(214 days)
These instruments have been designed to be used with endoscopes and electrosurgical for dissection, elevation, irrigation and preparation of tissue layers in combination with monopolar cutting and coagulation within the digestive tract.
The proposed device Single Use Electrosurgical Knife is a sterile, single-use endoscopic device, intended to be used with endoscopes and electrosurgical units for dissection, elevation, irrigation and preparation of tissue layers in combination with monopolar cutting and coagulation within the digestive tract.
The Single Use Electrosurgical Knife is used with the Electrosurgical Unit (ESU), the ESU supplies high frequency (HF) energy through a retractable electrode of the Single Use Electrosurgical Knife for the cutting and coagulation of tissue. The Single Use Electrosurgical Knife consists of Cutting Knife, outer tube assembly, Middle Tube assembly and handle assembly. Physicians would attach it to the ESU. For endoscopic procedures, the Single Use Electrosurgical Knife is placed down the channel of an endoscope that has a working channel equal to or greater than 2.8mm.
Upon the setup of the ESU, the Single Use Electrosurgical Knife is ready for use. To activate cautery, the Cutting Knife is extended out and the ESU's footswitch is depressed. The subject devices with injection models can supply fluid into the submucosa to supply liquid, use a syringe or pump to connect with luer tap on the hand components.
The Single Use Electrosurgical Knife is divided into I type, T type, O type and IT type according to the shape of the Cutting Knife. The main materials include ABS, Stainless Steel, PTFE, Zirconia, TPU and Gold. The physical and chemical performances of the device are stable. The proposed devices are EO sterilized to achieve the Sterility Assurance Level (SAL) of 10-6 and placed in a sterility maintenance package to ensure a shelf life of 3 years.
The Single Use Electrosurgical Knife has twenty-two (22) specifications; the main differences of these specifications are Cutting Knife Shape, Cutting Knife Length, and Effective Working Length and with injection function or without injection function.
The provided text describes a 510(k) premarket notification for a medical device, the "Single Use Electrosurgical Knife". This document establishes substantial equivalence to a predicate device, rather than proving a device meets specific acceptance criteria through a comparative study with a "reported device performance" in the way an AI/ML device would.
Therefore, the requested information elements such as "reported device performance," "sample sizes for test set," "data provenance," "number of experts," "adjudication method," "MRMC study," "effect size," "standalone performance," "type of ground truth," "training set sample size," and "how ground truth for training set was established" are not applicable to this submission, as they pertain to clinical or AI/ML performance evaluation, which is not the focus of this 510(k) summary.
The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device through a comparison of technological characteristics and performance data from bench testing.
Here's a breakdown of the information that is available in the document, formatted as requested where applicable, with explanations for missing sections:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of "acceptance criteria" against "reported device performance" in the context of clinical metrics (e.g., sensitivity, specificity for diagnostic devices, or specific outcomes for therapeutic devices) that would typically be associated with an AI/ML or comparative effectiveness study. Instead, it lists performance data from bench testing used to establish substantial equivalence to a predicate device. The acceptance criteria for these tests are implied to be that the proposed device performs comparably to the predicate device and works as intended.
| Item | Proposed Device Performance (Bench Testing) | Predicate Device Performance / Acceptance Criteria (Implied) |
|---|---|---|
| Dimension | Tested and confirmed to perform as intended. | Expected to be substantially equivalent to predicate device. |
| Actuation Performance | Tested and confirmed to perform as intended. | Expected to be substantially equivalent to predicate device. |
| Compatible Performance | Tested and confirmed to perform as intended with compatible devices. | Expected to be substantially equivalent to predicate device. |
| Sealing Performance | Tested and confirmed to perform as intended. | Expected to be substantially equivalent to predicate device. |
| Flowing Performance | Tested and confirmed to perform as intended (for injection models). | Expected to be substantially equivalent to predicate device. |
| Mucosa Lift Performance | Tested and confirmed to perform as intended. | Expected to be substantially equivalent to predicate device. |
| Cutting Performance | Tested and confirmed to perform as intended. | Expected to be substantially equivalent to predicate device. |
| Connected Force Performance | Tested and confirmed to perform as intended. | Expected to be substantially equivalent to predicate device. |
| Shelf-life | Demonstrated via accelerated aging test (ASTM F1980-16). 3-year aging test to be performed for longer stability. | 3 years (Same as predicate device). |
| Sterilization Validation | Conforms to ISO 11135:2014, SAL: $10^{-6}$. | SAL: $10^{-6}$ (Same as predicate device). |
| Biocompatibility | Conforms to ISO 10993-1 and FDA Guidance June 16, 2016. | Conforms to ISO 10993-1 (Same as predicate device). |
| Electrical Safety / EMC | Conforms to IEC60601-1, IEC 60601-1-2, IEC 60601-2-2, IEC 60601-2-18. | Same standards as predicate device. |
2. Sample size used for the test set and the data provenance
- Sample size: Not explicitly stated in terms of a specific numerical count for each bench test. The document refers to "bench testings" but does not give a specific n-value for the items tested.
- Data provenance: The performance data comes from "bench testings" performed by the manufacturer, Micro-Tech (Nanjing) Co., Ltd., based in China. This is not clinical data, so country of origin of patient data or retrospective/prospective is not applicable.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. This is a 510(k) for a physical electrosurgical knife, not an AI/ML diagnostic or prognostic device that would require expert-established ground truth for a test set. The "ground truth" for its performance is assessed via engineering and biocompatibility standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. As noted above, this is not a study requiring expert adjudication of results.
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
- Not applicable. No MRMC study was conducted. This device is a physical electrosurgical knife, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This is not an AI/ML algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable in the context of clinical ground truth. For the bench testing, "ground truth" is defined by established engineering standards (e.g., ISO, IEC, ASTM) and performance expectations for electrosurgical devices, and comparison to the predicate device's known performance.
8. The sample size for the training set
- Not applicable. This device does not involve a "training set" in the context of AI/ML or statistical modeling.
9. How the ground truth for the training set was established
- Not applicable. This device does not involve 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.