(393 days)
The Blood Transfer Accessory is a sterile non invasive device for use in venous blood collection procedures in combination with blood collection devices with a male luer feature.
The Blood Transfer Accessory (BTA) is a single use device comprising of a holder made from polypropylene plastic with a female luer feature. A stainless-steel needle covered with a rubber sleeve is attached to the inside of the holder.
The Blood Transfer Accessory (BTA) has a Holder that encases the Needle preventing any needle stick issue with user. The Holder of the Blood Transfer Accessory (BTA) 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 Transfer Accessory (BTA) by pulling away.
The provided text describes the regulatory clearance of a medical device, the Blood Transfer Accessory (BTA), by the FDA. However, it does not contain the detailed information necessary to answer all parts of your request regarding acceptance criteria and performance studies in the context of an AI/human-in-the-loop system. The document focuses on the substantial equivalence of the BTA to a predicate device, primarily through biocompatibility and performance testing of the physical device, not an AI algorithm.
Specifically, the document discusses:
- Acceptance Criteria for the physical device: Things like sterility assurance level, material biocompatibility (ISO 10993 series), and physical performance (flow rate, leakage, holding strength, deformation).
- Studies conducted: Biocompatibility testing and performance testing against international standards (e.g., ISO 80369-7:2016) and benchmarking against the predicate device.
Missing Information:
The document does not include:
- A table of acceptance criteria for an AI system or its reported performance.
- Sample sizes for test sets in an AI context.
- Information on data provenance (country, retrospective/prospective).
- Number of experts, their qualifications, or adjudication methods for ground truth in an AI context.
- Any mention of Multi-Reader Multi-Case (MRMC) comparative effectiveness studies.
- Standalone (algorithm only) performance or human-in-the-loop studies for an AI system.
- The type of ground truth used for an AI system (expert consensus, pathology, etc.).
- Sample size for a training set or how ground truth was established for a training set (as this is not an AI device).
Therefore, I can only provide information based on the physical device's characteristics and its equivalence to a predicate, not for an AI component.
Based on the provided text, here's what can be extracted and what remains unknown regarding acceptance criteria and device performance:
Acceptance Criteria and Device Performance (for the physical Blood Transfer Accessory):
The document primarily focuses on demonstrating substantial equivalence to a predicate device (Vacutainer® Brand Multiple Sample Luer Adapter) based on material, function, and performance tests for the physical device. It does not describe an AI component.
1. Table of acceptance criteria and the reported device performance:
| Acceptance Criteria Category | Specific Acceptance Criteria (as implied/tested) | Reported Device Performance/Conclusion |
|---|---|---|
| Biocompatibility | Compliance with FDA Guidance: ISO 10993-1 for Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity, Pyrogenicity, Hemocompatibility (Coagulation, Platelets, Hemolysis). | "Biocompatibility Testing... was conducted to demonstrate SE [Substantial Equivalence]." "Biocompatibility was evaluated per the FDA Guidance... with the following endpoints: Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity, Pyrogenicity, Hemocompatibility (Coagulation, Platelets and Hemolysis)." The implication is that the BTA passed these tests. |
| Luer Lock Adapter Standard | Compliance with ISO 80369-7:2016 and ISO 80369-20:2015. | "the Luer Lok adapter is tested with reference to the ISO 80369-7:2016 and ISO 80369-20:2015." The implication is that it met the standards. |
| Flow Rate | Comparable time to fill a 3.0 ml blood collection tube with liquid of similar viscosity to blood (benchmarked against predicate). | "Flow Rate: The time taken to fill up a 3.0 ml blood collection Test tube with liquid of viscosity similar to blood is recorded." The conclusion is that "Performance testing demonstrated that this does not raise different questions of safety or effectiveness" implying comparable performance to the predicate. |
| Leakage Test | Withstand maximum number of insertion/evacuation rounds before leakage (benchmarked against predicate). | "Leakage Test: maximum numbers of round of insertion and evacuation of blood collection tube the device can withstand before leakage start occurring at the device is recorded." Implied comparable performance. |
| Evacuation Force Test | Force required to insert/evacuate a blood collection tube (benchmarked against predicate). | "Evacuation Force Test: The force taken to insert or evacuate a blood collection tube into the holder of the device is recorded." Implied comparable performance. |
| Needle Holding Strength | Force to dislodge the needle from the adapter (benchmarked against predicate). | "Holding Strength of needle to Adapter Test: The force taken to dislodge the needle from the adapter is recorded." Implied comparable performance. |
| Sleeve Holding Strength | Force to dislodge the sleeve from the adapter (benchmarked against predicate). | "Holding Strength of sleeve to Adapter Test: The force taken to dislodge the sleeve from the adapter is recorded." Implied comparable performance. |
| Deformation Test | Permanent change in outer diameter after 5kg force for 5 minutes (assesses holder quality). | "Deformation Test: The permanent change in outer diameter of the holder of the device before and after compression by the applied force is measured and recorded." Implied the device maintained integrity. |
| Sterilization | Sterility Assurance Level (SAL) of 10-6 in accordance with ISO 11135-1:2014. | "Sterilization is done in accordance to ISO 11135-1:2014. The Sterility Assurance Level (SAL) is 10-6." (This is stated as both criterion and met performance). |
| Shelf Life | Maintain performance for 1 year. | "Non-Clinical Performance Testing was conducted to demonstrate SE." (indicating the 1-year shelf life was supported by testing, though the predicate had 3 years). |
| Overall | Meet predetermined specifications, be substantially equivalent to predicate, and not raise different questions of safety or effectiveness. | "The result of non-clinical testing demonstrates that the Blood Transfer Accessory (BTA) is substantially equivalent to the predicate device... and has been demonstrated to meet its predetermined specifications." |
2. Sample sizes used for the test set and the data provenance:
- Sample Size: Not specified in the document for any of the performance or biocompatibility tests.
- Data Provenance: Not applicable as this is a physical device testing, not a data-driven AI model. The manufacturing applicant is NSP Tech Pte Ltd, Singapore.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. Ground truth for a physical medical device typically comes from laboratory testing against established standards and engineering specifications, often involving engineers and lab technicians, not clinical experts for "ground truth" in the AI sense.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. This concept applies to human reader studies, not physical device testing.
5. 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:
- Not applicable. This is not an AI device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an AI device.
7. The type of ground truth used:
- For physical device performance: Established international standards (e.g., ISO 80369-7:2016, ISO 11135-1:2014) and benchmarking against a legally marketed predicate device's measured performance characteristics.
- Not applicable for AI-related ground truth types like expert consensus, pathology, or outcomes data, as this is not an AI device.
8. The sample size for the training set:
- Not applicable. This is not an AI device, so there is no "training set."
9. How the ground truth for the training set was established:
- Not applicable. This is not an AI 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.