The Kawasumi Multiple Sample Adapter with Pr-Attached Holder (MBCH) is a sterile, non-invasive device used for connection with a female luer system and non-needle devices in order to collect blood specimen to blood collection tube.

Device Description

The Kawasumi Multiple Sample Adapter with Pre-Attached Holder (MBCH) is a sterile, singleuse device consisting of a plastic holder with a non-patient contacting stainless steel cannula covered with a rubber sheath and a male luer adapter which is attached into the holder. This device is used to collect blood specimen by connecting to female luer connectors of vascular access devices such as peripheral, central catheter, Huber needle, etc. As this device can be connected to various devices with female luer adapter, it is called "multiple sample adapter".

When blood is collected, the blood collection tube is placed over the cannula, pushing the rubber sheath back, allowing blood flow. After obtaining the correct amount of blood, the blood collection tube is removed from the holder. When the blood collection tube is removed, the rubber sheath extends back over the cannula and stopping blood flow. Blood collection may be continued by connecting additional blood collection tubes, if required.

The device is sterilized using Ethylene Oxide. The device is a prescription-use device intended to be used in hospitals or healthcare facilities.

AI/ML Overview

Here's an analysis of the provided text, focusing on the acceptance criteria and the study proving the device meets them, based on the requested information.

It's important to note that this document is a 510(k) summary for a medical device (blood specimen collection adapter), not an AI/ML software device. Therefore, many of the typical questions for an AI/ML device, such as those related to AI model training, ground truth establishment, expert adjudication, MRMC studies, or standalone algorithm performance, are not applicable to this type of submission. The 'device' here refers to a physical, non-digital product.

Acceptance Criteria and Study Proving Device Performance

1. A table of acceptance criteria and the reported device performance:

The document doesn't provide a direct "acceptance criteria" table with specific quantitative limits for each test. Instead, it describes various performance tests conducted to demonstrate substantial equivalence (SE) to a predicate device. The general acceptance criterion for all tests is "meets design requirements and specifications" and "confirm performance," ultimately aiming to show comparable function and performance to the predicate device, thereby demonstrating substantial equivalence in terms of safety and effectiveness.

Here's an interpretation based on the "Non-Clinical Testing" section and "Technological Characteristics" comparison, outlining the tests performed to demonstrate that the device meets its design requirements and is substantially equivalent:

Acceptance Criteria (Implied)	Reported Device Performance
Comparative Testing (Functional/Performance Equivalence)	Conducted to verify equivalent function and performance as the predicate device across:
	- Appearance and Measurement (Dimensions: Subject: 20G, L: 64.1mm, WA: 31.1mm, WB: 23.6mm; Predicate: 20G, L: 64.3mm, WA: 30.5mm, WB: 24.9mm - "Comparable," despite minor differences, supported by non-clinical testing).
	- Attachment and Detachment
	- Pressure Resistance
	- Connection Strength
	- Vacuum Tube Insertion and Removal
	- Chemical Resistance
Shelf Life/Accelerated Aging	Conducted to ensure functionality, performance, quality, and safety over time (up to 36 months equivalent) for both physical and chemical properties.
Physical Testing (Accelerated Aging)	Assessed: Packaging Study/Stability Test (Transportation, Appearance, Seal Strength, Dye Test), Physical Study/Stability Test (Leakage, Tensile Strength, Blood Taking Needle functionality).
Chemical Testing (Accelerated Aging)	Assessed: Reducing matter, Metal ions, Titration acidity and alkalinity, Nonvolatile residue, Absorbance (per ISO 1135-3:2016).
Sterilization Effectiveness	Demonstrated compliance with ISO 11135:2014 (Ethylene Oxide sterilization) and United States Pharmacopeia <71> for sterility testing.
EO Residuals	Complies with ISO 10993-7 for residual gas and chemicals.
Particulate Contamination	Complies with ISO 1135-3:2016 for particulate contamination via accelerated aging.
Packaging Integrity	Verified through Transportation Test (ISTA 2A), Appearance Test (ISO 11607-1), Seal Strength Test (ISO 11607-2), and Dye Test (ISO 11607-2).
Luer Fitting Conformance	Conformed to ISO 80369-7:2016 (small-bore connectors) at 0 and 36 months, with measured dimensions within tolerance.
Biocompatibility	Complies with ISO 10993-1, including Cytotoxicity (ISO 10993-5), Sensitization and Irritation (ISO 10993-10), Acute Systemic Toxicity and Material-Mediated Pyrogenicity (ISO 10993-11), and Hemocompatibility (ASTM F756-17, ISO 10993-4).
Materials Equivalence	Materials (Hub: Polycarbonate (PC); Cannula: Stainless Steel; Glue: Epoxy; Silicon: Silicon Oil; Sheath: Isoprene Rubber; Holder: Polypropylene (PP)) were compared. While the Predicate uses Polystyrene for the Hub, the Subject device's use of Polycarbonate was supported by "Biocompatibility Testing and Performance Testing was conducted to demonstrate SE." All other materials are the same.

