(192 days)
The Solero Microwave Tissue Ablation (MTA) System is indicated for the ablation of soft tissue during open procedures. The Solero MTA System is not indicated for cardiac use.
The device description of the Solero MTA System from the previous cleared K162449, has not been modified with the exception of the addition of the Solero MTA Cart as an optional accessory to the Solero MTA System.
The Solero MTA Cart is an optional accessory, that allows for transport, storage, and maneuverability of the system pre- and post-use. The Solero MTA Cart provides a shelf that is designed to securely hold the Solero MTA Generator in place. Once on the cart, the Solero MTA Generator is at an appropriate working height. The Solero MTA Cart has an incorporated IV pole for holding the chilled saline source used for maintaining the Solero Applicator at an appropriate temperature. There is a cable management system built into the Solero MTA Cart that allows for the mains power cable and footswitch to be stored for transporting the device or storage. The Solero MTA System can be transported using the handle on the cart. There is a tray on the stand of the cart intended to hold Directions for Use and Operators Manual. The Solero MTA Cart sits on four rotating casters that can all be locked into place during use, storage, or as appropriate during transit.
The provided text describes a 510(k) premarket notification for the Solero MTA Cart, an accessory to the Solero Microwave Tissue Ablation (MTA) System. It does not contain information about acceptance criteria and a study proving the device meets those criteria in the context of an AI/algorithm-based medical device.
The document is a regulatory submission for a physical accessory (a cart) for an existing medical device, not a software or AI-driven device. Therefore, the questions related to AI performance metrics (like sample size for test/training sets, expert consensus, MRMC studies, standalone performance, and ground truth establishment) are not applicable to this submission.
Here's a breakdown of what is available in the document, which pertains to the physical accessory:
1. A table of acceptance criteria and the reported device performance:
The document doesn't present a formal table of acceptance criteria with corresponding performance data. Instead, it describes general safety and functional requirements.
| Acceptance Criteria (Inferred) | Reported Device Performance (Summary from text) |
|---|---|
| Appropriate worksurface height | Carts worksurface heights are appropriate for performing microwave tissue ablation procedures. |
| No rough surfaces, sharp corners, sharp edges | No rough surfaces, sharp corners and/or edges. |
| Rotating locking casters | Four (4) rotating locking casters. Casters successfully completed 5,000 full "on" and "off" cycles without failure, wear, or permanent deformation. |
| Accommodates generator | Frame/shelf accommodates a specific microwave tissue ablation generator. |
| Tray/shelf for accessories storage | Includes tray/shelf for accessories storage. |
| Cable management system | Cable management system (hooks) allows power cords, connection leads, cables, footswitch, etc, to be properly stored. |
| Manageable by single user | Cart movement is manageable by a single user. |
| Integrated IV pole (for Solero MTA Cart) | Solero MTA Cart incorporates an IV pole for holding the chilled saline source. (This is a differentiating feature from the reference device). |
| Electrical safety (related to isolation) | All isolation electronics are contained within the Solero MTA Generator. A separate isolation transformer is not required for the cart. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This is a hardware accessory; testing was likely bench testing and functional evaluations rather than clinical studies with patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. Ground truth and expert consensus are irrelevant for a physical cart accessory.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable.
5. If a multi reader mult-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. This device is not AI-driven.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable.
8. The sample size for the training set
Not applicable.
9. How the ground truth for the training set was established
Not applicable.
Summary of the study that proves the device meets the acceptance criteria:
The document states that the following performance testing was used to substantiate safety and effectiveness:
- IEC 60601-1: General Requirements for Basic Safety and Essential Performance: This likely involved electrical safety, mechanical stability, and general design integrity testing according to international standards for medical electrical equipment.
- Packaging Testing: Ensures the device can be transported without damage.
- Functional Testing including (e.g. electromagnetic compatibility and coexistence in a simulated use environment): This would involve testing the cart's ability to perform its intended functions (transport, hold generator, provide IV pole), as well as ensuring it doesn't interfere with other electronic devices and operates correctly in a typical medical environment. Specific mention is made of the casters' durability: "The Solero MTA Cart's casters have successfully completed 5,000 full "on" and "off" cycles without failure of the locking holding power, wear or permanent deformation that would adversely affect the locking performance of the casters."
The document concludes that "The results of comparison of technology similarities and the non-clinical performance testing demonstrates that the subject device (cart accessory), when used as an accessory for the predicate device (Solero MTA System), is substantially equivalent to the predicate device when used without it." This suggests that the performed non-clinical tests (bench testing, functional evaluations, and comparison to a legally marketed predicate device's cart) were sufficient to demonstrate the safety and effectiveness for a 510(k) clearance for this type of accessory. No clinical studies are mentioned for the cart itself, as it has no direct patient contact and its function is primarily transport and support.
§ 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.