(93 days)
The safety blood collection needle without a needle holder is intended to be used with a vacuum blood collection tube to collect venous blood. The safety shield is intended to protect against accidental needle stick injury.
The proposed device is a blood collection device to form a channel between the patient's vein and the evacuated blood collection tube intended for blood collection. The Pipe pluq piercing needle is designed with a rubber cap, which can be activated to cover the needle immediately following venipuncture to aid in the protection against accidental needle stick injury. The product is to be used by appropriately trained healthcare professionals only in accordance with these instructions. The Safety blood collection needles without needle holders are manufactured from tubular stainless steel sharpened at both ends that are attached as follows:
- -The threaded hub has one side that is to connect with the needle holder, which is used to guide the needle into a vacuum blood collection tube. This end of the needle is shorter and fitted with a rubber cap and a needle hub.
- -The opposite end of the needle tube is 3/4"-1 1/2" for blood collection and is fitted with a protective sleeve.
The needle hub and protective cap protect the needle tube.
The safety feature is easily operated through the release of a latch mechanism whereby the user slides a safety shield over the needle as it is removed from the patient. Once the needle is covered, the safety shield locks in place. This mechanism is substantially equivalent to that of the predicate device.
The devices are packaged as sterile, single-use, and single-patient use only.
The proposed device is comprised of the components listed below: -
- Bottom sheath
-
- Rubber cap
-
- Needle hub
-
- Connecting base
-
- Safety shield
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- Needle tube
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- Upper sheath
The provided text describes a 510(k) premarket notification for a medical device called "Safety Blood Collection Needle (Without Needle Holder)". This notification primarily focuses on establishing "substantial equivalence" to a predicate device, rather than providing detailed acceptance criteria and a comprehensive study report in the way scientific literature or a clinical trial would. Therefore, some of the requested information, particularly regarding specific numerical performance metrics, sample sizes for test/training sets, expert qualifications, and effect sizes for AI, is either not applicable or not explicitly stated in the document.
Based on the provided text, here's an analysis of the acceptance criteria and supporting information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly defined by compliance with applicable international standards (ISO, AAMI, ASTM) and demonstrating performance equivalent to the predicate device. The reported performance is generally stated as "Complies with" or "Identical," implying that the device met the requirements of these standards. Exact numerical values for performance are not typically included in a 510(k) summary unless there's a specific, quantifiable, and comparative requirement to highlight.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Functional Performance (e.g., needle sharpness, strength) | Complies with ISO 9626 (Stainless steel needle tubing requirements), ISO 7864 (Sterile hypodermic needles requirements), ISO 80369-7 (Small-bore connectors), ISO 80369-20 (Common test methods), ISO 23908 (Sharps injury protection), ISO 6009 (Color coding for identification) |
| Biocompatibility (tissue interaction, toxicity) | Complies with ISO 10993-1 (Biological evaluation), ISO 10993-5 (Cytotoxicity), ISO 10993-10 (Sensitization, Intracutaneous Reactivity), ISO 10993-11 (Acute Systemic Toxicity, Pyrogen Test), ISO 10993-4 (Hemolytic Properties, Complement activity, Coagulation - PPT Test) |
| Sterilization Efficacy (elimination of microorganisms) | Complies with ISO 11135-1 (Ethylene oxide sterilization), ISO 11737-1/2 (Microbiological methods), ISO 10993-7 (Ethylene Oxide Residuals), AAMI/ANSI ST72 (Bacterial endotoxins) |
| Package Integrity & Shelf Life (maintaining sterility) | Complies with AAMI/ANSI/ISO 11137-1 (Radiation sterilization), AAMI/ANSI/ISO 11737-2 (Sterility tests), AAMI/ANSI/ISO 11607-1 (Packaging requirements), ASTM F1929 (Dye Penetration), ASTM F1980 (Accelerated Aging), ASTM D3078 (Bubble Emission), DIN58953-6 (Microbial barrier testing), ASTM F88/F88M (Seal Strength) |
| Safety Mechanism Effectiveness (prevention of needlesticks) | Identical to predicate: "The safety shield is intended to prevent needle sticks." (Implicitly meets predicate's acceptance for this feature) |
| Indications for Use | Substantially equivalent to predicate, designed for venous blood collection with vacuum tubes and protection against accidental needle stick injury. |
| Operating Mode | Identical (Manual) |
| Sterile Status | Identical (Yes) |
| Single Patient Use | Identical (Yes) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify the exact sample sizes used for each performance test. It refers to compliance with standards like ISO and ASTM, which typically outline specific testing methodologies and required sample quantities. For instance, ISO 2859-1 (Sampling procedures for inspection by attributes) is mentioned, indicating statistically derived sample sizes for lot-by-lot inspection, but the actual number of units tested is not reported.
- Data Provenance: The testing was non-clinical ("Non-Clinical Performance Testing"). The origin of the data is the manufacturer's testing, conducted to demonstrate compliance with international standards. There is no mention of country of origin for the data itself, only the manufacturer's location (Anhui, China). The data is implicitly "retrospective" in the sense that it was generated for this specific submission to demonstrate compliance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable in the context presented. The document describes a medical device (a blood collection needle), not an AI/ML-based diagnostic system that requires expert interpretation for ground truth establishment. The "ground truth" for this device's performance is objective measurements against established engineering and biological standards.
4. Adjudication Method for the Test Set
This information is not applicable. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies or AI/ML evaluations where there might be disagreement among human annotators or evaluators. For the engineering and biological tests described (e.g., tensile strength, sterility, biocompatibility), the results are objective measurements against defined criteria, not subjective interpretations requiring adjudication.
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
This information is not applicable. The device is not an AI-assisted diagnostic or interpretation tool. It is a physical medical device (blood collection needle). Therefore, an MRMC study and AI-related effect sizes are irrelevant to this submission.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. The device is not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is based on objective measurements defined by nationally and internationally recognized standards. These include:
- Engineering Specifications: Standards like ISO 9626 (stainless steel needle tubing), ISO 7864 (hypodermic needles), ISO 80369 series (small-bore connectors), ISO 23908 (sharps injury protection), ASTM F88/F88M (seal strength), etc., which define measurable physical and chemical properties and test methods.
- Biological Standards: ISO 10993 series (biocompatibility) provides established methods for assessing biological safety (e.g., cytotoxicity, sensitization, systemic toxicity).
- Microbiological Standards: ISO 11135-1 (sterilization), ISO 11737-1/2 (microbiological methods) define criteria for sterility and validation of sterilization processes.
- Clinical Outcomes/Pathology: This type of ground truth is not used here, as no clinical data or pathology results are reported for the device itself.
8. The Sample Size for the Training Set
This information is not applicable. The device is not an AI/ML system that requires a "training set."
9. How the Ground Truth for the Training Set was Established
This information is not applicable. As the device is not an AI/ML system, there is no training set and therefore no ground truth established for it in that context.
§ 862.1675 Blood specimen collection device.
(a)
Identification. A blood specimen collection device is a device intended for medical purposes to collect and to handle blood specimens and to separate serum from nonserum (cellular) components prior to further testing. This generic type device may include blood collection tubes, vials, systems, serum separators, blood collection trays, or vacuum sample tubes.(b)
Classification. Class II.