2. Sample sized used for the test set and the data provenance:

Sample Size: The document does not explicitly state the numerical sample size (e.g., number of devices) used for each individual test. It lists the types of tests performed. For physical device testing, sample sizes are typically determined by relevant ISO standards or internal quality protocols.
Data Provenance: The document does not specify the country of origin of the data. Given the "Kawasumi Laboratories, Inc." address in Tokyo, Japan, it is highly likely that testing was performed by or for the manufacturer, potentially in Japan or at contract labs globally.
Retrospective or Prospective: These are non-clinical, controlled laboratory tests on manufactured devices, so the terms "retrospective" or "prospective" as they apply to clinical studies or real-world data collection are not applicable.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This is a review of a physical medical device. The "ground truth" is established through engineering and laboratory testing against established physical, chemical, and biological standards (e.g., ISO, USP, ASTM). It does not involve human expert interpretation of data in the way an AI/ML device would. Therefore, the concept of "experts establishing ground truth" in this context is not applicable.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not applicable for a physical device undergoing laboratory testing. This concept is relevant for human interpretation tasks, often in AI/ML performance evaluations.

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:

Not applicable. This is a physical blood collection device, not an AI/ML radiology or diagnostic aid. MRMC studies are for evaluating diagnostic accuracy with and without AI assistance.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Not applicable. This is not an algorithm or software device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The "ground truth" for this device's performance is defined by adherence to established international standards (ISO, ASTM, USP) for physical properties, chemical properties, sterility, biocompatibility, and functional performance of medical devices. The predicate device's performance also serves as a benchmark for comparative testing to demonstrate equivalence.

8. The sample size for the training set:

Not applicable. This is not an AI/ML device, so there is no "training set."

9. How the ground truth for the training set was established:

Not applicable. As above, there is no "training set" for a physical medical device.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

July 8, 2019

Kawasumi Laboratories, Inc. % Lisa Michels Regulatory Compliance Associates, Inc. (RCA) 10411 Corporate Drive, Suite 102 Pleasant Prairie, Wisconsin 53158

Re: K190485

Trade/Device Name: Kawasumi Multiple Sample Adapter with Pre-Attached Holder (MBCH) Regulation Number: 21 CFR 862.1675 Regulation Name: Blood Specimen Collection Device Regulatory Class: Class II Product Code: JKA Dated: June 6, 2019 Received: June 11, 2019

Dear Lisa Michels:

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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

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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 (QS) 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 medical devices and radiation-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,

for Nikhil Thakur 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) K190485

Device Name

Kawasumi Multiple Sample Adapter with Pre-Attached Holder (MBCH)

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(K) Summary: K190485

Manufacturer:

Kawasumi Laboratories, Inc.

Address:

Shinagawa Intercity Tower B, 9th Floor 2-15-2. Konan. Minato-Ku. Tokyo, 108-6109, Japan

Corresponding Official/Contact:

Lisa L. Michels, J.D., M.S.O.L.Q Regulatory Consultant

Telephone Number: (602)-935-2565 Email: I.michels@rcainc.com

Summary Date: July 3, 2019

Trade Name: Kawasumi Multiple Sample Adapter with Pre-Attached Holder (MBCH)

Common or Usual Name: Blood Specimen Collection Device

Requlation Number: 21 CFR 862.1675

Regulation Name: Blood specimen collection device

Product Code: JKA

Class: Class 2

Panel: Clinical Chemistry

Predicate Device: Becton Dickinson BD Vacutainer® Brand Multiple Sample Luer Adapter / BD Vacutainer® Safety-Lok Blood Collection Set with Pre-Attached Holder (K991088)

Device Description:

The device is sterilized using Ethylene Oxide. The device is a prescription-use device intended to be used in hospitals or healthcare facilities.

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Indications for Use:

The Kawasumi Multiple Sample Adapter with Pre-Attached Holder (MBCH) is a sterile, noninvasive device used for connection with a female luer system and non-needle devices in order to collect blood specimen to blood collection tube.

