(62 days)
The Novalung® surgical Lung Assist (sLA) Membrane Lung™ is intended to be used for extracorporeal circulation during cardiopulmonary bypass in the field of open-heart surgery. Within the indicated flow rates blood is oxygenated and carbon dioxide is removed. The utilization period of this device is restricted to six hours.
The Novalung® surgical Lung Assist (sLA) Membrane Lung™ is a sterile device for single use only and it is not intended to be resterilized by the user. The Novalung® surgical Lung Assist (sLA) Membrane Lung™ is used to deliver oxygen into the blood and remove carbon dioxide from the blood. It is intended to be used as a component in an extracorporeal circuit for patients undergoing cardiopulmonary bypass. The Novalung® surgical Lung Assist (sLA) Membrane Lung™ incorporates a solid surface hollow polymethylpentene (PMP) fiber membrane and has a 1.3 m² surface area. The Novalung® surgical Lung Assist (sLA) Membrane Lung™ has a nominal flow range from 0.5 L/min. to 4.5 L/min and is suitable for patients weighing >20kg.
The provided text describes a medical device submission (K072362) for the Novalung® surgical Lung Assist (sLA) Membrane Lung™. This is a 510(k) premarket notification for a new oxygenator device, aiming to demonstrate substantial equivalence to a predicate device.
Crucially, the provided text describes a submission for a physical medical device (an oxygenator), not a software or AI-driven diagnostic device. Therefore, many of the requested categories related to acceptance criteria for AI performance, sample sizes for AI test sets, expert ground truth, adjudication methods, MRMC studies, standalone AI performance, and AI training sets are not applicable.
Below is an attempt to answer the relevant questions based on the provided text, with explanations for the questions that are not applicable to this type of device submission.
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of acceptance criteria with corresponding performance against those criteria in a quantitative manner as would be expected for an AI/software device. Instead, it describes general performance testing and a comparison to a predicate device.
| Acceptance Criteria (Inferred from device function and comparison) | Reported Device Performance (from text) |
|---|---|
| Intended Use Equivalence: | |
| - Used for extracorporeal circulation during cardiopulmonary bypass | Intended use matches predicate: "extracorporeal circulation during cardiopulmonary bypass in the field of open-heart surgery." |
| - Oxygenation of blood | "blood is oxygenated" |
| - Carbon Dioxide removal from blood | "carbon dioxide is removed" |
| - Utilization period up to 6 hours | "utilization period of this device is restricted to six hours" |
| Functional Equivalence: | |
| - Compatible with specified flow rates | Nominal flow range: 0.5 L/min to 4.5 L/min. Suitable for patients >20kg. |
| - Physical characteristics | Incorporates a solid surface hollow polymethylpentene (PMP) fiber membrane, 1.3 m² surface area. |
| Safety & Effectiveness Equivalence: | |
| - No new issues of safety and effectiveness compared to predicate | "Comparative testing has demonstrated that these differences do not raise new issues of safety and effectiveness." |
| - Characterization by bench testing | "fully characterized by bench testing in accordance with FDA Guidance." |
| - Evaluation of potential failure modes | "A failure mode and effects analysis has been performed... Potential failure modes... have been evaluated in vitro and results are provided..." |
2. Sample size used for the test set and the data provenance
Not Applicable for this type of physical medical device. This device undergoes bench testing and in-vitro evaluation, not a "test set" with human data provenance in the context of an AI/software submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not Applicable. This device does not rely on expert-established ground truth for a test set in the way an AI/software diagnostic device would. Its performance is evaluated through physical and chemical testing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not Applicable. There is no "test set" and no human or expert adjudication involved in the evaluation of this physical medical device.
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 a physical medical device (oxygenator), not an AI diagnostic tool. MRMC studies are specific to evaluating human reader performance with and without AI assistance for tasks like medical image interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not Applicable. This is a physical medical device, not an algorithm. Therefore, "standalone" algorithm performance is not a concept relevant to its evaluation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance would be established through principles of physics, chemistry, and established clinical performance standards for oxygenators. This would involve:
- Bench Test Results: Measurements of oxygen transfer, CO2 removal, pressure drops, blood compatibility, and other physical/chemical parameters.
- Predicate Device Performance: The established performance characteristics of the "Jostra Quadrox D Safeline Diffusion Membrane Oxygenator" serve as a benchmark for substantial equivalence.
- FDA Guidance: Adherence to recognized FDA guidance for oxygenator testing.
8. The sample size for the training set
Not Applicable. This is a physical medical device, not an AI model requiring a training set.
9. How the ground truth for the training set was established
Not Applicable. As there is no AI model or training set, this question is irrelevant.
§ 870.4350 Cardiopulmonary bypass oxygenator.
(a)
Identification. A cardiopulmonary bypass oxygenator is a device used to exchange gases between blood and a gaseous environment to satisfy the gas exchange needs of a patient during open-heart surgery.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance for Cardiopulmonary Bypass Oxygenators 510(k) Submissions.”