(128 days)
The Blood Culture Holder is used to fill blood into blood culture bottles and tubes in routine venipuncture procedures. This device is to be used by properly trained healthcare professionals only in accordance with these instructions.
The SAFETY Blood Collection Set and/or Blood Collection Set + Blood Culture Holder are used in routine venipuncture procedures. The winged needle of the SAFETY Blood Collection Set is designed with a while shield, which can be activated to cover the needle immediately following blood collection to aid in the protection against accidental needlestick injury. The Blood Culture Holder is used to fill blood into blood culture bottles and tubes.
The Blood Culture Holder is a single-use, non-sterile, plastic holder with threads which are compatible with male luer adapters. The holder can be used with all VACUETTE® Multiple Sample Luer Adapters and Safety Blood Collection Sets for routine venipuncture into various manufacturers' evacuated blood culture bottles and tubes. It is supplied alone or with the Greiner sterile Safety Blood Collection Set with Luer Adapter.
The Blood Culture Holder does not come into contact with the blood specimen. It is an external holder for the Safety Blood Collection Set and the VACUETTE® Multiple Sample Luer Adapter. The Safety Blood Collection Set consists of tubing with a blood collection needle at one end and a female luer at the other. The VACUETTE® Multiple Sample Luer Adapter consists of a male luer at one end and a cannula covered with a sheath. The luer adapter is threaded into the Blood Culture Holder, with the male luer end on the outside and the covered cannula on the inside of the holder barrel. The blood flows through the blood collection needle and tubing of the Safety Blood Collection Set, into the male luer of the VACUETTE® Multiple Sample Luer Adapter, through the luer into the cannula, and into the blood culture tube or holder when punctured by the cannula. The fluid path consists of the Safety Blood Collection Set and the VACUETTE® Multiple Sample Luer Adapter. The Blood Culture Holder never comes into contact with the blood specimen during conditions of use.
When the Blood Culture Holder is supplied attached to the Safety Blood Collection Set and the VACUETTE® Multiple Sample Luer Adapter, it undergoes sterilization as part of the entire system because the fluid path must be sterilized. However, when the Blood Culture Holder is provided alone, it is not sterilized and the user attaches their own sterile blood collection needle and luer adapter.
The Safety Blood Collection Set with Blood Culture Holder is non-pyrogenic and tested according to ISO-10993-11 rabbit pyrogen test. The devices also are below the limit for endotoxin and tested according to ISO-10993-11 LAL Turbidimetric Method.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Blood Culture Holder:
Acceptance Criteria and Device Performance Study for Greiner Bio-One North America, Inc. Blood Culture Holder
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Fit of Blood Culture Holders to Safety Blood Collection Sets | Met acceptance criteria for fit. |
| Leakage of Blood Culture Containers | Met acceptance criteria for leakage. |
| Function of Blood Culture Containers | Met acceptance criteria for function. |
| Leakage of Blood Collection Tubes | Met acceptance criteria for leakage. |
| Function of Blood Collection Tubes | Met acceptance criteria for function. |
| Compatibility with Blood Culture Bottles/Vials | The Blood Culture Holder can be used with blood culture bottles and blood culture vials. |
| Compatibility with Blood Collection Tube Sizes | The Blood Culture Holder can be used with the range of blood collection tube sizes from 13x75mm (smallest diameter cap and tube size) to 16x100mm (largest diameter cap and tube size). |
| Non-pyrogenic | Tested according to ISO-10993-11 rabbit pyrogen test and found to be non-pyrogenic. |
| Below Endotoxin Limit | Tested according to ISO-10993-11 LAL Turbidimetric Method and found to be below the limit for endotoxin. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Twenty (20) Blood Culture Holders were connected to 20 Safety Blood Collection Sets with Luer Adapters.
- Data Provenance: The study was a simulated blood draw testing conducted by the manufacturer, Greiner Bio-One North America, Inc. The country of origin of the data is not explicitly stated but can be inferred as the USA, where Greiner Bio-One North America, Inc. is located. It is a prospective study as it involved testing new devices.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- The document does not mention the use of experts to establish ground truth for the simulated blood draw testing. The evaluation of proper fit, leakage, and function appears to have been performed internally by the manufacturer's testing personnel, based on pre-defined criteria.
4. Adjudication Method for the Test Set
- The document does not mention any adjudication method (e.g., 2+1, 3+1, none) for the test set. The evaluation seems to be a direct assessment against the defined acceptance criteria.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
- No MRMC comparative effectiveness study was done. This study focuses on the performance of a medical device (Blood Culture Holder) in a standalone, mechanical/functional context, not on the comparative effectiveness of human readers with or without AI assistance. Therefore, there is no effect size of human readers improving with AI vs. without AI assistance.
6. Standalone Performance Study
- Yes, a standalone study was done. The "Product Performance" section describes a study of the Blood Culture Holder and Safety Blood Collection Set with Luer Adapter's performance in simulated blood draws. This study evaluates the algorithm's (in this case, the device's) function without human intervention influencing the fundamental mechanical performance being assessed.
7. Type of Ground Truth Used
- The ground truth used was based on pre-defined engineering and functional specifications/acceptance criteria for fit, leakage, and function. This is a form of empirical ground truth where the device's physical performance is directly observed and measured against established performance standards. For pyrogenicity and endotoxin, the ground truth was based on adherence to ISO-10993-11 standards.
8. Sample Size for the Training Set
- The document does not mention a training set as this is a physical medical device, not an AI or algorithmic system that requires machine learning training. The focus is on product performance validation, not algorithm development.
9. How the Ground Truth for the Training Set Was Established
- As there is no training set mentioned or required for this type of device, 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.