(185 days)
K/DEN numbers not found.
Not Found
No
The summary describes a disposable cuvette, a passive component, and makes no mention of AI or ML.
No
The device is a disposable component intended for use with a monitor, which suggests it is an accessory for a diagnostic or monitoring device rather than a therapeutic one. It facilitates the measurement of blood oxygen saturation (OxySat Monitor) but does not actively treat or alleviate a condition.
No
The device is a disposable component (cuvette) used with a monitor. While the monitor itself might perform diagnostic functions, the cuvette is a consumable part, not a diagnostic device in its own right; it facilitates the diagnostic function of the monitor.
No
The device description explicitly states it is a "single piece, single use, disposable component" constructed of "injection molded polycarbonate," indicating it is a physical hardware component, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device as a "single piece, single use, disposable component intended for use with the Bentley OxySat Monitor". It's a component of a larger system, not a device that performs a diagnostic test on a sample in vitro (outside the body).
- Device Description: The description reinforces that it's a physical component made of polycarbonate, designed to be used with a monitor.
- Lack of IVD Characteristics: There is no mention of:
- Analyzing biological samples (blood, urine, tissue, etc.).
- Detecting or measuring specific substances or markers in those samples.
- Providing diagnostic information about a patient's health status based on the analysis of samples.
The device appears to be a flow-through cuvette, which is a container used to hold a sample while it is being analyzed by an instrument. In this case, it's used with an "OxySat Monitor," which likely measures oxygen saturation, a physiological parameter measured in vivo (within the body) or ex vivo (outside the body but still related to the body's function), not in vitro analysis of a sample for diagnostic purposes.
N/A
Intended Use / Indications for Use
The IBC CMO2 Flow Through Cuvette is a single piece, single use, disposable component intended for use with the Bentley OxySat Monitor as a direct substitute for the Bentley OTC Flow Through Cuvette.
Product codes
Not Found
Device Description
The IBC CMO2 Flow Through Cuvette is a single piece, single use, disposable component. It is constructed of a single piece of injection molded polycarbonate. It is sold sterile and pyrogen free in a Tyvek peel pouch.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Not Found
Key Metrics
Not Found
Predicate Device(s)
Bentley OTC Flow Through Cuvette
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.4410 Cardiopulmonary bypass in-line blood gas sensor.
(a)
Identification. A cardiopulmonary bypass in-line blood gas sensor is a transducer that measures the level of gases in the blood.(b)
Classification. Class II (performance standards).
0
MAR 2 0 1997
Image /page/0/Picture/2 description: The image shows a logo with the letters "IBC" in a stylized font. Each letter is overlaid with a globe graphic, suggesting an international or global theme. The letters are bold and black, creating a strong visual impact. The globe graphics add a layer of complexity to the design.
510(k) SUMMARY
IBC CMO2 Flow Through Cuvette
The IBC CMO2 Flow Through Cuvette is a single piece, single use, disposable component intended for use with the Bentley OxySat Monitor as a direct substitute for the Bentley OTC Flow Through Cuvette. It is sold sterile and pyrogen free in a Tyvek peel pouch. It is substantially equivalent to the Bentley OTC Flow Through Cuvette which is marketed by the Bentley Division of Baxter Healthcare.
| CHARACTERISTIC | CMO2 CUVETTE | OTC CUVETTE |
|---|---|---|
| Packaging | Single, sterile and disposable | Single, sterile and disposable |
| Construction | Single piece molded | 4 molded pieces assembled |
| Sizes | 1/4", 3/8", 1/2" | 1/4", 3/8", 1/2" |
| Material | Polycarbonate | Polycarbonate |
| Sterilization | Ethylene Oxide | Ethylene Oxide |
| Accuracy | Identical (r=.998) | Identical (r=.998) |
| Toxicity | Tripartite Guidelines | Tripartite Guidelines |
| Blood Compatibility | Non-Hemolytic | Non-Hemolytic |
TABLE OF COMPARISON
DISCUSSION OF SIMILARITIES AND DIFFERENCES
The IBC CMO2 Flow Through Cuvette is constructed of a single piece of injection molded polycarbonate while the Bentley OTC Flow Through Cuvette is Assembled by adhesively bonding 4 molded pieces together. The reason for the single piece construction in the CMO2 is to reduce cost of manufacture while at the same time eliminating a source of leaks and product failure (the bonds) and finally to control the final geometry for the least variation in the attachment fit with the OxySat Transducer. The functional geometry and material of construction are identical as is the performance when used according to manufacturer's instructions in the Bentley OxySat monitoring system.