(164 days)
Not Found
No
The device description and performance studies focus on mechanical components and standard sterilization/biocompatibility testing. There is no mention of AI, ML, or any computational analysis of data.
No
The device is described as a blood collection set for accessing peripheral veins to collect blood, and its mechanism of action is for blood collection. It does not provide any therapeutic benefit.
No
Explanation: The device is described as a winged blood collection set designed for accessing peripheral veins to collect blood. Its primary function is blood collection, not diagnosing a condition.
No
The device description clearly outlines physical components such as a cannula, flexible tube, connection parts, and an anti-needle stick protector, indicating it is a hardware device for blood collection. There is no mention of software as a component or function.
Based on the provided information, the K-SHIELD Zen is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is "accessing peripheral veins to collect blood." This describes a device used for the collection of a biological sample (blood), not for the testing or analysis of that sample.
- Device Description: The description focuses on the physical components and mechanism for blood collection, including safety features to prevent needlestick injuries. It does not mention any components or functions related to analyzing or testing the collected blood.
- Lack of IVD Characteristics: IVD devices are typically used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The K-SHIELD Zen's function is solely to obtain the specimen.
The K-SHIELD Zen is a medical device used for blood collection, which is a pre-analytical step for many IVD tests, but the device itself is not an IVD.
N/A
Intended Use / Indications for Use
K-SHIELD Zen is designed for accessing peripheral veins to collect blood. The Press Button antineedle stick protector is an integral safety device intended to minimize accidental needlestick injuries.
Product codes (comma separated list FDA assigned to the subject device)
JKA, FMI
Device Description
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 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 (
§ 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.
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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
August 29, 2022
SB-Kawasumi Laboratories, Inc. % Valerie Followell Official Correspondent for Kawasumi Laboratories, Inc. / Regulatory Consultant Regulatory Compliance Associates, Inc. (RCA) 10411 Corporate Drive, Suite 102 Pleasant Prairie, Wisconsin 53158
Re: K220799
Trade/Device Name: K-SHIELD Zen Regulation Number: 21 CFR 862.1675 Regulation Name: Blood Specimen Collection Device Regulatory Class: Class II Product Code: JKA, FMI Dated: July 29, 2022 Received: August 1, 2022
Dear Valerie Followell:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's
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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
David Wolloscheck, Ph.D. For Payal Patel Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices, and Human Factors OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
Device Name K-SHIELD Zen
Indications for Use (Describe)
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.
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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K220799 510(k) Summary
I. SUBMITTER
Sponsor/Manufacturer
SB-KAWASUMI LABORATORIES, INC. 3-25-4 Tonomachi, Kawasaki-ku, Kawasaki-shi, Kanagawa 210-8602, Japan Tel:+81-44-589-9750 Fax:+81-44-589-9768
US Contact and Official Correspondent for SB-KAWASUMI LABORATORIES, INC.
Valerie Followell Official Correspondent Regulatory Compliance Associates®, Inc. 10411 Corporate Drive, Suite 102 Pleasant Prairie, Wisconsin 53158 Phone: (847) 400-6187 Email: v.followell@rcainc.com
II. DEVICE
| Device Trade/Proprietary Name: | K-SHIELD Zen |
|---|---|
| Device Common or Usual Name: | Blood Specimen Collection Device |
| Device Classification Name: | Tubes, Vials, Systems, Serum Separators, Blood Collection |
| Device Regulatory Classification: | Class II |
| Device Classification Regulation: | 21 CFR 862.1675 |
| Product Code: | JKA - Blood Specimen Collection Device |
| FMI - Needle, Hypodermic, Single Lumen | |
| Submission Type: | 510(k) |
| Classification Panel: | General Hospital |
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●
III. PREDICATE DEVICE
Predicate Device:
BD VACUTAINER Push Button Blood Collection Set (K011984)
IV. DEVICE DESCRIPTION
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 (Biocompatibility Testing including: | | Test Results: PASSED
The results of these Non-
Clinical Bench Performance
Data were provided in
support of the substantial
equivalence determination. | |
| 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 | | |
| FDA Recognized Testing Standards: | | | |
| ISO 10993-1:2018-Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process ISO 10993-4:2017-Biological Evaluation of Medical Devices - Part 4: Selections of Tests for Interactions with Blood ISO 10993-5:2009-Biological Evaluation of Medical Devices – Part 5: Tests for In Vitro Cytotoxicity ISO 10993-10:2010-Biological Evaluation of Medical Devices – Part 10: Tests for Irritation and Skin Sensitization ISO 10993-11:2017-Biological Evaluation of Medical Devices – Part 11: Tests for Systemic Toxicity ASTM F756-17-Standard Practice for Assessment of Hemolytic Properties of Materials ASTM F2382-18 - Standard Test Method for Assessment of Circulating Blood-Contacting Medical Device Materials on Partial Thromboplastin Time (PTT) ASTM F2888-19 – Standard Practice for Platelet Leukocyte Count-An In-Vitro Measure for Hemocompatibility Assessment of Cardiovascular Material USP General Chapter Pyrogen Test (USP Rabbit Test), USP42-NF37 | | | |
| Simulated Use Testing | | | |
| Simulated Use Testing | | | |
| FDA Recognized Standards | | | |
| ISO 23908:2011: Sharps Injury Protection-Requirements and Test Methods-Sharps Protection Features for Single-Use Hypodermic Needles, Introducers for Catheters, and Needles used for Blood Sampling FDA Guidance document – Medical Devices with Sharps Injury Prevention Features, CDRH issued, 2005 | | | |
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VIII. SUMMARY OF PERFORMANCE DATA AND PERFORMANCE TEST CONCLUSIONS
The following Performance Data were provided in support of the substantial equivalence (SE) determination.