Feature of theDevice	Subject Device:	Primary Predicate:	Discussion/Comment:
	Kawasumi Multiple SampleAdapter with Pre-AttachedHolder (MBCH)	BD Vacutainer® BrandMultiple Sample LuerAdapter / BD Vacutainer®Safety-Lok Blood CollectionSet with Pre-Attached Holder(K991088)
Product Code	JKA	JKA	Same
Classification	21 CFR 862.1675	21 CFR 862.1675	Same
Number of Uses	Single-Use Rx Only	Single-Use Rx Only	Same
Materials	Hub: Polycarbonate (PC)	Hub: Polystyrene	Biocompatibility Testingand PerformanceTesting was conductedto demonstrate SE.
	Cannula: Stainless Steel	Cannula: Stainless Steel	Same
	Glue: Epoxy	Glue: Epoxy	Same
	Silicon: Silicon Oil	Silicon: Silicon Oil	Same
	Sheath: Isoprene RubberNot made with NaturalRubber Latex	Sheath: Isoprene RubberNot made with NaturalRubber Latex	Same
	Holder: Polypropylene (PP)	Holder: Polypropylene (PP)	Same
Biocompatibility	Complies with ISO 10993	Complies with ISO 10993	Same
SterilizationMethod	Ethylene Oxide	Ethylene Oxide	Same
Indication forUse	The Kawasumi MultipleSample Adapter with Pre-Attached Holder (MBCH) isa sterile, non-invasivedevice used for connectionwith a female luer systemand non-needle devices inorder to collect bloodspecimen to bloodcollection tube.	The Vacutainer BrandMultiple Sample LuerAdapter / BD Vacutainer®Safety-Lok Blood CollectionSet with Pre-Attached Holderis a sterile, non-invasivedevice used to connectvenous access device suchas needles, blood collectionsets, and infusion sets toblood collection tubes. Theyare also used in connectionwith non-needle devices forcollection of blood fromcatheters. The VacutainerBrand Luer Adapter is soldby itself and as a componentof other Vacutainer Branddevices.	Similar-The differenceis in the name of thedevice, this does notraise any questions ofsafety or effectiveness.
Design Feature	Gauge: 20GLength: 64.1 mmWidth (A): 31.1 mmWidth (B): 23.6 mm	Gauge: 20GLength: 64.3 mmWidth (A): 30.5 mmWidth (B): 24.9 mm	Non-ClinicalPerformance Testingwas conducted todemonstrate SE.

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Technological Characteristics:

The Subject Device and the Predicate Device have similar technological characteristics. Both devices are sterile, single-use, non-invasive devices with a Pre-Attached Holder used for connection with a female luer system and non-needle devices in order to collect blood specimen to blood collection tube.

The Kawasumi Multiple Sample Adaptor with Pre-Attached Holder (MBCH) (Subject Device) is substantially equivalent to the Becton Dickinson Vacutainer Brand Multiple Sample Luer Adapter / BD Vacutainer® Safety-Lok Blood Collection Set with Pre-Attached Holder (K991088) (Predicate Device) with regard to technologic characteristics, materials, performance and intended use.

Non-Clinical Testing:

Non-Clinical Performance Testing was performed to ensure that the device meets design requirements and specifications and to confirm performance of the Kawasumi Multiple Sample Adaptor with Pre-Attached Holder (MBCH).

