(113 days)
VAKU-8™ Blood Collection Needles are designed for routine blood collection by a qualified practitioner
VAKU-8™ Single use Multi Sample blood collection needles are composed of a stainless steel needle tube that is ground at both ends and affixed to a plastic hub. A rubber sleeve covers the backend needle tube and hub tip. The front end needle is used to withdraw blood once placed in the patient. The needle tube is protected by a plastic needle cover on either end. The "front end needle" is designed to withdraw blood from the patient. The "back end needle" is covered by a rubber sleeve and is designed with a threaded hub that can be attached to a blood collection tube holder. The tube holder facilitates attachment to a evacuated blood collection tube. Each needle is individually packaged sterile utilizing two plastic end covers. A perforated label serves to simplify identification of needle size and also acts as a seal of integrity.
The provided text describes the 510(k) submission for the VAKU-8™ Blood Collection Needle, establishing its substantial equivalence to a predicate device. The information details the device, its intended use, a comparison with the predicate device, and various tests and certifications.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are primarily based on the device conforming to British Standard 4843 for measurements and tolerances, color coding according to ISO 6009, and comparable physical and performance characteristics to the predicate device. The "Bench Mark Study of Blood Collection Needle" provides the reported performance.
| Element of Comparison | Acceptance Criteria (based on predicate or standard) | Reported Device Performance (VAKU-8™) |
|---|---|---|
| Intended Use | Sterile, Single Use Needle for Blood Collection | Sterile, Single Use Needle for Blood Collection |
| Cannula Material | SUS304 Stainless Steel | SUS304 Stainless Steel |
| Needle Gauges | 21G, 22G | 21G, 22G, 23G |
| Needle Lengths | 1" and 1.5" | 1" and 1.5" |
| Lumen | Single | Single |
| Bottom Cover Material | PP | PP |
| Bottom Cover Transparency | Transparent | Transparent |
| Rubber Sleeve Color | Gray | Gray |
| Rubber Sleeve Transparency | Opaque | Opaque |
| Rubber Sleeve Material | Latex free Isoprene | Latex free Isoprene |
| Hub Design | Threaded | Threaded |
| Front End Needle Effective Length | 22.60-23.00mm | 25.00-25.50mm |
| Back End Needle Effective Length | 14.60-14.80mm | 15.0-15.50mm |
| Front End Bevel Length | 3.69-3.80mm | 3.55-3.65mm |
| Front Section Bevel Length | 1.55-1.60mm | 1.60-1.66mm |
| Front Angle of Bevel | 9° 30' - 10° 00' | 10° 30' - 11° 30' |
| Removal of Covers | Comfortable (Predicate device performance) | Comfortable |
| Fitment with Holder | Comfortable (Predicate device performance) | Comfortable |
| Maximum Load | 0.83-1.00N (Predicate device performance) | 0.67-0.88N |
| Shaft Friction | 0.13-1.5N (Predicate device performance) | 0.10-0.15N |
| Retraction of tube over cannula | OK (Predicate device performance) | OK |
| Cannula Penetration over rubber sleeve | OK (Predicate device performance) | OK |
| Biocompatibility | USP Class VI Plastic requirements (for PP) | Meets USP Class VI Plastic |
| Sterility | Sterilized by ETO Gas, SAL requirements per guidance document, USP sterility tests | Sterilized by ETO Gas, validated per EN 550, USP sterility tests |
| Freedom from Pyrogen | USP test for "freedom from Pyrogenic materials" | Meets USP requirements |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample size for the "Bench Mark Study of Blood Collection Needle" or for any performance tests that directly compared the VAKU-8™ to its predicate. It mentions:
- "Samples are drawn from each batch produced as per defined sampling plan, performance tests are conducted as per the standards cited above and defined criteria for acceptance are applied." (Section 13)
- "Samples are drawn from each sterilization load and subjected to the tests for sterility as per USP." (Section 15)
- "Freedom from Pyrogen is determined by taking samples from each sterilizer load and subjected to the test 'freedom from Pyrogenic materials' as per USP" (Section 15)
This indicates that testing is done on batches and sterilization loads, but the exact number of samples per test is not specified.
The data provenance is not explicitly mentioned in terms of country of origin for the test data, nor is it specified if it's retrospective or prospective. However, given that it's a 510(k) submission for a new device, the performance data would be prospective, obtained during the development and validation of the VAKU-8™.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not provide information about the number of experts or their qualifications used to establish ground truth for the test set. The tests appear to be a mix of objective measurements against standards (BS 4843, ISO 6009) and functional assessments (e.g., "Comfortable," "OK") that would likely be evaluated by trained personnel, but specific expert involvement is not detailed.
4. Adjudication Method for the Test Set
No adjudication method (e.g., 2+1, 3+1, none) is mentioned or implied for the performance tests. The assessments seem to be based on direct measurement or functional observation against a standard or predicate.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No MRMC comparative effectiveness study was done. This type of study is typically associated with diagnostic imaging devices or algorithms where human interpretation is a key component, and the device aims to assist or replace human readers. The VAKU-8™ is a physical medical device (blood collection needle) where human interaction is primarily mechanical (e.g., proper technique by a qualified practitioner), not interpretative.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The concept of a "standalone" performance for an algorithm is not applicable to this device, as it is a physical medical instrument, not an algorithm. Performance tests are conducted on the physical device itself.
7. The Type of Ground Truth Used
The "ground truth" for the VAKU-8™ is established through:
- Objective Measurements/Standards: Conformance to British Standard 4843 for measurements and tolerances, and ISO 6009 for color coding.
- Predicate Device Performance: Direct comparison of physical attributes and functional characteristics (e.g., "Removal of Covers," "Fitment with holder," "Maximum load," "Shaft friction") against the established performance of the legally marketed predicate device (K992699).
- Biocompatibility Certifications: Testing of materials (e.g., Topilene PP) to meet USP Class VI Plastic requirements.
- Sterilization and Pyrogenicity Standards: Conformance to EN 550 for sterilization validation and USP tests for sterility and freedom from pyrogenic materials.
8. The Sample Size for the Training Set
This information is not applicable. The VAKU-8™ Blood Collection Needle is a physical device, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable, as the device does not involve a "training set."
§ 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).