Summary of Non-Clinical Bench Performance Testing
Non-Clinical Bench Performance Testing was conducted on the K-SHIELD Zen [subject device]. The table below includes the list of the performance testing results submitted, referenced, or relied on in this premarket notification submission for a determination of substantial equivalence.
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| Particulate Contamination Testing | |
|---|---|
| Particulate Contamination Testing | Test Results: PASSED |
| FDA Recognized Testing Standards: | The results of these Non-Clinical Bench Performance |
| Data were provided in support of the substantial equivalence determination. | |
| • USP General Chapter Particulate Matter in Injections, USP42-NF37 | |
| Functional Testing / Packaging Study/ Physical Testing | |
| (Including Stability Testing) | |
| Functional Testing including: | |
| • False Sting Prevention Operation Check | |
| • Piercing Resistance Test | Test Results: PASSED |
| The results of these Non-Clinical Bench | |
| Performance Data were provided in support of the substantial equivalence determination. | |
| Packaging Study including: | |
| • Transportation | |
| • Packaging | |
| • Appearance | |
| • Seal Strength | |
| • Dye Test | • Bubble Test |
| • Stability test | |
| Physical Testing (Including Stability Testing) including: | |
| • Leakage | |
| • Tensile Strength | |
| • Bonding Strength | • Blood-Taking Needle |
| • Tolerance on Length | |
| • Needle Point | |
| FDA Recognized Testing Standards: | |
| • ISO 1135-3:2016 (Second Edition 2016-11) - Transfusion Equipment for Medical Use – Part 3: Blood-Taking Sets for Single-Use | |
| • ISO 7864:2016 (Fourth Edition 2016-08-01) - Sterile Hypodermic Needles for Single-Use: Requirements and Test Methods | |
| • ISO 11607-1:2019 (E): Packaging for terminally sterilized medical devices-Part I: Requirements for materials, sterile barrier systems and packaging systems | |
| • ISO 11607-2:2019 (E): Packaging for terminally sterilized medical devices-Part 2: Validation Requirements for Forming, Sealing and Assembly process | |
| • ASTM D4169-16: Standard Practice for Performance Testing of Shipping Containers and Systems | |
| • ASTM F2096-11 Standard Test Method for Detecting Gross Leaks in Packaging by Internal Pressurization (Bubble Test) |
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| Needle Cover Strength Testing | ||
|---|---|---|
| Needle Cover Strength Testing | Test Results: PASSED | |
| In-House Testing Methods/Standards Utilized for: | The results of these Non- | |
| • Needle Cover Strength Testing | Clinical Bench | |
| Performance Data | ||
| demonstrate that the | ||
| needle cover strength met | ||
| the applicable In-House | ||
| Testing Method/Standard | ||
| utilized for this device | ||
| specific testing which is | ||
| required per the FDA | ||
| Guidance on the Content | ||
| of Premarket Notification | ||
| [510(k)] Submissions for | ||
| Hypodermic Single Lumen | ||
| Needles. Therefore, these | ||
| results were provided in | ||
| support of the substantial | ||
| equivalence | ||
| determination. | ||
| ISO 9626:2016 Confirmation Testing | ||
| ISO 9626:2016 Testing including: | Test Results: PASSED | |
| The results of these Non- | ||
| Clinical Bench | ||
| Performance Data were | ||
| provided in support of the | ||
| substantial equivalence | ||
| determination. | ||
| • Limits for acidity and alkalinity | ||
| • Stiffness test | ||
| • Resistance to breakage | ||
| • Resistance to corrosion | ||
| FDA Recognized Standards | ||
| • ISO 9626:2016: Stainless Steel Needle Tubing for the Manufacture of Medical | ||
| Devices-Requirements and Test Methods | ||
| ISO 7864:2016 Patency of Lumen Testing | ||
