Kawasumi Laboratories Blood Drawing Kit (BDK) System

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September 28, 2018 Kawasumi Laboratories, Inc. % Lisa Michels Regulatory Compliance Associates, Inc. 10411 Corporate Drive, Suite 102 Pleasant Prairie, Wisconsin 53158 Re: K172957 Trade/Device Name: Kawasumi Laboratories Blood Drawing Kit (BDK) System Regulation Number: 21 CFR 864.9875 Regulation Name: Transfer set Regulatory Class: Class II Product Code: KSB, LHI, FMI Dated: August 21, 2018 Received: August 28, 2018 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 {1}------------------------------------------------ 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 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Geeta K. Pamidimukkala -S for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K172957 ### Device Name Kawasumi Laboratories Blood Drawing Kit (BDK) System Indications for Use (Describe) The Blood Drawing Kit with Antineedle Stick Protector is a single use, sterile transfer set designed for vascular access for blood withdrawal. Use of the Needleless Access Connector allows the clinician needle-free blood withdrawal when blood sampling is required. The Antineedle Stick Protector is an integral, active safety device intended to minimize accidental needle stick injuries when used to shield needles. This device is not intended for blood transfusion. | Type of Use (Select one or both, as applicable) | | |----------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------| | <div> <span> <span style="font-size: 16px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> <span style="font-size: 16px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> | # CONTINUE ON A SEPARATE PAGE IF NEEDED. 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SUBMITTER # Owner/Manufacturer: Kawasumi Laboratories, Inc. Shinagawa Intercity Tower B, 9th Floor 2-15-2, Konan, Minato-Ku, Tokyo, 108-6109, Japan Phone: (81)-3-5769-2663 Contact Person: Katsu Furuya Date Prepared: September 12, 2017 ### ll. DEVICE Trade Name of Device: Kawasumi Laboratories Blood Drawing Kit (BDK) System Common or Usual Name of Device: Blood Drawing Kit System Classification Name: Set, Transfer (Blood Plasma) # Primary Classification Product Code and Classification Regulation: - KSB (Set, Transfer Blood/Plasma -21 CFR 864.9875) ● # Subsequent Classification Product Code(s) and Classification Regulation(s): - . LHI (Set I.V Fluid Transfer - 21 CFR 880.5440) - FMI (Needle, Hypodermic, Single Lumen 21 CFR 880.5570) . Device Class: Class II #### lll. PREDICATE DEVICE(S) The Blood Drawing Kit (BDK) System is substantially equivalent to Kawasumi Laboratories' own predicate device(s) including the following Primary Predicate Device: #### . Kawasumi Laboratories Blood Drawing Kit - cleared under (K001043) ### IV. DEVICE DESCRIPTION The Kawasumi Laboratories Blood Drawing Kit (BDK) System is a therapeutic device used to access a patient's vein for blood removal from the patient to a blood bag reservoir to aid in the treatment of a disease or other condition. The device is not intended for blood transfusion. The Kawasumi Laboratories Blood Drawing Kit (BDK) System consists of a Blood Drawing Kit device that is designed with an integral Antineedle Stick Protector that provides a safety feature intended to minimize accidental needle stick injuries when the device is activated during removal from the patient's vein and may incorporate a needleless access connector site used for blood sampling. {4}------------------------------------------------ The Blood Drawing Kit System is a single use, disposable Ethylene Oxide Sterilized medical device. Sterilization Validation was conducted per ISO 11135-1: 2007 – Sterilization of Health Care Products – Ethylene Oxide – Part 1: Requirement, Validation, and Routine Control of a Sterilization Process for Medical Devices. The Blood Drawing Kit System is considered blood path, indirect, limited contact (< 24 