(460 days)
The CHIRAVAC™ Blood Collection Needles are single use and are intended for venous blood collection in connection with blood collection tubes.
The CHIRAVAC™ Blood Collection Needles consists of a double-ended hollow stainless steel thin-walled cannula, a threaded polypropylene hub, a sleeve that interrupts blood flow between filling multiple tubes, and polypropylene caps. The device is single use and supplied sterile (ethylene oxide sterilized). The stainless steel cannula and silicone cannula lubricants are classified as externally communicating with limited (≤24 hours) duration contact; all other device components have no contact with patient blood, tissue, or skin. Once the vein has been accessed by puncturing with the intravenous end of the cannula, the healthcare professional will begin the blood collection process by placing evacuated blood collection tubes on the cannula's non-patient end, where the sleeve acts as a non-return valve and allows for more than one tube to be used to collect blood from the vein puncture.
This document describes a 510(k) premarket notification for the CHIRAVAC™ Blood Collection Needles. It does not present a clinical study involving human readers or AI algorithms. Instead, it focuses on demonstrating substantial equivalence to a legally marketed predicate device through performance testing (bench testing, biocompatibility, sterilization, shipping, and shelf-life).
Therefore, the requested information regarding acceptance criteria and studies proving the device meets those criteria, specifically concerning human reader performance, AI assistance, standalone algorithm performance, and sample sizes for training/test sets, cannot be fully provided as it is not present in the document.
However, I can extract information related to the acceptance criteria for the device's physical and functional characteristics and the bench testing conducted to meet these criteria.
Here's a summary of the available information:
1. Table of Acceptance Criteria and Reported Device Performance (Summary of Bench Testing)
The document lists several international standards (ISO) and internal procedures to which the CHIRAVAC™ Blood Collection Needles were tested. The "reported device performance" is generally implied as "passed" or "met requirements" for each test, as the overall conclusion is that the device is substantially equivalent to the predicate. The document does not provide specific quantitative results for each test (e.g., "Fragmented less than X%").
| Acceptance Criteria (Test Mode) | Standard/Procedure | Reported Device Performance (Implied) |
|---|---|---|
| Performance Testing - Bench | ||
| Color Coding | ISO 7864:2016, ISO 6009:2016 | Met standard requirements |
| Size Designation | ISO 7864:2016 | Met standard requirements |
| Cleanliness | ISO 7864:2016, Internal Procedure SOP 4405 | Met standard requirements |
| pH Limits | ISO 7864:2016, ISO 9626:2016 | Met standard requirements |
| Limits of Extractable Metals | ISO 7864:2016 | Met standard requirements |
| Inspection of Needle Length | ISO 7864:2016 | Met specified lengths |
| Inspection of Defects | ISO 7864:2016 | No defects found |
| Inspection of Lubrication | ISO 7864:2016 | Met standard requirements |
| Needle/Hub Bond Strength | ISO 7864:2016 | Met standard requirements |
| Lumen Patency | ISO 7864:2016 | Patent |
| Fragmentation | ISO 7864:2016 | No fragmentation observed |
| Inspection of Needle Sharpness/Cleanness | ISO 7864:2016 | Met standard requirements |
| Penetration Force Test | ISO 7864:2016 | Met standard requirements |
| Inspection of Surface Appearance | ISO 9626:2016 | Met standard requirements |
| Inspection of Tubing Dimensions | ISO 9626:2016 | Met specified dimensions |
| Stiffness Test | ISO 9626:2016 | Met standard requirements |
| Breakage Resistance Test | ISO 9626:2016 | Met standard requirements |
| Corrosion Resistance Test | ISO 9626:2016 | No corrosion observed |
| Visual Inspection of Labeling | Internal Procedure SOP 4113 | Conformed to labeling requirements |
| Inspection of Blister/Label Perforation | Internal Procedure SOP 4401 | No perforations/damage observed |
| Vacuum Function Evaluation | Internal Procedure SOP 4401 | Functional |
| Test for Rubber Sleeve Returning to Original Position | Internal Procedure SOP 4401 | Returned to original position, no damage |
| Inspection of Cannula Transparency | Internal Procedure SOP 4405 | Transparent |
| Biocompatibility | ||
| Cytotoxicity | ISO 10993-5 | Non-cytotoxic |
| Sensitization | ISO 10993-10 | Non-sensitizing |
| Irritation | ISO 10993-10 | Non-irritating |
| Acute Systemic Toxicity | ISO 10993-11 | Non-toxic |
| Hemocompatibility | ASTM F756 | Hemocompatible |
| Material Mediated Pyrogenicity | European Pharmacopoeia 10.0 Article 2.6.8 | Non-pyrogenic |
| Sterilization, Shipping & Shelf-life | ||
| Packaging Integrity | Internal procedures | Integrity maintained |
| Sterile Barrier Packaging | ISO 7886-1 | Integrity maintained |
| Shelf Life (5 years) | ASTM F1980 (validated by accelerated aging) | Established 5-year shelf life |
2. Sample Size Used for the Test Set and Data Provenance
This document describes bench testing of a physical medical device (blood collection needles), not a diagnostic algorithm that relies on a "test set" of data in the common sense (e.g., medical images).
- Sample Size: The document does not explicitly state the number of samples (e.g., individual needles or batches) used for each specific test. This level of detail is typically found in the full test reports, not the 510(k) summary.
- Data Provenance: The tests are conducted according to international standards (ISO, ASTM, European Pharmacopoeia) and internal Standard Operating Procedures (SOPs). The testing was performed by CHIRANA T. Injecta or third-party labs on their behalf, based in the Slovak Republic (Submitter's address). This is a prospective evaluation of manufactured devices.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
Not applicable. This is not a study requiring expert interpretation of data to establish a "ground truth" for a diagnostic task. The ground truth for device performance is established by objective measurements against predefined acceptance criteria from the relevant standards (e.g., physical dimensions, strength, sterility).
4. Adjudication Method for the Test Set
Not applicable. No "adjudication" is described as this is not a diagnostic performance study involving multiple human readers or AI.
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
No. This is not an MRMC comparative effectiveness study, nor does it involve AI. It's a submission for a physical medical device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
No. This device does not involve an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this device is based on:
- International Standards: e.g., ISO 7864, ISO 6009, ISO 9626, ISO 10993 series, ASTM F756, ASTM F1980, European Pharmacopoeia. These standards define the acceptable physical, chemical, and biological properties.
- Predicate Device Characteristics: The device is compared to a legally marketed predicate (Sol-M Blood Collection Needles, K182146) to demonstrate substantial equivalence, implying the predicate's performance against relevant standards serves as a benchmark for safety and effectiveness.
8. The Sample Size for the Training Set
Not applicable. This is not a machine learning or AI-based device, so there is no training set.
9. How the Ground Truth for the Training Set was Established
Not applicable. There is no training set or associated ground truth as this is not an AI/ML device.
§ 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.