(129 days)
(1) Blood Collection Needle for Single Use
The Blood Collection Needle for Single Use is intended to be used with vacuum blood collection tube for multiple collections of venous blood.
(2) Safety Blood Collection Needle for Single Use
The Safety Blood Collection Needle for Single Use 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.
(3) Blood Collection Needle with Holder for Single Use
The Blood Collection Needle with Holder for Single Use is intended to be used with vacuum blood collection tube for multiple collections of venous blood.
(4) Safety Blood Collection Needle with Holder for Single Use
The Safety Blood Collection Needle with Holder for Single Use 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.
(5) Blood Collection Set for Single Use
The Blood Collection Set for Single Use is intended to be used with vacuum blood collection tube for multiple collections of venous blood.
(6) Safety Blood Collection Set for Single Use
The Safety Blood Collection Set for Single Use 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.
(7) Blood Collection Set with Holder for Single Use
The Blood Collection Set with Holder for Single Use is intended to be used with vacuum blood collection tube for multiple collections of venous blood.
(8) Safety Blood Collection Set with Holder for Single Use
The Safety Blood Collection Set with Holder for Single Use 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 subject devices are single use, EtO sterilized with a shelf-life of 5 years. Blood collection needles and holders are intended to be used with a 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.
(1) Blood Collection Needle for Single Use
This product use PP, Polyisoprene rubber and SUS304 as the main materials. It contains needle cap, needle hub, needle tube and needle sleeve.
(2) Safety Blood Collection Needle for Single Use
This product use PP, Polyisoprene rubber and SUS304 as the main materials. It contains needle cap, needle hub with safety shield, needle tube, needle sleeve.
(3) Blood Collection Needle with Holder for Single Use
This product use PP, Polyisoprene rubber and SUS304 as the main materials. It contains needle cap, needle hub, needle tube, needle sleeve, holder.
(4) Safety Blood Collection Needle with Holder for Single Use
This product use PP, Polyisoprene rubber and SUS304 as the main materials. It contains needle cap, needle hub with safety shield, needle tube, needle sleeve, holder.
(5) Blood Collection Set for Single Use
The products use PP, ABS, PVC, Polyisoprene rubber and SUS304 as the main materials. It contains needle cap, needle hub, needle tube, tubing, butterfly wings, needle sleeve.
(6) Safety Blood Collection Set for Single Use
The products use PP, ABS, PVC, Polyisoprene rubber and SUS304 as the main materials. It contains needle cap, safety shield, needle tube, tube, tubing, butterfly wings, needle sleeve.
(7) Blood Collection Set with Holder for Single Use
The products use PP, ABS, PVC, Polyisoprene rubber and SUS304 as the main materials. It contains needle cap, needle hub, needle tube, tubing, butterfly wings, needle sleeve, holder.
(8) Safety Blood Collection Set with Holder for Single Use
The products use PP, ABS, PVC, Polyisoprene rubber and SUS304 as the main materials. It contains needle cap, needle hub, safety shield, needle tube, tubing, butterfly wings, needle sleeve, holder.
The provided text describes a 510(k) premarket notification for various blood collection devices and compares them to a predicate device. This document focuses on demonstrating substantial equivalence to an already legally marketed device rather than proving a novel device meets specific acceptance criteria through a clinical study or AI performance evaluation.
Therefore, many of the requested points related to AI performance, multi-reader multi-case studies, expert consensus, and training/test set ground truth establishment are not applicable to this type of regulatory submission and the information provided.
However, I can extract the relevant information regarding the non-clinical tests performed to demonstrate safety and effectiveness.
