(177 days)
The Blood Collection Set is intended to be used with vacuum blood collection tube for multiple collections of venous blood.
The Blood Collection Set with Holder is intended to be used with vacuum blood collection tube for multiple collections of venous blood.
The Safety Blood Collection Set is intended to be used with vacuum blood collection tube for multiple collections of venous blood. The safety shield is intended to aid in the protection against accidental needle stick injury.
The Safety Blood Collection Set with Holder is intended to be used with vacuum blood collection tube for multiple collections of venous blood. The safety shield is intended to aid in the protection against accidental needle stick injury.
The Blood Collection Needle is intended to be used with vacuum blood collection tube for multiple collections of venous blood.
The Blood Collection Needle with Holder is intended to be used with vacuum blood collection tube for multiple collections of venous blood.
The Safety Blood Collection Needle is intended to be used with vacuum blood collection tube for multiple collections of venous blood. The safety shield is intended to aid in the protection against accidental needle stick injury.
The Safety Blood Collection Needle with Holder is intended to be used with vacuum blood collection tube for multiple collections of venous blood. The safety shield is intended to aid in the protection against accidental needle stick injury.
The Luer adapter with Holder is intended to be used with vein puncture needle and vacuum blood collection tube for multiple collections of venous blood.
The proposed devices are blood collection devices form a channel between patient's vein and the evacuated blood collection tube intended for collection of blood.
The Blood Collection Set with/without Holder is intended to be used with vacuum blood collection tube for multiple collections of venous blood. It is provided sterile and single use. The proposed devices are composed of Needle cap, Needle cannula, Needle handle, Flexible tube, Connector Luer adapter and Holder.
The Safety Blood Collection Set with/without Holder is intended to be used with vacuum blood collection tube for multiple collections of venous blood. The safety shield to aid in the protection against accidental needle stick injury. It is provided sterile and single use. The proposed devices are composed of Needle cap, Needle cannula, Needle handle, Safety sheath, Flexible tube, Connector, Luer adapter and Holder.
The Blood Collection Needle with/without Holder is intended to be used with vacuum blood collection tube for multiple collections of venous blood. It is provided sterile and single use. The proposed devices are composed of Needle cap, Needle cannula, Needle hub, Luer adapter and Holder.
The Safety Blood Collection Needle with/without Holder is intended to be used with vacuum blood collection tube for multiple collections of venous blood. It is provided sterile and single use. The proposed devices are composed of Needle cannula, Safety sheath, Needle hub, Luer adapter and Holder.
The Luer adapter with Holder is intended to be used with vein puncture needle and vacuum blood collection tube for multiple collections of venous blood. The Pre-attached Holder is designed to aid in protection against accidental non-patient needle injury and blood splatter. It is provided sterile and single use. The proposed devices are composed of Connect base (ABS), Non-patient end needle tube (Stainless Steel SUS304), Rubber sleeve (Gather Isoprene Rubber), Needle Holder (PP).
The provided document is a 510(k) Summary for a Blood Collection Set. It does not contain information typically found in an AI/ML device submission regarding acceptance criteria, study details, human reader performance, or specific ground truth methodologies for algorithmic performance.
Instead, this document focuses on demonstrating substantial equivalence to a predicate device based on regulatory requirements for a traditional medical device (not an AI/ML device). The "acceptance criteria" here refer to conformity with established industry standards and regulations for blood collection devices, rather than performance metrics for an AI algorithm.
Therefore, many of the requested fields cannot be directly answered from the provided text.
Here's an attempt to extract relevant information and explain why other fields are not applicable:
1. A table of acceptance criteria and the reported device performance
The document does not present specific quantitative acceptance criteria or numerical performance results in a table format as would be expected for an AI/ML device validating diagnostic accuracy metrics (e.g., sensitivity, specificity, AUC). Instead, "acceptance criteria" are implied by adherence to recognized standards and successful completion of various tests.
| Acceptance Criterion (Implied by Standards/Tests) | Reported Device Performance |
|---|---|
| Sterility | EO sterilized, SAL: 10-6 |
| Endotoxin Limit | 20 EU per device |
| Needle Performance (ISO 7864:2016, ISO 9626:2016) | Met the requirements of the standards for various gauges and lengths |
| Sharps Injury Protection (ISO 23908:2011, FDA Guidance) | Safety shield intended to prevent needle sticks; met requirements |
| Small-bore Connectors (ISO 80369-7:2016, ISO 80369-20:2015) | Met requirements |
| Seal Strength (ASTM F88/F88M-15) | Met requirements |
| Seal Leak Detection (ASTM F1929-15) | Met requirements |
| Bacterial Endotoxins (USP 41-NF 36:2018 ) | Met requirements |
| Biocompatibility (ISO 10993-5, 10, 11) | Complies with requirements (tests include cytotoxicity, skin sensitization, intracutaneous reactivity, acute systemic toxicity, hemolytic properties, pyrogen, complement activation, PTT, platelet leukocyte count) |
| Ethylene Oxide Sterilization Residuals (ISO 10993-7:2008) | Met requirements |
| Sterilization Process Validation (ISO 11135:2014) | Met requirements |
| Particulate Matter in Injections (USP ) | Met requirements |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not applicable and not provided. The "test set" in this context refers to physical samples of the device undergoing mechanical, chemical, and biological testing, not a dataset for an algorithm. The document does not specify the number of physical units subjected to each test. Data provenance (country, retrospective/prospective) is typically for clinical data or imaging datasets, which are not relevant here.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This is not applicable as the device is not an AI/ML diagnostic or image analysis tool requiring human expert annotation for ground truth. The "ground truth" for this device is established through validated laboratory testing protocols and adherence to international standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable. Adjudication methods like 2+1 are used for resolving disagreements among human annotators in AI/ML performance studies. This is a traditional medical device demonstrating substantial equivalence through bench 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
This is not applicable. No MRMC study was performed as this is not an AI-assisted diagnostic device. The document explicitly states: "No clinical study is included in this submission as the device does not require clinical studies to determine substantial equivalence with the predicate device."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is a physical blood collection implement, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device's performance is established by objective measurements against recognized international standards and validated laboratory test methods. Examples include:
- Physical dimensions and material properties.
- Sterility validation (absence of microorganisms).
- Chemical purity (endotoxin limits, residuals).
- Biocompatibility (absence of toxic, irritating, or sensitizing effects on biological systems).
- Mechanical integrity (seal strength, needle sharpness, flexibility).
8. The sample size for the training set
This is not applicable. There is no AI/ML component, so there is no "training set."
9. How the ground truth for the training set was established
This is not applicable as there is no AI/ML component and therefore no training set.
§ 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.