(196 days)
The Gish Soft Venous Reservoir with HA Coating is indicated for use collecting systemic venous and cardiotomy return blood during cardiopulmonary bypass procedures. It is designed to operate at flow rates of one (1.0) to eight (8.0) liters per minute for periods up to six (6.0) hours.
The Gish Soft Venous Reservoirs with HA 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 ½" 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 non-pyrogenic. All materials of the Soft Venous Reservoirs are biocompatible and coated with a proprietary coating. The Gish the Soft Venous Reservoirs with HA Coating may be purchased separately or pre-connected with tubing and other components of an extracorporeal circuit.
Here's a breakdown of the acceptance criteria and study information for the Gish Soft Venous Reservoir (SVR) with HA Coating, based on the provided 510(k) summary:
The provided document is a 510(k) summary for a medical device (Gish Soft Venous Reservoir with HA Coating). These types of submissions primarily demonstrate substantial equivalence to a legally marketed predicate device rather than presenting detailed "acceptance criteria" and "study results" in the way one might expect for a novel AI/software product or a clinical trial. Instead, the "acceptance criteria" are implied by the performance of the predicate devices and the "study" is a series of engineering and performance tests to ensure the new device functions similarly and safely.
Therefore, I will interpret your request within the context of a 510(k) submission for a physical medical device.
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Functional Requirements: |
- Capable of collecting systemic venous and cardiotomy return blood.
- Designed to operate at flow rates of 1.0 to 8.0 liters per minute.
- Designed to operate for periods up to 6.0 hours.
- Prevents venous air from entering the extracorporeal circuit.
- Reduces blood stagnation.
- Collapses if emptied (safety mechanism). | Device is indicated for collecting systemic venous and cardiotomy return blood during cardiopulmonary bypass procedures.
Designed to operate at flow rates of 1.0 to 8.0 liters per minute.
Designed to operate for periods up to 6.0 hours.
Intended to prevent venous air from entering the extracorporeal circuit.
Design reduces blood stagnation.
Will collapse if emptied; a built-in safety mechanism that minimizes accidental air delivery to the oxygenator. |
| Material Biocompatibility: - All materials contacting fluid path must be biocompatible. | All materials of the Soft Venous Reservoirs are biocompatible and coated with a proprietary coating. |
| Sterility & Non-pyrogenicity: - Components in fluid path must be sterile and non-pyrogenic. | The components of this system which have contact with the fluid path are sterile and non-pyrogenic. |
| Safety and Effectiveness: - Equivalent in safety and effectiveness to predicate devices. | The device has been subjected to extensive safety, performance, and validations.
Concluded to have the same intended use and similar technological characteristics as predicate devices, thus equivalent in safety and effectiveness. |
Study Information
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Sample size used for the test set and the data provenance:
- The document does not specify a sample size for a "test set" in the context of clinical data or patient outcomes. The "test set" here refers to the actual physical devices (Gish SVR with HA Coating) that underwent "various performance tests" and "validations". The number of devices tested is not explicitly stated.
- Data Provenance: The testing was conducted by Gish Biomedical, Inc. This is internal company testing, likely done in a laboratory or simulated environment, rather than involving human clinical data from a specific country or being retrospective/prospective in a clinical study sense.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This concept is not applicable in this 510(k) submission. "Ground truth" established by experts is typically relevant for diagnostic devices or AI algorithms where interpretation is involved. For a physical blood reservoir, engineering specifications and established test methodologies serve as the "ground truth" or benchmarks. Product specifications and performance standards are typically set by internal R&D, engineering, and regulatory teams, often informed by industry standards and regulatory guidance.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods (like 2+1 or 3+1) are used in clinical trials or studies to resolve discrepancies in expert interpretation, particularly in diagnostic contexts. For physical device performance testing, results are typically objective measurements against predefined specifications; there is no "adjudication" between expert opinions on the performance data itself.
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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:
- No. This is a physical medical device (blood reservoir) and not an AI or imaging diagnostic device. Therefore, an MRMC study is completely irrelevant and was not performed.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical blood reservoir, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth," while not referred to as such, is based on engineering specifications, performance standards, and comparison to the predicate devices' established safety and effectiveness. The device's ability to meet its functional requirements (flow rates, volume, air prevention, etc.) and demonstrate biocompatibility and sterility are the "truths" being validated.
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The sample size for the training set:
- Not applicable. This is not a machine learning or AI device that requires a "training set."
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How the ground truth for the training set was established:
- Not applicable for the same reason as above.
§ 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.