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The SB Knife Jr2 is a single-use sterile Electrosurgical Knife (Model Numbers: MD-47702, MD-47702L). This device is designed to be used with Olympus and ERBE Electrosurgical monopolar HF generators, connectors and patient grounding plates to cut tissue including Zenker's diverticulum within the digestive tract using high-frequency current.

SB Knife Jr2 under application (Hereinafter "the Subject Device" is a single-patient use EtOsterilized hand-held device that connects to an external high frequency (HF) generator and is designed to be used with Olympus and ERBE Electrosurgical monopolar HF generators, connectors and patient grounding plates to cut tissue including Zenker's diverticulum within the digestive tract using high-frequency current. Varying generator power, cycle and duration results in a control of these surgical capabilities. The Subject Device is designed to connect with Olympus and ERBE connectors and uses the disposable or reusable Olympus or ERBE grounding plates and connecting cables intended for the generators. The Subject Device is not life supporting or life sustaining. It is designed as a short-term limited contact device (less than 24 hours), has no software, and has been certified to comply with IEC 60601-1, IEC 60601-2-2, IEC 60601-1-2, IEC 60601-1-6 and IEC 60601 2-18 by ISO 17025 accredited laboratory. The Subject Device consists of two models as follows: MD-47702 Working Length: 1970 mm MD-47702L Working Length: 2320 mm

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.

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)

Female luer type · The Kawasumi Multiple Sample Adapter with Pre-Attached Holder (MBCH) is a sterile, non-invasive device used for connection with syringes when transferring blood specimen from a syringe to blood collection tube or blood culture bottle. Male luer type · The Kawasumi Multiple Sample Adapter with Pre-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.

The Kawasumi Multiple Sample Adapter with Pre-attached Holder (MBCH) is a sterile, single use device consisting of a plastic holder with a non-patient contacting stainless steel cannula covered with a rubber sheath and a luer adapter. There are two types of the device with difference in luer adapter type; male luer adapter type and female luer adapter type. The predicate device (K190485) is the male luer type and the proposed device is the female luer type, and the subject of this special 510(k) premarket notification submission. - The male luer adapter type is used to collect blood specimen into blood collection tube by . connecting to female luer connectors of vascular access devices such as peripheral, central catheter, Huber needle, etc. (predicate [Item number MBCH-01]) - The female luer adapter type is used to transfer blood from a syringe into blood collection tube . or blood culture bottle. After drawing patient blood into a syringe, connect the female luer adapter of the device to the syringe. When inserting a tube, the blood is transferred into the tube using tube's vacuum. (subject [Item number MBCH-02]) The device is sterilized using Ethylene Oxide. The device is a prescription-use device intended to be used in hospitals or healthcare facilities.

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.

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)