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The UTC 3 ml Medication Cartridge is intended for use in hospital and outpatient care environments with the CADD-MS® 3 Ambulatory Infusion Pump for subcutaneous infusion of medication in adults.

The UTC 3 mL Cartridge (UTC Cartridge) is a is a sterile, single-use cartridge intended for use with the Smiths Medical MD, Inc. CADD-MS®3 Ambulatory Infusion Pump. The UTC Cartridge is for use in hospitals and outpatient care environments. The UTC 3 mL Medication Cartridge consists of 3 primary components: a 3mL cartridge that looks like a small syringe, 22G x 0.5 in. needle, and protective cap. The distal end of the device has a male luer lock used to attach the needle and withdraw medication from a vial. Once filled, the plunger is removed, needle is discarded, and protective cap is place on the luer until the cartridge is inserted into the CADD-MS 3 Infusion Pump and secured into place with the infusion pump's lid. The protective cap can then be discarded and the male luer can then be attached to the female luer of an infusion set.

The Elite Biomedical Solutions Dose Request Cord is an accessory for a syringe pump and may be used in the same environment as the corresponding pump. The healthcare worker connects the device to the pump. The patient uses the switch on the cable to signal the syringe pump to deliver medication consistent with the parameters entered into the pump by the healthcare worker. The Elite Biomedical Solutions Dose Request Cord is a non-sterile, reusable device intended for multi-patient use in adult and adolescent (over 12 years of age) population.

Elite Biomedical Solutions Dose Request Cord is a replacement for the BD Alaris PCA Pump Model 8120 syringe infusion pump. Elite Biomedical Solutions does not manufacture the pump. The Dose Request Cord is an accessory for the pump and is available as a replacement part. The Dose Request Cord contains a handpiece with integral cable which plugs into the mating connector on the BD Alaris PCA Pump to allow the patient to request medication within the parameters entered into the syringe/infusion pump by the healthcare provider and the designed limits on the pumps. The Elite Biomedical Solutions Dose Request Cord has the same type of construction and technological characteristics as the predicate device, which is also a replacement bolus cable. Both the subject and predicate device are equivalent to the accessories supplied with the original pump. The Dose Request Cords are passive devices that contain no powered electronic components. They are powered by the mating equipment using low voltages to detect changes in the state of the push button. Shielding and insulation of these devices is substantially equivalent to the predicate device.

The RG 3ml Medication Cartridge is designed for use in hospitals and outpatient care environments with the CADD-MS®3 Ambulatory Infusion Pump for subcutaneous infusion of medication in adults.

The RG 3ml Medication Cartridge is a sterile, single-use, non-pyrogenic, 3.0 ml piston syringe intended for use with the Smiths Medical MD, Inc. CADD-MS®3 Ambulatory Infusion Pump. The CADD-MS®3 Ambulatory Infusion Pump requires use of a 3 ml medication cartridge and an infusion set. The RG 3ml Medication Cartridge consists of a hollow barrel, movable plunger with O-rings for sealing and a male Luer lock fitting at the distal end. The male Luer lock fitting of the cartridge is connected to the female Luer fitting of an infusion set. The reservoir is placed in the CADD-MS®3 Ambulatory Infusion Pump to achieve its intended use. The RG 3ml Medication Cartridge is available with a 0.7mm (22G) x 12.5mm (1/2in.) needle and cap. The needle is attached to the end of the RG 3ml Medication Cartridge and operates as a syringe to withdraw medication from a vial. After the medication is filled in the RG 3ml Medication Cartridge, the plunger stopper is removed to allow the RG 3ml Medication Cartridge to fit inside the Smiths CADD-MS®3 Infusion Pump. A cartridge cap from the Smiths CADD-MS®3 Infusion Pump secures the RG 3ml Medication Cartridge into place. An infusion set is then attached to the luer lock fitting of the RG 3ml Medication Cartridge.