hours) per section 5.2.2 (a) of ISO 10993-1: 2009 - Biological Evaluation of Medical Devices -Part 1: Evaluation and Testing within a Risk Management Process. The Kawasumi Laboratories Blood Drawing Kit (BDK) System is a sterile, single-use device that consists of the following components: *(Y) means the fluid contact components - Needle Protector ● - . Cannula (Y) - . Hub (Y) - Wing (Y skin contact only) . - Antineedle Stick Protector "K-Shield" - . Tubing (Y) - . Needleless Access Connector (NAC) Y-Site (Y) - . Clamp - . Blood Bag Unit Reservoir (Y) The device is intended for use at healthcare facilities or in hospitals. #### V. INDICATIONS FOR USE The Blood Drawing Kit with Antineedle Stick Protector is a single use, sterile transfer set designed for vascular access for blood withdrawal. Use of the Needleless Access Connector allows the clinician needlefree blood withdrawal when blood sampling is required. The Antineedle Stick Protector is an integral, active safety device intended to minimize accidental needle stick injuries when used to shield needles. The device is not intended for blood transfusion. ### VI. COMPARISON OF TECHNOLOGICAL CHARAGTERISTICS WITH THE PRIMARY PREDICATE DEVICE The Comparison of Technological Characteristics of the Subject Device and the Primary Predicate Device (K001043) are shown in the table below: | Kawasumi Laboratories Blood Drawing Kit (BDK) System<br>Table of Substantial Equivalence | | | | |------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | REGULATORY INFORMATION | | | | | Device Name | [Proposed Subject Device] | [Primary Predicate Device] | Similarities/<br>Differences | | | Kawasumi Laboratories<br>Blood Drawing Kit (BDK) System | Kawasumi Laboratories<br>Blood Drawing Kit (K001043) | | | 510(k) Status | Pending - K172957 | K001043 | Same | | Device<br>Classification<br>Name | Set, Transfer<br>(Blood, Plasma) | Set, Transfer<br>(Blood, Plasma) | Same | | Device<br>Classification | Class II | Class II | Same | | Product<br>Code and<br>Regulation<br>Number | (KSB)<br>21 CFR 864.9875 | (KSB)<br>21 CFR 864.9875 | Same | | Subsequent<br>Product Code(s)<br>and Regulation<br>Number(s) | (LHI)<br>21 CFR 880.5440<br>(FMI)<br>21 CFR 880.5570 | (LHI)<br>21 CFR 880.5440 | Same | | | DESIGN FEATURES AND CAPABILITIES OF THE DEVICE | | | | Intended<br>Use /<br>Indication<br>for Use | The Blood Drawing Kit with Antineedle Stick<br>Protector is a single use, sterile set<br>designed for vascular access for blood<br>withdrawal. Use of the Needleless Access<br>Connector allows the clinician needle-free<br>blood withdrawal when blood sampling is<br>required. The Antineedle Stick Protector is<br>an integral, active safety device intended to<br>minimize accidental needle stick injuries<br>when used to shield needles. This device is<br>not intended for blood transfusion. | The Blood Drawing Kit is a sterile, single-use<br>device used for therapeutic purposes to collect<br>patient's blood into a blood bag reservoir. The<br>collected blood is properly discarded and not<br>intended for transfusion.<br><br>This 510(k) Submission did not originally<br>include the Antineedle Stick Protector. It was<br>cleared for use with the BDK under K073257<br>and K102994. | BDK same as<br>K001043; Antineedle<br>Stick Protector same<br>as K073257 and<br>K102994 | | | DESIGN FEATURES | | | | Dimensions,<br>Gauge, Length,<br>Width | Needle Gauge: 16<br>Length: 1450 mm including needle cap) | Needle Gauge: 16<br>Length: 1450 mm including needle cap) | Same | | Venipuncture<br>Needle | Option with the pre-attached venipuncture<br>needle or option without the pre-attached<br>venipuncture needle | Option with the pre-attached venipuncture<br>needle or option without the pre-attached<br>venipuncture needle | Same | | Antineedle<br>Stick<br>Protector<br>(ANSP)<br>Option | Antineedle Stick Protector (ANSP) Option. | None | The Antineedle Stick<br>Protector Option was<br>cleared for use with the<br>Blood Drawing Kit<br>under K073257 and<br>K102994. | | Injection<br>Option | Needleless Access Connector (NAC) Y-Site<br>Option | None | NAC Y-Site Option is<br>the Same as K073257<br>and K102994.