(106 days)
K-SHIELD Zen is designed for accessing peripheral veins to collect blood. The Press Button anti-needle stick protector is an integral safety device intended to minimize accidental needlestick injuries.
The K-SHIELD Zen is a sterile, single use winged blood collection set consisting with a cannula, flexible tube, connection parts and the Press Button anti-needle stick protector designed to minimize accidental needlestick injuries when accessing peripheral veins to collect patient blood. The Press Button anti-needle stick protector stores the needle within the housing when the activation button is pressed after blood collection procedure.
This product has a variety of Needle gauge sizes (21G, 23G, 25G) and a lineup of 3 types of connection parts, Luer connector (PBM), Multiple Sample Luer Adapter (PBMA) and Preattached Holder (PBMH). During blood collection, the Luer connector is connected to a syringe. Multiple Sample Luer Adapter and Pre-attached holder are connected to vacuum blood collection tubes / blood culture bottles to obtain multiple samples. The different configurations (connection options) are chosen by the user based on facility blood collection procedure.
The mechanism of action for the device, all configurations, is blood collection using syringes or vacuum blood collection tubes / blood culture bottles to assist the user with obtaining blood from a patient.
The K-SHIELD Zen is a single use, disposable Ethylene Oxide Sterilized medical device. Sterilization Validation was conducted per ISO 11135: 2014 – Sterilization of Health-Care Products – Ethylene Oxide –Requirements for the Development, Validation, and Routine Control of a Sterilization Process for Medical Devices.
The K-SHIELD Zen is considered blood path, indirect, limited contact (
The provided document is a 510(k) summary for the K-SHIELD Zen blood collection device. It details the device's characteristics, intended use, and a comparison to a predicate device, along with performance data.
Here's an analysis based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in a table format with specific numerical targets. Instead, it references conformity to recognized standards and provides "PASSED" as the performance result for specific tests. The primary acceptance criterion for a 510(k) submission is demonstrating substantial equivalence to a predicate device. The performance data presented supports this claim by showing compliance with biological safety and sterilization standards.
| Acceptance Criterion (Implied) | Reported Device Performance |
|---|---|
| Biocompatibility (DEHP) | PASSED |
| EtO Residuals (Chemical) | PASSED |
| Substantial Equivalence | Achieved |
2. Sample Sizes Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not specify the exact sample sizes (number of units tested) for the Biocompatibility (DEHP Extraction) or EtO Residuals tests. It only states that these tests were conducted.
- Data Provenance: The tests are described as "Non-Clinical Bench Performance Data," implying in-vitro or laboratory testing. The country of origin for the testing data is not explicitly stated. The manufacturer is SB-KAWASUMI LABORATORIES, INC., based in Japan, so it's plausible the tests were conducted there or by a recognized lab. The data is retrospective in the sense that it was generated prior to this submission for the purpose of demonstrating equivalence.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This information is not applicable to this type of device and submission. The tests performed are objective chemical and biological evaluations based on recognized standards (ISO 10993-17, ISO 10993-18, ISO 10993-7). Ground truth, in the context of expert consensus, is typically relevant for interpretative devices (e.g., AI in radiology), not for a blood specimen collection device's bench testing. The "truth" is determined by the measured values against established standard limits.
4. Adjudication Method for the Test Set
This information is not applicable for the same reasons as point 3. Bench tests are typically passed or failed based on objective measurements against predefined limits, not through expert adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
This information is not applicable. The K-SHIELD Zen is a physical medical device (blood collection set), not an AI algorithm or a diagnostic imaging system that would involve human readers or MRMC studies.
6. Standalone (Algorithm Only) Performance Study
This information is not applicable. The K-SHIELD Zen is a physical medical device and does not involve any standalone algorithms.
7. Type of Ground Truth Used
For the performance tests described:
- Biocompatibility (DEHP Extraction) and EtO Residuals: The ground truth is established by the limits specified in the harmonized ISO standards (ISO 10993-17, ISO 10993-18, ISO 10993-7). The device "passes" if its measured chemical concentrations are below these pre-defined, scientifically established safety limits.
8. Sample Size for the Training Set
This information is not applicable. The K-SHIELD Zen is a physical medical device and is 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 for the same reason as point 8.
§ 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.