BlueStar® Rx is indicated for use by healthcare providers (HCPs) and their patients – aged 18 years and older – who have type 1 or type 2 diabetes. The BlueStar® Rx is intended to provide secure capture, storage, and transmission of blood glucose data as well as information to aid in diabetes self-management. The BlueStar® Rx analyzes and reports blood glucose test results and supports medication adherence. In addition, the BlueStar® Rx provides coaching messages (motivational, behavioral, and educational) based on real-time blood glucose values and trends. It includes software intended for use on mobile phones or personal computers in the home or in professional healthcare settings. The software also allows for entry of other diabetes-related healthcare information and provides educational information. For bolus insulin users with type 1 and type 2 diabetes, BlueStar® Rx includes an insulin dose calculator to allow patients to use their prescribed regimen to calculate a dose of bolus insulin for a given amount of carbohydrates and/or blood glucose value. For basal insulin users with type 2 diabetes, BlueStar® Rx includes an Insulin Adjustment Program (IAP) which calculates appropriate long-acting basal insulin doses for titrating insulin levels based on configuration by a healthcare provider knowledgeable in the care and management of diabetes. The healthcare provider must activate the Insulin Adjustment Program and configure it for patient-specific parameters. The BlueStar® Rx is not intended to replace the care provided by a licensed healthcare professional, including prescriptions, diagnosis, or treatment.

BlueStar Rx is a modified version of the primary predicate (WellDoc BlueStar Rx cleared under K190013). BlueStar Rx maintains all of the features of the primary predicate and adds the titration of long-acting basal insulin doses for qualified type 2 diabetes patients who are not using bolus insulin. This long-acting basal insulin titration feature is included as part of the Insulin Adjustment Program (IAP) in BlueStar Rx. WellDoc BlueStar® as cleared under K190013, is a stand-alone software system intended to be used by healthcare providers (HCPs) and their patients – aged 18 years and older - who have type 1 or type 2 diabetes. The system is intended to assist type 1 and type 2 diabetes patients to self-manage their disease. Patients receive guidance on diabetes selfmanagement and are encouraged to reach out to their healthcare team when needed. There are two versions of the primary predicate WellDoc BlueStar® (cleared under K190013) -BlueStar® (OTC version) and BlueStar® Rx (prescription only) applications. In this submission, Welldoc does not propose to change the OTC version of BlueStar application. Like the bolus insulin dose calculator already included in the primary predicate (BlueStar Rx), the new long-acting basal insulin titration feature is also limited to the prescription use (Rx) version. The bolus insulin calculator feature will be disabled in patients using long-acting basal insulin titration feature in the BlueStar Rx. Health care providers (HCPs) will be required to initiate and manage the basal insulin titration for their qualified type 2 diabetes patients using the following two interfaces: - Web based HCP interface for use by the providers to prescribe long-acting basal insulin doses for the qualified type 2 diabetes patients. - Web and mobile patient interface for use by patients to follow provider's basal insulin titration plan. The IAP feature in BlueStar Rx provides directions to the patients based on prescription by their HCP for titrating long-acting insulin doses only. BlueStar® Rx will also maintain the following features of the primary predicate (WellDoc BlueStar Rx cleared under K190013): (1) ability to connect to the One Touch Verio Flex Blood Glucose Meter via Bluetooth which allows users to send data from their BG meter to the BlueStar® Rx app. which will provide coaching messages (motivational, and educational) based on the real-time blood glucose values and trends. (2) The BlueStar Server will also have the ability to transmit data to the OneTouch Reveal Server. With this application, 3-hour delayed continuous glucose monitoring device data can be accessed via API and uploaded for data visualization purposes only.