<br>The Needleless Acces<br>Connector (NAC) Y-<br>Site Option was<br>cleared for use with the<br>Blood Drawing Kit<br>under K073257 and<br>K102994. This<br>difference does not<br>raise new questions of<br>safety and<br>effectiveness. | | Sterilization<br>Method | Ethylene Oxide Gas (ETO) | Autoclave (AC) | Different Method.<br>SAL is identical.<br>Differences do not<br>raise new questions of<br>safety and<br>effectiveness | | MATERIALS | | | | | Needle<br>Protector | Polyethylene (PE) | Polyethylene (PE)<br>Polyvinyl Chloride (PVC)<br>Poly-Propylene (PP) | Differences do not<br>raise new questions of<br>safety and<br>effectiveness | | Cannula | Stainless Steel | Stainless Steel | Same | | Hub | Polycarbonate (PC) | Polyvinyl Chloride (PVC) | Differences do not<br>raise new questions of<br>safety and<br>effectiveness | | Wing | Polyvinyl Chloride (PVC) | None | Same as K073257 and<br>K102994 | | K-Shield | Polypropylene (PP) | None | Same as K073257 and<br>K102994 | | Tubing | Polyvinyl Chloride (PVC) | Polyvinyl Chloride (PVC) | Same | | Injection<br>Site<br>(NAC-Y site) | Polycarbonate /<br>Synthetic Polyisoprene | None | Same as K073257 and<br>K102994 | | Clamp | Polypropylene (PP) | Polypropylene (PP) | Same | | Bag Unit | Polyvinyl Chloride (PVC) | Polyvinyl Chloride (PVC) | Same | | DISCUSSION OF TECHNOLOGICAL SIMILARITIES AND DIFFERENCES | | | | {5}------------------------------------------------ {6}------------------------------------------------ ## Technological Characteristics and Substantial Equivalence The Blood Drawing Kit (BDK) System is substantially equivalent in both function and use to the following Primary Predicate Device – Kawasumi Laboratories Blood Drawing Kit (cleared under K001043) as noted below: - Kawasumi Laboratories Blood Drawing Kit (Primary Predicate Device cleared under K001043); and the ● - Components including the K-Shield Antineedle Stick Protector (ANSP Option) and the Needleless Access Connector Site ● (NAC- Y Injector Site Option) used for blood sampling cleared under (K073257) and (K102994) for use with the Blood Drawing Kit (Primary Predicate Device cleared under K001043)] These differences do not raise new questions of safety and effectiveness over the Primary Predicate Device. Therefore, the Blood Drawing Kit (BDK) System is substantially equivalent to the Primary Predicate Device based on the intended use of the device. | Summary of<br>Nonclinical<br>Performance<br>Testing | The determination of substantial equivalence was based on an assessment of non-clinical performance data including<br>the following nonclinical tests that have been submitted, referenced, and relied on in this premarket notification<br>submission for a determination of substantial equivalence. | |-----------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | [Biocompatibility Testing] | | | The biocompatibility evaluation for the Blood Drawing Kit System was conducted in accordance with the following<br>guidance documents and standards as recognized by the FDA: | | | FDA Blue Book Memorandum #G95-1 "Use of International Standard ISO 10993, "Biological Evaluation of<br>Medical Devices Part 1: Evaluation and Testing," issued May 1, 1995; | | | ISO 10993-1 "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk<br>Management Process" | | | ISO 10993-2 Biological Evaluation of Medical Devices - Part 2: Animal Welfare Requirements | | | ISO 10993-4 "Biological Evaluation of Medical Devices – Part 4: Selection of Tests for Interaction with Blood<br>[Including: Amendment 1 (2006)] | | | ISO 10993-5 "Biological Evaluation of Medical Devices - Part 5: Tests for In Vitro Cytotoxicity | | | ISO 10993-10 "Biological Evaluation of Medical Devices – Part 10: Tests for Irritation and Skin Sensitization | | | ISO 10993-11 "Biological Evaluation