is interrupted, the host will stop the power output and trigger alarm. When the temperature of catheter detected by the generator exceeds 130 ℃, the device will automatically cut off the power output and give a corresponding reminder. The power output can also be manually stopped.

AI/ML Overview

The provided FDA 510(k) summary (K232505) for the Zhejiang CuraWay Medical Technology Co., Ltd. Endovenous Radiofrequency Generator and Catheter does not contain explicit acceptance criteria tables or detailed comparative effectiveness studies with human readers (MRMC). The document primarily focuses on demonstrating substantial equivalence to a predicate device (VNUS Radiofrequency Generator K040638 and VNUS®Closure FAST™ Catheter K061373) through non-clinical performance and safety standards testing.

Here's an breakdown based on the information provided, addressing your questions where possible:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present a formal table of acceptance criteria with specific numerical targets. Instead, it describes performance through comparison to the predicate device and compliance with established standards. The qualitative "acceptance" is based on demonstrating substantial equivalence in various aspects.

Feature/Test	Acceptance Criteria (Implied)	Reported Device Performance
Indications for Use	Identical to predicate device.	Identical for endovascular coagulation of blood vessels in patients with superficial vein reflux.
Monopolar or Bipolar	Identical to predicate (Bipolar).	Bipolar.
Catheter Length (cm)	Similar range to predicate (60, 100).	60, 100. (Also 1, 2, 3, 5, 7 for heating element, predicate only 3, 7).
Outer Diameter of Catheter (mm)	Similar to predicate (2.3).	1.6, 2.0, 2.3.
Patient Contact Materials	Identical to predicate (PET, FEP, PEEK).	PET, FEP, PEEK.
Disposable/Single-use	Identical to predicate.	Disposable, single-use per patient.
Catheter Sterilization	Identical to predicate (EO).	EO.
Output Frequency	Not significantly different in effect from predicate (460 kHz).	480 kHz. (Difference noted as small and not affecting thermal efficiency).
Maximum Power Output	Equivalent to predicate for corresponding lengths.	Catheter 7cm: 40W (@200Ω); Catheter 5cm: 30W (@200Ω); Catheter 3cm: 18W (@200Ω); Catheter 2cm: 12W (@200Ω); Catheter 1cm: 6W (@200Ω). (Predicate 7cm: 40W, 3cm: 18W).
Drive on Time	Identical to predicate (10 to 40s).	10 to 40s.
Crest Factor	Not significantly different in effect from predicate (1.7).	1.4.
Ex-vivo tissue thermal spread testing	Ablation effect and zones substantial equivalent to predicate and reference devices.	Demonstrated substantial equivalence in ablation effect and ablation zones using bovine liver.
In-vivo animal (goat) testing	Absence of significant adverse differences compared to predicate in general observe, blood routine, blood biochemistry, ultrasound, histopathology, intravascular blood coagulation, vascular wall thermal damage, and inflammation.	No significant adverse differences reported.
Electrical Safety Standards	Compliance with IEC 60601-1, IEC 60601-2-2.	Complied.
EMC Standards	Compliance with IEC 60601-1-2.	Complied.
Usability Standards	Compliance with IEC 60601-1-6.	Complied.
Biocompatibility Standards	Compliance with ISO 10993 series (cytotoxicity, irritation, sensitization, systemic toxicity, pyrogen, hemocompatibility, genotoxicity).	Complied.
Sterilization Standards	Compliance with ISO 10993-7 (EO residuals), ISO 11135 (EO sterilization), ISO 11137-2 (Radiation sterilization), ASTM F1980-16 (Accelerated aging).	Complied.
Software Validation standards	Compliance with IEC 62304:2015 and FDA Guidance Content of Premarket Submissions for Device Software Functions.	Complied.

2. Sample Size for Test Set and Data Provenance

Ex-vivo tissue thermal spread testing: "bovine liver tissue" was used. The specific number of samples or livers is not provided.
In-vivo animal (goat) testing: "In-vivo animal (goat) testing" was conducted. The specific number of goats is not provided.
Data Provenance: The nature of these tests (ex-vivo and in-vivo animal) suggests prospective experimental data generated for the purpose of this submission. The country of origin for the studies is not explicitly stated, but the company is based in China.

3. Number of Experts and Qualifications for Ground Truth

This type of submission (510(k) for a medical device that performs a physical action, like RF ablation) does not typically involve human expert readers establishing ground truth for diagnostic imaging. The "ground truth" here is based on physical and biological measurements.

For the ex-vivo testing, results are likely analyzed by researchers with expertise in thermal tissue ablation and potentially a pathologist or histologist to assess ablation zones.
For the in-vivo animal testing, the ground truth would be established through:
- Direct observation (general observe).
- Clinical laboratory tests (blood routine, blood biochemistry) interpreted by veterinary or medical lab experts.
- Ultrasound monitoring interpreted by veterinary radiologists or sonographers.
- Histopathological examination interpreted by veterinary pathologists.
- These assessments would determine the "truth" of the device's effects on the animal models.

The specific number of experts and their detailed qualifications are not provided in the 510(k) summary.

4. Adjudication Method for the Test Set

Adjudication methods like "2+1" or "3+1" are relevant for expert consensus in diagnostic studies, particularly when there might be disagreement in image interpretation. This 510(k) summary does not indicate such a method, as the "ground truth" is derived from objective physical measurements and biological assessments rather than subjective expert interpretation of images.

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

No MRMC comparative effectiveness study was done or reported. This type of study is typically conducted for AI-powered diagnostic devices where the AI assists human readers in interpreting images. The Zhejiang CuraWay device is an Endovenous Radiofrequency Generator and Catheter, a therapeutic device designed to perform an ablation procedure, not a diagnostic imaging interpretation tool. Therefore, a study comparing human readers with and without AI assistance is not applicable here.

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

No standalone performance study for an algorithm without human-in-the-loop was done or reported. Similarly to the point above, this device performs a physical therapeutic action and is operated by a clinician. While it includes embedded software for monitoring parameters (power, time, impedance, temperature), its "performance" is inherently tied to its physical interaction with tissue under human control, not as an autonomous diagnostic algorithm. The software is part of the control system, not a standalone diagnostic tool.

7. Type of Ground Truth Used

Ex-vivo testing: The ground truth for thermal spread and ablation effect was based on direct observation and measurement of the treated bovine liver tissue. This is a pathology/histology-based ground truth for the physical effect.
In-vivo animal testing: The ground truth for the device's impact on living tissue was established through a combination of:
- Clinical observation
- Laboratory outcomes data (blood routine, blood biochemistry)
- Imaging data and interpretation (Ultrasound Monitoring)
- Pathology/histology (Histopathological examination, vascular wall thermal damage, vascular wall inflammation)
- This represents a comprehensive outcomes-based and pathology-based ground truth from an animal model.

8. Sample Size for the Training Set

The document does not mention a "training set" in the context of machine learning or AI algorithm development. The software in this device is described as "embedded software, which is written in C language and is developed on the Atollic TrueSTUDIO integrated development compilation software." This implies traditional software engineering and validation rather than statistical model training. If any internal parameters of the RF generator were optimized through data, that information is not provided.

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

As no "training set" in the context of machine learning is indicated, this question is not applicable. The software validation refers to compliance with IEC 62304:2015 and FDA Guidance Content of Premarket Submissions for Device Software Functions, which focus on rigorous software development lifecycle processes, risk management, and verification/validation, rather than data-driven model training and ground truth establishment for a predictive algorithm.

Summary

Regulation Number and Section

§ 878.4400 Electrosurgical cutting and coagulation device and accessories.

(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.