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 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 (< 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

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 <151> 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 <788> 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 <71> 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.

Summary

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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)

K220799

Device Name K-SHIELD Zen

Indications for Use (Describe)

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 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 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 BD VACUTAINER Push Button Blood Collection Set (K011984) (predicate device) is provided in the Substantial Equivalence (SE) Comparison Table below.

Substantial Equivalence (SE) Comparison Table
	K-SHIELD Zen(Subject Device)	BD VACUTAINER Push Button BloodCollection Set (K011984)(Predicate Device)	Same/Similarities/Differences
Manufacturer	SB-KAWASUMI LABORATORIES, INC	Becton Dickinson	--
Device Trade orProprietaryName	K-SHIELD Zen	BD VACUTAINER Push Button BloodCollection Set	--
510(k)Number	K220799	K011984	--
Device Class	Class II	Class II	Same
Product Code	JKA and FMI	FMI and JKA	Same
RegulationNumber	21 CFR 862.1675	21 CFR 880.557021 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 minimize	The BD VACUTAINER Push ButtonBlood Collection Set is a sterile,multiple-sample, single-use wingedblood collection set intended forvenipuncture to obtain blood	Different. Thedifference in wordingof Indications for usedoes not raise anynew or differentquestions of safetyand effectiveness.

	accidental needlestick injuries.	specimens from patients. The
		recommended use of the device is to
		activate the needle prior to removal
		from the venipuncture site. The
		retraction of the intravenous (IV) end
		of the needle aids in the prevention
		of needlestick injury.
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 BD VACUTAINER Push ButtonBlood Collection Set is for venousblood collection. The wing setcontains a needle that will retractinto the body of the device when abutton is depressed, helping toprevent accidental needle sticks. Theretraction of the needle occurswhen the user depressesthe button.	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	Thin Wall	Different. Thedifference in thediameter does notraise new or differentquestions of safetyand effectiveness.PerformanceTesting was
			conducted todemonstratesubstantialequivalence.
Needle Protector	PP	Information not available	Different (assumed).Subject devicematerials complywith ISO 10993-1and have a longhistory of use inmedical deviceapplications.
Needle SheathCover	Isoprene Rubber	Isoprene Rubber	Same
Wing	PP	Polyolefin	Different. Thedifferent butcomparable materialof the wing does notraise new ordifferent questionsof safety andeffectiveness. Bothmaterials complywith ISO 10993-1and have a longhistory of use inmedical deviceapplications. Non-Clinical Testing wasconducted todemonstrate SE.
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	Blister Pack	Different. Thedifferent butcomparablepackaging does notraise new ordifferent questionsof safety andeffectiveness. Non-Clinical Testing wasconducted todemonstrate SE.
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)	Gamma Radiation	Different. Thedifference insterilization methoddoes not raise newor differentquestions of safetyand effectiveness.Product SterilityTesting wasconducted todemonstrate SE.
Shelf-Life	3 Year Shelf-Life	2 Year Shelf-Life	Different. Thedifference in Shelf-Life does not raisenew or differentquestions of safetyand effectiveness.Shelf- Life Testingwas conducted todemonstrate SE.
Biocompatibility Testing
Biocompatibility Testing including:		Test Results: PASSEDThe results of these Non-Clinical Bench PerformanceData were provided insupport of the substantialequivalence 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<151> 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 PerformanceData were provided in support of the substantial equivalence determination.
• USP General Chapter <788> 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: PASSEDThe results of these Non-Clinical BenchPerformance 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 BenchPerformance Datademonstrate that theneedle cover strength metthe applicable In-HouseTesting Method/Standardutilized for this devicespecific testing which isrequired per the FDAGuidance on the Contentof Premarket Notification[510(k)] Submissions forHypodermic Single LumenNeedles. Therefore, theseresults were provided insupport of the substantialequivalencedetermination.
ISO 9626:2016 Confirmation Testing
ISO 9626:2016 Testing including:	Test Results: PASSEDThe results of these Non-Clinical BenchPerformance Data wereprovided in support of thesubstantial equivalencedetermination.
• 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 MedicalDevices-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: PASSEDThe 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: PASSEDThe 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: PASSEDThe 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 substantialequivalence 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 substantialequivalence determination.
●	USP General Chapter <71> Sterility Test, USP 43, NF-38
Conclusions: The data generated from the results of the Non-Clinical Performance Bench Testing support the safety ofthe device and demonstrate that the K-SHIELD Zen performs as intended in the specified use conditions andcomparably 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-ClinicalPerformance 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.

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.