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The OCTO™ Port is intended to use as a multiple instrument and/or camera port during minimally invasive abdominal laparoscopic surgery.

The OCTO™ Port is a sterile, disposable laparoscopic instrument port which retracts a small abdominal incision to allow multiple laparoscopic instruments to pass through to the abdomen.

The provided text describes modifications to an existing device (OCTO™ Port) and asserts its substantial equivalence to a predicate device (OCTO™ K100045) rather than presenting detailed acceptance criteria and a study to prove they are met. The document focuses on demonstrating that the new modifications do not alter the fundamental safety or effectiveness of the device.

Here's an analysis based on the information provided and how it relates to your requested points:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not provide specific, quantifiable acceptance criteria with corresponding performance results in a tabular format. Instead, it lists general types of bench tests conducted to ensure the device performs as expected after modifications.

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

The document does not specify the sample size used for any of the bench tests listed. It states "The testing scope for Bench Test was selected to include..." which indicates tests were performed, but no details on the number of samples or data provenance are given.

3. Number of Experts Used to Establish the Ground Truth and Qualifications

This information is not applicable or provided in the context of this 510(k) submission. No clinical study involving experts establishing ground truth is described. The assessment is based on physical and functional changes to the device compared to a predicate.

4. Adjudication Method for the Test Set

This information is not applicable or provided. There's no mention of expert adjudication for the bench tests.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was conducted or mentioned. The device is a surgical access port, not an imaging or diagnostic device that would typically involve MRMC studies for AI assistance.

6. Standalone (Algorithm Only) Performance

This is not applicable as the device is a physical surgical instrument, not an algorithm or AI.

7. Type of Ground Truth Used

The concept of "ground truth" as typically used in AI/diagnostic studies is not directly applicable here. For the bench tests, the "ground truth" would be established engineering specifications, performance standards, and comparisons to the known performance of the predicate device. For example, "pressure leak test" would likely have a pre-defined maximum allowable leak rate, and the test results would be compared against that.

8. Sample Size for the Training Set

This is not applicable as the device is not an AI or machine learning model that requires a training set.

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

This is not applicable as the device is not an AI or machine learning model.

Summary Explanation:

This 510(k) submission (K112196) is for modifications to an already cleared medical device (OCTO™ Port, predicate K100045). The purpose of the submission is to demonstrate "substantial equivalence" of the modified device to the predicate. This means showing that the changes (e.g., color, thickness, gas valve addition/relocation) do not fundamentally alter the device's safety, effectiveness, indications for use, or technological characteristics.

Instead of presenting detailed acceptance criteria and performance data for a novel device, the submission asserts that:

• The modified system has the "same intended use and fundamental scientific technology" as the previously-cleared system.
• "Performance testing (Bench)" was conducted to include a list of various physical and mechanical tests (e.g., pressure leak, tensile strength, instrument insertion/removal). However, no specific acceptance criteria or quantitative performance results for these tests are provided in this summary. The implication is that the device passed these tests and met internal specifications consistent with its intended use and comparison to the predicate.
• "No additional animal testing was performed" because the mechanism and materials are "identical and consistent with the previously submitted models."
• "No additional biocompatibility testing was performed" for the same reason.

In essence, the "study" proving the device meets criteria is a battery of specified bench tests, but the specific quantifiable passing criteria and detailed results are not included in this high-level summary. The FDA's clearance (SEP 14 2011) indicates that they were satisfied with the provided information, which presumably included detailed test reports that are not part of this public summary.

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The OCTO™ is intended for use as a multiple instrument and/or camera port during minimally invasive abdominal laparoscopic surgery.

The OCTOTM is a sterile, disposable laparoscopic instrument port which retracts a small abdominal incision to allow multiple laparoscopic instruments to pass through to the abdomen .

The provided text describes the 510(k) submission for the OCTO™ laparoscopic accessory, focusing on its substantial equivalence to a predicate device. The information presented is primarily about performance testing related to the device's mechanical functionality and surgical utility, rather than AI-driven diagnostic or prognostic capabilities. Therefore, many of the requested categories related to AI performance metrics (e.g., expert consensus, MRMC studies, training set details) are not applicable to this document.

Here's an analysis of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Bench Testing: No specific sample sizes are mentioned for the bench tests. The data provenance is implied to be laboratory testing.
• Animal Testing: No specific sample size (number of animals) is mentioned for the animal tests. The data provenance is animal studies.
• Retrospective/Prospective: Not applicable, as this is primarily a device performance evaluation, not a clinical study on human data.

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

• Not applicable. The tests described are physical and mechanical performance tests, and animal studies, not expert-based diagnostic evaluations.

4. Adjudication Method for the Test Set

• Not applicable. Adjudication methods are typically relevant for human-read interpretations or clinical outcomes, not for mechanical device performance.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of AI Improvement

• No. This is a submission for a laparoscopic accessory, not an AI-driven diagnostic device. Therefore, no MRMC study or AI improvement statistics are relevant or provided.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done

• Not applicable. This device does not involve an algorithm.

7. The Type of Ground Truth Used

• Bench Testing: Ground truth is based on engineering specifications, physical measurements, and comparison to predicate device performance (e.g., measured leak rates, forces, dimensions).
• Animal Testing: Ground truth is based on direct observation of the device's functionality during animal surgical procedures by the testing personnel.

8. The Sample Size for the Training Set

• Not applicable. There is no "training set" as this is not an AI/machine learning device.

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

• Not applicable. There is no training set.

