(34 days)
The VACUTAINER Brand Blood Collection Syringe is intended to collect whole blood specimens for diagnostic testing which may include: pH, blood gases, electrolytes (including ionized calcium and magnesium), metabolytes, co-oximetry, and other tests.
The VACUTAINER® Brand Blood Collection Syringe is a sterile, single use device designed to collect whole blood specimens for diagnostic testing. The syringe contains dry calcium-balanced lithium heparin (approximately 50 IU per mL of whole blood) derived from porcine intestinal mucosa, as the anticoagulant. Calcium chloride has been added to the formulation to provide a calcium-balanced lithium heparin solution, specifically allowing the measurement of ionized calcium and magnesium. The calcium chloride solution binds to the heparin prior to blood collection allowing electrolytes such as ionized calcium and magnesium in the blood to be measured without interference from the heparin (calcium-balanced).
VACUTAINER Brand A-LINE Kit: Contains a specifically designed syringe only for aspiration of blood samples from arterial lines.
VACUTAINER Brand PRESET™ Kit: Contains a specifically designed syringe (may include needle) that can be preset to a desired volume, but permits aspiration when necessary. Includes a venting system that expels residual air through the self-venting membrane (as blood fills the syringe), which ensures rapid filling.
VACUTAINER Brand DRIHEP® PLUS Kit: Contains a specifically designed syringe (may include needle) with a self-venting membrane, (which seals automatically upon blood contact), and low plunger resistance which permits preset, aspiration, and natural fill sampling. Plunger auto-stop avoids overfill and leakage.
Please Note: The needle component may be one of two configurations. The needle may be a single lumen hypodermic needle or a SafetyGlide™ Needle, a single lumen hypodermic needle with a hinge safety mechanism.
The provided text describes the 510(k) summary for the VACUTAINER® Brand Blood Collection Syringe. However, it does not contain the detailed information necessary to fully answer all aspects of your request regarding acceptance criteria and a study proving device conformance. The document focuses on demonstrating substantial equivalence to predicate devices rather than reporting specific performance metrics against defined acceptance criteria.
Therefore, I cannot provide a complete answer to all your questions from the given text. I will extract what information is available and note where specific details are missing.
Here's the breakdown of the available information:
Acceptance Criteria and Device Performance
The document states that "Three separate performance studies (anticoagulant & hemolysis, analytical, and clinical) were done to show the performance and equivalence of the principal device with the new calcium-balanced lithium heparin anticoagulant to the predicate devices currently marketed in the United States." It concludes that "All results from the three studies show equivalence between the principal device and the predicate device."
Missing Information:
- Specific quantitative acceptance criteria (e.g., "pH measurement should be within X units of the reference method").
- Reported device performance values for these criteria.
- The actual results of the "anticoagulant & hemolysis, analytical, and clinical" studies. The document only reports "equivalence" without detailing the specific findings.
Therefore, I cannot provide a table of acceptance criteria and reported device performance from this document.
Study Details
Sample size used for the test set and the data provenance:
- Sample Size: Not specified in the provided text.
- Data Provenance: Not specified (e.g., country of origin, retrospective or prospective). The text only indicates the studies were conducted to show equivalence to predicate devices marketed in the United States.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Adjudication Method: Not specified.
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:
- MRMC Study: Not applicable. This device is a blood collection syringe, not an AI-assisted diagnostic tool involving human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Standalone Performance: Not applicable. This device is a medical device (syringe), not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Ground Truth Type: Not explicitly stated. The studies focused on demonstrating "equivalence" in anticoagulant & hemolysis, analytical, and clinical performance, implying comparisons to established reference methods or predicate device performance. For example, "analytical studies" would likely compare measured values (pH, blood gases, electrolytes) to a gold standard analytical instrument.
The sample size for the training set:
- Sample Size: Not applicable. This device is a physical product (syringe), not an algorithm that requires a training set.
How the ground truth for the training set was established:
- Ground Truth Establishment: Not applicable.
In summary, the provided 510(k) summary (K981922) for the VACUTAINER® Brand Blood Collection Syringe mainly focuses on establishing substantial equivalence to existing predicate devices based on the description of the device, its intended use, and general statements about performance studies ("anticoagulant & hemolysis, analytical, and clinical") showing equivalence. It does not provide the detailed quantitative data, sample sizes, or specifics about ground truth establishment that would typically be found in a comprehensive study report for certain types of medical devices, especially AI/ML-based ones.
§ 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.