(173 days)
The OCS™ Heart Leukocyte Depleting Filter is indicated for the reduction of leukocytes from donor blood prior to its introduction into the OCS™ Heart System for the preservation of a donor heart from the same donor.
The OCS™ Heart Leukocyte Depleting Filter is a sterile, single-use filter intended for depletion of leukocytes in donor blood prior to its introduction into the OCS Heart system. The polycarbonate housing is 3.2" high and 3.0" in diameter. It has 1/4" fittings and includes a hydrophobic gas-permeable membrane and vent port to allow air to efficiently vent during priming and use. The leukocyte depleting material is a melt blown polyester media supplied by Pall Biomedical (the same material as is used in the predicate device). It has 6 layers, approximately 5 pleats per inch. It includes a polypropylene extruded diamond mesh that provides support for the polyester filter media. The priming volume is 273.5 mL and the anticipated flow rate (associated with gravity feed from a blood collection bag) is 1.9 L/min. During use, the blood enters through the inlet port, flows through the filter media to the interior of the filter element, and then exits through the outlet port. The device is sterilized by ethylene oxide and is provided in a Tyvek pouch packaged in a corrugated box.
This document describes the TransMedics, Inc. OCS™ Heart Leukocyte Depleting Filter, for which a 510(k) premarket notification (K231362) was submitted. The device is a sterile, single-use filter intended to reduce leukocytes from donor blood before it is introduced into the OCS™ Heart System for heart preservation. The submission claims substantial equivalence to the legally marketed predicate device, LeukoGuard BC2 (K902518) by Pall Biomedical.
The document does not contain a table of acceptance criteria or specific reported device performance values for the OCS™ Heart Leukocyte Depleting Filter, nor does it detail a study that explicitly proves the device meets these criteria with quantitative results. Instead, it broadly states that "Bench testing has demonstrated acceptable performance of the device, that it meets all acceptance criteria and that the OCS Heart Leukocyte Depleting Filter is acceptable for clinical use."
However, based on the provided information, we can infer some aspects related to its performance and the studies conducted:
1. Table of Acceptance Criteria and Reported Device Performance:
As mentioned, a direct table is not present. However, the document lists areas of testing that imply acceptance criteria would be related to:
- Leukocyte and platelet depletion: The device is expected to effectively deplete leukocytes (and platelets). It's stated that the proposed device removes more leukocytes and platelets due to its larger size, implying higher effectiveness in this aspect. For the predicate, the acceptance criteria would be established historical performance data.
- Filtration time: The device must filter blood within an acceptable timeframe.
- Hold-up volume, priming volume, and pressure drop: These physical characteristics must be within specifications.
- Maximum flow rate: The device must be compatible with the OCS Heart system's flow requirements (antecedently, 1.9 L/min).
- Structural integrity: The filter must maintain its structural integrity during use.
- Hemolysis: The device should not cause excessive hemolysis.
- Biocompatibility: Meet ISO 10993-1 standards (Cytotoxicity, Sensitization, Intracutaneous Reactivity, Acute Systemic Toxicity, Hemocompatibility, Genotoxicity, Pyrogenicity, USP Physicochemical Test for plastics).
- Sterility: Achieve a sterility assurance level (SAL) of 10^-6.
- Shelf life: Maintain integrity and performance for 12 months.
Reported Device Performance:
The document states that "The testing demonstrated that the OCS Heart Leukocyte Depleting filter met all specifications and was shown to be equivalent to the predicate device."
Specifically, regarding leukocyte and platelet depletion, it mentions: "The OCS Heart Leukocyte Depleting Filter is larger (273.5 mL priming volume compared to 95 mL priming volume for the LeukoGuard BC2) and therefore removes more leukocytes and platelets than the predicate device." It further clarifies, "an increased level of leukocyte depletion does not raise a different question of safety or effectiveness."
2. Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: Not explicitly stated. The testing includes "Bench performance testing" and "Pre-Clinical Validation using the OCS Heart Leukocyte Depleting Filter with the OCS Heart System to preserve swine hearts." The number of "swine hearts" or other samples used for bench testing is not provided.
- Data Provenance: The biocompatibility studies were conducted by NAMSA (Norwood, OH) and Ethide Laboratories (West Warwick, RI), both in the USA. The "Pre-Clinical Validation" using swine hearts suggests an animal model, likely conducted in a controlled laboratory setting. The data is retrospective in the sense that the testing was performed to support the 510(k) submission, not as a continuous monitoring effort.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- General Assessment: This information is not applicable in the context of device performance testing for a medical filter. The "ground truth" for the performance tests (e.g., leukocyte count, flow rate, hemolysis level) would be established by scientific measurement techniques and validated laboratory standards, not by expert consensus in the typical sense of diagnostic accuracy studies.
- Biocompatibility Testing: Conducted in compliance with 21 CFR Part 58 (GLPs) and according to ISO-10993-1 and USP standards. Experts involved would be qualified laboratory personnel in toxicology, microbiology, and materials science.
4. Adjudication Method for the Test Set:
- Not applicable. This concept is typically relevant for studies involving human interpretation (e.g., imaging studies) where discrepancies among readers need to be resolved. Performance testing of a filter involves objective measurements against predefined specifications.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:
- No. An MRMC study is not relevant for this device. This type of study assesses diagnostic accuracy and inter-reader variability, usually in imaging or pathology. The OCS Heart Leukocyte Depleting Filter is a physical device with measurable performance characteristics.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, in a sense. The bench testing and pre-clinical validation (swine hearts) represent "standalone" performance evaluations as they assess the device's function directly without human interaction being the primary variable. The device itself does not involve an algorithm or AI.
7. The Type of Ground Truth Used:
- Objective Measurements/Scientific Standards: The "ground truth" for the device's performance is based on objective measurements against established scientific and engineering standards.
- Leukocyte/Platelet Depletion: Laboratory assays to quantify cell counts before and after filtration.
- Filtration Time, Flow Rate, Volumes, Pressure Drop: Engineering measurements.
- Structural Integrity: Physical stress tests and observation.
- Hemolysis: Laboratory assays to measure hemoglobin release.
- Biocompatibility: Results from validated in vitro and in vivo toxicological tests (e.g., cytotoxicity, sensitization tests according to ISO 10993-1).
- Sterility: Microbiological validation tests to confirm SAL.
- Pre-Clinical Validation (Swine Hearts): Likely physiological measurements of heart function and integrity after blood processing by the device in an isolated organ system.
8. The Sample Size for the Training Set:
- Not applicable. This device is a physical filter, not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning. The device's design, materials, and manufacturing process are based on established engineering principles and the performance of the predicate device.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable, as there is no training set for this type of device.
§ 870.4260 Cardiopulmonary bypass arterial line blood filter.
(a)
Identification. A cardiopulmonary bypass arterial line blood filter is a device used as part of a gas exchange (oxygenator) system to filter nonbiologic particles and emboli (blood clots or pieces of foreign material flowing in the bloodstream which will obstruct circulation by blocking a vessel) out of the blood. It is used in the arterial return line.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance for Cardiopulmonary Bypass Arterial Line Blood Filter 510(k) Submissions.”