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The Medtronic Octopus TE Stabilizer is used to stabilize the epicardial surface of the non-arrested heart during coronary artery surgery. It is intended to be used by trained medical professionals in operating room environments.
The Stabilizer is intended to stabilize the epicardial surface of the nonarrested heart during coronary artery surgery. It is intended to be used only by medical professionals in operating room environments.

The non-sterile, reusable Medtronic Octopus TE Heart Stabilizing System is a suction-based tissue stabilizer with a collapsible pod assembly, a rigid shaft and 5 articulating links designed to enable transfer into the thoracic cavity via a 12 mm thoracic port or traditional sternotomy access. It is comprised of four distinct elements: (1) the Medtronic Octopus TE Tissue Stabilizer, (2) the Medtronic Octopus TE Suction Lines, (3) the Medtronic Octopus TE Vacuum Lines, and (4) the Medtronic Octopus TE Irrigator (optional).
The Medtronic Octopus TE Heart Stabilizer is secured to a flexible arm and universal mounting rail, which attached to the operating table rail. Vacuum is delivered to the pod assembly by a disposable suction line inserted through the shaft of the stabilizer and a disposable vacuum line that connects the stabilizer to the vacuum source. The accessories are sold separately.

The provided text is a 510(k) summary for the Medtronic Octopus® TE Stabilizer & Accessories, which is a cardiovascular surgical instrument. It outlines the device's description, intended use, and substantial equivalence to predicate devices. However, the document does not contain information about specific acceptance criteria or a study proving the device meets those criteria, as it would apply to a diagnostic or AI-driven medical device.

This 510(k) pertains to a physical surgical instrument, not a device that generates data or requires performance metrics like sensitivity, specificity, or accuracy. The assessment of such a device focuses on "substantial equivalence" to legally marketed predicate devices in terms of design, materials, manufacturing processes, and intended use, rather than a clinical performance study with statistical endpoints.

Therefore, most of the requested information (acceptance criteria, device performance table, sample sizes, data provenance, expert qualifications, adjudication, MRMC study, standalone performance, ground truth types and establishment) is not applicable to this type of regulatory submission and is not present in the provided text.

Here's a breakdown of why the information is not present based on the nature of the device:

• 1. A table of acceptance criteria and the reported device performance: Not applicable. Performance for a surgical instrument is assessed through comparisons of its technological characteristics (e.g., design, materials, principle of operation) to predicate devices, and potentially through bench testing for safety and functional specifications, not a performance table against clinical acceptance criteria as would be seen for a diagnostic or AI device.
• 2. Sample sized used for the test set and the data provenance: Not applicable. There is no "test set" in the context of clinical performance data for this type of surgical instrument in this document.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth or expert review process of clinical data is described in this 510(k) summary for the device's performance.
• 4. Adjudication method for the test set: Not applicable.
• 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. This is not an AI-assisted diagnostic device.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm-based device.
• 7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable.
• 8. The sample size for the training set: Not applicable. This is not a machine learning device.
• 9. How the ground truth for the training set was established: Not applicable.

Summary of Relevant Information from the Document:

• Device Type: Cardiovascular Surgical Instrument/Heart Stabilizer.
• Regulatory Pathway: 510(k) Premarket Notification, indicating substantial equivalence to predicate devices.
• Predicate Devices: Medtronic Octopus Tissue Stabilizer (K964445) and the CTS (Guidant) Vacuum Assist Stabilizer (K992833).
• Basis of Equivalence: Patient population, intended use, function, basic system components, device design, and principal of operation were found to be substantially equivalent to the predicate devices.
• Study Described: The document refers to "Comparisons between the new and predicate devices shows that technological characteristics (i.e. device design and principal of operation) are substantially equivalent." This implies an engineering and design comparison rather than a clinical study with performance metrics in the typical sense.

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The indications or intended use for the DLP Octopus™ Tissue Stabilizer and the predicate product, Cardiothoracic Systems, Inc. (CTS) Thoracic Access Platform and Stabilizer are the same. Both are intended for use du ring coronary artery bypass grafting to isolate diseased artery and minimize motion of the beating heart to facilitate the grafting procedure.

The design of the Octopus"" is similar to both predicate products referenced in the Comparison Information Section. It features plastic handle with vacuum tubing connection, malleable stainless steel arm and suction tip similar to the DLP Cardiac Suction Tube product. The "feet" design of the Octopus" is intended to position the anastomosis site between two "feet" for isolation and stabilization control which is the same as the CTS Thoracic Access Platform and Stabilizer.

This document is a 510(k) summary for a medical device (Octopus™ Tissue Stabilizer) and does not contain information about acceptance criteria or a study proving device performance in the way a clinical trial or AI/ML study would. It's a regulatory document demonstrating substantial equivalence to a predicate device.

Therefore, most of the requested information cannot be extracted from this text.

Here's how I can address the parts that are relevant to this type of document:

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

This document does not specify quantitative acceptance criteria or report performance metrics in the way a clinical study would (e.g., sensitivity, specificity, accuracy). Instead, it focuses on demonstrating substantial equivalence to existing predicate devices.

The "acceptance criteria" in this context are implicitly related to the regulatory requirements for showing that the new device is as safe and effective as the predicate device.

Reported Device Performance (Implicit from the document):

The rest of the requested information (sample size, data provenance, number of experts, adjudication method, MRMC study, standalone performance, type of ground truth, training set size, training set ground truth) is not applicable to this 510(k) summary document, as it describes a mechanical device for surgical use and not an AI/ML algorithm or a study involving human readers and a test set. This document relies on comparisons to predicate devices and biocompatibility testing, not on clinical performance metrics in the sense of accuracy, sensitivity, etc., that would require a ground truth or expert evaluation.

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