(144 days)
The Disposable blood collection sets are intended to be used with vacuum blood collection tube for venipuncture to collect blood specimens from patients.
The Safelock disposable blood collection sets are intended to be used with vacuum blood collection tube for venipuncture to collect blood specimens from patients, and the safety sheath is designed to aid in the reduction of accidental needlesticks.
The proposed devices are provided sterile, single use. The proposed devices are intended to be used with vacuum blood collection tube for venipuncture to collect blood specimens from patients. It has two models, Safelock disposable blood collection set and Disposable blood collection set.
For disposable blood collection set, they consist nine pieces components: (1) needle protect cover (2) patient-end tube needle (3) double wing needle handle (4)flexing tube (5) connect A (6) non-patient needle hub (7) puncture needle (8) rubber sleeve (9) puncture needle protective cover.
For Safelock disposable blood collection sets, they consist twelve components: (1) needle protect cover (2) patient-end tube needle (3) safety needle handle (4) double wing (5) safety sheath (6) Locking joint (7) flexing tube (8) connect A (9) non-patient needle hub(10) puncture needle (11) rubber sleeve (12) puncture needle protect cover.
This is a 510(k) premarket notification for a medical device, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed clinical study with acceptance criteria and performance metrics in the way a new drug or high-risk device might.
Therefore, the information requested for a detailed study description such as sample sizes for test and training sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone algorithm performance, and how ground truth was established for the training set, is not present in this document.
The document primarily details non-clinical tests conducted to ensure the device meets design specifications and is safe and effective for its intended use, comparable to predicate devices.
Here's what information can be extracted or inferred:
1. Table of Acceptance Criteria (Inferred from non-clinical tests) and Reported Device Performance:
| Acceptance Criteria (Standard / Test) | Reported Device Performance |
|---|---|
| Material Specifications: | |
| ISO 9626:1991 AMENDMENT 1 2001 (Stainless steel needle tubing) | Complied with the standard. |
| Sterile Barrier Packaging: | |
| Seal strength (ASTM F88/F88-09) | Test performed. |
| Internal pressure (ASTM F1140/F1140M-13) | Test performed. |
| Dye penetration (ASTM F 1929-12) | Test performed. |
| Sterilization & Shelf Life: | |
| EO/ECH residue (ISO 10993-7:2008) | Test performed. |
| Bacteria Endotoxin Limit (USP 37-NF 32 ``) | Test performed. |
| Shelf Life Evaluation (Physical, Mechanical, Chemical, Package, Sterility on accelerated aging samples) | Verified claimed shelf life. |
| Biocompatibility Testing: | |
| Cytotoxicity (ISO 10993-5: 2009) | Test performed. |
| Intracutaneous Reactivity (ISO 10993-10: 2010) | Test performed. |
| Skin Sensitization (ISO 10993-10: 2010) | Test performed. |
| Acute Systemic Toxicity (ISO 10993-11:2006) | Test performed. |
| Biocompatibility (Overall) | Conformed with ISO 10993. |
| Sharps Injury Prevention (for Safelock model): | |
| Simulated Clinical Study (FDA Guidance for Industry and FDA Staff: Medical Device with Sharps Injury Prevention Feature, August 9, 2005) | Met pre-established criteria. |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified in the document for any of the non-clinical tests.
- Data Provenance: The tests were conducted internally or by contracted labs. The document does not specify country of origin for the data, but the manufacturer is based in China. The tests are non-clinical (laboratory/bench tests), not human subject trials, so "retrospective or prospective" is not directly applicable in the typical sense.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as no human-read test set requiring expert ground truth is described. The acceptance criteria are based on recognized international and national standards for device performance, materials, and safety.
4. Adjudication method for the test set:
- Not applicable. No adjudication is described for the non-clinical tests.
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 MRMC study was conducted or mentioned, as this is not an AI-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable, as this is not an algorithm-based device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for the non-clinical tests is adherence to the specified technical standards (e.g., ISO, ASTM, USP) and the FDA's guidance document for sharps injury prevention.
8. The sample size for the training set:
- Not applicable. No training set for an algorithm is mentioned.
9. How the ground truth for the training set was established:
- Not applicable. No training set for an algorithm is mentioned.
Summary of what the document focuses on:
This 510(k) submission primarily relies on non-clinical bench testing and adherence to established standards to demonstrate the safety and effectiveness of the "Safelock Disposable Blood Collection Set" and "Disposable Blood Collection Set". The key finding is that these devices are "Substantially Equivalent (SE)" to existing predicate devices (EXEL Vaculet Blood Collection Set K020533 and SURSHIELD™ Safety Winged Blood Collection Set K031279), meaning they share similar intended use, technology, and performance characteristics, and do not raise new questions of safety or effectiveness. No clinical studies were included in this submission.
§ 880.5440 Intravascular administration set.
(a)
Identification. An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.(b)
Classification. Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.