| ISO 7864:2016 Testing including: | ||
| • Patency of Lumen | FDA Recognized Standards | |
| • ISO 7864:2016: Sterile Hypodermic Needles for Single Use-Requirements and Test Methods | Test Results: PASSED | |
| The results of these Non-Clinical Bench Performance Data were provided in support of the substantial equivalence determination. | ||
| ISO 23908:2011 Confirmation Testing | ||
| ISO 23908:2011 Testing including: | ||
| • ISO 23908 Confirmation Test (Sphere Simulation) | ||
| • ISO 23908 Confirmation Test (Testing Simulated Clinical Use) | ||
| • ISO 23908 Confirmation Test (Challenging the Device in Safe Mode) | ||
| • ISO 23908 Confirmation Test (Testing Activation of a Sharps Injury Protection Feature) | FDA Recognized Standards | |
| • ISO 23908:2011: Sharps Injury Protection-Requirements and Test Methods-Sharps Protection Features for Single-Use Hypodermic Needles, Introducers for Catheters, and Needles used for Blood Sampling | Test Results: PASSED | |
| The results of these Non-Clinical Bench Performance Data were provided in support of the substantial equivalence determination. | ||
| ISO 80369-7:2016 Compliance Testing | ||
| ISO 80369-7:2016 Testing including: | ||
| • ISO 80369-7:2016 Compliance Test, Identification of ISO 80369-7 in Luer Connector (Accelerated 0 Month/6 Months/3 Years) | FDA Recognized Standards | |
| • ISO 80369-7:2016: Small-Bore Connectors for Liquids and Gases in Healthcare Applications-Part 7: Connectors for Intravascular or Hypodermic Applications | Test Results: PASSED | |
| The results of these Non-Clinical Bench Performance Data were provided in support of the substantial equivalence determination. |
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| Chemical Testing (Including Stability Testing) | Test Results: PASSED | |
|---|---|---|
| ● | Reducing Oxidizable Matter | The results of these Non-Clinical Bench Performance |
| ● | Metal lons | Data were provided in support of the substantial |
| equivalence determination. | ||
| ● | Titration Acidity or Alkalinity | |
| ● | Residue on Evaporation | |
| ● | UV Absorption of Extract Solution (UV) | |
| ● | EtO Residuals | |
| FDA Recognized Testing Standards: | ||
| ● | ISO 10993-7:2008 (Second Edition 2008-10-15) – | |
| Biological Evaluation of Medical Devices – Part 7: | ||
| Ethylene Oxide Sterilization Residuals | ||
| ● | ISO 1135-3:2016 (Second Edition 2016-11) - | |
| Transfusion Equipment for Medical Use – Part 3: | ||
| Blood-Taking Sets for Single-Use | ||
| Sterility Testing | Test Results: PASSED | |
| The results of these Non-Clinical Bench Performance | ||
| FDA Recognized Testing Standards: | Data were provided in support of the substantial | |
| equivalence determination. | ||
| ● | USP General Chapter Sterility Test, USP 43, NF-38 | |
| Conclusions: The data generated from the results of the Non-Clinical Performance Bench Testing support the safety of | ||
| the device and demonstrate that the K-SHIELD Zen performs as intended in the specified use conditions and | ||
| comparably in terms of safety, effectiveness, and performance to the BD VACUTAINER Push Button Collection Set | ||
| (K011984) [predicate device] which is currently marketed for the same intended use. Therefore, this Non-Clinical | ||
| Performance Bench Testing supports a determination of substantial equivalence of the K-SHIELD Zen [subject device] |
when compared to the predicate device.
IX. OVERALL CONCLUSIONS
The differences between the predicate device and the subject device do not raise any new or different questions of safety or effectiveness. The K-SHIELD Zen is substantially equivalent to the BD VACUTAINER Push Button Blood Collection Set (K011984) with respect to indications for use, treatment method and technological characteristics.