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The Pajunk insufflation cannula acc. Veress and the modular insufflation cannula acc. Veress is employed in minimal invasive surgery. The cannula is designed for the initial puncture with subsequent gas insuffation for laparoscopic operations. It is used to establish a pneumoperitoneum.

The insufflation cannulae according Veress were developed especially for the safe and efficient r rio moumation oannalae and insufflation cannulae are equipped with maintenance free cocks and a female LuerLock connector. Before application, a sharp outer cannula (sterile packed for modular Veress, reusable for Standard Veress) is mounted onto the reusable inner cannula and fastened by means of a LuerLock connector. Therefore within the modular system , a new, absolutely sharp disposable outer cannula is used for every application. In comparison with totally disposable Veress-cannulae, with the same advantages, the modular system offers a large potential to reduce cost.

This is a premarket notification for a Veress and Modular Veress Insufflation Cannula. This type of submission typically focuses on demonstrating substantial equivalence to a predicate device rather than presenting extensive de novo clinical study data with specific acceptance criteria and detailed device performance metrics. Therefore, many of the requested data points (e.g., sample sizes for test and training sets, number of experts for ground truth, MRMC study details, acceptance criteria table) are not applicable or explicitly provided in this document.

Here's the information that can be extracted or inferred based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

This type of information is generally not included in 510(k) submissions for devices like the Veress cannula, which are often cleared based on substantial equivalence to predicate devices rather than meeting specific performance criteria in a new clinical study. The device's performance is assumed to be equivalent to the predicate devices.

2. Sample Size Used for the Test Set and Data Provenance

A formal "test set" in the context of a prospective clinical study with a defined sample size to prove performance against specific acceptance criteria is not described. The submission relies on substantial equivalence and "clinical evaluation and summarizing literature." Therefore, specific sample sizes for a 'test set' derived from a new study are not provided. The data provenance is described as "clinical evaluation and summarizing literature," suggesting a review of existing data rather than a new prospective study.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. The submission does not describe a new clinical study with a ground truth established by experts.

4. Adjudication Method for the Test Set

Not applicable. The submission does not describe a new clinical study with an adjudication process.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs without AI Assistance

Not applicable. This device is a surgical instrument (insufflation cannula), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study and AI-related metrics are irrelevant.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

Not applicable. This device is a surgical instrument, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the device's safety and effectiveness is primarily based on substantial equivalence to existing legally marketed predicate devices, which have a history of safe and effective use. Additionally, the submission mentions "clinical evaluation and summarizing literature," suggesting that the medical community's existing knowledge and published findings on similar devices serve as a form of "ground truth" regarding the general principles of Veress cannula use.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable. This is not an AI/ML device that requires a training set with established ground truth.

Summary of Device Rationale from the Submission:

The submission for the Veress and Modular Veress Insufflation Cannula focuses on demonstrating substantial equivalence to two predicate devices:

1. Cannula with sharp obturator & Veress Needle by Karl Storz (K800668)
2. Veress Cannula et al. by Richard Wolf Medical (K041321)

The rationale provided is that the proposed devices are "as safe and effective as and therefore substantial equivalent to the predicate devices" in terms of intended use, indication, and technical characterization. The document explicitly states: "The comparison between the predicate devices and the proposed devices... demonstrates that the proposed devices are safe and effective, as well as substantially equivalent to the predicate devices." It also mentions "The cannula system acc. Veress has been used for years now. The clinical evaluation and summarizing literature, which is part of this submission (10.0), makes this aspects evident." This implies that prior clinical experience and published data on this type of device support its safety and effectiveness without requiring a new, formal clinical trial with specific performance criteria.

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