Search Results

The SealGuard Evac Endotracheal tube is indicated for airway management by oral/nasal intubation of the trachea, and for evacuation or drainage of the subglottic space.

The SealGuard Endotracheal tube is a device inserted into a patient's trachea via the nose or mouth to maintain an open airway.

The SealGuard™ and the SealGuard™ Oral Evac Tracheal Tubes are sterile, single-use devices supplied with a standard 15mm connector. On the Evac tubes, in addition to the main lumen, the tube has a separate Evac lumen which has a dorsal opening above the cuff. Access to the lumen is accomplished via a clear connecting tube with a capped Luer connector. The tube features a unique ultra thin high volume low pressure cuff and self sealing valve with attached pilot balloon. The unique cuff material of the SealGuard products ideally gives an improved sealing performance over historical PVC cuffed product. The tube incorporates a Magill curve, a hooded tip with Murphy Eye and a Tip-To-Tip™ radiopaque line to assist in radiographic visualization.

This document is a 510(k) summary for the SealGuard Endotracheal Tube and SealGuard Evac Endotracheal Tubes. It primarily focuses on demonstrating substantial equivalence to predicate devices and does not contain detailed information about a study proving the device meets specific acceptance criteria in the way one might expect for a novel AI/software medical device.

Therefore, many of the requested sections (sample size, experts, adjudication, MRMC, standalone performance, ground truth establishment, training set size) are not applicable or cannot be extracted from the provided text, as the submission is for a physical medical device (endotracheal tube) and its performance is typically evaluated through bench testing and clinical equivalence, not machine learning model evaluation.

Here's an analysis based on the provided text, addressing the applicable points and noting where information is not present:

Acceptance Criteria and Device Performance Study

The document does not explicitly present a table of "acceptance criteria" with quantitative metrics for performance and corresponding study results in the context of a software or AI device. Instead, the submission for this physical device focuses on demonstrating substantial equivalence to existing predicate devices (Hi-Lo Cuffed Tracheal Tube K871204 and Hi-Lo Evac Endotracheal Tubes K965132). This means the "acceptance criteria" are implicitly met by demonstrating that the new device is as safe and effective as the predicate device(s) for the stated indications for use.

The primary differences between the proposed and predicate devices are:

• Cuff material: PU (polyurethane) for SealGuard vs. PVC (polyvinylchloride) for predicate.
• Cuff shape: Tapered for SealGuard vs. barrel shape for predicate.

The study that "proves" the device meets the acceptance criteria (i.e., is substantially equivalent) would typically involve a combination of:

• Bench testing: To compare physical characteristics, sealing ability, and other performance metrics against the predicate devices.
• Biocompatibility testing: To ensure the new cuff material is safe.
• Design verification and validation: To confirm the device consistently performs as intended.

However, the provided text does not include the details of these studies or their specific results, nor does it list quantitative acceptance criteria. It only states that the device "maintain the same intended use as the predicate device" and "consist of the same fundamental technology." The FDA's letter confirms substantial equivalence based on the submitted information.

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

• Acceptance Criteria: Not explicitly stated in a quantitative table format within the provided text. The overall acceptance criterion is "substantial equivalence" to the predicate devices. This implies meeting the same safety and effectiveness standards, likely through performance testing related to sealing, material properties, and functionality consistent with an endotracheal tube.
• Reported Device Performance: Not detailed in a quantitative table within the provided text. The document describes the device's features (e.g., "unique ultra thin high volume low pressure cuff," "improved sealing performance over historical PVC cuffed product") but does not provide specific performance data or a direct comparison to predicate device data.

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 applicable/not provided as the submission is not for an AI/software device that typically utilizes "test sets" of data for performance evaluation. The "study" mentioned is likely a set of engineering tests and possibly small-scale clinical equivalence evaluations (though not detailed here) for a physical medical device.

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 applicable/not provided. Ground truth in the context of AI/software refers to the expert-labeled data used to evaluate algorithm performance. For a physical device, performance is typically assessed through direct measurement, mechanical testing, and observation, often against established standards or predicate device performance, rather than expert-labeled "ground truth."

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

This information is not applicable/not provided. Adjudication methods are relevant for resolving discrepancies in expert labeling for ground truth in AI studies.

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

This information is not applicable/not provided. An MRMC study is specific to evaluating diagnostic performance with and without AI assistance for tasks involving human interpretation of medical images or data. This is not relevant to an endotracheal tube.

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

This information is not applicable/not provided. "Standalone performance" refers to the performance of an algorithm without human intervention, which is not relevant for a physical medical device like an endotracheal tube.

