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510(k) Data Aggregation
(60 days)
Laparoscopic Curved Spatula Electrode, Retractable, Aspiration Hole, 28cm ; Laparoscopic Wire J-Hook
These electrodes are intended for use in minimally invasive surgical procedures where monopolar electrosurgical cutting and coagulation are desired. Irrigation and suction capabilities via the same handset are available as well.
The New Deantronics Laparoscopic Hollow Electrodes, sold as sterile packaged, and ready for use devices, are intended for use in minimally invasive surgical procedures where monopolar electrosurgical cutting and coagulation are desired. The laparoscopic electrodes are used in conjunction with a Valleylab™ E2750 Laparoscopic Handset and 5 mm (internal diameter) or larger trocar, electrosurgical generator, and patient return electrode. During the operation, the electrode tip and the insulated shaft are to be inserted through a trocar, then conductive shaft end is inserted into the nose of an electrosurgical pencil from which it receives the high frequency current and delivers the current onto a target tissue for cutting and coagulation in a laparoscopic procedure. These devices can be used in hospitals and are used by trained professionally only.
This document is a 510(k) Pre-market Notification for Laparoscopic Hollow Electrodes. It describes the device, its intended use, and compares it to predicate devices to establish substantial equivalence.
Here's a breakdown of the requested information based on the provided text.
1. Table of Acceptance Criteria and Reported Device Performance
The document states that "All the test results demonstrate the performance of New Deantronics Laparoscopic Hollow Electrodes meet the requirements of its pre-defined acceptance criteria and intended uses." However, specific quantitative acceptance criteria or detailed reported performance values for each test are not explicitly provided in this document. The document broadly states that the device "passed all" relevant tests and "met the requirements."
| Test Category | Acceptance Criteria (Not explicitly quantitative in this document) | Reported Device Performance |
|---|---|---|
| Bench Testing | Meet design specification, function as intended | "Meet the requirements of its pre-defined acceptance criteria and intended uses." |
| Suction & Aspiration testing | Adequate performance within a system | Adequate performance demonstrated |
| Thermal Effects on Tissue testing | Adequate performance within a system | Adequate performance demonstrated |
| Electrical Safety (IEC 60601-1, IEC 60601-2-2) | Compliance with standards | "Passed all electrical safety and EMC testing." |
| Electromagnetic Compatibility (EMC) (IEC 60601-1-2) | Compliance with standards | "Passed all electrical safety and EMC testing." |
| Shelf-Life Testing | Maintain functionality and sterility | "Established that the device and packaging remain functional and maintain sterility for 2 years." |
| Biocompatibility Testing (ISO 10993-1) | Not cause a biocompatibility reaction | "Demonstrates that the materials in the device will not cause a biocompatibility reaction when used as intended." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample sizes used for any of the bench, electrical safety, EMC, shelf-life, or biocompatibility tests. It also does not explicitly state the country of origin of the data or whether the studies were retrospective or prospective. These were all bench tests conducted by New Deantronics, presumably in their facilities in Taiwan, R.O.C., as per the sponsor information.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable as the evaluation involved physical, electrical, and material testing of a medical device, not a diagnostic or prognostic system requiring expert interpretation of results for ground truth establishment.
4. Adjudication Method for the Test Set
This information is not applicable for the same reasons as above. The tests performed are objective measurements against predefined standards or specifications.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
An MRMC comparative effectiveness study was not performed, nor is it applicable to this type of device (electrosurgical electrodes). The device is a tool used by a surgeon, not a diagnostic aid that would improve human reader performance.
6. Standalone Performance (Algorithm Only without Human-in-the Loop Performance)
This is not applicable as the device is a physical electrosurgical electrode and does not involve any algorithms or AI for its function.
7. Type of Ground Truth Used
The "ground truth" for the tests performed was established through objective engineering and material science standards and specifications.
- Bench Testing: Internal requirements, FDA guidance (Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery).
- Electrical Safety & EMC: International standards (IEC 60601-1, IEC 60601-2-2, IEC 60601-1-2).
- Shelf-Life Testing: FDA guidance and internal requirements.
- Biocompatibility Testing: ISO 10993-1 and FDA guidance.
8. Sample Size for the Training Set
This is not applicable as the device does not employ machine learning or AI, and therefore does not have a "training set."
9. How the Ground Truth for the Training Set Was Established
This is not applicable as there is no training set for this device.
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