(192 days)
The HLM Tubing Sets with Bioline Coating are designed to be used in extracorporeal circulation during cardiopulmonary bypass procedures lasting six hours or less.
The HLM Tubing Sets with Bioline Coating are for single use only. They may be sold sterile, non-sterile, and bulk packed. Tubing sets that are sold sterile are not to be re-sterilized by the user. In open heart surgery the HLM Tubing Sets with Bioline Coating are used in combination with the heart-lung machine for the oxygenation of blood and removal of carbon dioxide. The main purpose of the HLM Tubing Sets with Bioline Coating is to connect the patient to the heart-lung machine and it's components. The HLM Tubing Sets with Bioline Coating are therefore a component in the extracorporeal perfusion circulation system. The utilization period of the use of the tubing sets is restricted to six hours. The Bioline Coating improves the physical surface properties of products for the extracorporeal circulation system.
This document is a 510(k) summary for a medical device called "HLM Tubing Sets with Bioline Coating." It focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria for a novel device. Therefore, many of the requested categories for a study proving device meets acceptance criteria are not directly applicable or explicitly detailed in this type of submission.
Here's an analysis based on the provided text:
Acceptance Criteria and Reported Device Performance
The submission states that "Evaluation on safety and effectiveness was executed to demonstrate that the HLM-Tubing Set with Bioline Coating described in this submission is substantially equivalent to the Jostra HLM-Tubing Set as a custom tubing pack and to the Quadrox D Diffusion Membrane Oxygenator with Bioline Coating with regards to the Bioline Coating."
The areas evaluated were: Integrity, Performance, Biocompatibility, and Sterility.
The document does not provide a specific table of numerical acceptance criteria or detailed reported performance values. Instead, it concludes that the device is "substantially equivalent" to predicate devices, implying it meets the same implicit performance and safety standards as those already cleared.
| Acceptance Criteria Category | Reported Device Performance (Summary) |
|---|---|
| Integrity | Deemed substantially equivalent to predicate devices. |
| Performance | Deemed substantially equivalent to predicate devices. |
| Biocompatibility | Deemed substantially equivalent to predicate devices. |
| Sterility | Deemed substantially equivalent to predicate devices. |
| Intended Use | Same as predicate devices: for oxygenation of blood and removal of carbon dioxide in open heart surgery with a heart-lung machine; utilization period restricted to six hours. |
| Design/Principles of Operation | Same as uncoated Jostra HLM Tubing Set; only difference is the Bioline Coating application. |
Missing Information: Numerical performance metrics, specific pass/fail thresholds, and detailed results of the evaluations are not included in this summary.
Study Details
Given this is a 510(k) summary for substantial equivalence, a traditional "study" in the sense of a large-scale clinical trial with specific acceptance criteria and detailed statistical analysis is not typically presented in this format. The evaluations are likely bench tests and material science assessments.
- Sample size used for the test set and the data provenance: Not specified in the summary. The studies would likely involve multiple tubing sets and connectors for integrity, performance (e.g., flow rates, pressure resistance), biocompatibility (e.g., in vitro or in vivo tests), and sterility tests. Data provenance is not mentioned, but given the manufacturer is in Germany, a portion of the testing might have occurred in Germany.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. For this type of device and submission, ground truth would be established by scientific and engineering standards (e.g., ISO, ASTM, internal specifications) for material properties and device function, rather than expert consensus on diagnostic imaging.
- Adjudication method for the test set: Not applicable. Adjudication methods like 2+1 or 3+1 are used in studies involving human interpretation (e.g., medical imaging). For device integrity and performance, results are typically determined by measurement against predefined specifications.
- 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 device is not an AI-powered diagnostic tool, so MRMC studies or AI assistance are irrelevant.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical device (tubing set), not an algorithm or software.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Ground truth for this device would be based on established engineering principles, material science specifications, validated test methods (e.g., for biocompatibility and sterility), and performance standards relevant to cardiopulmonary bypass equipment. For example, sterility would be confirmed by validated sterilization processes and sterility testing, biocompatibility by cytotoxicity, sensitization, and irritation tests according to ISO 10993.
- The sample size for the training set: Not applicable. This is a physical device, not an AI model requiring a training set.
- How the ground truth for the training set was established: Not applicable.
Conclusion from the document:
The submission concludes that "The data given demonstrate that the HLM-Tubing Set with Bioline Coating is substantially equivalent to the named predicate devices which hold currently market clearance." This means the conducted evaluations confirmed that the modified device (with Bioline coating) performs as safely and effectively as the existing, legally marketed predicate devices, with no new questions of safety or effectiveness raised.
§ 870.4390 Cardiopulmonary bypass pump tubing.
(a)
Identification. A cardiopulmonary bypass pump tubing is polymeric tubing which is used in the blood pump head and which is cyclically compressed by the pump to cause the blood to flow through the cardiopulmonary bypass circuit.(b)
Classification. Class II (performance standards).