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

This information is not applicable/not provided. For a physical medical device, "ground truth" relates more to whether the device physically functions as intended and meets specifications (e.g., does the cuff inflate and seal effectively? Is the material biocompatible?). This is confirmed through engineering tests and material analysis rather than establishing "ground truth" from experts or pathology in the AI sense.

8. The sample size for the training set

This information is not applicable/not provided. A "training set" is used to develop and train machine learning models, which is irrelevant for this physical medical device submission.

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

This information is not applicable/not provided for the same reasons as point 8.

Ask a specific question about this device

The Mallinckrodt Inc. Shiley TracheoSoft XLT Extended Length Tracheostomy Tube and Disposable Inner Cannula are intended to be placed into a surgical opening of the trachea to provide tracheal access for airway management. The device is intended to be a component of a life-sustaining device to be used with adult patients.

The Shiley TracheoSoft XLT Extended Length Tracheostomy Tube and Disposable Inner Cannula includes an extended length outer cannula, extended length disposable inner cannula, tracheostomy tube holder, neck strap, and obturator. The device is used to provide an artificial airway, in order to provide access to the patient's airway for airway management. The device is introduced into a tracheotomy incision in the patient's neck that provides access to the trachea. The tracheostomy tube is secured by means of the swivel neck plate/flange that is connected to a tracheostomy tube holder or neck strap. When appropriately connected to a tracheostomy tube holder or neck strap, the device provides a secure artificial airway for spontaneous or mechanical ventilation.

This 510(k) summary describes a Special 510(k) submission for the Shiley TracheoSoft XLT Extended Length Tracheostomy Tube and Disposable Inner Cannula. A Special 510(k) can be submitted when modifications to a legally marketed device do not require a new clinical study to demonstrate substantial equivalence. Instead, the submission relies on design control activities and verification testing to show that the modified device remains safe and effective for its intended use, similar to the predicate device.

Given that this is a Special 510(k) and the provided text focuses on the substantial equivalence to a predicate device based on design, materials, and technical characteristics, it does not contain the detailed study information typically found for devices requiring performance testing against acceptance criteria in a standalone study or a comparative clinical effectiveness study. The submission essentially states that the new device meets the same performance as the predicate due to similar design and materials, and that verification testing confirmed these aspects.

Therefore, the requested information elements related to specific performance studies, expert involvement, and ground truth establishment, as typically applied to novel devices or those undergoing significant functional changes, are not explicitly provided in this document.

Here's a breakdown of the available information based on your request:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly provide a table of acceptance criteria with corresponding performance metrics for the Shiley TracheoSoft XLT Extended Length Tracheostomy Tube and Disposable Inner Cannula. Instead, it states that:

• "Product design and development, (including verification testing, test and quality procedures) were conducted using internal company requirements, referencing external standards."
• "Information provided in this Special 510(k) submission provides comparative, predicate device information and describes development procedures that support the determination of substantial equivalence and assertion that the modified device is safe and effective for its intended use."

This implies that the device's performance was evaluated against internal design specifications and relevant standards, and found to be comparable to the predicate device. However, the specific quantitative acceptance criteria and results are not detailed in this summary.

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

The document does not mention a specific "test set" in the context of clinical data or a formal study with statistical sample sizes. The evaluation relies on "verification testing," which typically involves engineering and bench testing, rather than human subject testing in the sense of a clinical trial. Therefore, information about data provenance (e.g., country of origin, retrospective/prospective) for a test set is not applicable here.

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

Not applicable. The submission focuses on device modifications and verification testing, not on a diagnostic or interpretive task that would require expert-established ground truth.

4. Adjudication Method for the Test Set:

Not applicable for the same reasons as above.

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

No MRMC study was done. This type of study is typically performed for imaging or diagnostic AI devices to assess the impact of AI assistance on human reader performance. This device is a medical accessory, not an AI-powered diagnostic tool.

6. Standalone (Algorithm Only) Performance Study:

No standalone performance study of an algorithm was done. This device does not inherently contain an algorithm.

7. Type of Ground Truth Used:

The "ground truth" for this type of device is established through engineering principles, material science, and conformance to recognized standards for medical devices of this class. It would involve demonstrating physical properties, biocompatibility, and functional integrity through various tests (e.g., tensile strength, flexibility, dimensions, leakage) to ensure it performs as intended and is safe. It is not based on expert consensus, pathology, or outcomes data in the way a diagnostic device would be.

8. Sample Size for the Training Set:

Not applicable. This device does not involve machine learning or a "training set" in the context of AI.

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

Not applicable due to the absence of a training set for an AI algorithm.

