(238 days)
Wandy's Dispersive Electrode is intended use to the patient during Electrosurgical procedures to provide a path for RF current to leave the patient and return to the Generator
Wandy Dispersive Electrode is designed to provide a safe return path Electrosurgical current between Generator, to active electrode and to patient without cord. And able to use to any patient if full skin contact available. non sterilized and to use only one time.
The surface of the conductive area is covered with a Bio-compatible Hydro-gel and the surface of the non-conductive area made of PE Foam and Texture Fabric is covered with Medical grade adhesive for maximum skin adhesion. This device are non sterilized and one time use only, available 3 sizes with various shape for Adult / Pediatric
The Wandy Dispersive Electrode is an electrosurgical grounding pad. The provided text, a 510(k) summary, details its safety and effectiveness for FDA clearance.
Here's an analysis of the acceptance criteria and the study information based on the provided document:
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance | Study that Proves Device Meets Criteria |
|---|---|---|
| Biocompatibility | * Conforms to ISO 10993-1: Biological Evaluation of Medical Device. | Test Report attached (mentioned in section 7. Bio-Compatibility). Details not provided in this summary. |
| * In vitro Cytotoxicity: ISO 10993-5 (2002) | Conformed | Test Report attached (mentioned in section 7. Bio-Compatibility). Details not provided. |
| * Skin Sensitization/Irritation: ISO 10993-10 (2009) | Conformed | Test Report attached (mentioned in section 7. Bio-Compatibility). Details not provided. |
| Electrical Safety/Performance | * Meets IEC 60601-2-2 (Ed 5/9, 2009-02) General requirement for safety. | Bench test done by manufacturer in accordance with IEC 60601-2-2: 2006-59.104.5 / 104.79b(b).(c). Report attached (mentioned in section 6. Intended use). Details not provided. |
| * Output Power: 300W, 700mA @615 ohms for less than 60 seconds. | Same as predicate cleared electrode device. | Bench testing (explicitly mentioned for electrical safety). Comparison to predicate. No specific study details provided beyond "Bench test done by manufacturer." |
| Substantial Equivalence | * Substantially equivalent to several predicate devices in respect to intended use, main function, technology, principal operation, and performance. * Does not raise any additional concerns regarding safety and effectiveness. | This is an overall claim based on the technical characteristics and testing described. The 510(k) process itself establishes substantial equivalence. No specific comparative study with the predicate is detailed beyond a statement of "intended use, same output power... as predicate cleared electrode device." |
Note: The provided 510(k) summary emphasizes equivalence to a predicate device and adherence to international standards. It references "attached reports" for biocompatibility and bench testing, but the actual data and detailed methodologies of these studies are not included in the provided text.
Study Information (Based on available text)
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Sample size used for the test set and the data provenance:
- Test set sample size: Not explicitly stated for any of the tests. The document refers to "Bench test done by manufacturer" and "Test Report attached" for biocompatibility, but no specifics on sample size are provided.
- Data provenance: The tests were conducted by the manufacturer (Wandy Rubber Industrial Co., Ltd) in Taiwan, R.O.C., as indicated by the manufacturer's address. The data is retrospective in the sense that the tests were performed to support the 510(k) submission.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This is not applicable in the context of this device and submission. The "ground truth" for a medical device like a dispersive electrode is typically established through adherence to recognized international standards (e.g., ISO for biocompatibility, IEC for electrical safety), not through expert consensus on diagnostic images or clinical outcomes. The standards themselves define acceptance criteria.
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Adjudication method for the test set:
- Not applicable. The tests performed (biocompatibility, electrical safety) are objective measurements against defined criteria in international standards, not subjective assessments requiring adjudication.
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If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
- No. An MRMC study is relevant for diagnostic imaging devices where human readers interpret medical images. This is a therapeutic device (electrosurgical accessory), and such a study is not appropriate or required for its clearance.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, in a way. The device's performance was evaluated in standalone bench tests according to specified standards (e.g., IEC for electrical performance, ISO for biocompatibility) without requiring human intervention in its primary function for the evaluation. These tests assess the device's inherent characteristics.
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The type of ground truth used:
- Standards-based performance criteria: For electrical safety, the ground truth is defined by the parameters and limits specified in IEC 60601-2-2. For biocompatibility, it's the criteria outlined in ISO 10993-1, ISO 10993-5, and ISO 10993-10. These are objective engineering and biological safety standards.
- Comparison to predicate device: For technological characteristics like output power, the "ground truth" for substantial equivalence is the established performance of the legally marketed predicate device (K100686 Conmed Corp Macrolyte Dispersive Electrode).
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The sample size for the training set:
- Not applicable. This device does not use machine learning or AI, so there is no "training set."
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How the ground truth for the training set was established:
- Not applicable, as there is no training set for this device.
§ 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.