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510(k) Data Aggregation
(84 days)
BIOTREND OXYGEN SATURATION AND HEMATOCRIT SYSTEM
The BioTrend Oxygen Saturation and Hematocrit System measures percent oxygen saturation and hematocrit of the blood in the extracorporeal circuit. The extracorporeal circuit is used for, but is not limited to, cardiopulmonary bypass, closed-chest support, and limb perfusion.
The modified BioTrend Oxygen Saturation and Hematocrit System is an on-line monitoring instrument that combines both venous (SvO2) and arterial (SaO2) oxygen saturation measurement with hematocrit (Hct) measurement. The BioTrend System consists of the BioTrend Instrument, two Sensor Cables, and a power cord. The BioTrend system is designed to be used with the Tri-optic Measurement Cells.
The Tri-optic Measurement Cell is a disposable device in the extracorporeal circuit that provides a sealed interface between the blood pathway and the BioTrend sensor cable. No change is being made to the Tri-optic Measurement Cell, which was previously cleared under K910421 and K012743.
Using fiber optic technology, the BioTrend System continuously measures the percentage of oxygen saturation and hematocrit and displays the results on large, easy-to-read, color-coded Light Emitting Diodes (LEDs). The display panel indicates operating status and error messages, and provides a means for system calibration.
BioTrend Sensor Cables connect to the BioTrend instrument and the in-line Tri-optic Measurement Cells (TMC) to transmit optical measurement signals. The BioTrend sensor cables isolate the patient from the instrument electronics, providing patient protection. The BioTrend instrument contains a built-in, rechargeable battery pack to provide the battery power. Consequently, the BioTrend instrument can be operated on AC or battery power. A continuous, built-in self-check immediately alerts the operator of equipment failure and displays a corresponding error code.
This submission (K093652) is for a modification to an existing device, the BioTrend Oxygen Saturation and Hematocrit System, and does not include a study to prove the device meets acceptance criteria related to clinical performance.
The modifications are to the hardware and software of the BioTrend Instrument, and the submission emphasizes that the "fundamental scientific technology and the intended use are unchanged." Consequently, clinical testing was not required to establish substantial equivalence.
Here's an analysis based on the provided document, addressing the requested points:
Description of Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria
This 510(k) submission for the modified BioTrend Oxygen Saturation and Hematocrit System (K093652) establishes substantial equivalence to its predicate device (K954501) through a series of preclinical (bench) tests. Clinical effectiveness was not evaluated as part of this submission, as the modifications were to the instrument's hardware and software, with no change to the core measurement technology, intended use, or performance claims. Therefore, specific clinical acceptance criteria, a multi-reader multi-case study, or a standalone algorithm performance study are not relevant to this submission.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not provide a table with specific quantitative acceptance criteria or reported device performance for a clinical outcome. Instead, it lists various "Preclinical testing data were used to establish the performance characteristics of the modifications to this device." These tests were designed to ensure the modified device maintained its original performance and met safety requirements.
| Test Category | Acceptance Criteria (Implied) | Reported Performance |
|---|---|---|
| Blood Testing | Verify oxygen saturation and hematocrit measurement accuracy. (Implied: maintain accuracy of predicate device) | Not explicitly detailed, but implied as successful |
| Environmental Testing | Verify operational temperature, storage temperature, thermal shock, storage humidity, vibration, mechanical shock, cautery, defibrillation, spill resistance, and chemical resistance. | Not explicitly detailed, but implied as successful |
| Packaging Testing | Verify packaging requirements per ASTM D 4169 performance testing (Distribution Cycle 13, Assurance Level 1). | Not explicitly detailed, but implied as successful |
| System Testing | Verify the device meets system-level requirements. | Not explicitly detailed, but implied as successful |
| Software Testing | Verify the device meets software requirements. | Not explicitly detailed, but implied as successful |
| Hardware Testing | Verify PCB assemblies meet design specifications. | Not explicitly detailed, but implied as successful |
| UL/TUV Testing | Verify the device meets emissions, immunity/susceptibility, and safety requirements. | Not explicitly detailed, but implied as successful |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not applicable in the context of a clinical performance study. The "test set" for this submission comprised various physical components and software modules of the BioTrend Instrument. The document specifies "Blood testing" was conducted, but it doesn't provide details on the number of blood samples or their characteristics.
- Data Provenance: Not applicable in the context of a clinical performance study. The tests were preclinical bench tests, not involving human subjects or clinical data collection.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. This submission relies on engineering and scientific testing to demonstrate substantial equivalence, not expert consensus on clinical ground truth.
4. Adjudication Method for the Test Set
Not applicable. Clinical adjudication methods are not relevant to the bench testing conducted for this submission.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. The submission explicitly states, "Clinical testing was not required to establish substantial equivalence."
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
A "Software testing" was done "to verify the device meets the software requirements called out in the software requirements document." This implies testing of the algorithm's performance in isolation from user interaction, but it is not a standalone clinical performance study to assess accuracy against a clinical ground truth. The algorithm for oxygen saturation and hematocrit calculation remains the same as the predicate device.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
For the "Blood testing" mentioned, the ground truth would have been established by a reference method for measuring oxygen saturation and hematocrit. However, the document does not specify this method. For other tests (environmental, packaging, system, software, hardware, UL/TUV), the "ground truth" would be adherence to established engineering specifications, regulatory standards, and internal requirements documents.
8. The Sample Size for the Training Set
Not applicable. This device is an on-line monitoring instrument, not an AI/ML algorithm that undergoes a training phase for a specific diagnostic task from a dataset. The phrase "Same Algorithm used to calculate oxygen saturation and hematocrit" indicates that the core calculation method is pre-established and carried over from the predicate device.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as this device does not utilize a "training set" in the context of machine learning. The algorithm is based on established principles of optical measurement for oxygen saturation and hematocrit.
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(110 days)
BIOTREND OXYGEN SATURATION & HEMATOCRIT SYSTEM
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