(259 days)
The Jostra HL-20 Twin Pump is intended for use as an extra corporeal circulation device for perfusion appropriate to cardiopulmonary bypass procedures of six hours or less. It is only intended for use with the Jostra HL-20 Heart Lung Machine.
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The provided text describes a 510(k) submission for the Jostra HL-20 Twin Pump, aiming to demonstrate its substantial equivalence to a predicate device, the Jostra HL-20 Single Head Roller Pump. The submission focuses on functional and design similarities, rather than a clinical study evaluating diagnostic performance. Therefore, many of the requested categories for AI/diagnostic device studies (like sample size, ground truth, expert qualifications, MRMC studies, standalone performance) are not applicable or cannot be extracted directly from this document.
However, I can extract the acceptance criteria and performance related to the engineering and safety standards that the device adheres to, as this is the basis of the equivalence claim.
Acceptance Criteria and Reported Device Performance
| Acceptance Criterion | Reported Device Performance (Reference to Standard) |
|---|---|
| General Safety | Complies with EN93/42: EU Council Directive 93/42/EEC concerning Medical Devices |
| Constructional Safety | Complies with IEC 601-1: IEC 601-1, 2nd Edition: 1988 (identical with DIN VDE 0750 Part 1) |
| Electromagnetic Compatibility (EMC) | Complies with EU 89/336: EMC Directive 89/336/EEC 1993 (identical with DIN VDE 0750, Part 1-2) |
| Functional Performance | "performs within its specifications and also within acceptable limits for performance standards" (Implied: this covers the specific operational aspects of the pump, which are not detailed in the provided text but are indicated to be satisfactory.) |
Study Details (as inferable from the document, recognizing this is not a diagnostic AI study):
- Sample size used for the test set and the data provenance: Not applicable. This is not a study involving a "test set" of patient data for diagnostic performance. The "performance data" mentioned in F and G likely refers to engineering tests and measurements on the device itself to verify it meets the specified standards.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for diagnostic purposes is not established here. The "ground truth" in this context is adherence to established engineering and safety standards (e.g., IEC, EU Directives).
- Adjudication method: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No. This is not a diagnostic device or an AI system that interacts with human readers in a diagnostic context.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: No. This is a mechanical/electronic medical device, not an algorithm.
- The type of ground truth used: Not applicable in the context of diagnostic performance. The "ground truth" for the device's substantial equivalence claim is its conformity to established international safety and performance standards (e.g., EN93/42, IEC 601-1, EU 89/336).
- The sample size for the training set: Not applicable. This device does not use machine learning or require a training set.
- How the ground truth for the training set was established: Not applicable.
Summary of the "Study" (Demonstration of Equivalence):
The "study" or demonstration of equivalence for the Jostra HL-20 Twin Pump involves:
- Comparison to a Predicate Device: The new device (Twin Pump) is compared to a legally marketed predicate device (Single Head Roller Pump) regarding indications for use, technological characteristics (design, materials), and safety/effectiveness concerns.
- Adherence to Standards: Performance data (Attachment #5, not provided here) was submitted to demonstrate that the Twin Pump performs within its specifications and meets the acceptable limits of several key performance and safety standards:
- EU Council Directive 93/42/EEC (General Medical Devices)
- IEC 601-1, 2nd Edition: 1988 (Safety of Medical Electrical Equipment, Part 1: General Requirements)
- EMC Directive 89/336/EEC 1993 (Electromagnetic Compatibility)
- Conclusion: The provided data demonstrated that the HL-20 Twin Pump model is "similar in materials, design and function to that of the predicate device" and that its performance falls within acceptable limits relative to established safety and performance standards. This leads to the FDA's determination of substantial equivalence.
§ 870.2100 Cardiovascular blood flowmeter.
(a)
Identification. A cardiovascular blood flowmeter is a device that is connected to a flow transducer that energizes the transducer and processes and displays the blood flow signal.(b)
Classification. Class II (performance standards).