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.

Device Description

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 (< 24 hours) per /SO 10993-1: 2018 - Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing within a Risk Management Process. All device materials comply with ISO 10993-1.

The K-SHIELD Zen is a sterile, single-use device that consists of the following components:

Winged needle with Press Button Anti-needle Stick Protector
Luer Connector
Main Tube
Clip
Connector Tube
Locking Cap (optional)
Multiple Sample Luer Adapter (optional)
Pre-attached Holder (optional)

AI/ML Overview

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.

Summary

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June 1, 2023

SB-Kawasumi Laboratories, Inc. % Valerie Followell Official Correspondent for SB-KAWASUMI LABORATORIES, INC. Regulatory Compliance Associates, Inc. (RCA) 10411 Corporate Drive, Suite 102 Pleasant Prairie, Wisconsin 53158

Re: K230408

Trade/Device Name: K-SHIELD Zen (Model Numbers: PBMH/ PBMA/ PBM) Regulation Number: 21 CFR 862.1675 Regulation Name: Blood Specimen Collection Device Regulatory Class: Class II Product Code: JKA Dated: May 2, 2023 Received: May 3, 2023

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 Walloschek

David Wolloscheck, Ph.D. 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

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Enclosure

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Indications for Use

510(k) Number (if known) K230408

Device Name

K-SHIELD Zen (Model Numbers: PBMH/ PBMA/ PBMA/ PBM)

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary -K230408

DATE: 06/01/2023

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 (Model Numbers: PBMH/ PBMA/ PBM)
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 DeviceFMI – Needle, Hypodermic, Single Lumen
Submission Type:	510(k)
Classification Panel:	General Hospital

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III. PREDICATE DEVICE

K-SHIELD Zen (K220799) Predicate Device: ●

IV. DEVICE DESCRIPTION

The K-SHIELD Zen is a sterile, single-use device that consists of the following components:

●

. Winged needle with Press Button Anti-needle Stick Protector
Luer Connector
. Main Tube
Clip
. Connector Tube
Locking Cap (optional) Multiple Sample Luer Adapter (optional) ●
Pre-attached Holder (optional) ●

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The K-SHIELD Zen is intended for use at healthcare facilities or in hospitals.

V. INTENDED 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.

VI. INDICATIONS FOR USE

VII. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

The comparison of the similarities and differences between the K-SHIELD Zen (subject device) and the ● K-SHIELD Zen (K220799) (predicate device) is provided in the Substantial Equivalence (SE) Comparison Table below.

