(247 days)
The Blood Collection Needle with/without holder is intended to be used with vacuum blood collection tube for the collection of venous blood.
The Safety Blood Collection Needle with/without holder is intended to be used with vacuum blood collection tube for the collection of venous blood. The safety shield is intended to aid in the protection against accidental needle stick injury.
The Luer access device- holder with preattached multiple sample adapter is a sterile, non-invasive device used to connect devices with male or female luer connectors to blood collection tubes for the collection of 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 Needle with/without Holder is intended for single use only, which consists of a non-patient needle cap or holder, non-patient needle, rubber sleeve, patient needle cap, patient needle, hub. They are available in different configurations.
The Safety Blood Collection Needle with/without Holder is intended for single use only, which consists of a non-patient needle cap or holder, non-patient needle, rubber sleeve, patient needle cap, patient needle, hub, safety shield. They are available in different configurations. The safety shield will be manually activated to cover the needle immediately after use to minimize risk of accidental needle sticks.
In addition, the proposed devices are available in different specifications of needle gauge(27G-18G) and length (1"-1.5").
The Luer Access Device- holder with Pre-attached Multiple Sample Adapter is intended for single use only, which consists of a holder, non-patient needle, rubber sleeve, and a male (or female) luer lock hub which mates the female (or male) connector of other medical devices. The luer hub is permanent assembled with holder. It can be used to establish a channel to connect with medical vacuum tubes and transfer fluids.
This document is a 510(k) summary for a blood collection device, focusing on its substantial equivalence to predicate devices, rather than an AI/ML device study. Therefore, the requested information on acceptance criteria, AI/ML performance, and related study details is not present in the provided text.
The document discusses the substantial equivalence of the "Blood Collection Needle with/without Holder", "Safety Blood Collection Needle with/without Holder", and "Luer Access Device-holder with Preattached Multiple Sample Adapter" to existing predicate devices (K172763 and K991088).
Here's the relevant information that is available in the document:
1. A table of acceptance criteria and the reported device performance:
The document lists various performance characteristics and standards, indicating that the proposed device complies with them. It doesn't necessarily present these as "acceptance criteria" in the formal sense that one might expect for a novel AI/ML device, but rather as compliance with established norms for similar medical devices.
| Item | Acceptance Criteria (Standard/Requirement) | Reported Device Performance (Compliance Statement) |
|---|---|---|
| Performance (Needles) | ISO 9626, ISO 7864 | Comply with ISO 9626, ISO 7864 |
| Biocompatibility (Needles, leveraged from K172938) | ISO 10993-5 (In Vitro Cytotoxicity), ISO 10993-10 (Skin Sensitization, Irritation), ISO 10993-11 (Acute Systemic Toxicity, Pyrogen), ASTM F756-17 (Hemocompatibility) | Testing leveraged from reference device K172938, results comply with ISO 10993 requirements |
| Biocompatibility (Luer Access Device-holder) | ISO 10993-5 (In Vitro Cytotoxicity), ISO 10993-10 (Skin Sensitization, Irritation), ISO 10993-11 (Acute Systemic Toxicity, Pyrogen), ASTM F756-17 (Hemocompatibility) | Conform with ISO 10993 Standards |
| Sterilization Method | EO sterilized | EO sterilized |
| SAL (Sterility Assurance Level) | 10-6 | 10-6 |
| Endotoxin Limit | 20 EU per device | 20 EU per device |
| Extraction Force Test | Internal test | Able to successfully extract blood from a patient and fill blood tubes |
| Needle Gauge and Length | Varies by configuration (e.g., 20G~23G, 1" | Proposed device has a broader range of gauges (27G-18G) and specified lengths. Difference does not affect safety/effectiveness. |
| Design Feature (Luer Access Device-holder) | Length: 60.8 ± 0.2 mm (proposed); 64.3 mm (predicate K991088) | Difference is just in dimension and does not affect intended use, safety, or effectiveness. |
| Performance (Luer Access Device-holder) | ISO 80369-7 | Comply with ISO 80369-7 |
| Label/Labeling | Conform with 21 CFR Part 801 | Conform with 21 CFR Part 801 |
2. Sample sized used for the test set and the data provenance: Not applicable. This document describes non-clinical performance and biocompatibility testing for a physical medical device (blood collection needles and holders), not an AI/ML system. There is no "test set" in the context of an AI/ML model for which sample size or data provenance would be relevant.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as this is not an AI/ML device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable, as this is not an AI/ML device.
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, as this is not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is not an AI/ML device.
7. The type of ground truth used: Not applicable in the AI/ML sense. The "ground truth" for this device's performance is established by compliance with international and national standards (e.g., ISO standards for sterility, biocompatibility, needle dimensions, performance).
8. The sample size for the training set: Not applicable, as this is not an AI/ML device.
9. How the ground truth for the training set was established: Not applicable, as this is not an AI/ML device.
Summary of the Study:
The document describes non-clinical performance testing for a blood collection device to demonstrate its substantial equivalence to predicate devices. The studies involved:
- Biocompatibility testing: This was either leveraged from a previous reference device (K172938) for the needles or conducted directly for the Luer Access Device-holder. The tests included in vitro cytotoxicity, skin sensitization, irritation sensitivity, acute systemic toxicity, pyrogen test, and hemocompatibility, all complying with ISO 10993 standards and ASTM F756-17.
- Extraction Force Test: An internal test performed on the proposed device to demonstrate its ability to extract blood and fill tubes.
- Compliance with various ISO standards: This includes standards for sterile hypodermic needles (ISO 7864), stainless steel needle tubing (ISO 9626), small-bore connectors (ISO 80369-7, ISO 80369-20), sterilization (ISO 11135), sharps injury protection (ISO 23908), and bacterial endotoxins (USP 41-NF 36:2018 ).
- Sterilization validation: Demonstrated through compliance with EO sterilization, SAL of 10-6, and endotoxin limit of 20 EU per device.
The study concludes that, based on these comparisons and performance testing, the proposed devices are Substantially Equivalent (SE) to the predicate devices. No clinical studies were included in this submission.
§ 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.