(201 days)
The SecuMax™ Blood Collection System is a sterile and single-use package consisting of a sterile Luer holder with a sterile Luer adapter to hold Exel hypodermic needles during venipuncture. The entire device will be disposed as a unit in a sharps container.
The SecuMax ™ Blood Collection System is a single-use sterile blood collection system. There are three main components in the package, i.e., sterile hypodermic needle, sterile Lucr adapter, and sterile Luer type holder. Special N-typed ergonomic lucr adapter can eliminate the collection angle by placing the nearly parallel with the arm. The special design luer adapter can be used with any size of hypodermic needle. Push-off Luer holder is designed to fit N-typed luer adapter. The hypodermic needle used is Exel International disposable hypodermic needles with 510K # 861153.
The provided text describes a 510(k) premarket notification for the Tiger Meditech™ SecuMax Blood Collection System. The submission primarily focuses on establishing substantial equivalence to a predicate device rather than presenting a detailed study with acceptance criteria and performance data in the format typically seen for complex diagnostic devices.
Based on the provided information, I can extract the following:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria or detailed performance metrics in the format of a table. The primary method for demonstrating safety and effectiveness is through a claim of "substantial equivalence" to a predicate device.
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Bench Testing | Performed |
| Pyrogen Test | Performed |
| Sterility | Performed |
| Simulated Clinical Testing | Performed |
| Substantial Equivalence | Claimed to Becton Dickinson Vacutainer Systems (K980098) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a separate "test set" with a defined sample size for a performance study. It mentions "Bench, pyrogen test, sterility, substantial equivalence, and simulated clinical testing" as employed upon submission, but no details on sample size or data provenance (country of origin, retrospective/prospective) are provided for these tests. The focus is on comparing the characteristics of the new device to the predicate.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Not applicable. The submission relies on demonstrating substantial equivalence to a legally marketed predicate device rather than establishing a new "ground truth" through expert consensus for performance evaluation. The "ground truth" implicitly lies with the predicate device's established safety and effectiveness.
4. Adjudication Method for the Test Set
Not applicable, as no specific test set requiring adjudication by experts is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study is mentioned. This type of study is more common for diagnostic imaging AI systems to assess human reader performance with and without AI assistance. The SecuMax™ Blood Collection System is a physical medical device.
6. Standalone Performance Study (Algorithm Only)
Not applicable. The SecuMax™ Blood Collection System is a physical blood collection system, not an algorithm, so a standalone algorithm-only performance study is not relevant. The studies performed (bench, pyrogen, sterility, simulated clinical testing) are evaluating the physical device and its properties.
7. Type of Ground Truth Used
The primary "ground truth" concept applied here is the established safety and effectiveness of the predicate device (Becton Dickinson Vacutainer Systems, K980098). The new device is deemed safe and effective if it can demonstrate substantial equivalence to this predicate. Where tests were performed (e.g., sterility, pyrogen), the "ground truth" would be established by standard scientific and regulatory methods for those specific tests.
8. Sample Size for the Training Set
Not applicable. This is a physical medical device, not an AI/ML algorithm that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of 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).