(60 days)
The safety winged blood collection set is single-use, sterile, winged venipuncture needle bonded to a flexible tubing with or without a luer adaper and/or tube holder. The device is used for blood collection and/or the short-term infusion of intravenous fluids (up to 2 hours under direct clinical supervision). The blood-collection needle is designed to be covered with a safety mechanism, which can be activated to cover the needle immediately following venipuncture to aid in the protection against accidental needlestick injury.
The Promisemed Safety Blood Collection sets are single-use, sterile, venipuncture needles used for blood collection or short-term infusion of intravenous fluids (up to 2 hours under direct clinical supervision). The blood-collection needle is designed to be covered with a safety mechanism, which can be activated to cover the needle immediately following venipuncture to aid in the protection against accidental needlestick injury.
This document describes the premarket notification (510(k)) for the Promisemed Safety Winged Blood Collection Set. The core of this submission is to demonstrate "substantial equivalence" to a legally marketed predicate device (K170276). It does not involve AI or algorithms, but rather a physical medical device. Therefore, many of the requested elements regarding AI/algorithm performance are not applicable.
Here's an analysis based on the provided document:
1. A table of acceptance criteria and the reported device performance
The acceptance criteria are demonstrated through adherence to various international and national standards, showing the device's conformance to established safety and performance benchmarks. The reported device performance is indicated by "passing results" for all tests.
| Acceptance Criteria (Standard / Test) | Reported Device Performance |
|---|---|
| Physical Performance | |
| Needle appearance and cleanliness (ISO 7864:2016, clause 4.3) | Meets requirements |
| Needle Size color code (ISO 6009:2016) | Meets requirements |
| Needle Particulate contamination (USP , METHOD 1, Test 1.B) | Meets requirements |
| Bonding strength: Needle and hub (ISO 7864:2016, clause 4.12) | Meets requirements |
| Bonding strength: Tubing and hub (ISO 8536-4:2019, clause 7.3) | Meets requirements |
| Bonding strength: Tubing and double wings luer adapter (ISO 8536-4:2019, clause 7.3) | Meets requirements |
| Infusion set leakage (ISO 8536-4:2019, clause 7.2) | Meets requirements |
| Needle patency of lumen (ISO 7864:2016, clause 4.13, a) | Meets requirements |
| Dimension: Blood collection needle (ISO 9626:2016, clause 5.6, table 1, (TW)) | Meets requirements |
| Dimension: Puncturing needle (ISO 9626:2016, clause 4.10.2, table1) | Meets requirements |
| Needle point (ISO 7864:2016, clause 4.11) | Meets requirements |
| Needle Lubrication: Appearance (ISO 7864:2016, clause 4.10.4) | Meets requirements |
| Needle Lubrication: Quantity (ISO 7886-1:2017, Annex F) | Meets requirements |
| Luer Connector (ISO 80369-7:2016, ISO 80369-20:2015) | Meets requirements |
| Tubing kink stability (ISO 20696:2018, clause 6.7) | Meets requirements |
| Puncture force of needle (ISO 7864:2016, clause 4.11) | Meets requirements |
| Safety protection mechanism (ISO 23908:2011) | Meets requirements |
| Stiffness of needle (ISO 9626:2016, clause 5.8, table 2 (TW)) | Meets requirements |
| Toughness of needle (ISO 9626:2016, clause 5.9) | Meets requirements |
| Resistance to corrosion of needle (ISO 9626:2016, clause 5.10) | Meets requirements |
| Chemical Performance | |
| Reducing matter (ISO 8536-4:2019, clause 8.1) | Meets requirements |
| Metal ions (ISO 8536-4:2019, clause 8.2) | Meets requirements |
| Limits for acidity or alkalinity (ISO 8536-4:2019, clause 8.3) | Meets requirements |
| Residue on evaporation (ISO 8536-4:2019, clause 8.4) | Meets requirements |
| Ethylene oxide residue (EO&ECH) (ISO 10993-7:2008, clause 4.3.4) | Meets requirements |
| Biological Performance (Biocompatibility) | |
| Bacterial endotoxin (USP ) | Passing results |
| Sterility (USP ) | Passing results |
| Pyrogen Test (Rabbit) (USP ) | Passing results |
| Hemolytic Properties (ASTM F756-17) | Passing results |
| Hematology (ISO 10993-4:2017) | Passing results |
| Platelet Count | Passing results |
| Partial Thromboplastin Time | Passing results |
| Cytotoxicity (ISO 10993-5:2009) | Passing results |
| Skin Sensitization (ISO 10993-10:2010) | Passing results |
| Intracutaneous Reactivity | Passing results |
| Acute Systemic Toxicity (ISO 10993-11:2017) | Passing results |
| Safety Mechanism Activation (Sharps Injury Protection) | |
| Safety mechanism activation requirements (ISO 23908, internal protocol and test results) | Meets requirements |
| Safety overriding/unlocking force after activation requirements (ISO 23908, internal protocol and test results) | Meets requirements |
| Sterilization | |
| Sterility Assurance Level (SAL) of 10-6 (ISO 11135:2014 for Ethylene Oxide) | Validated |
2. Sample size used for the test set and the data provenance
The document does not specify exact sample sizes for each test listed, but it indicates "Non-Clinical bench testing" was performed. The data provenance is implied to be from the manufacturer's internal testing in China (Promisemed Hangzhou Meditech Co., Ltd., Hangzhou City, Zhejiang, China). The tests are retrospective, as they are part of the device development and verification process before submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is a physical medical device. Ground truth is established through adherence to international standards and validated laboratory testing procedures for physical, chemical, and biological properties, not through expert consensus on images or interpretations.
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., radiologists reading images) where disagreement might occur. For physical device testing, the results are typically quantitative or pass/fail based on established 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
Not applicable. This product is a physical blood collection device, not an AI or imaging diagnostic tool. Therefore, MRMC studies and human reader improvement are irrelevant.
6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done
Not applicable. This product is a physical blood collection device, not an algorithm.
7. The type of ground truth used
The "ground truth" for this device's performance is established by the specified international and national consensus standards (e.g., ISO, USP, ASTM) for medical devices, which define acceptable physical, chemical, and biological properties. This includes:
- Physical performance metrics: Bond strength, needle dimensions, patency, kink stability, puncture force, safety mechanism activation.
- Chemical properties: Absence of harmful residues or leaching.
- Biological properties: Biocompatibility tests (cytotoxicity, sensitization, irritation, systemic toxicity, hemolysis, pyrogenicity, bacterial endotoxin) and sterility.
- Outcomes: The device is designed to prevent needlestick injuries, and its safety mechanism is tested to meet this outcome requirement.
8. The sample size for the training set
Not applicable. This is a physical medical device, not an AI/machine learning model. There is no "training set" in the context of this 510(k) submission.
9. How the ground truth for the training set was established
Not applicable. As there is no training set, this question is not relevant.
§ 880.5570 Hypodermic single lumen needle.
(a)
Identification. A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.(b)
Classification. Class II (performance standards).