(84 days)
The SIMS Pro-Vent® 250 (500) Plus is intended for obtaining small volume samples of blood for the measurement of pH, pO2, pCO2, CO-oximetry, electrolytes (Ca++, Mg++, Na+. Cl-, K+) and the metabolites (Glucose and Lactate).
The SIMS Pro-Vent® 250 (500) Plus contains a precision small volume sampling device for obtaining an arterial blood sample. The device consists of a small gauge needle (25g) attached to a single cannula vented tube with a micro volume of 250ul or 500pl (.25 or .50cc). The SIMS Pro-Vent® 250 (500) Plus is ideal for obtaining blood samples from pediatric, neonatal and geriatric patients. Each device contains approximately 40 units of Calcium Neutralized Dry Lithium Heparin per ml. The 250pl device contains approximately 10 U.S.P. units of heparin and the 500ul device contains approximately 20 U.S.P. units of heparin.
The provided text describes a 510(K) summary for the SIMS Pro-Vent® 250 (500) Plus, an arterial blood sampling kit. The summary focuses on demonstrating substantial equivalence to predicate devices, particularly in terms of performance for blood gas analysis and fill time.
Here's an analysis of the acceptance criteria and study information provided:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state numerical acceptance criteria in a formal table format. Instead, it describes performance in relation to a predicate device. The primary acceptance criteria appear to be:
- No statistical difference in key blood gas parameters (pO2, pCO2, pH, Ca++, Na+, K+, Cl-, Glucose) compared to the predicate device.
- No drift in CO-oximetry measurements compared to baseline.
- Faster fill time and ability to fill under lower pressure compared to a competing predicate device.
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Blood Gas Parameters (pO2, pCO2, pH, Ca++, Na+, K+, Cl-, Glucose) | No statistical difference between the proposed device and the SIMS Pro-Vent® Arterial Blood Sampling Kit with Calcium Neutralized Dry Lithium Heparin (predicate device). |
| CO-oximetry Measurement Drift | No drift in the measurement of CO-oximetry when compared to the baseline for the blood sampled. |
| Fill Time (compared to AVL Scientific Corporation's Microsampler) | The proposed device fills in less time than the predicate device (AVL Microsampler). |
| Ability to Fill Under Pressure (compared to AVL Scientific Corp.) | The proposed device fills under lower pressure than the predicate device (AVL Microsampler). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not specify a sample size for the "side-by-side comparison" or the "fill time" comparison studies. This information is crucial for evaluating the statistical power of the conclusions.
- Data Provenance: The document does not explicitly state the country of origin of the data or whether the study was retrospective or prospective. Given the nature of a 510(k) submission for a medical device (blood sampling kit), it's highly probable the studies were prospective clinical or laboratory evaluations, but this is an inference.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- This question is not applicable in the context of this device. The "ground truth" for the test set was established by direct laboratory measurements of blood parameters and fill times, not by expert interpretation or consensus. The comparison was against measurements from predicate devices or baseline values.
4. Adjudication Method for the Test Set
- This question is not applicable for this type of device and study. Adjudication methods like "2+1" or "3+1" are typically used in studies where human interpretation of medical images or other subjective data is involved. Here, the outcome measures (blood gas values, fill times) are direct quantitative measurements.
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
- This question is not applicable. This document describes a medical device (blood sampling kit), not an AI-powered diagnostic or interpretive system that would involve human readers or AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- This question is not applicable. This device is a physical blood sampling kit, not an algorithm.
7. The Type of Ground Truth Used
- The ground truth was established through direct laboratory measurements of various blood parameters (pO2, pCO2, pH, Ca++, Na+, K+, Cl-, Glucose, CO-oximetry) and physical performance characteristics (fill time, pressure). These measurements were acquired using the proposed device and compared to measurements obtained using established predicate devices or baseline values.
8. The Sample Size for the Training Set
- This question is not applicable. The device is a physical product, not a machine learning model, so there is no "training set" in the computational sense. The design and validation of the device rely on engineering principles and performance testing, not on data training.
9. How the Ground Truth for the Training Set Was Established
- This question is not applicable as there is no training set for this type of device.
§ 862.1675 Blood specimen collection device.
(a)
Identification. A blood specimen collection device is a device intended for medical purposes to collect and to handle blood specimens and to separate serum from nonserum (cellular) components prior to further testing. This generic type device may include blood collection tubes, vials, systems, serum separators, blood collection trays, or vacuum sample tubes.(b)
Classification. Class II.