of Medical Devices – Part 11: Tests for Systemic Toxicity | | | ISO 10993-12 "Biological Evaluation of Medical Devices – Part 12: Sample Preparation and Reference<br>Materials | | | The following non-clinical performance testing data were provided in support of the substantial equivalence<br>determination: | | | Cytotoxicity Testing | | | Skin Sensitization Testing | | | Intracutaneous Reactivity Testing | | | Acute Systemic Toxicity Testing | {7}------------------------------------------------ - Pyrogen Testing - . Hemolysis Testing ## [Functional Performance Testing] The functional performance testing for the Blood Drawing Kit System was conducted in accordance with the following guidance documents and standards as recognized by the FDA: - FDA Guidance for Industry and FDA Staff: Medical Devices with Sharps Injury Prevention Features, issued on ● August 9, 2005 - . ISO 3826-1:2003 - Plastic Collapsible Containers for Blood and Blood Components - ISO 1135-3:1986 Transfusion Equipment for Medical Use Part 3: Blood-Taking Sets . - ISO 1135-4:2012 Transfusion Equipment for Medical Use Part 4: Transfusion Sets for Single Use . - ISO 594-2: Conical Fittings with a 6% (Luer) Taper for Syringes, Needles and Certain Other Medical . Equipment - Part 2: Lock Fittings The following non-clinical performance testing data were provided in support of the substantial equivalence determination: - Physical Test for BDK (Non-Aging, 6 Months Aging and 3 Years Aging) - Visual Inspection of Set and Packing — - Test for Leakage - Flow Regulator (Clamp Test) - Volume Marking Accuracy Test & Blockage Test - Function of Large K-Shield Antineedle Stick Protector (Activation Test) - -Function Test of NAC Needleless Access Connector (NAC) Y-Site Option - Pull Strength Test - Sharpness Test - Chemical Test for BDK (Non-Aging, 6 Months Aging and 3 Years Aging) - Test for Reducing (Oxidizable) Matter - Test for Metal Ions - Test for Titration Acidity or Alkalinity - Test for Non-Volatile Residue ー - -Test for Absorbance ### [Sterilization Testing / Sterility Testing / Packaging Testing] The sterilization testing / sterility testing for the Blood Drawing Kit System was conducted in accordance with the following guidance documents and standards as recognized by the FDA: - ISO 10993-7 "Biological Evaluation of Medical Devices Part 7: Ethylene Oxide Sterilization Residuals . [Including Technical Corrigendum 1 (2009)] - . 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 - ISO 11138-1: Sterilization of Health Care Products – Biological Indicators – Part 1: General Requirements - ISO 11607-1: Packaging for Terminally Sterilized Medical Devices Part 1: Requirements for Sterile Barrier . Systems and Packaging Systems [including Amendment 1 (2014)] - . ISO 11607-2: Packaging for Terminally Sterilized Medical Devices – Part 2: Validation Requirements for Forming Sealing and Assembly Processes [including Amendment 1 (2014)] - . ISO 11737-1: Sterilization of Medical Devices – Microbiological Methods – Part 1: Determination of a Population of Microorganisms on Products [including Technical Corrigendum 1 (2007)] {8}------------------------------------------------ | | ISO 14644-1: Cleanrooms and Associated Controlled Environments – Part 1: Classification of Air Cleanliness<br>by Particle Concentration ISO 14622-2: Cleanrooms and Associated Controlled Environments – Part 2: Monitoring to Provide Evidence<br>of Cleanroom Performance related to Air Cleanliness by Particle Concentration The following non-clinical performance testing data were provided in support of the substantial equivalence determination: Material Mediated Pyrogen Testing Particulate Testing Sterilization Validation Testing Residual Gas Analysis Testing Packaging Testing | |-------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Conclusions | The non-clinical performance data demonstrate that the Blood Drawing Kit (BDK) System is substantially equivalent to the Primary Predicate Device. |