(30 days)
The Jostra Venous Hardshell Cardiotomy Reservoir (non-vacuum-tight model) is designed to collect, store and filter the blood in an extracorporeal circuit during cardiopulmonary bypass procedures up to six hours in adult surgery . It can be integrated into almost all perfusion systems. The Jostra Venous Hardshell Cardiotomy Reservoir is designed and sold for use only as indicated.
The Jostra Venous Hardshell Cardiotomy Reservoir (vacuum-tight model) is designed to collect, store and filter the blood in an extracorporeal circuit during cardiopulmonary bypass procedures with or without vacuum assisted venous return up to six hours in adult surgery . It can be integrated into almost all perfusion systems. The Jostra Venous Hardshell Cardiotomy Reservoir is designed and sold for use only as indicated. This reservoir is also designed to be used postoperatively as a drainage and autotransfusion reservoir (e.g. for chest drainage) to return autologous blood shed from the chest to the patient for volume replacement.
The Jostra Venous Hardshell Cardiotomy Reservoir (non-vacuum-tight model) is designed to collect, store and filter the blood in an extracorporeal circuit during cardiopulmonary bypass procedures up to six hours in adult surgery . It can be integrated into almost all perfusion systems. The Jostra Venous Hardshell Cardiotomy Reservoir is designed and sold for use only as indicated.
The Jostra Venous Hardshell Cardiotomy Reservoir (vacuum-tight model) is designed to collect, store and filter the blood in an extracorporeal circuit during cardiopulmonary bypass procedures with or without vacuum assisted venous return up to six hours in adult surgery . It can be integrated into almost all perfusion systems. The Jostra Venous Hardshell Cardiotomy Reservoir is designed and sold for use only as indicated. This reservoir is also designed to be used postoperatively as a drainage and autotransfusion reservoir (e.g. for chest drainage) to return autologous blood shed from the chest to the patient for volume replacement.
The Jostra Venous Hardshell Cardiotomy Reservoirs (vacuum-tight and non-vacuum-tight model) with Safeline Coating are identical to the Jostra Venous Hardshell Cardin tygn Reservoirs with the only exception that the Venous Hardshell Cardiotomy Reservoirs with Safeline Coating have been coated with Safeline. The Safeline Coating is the same as with the Jostra RotaFlow Centrifugal Pump with Safeline Coating. Besides this difference the Venous Hardshell Cardiotomy Reservoirs with Safeline Coating are the same in design. intended use, method of operation, components, packaging, and fundamental scientific technology as compared to the uncoated Venous Hardshell Cardiotomy Reservoirs.
This document describes a 510(k) submission for a medical device modification, not an AI/ML powered device. Therefore, the questions related to AI/ML specific aspects like "test set," "ground truth," "MRMC study," "human readers," and "training set" are not applicable.
The submission focuses on demonstrating substantial equivalence of a modified medical device to existing predicate devices.
Here's an analysis of the provided text in the context of the questions that are applicable:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table with specific acceptance criteria or quantitative performance metrics in the way one would expect for an AI/ML model. Instead, it states that the device was evaluated for "safety and effectiveness" and that the data "demonstrate that the Jostra Venous Hardshell Cardiotomy Reservoirs (sealed and non-sealed model) with Safeline Coating are substantially equivalent to the named predicate devices."
The evaluation areas mentioned are:
- Integrity
- Performance
- Biocompatibility
- Sterility
No specific performance thresholds or detailed results are reported in this summary. The "performance" assessment refers to the device's functional integrity and ability to perform its intended purpose (collecting, storing, and filtering blood) without adverse effects compared to the predicate.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable in the context of an AI/ML model's test set. This submission refers to a medical device modification (adding a coating). The "testing" here refers to standard medical device verification and validation activities (e.g., bench testing, biocompatibility studies). The document does not specify sample sizes for these tests, nor their provenance as would be relevant for a data-driven model. The submitter is Maquet Cardiopulmonary AG from Germany.
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. There is no concept of "ground truth" or "experts" establishing it in the context of this device modification. The evaluation is based on standard engineering and biological testing against established specifications or predicate device performance.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This concept is relevant for AI/ML models where human disagreement on ground truth might occur.
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/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable for an AI/ML model. For this device, "ground truth" would be established specifications, regulatory requirements, and the performance characteristics of the predicate device. For example, "sterility" ground truth would be a validated sterile state, "biocompatibility" would be a state of not causing adverse biological reactions, and "integrity" would be a state of structural soundness.
8. The sample size for the training set
Not applicable. This is not an AI/ML device. There is no "training set."
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML device. There is no "training set" or corresponding ground truth.
Summary for K061743: Device Modification - Venous Hardshell Cardiotomy Reservoirs with Safeline Coating
This 510(k) submission is for a modification to an existing medical device, the Jostra Venous Hardshell Cardiotomy Reservoirs, by adding a "Safeline Coating." The submission aims to demonstrate substantial equivalence to predicate devices. It is not an AI/ML enabled device, therefore many of the requested criteria related to AI/ML performance evaluation are not applicable.
The core of the study is a comparison to predicate devices, showing that the modified device is "the same in design, intended use, method of operation, components, packaging, and fundamental scientific technology as compared to the uncoated Venous Hardshell Cardiotomy Reservoirs," with the only difference being the Safeline coating. The coating itself is also stated as being the same as already cleared for the Jostra RotaFlow Centrifugal Pump (K061072).
The "study" refers to the evaluation and testing conducted to demonstrate safety and effectiveness, leading to the conclusion of substantial equivalence.
Applicable Information:
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Acceptance Criteria & Reported Device Performance: General acceptance of "safety and effectiveness" through demonstration of substantial equivalence to predicate devices (Jostra Venous Hardshell Cardiotomy Reservoirs and Jostra RotaFlow Centrifugal Pump with Safeline Coating).
- Evaluation Areas: Integrity, Performance, Biocompatibility, Sterility.
- Reported Performance: The data "demonstrate that the Jostra Venous Hardshell Cardiotomy Reservoirs (sealed and non-sealed model) with Safeline Coating are substantially equivalent to the named predicate devices." No specific quantitative performance metrics are provided in the summary, as the focus is on equivalence.
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Sample Size and Data Provenance: Not explicitly detailed in the summary for individual tests (e.g., "N=XX samples tested for biocompatibility"). The device manufacturer is Maquet Cardiopulmonary AG, Germany. The testing would be prospective validation of the modified device.
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Ground Truth: For non-AI/ML devices, "ground truth" refers to recognized standards, established specifications, and the performance of legally marketed predicate devices. The modified device's performance across the evaluation areas (integrity, performance, biocompatibility, sterility) would be measured against these benchmarks.
Non-Applicable Information (for this type of device submission):
- Test set/Training set sample sizes
- Number/Qualifications of experts for ground truth
- Adjudication method
- MRMC comparative effectiveness study
- Standalone (algorithm-only) performance
- Specific types of ground truth (e.g., pathology, outcomes data relevant to AI diagnostics)
§ 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.