Search Results

The Carevix™ Suction Cervical Stabilizer is indicated to snare, grasp, hold and manipulate cervical tissue.

Carevix™ Suction Cervical Stabilizer is a sterile, single-use, two-piece device consisting of three main parts: a reloadable vacuum reserve embedded inside the main body, including a piston to generate the vacuum, an activation/deactivation push-button, and an anatomic-shaped suction head to put in contact with the cervix. The suction head includes a rod that connects the main body.

The provided text describes a 510(k) premarket notification for the Carevix™ Suction Cervical Stabilizer. This document focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed acceptance criteria and a full study report for a novel medical device, especially an AI/ML-driven one.

Therefore, many of the requested details, particularly those pertaining to AI/ML device performance (sample size for test set, data provenance, number of experts for ground truth, adjudication, MRMC studies, standalone performance, training set details), are not present in the provided text, as this is a traditional medical device submission.

Here's what can be extracted based on the provided text:

Acceptance Criteria and Device Performance:

The document states that the device was evaluated against its design and user specifications, and that "All the results were in accordance with the test acceptance criteria." However, it does not provide a table of specific quantitative acceptance criteria or the reported device performance metrics for different parameters (e.g., specific force applied, vacuum pressure achieved, or a pass/fail rate for a clinical outcome).

Instead, it lists the types of tests performed and their general outcomes:

Missing Information (as per the provided text):

• Sample size used for the test set and the data provenance: Not mentioned. The testing appears to be primarily bench testing (biocompatibility, sterilization, performance) rather than clinical studies with patient data.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/not mentioned. Ground truth as typically understood for AI/ML devices (e.g., disease presence) is not relevant to this device's testing.
• Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable/not mentioned.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No. This is not an AI/ML device nor a diagnostic imaging device that would typically involve human readers.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No, as this is not an AI/ML algorithm.
• The type of ground truth used: For biocompatibility, the ground truth is established by standardized lab tests (e.g., cell viability, skin irritation). For performance, the ground truth is the device's design specifications. No "expert consensus" or "pathology" ground truth is mentioned.
• The sample size for the training set: Not applicable, as this is not an AI/ML device.
• How the ground truth for the training set was established: Not applicable, as this is not an AI/ML device.

Summary of what the document focuses on instead:

The document outlines a 510(k) submission for a modified medical device. The primary goal is to demonstrate "substantial equivalence" to a previously cleared predicate device (ASPIVIX v1.1 Cervical Suction Tenaculum, K203820). This is achieved by:

• Comparing Indications for Use: Stating they are the same ("to snare, grasp, hold and manipulate cervical tissue").
• Comparing Technological Characteristics: Identifying both similarities and differences (e.g., changes in rod length, inner diameter, trigger mechanism, vacuum generation, and two-piece vs. one-piece design).
• Providing Safety and Performance Data for the Modifications: This includes:
  • Biocompatibility testing: Performed in accordance with ISO 10993-1, 10993-5, 10993-10, and ISO 14971:2019. Tests confirmed non-cytotoxic, non-sensitizing, and non-irritating results.
  • Sterilization validation: Performed via e-beam in accordance with ANSI/AAMI/ISO 11137-2:2013.
  • Performance and Safety testing: Conducted according to protocols used for the predicate device, with all results meeting acceptance criteria. The document states that newly identified risks (related to assembly) do not raise new questions of safety or effectiveness because they are identifiable before patient use.
• Conclusion: The testing results support the determination of substantial equivalence, meaning the modified device is considered as safe and effective as the predicate device.

In essence, this is a clearance for a physical medical instrument based on engineering and biological testing, not an AI/ML software device.

Ask a specific question about this device