(879 days)
The Velano Vascular Blood Collection Adapter is indicated for use as a blood collection system that manually diverts the initial specimen prior to collection of a subsequent test sample to reduce the frequency of blood culture contamination when contaminants are present in the initial blood sample compared to blood cultures drawn with standard procedure without manual diversion.
The Blood Collection Adapter is a sterile, single-use device that removes the initial portion of the blood specimen (potentially contaminated) into a waste or discard tube prior to collecting a subsequent blood sample. The Blood Collection Adapter is comprised of a transfer device, a waste tube, a skirt that holds the waste tube in place, and an adapter inside the transfer device that is used for narrow neck culture tubes and additional blood collection tubes. The device is designed to be attached to a newly placed IV-line, vascular access device, or venipuncture needle set and is not intended for blood specimen collection from preexisting lines or IV site. Place a new peripheral IV catheter prior to drawing blood sample. The device collects approximately 3mL of the initial blood sample into the waste tube. The subsequent blood sample is collected directly into a culture bottle (not provided by Velano Vascular) or into an evacuated tube for additional processing.
Acceptance Criteria and Device Performance Study for Velano Vascular Blood Collection Adapter
The provided FDA 510(k) summary for the Velano Vascular Blood Collection Adapter (K201237) outlines the device's indications for use and the testing performed to demonstrate its substantial equivalence to a predicate device. The core function of the device is to reduce blood culture contamination by diverting the initial potentially contaminated blood specimen.
While the document does not explicitly present a formal "acceptance criteria table" with numerical metrics for clinical efficacy (e.g., specific contamination rate reduction targets), the contamination study serves as the primary evidence for meeting the performance requirement related to its intended use: reducing blood culture contamination.
1. Table of Acceptance Criteria and Reported Device Performance
Given the nature of the device and the provided documentation, the acceptance criteria are implicitly derived from the successful outcome of the contamination study, demonstrating the device's ability to prevent the passage of contaminants under simulated conditions.
| Acceptance Criteria Category | Specific Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Functional Performance | Device mechanically functions as intended, including proper diversion of waste blood and collection of subsequent samples. No leaks or malfunctions during simulated use. | - Visual inspection: Passed |
- Simulated shipping: Passed
- Dimensional measurements: Passed
- Activation force: Passed
- Inlet compatibility: Passed
- Outlet compatibility: Passed
- Simulated use: Passed
- Discard volume: Achieved 3mL discard
- Multiple engagements: Passed |
| Sterilization | Device achieves and maintains sterility. | - Ethylene Oxide Sterilization: Performed to ISO 11135 and AAMI TIR28, achieving a minimum SAL of 1 x 10-6. |
| Biocompatibility | Device materials are biocompatible and do not cause adverse biological reactions. | - In vitro cytotoxicity: Passed (ISO 10993-5) - Skin sensitization: Passed (ISO 10993-10)
- Irritation: Passed (ISO 10993-23) |
| Efficacy (Contamination Reduction) | Device effectively prevents the passage of various bacterial contaminants from the initial diverted sample to the subsequent collected sample under simulated use conditions. | - Contamination Study: Test samples using the Blood Collection Adapter demonstrated no growth of
Staphylococcus aureus, Bacillus Cereus, Escherichia coli, Pseudomonas aeruginosa from the collected sample. |
2. Sample Size Used for the Test Set and Data Provenance
-
Contamination Study (Test Set):
- Sample Size: The document states "Test samples" and "all positive control test samples" but does not explicitly provide the numerical sample size (number of devices or tests performed) for this study.
- Data Provenance: The study was a "simulated use" study, implying it was conducted in a laboratory setting, not on human subjects. Therefore, there is no country of origin of data or retrospective/prospective classification in the typical clinical study sense.
-
Functional and Safety Testing (Excluding Contamination Study):
- Sample Size: The document does not specify the sample size for tests like visual inspection, simulated shipping, dimensional measurements, etc.
- Data Provenance: These are laboratory-based engineering and quality assurance tests.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The provided document does not indicate that expert review was used to establish ground truth for the contamination study or other functional/safety tests. The ground truth for the contamination study was established through laboratory culture results (presence or absence of bacterial growth).
4. Adjudication Method for the Test Set
Not applicable. The contamination study's outcome (bacterial growth or no growth) is an objective laboratory result, not subject to subjective interpretation requiring an adjudication process.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. This type of study is typically used for diagnostic imaging devices where human readers interpret medical images with and without AI assistance. The Velano Vascular Blood Collection Adapter is a mechanical blood collection device, not an imaging or diagnostic algorithm.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
Yes, the contamination study effectively represents a standalone performance evaluation of the device's ability to prevent contamination. The device's efficacy in diverting contaminants was assessed independently in a simulated environment, without direct human influence on the contamination-prevention mechanism during the "collection" phase of the study setup. While human manipulation is required to use the device, the study isolates the device's functional performance regarding contamination prevention.
7. The Type of Ground Truth Used
- Contamination Study: The ground truth was laboratory culture results (positive for growth in controls, negative for growth in test samples). This is a definitive biological outcome.
- Functional and Safety Testing: The ground truth was based on engineering specifications and established test methodologies (e.g., measurements falling within specified ranges, successful activation, absence of visible defects).
8. The Sample Size for the Training Set
Not applicable. The Velano Vascular Blood Collection Adapter is a mechanical device, not an artificial intelligence (AI) or machine learning (ML) algorithm. Therefore, there is no "training set" in the context of AI/ML.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for an AI/ML algorithm.
§ 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.