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Electrosurgical cutting and mechanical dissection of tissue, during the performance of laparoscopic and general surgical procedures.

The Bipolar Needle Electrode is a modification to the predicate device cleared under K904993. The bipolar Needle Electrodes are identical in construction (with the exception of shaft length) and in component materials when compared to the predicate device. The cutting electrode is electrically isolated from the return electrode, enabling one electrode to act as a return electrode, eliminating the need for a return pad. The modification has not altered the fundamental technology of the predicate device cleared under K904993. The intended use, electrosurgical cutting, and mechanical dissection are identical to the predicate devices cleared under K904993. The energy source, bipolar electrosurgical energy, is the same energy type as used for the predicate devices.

The provided text describes a 510(k) premarket notification for a medical device, the Everest Bipolar Needle Electrode and Gyrus Bipolar Needle Electrode. This submission aims to demonstrate substantial equivalence to a predicate device, rather than proving the device meets specific acceptance criteria through a clinical study with detailed performance metrics.

Therefore, most of the requested information regarding acceptance criteria and a study proving performance is not present in the provided document. The document focuses on demonstrating that the modified device is substantially equivalent to an already cleared predicate, meaning its design, materials, function, and intended use are similar enough that it raises no new issues of safety and effectiveness.

Here's a breakdown based on the information provided and what is not present:

1. Table of Acceptance Criteria and Reported Device Performance

• Not Applicable / Not Provided: The document does not specify quantitative acceptance criteria (e.g., minimum accuracy, sensitivity, specificity, or specific performance thresholds) that the device must meet, nor does it present detailed performance results from a study against such criteria. The basis for clearance is substantial equivalence to a predicate, not meeting novel performance benchmarks.

2. Sample size used for the test set and the data provenance

• Not Applicable / Not Provided: The submission is not based on a new clinical study with a test set of data. It relies on the assertion that the modified device is identical in construction (except for shaft length) and materials, and has the same intended use and energy source as the predicate (K904993). Therefore, no "test set" in the context of performance data is mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not Applicable / Not Provided: As no new clinical study with a test set is discussed, there is no mention of experts establishing a ground truth for performance evaluation.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

• Not Applicable / Not Provided: No test set or related adjudication method is mentioned.

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

• Not Applicable / Not Provided: This device is an electrosurgical cutting and coagulation device, not an AI-assisted diagnostic tool. Therefore, an MRMC study or AI-related effectiveness metrics are irrelevant and not part of this submission.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not Applicable / Not Provided: This device is a manual surgical instrument, not an algorithm. Standalone performance for an algorithm is not relevant here.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Not Applicable / Not Provided: No ground truth in the context of performance metrics is established or discussed, as the submission focuses on substantial equivalence of design and function. The "ground truth" for the submission is the established safety and effectiveness of the predicate device.

8. The sample size for the training set

• Not Applicable / Not Provided: This device is not an AI/ML algorithm that requires a "training set."

9. How the ground truth for the training set was established

• Not Applicable / Not Provided: As above, this is not an AI/ML device, so a training set and its ground truth establishment are not relevant.

Summary Explanation:

The provided document is a 510(k) summary, which is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective as a legally marketed predicate device. The core argument for the Everest Bipolar Needle Electrode and Gyrus Bipolar Needle Electrode is that it is a modification to an existing predicate device (K904993).

The key statements supporting this are:

• "The Bipolar Needle Electrode is a modification to the predicate device cleared under K904993."
• "The bipolar Needle Electrodes are identical in construction (with the exception of shaft length) and in component materials when compared to the predicate device."
• "The modification has not altered the fundamental technology of the predicate device cleared under K904993."
• "The intended use, electrosurgical cutting, and mechanical dissection are identical to the predicate devices cleared under K904993."
• "The energy source, bipolar electrosurgical energy, is the same energy type as used for the predicate devices."

Based on these points, Gyrus Medical Inc. concludes that "no new issues of safety and effectiveness are raised and that the submitted device is substantially equivalent." This type of submission relies heavily on comparison to a predicate device and demonstration that the changes are minor and do not introduce new risks or alter fundamental performance characteristics, rather than presenting a performance study against specific, novel acceptance criteria.

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Electrosurgical cutting and coagulation, mechanical grasping and dissection of tissue Droving the performance of laparoscopic and general surgical procedures.

