(116 days)
The ShinEvac® Smoke Evacuation Pencil is designed for general electrosurgical applications, including cutting and coagulation, and for removing smoke generated by electrosurgery when used in conjunction with an effective smoke evacuation system. The pencil enables the operator to remotely conduct and electrosurgical current from the output connector of an electrosurgical unit to the operative site for the desired surgical effect.
The ShinEvac® Smoke Evacuation Pencil, model: SW12200-APBCSE36, SW12200-APBCSE36G, SW12200-APBCSE56, SW12200-APBCSE56G, SW12200-APBCSB36 and SW12200-APBCSB56 is designed for general electrosurgical applications, including cutting and coagulation, and for removing smoke generated by electrosurgery when used in conjunction with an effective smoke evacuation system. The pencil enables the operator to remotely conduct an electrosurgical current from the output connector of an electrosurgical unit to the operative site for the desired surgical effect. Electro surgical Pencil is one of accessories of HF Electro Surgical Unit generates frequency from 300~600KHz for coagulation and cutting function, power up to 80W and 120W respectively. It is connected with cable conducting electro energy from unit and is holding a detachable tip electrode for the electrosurgery. This device is compatible with the Ø 2.38mm tip electrode and the maximum voltage is 4.5 KV peak. This device can remove surgical smoke when connected to a smoke evacuator.
The provided text describes a medical device, the ShinEvac® Smoke Evacuation Pencil, seeking FDA clearance via a 510(k) submission. This type of submission generally demonstrates substantial equivalence to a predicate device rather than providing extensive de novo clinical studies with acceptance criteria in the same way a PMA (Premarket Approval) submission would.
Therefore, the study described here focuses on demonstrating that the new device performs similarly to a legally marketed predicate device, especially regarding safety and functional aspects, rather than setting and meeting specific quantitative clinical performance metrics like sensitivity, specificity, or AUC as one might see for diagnostic AI devices.
However, I can extract information related to performance testing and safety, which serve as the acceptance criteria for this type of device within the context of a 510(k):
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Test/Standard | Acceptance Criteria Definition / Purpose | Reported Device Performance (Summary) |
|---|---|---|---|
| Performance Testing | Electrosurgical cutting performance | To evaluate the safety and performance of the device in cutting various tissues under worst-case scenarios. | The animal study evaluated "the safety and performance of the device in three different tissues under worst case scenarios. The outputs of energy were applied with low, moderate, and high watts in liver, kidney and muscle to test of the cutting performance and also evaluated the safety from tissue temperature, tissue cooling time and the extent of tissues' thermal damage." (Implied: met expected performance for cutting and safety based on thermal damage). |
| Safety Testing | IEC 60601-1 (Basic Safety and Essential Performance General) | To ensure the device meets fundamental safety requirements for medical electrical equipment. | The device was tested in accordance with this standard. (Implied: passed, confirming basic safety). |
| IEC 60601-1-2 (Electromagnetic Compatibility) | To ensure the device does not interfere with other equipment and is not adversely affected by electromagnetic interference. | The device was tested in accordance with this standard. (Implied: passed, confirming EMI compatibility). | |
| IEC 60601-2-2 (HF Surgical Equipment & Accessories) | Specific safety and essential performance requirements for high-frequency surgical equipment and their accessories (like this device). | The device was tested in accordance with this standard. (Implied: passed, confirming specific HF surgical safety). | |
| IEC 60601-1-6 (Usability) | To ensure the device is safely and effectively usable by its intended users. | The device was tested in accordance with this standard. (Implied: passed, confirming usability). | |
| Biocompatibility Testing | ISO 10993-5 (Cytotoxicity) | To assess the potential for the device materials to cause cell damage. | The device was tested in accordance with this standard. (Implied: passed, confirming non-cytotoxic). |
| ISO 10993-10 (Irritation & Sensitization) | To assess the potential for the device materials to cause irritation or allergic reactions. | The device was tested in accordance with this standard. (Implied: passed, confirming minimal irritation/sensitization). | |
| ISO 10993-11 (Systemic Toxicity) | To assess the potential for the device materials to cause systemic toxic effects. | The device was tested in accordance with this standard. (Implied: passed, confirming no systemic toxicity). | |
| USP 42/NF37:2019 (Pyrogen Test) | To test for the presence of substances that can cause fever. | The device was tested in accordance with this standard. (Implied: passed, confirming non-pyrogenic). | |
| Sterilization Validation | ISO 11135 (Ethylene Oxide Sterilization) | To confirm the efficacy and reliability of the Ethylene Oxide (EO) sterilization process used for the device. | The device was tested in accordance with this standard for "development, validation and routine control of a sterilization process." (Implied: validated, ensuring sterility). |
2. Sample size used for the test set and the data provenance
- Performance Testing (Animal Study): The animal study involved evaluating the device in "three different tissues" ("liver, kidney and muscle"). The exact number of animals or trials within each tissue type is not specified.
- Data Provenance: The animal study is prospective (conducted for the purpose of this submission). The country of origin for the animal study is not specified in the provided text.
- Other tests (Safety, Biocompatibility, Sterilization): These are typically laboratory-based tests conducted on device samples. The specific sample sizes for these tests are not provided but would be defined by the respective international standards (e.g., ISO, IEC).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This device is an electrosurgical pencil, not an AI/diagnostic device that typically relies on expert-established ground truth for its performance metrics (like sensitivity/specificity).
- For the animal study, the evaluation of "safety from tissue temperature, tissue cooling time and the extent of tissues' thermal damage" would likely involve veterinary pathologists or researchers with expertise in electrosurgery and tissue histopathology. However, the exact number and qualifications of these experts are not specified in the document.
- For the other tests (safety, biocompatibility, sterilization), the "ground truth" is established by adherence to the objective criteria and protocols defined in the referenced international standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable as this is not a diagnostic AI device requiring expert consensus for ground truth labeling. Performance is assessed against objective engineering and biological standards.
5. 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, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-assisted diagnostic tools and is not applicable to an electrosurgical pencil. The submission is for a physical medical device, not an AI algorithm assisting human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a physical electrosurgical tool and not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For the animal study, the "ground truth" for assessing cutting performance, tissue temperature, cooling time, and thermal damage is established through direct observation, measurement, and potentially pathological examination of a histologist or other experts.
- For safety, biocompatibility, and sterilization tests, the "ground truth" is defined by the objective pass/fail criteria and methodologies stipulated within the referenced IEC and ISO international standards. Compliance with these standards serves as the benchmark.
8. The sample size for the training set
- Not applicable. This device is not an AI algorithm that requires a training set.
9. How the ground truth for the training set was established
- Not applicable. This device is not an AI algorithm that requires a training set.
§ 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.