(71 days)
The FlexiView CO2 Blower is designed to improve visibility at the anastomotic site or other surgical sites where opaque bodily fluid interferes with visualization. It can be used to assist in anastomoses of tubular structures, such as vessels, nerves, ducts, during procedures such as CABG, MIDCAB, trauma, dialysis access graft procedures, femoral-popliteal, tibial or distal bypasses, and in situ bypass. The Flexi View CO2 Blower has application in open surgical procedures, such as cardiovascular, peripheral vascular, thoracic, general, gynecological, and urological procedures.
The FlexiView CO2 Blower With Mist is a sterile, single patient use instrument designed to improve visibility at an anastomotic site or other surgical sites by providing an adjustable flow of CO2 to clear blood or obscuring fluid away and assist in maintaining an open incision or arteriotomy. The optional saline mist helps to prevent desiccation of the graft and surrounding tissue. The FlexiView CO₂ Blower consists of a handle, a 6" malleable shaft with a nozzle, and connectors for hook up to standard CO2 source and saline.
The provided text describes a 510(k) premarket notification for the FlexiView CO2 Blower With Mist, a medical device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device as opposed to proving novel effectiveness through clinical studies. Therefore, the information requested regarding acceptance criteria, specific performance metrics, and detailed study methodologies (like sample sizes for test/training sets, expert adjudication, MRMC studies, standalone performance, and ground truth establishment) common in AI/novel device submissions is largely not applicable in this context.
Here's an breakdown based on the provided document:
Acceptance Criteria and Reported Device Performance
The document states that "Pre-clinical laboratory evaluations were performed to ensure that the device can be used as designed. The studies demonstrated acceptable performance to the Predicate Device."
This indicates that the "acceptance criteria" were likely related to demonstrating functional equivalence and safety compared to the predicate device, rather than achieving specific quantitative performance thresholds for a diagnostic task. The criteria would have been focused on aspects like CO2 flow rate, mist generation, sterility, material compatibility, and overall functionality as a visibility aid during surgery.
Table 1: Acceptance Criteria and Reported Device Performance (Inferred)
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Device can be used as designed (e.g., CO2 flow, mist) | Demonstrated acceptable performance. |
| Safe for its intended use (e.g., sterility, biocompatibility) | Demonstrated acceptable performance. |
| Performance is substantially equivalent to the Predicate Device | Studies demonstrated acceptable performance to the Predicate Device. |
Study Details
Given the context of a 510(k) for a physical medical device, the following points are largely not applicable as they relate more to AI/diagnostic device studies.
- Sample size used for the test set and the data provenance: Not specified, as the evaluation was pre-clinical laboratory work, likely involving device prototypes or test setups rather than patient data.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physical device's function would be based on engineering specifications and direct measurements, not expert interpretation of data.
- Adjudication method for the test set: Not applicable.
- 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. This device is not an AI/diagnostic tool and does not involve "human readers" in this sense.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical surgical accessory.
- The type of ground truth used: For a physical device, ground truth would be based on direct measurements and engineering specifications of its physical properties and functionality (e.g., CO2 flow rate, mist particle size, material integrity).
- The sample size for the training set: Not applicable. The "training set" concept is not relevant for this type of device and its evaluation.
- How the ground truth for the training set was established: Not applicable.
Summary of the Study
The study was a series of pre-clinical laboratory evaluations aimed at demonstrating the FlexiView CO2 Blower With Mist's acceptable performance in relation to a predicate device. The document emphasizes "Technological characteristics of the New Device are the same as the Predicate Device."
The conclusion states: "Based on the 510(k) summaries and 510(k) statements (21 CFR §807) and the information provided herein, we conclude that the New Device is substantially equivalent to the Predicate Device under the Federal Food, Drug and Cosmetic Act."
This indicates that the "study" was primarily a technical and functional comparison to an existing, legally marketed device, rather than a clinical trial to establish novel efficacy or diagnostic performance. The acceptance criteria were met by demonstrating that the new device performed equivalently to the predicate and met basic safety and functional requirements for its intended use.
§ 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.