(85 days)
For use in venous blood collection
a tubular stainless steel device sharpened at both ends, one end to withdraw blood, and the other end to be threaded into a needle holder which is used to guide the needle into an evacuated blood collection tube.
This device, the Greiner Vacuette® Multi-sample needle (K973620), is a Class II medical device that received 510(k) clearance based on substantial equivalence to an existing predicate device, Gainor Medical's Suresharp® needles (K950159).
Therefore, this submission does not contain acceptance criteria in the traditional sense of performance metrics with thresholds that the device must meet through a new study. Instead, the "acceptance criteria" are implicitly met by demonstrating that the device is identical in materials and intended use to a previously cleared device.
Here's a breakdown of the information requested, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Same intended use as predicate device (Gainor Medical's Suresharp® needles - K950159) | For use in venous blood collection (identical to predicate device's intended use). |
| Same material composition as predicate device | Needle: Stainless steel (same as Gainor needle) |
| Hub: Polypropylene (same as Gainor needle) | |
| Sleeve: Rubber (same as Gainor needle) | |
| Needle Shield: Polypropylene (same as Gainor needle) | |
| Purchased from the same supplier as the predicate device | Needles are purchased from the same supplier in Japan as the predicate. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not applicable. No new performance testing in a "test set" was conducted or reported for this 510(k) submission.
- Data Provenance: Not applicable. The submission relies on a statement of material and supplier identity, not new data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
- Not applicable. As no new "test set" was evaluated, no experts were needed to establish ground truth for performance.
4. Adjudication Method for the Test Set
- Not applicable. No "test set" was evaluated.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
- No. This type of study is not relevant for a device seeking clearance based on substantial equivalence of materials and intended use.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a manual blood collection needle; it does not involve an algorithm or AI.
7. The Type of Ground Truth Used
- The "ground truth" for this submission is based on material composition and supplier identity, verified through a statement by the manufacturer. The core assumption is that if the materials and supplier are the same as a legally marketed predicate device, the performance will be substantially equivalent.
8. The Sample Size for the Training Set
- Not applicable. This device does not involve a "training set" as it is not an AI/ML algorithm or a device requiring such data.
9. How the Ground Truth for the Training Set was Established
- Not applicable. No "training set" was used.
Summary of the "Study" (Demonstration of Substantial Equivalence):
The "study" in this case is a comparative analysis of device characteristics against a predicate device, rather than a clinical or performance study involving human subjects or data analysis. The manufacturer, Greiner Meditech, Inc., established substantial equivalence by reporting that their Vacuette® Multi-sample needle:
- Has the same intended use (venous blood collection) as the predicate device (Gainor Medical's Suresharp® needles - K950159).
- Is made of the same materials for each of its components (stainless steel for the needle, polypropylene for the hub and shield, rubber for the sleeve) as the predicate device.
- Is purchased from the same supplier in Japan as the predicate device, further supporting the claim of identicality.
This approach is common for straightforward Class II devices where the risks are well-understood and the device is a direct copy or very minor modification of an already cleared product. The FDA's acceptance of this submission indicates they found these claims sufficient to establish substantial equivalence.
§ 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).