(90 days)
The PlaDuo is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis. The Argon handpiece is intended for the removal and destruction of skin lesions and the coagulation of tissue.
The PlaDuo System is an electro-surgical device for use in dermatological applications. The device utilizes nitrogen and argon gas to be used separately to generate the desired power level to patients. The effect of the device is achieved by heating the outer layer of the skin so that part or all of it becomes non-viable and there is controlled damage to the underlying skin.
The PlaDuo system consists of a system console with wells for 2 gas tanks, footswitch, 2 handpieces, and tip with 3 interchangeable guides.
This document describes the FDA's 510(k) clearance for the ShenB Co Ltd's PlaDuo System. The system is an electrosurgical device that uses nitrogen and argon gas to generate plasma for dermatological and general surgical procedures.
Based on the provided text, the device meets acceptance criteria through various performance tests, including:
- IEC 60601-1:2005 + A1:2012: Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance.
- IEC 60601-1-2:2014: Medical Electrical Equipment - Part 1-2: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Disturbances - Requirements And Tests.
- IEC 60601-2-2:2017: Medical Electrical Equipment - Part 2-2: Particular Requirements For The Basic Safety And Essential Performance Of High Frequency Surgical Equipment And High Frequency Surgical Accessories.
- IEC 62304:2006+A1:2015: Medical Device Software Life Cycle Processes.
- EN ISO 14971:2012: Medical Devices - Application Of Risk Management To Medical Devices.
- Biocompatibility testing (cytotoxicity, irritation, and sensitization) per ISO 10993-1:2018 for patient-contacting materials (space guides).
- Software verification and validation testing in accordance with FDA's guidance.
- Thermal testing on ex vivo tissue specimens to verify the performance of the argon gas.
Table of Acceptance Criteria and Reported Device Performance
| Category | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Electrical Safety & Performance | Compliance with relevant IEC standards (60601-1, 60601-1-2, 60601-2-2) for basic safety and essential performance of electrosurgical equipment. | "Verification and validation activities were successfully completed and establish that the PlaDuo System control unit performs as intended. Testing included the following: IEC 60601-1:2005 + A1:2012; IEC 60601-1-2:2014; IEC 60601-2-2:2017;" |
| Software Safety & Performance | Compliance with IEC 62304 for medical device software life cycle processes and FDA's software guidance. | "IEC 62304:2006+A1:2015; Medical Device Software Life Cycle Processes;" and "Software verification and validation testing was conducted, and documentation provided in accordance with FDA's Guidance or the Content of Premarket Submissions for Software Contained in Medical Devices." |
| Risk Management | Compliance with ISO 14971 for application of risk management to medical devices. | "EN ISO 14971:2012; Medical Devices - Application Of Risk Management To Medical Devices" |
| Biocompatibility | All patient-contacting materials must be biocompatible (non-cytotoxic, non-irritating, non-sensitizing). | "Biocompatibility –The only patient contacting material in the device are the space guides attached to each handpiece. Biocompatibility testing for cytotoxicity, irritation, and sensitization per ISO 10993-1:2018 are included with the submission and show no concern for patient contacting materials." |
| Thermal Performance (Argon Handpiece) | The argon handpiece should achieve consistent and desirable thermal damage profiles comparable to predicate/reference devices for the intended clinical effect. | "In addition, thermal testing on ex vivo tissue specimens was conducted to verify the performance of the argon gas used with the device. The Test device at stacked pulses produced measurable thermal damage in skin and in liver models and traceable thermal effect in muscle. The study demonstrated the ability of the device to achieve consistent thermal damage profiles in line with the target treatment and comparable to the profiles produced by the predicate and reference devices. Thus, it can be concluded that treatment by such a device at the appropriate testings will possess a desirable clinical treatment effect." |
| Substantial Equivalence (Overall) | The modified PlaDuo System (with Argon handpiece) must be substantially equivalent to the predicate device(s) for the proposed indications for use. | "The PlaDuo System that is the subject of this application is a next-generation of the currently cleared PlaDuo with Nitrogen only. Besides the addition of the gas and handpiece tip for use with Argon, there have been no changes to the device. Performance testing shows that the newly added argon feature produces consistent thermal damage profiles similar to predicate and reference devices. The subject device is substantially equivalent to the predicate device for the requested indications for use." |
Study Details:
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Sample sizes used for the test set and data provenance:
- The document mentions "thermal testing on ex vivo tissue specimens." It specifies "skin and in liver models" and "muscle" as the tissue types. However, the exact sample size (number of specimens or tests) is not provided.
- Data provenance: "ex vivo tissue specimens." The country of origin is not specified. The study's nature is likely prospective as it involves new testing for the modified device.
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Number of experts used to establish the ground truth for the test set and qualifications of those experts:
- The document does not specify the number of experts or their qualifications used to establish ground truth or interpret the thermal testing results. The conclusion about "desirable clinical treatment effect" based on thermal damage profiles implies expert assessment, but details are absent.
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Adjudication method for the test set:
- Since the thermal testing is described as direct measurement of physical effects ("measurable thermal damage," "traceable thermal effect"), a human adjudication method in the sense of consensus reading (2+1, 3+1) is not applicable in the same way it would be for image interpretation. The method of assessing "consistent thermal damage profiles" and comparability to predicate devices would likely rely on quantitative measurements and engineering/biomedical expertise, but no specific adjudication method is mentioned.
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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:
- No MRMC study was done. This device is an electrosurgical tool, not an AI interpreting medical images. The evaluation focuses on the safety and performance of the electrosurgical function itself, particularly its thermal effects, rather than how it assists human interpretation or decision-making in a diagnostic context.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This question is not applicable as the device is a piece of hardware with integrated software for control, not an AI algorithm to be evaluated in a standalone diagnostic capacity. The "software verification and validation testing" confirms the software's functional performance, which is a component of the device's overall standalone performance.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the thermal testing, the ground truth was observed thermal damage profiles on ex vivo tissue, measured directly. The comparison was made against profiles produced by predicate and reference devices, implying their established effectiveness provides a benchmark. It's a physical/biophysical ground truth.
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The sample size for the training set:
- The document describes a 510(k) submission for a physical medical device, not an AI/machine learning model that typically has a "training set." Therefore, the concept of a training set sample size does not apply in this context.
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How the ground truth for the training set was established:
- As this is not an AI/ML device, the question of establishing ground truth for a training set is not applicable.
§ 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.