FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

VACUETTE® VISIO PLUS Blood Collection Needles are manufactured from stainless steel and are fitted with a safety valve at one end. The flashback window is situated in the transparent part of the cannula hub, which assists the user to recognize successful vein penetration. The perforated label not only serves to simplify identification, but also acts as a seal of integrity. VACUETTE® VISIO PLUS Blood collection needles are a sterile single-use product. They are for single-use only and should only be used by adequately trained healthcare personnel in accordance with these instructions. The VACUETTE® VISIO PLUS Blood Collection Needles will be available in four configurations to include two needle gauge sizes (21G and 22G) and two corresponding needle lengths (25 mm [1 inch] and 38 mm [ 1 ½ inches]): - Needle gauge = 21G; Front needle length = 25 mm [1 inch] . - Needle gauge = 22G; Front needle length = 25 mm [1 inch] . - Needle gauge = 21G; Front needle length = 38 mm [1 ½ inch] . - Needle gauge = 22G; Front needle length = 38 mm [1 ½ inch] . The needles are packaged as sterile and are labeled for single use only. There is no ability to clean and reuse these devices.

AI/ML Overview

This document, K061483, is a 510(k) summary for a blood collection needle and does not describe acceptance criteria or a study that proves the device meets specific performance criteria in the way envisioned by the prompt for AI/diagnostic devices.

Instead, it's a submission for a medical device (a blood collection needle) seeking clearance based on substantial equivalence to a predicate device. For such devices, the "acceptance criteria" are related to safety, effectiveness, and substantial equivalence, often demonstrated through comparison to a legally marketed predicate device and adherence to recognized standards, rather than numerical performance metrics from a dedicated study.

Therefore, many of the requested categories related to AI/diagnostic device performance studies (sample sizes, ground truth, expert opinions, MRMC studies) are not applicable or extractable from this type of regulatory document.

Here's a breakdown of what can be extracted and explanations for what cannot:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria: The primary "acceptance criteria" for K061483 is demonstrating substantial equivalence in intended use, materials, and general design to the predicate device, Greiner VACUETTE® Multi-Sample Needle (K973620), and compliance with general controls for Class II devices. Specific numerical performance metrics for the device itself (like sensitivity/specificity for a diagnostic) are not detailed as this is a physical medical device.
Reported Device Performance: This document does not contain a study with reported performance metrics for the VACUETTE® VISIO PLUS Blood Collection Needles beyond stating its design features. The clearance is based on its similarity to an already approved device.

Table (Not Applicable for detailed numerical performance results in this context):

Acceptance Criteria (Implied)	Reported Device Performance
Substantially equivalent in intended use to predicate device.	Intended use is identical to predicate: "designed for use in the daily blood collection routine when delegated by a qualified practitioner."
Substantially equivalent in materials to predicate device.	Manufactured from stainless steel, similar to predicate.
Substantially equivalent in general design to predicate device.	Fitted with a safety valve, similar to predicate. Includes a flashback window, which is a design feature.
Compliance with general controls (e.g., sterilization, single-use).	Stated as sterile and for single-use only.

2. Sample size used for the test set and the data provenance:

Not Applicable. This submission does not describe a "test set" or a performance study with a sample size in the context of diagnostic accuracy or AI model evaluation.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):

Not Applicable. This document pertains to regulatory clearance of a physical medical device, not a diagnostic or AI algorithm requiring expert-established ground truth.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not Applicable. See point 3.

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 is a physical blood collection needle, not an AI-assisted diagnostic tool.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Not Applicable. This is a physical blood collection needle, not an AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Not Applicable. The "ground truth" for this device would be its physical properties, sterility, and functionality as a blood collection needle, which are assessed through engineering and biocompatibility testing, manufacturing controls, and comparison to existing standards/devices, not expert consensus on diagnostic images or pathology.

8. The sample size for the training set:

Not Applicable. This is not an AI/ML device; there is no "training set."

9. How the ground truth for the training set was established:

Not Applicable. There is no training set for this type of device.

Summary

Regulation Number and Section

§ 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).