(171 days)
The Disposable Monopolar Laparoscopic Shafts and Reusable Handles are intended for use in endoscopic surgical procedures. It is a family of instruments which includes graspers, dissectors, and scissors, which are intended to be used to grasp, manipulate, cut, and cauterize soft tissue.
The Disposable Monopolar Laparoscopic Shafts and Reusable Handles are sterile packaged single use monopolar attachments intended for use in combination with the Reusable Handle. It is designed to include graspers, dissectors, and scissors, intended to grasp, manipulate, cut, and cauterize soft tissue.
The Disposable Monopolar Laparoscopic Shafts are offered in working diameters of 3 to 5 mm and lengths between 20 to 45 cm. The shaft is made from aluminum covered with a fluorinated ethylene polypropylene external insulation. The shaft is attached to the handle using the locking knob and a stainless-steel drive rod which connects to the jaws and interacts with the handle activation rod.
The Reusable Handle is supplied non-sterile and in intended to be sterilized by the user using an autoclave process. Handles are offered in ratcheting and non-ratcheting configurations and are intended to be connected to the sterile disposable shaft. Once connected the rotation knob provides 360 degrees of rotation for the instrument shaft and jaws. The handle includes an RF Post for electrosurgery when attached to an approved electrosurgical generator to provide coagulation of tissue when used with an appropriate ground (neutral) electrode.
This is a 510(k) premarket notification for a medical device (Disposable Monopolar Laparoscopic Shafts and Reusable Handles), which focuses on demonstrating substantial equivalence to a predicate device rather than proving clinical effectiveness through novel acceptance criteria and studies. Therefore, many of the requested categories are not directly applicable or explicitly detailed in the provided document in the way they would be for a de novo device or a device requiring clinical trials.
Here's an analysis based on the provided text, addressing the points where information is available and noting where it is not:
1. Table of Acceptance Criteria and Reported Device Performance
For a 510(k) submission, the "acceptance criteria" are generally based on demonstrating equivalence to the predicate device's performance in specific non-clinical tests. The document doesn't present a formal table of acceptance criteria with specific numerical targets. Instead, it describes comparative testing against the predicate.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Mechanical Performance: |
- Equivalent cut performance (no slipping, overall cut length, scissor opening) across different mediums compared to the predicate device. | "Testing showed the Disposable Monopolar Laparoscopic Shafts and Reusable Handles devices performed equivalent to the predicate product." |
| Electrical Performance: - Equivalent thermal spread across different tissue types and power settings (minimum, default, maximum generator power) compared to the predicate device. | "Results showed an equivalent thermal spread under the same conditions across the different tissue types and power settings." (Testing followed FDA guidance "Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery" issued August 15, 2016, requiring testing on three different tissue types at minimum, default, and maximum generator power). |
| Safety and Biocompatibility: - Conformance to relevant ISO standards (e.g., ISO 10993 for biocompatibility, ES60601-1, IEC 60601-2-2, IEC 60601-2-18 for electrical safety). | "Conforms to ISO 10993"
"[Testing was] performed in accordance with... ANSI AAMI ES60601-1:2005/(R)2012... IEC 60601-2-2:2017... IEC 60601-2-18:2009." (Specific quantitative results for these are not provided, but conformance implies meeting the standards' requirements). |
| Sterilization: - Validation of Ethylene Oxide sterilization to SAL of 10^-6. | "Sterilized using Ethylene Oxide for single patient use in accordance with ISO 11135 to an SAL of 10^-6."
"Ethylene Oxide Sterilization Validation per ISO 11135:2014..." |
| Aging Study: - Performance maintained after accelerated aging. | An "Aging Study" was performed, implying successful completion, though specific results are not detailed. |
| Autoclave Sterilization Validation (for Reusable Handle): - Validation of autoclave sterilization process. | An "Autoclave Sterilization Validation" was performed, implying successful completion, though specific results are not detailed. |
2. Sample size used for the test set and the data provenance
- Sample Size: The document does not explicitly state the sample sizes used for the non-clinical tests (e.g., number of devices tested for cut performance, number of thermal spread measurements). This information is typically found in detailed test reports, not usually in the 510(k) summary itself.
- Data Provenance: The data provenance is from non-clinical bench testing. The country of origin of the data is not specified, but it would typically be from a testing laboratory (either in-house or third-party) adhering to international standards. The data is prospective in the sense that the tests were conducted specifically for this 510(k) submission to demonstrate equivalence.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This concept is not applicable here. "Ground truth" established by experts is relevant for studies involving diagnosis, image interpretation, or clinical outcomes. The studies for this device are non-clinical bench tests comparing physical and electrical properties to a predicate device. The "ground truth" is established by the direct physical measurements and compliance with engineering and safety standards.
4. Adjudication method for the test set
Not applicable, as this is related to expert review or clinical trial data, which is not part of this 510(k) submission for non-clinical testing.
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. MRMC studies are typically used for diagnostic imaging devices involving human interpretation of data, often with AI assistance. This device is a surgical instrument, and no such study was conducted or required. The document explicitly states: "There were no clinical trials performed on these devices."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is geared towards AI-enabled devices. The device described (Monopolar Laparoscopic Shafts and Reusable Handles) is a physical surgical instrument and does not incorporate an algorithm or AI. Therefore, this is not applicable.
7. The type of ground truth used
As mentioned in point 3, the concept of "ground truth" in the context of expert consensus, pathology, or outcomes data is not directly applicable to this type of non-clinical device testing. For the non-clinical tests performed:
- Mechanical and Electrical Performance: The "ground truth" is based on direct physical measurements (e.g., cut length, thermal spread measurement under magnification) conducted in a controlled laboratory environment against the performance of a legally marketed predicate device.
- Safety and Biocompatibility: The "ground truth" is defined by compliance with recognized international standards (e.g., ISO 10993 for biocompatibility, IEC 60601 series for electrical safety).
8. The sample size for the training set
Not applicable. This device is a physical surgical instrument and does not involve machine learning or a "training set" in the computational sense.
9. How the ground truth for the training set was established
Not applicable, for the same reason as point 8.
§ 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.