(129 days)
The VACUETTE EVOPROTECT Safety Blood Collection/Infusion Set is indicated for venous blood collection and/or the short-term infusion of intravenous fluids. It is to be used by appropriately trained healthcare professionals in accordance with the instructions.
The VACUETTE® EVOPROTECT SAFETY Blood Collection/Infusion Set is a singleuse, sterile, winged needle bonded to flexible tubing with a Luer connector and a semiautomatic release of the safety mechanism. The winged needle is designed with a safety mechanism, which allows for activation ensuring the needle is covered immediately following venipuncture to aid in the protection against accidental needlestick injury. The EVOPROTECT Safety Blood Collection/Infusion Set is individually wrapped, sterile with a luer port. The luer port can be used to connect FDA cleared accessories like luer adapter, holder, etc.
Here's an analysis of the provided text regarding the acceptance criteria and study for the VACUETTE EVOPROTECT Safety Blood Collection / Infusion Set:
It's important to note that this document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed clinical trial report for novel technologies. Therefore, some of the requested information (like MRMC studies, specific sample sizes for all tests, or detailed expert qualifications) is not typically found in this type of submission.
1. Table of Acceptance Criteria and Reported Device Performance
| Requirement | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Penetration resistance Cap | >3N for 21G, 23G, and 25G. Equivalent to predicate device. | pass |
| Cannula cleanliness | Tested in accordance with ISO 7864:2014 | pass |
| Cannula radial orientation | Equivalent to predicate device. | pass |
| Cannula puncture & friction force 21G | Equivalent to predicate device | pass |
| Cannula puncture & friction force 23G | Equivalent to predicate device | pass |
| Cannula puncture & friction force 25G | Equivalent to predicate device | pass |
| Cannula bond force 21G | Tested in accordance with ISO 7864:2016 | pass |
| Cannula bond force 23G | Tested in accordance with ISO 7864:2016 | pass |
| Cannula bond force 25G | Tested in accordance with ISO 7864:2016 | pass |
| Flow rate water 10cm tubing, 21G (extreme: max) | Equivalence, internal Specification | pass |
| Flow rate water 19 cm tubing, 21G | Equivalence, internal Specification | pass |
| Flow rate water 19 cm tubing, 23G | Equivalence, internal Specification | pass |
| Flow rate water 30 cm tubing, 23G | Equivalence, internal Specification | pass |
| Flow rate water 30cm tubing, 25G (extreme: min) | Equivalence, internal Specification | pass |
| Breaking compressive force cannula before activation | Tested in accordance with ISO 23908:2011 | pass |
| Size designation | Tested in accordance with ISO 9626:2016 | pass |
| Dimensional | Tested in accordance with ISO 9626:2016 | pass |
| Resistance for stiffness | Tested in accordance with ISO 9626:2016 | pass |
| Resistance for breakage | Tested in accordance with ISO 9626:2016 | pass |
| Resistance for corrosion | Tested in accordance with ISO 9626:2016 | pass |
| Activation force safety mechanism | Tested in accordance with ISO 23908:2016 | pass |
| Breaking force safety mechanism compression | Tested in accordance with ISO 23908:2011 | pass |
| Breaking force safety mechanism tension | Tested in accordance with ISO 23908:2011 | pass |
| Bond strength Hub to Stopper | Equivalence, ISO 8536-4:2010 + Amd 1:2013 | pass |
| Bond strength Tubing to Stopper | Equivalence, ISO 8536-4:2010 + Amd 1:2013 | pass |
| Bond strength Tubing to Connector | Equivalence, ISO 8536-4:2010 + Amd 1:2013 | pass |
| Tubing breaking force | Equivalence, ISO 8536-4:2010 + Amd 1:2013 | pass |
| Detaching torque Luer Adapter (LA) to Connector | Equivalent to predicate device | pass |
| Detaching force Luer Adapter to Connector | Equivalent to predicate device | pass |
| Spring characteristic | Equivalent to ISO 23908:2011, simulated use | pass |
| Leakage of product (pressure & vacuum) | Equivalent to predicate device | pass |
| Simulated use | According to intended use and specification | pass |
| Tightness single packaging (Bubble test) | According to ASTM F2096-04 | pass |
| Tightness single packaging (Dye penetration) | According to ASTM F1929-15, ISO 11607-2 and EN 868-5 | pass |
| Sealing strength and max. opening force single packaging | According to ISO 11607-1 and EN 868-5 | pass |
| Biocompatibility testing | Testing according to ISO 10993-1 and FDA guidance (Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity, Pyrogenicity, Hemocompatibility, Particulate Matter, Genotoxicity) | pass |
| Sterility testing | Testing according to 11137-1 (SAL of 10-6), Bacterial endotoxin testing (ANSI/AAMI ST72:2011) | pass |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes for each specific test or the "test set" in the context often used for AI/algorithm performance. The studies performed are primarily bench and biocompatibility tests for medical devices.
