(86 days)
The Gish Soft Venous Reservoirs with GBS™ Coating are indicated to collect systemic venous and cardiotomy return blood during cardiopulmonary bypass procedures. It is designed to operate at flow rates of one (1.0) to six (6.0) liters per minute for periods up to six (6.0) hours.
The Gish Soft Venous Reservoirs with GBS™ Coating consist of a bag with three fluid ports and two aspiration ports and are intended to prevent venous air from entering the extracorporeal circuit. The design of the Soft Venous Reservoir reduces blood stagnation and will collapse if emptied; a built in safety mechanism that minimizes accidental air delivery to the oxygenator. Each Soft Venous Reservoir contains one 12" venous inlet (blue) with integral temperature port and luer port, one 3/8" cardiotomy inlet (white), one 3/8" arterial outlet (red) and two 1/8" aspiration ports with attached 3-way stopcocks.
The components of this system which have contact with the fluid path are sterile and nonpyrogenic.
All materials of the Soft Venous Reservoirs are biocompatible and coated with a proprietary coating.
The Gish the Soft Venous Reservoirs with GBS™ Coating may be purchased separately or pre-connected with tubing and other components of an extracorporeal circuit.
The provided text describes a submission for a medical device, the "Gish Soft Venous Reservoirs SVR with GBS™ Coating," claiming substantial equivalence to a predicate device. However, it does not include specific acceptance criteria, detailed study designs, or reported device performance metrics in a way that allows for the creation of the requested table or the detailed answers to all the questions. The submission focuses on describing the device, its indications for use, and a claim of equivalence based on general "safety, performance, and validations prior to release."
Here's an attempt to answer the questions based only on the provided text, highlighting what information is missing:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not Specified | Not Specified |
| (No specific quantitative or qualitative criteria for performance are mentioned in the document.) | The document states: "Final testing for the systems includes various performance tests designed to ensure that the device meets all of its functional requirements and performance specifications." However, the results of these tests and the specific specifications they met are not provided. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified.
- Data Provenance: Not specified. (The document mentions "extensive safety, performance, and validations prior to release," but provides no details on where or how these were conducted, or whether they were retrospective or prospective).
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)
- Not applicable/Not specified. This device is a physical medical device (blood reservoir), not an AI/diagnostic software. The concept of "ground truth" as typically applied to diagnostic studies or AI algorithms does not directly apply here in the same way. The evaluation would be based on engineering specifications, biocompatibility tests, and functional performance, not expert-adjudicated diagnostic labels.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not specified. (See explanation for question 3).
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 device is a blood reservoir, not an AI or diagnostic tool that would involve human readers or an MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a physical blood reservoir, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable/Not specified. For a physical device like this, "ground truth" would relate to meeting engineering specifications, biocompatibility standards (e.g., ISO 10993), and functional performance parameters (e.g., flow rates, air removal efficiency, blood damage). The document states "extensive safety, performance, and validations" were done but does not detail the nature of these tests or how their "ground truth" (i.e., acceptable performance) was established beyond stating they meet "functional requirements and performance specifications."
8. The sample size for the training set
- Not applicable. This device is a physical blood reservoir, not a machine learning model.
9. How the ground truth for the training set was established
- Not applicable. This device is a physical blood reservoir, not a machine learning model.
Summary of Findings:
The provided 510(k) summary is for a physical medical device (a blood reservoir) and focuses on demonstrating substantial equivalence to a predicate device. It references general "safety, performance, and validations" but does not provide the detailed scientific study data, specific acceptance criteria, or performance metrics that would be necessary to answer most of the questions, particularly those related to diagnostic performance or AI algorithms. The questions posed seem to be more tailored for a submission involving AI software or diagnostic tools, rather than a hardware device like the one described.
§ 870.4400 Cardiopulmonary bypass blood reservoir.
(a)
Identification. A cardiopulmonary bypass blood reservoir is a device used in conjunction with short-term extracorporeal circulation devices to hold a reserve supply of blood in the bypass circulation.(b)
Classification. Class II (special controls), except that a reservoir that contains a defoamer or filter is classified into the same class as the defoamer or filter. The device, when it is a cardiopulmonary bypass blood reservoir that does not contain defoamers or blood filters, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.