(393 days)
The Blood Collection Accessory (BUCA) is a single use, sterile and non invasive device used for connecting to venous access device for the collection of blood specimens.
The Blood Collection Accessory (BUCA) is a single use device comprising of a holder made from polypropylene plastic with a male luer feature. A stainless-steel needle covered with a rubber sleeve is attached to the inside of the holder.
The Blood Collection Accessory (BUCA) has a Holder that encases the Needle preventing any needle stick issue with user. The Holder of the Blood Collection Accessory (BUCA) also house the sample collection tube and protects the user or healthcare personnel from direct contact with blood specimen. The Adapter connected to the blood collection device for the blood transfer. The sample collection tube is inserted from the far end of the holder where the opening is located. This transfer is conducted until the required amount of blood is completed. The sample collection tube is then evacuated from the Blood Collection Accessory (BUCA) by pulling it away from the latter.
The provided text describes the acceptance criteria and the study conducted for the Blood Collection Accessory (BUCA) device to demonstrate substantial equivalence to a predicate device, the Vacutainer® Brand Multiple Sample Luer Adapter.
Here's the breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document indicates that the device "passed predetermined acceptance criteria" for various tests, but it does not explicitly list the numerical acceptance criteria for each test. Instead, it states that the tests demonstrated substantial equivalence.
| Acceptance Criteria Category | Reported Device Performance (as stated in the document) |
|---|---|
| Biocompatibility | Evaluated per FDA Guidance ISO 10993-1, with endpoints of Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity, Pyrogenicity, Hemocompatibility (Coagulation, Platelets, and Hemolysis). Result: Biocompatibility Testing was conducted to demonstrate SE. |
| Luer Lok Adapter Conformance | Tested with reference to ISO 80369-7:2016 and ISO 80369-20:2015. |
| Blood Collection Performance (Benchmarking) | Compared against the predicate device for: |
- Flow Rate: Time taken to fill a 3.0 ml blood collection Test tube with liquid of viscosity similar to blood.
- Leakage: Maximum number of insertion/evacuation rounds before leakage.
- Evacuation Force: Force to insert/evacuate a blood collection tube.
- Holding Strength of Needle to Adapter: Force to dislodge needle.
- Holding Strength of Sleeve to Adapter: Force to dislodge sleeve.
- Deformation Test: Permanent change in outer diameter after 5 kg force for 5 minutes. |
| Sterilization | Achieved a Sterility Assurance Level (SAL) of 10^-6 as per ISO 11135-1:2014. |
| Shelf Life | 1 year (The predicate device had 3 years; Non-Clinical Performance Testing was conducted to demonstrate SE for 1 year). |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the sample sizes (number of devices tested) for the performance and biocompatibility tests. It also does not specify the country of origin of the data or whether the studies were retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Not applicable. This device is a physical blood collection accessory, and the "ground truth" for its performance is established through objective physical and chemical testing, not through expert consensus on interpretation.
4. Adjudication Method for the Test Set:
Not applicable. Adjudication methods like 2+1 or 3+1 are typically used in studies involving human interpretation (e.g., image reading), not for the direct measurement of physical device properties.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No. An MRMC study is not relevant for this type of device, which is evaluated based on its physical and biological performance characteristics.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
Not applicable. This device is a physical medical device, not an algorithm or AI system. Its performance is inherently "standalone" in the sense that it is measured directly without human interpretive involvement in the outcome.
7. The Type of Ground Truth Used:
The "ground truth" for this device's performance is based on objective measurements and adherence to international standards and benchmarks against a predicate device. For example:
- Biocompatibility: Adherence to ISO 10993 series and FDA guidance.
- Luer Lok Adapter: Conformance to ISO 80369-7:2016 and ISO 80369-20:2015.
- Performance Testing (Flow Rate, Leakage, Holding Strength, Deformation): Direct physical measurements and comparison to the predicate device's performance benchmarks.
- Sterilization: Achievement of a specific Sterility Assurance Level (SAL) according to ISO 11135-1:2014.
8. The Sample Size for the Training Set:
Not applicable. This is not an AI/ML device, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established:
Not applicable. There is no training set for this device.
§ 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.