(210 days)
The Kurin Blood Culture Collection Set is a winged blood collection needle with flexible tubing intended for venipuncture to obtain blood samples. It is provided with a safety shield for covering the used venipuncture needle prior to disposal to aid in the prevention of needlestick injury if manually activated after the blood collection, the set also includes a blood collection holder for connection to vacuum-based collection vials.
The Subject Device is a sterile, single-use blood culture collection set. The blood collection set incorporates a venipuncture needle assembly that is connected with flexible tubing to a blood lock mechanism that is connected by flexible tubing to a blood collection holder. Blood collection is accomplished by inserting the venipuncture needle into the patient's peripheral vascular system. Blood will travel up the lumen into the blood lock mechanism where the initial draw of blood (approximately 0.15 ml) is held in a side chamber. The purpose of the side chamber is to automate the initial specimen diversion volume method (ISDVM). Once the side chamber volume is retained, the blood upon connection to a vacuum bottle continues to travel up the lumen to the blood collection holder into the attached blood culture bottle/vial.
The Subject Device's venipuncture needle assembly incorporates an active, semi-automatic needlestick safety design where the safety mechanism is activated via a button on the needle hub. When the safety mechanism is activated, a protective shield is deployed. It advances distally to cover the entire length, including the distal tip, of the venipuncture needle. The protective shield is locked in this position protecting the clinician/patient from needlestick injuries. Silicone coating is applied to the outside of the venipuncture needle, which aids in the insertion into the peripheral vascular system.
The Subject Device incorporates various blood collection holders to interact with various types of vacuum-based collection vials.
The Kurin Blood Culture Collection Set with Kurin Lock Technology, Push-Button Needle, has undergone various evaluations to demonstrate its substantial equivalence to a predicate device. Here's a breakdown of the acceptance criteria and the supporting study information:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document doesn't present a formal table of specific, quantified acceptance criteria for each test. Instead, it lists the types of evaluations performed and implies that the performance met acceptable standards for demonstrating substantial equivalence. The "Reported Device Performance" column below is based on the conclusion stated in the document that the device "has demonstrated it is substantially equivalent... based on the intended use and performance testing conducted."
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Sterilization (product adoption per AAMI TIR 28) | Successfully met requirements for Ethylene Oxide sterilization (SAL 10-6). |
| Biocompatibility | Successfully met biocompatibility requirements. |
| Pyrogenicity | Successfully met pyrogenicity requirements. |
| Needle Performance (Stiffness, Resistance to Breakage, Corrosion) | Successfully met performance standards for stiffness, resistance to breakage, and resistance to corrosion. |
| Device Performance (Functionality, Leakage, Flow Rate, Needlestick Safety Mechanism, Tensile Strength) | Demonstrated proper functionality, no leakage, acceptable flow rate, effective needlestick safety mechanism, and adequate tensile strength. |
| Packaging Integrity (Visual Inspection, Gross Leak, Dye Penetration, Seal Strength Batch) | Successfully maintained packaging integrity through visual inspection, gross leak (bubble emission), dye penetration, and seal strength (peel) tests. |
| Blood Collection Holder and Compatibility with Blood Culture Bottles | Demonstrated compatibility with various blood culture bottles and established blood collection holders. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample sizes (number of devices or tests performed) for each individual test conducted to support the 510(k) submission. It broadly states that "evaluations were conducted."
The data provenance is implicit: the tests were conducted by Kurin, Inc. to support their premarket notification. Therefore, this would be considered prospective data collected specifically for regulatory submission. There is no information provided about the country of origin for the data collection, but given the company's address in San Diego, California, it is reasonable to infer the testing was likely conducted in the United States or under conditions compliant with U.S. regulatory standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This type of information (number and qualifications of experts for ground truth establishment) is typically not applicable to the evaluation of mechanical or material performance of a blood collection device, which relies on standardized engineering and biological tests rather than expert interpretation of complex clinical data. The "ground truth" for these tests is defined by the passing criteria of the relevant ISO standards and FDA guidance documents.
4. Adjudication Method for the Test Set
Adjudication methods (e.g., 2+1, 3+1) are usually relevant for studies involving human interpretation or clinical outcomes where discrepancies need to be resolved. For the types of performance and material tests described for this device, which are objective and quantitative, an adjudication method is not applicable. The results are typically pass/fail based on pre-defined criteria from recognized standards.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done or mentioned in the provided text. MRMC studies are typically employed for diagnostic imaging devices or algorithms where the performance of human readers (with and without AI assistance) is compared. This device is a blood specimen collection device, not an imaging or diagnostic AI tool.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
No, a standalone (algorithm only) performance study was not done or mentioned. This device is a physical medical device for blood collection, not an algorithm or AI system.
7. Type of Ground Truth Used
The "ground truth" for the various evaluations conducted for this device was established based on recognized industrial standards, international standards (ISO), and FDA guidance documents.
Examples of ground truth sources include:
- AAMI TIR 28 for sterilization.
- ISO 10993-1:2018 for biocompatibility.
- ISO 1135-3:2016 for blood-taking sets.
- ISO 7864:2016 and ISO 9626:2016 for sterile hypodermic needles.
- ISO 23908:2011 for sharps injury protection.
- ISO 11135:2014 for ethylene oxide sterilization.
- ISO 11607-1:2006 for packaging integrity.
- FDA Guidance documents (e.g., Medical Devices with Sharps Injury Prevention Features).
The outcomes of these tests are objective measurements against the specified criteria within these standards.
8. Sample Size for the Training Set
The concept of a "training set" is not applicable to the evaluation of this medical device. Training sets are used in machine learning and AI development. The evaluations performed here are for a physical product and its constituent materials and mechanisms.
9. How the Ground Truth for the Training Set Was Established
As there is no training set for this type of device evaluation, this question is not applicable.
§ 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.