CM02 CUVETTE, 1/2, CM02 CUVETTE, 3/8 AND CM02 CUVETTE, 1/4

K963698 · International Biophysics Corp. · DTY · Mar 20, 1997 · Cardiovascular

Device Facts

• Record ID: K963698
• Device Name: CM02 CUVETTE, 1/2, CM02 CUVETTE, 3/8 AND CM02 CUVETTE, 1/4
• Applicant: International Biophysics Corp.
• Product Code: DTY · Cardiovascular
• Decision Date: Mar 20, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4410
• Device Class: Class 2

Intended 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.

Device Story

Single-use, disposable flow-through cuvette; used with Bentley OxySat Monitor; facilitates blood oxygen saturation monitoring. Input: blood flow through cuvette; Output: optical path for transducer measurement. Operation: single-piece injection-molded polycarbonate housing; replaces multi-piece assembled cuvettes to improve structural integrity, reduce leak risk, and ensure consistent geometry for transducer attachment. Used in clinical settings where OxySat monitoring is required. Benefits: reduced manufacturing cost, improved reliability, and consistent performance compared to predicate.

Clinical Evidence

Bench testing only. Comparative performance analysis against predicate demonstrated identical accuracy (r=.998). Biocompatibility testing performed per Tripartite Guidelines; device confirmed non-hemolytic.

Technological Characteristics

Single-piece injection-molded polycarbonate; available in 1/4", 3/8", and 1/2" sizes; sterile (Ethylene Oxide); disposable; non-hemolytic.

Indications for Use

Indicated for use with the Bentley OxySat Monitor as a flow-through cuvette for blood monitoring in patients requiring oxygen saturation measurement.

Regulatory Classification

Identification

A cardiopulmonary bypass in-line blood gas sensor is a transducer that measures the level of gases in the blood.

Predicate Devices

• Bentley OTC Flow Through Cuvette

Submission Summary (Full Text)

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K963698

MAR 20 1997

# 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.

### TABLE OF COMPARISON

| 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 |

### 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.

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