(88 days)
The CDI System 550 provides continuous, on-line monitoring of the extracorporeal partial pressure of oxygen and carbon dioxide, pH, potassium, oxygen saturation, hemoglobin and temperature. In addition, calculated values of base excess, bicarbonate, oxygen saturation, oxygen delivery and oxygen consumption may also be provided. These parameters are displayed at either actual temperature or adjusted to 37°C. For documentation purposes, the systems integral printer provides a hard copy of displayed parameters.
The CDI System 550 is an AC-powered (battery back-up) microprocessor-based device used with the following components/accessories:
- CDI 550 Monitor ●
- Arterial and/or Venous Blood Parameter Modules (BPM) ●
- CDI Hematocrit/Saturation (H/S) Probe ●
- CDI 540 Gas Calibrator and Calibration Gases (A and B) ●
- CDI 510H Shunt Sensor ●
- Shunt Bypass Line
- CDI H/S Cuvette with or without extension tubing ●
- Monitor Mounting Hardware (Pole Clamp and Cable Head Bracket) ●
- Printer Paper ●
The CDI System 550 measures blood parameters in real time by utilizing a microprocessor based monitor, electro-optics modules (i.e., BPM and H/S probe), fluorescence chemistry technology, and optical reflectance technology. The electro-optics modules connect the monitor to the disposables (i.e., shunt sensor or cuvette) which are inserted into the extracorporeal circuit. Light is emitted from the modules, and the optical responses from the blood via the sensor(s) are measured by the monitor. The blood parameters are measured or calculated by the CDI 550 Monitor in real time, and displayed to the user via a graphical LED display.
The information provided does not contain a study that proves the device meets specific acceptance criteria in terms of clinical performance metrics (e.g., sensitivity, specificity, accuracy) for diagnosis or treatment. The document is a 510(k) premarket notification for the CDI Blood Parameter Monitoring System 550, asserting substantial equivalence to a predicate device (CDI Blood Parameter Monitoring System 500, K133658).
The "Performance Data" section primarily addresses:
- Biocompatibility Testing: Not required as the device does not contact the patient and disposables haven't changed.
- Electrical Safety and Electromagnetic Compatibility (EMC): Compliance with IEC 60601-1 and IEC 60601-1-2.
- Software Verification and Validation Testing: Completed successfully as per FDA guidance for "moderate" level of concern software.
- Design Verification and Validation Testing: Conducted to demonstrate the device performs according to defined design input requirements and meets them through simulated use testing.
- Animal Study: Not required.
- Clinical Studies: Not required.
The document discusses modifications to the device (new calculated parameter, alarm scheme updates, expanded operating ranges for hematocrit/hemoglobin, improved temperature correction algorithm, improved pre-in-vivo calibration performance). These modifications resulted in "modified blood parameter module (BPM) accuracy claims" and expanded "hematocrit (HCT) and hemoglobin (Hgb) operating ranges and their corresponding modified accuracy claims." However, the specific acceptance criteria for these accuracy claims or the data supporting these claims are not detailed in the provided text.
Therefore, many of the requested items cannot be fully answered from the given document as it focuses on demonstrating substantial equivalence through engineering and software testing rather than clinical performance studies with defined acceptance criteria.
Here's a breakdown of what can be extracted and what is missing:
1. A table of acceptance criteria and the reported device performance
| Parameter | Acceptance Criteria (Not Explicitly Stated for Clinical Performance) | Reported Device Performance (Summary) |
|---|---|---|
| General Performance | Device performs pursuant to defined design input requirements. Meets defined design input requirements. | Design verification and validation testing completed successfully, including simulated use testing. |
| Electrical Safety | Compliance with IEC 60601-1 standard. | Complies with IEC 60601-1. |
| EMC | Compliance with IEC 60601-1-2 standard. | Complies with IEC 60601-1-2. |
| Software | Software verification and validation successful per FDA guidance for "moderate" level of concern. | Software verification and validation testing completed successfully. |
| Blood Parameter Module (BPM) Accuracy | Not explicitly stated in terms of specific numeric ranges/tolerances. | Improved temperature correction algorithm resulted in modified accuracy claims for BPM. (Specific claims not provided). |
| Hematocrit (Hct) & Hemoglobin (Hgb) Accuracy/Range | Not explicitly stated in terms of specific numeric ranges/tolerances. | Expanded operating ranges and corresponding modified accuracy claims for Hct and Hgb. (Specific claims not provided). |
| Pre-in-vivo Calibration Performance | Not explicitly stated. | Improved performance prior to in vivo calibration as measured by the HSAT Module. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified. The document mentions "Design verification and validation testing" and "simulated use testing" but does not detail the sample sizes for these tests. There were no clinical studies.
- Data Provenance: Not specified. As clinical studies were not performed or required, there is no mention of country of origin or whether data was retrospective/prospective.
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 studies with expert-established ground truth were performed or referenced for performance evaluation in this document. The testing described is engineering and software validation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable as no clinical studies with adjudicated ground truth were performed or referenced.
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 device is a blood parameter monitoring system, not an AI-assisted diagnostic tool involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- The document implies standalone performance testing for the device's measurements and calculations through "Design verification and validation testing." However, the raw data or detailed results of this standalone performance are not provided, only a summary statement of successful completion.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the engineering and software validation, the "ground truth" would be established by design specifications, industry standards (e.g., IEC 60601-1), and potentially comparison to reference instruments or methods during bench testing. Specific details are not provided in the document. No clinical ground truth (like pathology or outcomes data) was used based on the stated lack of clinical studies.
8. The sample size for the training set
- Not applicable. This is a medical device, not an AI/machine learning algorithm requiring a separate training set in the typical sense. The "training" would be the device's internal calibration and programming based on established physical and chemical principles.
9. How the ground truth for the training set was established
- Not applicable. As above, this is a monitoring device based on established technology, not an AI algorithm that learns from a training set with specific ground truth labels. Its "ground truth" is intrinsically linked to the physical and chemical principles it measures and calculates, developed and verified during its design and engineering phases.
§ 870.4330 Cardiopulmonary bypass on-line blood gas monitor.
(a)
Identification. A cardiopulmonary bypass on-line blood gas monitor is a device used in conjunction with a blood gas sensor to measure the level of gases in the blood.(b)
Classification. Class II (performance standards).