Search Results

The Dideco D920, Lilliput I twin reservoir is intended for use in infants who undergo cardiopulmonary bypass surgery requiring extracorporeal circulation for whom a low circuit priming volume is required. The venous reservoir with cardiotomy filter is intended for use as a storage reservoir (gravity or vacuumassisted) for venous return blood and as a filtered reservoir for cardiac suction during ECC. The cardiotomy reservoir has the same intended use as the venous reservoir, as a filtered reservoir for cardiac suction blood in a bypass extracorporeal circuit, but does not have a venous return. Following intraoperative use, the reservoirs are used for the collection and autotransfusion of shed blood.

The D 920 serves as a collection reservoir for venous blood recovered by intracardiac sucker and ventricular vent devices. The D 920 device can also be attached to an oxygenator, previously cleared by the Agency for the same patient population, in order to collect blood during normal operations, assuring the proper oxygenation capability of the device is currently being developed in an open system configuration which includes the Dideco D901 Lilliput oxygenator, cleared by the Agency on March 15th 1996 (K953835).

The hard-shell cardiotomy/venous reservoirs are comprised of a rigid polycarbonate housing with an internal support; in which a filtering system is placed around the support. The D 920 has two distinct (upper and lower) sections connected by an overflow system. The upper section contains a defoamer sponge and screen filter which are designed to remove microaggregates and microemboli from cardiotomy suction and vent blood. The devices are available with a 30 micron filter. The venous return blood enters the lower section and passes through a defoamer sponge. Only the lower section is contained within a polyester outer screen.

The D 920 has four cardiotomy suction/vent inlet ports which accommodate both 1/4 and 3/16" inner diameter tubing. Three priming ports are positioned on the top of the reservoir: 3 x luer lock (filtered), 1 x luer lock (unfiltered) and 1 x 1/4-3/16". Fluid added through the one outer priming port bypasses the integral cardiotomy section. Fluids added through the three inner luer and 1/4-3/16" ports flow through the defoamer and filter elements in the cardiotomy section. Venous blood enters through the 1/4-3/16" inlet port at the bottom of the unit. The D 920 has a 1/4-3/16" blood outlet port at the bottom of the unit. The 1/4" gas outlet port is located at the top of the unit. Both devices are supported by a holder.

The provided text describes a 510(k) premarket notification for the Dideco D920, Lilliput 1 twin reservoir, a medical device for infant cardiopulmonary bypass surgery. However, the document does not present a formal study with acceptance criteria and device performance metrics in the way that would typically be seen for a new, substantially different device.

Instead, the submission focuses on demonstrating substantial equivalence to previously cleared predicate devices (VENOMIDICARD/MIDICARD and MICRO SAFE). This means the "acceptance criteria" are implicitly met by demonstrating that the new device is as safe and effective as existing legally marketed devices, primarily through comparison of design, materials, and intended use, along with standard biocompatibility and in vitro performance testing.

Therefore, many of the specific questions about sample sizes, ground truth establishment, expert adjudication, and MRMC studies are not applicable to this type of regulatory submission focusing on substantial equivalence based on predicate devices.

Here's a breakdown of the information that can be extracted or deduced from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The concept of "acceptance criteria" for this 510(k) is primarily centered on demonstrating similar safety and effectiveness to the predicate devices. The "performance" is shown through direct comparisons of technical specifications and an assertion of similar operating principles.

Note: The "acceptance criteria" in the table are inferred from the 510(k) process for substantial equivalence. The goal is to demonstrate that the new device is as safe and effective as the predicate, not necessarily to meet specific numerical targets beyond what the predicates achieve.

2. Sample Size Used for the Test Set and Data Provenance

This information is not provided in the document. For a 510(k) based on substantial equivalence, specific "test sets" with clinical outcome data in the sense of a new clinical trial are typically not required unless there are significant technological differences or new indications. The performance data mentioned (biocompatibility, in vitro performance) would be conducted on device samples, but the number of samples is not specified, nor is the "data provenance" in terms of patient cohorts. These are laboratory/bench tests.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This is not applicable as there is no mention of a clinical "test set" requiring expert ground truth establishment for diagnostic or prognostic accuracy. The testing performed (biocompatibility, in vitro performance) relies on standardized laboratory procedures.

4. Adjudication Method for the Test Set

This is not applicable as there is no mention of a clinical "test set" requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted or mentioned. This type of study focuses on human reader performance, often with and without AI assistance, which is typically for diagnostic imaging devices. The Dideco D920 is a physical medical device (venous cardiotomy reservoir), not a diagnostic or AI-powered system, so an MRMC study would not be relevant.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Not Applicable. The Dideco D920 is a physical medical device, not an algorithm or AI system, so the concept of "standalone algorithm performance" does not apply.

7. The Type of Ground Truth Used

For the biocompatibility testing, the "ground truth" would be the established safety profiles outlined in ISO 10993-1:1992 and FDA guidance, ensuring the device materials are not toxic or harmful.
For the in vitro performance testing (based on ISO 7199), the "ground truth" would be the predefined performance specifications and test methods in the standard, demonstrating the device's functional integrity (e.g., flow rates, filtration efficiency under simulated conditions).

8. The Sample Size for the Training Set

Not Applicable. As the Dideco D920 is a physical medical device and not an AI/machine learning system, there is no "training set."

9. How the Ground Truth for the Training Set Was Established

Not Applicable (as there is no training set).

Ask a specific question about this device