(520 days)
Code 150 Blood Component Collection Set is intended for separation of Platelet-Poor Plasma (PPP) and Platelet-Rich Plasma (PRP) from whole blood collected into transfer bags.
Code 151 Blood Component Set with Direct Draw Line is intended for separation of Platelet-Poor Plasma (PPP) and Platelet-Rich Plasma (PRP) from whole blood collected from directly the patient.
The process of PRP/PPP is to be performed in the immediate preoperative period, prior to the surgical procedure and before the establishment of cardiopulmonary bypass. The collected PRP/PPP shall be administered during or after the operation to aid in the normalization of the patient's hemocoagulative state.
The Electronmedics PRP/PP Sequestration Kits are indicated for the same use as the Code 150 and Code 151 Blood Component Collection Sets.
The Blood Components Collection Set consists of a four-way adapter, a bag spike assembly, and two (2) collection bags. The four way adapter is inserted between the wash bowl and waste bag components of a preassembled surgical wash. The collection bags are attached to the free arms of the adapter. Whole blood to be processed may be collected in the immediate preoperative period into a transfer bag, which is then attached to the inlet side of the wash set using the bag spike assembly. In addition, blood may be collected directly from the patient by utilization of a filtered burette assembly intended for the administration of anticoagulation solution during preoperative collection of patient blood for sequestration of PRP/PPP. Alternately, whole blood from the extracorporeal circuit (e.g. cardiotomy reservoir or oxygenator) may be processed during the intraoperative period in the same manner.
The provided text describes a 510(k) premarket notification for the Sorin Biomedical Inc. Dideco Blood Component Collection Sets (Code 150 and Code 151). This notification focuses on demonstrating "substantial equivalence" to a predicate device, rather than providing detailed acceptance criteria and a study report as might be expected for novel devices or performance claims. Therefore, much of the requested information regarding detailed acceptance criteria, specific performance metrics, and study methodologies is not present in this document.
Here's an analysis of the available information:
Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria or specific performance metrics for the device's clinical efficacy (e.g., PRP purity, platelet recovery). Instead, it focuses on demonstrating substantial equivalence based on physical and functional tests to an existing predicate device (Electromedics Plasma Sequestration Set and AT-1000 Sequestration Set).
The "acceptance criteria" can be inferred as successful completion of these nonclinical tests, indicating the device performs as intended and is safe.
| Acceptance Criteria Category | Reported Device Performance | Comments |
|---|---|---|
| Physical Tests | ||
| Pull Testing | Secure connection established between blood components collection set and surgical wash set. | The device passed pull testing, ensuring secure attachment. |
| Volume Accuracy (Burette) | All burettes recorded accurately at specified volumes. | The device's burette accurately measures volume. |
| Leak Testing (Filtered Burette) | No leaks observed when pressurized to 15 ± 0.5 psi and submerged in water. | The device passed leak testing. |
| Biocompatibility | Blood contacting components are safe for intended use. | Testing performed per Tripartite Guidances for "externally communicating devices, blood path direct: with a short term contact duration (5 minutes to 29 days)". |
| Overall Equivalence (Implied Performance) | Substantially equivalent in intended use, materials, design, and performance characteristics to the Electromedics Plasma Sequestration Set. | The device is deemed to perform similarly to the predicate device for PRP/PPP separation. |
Study Details
The provided document describes nonclinical (in vitro) tests rather than a clinical study.
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Sample Size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated for any of the nonclinical tests. The text mentions "All burettes" for volume accuracy and "Each unit" for leak testing, implying the testing of multiple units, but the exact number isn't provided. For biocompatibility, it states "Biocompatibility testing was performed on finished devices," again without a specific number.
- Data Provenance: The tests were performed "in vitro" by Sorin Biomedical Inc.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The ground truth for these nonclinical tests would be defined by engineering specifications and direct measurements (e.g., known forces for pull tests, precise volumes for accuracy, direct observation of leaks). Experts were not involved in establishing the "ground truth" in the sense of clinical interpretation.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. These were objective physical and functional tests, not subjective assessments requiring expert adjudication.
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If a multi-reader, multi-case (MRMC) comparative effectiveness study was done: No, an MRMC study was not done. The document describes nonclinical in vitro tests and a comparison of technological characteristics to a predicate device, not a human reader study.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a physical blood component collection set, not an AI algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the nonclinical tests, the ground truth was based on:
- Engineering specifications and objective measurements: For pull testing (force required to disconnect), volume accuracy (comparison to known volumes), and leak testing (absence of bubbles under pressure).
- Regulatory standards/guidances: For biocompatibility testing, adherence to "Tripartite Guidances for the category of 'externally communicating devices, blood path direct: with a short term contact duration (5 minutes to 29 days)'."
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The sample size for the training set: Not applicable. This document does not describe the development or evaluation of an algorithm using a training set.
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How the ground truth for the training set was established: Not applicable.
§ 868.5830 Autotransfusion apparatus.
(a)
Identification. An autotransfusion apparatus is a device used to collect and reinfuse the blood lost by a patient due to surgery or trauma.(b)
Classification. Class II (performance standards).