The device is a Class II medical device. The PK ZIP WING Cutting Dissecting forceps is a modification to the predicate devices cleared under K904993. The bipolar dissecting forceps is identical in construction (with the exception of shaft length) and in component materials when compared to the predicate device. The dissector jaws are electrically isolated from each other enabling one jaw to act as a return electrode, eliminating the need for a return pad. In addition a cutting electrode mounted in one of the jaws is electrically isolated from the dissector jaw enabling the jaw to act as a return electrode. The modification has not altered the fundamental technology of the predicate devices cleared under K904993. The intended use: Electrosurgical cutting and coagulation, grasping and dissection during surgical procedures is identical when compared to the predicate devices. The energy source, Bipolar Electrosurgical Energy, is the same energy type as used for the predicate devices.

The provided text describes a 510(k) submission for the "PK ZIP WING Cutting Dissector" and focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a detailed study with specific acceptance criteria and performance metrics typically seen in clinical trials for novel devices.

Therefore, many of the requested categories of information, such as detailed acceptance criteria, specific device performance numerical values, sample sizes for test sets, expert qualifications, adjudication methods, MRMC studies, standalone performance studies, and training set information, are not present in this type of regulatory document.

However, based on the information provided, here's what can be extracted and inferred:

1. A table of acceptance criteria and the reported device performance

Note: For 510(k) submissions, the "acceptance criteria" are generally demonstrating that the new device is "substantially equivalent" to a legally marketed predicate device. This often involves showing similar design, materials, intended use, energy source, and performance characteristics (even if not quantified in the same way as a full clinical study). The "performance" is primarily demonstrated through this comparison to the predicate.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. The filing focuses on a technical comparison to a predicate device rather than a clinical study with a test set of 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)

This information is not provided as there is no mention of a clinical study involving experts establishing ground truth for a test set.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided as there is no mention of a clinical study or test set requiring adjudication.

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

An MRMC comparative effectiveness study was not conducted. This is an electrosurgical instrument, not an AI-assisted diagnostic device, so comparing human readers with/without AI assistance is not applicable.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

A standalone performance study in the context of an algorithm or AI was not done, as this is an electrosurgical device. The performance is assessed through its mechanical and electrical function.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The concept of "ground truth" as applied to diagnostic or AI devices is not directly applicable here. The assessment of this device is based on its functional equivalence to a predicate electrosurgical device, ensuring it performs its intended actions (cutting, coagulation, grasping, dissection) safely and effectively, similar to the already cleared device. This would likely involve engineering testing, material testing, and functional testing to confirm these aspects, rather than clinical ground truth as understood in diagnostic studies.

8. The sample size for the training set

This information is not provided. The device is an electrosurgical instrument, not a machine learning model, so the concept of a "training set" is not applicable.

9. How the ground truth for the training set was established

This information is not provided and is not applicable to this type of device.

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Electrosurgical Coagulation of soft tissue during ENT procedures.

The devices are Class II medical devices are similar in design to the referenced predicate devices. The BiTx devices are similar in construction and in component materials as compared to laparoscopic devices (Ref. BiLAP Probes submitted in 510(k) no's. K904993 and K945975). The devices are tubular instruments, either 3mm or 5mm in diameter, with shaft lengths of 12-15cm. The intended use of the device is to electrosurgically coagulate soft tissue during the performance of ENT procedures. The energy source, Bipolar Electrosurgical Energy, is the same energy type as used for the predicate devices with indications for ENT procedures. The device incorporates a return electrode on it's distal end, eliminating the need for a return pad.

The provided text describes a 510(k) submission for a medical device (BiTx Probe) and the FDA's "Substantially Equivalent" determination. However, it does not contain any information about acceptance criteria, device performance studies, sample sizes, expert involvement, or any other details related to a performance evaluation of the device against specific criteria.

The document is a regulatory submission for pre-market notification, focusing on demonstrating substantial equivalence to existing predicate devices, rather than presenting a detailed performance study with quantitative results.

Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria and study details. The input document simply does not contain this type of data.

Here's what the document does state, which is relevant to a 510(k) submission but not to a performance study:

• Device Name: BiTx Probe
• Intended Use: Electrosurgically coagulate soft tissue during the performance of ENT procedures.
• Mechanism of Action: Bipolar Electrosurgical Energy, similar to predicate devices.
• Comparison to Predicate Devices: The submission asserts that the device is similar in design, construction, component materials, function, and intended use as compared to predicate devices (BiLAP Probes and devices marketed by Elmed Incorporated and Ellman International).
• Conclusion for 510(k): "Everest Medical believes that no new issues of safety and effectiveness are raised and that this device is substantially equivalent."
• FDA Determination: The FDA found the device "substantially equivalent" to predicate devices, allowing it to be marketed.

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