(33 days)
The arterial blood sampling syringe is intended for sampling of arterial blood for the measurement of p02, pCO2, pH, CO-oximetry, electrolytes (Ca++, Na++, K+, Cl+, and Mg++), Total Magnesium, and the metabolites (Glucose and Lactate).
A commercially available hypodermic needle is modified by dispensing sodium heparin into the hub and cannula and then drying the heparin. The total recoverable volume of the heparin is approximately 5 U.S.P. units. The needle is then attached to a Pro-Vent® or Pulsator® Arterial Blood Sampling Syringe, which contains approximately 25 U.S.P. units of Calcium Neutralized Dry Lithium Heparin. The device is packaged and sterilized by Ethylene Oxide.
Here's an analysis of the provided text regarding the Pro-Vent® and Pulsator® Arterial Blood Sampling Syringes:
K981035: Acceptance Criteria and Study Details
Based on the provided 510(k) summary, the device's acceptance criteria and the study proving it meets these criteria are primarily based on demonstrating substantial equivalence to a previously cleared predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Functional Equivalence: The proposed syringes with dual heparin (dry calcium neutralized lithium heparin in syringe, dried sodium heparin in needle) must perform equivalently to the predicate device (Arterial Blood Sampling syringes with Calcium Neutralized Dry Lithium Heparin) for arterial blood sampling. | A side-by-side comparison was conducted. |
| Analytical Equivalence: The measurements obtained from blood samples using the proposed syringes must be statistically indistinguishable from those obtained using the predicate device for parameters including: pO2, pCO2, pH, CO-oximetry, Ca++, Mg++, Na+, K+, Cl-, Total Magnesium, Glucose, and Lactate. | "The results of the measurements were compared. There was no statistical difference between the proposed syringes and the predicate device" for all specified measurements (pO2, pCO2, pH, CO-oximetry, Ca++, Mg++, Na+, K+, Cl-, Total Magnesium, Glucose, and Lactate). This implies that the proposed syringe maintained the accuracy and reliability of the measurements compared to the predicate. |
| Material Equivalence: The materials of the syringe and needle should be unchanged from the predicate. | "Materials of the syringe and needle are unchanged from our current Arterial Blood Gas Sampling Syringes." |
| Sterilization Equivalence: Sterilization methods should be the same as those employed for the predicate. | "Sterilization is by the same methods employed in our existing Arterial Blood Gas Sampling Syringes, as authorized by FDA in 510(k) K952516." |
| Safety and Effectiveness: Demonstrate the proposed device is safe and effective. | "The testing performed and comparison to the predicate device demonstrate that the proposed device is safe and effective and is substantially equivalent to the predicate device." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify the sample size used for the side-by-side comparison test.
- Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. Given the nature of a 510(k) submission for a medical device modification, it is highly likely the data was prospectively collected as part of a formal verification and validation study. The testing was conducted by the manufacturer, SIMS Portex Inc.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- The document does not mention the use of experts to establish ground truth for this non-clinical study. The "ground truth" for this device comparison is the established performance of the legally marketed predicate device as measured by standard laboratory analysis. The comparison itself aims to show that the new device yields results consistent with these established analytical methods.
4. Adjudication Method for the Test Set
- No adjudication method is mentioned. This type of non-clinical comparison study evaluating analytical performance would not typically involve human adjudication in the way medical imaging studies might. The "adjudication" is based on statistical comparison of laboratory measurements.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
- No, an MRMC comparative effectiveness study was not done. This device is an arterial blood sampling syringe, and its performance is evaluated based on the analytical results of the blood sample, not on human interpretation of images or clinical findings. Therefore, an MRMC study is not applicable.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was Done
- Yes, in essence, a standalone performance was done for the device itself. The "device performance" in this context is its ability to collect a blood sample and preserve its analytes such that standard laboratory analysis yields results statistically equivalent to those obtained with a predicate device. This is inherently a "standalone" evaluation of the syringe's function prior to external analytical measurement. There is no "algorithm" involved in the clinical use or intended function of the syringe.
7. The Type of Ground Truth Used
- The ground truth relied upon the analytical performance of the legally marketed predicate device. The "truth" for this study is that the predicate device's performance characteristics (e.g., how well it preserves pO2 or pH values) are acceptable and that the new device yields comparable analytical results when measured by standard laboratory equipment. It's a comparison to an established and accepted device, rather than an independent "ground truth" like pathology or long-term outcomes.
8. The Sample Size for the Training Set
- Not applicable. This submission describes a non-clinical comparison study for a physical medical device (a syringe), not an algorithm or AI model that requires a "training set." There is no mention of machine learning or AI in the document.
9. How the Ground Truth for the Training Set was Established
- Not applicable. As there is no training set mentioned or implied for an AI/algorithm, this question is not relevant to the provided document.
§ 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.