(616 days)
The Blood Collection Needles are sterile, single use medical devices specifically intended to be used by trained healthcare professionals for the collection of blood samples into evacuated blood collection tubes.
The Safety Blood Collection Needles are sterile, single use medical devices specifically intended to be used by trained healthcare professionals for the collection of blood samples into evacuated blood collection tubes; they are designed with a safety mechanism, which can be activated to cover the needle immediately after puncture to provide protection from accidental needle sticks.
The Vacutest Kima blood collection needles are sterile and disposable single use devices intended for the daily blood collection routine.
They are intended for single or multiple blood collection from one single patient, with vacuum blood collection tubes. The needles must be applied on a holder; a separate use is not possible.
The Safety Needle models feature a mechanism covering the needle after use; in these models a holder with pre-assembled safety cover is part of the device. The safety mechanism applied to the holder requires no change of the operative manners for blood collection.
Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Important Note: The provided text is a 510(k) summary for a medical device (Blood Collection Needles). This type of document focuses on demonstrating substantial equivalence to an already legally marketed predicate device, rather than proving efficacy or diagnostic performance through clinical trials as one might expect for an AI diagnostic device. Therefore, many of the typical questions for AI device studies (like those involving expert consensus, MRMC studies, or training set details) are not directly applicable or addressed in this document. The "tests" here are primarily engineering and safety validations against established standards.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (based on standards) | Reported Device Performance |
|---|---|
| Biocompatibility | Meets ISO 10993-1 |
| Cytotoxicity | Conforms to ISO 10993-5:2009 |
| Irritation & Skin Sensitization | Conforms to ISO 10993-10:2010 |
| Systemic Toxicity | Conforms to ISO 10993-11:2006 |
| Material Mediated Pyrogenicity | Conforms to USP 41 |
| Haemolytic Properties | Conforms to ASTM F756-08 |
| Interactions with Blood | Conforms to ISO 10993-4:2002/Amd 1:2006 |
| Particulate Matter | Conforms to USP |
| Sterilization Validation | SAL 10-6 achieved |
| EO Sterilization Process | Conforms to ISO 11135:2014 |
| Biological Indicators | Conforms to ISO 11138-1:2017 |
| EO Sterilization Residuals | Conforms to ISO 10993-7:2008 |
| Packaging (Materials & Sterile Barrier) | Conforms to ISO 11607-1:2009 |
| Packaging (Validation Processes) | Conforms to ISO 11607-2:2006 |
| Microbiological Methods (Population) | Conforms to ISO 11737-1:2018 |
| Microbiological Methods (Sterility Tests) | Conforms to ISO 11737-2:2009 |
| Bacterial Endotoxins (LAL test) | Conforms to USP , USP , European Pharmacopoeia 2.6.14 |
| Performance Testing | |
| Sterile Hypodermic Needles (General) | Conforms to ISO 7864:2016 |
| Stainless Steel Needle Tubing | Conforms to ISO 9626:2016 |
| Sharps Injury Protection Features | Conforms to ISO 23908:2011 |
2. Sample size used for the test set and the data provenance
The document specifies non-clinical tests, primarily bench testing and laboratory analyses against international and FDA-recognized standards. It does not mention a "test set" in the context of patient data or images. Therefore, details like data provenance (country of origin, retrospective/prospective) and sample size in that sense are not applicable to this type of submission. The "samples" would be the manufactured devices themselves and their components, tested in laboratory conditions.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The "ground truth" for this device is based on established engineering and safety standards (e.g., ISO, ASTM, USP) for medical devices, rather than expert interpretation of clinical data or images. Compliance with these standards is demonstrated through laboratory testing conducted by qualified personnel within Vacutest Kima or accredited testing facilities.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This type of submission relies on objective measurements and conformance to standards, not human expert adjudication of clinical outcomes or diagnostic interpretations.
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 medical device (blood collection needle), not an AI diagnostic tool. No MRMC study was conducted or is relevant for this product.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this submission is established international and national standards for medical device safety and performance. This includes:
- Biocompatibility standards (e.g., ISO 10993 series, USP pyrogenicity, hemolytic properties)
- Sterilization validation standards (e.g., ISO 11135, ISO 11138, package integrity, endotoxin tests)
- Performance standards specific to hypodermic needles and sharps injury protection (e.g., ISO 7864, ISO 9626, ISO 23908)
The "proof" is the device's ability to consistently meet the specifications and requirements outlined in these standards through rigorous non-clinical testing.
8. The sample size for the training set
Not applicable. This is a physical medical device, not a machine learning model. There is no concept of a "training set" in this context.
9. How the ground truth for the training set was established
Not applicable, as there is no training set 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).