Ask a specific question about this device

This closed suction catheter system is indicated for patients with an endotracheal tube or tracheostomy tube to suction tracheobronchial secretions. This device is indicated for single patient use only. The suction catheter should be replaced after 24 hours.

Not Found

This document is a marketing clearance letter from the FDA for the "Hi-Care Closed Suction System." It states that the device is substantially equivalent to legally marketed predicate devices. However, this letter does not contain any information about acceptance criteria, device performance, study details, or ground truth establishment.

Therefore, I cannot provide the requested information. The provided text is a regulatory approval document, not a clinical study report or a performance evaluation.

Ask a specific question about this device

To provide tracheal access for airway management.

These devices are used to provide an artificial airway, in order to assist in the treatment of a variety of respiratory diseases and airway management in adults. After insertion in place through a tracheotomy incision in the patient's neck and trachea, the devices are then secured in place with a tiestrap around the patient's neck, which is attached to the tracheostomy tube's swivel neck plate/flange. Once in place, these devices provide a secure artificial airway for spontaneous breathing or direct hook-up to ventilation or anesthesia equipment.

This document describes the 510(k) submission for the Shiley Extended Length, Disposable Cannula, Tracheostomy Tube. The device is intended to provide an artificial airway for adults.

Here's an analysis of the acceptance criteria and study data provided:

1. Table of Acceptance Criteria and Reported Device Performance

Summary of Device Performance against Acceptance Criteria:

• For tests with no specified CEN standard requirement, the device performance is reported without a direct "pass/fail" criterion. However, the performance is presented to demonstrate its physical integrity and generally favorable or comparable results to predicate devices.
• For the "Neck Plate to Trach Tube Body Attachment Strength" test, the modified device's performance (27.7 lbs force) exceeds the specified minimum CEN standard requirement (11.3 lbs force), thus meeting this acceptance criterion.

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

• Sample Size: The document does not explicitly state the sample size used for each "in-vitro performance data" test. It provides single values for "Modified Device Test Results" and "Predicate Device Test Results," implying these are representative or average values from testing, but the number of units tested is not specified.
• Data Provenance: The data is generated from in-vitro performance testing, meaning it was conducted in a laboratory setting. There is no information regarding country of origin of the data provided, nor whether it's retrospective or prospective, as it's not clinical data.

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

• Not Applicable: This study relies on in-vitro performance data for medical device mechanical properties, not expert-derived "ground truth" observations from cases (e.g., image interpretation). Therefore, no human experts were involved in establishing ground truth for the test set in the conventional sense of clinical or diagnostic studies.

4. Adjudication Method for the Test Set

• Not Applicable: As stated above, this is an in-vitro performance study focusing on physical integrity, not a study involving human interpretation or clinical adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• No, an MRMC comparative effectiveness study was not done. The study explicitly states: "Clinical data was not necessary, since device performance can be adequately assessed by in-vitro testing." Therefore, there is no effect size reported for human readers with or without AI assistance.

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

• Not Applicable: This is a study on a physical medical device (tracheostomy tube), not an algorithm or AI system. Therefore, the concept of "standalone performance" for an algorithm doesn't apply here.

7. The Type of Ground Truth Used

• The "ground truth" for this study is based on objective measurements of physical and mechanical properties of the device (e.g., force, strength) in a laboratory setting, compared against established engineering standards (CEN Standard Requirements where applicable) or direct comparison to predicate device performance. It is an objective, quantifiable measurement of the device's physical integrity and functional parameters.

8. The Sample Size for the Training Set

• Not Applicable: This document describes a 510(k) submission for a physical medical device and its in-vitro performance. It does not involve machine learning or AI, and therefore there is no concept of a "training set" in this context.

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

• Not Applicable: As explained above, there is no training set for this type of device submission.

Ask a specific question about this device

This device is used to provide annartificial airway inforder torassist in commen the treatment of a variety of respiratory diseases and airway management for adult patients.
The device is to be used by the order of a nhysician.
The device is primarily intended for use in conjunction with Percutaneous Dilational (or Dilatational) Tracheotomy and is inserted into the natient using the Introducer provided with the Percutaneous Dilational Kit.
The device is intended to be used as the initial artificial airway immediately post tracheotomy.
There is no "new" intended theraneutic use of this device to existing devices marketed.

The device includes an Outer Cannula with a Cuff. The Cuff is deflated or inflated via an Inflation System comprised of tubing communicating between the Cuff and a Luer Valve to which a syringe can be attached. A Pilot Balloon is adjacent to the Luer Valve to indicate the inflation status of the Cuff. A Neck Plate is attached to the Outer Cannula. An Inner Cannula is included with an integral 15mm male conical connector. The Inner and Outer Cannula are attached together by a snap-lock mechanism. The Outer Cannula distal end is designed to have smooth transitions in outer diameter in order to minimize the amount of resistance that would occur with abrupt transitions.