- Sample Size: Not explicitly detailed for each test. The document mentions adherence to specific ISO and ASTM standards, which would dictate appropriate sample sizes for those tests. For example, biocompatibility studies would involve a certain number of samples for each test (e.g., cytotoxicity, sensitization, etc.).
- Data Provenance: The studies are laboratory and bench tests conducted to international (ISO, ASTM) and national (USP, ANSI/AAMI, FDA guidance) standards. It does not involve patient data or human clinical trials in the way an AI algorithm might be evaluated. Therefore, there's no country of origin of data in the typical sense, nor is it a retrospective or prospective clinical study. These are product performance verification and validation tests.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable and not provided in the document. The "ground truth" for these types of mechanical, chemical, and biological performance tests is established by adherence to recognized international and national standards (e.g., ISO 7864 for cannula cleanliness, ISO 10993 for biocompatibility). There isn't an "expert consensus" in the sense of clinicians reviewing images or patient outcomes. The "experts" would be the metrology and biological testing technicians and scientists performing the tests according to the specified standard operating procedures and trained in those specific methods.
4. Adjudication Method for the Test Set
This information is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies or expert reviews where there might be disagreement or a need for a definitive "ground truth" established by multiple human evaluators (e.g., in radiology image reading). For the enumerated engineering and material science tests, the results are typically quantitative measurements or qualitative observations that either meet or do not meet predefined criteria according to the standard.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic AI algorithms where human interpretation is involved. The VACUETTE EVOPROTECT is a physical medical device (blood collection/infusion set), not an AI-powered diagnostic or assistive tool for human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
No, a standalone AI algorithm performance study was not done. This device is not an AI algorithm. Its performance is evaluated through physical, mechanical, and biological testing as listed in the table.
7. The Type of Ground Truth Used
The "ground truth" used for this device's performance evaluation is based on:
- Adherence to Recognized Consensus Standards: Many tests refer to specific ISO or ASTM standards (e.g., ISO 7864:2014 for cannula cleanliness, ISO 23908:2011 for breaking compressive force, ISO 10993-1 for biocompatibility). These standards define the test methods and often the criteria for acceptable performance.
- Equivalence to Predicate Device: For several parameters (e.g., penetration resistance, cannula radial orientation, flow rate, detaching torque/force, leakage, spring characteristic), the acceptance criterion is "Equivalent to predicate device." This means the new device performed comparably to a previously cleared, legally marketed device that has demonstrated safety and effectiveness.
- Internal Specification: For some flow rate tests, "internal Specification" is cited, meaning the manufacturer has defined its own performance targets based on the intended use and established engineering principles.
8. The Sample Size for the Training Set
This information is not applicable. The concept of a "training set" refers to data used to train machine learning models. This document describes the testing of a physical medical device, not an AI algorithm.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable, as there is no "training set" in the context of an AI algorithm for this device.
§ 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).