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The Gas Filter is intended to remove particulate matter from medical gases flowing into the cardiopulmonary bypass circuit for periods up to 6 hours.

The proposed gas filter and the Gish filter are each made of materials that are commonly used in cardiopulmonary bypass devices and circuits. The Gish filter is made of ABS, and Versapor (Acrylic); the proposed devices are made of hydrophobic laminated glass media, Versapor (Acrylic) and polypropylene.

Here's an analysis of the provided 510(k) submission for the Gas Filter, focusing on acceptance criteria and supporting studies:

1. Acceptance Criteria and Reported Device Performance

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

The provided document does not specify a distinct "test set" in the context of typical AI/ML device testing. Instead, it relies on:

• Manufacturer Certification for Filtration Efficiency: The 99.98% efficiency for 0.3 µm particles is stated to be a "certification from original manufacturer." This implies no new testing was performed for this 510(k) submission. Therefore, details on sample size, "test set," or data provenance (country of origin, retrospective/prospective) are not applicable or provided in this document directly related to the filtration efficiency claim. It's likely based on the predicate device's performance data.
• Validation for Sterility and EO Residuals: These are standard regulatory tests. While they involve samples, the specific 'test set' sample sizes and data provenance are not detailed in this summary. These would typically be part of a separate validation report.

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

This document does not describe the use of experts to establish a "ground truth" for a test set, as this is a mechanical filtration device, not an AI/ML diagnostic system. The performance claims are based on direct physical measurements or established manufacturing certifications.

4. Adjudication Method for the Test Set

Not applicable, as there's no "ground truth" established by experts in this context.

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

No MRMC study was conducted or described. This type of study is typically relevant for interpretative AI/ML devices where human reader performance is a key metric. This device is a passive mechanical filter.

6. Standalone (Algorithm Only) Performance Study

No standalone algorithmic performance study was conducted. This device is not an algorithm, but a physical component. The "performance" refers to its mechanical capabilities.

7. Type of Ground Truth Used

The 'ground truth' for the performance metrics is:

• Filtration Efficiency: Manufacturer certification, which would have been based on established standardized test methods using calibrated particle counters and known particle sizes (e.g., using a test aerosol).
• Sterility: Achieved through validated sterilization cycles (e.g., bioburden testing, sterility testing after terminal sterilization), adhering to AAMI guidelines.
• Ethylene Oxide Residuals: Measured through analytical chemistry methods to ensure levels are below regulatory limits.

8. Sample Size for the Training Set

Not applicable. 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.

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The chest drainage tubing is intended to serve as a conduit for the flow of body fluids that are removed from the patient, via vacuum, and delivered to a reservoir during cardiopulmonary bypass procedures.

The chest drainage tube is piece of flexible polyvinylchloride tubing that is used as a conduit for body fluids suctioned from the chest cavity and moved into a reservoir following cardiopulmonary bypass procedures. The tubing is a 40 durometer tube with an inside diameter of 0.375" and an outside diameter of 0.562".

The provided text describes a 510(k) submission for "Chest Drainage Tubing" and establishes its substantial equivalence to a predicate device. This type of submission relies on demonstrating similarity to an already cleared device, rather than conducting new clinical trials with acceptance criteria based on performance metrics like sensitivity or specificity.

Therefore, many of the requested points regarding acceptance criteria, study design, and ground truth are not applicable in this context. The "acceptance criteria" here are that the new device is "substantially equivalent" to the predicate device in terms of intended use, design, technology/principle of operation, materials, and performance, and that it raises no new issues of safety and effectiveness.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Study Proving Device Meets Acceptance Criteria:

The "study" here is not a typical clinical trial but rather a demonstration of substantial equivalence through comparison to a predicate device.

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

Not applicable. There is no "test set" in the traditional sense of a clinical or analytical performance study with a specific number of samples. The demonstration of equivalence relies on comparing the device's characteristics and performance to those of a predicate device.

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

Not applicable. Ground truth, in the sense of expert consensus on diagnostic accuracy or clinical outcomes, is not established for this type of 510(k) submission. The "truth" is established by showing that the characteristics of the new device are sufficiently similar to a legally marketed predicate device.

4. Adjudication Method for the Test Set

Not applicable. There is no adjudication method described as there isn't a test set requiring adjudication of findings.

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, and no MRMC study was conducted.

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

Not applicable. This is not an algorithmic device.