The provided document describes the K963732 submission for the Shiley Percutaneous Dual Cannula Tracheostomy Tube. It details the device, its intended use, and its similarities and differences to predicate devices, but it does not contain a study with detailed acceptance criteria and reported device performance as requested.

Instead, the submission states:

• Non-Clinical Tests: "Physical integrity of the Cuff-to-Cannula bond strength of the new PERC device will be demonstrated to be equivalent to the predicate DCT device. Insertion force of the new PERC device will be less than that of the predicate DCT device. This data will be available from the manufacturer upon request." This indicates that these tests were planned or conducted, but the results and specific acceptance criteria are not included in the provided text.
• Clinical Tests: "It is not required to conduct clinical tests on the new PERC product due to its similarity to the predicate DCT product and other competitor's predicate products."

Therefore, based only on the provided text, I cannot complete the requested tables and sections with the specific details about acceptance criteria, reported performance, sample sizes, expert qualifications, adjudication methods, or multi-reader multi-case studies because this information is not present in the given document.

The document focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study report for the new device.

Ask a specific question about this device

Not Found

Not Found

The provided text describes a medical device, the COPA™ (Cuffed Oropharyngeal Airway), and a series of studies evaluating its performance. The text discusses preliminary feasibility studies, design modifications, functional (bench) testing, and several clinical studies.

It's important to note that this document is a summary and lacks specific acceptance criteria in a formal, quantitative manner that would be typical for a device's regulatory approval against pre-defined performance goals. Instead, the "acceptance criteria" are implied by the comparative nature of the studies against predicate devices (LMA, face mask/Guedel airway) and the general assessment of safety and effectiveness.

Given the information, here's an attempt to structure the response as requested, interpreting implied acceptance criteria from the study goals and findings:

1. Table of Implied Acceptance Criteria and Reported Device Performance

Ask a specific question about this device

Ask a specific question about this device

Ask a specific question about this device

The intended use of the modified devices with continue to be provision of tracheal access for airway management in adults.

These devices are used to provide an artificial airway, in order to assist in the treatment of a variety of respiratory diseases and airway management in adults. After insertion in place through a tracheotomy incision in the patient's neck and trachea, the devices are then secured in place with a tiestrap around the patient's neck. which is attached to the tracheostomy tube's swivel neck plate/flange. Once in place, these devices provide a secure artificial airway for spontaneous breathing or direct hook-up to ventilation or anesthesia equipment.

Each device described in this present notification will be essentially identical to an existing Shiley Tracheostomy Tube. The only modification to each of these nine marketed devices will be replacement of the current stiff swivel neck plate/flange with a soft, contoured swivel neck plate/flange to facilitate conformity to individual neck anatomies and, thus. improve patient comfort.

This report describes the acceptance criteria and the study that proves the enhanced Shiley Tracheostomy Tubes meet the acceptance criteria.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the sample sizes used for the in-vitro performance tests. The data provenance is also not specified, though it can be inferred that the testing was conducted internally by the manufacturer, Mallinckrodt Medical, Inc., as part of their 510(k) submission. These tests are in-vitro performance data (bench testing), not clinical data from patients.

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

This section is not applicable. The "ground truth" for this device modification is based on engineering performance standards (CEN Standard Requirements) and internal testing results, not on expert consensus from clinical cases.

4. Adjudication Method for the Test Set

This section is not applicable. The "adjudication" is based on direct comparison of the modified device's performance against established engineering standards and a predicate device, not on expert review of clinical cases.

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

This is not an AI-based device, nor is it a diagnostic device that would involve human readers interpreting results. Therefore, an MRMC comparative effectiveness study was not performed and is not relevant to this submission.

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

This is not an algorithm or AI-based device. Therefore, a standalone algorithm performance study was not done and is not relevant.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The ground truth for the in-vitro performance tests is based on engineering performance standards and comparison to predicate device performance. Specifically, for the "Neck Plate to Trach Tube Body Attachment Strength," the ground truth is a "minimum 11.3 lbs force" derived from CEN Standard Requirements. For "Tie Strap Hole Strength," there was no specific ground truth requirement, but the modified device's performance was reported alongside the predicate device's performance.

8. The Sample Size for the Training Set

This section is 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

This section is not applicable, as there is no training set for this device.

Ask a specific question about this device

Ask a specific question about this device