(164 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 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 device is intended for the Adult population only. Do not use in pediatric age groups, including newborn, neonate, or children.
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 (
Here's a breakdown of the acceptance criteria and the studies mentioned for the K-SHIELD Zen device, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The FDA 510(k) summary does not present specific quantitative acceptance criteria with corresponding performance metrics in a single, clear table. Instead, it lists various tests with a consistent "Test Results: PASSED" outcome, implying that the device met the requirements of the specified standards.
Implicit Acceptance Criteria (Based on Test Type) and Reported Device Performance:
| Acceptance Criteria Category | Specific Test / Standard | Reported Device Performance |
|---|---|---|
| Biocompatibility | Cytotoxicity, Sensitization, Intracutaneous Reactivity, Systemic Toxicity, Hemocompatibility (Pyrogenicity, In Vitro Partial Thromboplastin Time (PTT) Test, In Vitro Hemocompatibility Assessment by Evaluating Platelet Leukocyte Counts and its Adherence Testing) | PASSED for all specified biocompatibility tests. |
| FDA Recognized Testing Standards: ISO 10993-1, ISO 10993-4, ISO 10993-5, ISO 10993-10, ISO 10993-11, ASTM F756-17, ASTM F2382-18, ASTM F2888-19, USP General Chapter Pyrogen Test | N/A (Compliance with standards) | |
| Simulated Use Testing | Sharps Injury Protection (ISO 23908:2011) | PASSED. |
| FDA Guidance: Medical Devices with Sharps Injury Prevention Features, CDRH issued, 2005 | N/A (Compliance with guidance) | |
| Particulate Contamination | Particulate Contamination Testing | PASSED. |
| FDA Recognized Testing Standard: USP General Chapter Particulate Matter in Injections | N/A (Compliance with standard) | |
| Functional Testing / Packaging Study / Physical Testing | False Sting Prevention Operation Check, Piercing Resistance Test, Transportation, Packaging (Appearance, Seal Strength, Dye Test, Bubble Test, Stability test), Leakage, Tensile Strength, Bonding Strength, Blood-Taking Needle, Tolerance on Length, Needle Point | PASSED for all specified functional, packaging, and physical tests. |
| FDA Recognized Testing Standards: ISO 1135-3:2016, ISO 7864:2016, ISO 11607-1:2019, ISO 11607-2:2019, ASTM D4169-16, ASTM F2096-11 | N/A (Compliance with standards) | |
| Needle Cover Strength | Needle Cover Strength Testing (per In-House Testing Methods/Standards) | PASSED. |
| Needle Tubing Characteristics | ISO 9626:2016 Testing (Limits for acidity and alkalinity, Stiffness test, Resistance to breakage, Resistance to corrosion) | PASSED. |
| FDA Recognized Testing Standard: ISO 9626:2016 | N/A (Compliance with standard) | |
| Lumen Patency | ISO 7864:2016 Testing (Patency of Lumen) | PASSED. |
| FDA Recognized Testing Standard: ISO 7864:2016 | N/A (Compliance with standard) | |
| Sharps Injury Protection Feature (Confirmation) | ISO 23908:2011 Confirmation Test (Sphere Simulation, Testing Simulated Clinical Use, Challenging the Device in Safe Mode, Testing Activation of a Sharps Injury Protection Feature) | PASSED. |
| FDA Recognized Testing Standard: ISO 23908:2011 | N/A (Compliance with standard) | |
| Luer Connector Compliance | ISO 80369-7:2016 Compliance Test (Identification of ISO 80369-7 in Luer Connector at Accelerated 0 Month/6 Months/3 Years) | PASSED. |
| FDA Recognized Testing Standard: ISO 80369-7:2016 | N/A (Compliance with standard) | |
| Chemical Testing | Reducing Oxidizable Matter, Metal Ions, Titration Acidity or Alkalinity, Residue on Evaporation, UV Absorption of Extract Solution (UV), EtO Residuals (Including Stability Testing) | PASSED for all specified chemical tests. |
| FDA Recognized Testing Standards: ISO 10993-7:2008, ISO 1135-3:2016 | N/A (Compliance with standards) | |
| Sterility Testing | Sterility Test | PASSED. |
| FDA Recognized Testing Standard: USP General Chapter Sterility Test | N/A (Compliance with standard) | |
| Sterilization Validation | (Mentioned in Device Description) | Conducted per ISO 11135:2014. |
| Material Compliance (Biological Evaluation of Medical Devices) | (Mentioned in Device Description) | All device materials comply with ISO 10993-1. |
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes used for each individual performance test (test set). It simply states that "Non-Clinical Bench Performance Testing was conducted on the K-SHIELD Zen [subject device]."
The data provenance is not explicitly stated in terms of country of origin or whether it was retrospective or prospective. However, based on the nature of bench testing and the company's location (Japan with a US correspondent), it's highly likely to be prospective laboratory bench testing conducted at the manufacturer or a contract testing organization.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable to this type of device and study. The "ground truth" for the performance tests of a blood collection device (like sharps injury prevention, biocompatibility, sterility) is established by adherence to recognized international standards (e.g., ISO, ASTM, USP) and verified by standardized laboratory testing methods, not by expert consensus on clinical findings.
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 studies where subjective human interpretation of data (e.g., image analysis for disease detection) requires consensus or a tie-breaking mechanism. The tests described are objective, pass/fail bench 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
An MRMC comparative effectiveness study was not conducted and is not applicable to this device. This type of study is relevant for diagnostic devices, particularly those involving human interpretation of medical images, often with AI assistance. The K-SHIELD Zen is a blood collection device, not an AI-powered diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
A standalone algorithm performance study was not conducted and is not applicable. The K-SHIELD Zen is a physical medical device, not a software algorithm.
7. The type of ground truth used
The "ground truth" for the performance tests of the K-SHIELD Zen device is the defined requirements and specifications laid out in recognized international and national standards (e.g., ISO, ASTM, USP), as well as internal in-house testing methods. These standards specify acceptable limits for various physical, chemical, and biological properties, and the device's performance against these limits constitutes the ground truth for "passing" or "failing" a test.
8. The sample size for the training set
This information is not applicable. The K-SHIELD Zen is a physical blood collection device. It is not an AI/ML algorithm that requires a "training set" to learn from data. Its performance is evaluated through engineering and laboratory testing against established specifications.
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.