(84 days)
This device is intended for use during procedures when a wound or surgical site must be cleared by non-contact means for improved visibility at the site.
The ClearView Blower/Mister includes a hand grip with a 3 1/4" or 6 1/2" malleable stainless steel shaft for ease of positioning the device near the surgical site. The soft, silicone tip contains a plastic tube which carries saline to the tip. The proximal end includes a fluid inlet line which terminates in a locking female luer for connection to the fluid administration set. The gas line, located on the proximal end, has an in-line 0.2 micron filter and terminates in a slip connector for connection to the gas source tubing.
Here's an analysis of the provided text, focusing on acceptance criteria and the study demonstrating that the ClearView Blower/Mister meets them:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Predicate Performance | ClearView Blower/Mister Performance | Conclusion |
|---|---|---|---|---|
| Force Exerted by Gas/Saline Stream | Consistent force over range of discharge heights for a given flow rate | Not explicitly stated, but predicate exerted 70% more force at max flow/min discharge. | Consistent over tested flow and discharge height conditions. | Met (consistent force for ClearView) |
| Magnitude of Force (Comparative) | Force exerted by gas/saline stream at labeled maximum flow rates and max/min discharge heights should be comparable to predicate. | Approximately 70% greater than ClearView at maximum flow and minimum discharge height. | Exerted less force (by ~70%) than the predicate at maximum flow and minimum discharge height. | Met (considered acceptable given the "comparable" implication rather than exact match) |
| **Mist Pattern | Shape and Center** | Circular shape, centered under the discharge tip (implied ideal for surgical visibility). | Oval shape, major axis perpendicular to discharge tip. | Circular shape, centered under the discharge tip. |
| **Effect of Repeated Bends on Malleable Shaft | Air Flow Rate** | No measurable change in air flow rate after repeated/multiple bends. | Not applicable (ClearView specific test). | No measurable changes in air flow rate observed. |
| **Effect of Repeated Bends on Malleable Shaft | Saline Flow Rate** | No measurable change in saline flow rate after repeated/multiple bends. | Not applicable (ClearView specific test). | No measurable changes in saline flow rate observed. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not provide specific sample sizes (e.g., number of devices tested, number of repetitions for each test) for the non-clinical performance data. It describes the tests conducted on "this device" (ClearView Blower/Mister) and "the predicate device."
The data provenance is not explicitly stated. Given it's a 510(k) submission, it's highly likely to be internal company testing (Medtronic/DLP) conducted in a controlled laboratory environment. The testing is prospective in the sense that the experiments were designed and executed to evaluate the new device against its predicate and established criteria.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not applicable to this submission. The tests performed are non-clinical, measuring physical characteristics and performance of the device (force, mist pattern, flow rates). Ground truth was established through direct physical measurement using scientific instrumentation, not through expert consensus or clinical evaluation.
4. Adjudication Method for the Test Set
This information is not applicable. Since the tests are objective physical measurements, there's no need for an adjudication method as would be used for subjective assessments or image interpretation.
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
There was no MRMC comparative effectiveness study conducted. This is a non-clinical evaluation of a surgical device, not an AI or imaging diagnostic tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is a physical surgical instrument, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for the non-clinical performance tests was based on objective physical measurements using instruments and controlled experimental setups. This includes:
- Measurement of force exerted by the gas/saline stream.
- Visual/instrumental assessment of mist pattern shape and centering.
- Measurement of air and saline flow rates.
8. The sample size for the training set
This information is not applicable. There is no "training set" as this is not a machine learning or AI-based device.
9. How the ground truth for the training set was established
This information is not applicable. As stated above, there is no training set. The "ground truth" for the performance evaluation was established through direct physical measurements of the device's characteristics.
§ 880.5475 Jet lavage.
(a)
Identification. A jet lavage is a device used to clean a wound by a pulsatile jet of sterile fluid. The device consists of the pulsing head, tubing to connect to a container of sterile fluid, and a means of propelling the fluid through the tubing, such as an electric roller pump.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9.