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

The "ground truth" for this submission is established by the known characteristics, safety, and effectiveness of the predicate device (Gish Biomedical Tubing, K870792). The new device is compared against this established benchmark.

8. The sample size for the training set

Not applicable. There is no training set mentioned, as this is not a 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 Adapters are intended to be used to interconnect tubing and other devices during cardiopulmonary bypass procedures.

The adapters are used in connecting oxygenators, reservoirs, filters, tubing, and other cardiopulmonary bypass components into circuits used in surgical procedures requiring extracorporeal support.

The adapters are of the following generic types: straight adapters with or without luer locking mechanisms (male and female), large bore adapters, three-way connectors, and four-way connectors.

The materials used in the manufacturing of these adapters includes polycarbonate, acrylic, and Acrylonitrile-Butadiene-Styrene (ABS). The cleared Medtronics adapters are comprised of plexiglas and Note: polyvinyIchloride.

The provided text describes a 510(k) submission for medical device adapters, focusing on demonstrating substantial equivalence to previously cleared devices rather than a typical performance study with acceptance criteria and reported metrics for a new, innovative device.

Therefore, the requested information elements (1-9) which typically relate to a performance study for a novel device, are not directly applicable or available in this document.

Instead, the document highlights:

• Intended Use: The adapters are intended to be used to interconnect tubing and other devices during cardiopulmonary bypass procedures.
• Device Description: Various generic types of adapters (straight, large bore, three-way, four-way) made from polycarbonate, acrylic, and ABS.
• Substantial Equivalence Claim: The adapters are substantially equivalent in intended use, design, technology, principles of operation, materials, and performance to the cleared Medtronics "Y" adapter (K790563) and Medtronics 3/16″ Large Bore Male adapter (K830728).
• Validation of Safety Aspects:
  • Sterilization conditions validated according to AAMI guidelines to achieve a Sterility Assurance Level (SAL) of 10-6.
  • Ethylene oxide residuals will not exceed maximum limits.
  • Blood contacting materials tested for biocompatibility according to FDA General Program Memorandum #G95-1 (ISO-10993 Part 1) for External Communicating Devices, Circulating Blood, Limited Exposure (≤ 24 hours).
  • Expiration dating controlled by the shortest expiry component in a kit or two years, whichever is shorter.

The core of this submission is the argument that differences in design and materials raise no new issues of safety and effectiveness, and that the performance is substantially equivalent to the predicate devices. There is no independent performance study described with specific acceptance criteria in terms of clinical metrics (e.g., accuracy, sensitivity, specificity) for this type of component.

To directly answer your numbered points:

1. A table of acceptance criteria and the reported device performance: Not applicable. The "acceptance criteria" here are demonstrating substantial equivalence and meeting safety standards (sterilization, biocompatibility, residuals), not achieving specific performance metrics in a clinical trial. The "reported device performance" is essentially that it performs equivalently to the predicate devices and meets safety standards.

   • Acceptance Criteria for Substantial Equivalence:
     • Intended use is the same as the predicate device.
     • Technological characteristics are the same as the predicate device, OR technological characteristics are different but do not raise new questions of safety and effectiveness, AND the device is as safe and effective as the predicate device.
   • Reported Device Performance (based on 510(k) claim):
     • Performance is "substantially equivalent" to Medtronics adapters.
     • Sterilization: SAL of 10-6 achieved.
     • Ethylene oxide residuals: Will not exceed maximum limits.
     • Biocompatibility: Blood contacting materials found to be biocompatible per ISO-10993.
     • Expiration dating: Controlled by shortest expiry component or two years.

2. Sample sized used for the test set and the data provenance: Not applicable. No test set for performance comparison in the traditional sense is described. The "testing" refers to safety validations (sterilization, biocompatibility).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This type of submission relies on established safety guidelines and direct comparison to predicate devices, not expert-adjudicated ground truth for a test set.

4. Adjudication method: 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 document is not about AI assistance or human reader performance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical device (adapters), not an algorithm.

7. The type of ground truth used: For safety aspects, the ground truth is established by recognized standards (AAMI, FDA GPM #G95-1, Federal Register regulations) for sterilization, residuals, and biocompatibility. For "performance," the ground truth is the established performance of the predicate devices.

8. The sample size for the training set: Not applicable. No training set for an algorithm is involved.

9. How the ground truth for the training set was established: Not applicable.

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