Test Name	Test Description
ComparativeTesting	Comparative Evaluation Testing was conducted to verify that theKawasumi Multiple Sample Adapter with Pre-Attached Holder(MBCH) has equivalent function and performance as thepredicate device, the Becton Dickinson BD Vacutainer® Safety-Lok Blood Collection Set with Pre-Attached Holder (K991088).This Comparative Evaluation Testing assessed the followingcriterion of the subject and predicate devices:• Appearance and Measurement• Attachment and Detachment• Pressure Resistance• Connection Strength• Vacuum Tube Insertion and Removal• Chemical Resistance
Shelf LifeEvaluation	Physical Testing - Accelerated Aging Testing was conductedon the Kawasumi Multiple Sample Adapter with Pre-AttachedHolder (MBCH)[0 Month] / [6 Months] and [36 Months].Chemical Testing - Accelerated Aging Testing was conductedon the Kawasumi Multiple Sample Adapter with Pre-AttachedHolder (MBCH)[0 Month] and [36 Months].
Physical TestingAccelerated Aging[0 Month][6 Months][36 Months]	Physical Testing - Accelerated Aging Testing was conducted onthe Kawasumi Multiple Sample Adapter with Pre-Attached Holder(MBCH) to ensure the functionality, performance, quality, andsafety of the device to demonstrate substantial equivalence to thepredicate device. Physical Testing on the Ethylene Oxide (EtO)Sterilized Kawasumi Multiple Sample Adapter with Pre-AttachedHolder for [0 Months] / [6 Months] and [36 Months] aging byassessing the following:• Packaging Study / Stability TestTransportation per ISTA 2AAppearance per ISO 11607-1 2006/Amd.1:2014Seal Strength per ISO 11607-2: 2006/Amd.1:2014Dye Test per ISO 11607-2: 2006/Amd.1:2014• Physical Study / Stability TestLeakage per ISO 1135-3: 2016 5.2Tensile Strength per ISO 1135-3: 2016 5.3
Chemical TestingAccelerated Aging[0 Months][36 Months]	Blood Taking Needle per ISO 1135-3: 2016 5.6Chemical Testing - Accelerated Aging Testing was conducted onthe Kawasumi Multiple Sample Adapter with Pre-Attached Holder(MBCH) to ensure the functionality, performance, quality, andsafety of the device to demonstrate substantial equivalence to thepredicate device. The following items were assessed on the [0Months] and [36 Months] aging samples, per ISO 1135-3:2016.- Reducing matter- Metal ions- Titration acidity and alkalinity- Nonvolatile residue- Absorbance
SterilizationProduct Adoption	ISO 11135:2014-Sterilization of Health Care Products - EthyleneOxide - Requirements for the Development, Validation andRoutine Control of a Sterilization Process for Medical Devices.
Sterility	Product Sterility Testing was performed according to UnitedStates Pharmacopeia <71> Stability Test.
EO Residuals	Residual Gas & Chemical Testing was conducted on theKawasumi Multiple Sample Adapter with Pre-Attached Holder(MBCH) to ensure the functionality, performance, quality, andsafety of the device per ISO 10993-7: Biological Evaluation ofMedical Devices Part 7 – Ethylene Oxide Sterilization Residualsincluding:• Chemical Testing - Residual Gas & Chemical Testing- [0 Months]• Chemical Testing- [36 Months]
ParticulateContaminationTesting	Particulate Contamination Testing was conducted on theKawasumi Multiple Sample Adapter with Pre-Attached Holder(MBCH) to ensure the functionality, performance, quality, andsafety of the device to demonstrate substantial equivalence to thepredicate device. This Particulate Contamination Testing wasconducted per ISO 1135-3:2016, Item 5.1 on MBCH withaccelerated aging at 55°C, 138 days for real-time equivalent [36Months]. The test procedure follows Annex A.1 of ISO 1135-3:2018.
Packaging	Packaging Integrity Testing was conducted to verify the integrityof the packaging. The tests included:• Transportation Test (ISTA 2A)• Appearance Test (ISO 11607-1:2006/Amd.1:2014)• Seal Strength Test (ISO11607-2:2006/Amd.1:2014)• Dye Test (ISO11607-2:2006/Amd.1:2014)
Luer Fitting Testing(Conformance toISO 80369-7:2016)[0 Months][36 Months]	Luer Fitting Testing [0 Months] and Luer Fitting Testing [36Months] was conducted in accordance with ISO 80369-7:2016 -Small-Bore Connectors for Liquids and Gases in HealthcareApplications -- Part 7: Connectors for Intravascular or HypodermicApplications to confirm that the products produced based on theoutput of the design conform to the needs of the user and theintended use. The dimensions of the MBCH were measured toverify the parts of the MBCH were within the tolerance range andconform the standard.
Biocompatibility	Biocompatibility Testing was conducted on the Kawasumi MultipleSample Adapter with Pre-Attached Holder (MBCH) in accordancewith ISO 10993-1:2009 (Fourth Edition 2009-10-15) BiologicalEvaluation of Medical Devices – Part 1: Evaluation and TestingWithi
Cytotoxicity Testing per ISO 10993-5:2009 BiologicalEvaluation of Medical Devices – Part 5: Tests for In VitroCytotoxicity
Sensitization Testing per ISO 10993-10:2010 BiologicalEvaluation of Medical Devices - Part 10: Tests for Irritationand Skin Sensitization
Irritation or Intracutaneous Reactivity Testing per ISO10993-10:2010 Biological Evaluation of Medical Devices -Part 10: Tests for Irritation and Skin Sensitization
Acute Systemic Toxicity Testing per ISO 10993-11:2017●Biological Evaluation of Medical Devices – Part 11: Testsfor Systemic Toxicity
Material-Mediated Pyrogenicity Testing per USP GeneralChapter <151> Pyrogen Test and ISO 10993-11:2017Biological Evaluation of Medical Devices – Part 11: Testsfor Systemic Toxicity
Hemocompatibility Testing per ASTM F756-17 StandardPractice for Assessment of Hemolytic Properties ofMaterials and ISO 10993-4:2017 Biological Evaluation of
Medical Devices – Part 4: Selection of Tests forInteractions with Blood

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Conclusion:

Based on the Non-Clinical Performance Testing conducted on the subject device, intended use, and priciples of operation it may be concluded that the Kawasumi Multiple Sample Adapter with Pre-Attached Holder (MBCH) (Subject Device) is substantially equivalent to the legally marketed Predicate Device.

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.