(98 days)
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No
The device description details a manual process for marking interface points and a simple mathematical formula for calculation, with no mention of AI/ML terms or image processing for automated analysis.
No
Explanation: The device is used to calculate a ratio of Red Blood Cells to blood sample volume, which is a diagnostic function, not a therapeutic one. It analyzes a blood sample rather than treating a condition.
Yes.
Explanation: The device calculates the ratio of Red Blood Cells to blood sample volume, which is a common diagnostic measure (hematocrit).
No
The device description explicitly states it includes a centrifuge and a manual hematocrit reader, which are hardware components. The software component (microprocessor) is used for calculation based on user input from the hardware.
Based on the provided information, the Multi-Centrifuge is likely an IVD (In Vitro Diagnostic) device.
Here's why:
- Device Description: The description explicitly states that the device includes a centrifuge and a manual hematocrit reader. It describes how the hematocrit reader calculates a ratio of Red Blood Cells to blood sample volume using a blood sample.
- Function: The core function of the device is to process and analyze a blood sample to determine a specific characteristic (hematocrit). This is a classic example of an in vitro diagnostic test.
- Predicate Device: The predicate device listed, "Hematostat C-70," is also a device used for determining hematocrit, which is an in vitro diagnostic procedure.
While the "Intended Use / Indications for Use" section is listed as "Not Found," the detailed description of how the device works with a blood sample to measure hematocrit strongly indicates its use for diagnostic purposes outside of the body (in vitro).
N/A
Intended Use / Indications for Use
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Product codes
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Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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Key Metrics
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 864.6400 Hematocrit measuring device.
(a)
Identification. A hematocrit measuring device is a system consisting of instruments, tubes, racks, and a sealer and a holder. The device is used to measure the packed red cell volume in blood to determine whether the patient's total red cell volume is normal or abnormal. Abnormal states include anemia (an abnormally low total red cell volume) and erythrocytosis (an abnormally high total red cell mass). The packed red cell volume is produced by centrifuging a given volume of blood.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 864.9.
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ENCLOSURE - G
510(k) for Multi-Centrifuge
SAFETY AND EFFECTIVENESS STATEMENT
A reasonable literature search has been performed to determine pertinent issues related to safety and effectiveness. All available information points to concerns with regards to centrifuges and centrifuge techniques. There were no references to electronically controlled manual hematocrit readers. In reviewing this information, the Multi-Centrifuge as a centrifuge does not raise new questions or concerns with regards to safety and effectiveness. A comparison chart between the Multi-Centrifuge and the Hematostat C-70 illustrate the areas of concerns for safety and potential areas of hazard discussed in the literature search.
| CONCERNS | MULTI-CENTRIFUGE | HEMATOSTAT C-70 |
|---|---|---|
| Hematocrit Tube Cover | Yes | No |
| Aerosol Hazard Eliminated | No | No |
| Explosion Hazard Eliminated | No | No |
| Bio-Hazard Eliminated | No | No |
| Chemical Hazard Eliminated | No | No |
| Door Lock | Yes | Yes |
| Excessive Fiction Hazard | Yes | No |
| Low Power | Yes | No |
| Out of balance Hazard | Yes | Yes |
Although, there is no information with regards to manual hematocrit readers, the Multi-Centrifuge and Hematostat C-70 differ in one area, angle factor. Both hematocrit readers utilize various distances to calculate a ratio (Hct) of Red Blood Cells to blood sample volume. These distances are at key separation (interface) points marked by the user. This is similar to marking distances with a ruler. Using a flat disk rotor, the interface points run perpendicular to the hematocrit tube length. These marked interface points are as follows:
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ENCLOSURE - G Continue
- Sealant/Red Blood Cells. This is Point A or the starting point for the packed red 1. blood cells and blood sample volume.
- Red Blood Cells/Plasma. This is Point B or the ending point for the packed red 2. blood cells.
- Plasma/Air. This is Point C or the ending point for the blood sample volume. 3.
Once these areas are marked by the user, the microprocessor uses the following equation to calculate the ratio:
(A + B) / (A + C) x 100 = XX.X%
An example of a basic calculation once areas are marked is as follows:
A = 0 10 + 1) / (0 + 2) x 100 + 50.0% B = 1 inch C = 2 inch
However, the Hematostat C-70 has an addition "angle factor (Af)" added to the equation. (A + B) / (A + C) x ff x 100% = XX.X%. This angle factor is needed to account for the angle at which the various interface points occurs. This angle is the result of the 70° fixed angle Hct rotor used by the Hematostat. As blood separation occurs in the Hematostat C-70, the interface points also have a 70° angle. Because of this and the small LCD display, this makes it difficult and leads to potential inconsistencies for the user when marking each interface point. Because the Multi-Centrifuge uses a flat disk rotor, all interface points are perpendicular to the hematocrit tube. This and a larger LCD display provides ease of use and consistency.
The Multi-Centrifuge poses no increase risk to safety or diminishes effectiveness of use. This device does not raise any new or additional concerns for use. Further, the hematocrit reader offers a simpler linear algorithmic equation for Hct determination.
009.9