Substantial Equivalence (SE) Comparison Table
	K-SHIELD Zen(Subject Device)	K-SHIELD Zen(K220799)(Predicate Device)	Same/Similarities/Differences
Manufacturer	SB-KAWASUMI LABORATORIES, INC	SB-KAWASUMI LABORATORIES, INC	--
Device Trade orProprietaryName	K-SHIELD Zen	K-SHIELD Zen	--
510(k)Number	K230408	K220799	--
Device Class	Class II	Class II	Same
DeviceClassificationName	Tubes, Vials, Systems, SerumSeparators, Blood Collection	Tubes, Vials, Systems, SerumSeparators, Blood Collection	Same
Device CommonName	Blood specimen collection device	Blood specimen collection device	Same
Product Code	JKA and FMI	JKA and FMI	Same
RegulationNumber	21 CFR 862.1675	21 CFR 862.1675	Same
Indications forUse	K-SHIELD Zen is designed foraccessing peripheral veins to collectblood. The Press Button anti-needlestick protector is an integral safetydevice intended to minimizeaccidental needlestick injuries.	K-SHIELD Zen is designed for accessingperipheral veins to collectblood. The Press Button anti-needlestick protector is an integral safetydevice intended to minimizeaccidental needlestick injuries.	Same
Intended Use	Same as Indications for Use	Same as Indications for Use	Same
PatientPopulation	Adults and Pediatric	Adults Only	Different(Biocompatibilityassessments (DEHPextraction testing andrisk assessmentsupports comparison)
Device Description	The K-SHIELD Zen is a sterile, single usewinged blood collection setconsisting with cannula, flexibletube, connection parts and the PressButton anti-needle stick protectordesigned to minimize accidentalneedlestick injuries when accessingperipheral veins to collect patientblood. The Press Button anti-needlestick protector stores the needlewithin the housing when theactivation button is pressed afterblood collection procedure.	The K-SHIELD Zen is a sterile, singleuse winged blood collection setconsisting with cannula, flexibletube, connection parts and the PressButton anti-needle stick protectordesigned to minimize accidentalneedlestick injuries when accessingperipheral veins to collect patientblood. The Press Button anti-needlestick protector stores the needlewithin the housing when theactivation button is pressed afterblood collection procedure.	Same
Press ButtonFeature	Yes	Yes	Same
Anti-Needle StickPrevention	Yes	Yes	Same
Color-CodedWing	Yes	Yes	Same
Needle	Stainless Steel	Stainless Steel	Same
Needle GaugeDiameter OD	21G, 23G, 25G	21G, 23G, 25G	Same
NeedleDiameter ID	Ultra-Thin Wall	Ultra-Thin Wall	Same
Needle Protector	PP	PP	Same
Needle SheathCover	Isoprene Rubber	Isoprene Rubber	Same
Wing	PP	PP	Same
Tubing	PVC	PVC	Same
Female LuerConnector	ABS	ABS	Same
Luer AdaptorHub	PP	PP	Same
Adhesive	Heat Curing Epoxy	Heat Curing Epoxy	Same
Packaging	Envelope Pouch	Envelope Pouch	Same
Materials ComplywithISO 10993-1	Materials comply withISO 10993-1	Materials comply with ISO10993-1	Same
Non-Pyrogenic	Non-Pyrogenic	Non-Pyrogenic	Same
Non-Toxic	Non-Toxic	Non-Toxic	Same
Prescription (Rx)or Over- theCounter(OTC) Use	Prescription Use	Prescription Use	Same
UseEnvironment	Hospital / Clinic	Hospital / Clinic	Same
Single-Use	Single-Use Only	Single-Use Only	Same
Sterile	Sterile	Sterile	Same
SterilityAssurance Level(SAL 10-6)	SAL 10-6	SAL 10-6	Same
SterilizationMethod	Ethylene Oxide Sterilization (EtO)	Ethylene Oxide Sterilization (EtO)	Same
Shelf-Life	3 Year Shelf-Life	3 Year Shelf-Life	Same

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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
This submission is for the same device but for an expanded patient population and non-clinical performance andbiocompatibility data is leveraged/referenced from K220799.
The table below includes the list of the testing results submitted specific to supporting this expanded patient population.
Biocompatibility Testing
Biocompatibility Testing including:• DEHP Extraction test• Risk Analysis Report of DEHP ExposureFDA Recognized Testing Standards:• ISO 10993-17:2002(First Edition 2002-12-01) – Biological Evaluation of MedicalDevices – Part 17: Establishment of allowable limits for leachable substances• ISO 10993-18:2020 (Second edition 2020-01 Amendment 1 2022-05) -Biological evaluation of medical devices - Part 18: Chemical characterization ofmedical device materials within a risk management process [IncludingAmendment 1 (2022)]	Test Results: PASSEDThe results of these Non-Clinical Bench PerformanceData were provided insupport of the substantialequivalence determination.
Chemical Testing
Chemical Testing• EtO ResidualsFDA Recognized Testing Standards:• ISO 10993-7:2008 (Second Edition 2008-10-15) –Biological Evaluation of Medical Devices – Part 7: Ethylene Oxide SterilizationResiduals [Including: Technical Corrigendum 1 (2009), AMENDMENT 1: Applicabilityof allowable limits for neonates and infants (2019)]	Test Results: PASSEDThe result of the Non-Clinical Bench PerformanceData was provided insupport of the substantialequivalence determination.

IX. OVERALL CONCLUSIONS

The K-SHIELD Zen [subject device] is substantially equivalent to the K-SHIELD Zen (K220799) [predicate device] with respect to indications for use, treatment method and technological characteristics.

Regulation Number and Section

§ 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.