(126 days)
The autoLog is intended for use in the collection, concentration, washing, and reinfusion of autologous blood. Such areas of application may include, but are not necessarily limited to, the following:
- General, Cardiovascular, Orthopedic, Vascular, Plastic/Reconstructive, . Obstetric/Gynecologic and Neurosurgical
- Postoperative treatment areas
The autoLog® Autotransfusion System is an autotransfusion apparatus (including disposable kit). The system is a centrifugal unit that is used to collect autologous blood peri-operatively and post-operatively into a collection reservoir with an appropriate amount of anticoagulant. This autologous blood is then processed by centrifugation, separating the red cells from the plasma. Contaminating debris is subsequently washed out by the introduction of normal saline in a wash cycle. The resulting packed red cells, suspended in normal saline, are pumped to a transfer bag, and may be reinfused to the patient.
This document is a 510(k) summary for the autoLog® Autotransfusion System. It details the device, its intended use, and a comparison to a predicate device. This submission primarily focuses on modifications to an already cleared device, K982755.
Here's an analysis of the provided text in relation to your questions:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in a quantitative manner for specific performance metrics (e.g., cell recovery rate, leukocyte removal). Instead, it states that the device is substantially equivalent to a predicate device because the fundamental scientific principle, labeling, and intended use are unchanged. The performance "criteria" are met by demonstrating that modifications do not adversely affect the established performance characteristics.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Biocompatibility | Biocompatibility testing performed. (No specific quantitative results reported in this summary, but implies it met the necessary standards for patient contact.) |
| Software Functionality and Safety | Software validation testing performed. (Implies the software performs as intended and is safe.) |
| Manifold Bond Integrity | Manifold Bond Integrity Testing performed. (Implies the new manifold material (PETG) or its bonding is as robust as the previous PVC.) |
| Fan Guard Cooling Effectiveness | Fan Guard Cooling Testing performed. (Implies adequate cooling is maintained.) |
| Lipid Removal Characterization | Lipid Removal Characterization Testing performed. (Implies the device's ability to remove lipids is maintained or characterized, though no specific performance metric is given for comparison.) |
| Device remains substantially equivalent to predicate autoLog® Autotransfusion System (K982755) in: Indicated useOperating principleDisposables (wash kit)Shelf life for disposablesFluid path (patient-contacting) materialsPackaging and sterilization methods for patient-contacting devices | The submission states, "The modifications... result in a substantially equivalent device because the fundamental scientific principle, labeling and the intended use are unchanged as a result of these device modifications." (This is the overarching "performance" claim based on the conducted tests.) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document explicitly states: "Clinical testing was not required to establish substantial equivalence."
Therefore, there is no "test set" in the context of clinical patient data, and thus no sample size, country of origin, or retrospective/prospective designation for clinical studies. The "test set" for the non-clinical performance data (biocompatibility, software, etc.) would be specific to each test and is not detailed in this summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable, as no clinical testing was performed and therefore no ground truth established by experts in a clinical context.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no clinical testing was performed and no expert ground truth established for a test set.
5. 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
Not applicable. This is not an AI-assisted diagnostic device, nor was there any clinical comparative effectiveness study involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a medical device for autotransfusion, not a standalone diagnostic algorithm. The "software testing" mentioned refers to the internal software components of the device, not an external algorithm performing a diagnostic function.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical performance tests mentioned (Biocompatibility, Software, Manifold Bond Integrity, Fan Guard Cooling, Lipid Removal Characterization), the "ground truth" would be established by:
- Industry standards and regulatory guidelines: For biocompatibility (e.g., ISO 10993 series).
- Design specifications and established engineering principles: For software functionality, bond integrity, and cooling effectiveness.
- Internal characterization methods and scientific principles: For lipid removal.
There is no "expert consensus, pathology, or outcomes data" in the clinical sense, as clinical studies were not performed.
8. The sample size for the training set
Not applicable. This device does not use an AI or machine learning model that requires a "training set" of data.
9. How the ground truth for the training set was established
Not applicable, as no training set was used.
§ 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).