Here's the information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria here are derived from compliance with international standards for medical devices, particularly those related to sterile hypodermic needles and stainless steel needle tubing. The "reported device performance" is a statement of conformity to these standards.
| Acceptance Criteria (Standard Requirement) | Reported Device Performance (Conformity Statement) |
|---|---|
| Biocompatibility (ISO 10993 series): | Conforms to the requirements of ISO 10993 series Standards |
| - No cytotoxicity | No cytotoxicity |
| - No irritation to skin | No irritation to skin |
| - No significant evidence of sensitization (?) | No significant evidence of sensitization (?) |
| - No systemic toxicity | No systemic toxicity |
| - No hemolysis | No hemolysis |
| - No pyrogen | No pyrogen |
| Physical, Mechanical, Chemical Testing (ISO 7864): | Conforms with the requirements of ISO 7864:2016-08-01 |
| - Cleanliness | Tested and met requirements |
| - Limits for acidity or alkalinity | Tested and met requirements |
| - Limits for extractable metals | Tested and met requirements |
| - Size designation | Tested and met requirements |
| - Colour coding | Tested and met requirements |
| - Needle hub | Tested and met requirements |
| - Needle cap | Tested and met requirements |
| - Needle tube | Tested and met requirements |
| - Needle point | Tested and met requirements |
| - Bond between hub and needle tube | Tested and met requirements |
| - Patency of lumen | Tested and met requirements |
| Stainless Steel Needle Tubing (ISO 9626): | Conforms with the requirements of ISO 9626:2016-08-01 |
| - Limits for acidity or alkalinity | Tested and met requirements |
| - Surface finish and visual appearance | Tested and met requirements |
| - Cleanliness | Tested and met requirements |
| - Size designation | Tested and met requirements |
| - Dimensions | Tested and met requirements |
| - Stiffness | Tested and met requirements |
| - Resistance to breakage | Tested and met requirements |
| - Resistance to corrosion | Tested and met requirements |
| Small-Bore Connectors (ISO 80369-7): | Conforms with the requirements of ISO 80369-7:2016-10-15 |
| - Leakage by pressure decay | Tested and met requirements |
| - Positive pressure liquid leakage | Tested and met requirements |
| - Sub-atmospheric pressure air leakage | Tested and met requirements |
| - Stress cracking | Tested and met requirements |
| - Resistance to separation from axial load | Tested and met requirements |
| - Resistance to separation from unscrewing | Tested and met requirements |
| - Resistance to overriding | Tested and met requirements |
| Sharps Injury Protection (ISO 23908: 2011) | Tested and met requirements (for safety devices) |
| Risk Management (ISO 14971: 2019) | Risk Management Report was generated |
| Sterility Assurance Level (SAL) | $10^{-6}$ (Same as predicate) |
Note on "No significant evidence of sterilization": This phrasing appears in the document's comparison table under biocompatibility, but it's likely a typo and should refer to "sensitization" (as in ISO 10993-10).
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify the exact sample sizes for each non-clinical test (e.g., how many needles were tested for patency, or how many samples for biocompatibility). It states tests were performed "on the subjective device."
- Data Provenance: The tests were conducted as part of the submission process for the manufacturer, Jiangsu Micsafe Medical Technology Co., Ltd in China. The data would be prospective as it was generated specifically for this regulatory submission.
3. Number of Experts Used to Establish Ground Truth and Qualifications of Experts
- This information is not applicable. The ground truth for this device's performance is established by compliance with international standards and laboratory testing protocols, not by expert consensus in a clinical setting for diagnostic purposes.
4. Adjudication Method for the Test Set
- This information is not applicable. Adjudication methods (like 2+1, 3+1) are common in clinical trial ground truth establishment, especially for image-based diagnostic AI, not for physical device performance testing against engineering standards.
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 information is not applicable. This is a submission for physical blood collection devices, not an AI/diagnostic software. No MRMC study was done, nor would it be relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This information is not applicable. This is not an algorithm or AI device.
7. The Type of Ground Truth Used
- The "ground truth" for this submission is compliance with established international standards for medical devices (ISO standards). This involves objective measurements, chemical analyses, and physical performance tests conducted in a laboratory setting. A "simulated clinical use study" was also performed for the safety mechanism, where the success of the safety feature would be the measured outcome against pre-established criteria.
8. The Sample Size for the Training Set
- This information is not applicable. There is no "training set" as this is not an AI/machine learning device.
9. How the Ground Truth for the Training Set was Established
- This information is not applicable. There is 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.