The SpaceStation MRI is a MRI (Magnetic Resonance Imaging) System Rack for the operation of Space Infusion Pumps during MRI examinations (MRI procedures) of adult, pediatric or neonatal patients. The product is intended to be used by qualified healthcare professionals. The Perfusor® Space Infusion Syringe Pump System includes an external transportable electronic infusion syringe pump and pump accessories. The system is intended for use on adults, pediatrics, and neonates for the intermittent or continuous delivery of parenteral and enteral fluids through clinically accepted routes of administration. These routes include, but are not limited to intravenous, intra-arterial, subcutaneous, epidural, irrigation'ablation, and enteral. The system is used for the delivery of medications indicated for infusion therapy including but not limited to drugs like anesthetics, sedatives, analgesics, catecholamines, anticoagulants etc., blood components, Total Parenteral Nutrition (TPN), Lipids, and enteral fluids. The Perfusor® Syringe Pump System is intended to be used by trained healthcare professionals in healthcare facilities, home care, outpatient, and medical transport environments (only road ambulances). The Infusomat® Space Volumetric Infusion Pump System includes an external transportable electronic volumetric infusion pump, dedicated administration sets, and pump accessories. The system is intended for use on adults, pediativs, and neonates for the intermittent or continuous delivery of parenteral fluids through clinically accepted routes of administration. These routes include, but are not limited to intravenous, irrigation/ablation, and enteral. The system is used for the delivery of medications indicated for infusion therapy including but not limited to colloids and cristalloids, blood and blood components, Total Parenteral Nutrition (TPN), lipids, and enteral fluids. The Infusomat® Space Volumetric Infusion Pump System is intended to be used by trained healthcare professionals in healthcare facilities, home care, outpatient, and medical transport environments. (only road ambulances).

The SpaceStation MRI is a movable MRI Rack System for the operation of up to four B.Braun Space Infusions Pumps in MRI rooms (faraday cage of antimagnetic materials) during MRI examinations of patients. The SpaceStation MRI does not include the Infusion Pumps, and it does not control the operation of the user-installed Infusion Pumps. Patients are moved from nursing units to the MRI area with infusing pumps which are placed in the SpaceStation MRI for the MRI scan. The SpaceStation MRI is a RF-shielded housing which is mounted on the trolley. The mechanical construction of the housing makes it possible to position the system within the MRI room; it provides a shielded space and mechanical and electrical connections for up to four Space Infusion Pumps. A window in the door allows for direct viewing of the inserted infusion pumps, allowing all pump status and alarm conditions to be observed. The exterior housing provides IV line inlets and outlets, and knobs to release the infusion pumps. The SpaceStation MRI (Unit) includes the SpaceStation with SpaceCover comfort and Magnet Indicator Tesla Spy 2010. The SpaceCover comfort includes a large light display that shows the status and alarm condition of the pumps within the station as well as an audible alarm. The Magnet Indicator Tesla Spy 2010 allows the operator to correctly position the SpaceStation MRI within the MRI room by measurement of the magnetic flux density. An optical and audible alarm is triggered if the station is too close to the MRI, exceeding the permitted flux density. The Trolley has an IV pole and provides a mount for the Safety Tether. The SpaceStation MRI is not connected to a network. The Perfusor® Space Infusion Syringe Pump is a 12V DC or battery powered external, transportable, infusion syringe pump. The Perfusor® Space Infusion Syringe Pump utilizes a swivel-drive pumping mechanism and is intended to provide infusions of parenteral fluids. The Perfusor® Space Infusion Syringe Pump is intended to be used by trained healthcare professionals in healthcare facilities, home care, outpatient, and medical transport environments (only road ambulances). A trained Biomedical Technician must perform a complete set-up of the pump prior to use in a clinical setting. The system is intended to provide intermittent or continuous delivery of parenteral fluids to the patient. Parenteral fluids may include all standard fluids and/or medicated for infusion as well as blood and blood products. The Perfusor® Space Infusion Syringe Pump uses standard, single-use, disposable syringes (with luer-lock connectors) designed for use on syringe pumps and validated on the Perfusor® Space Infusion Syringe Pump. The Infusomat Space Volumetric Infusion Pump is a 12V DC or battery powered external, transportable, volumetric infusion pump. The Infusomat Space Volumetric Infusion Pump utilizes a linear peristaltic pumping mechanism and is intended to provide infusions of parenteral fluids. The Infusomat Space Volumetric Infusion Pump is intended for but not limited to be used by trained healthcare professionals in healthcare facilities, home care, outpatient, and medical transport environments (only road ambulances). A trained Biomedical Technician must perform a complete set-up of the pump prior to use in a clinical setting. The system created by using the administration sets with the Infusomat Space Volumetric Infusion Pump is intended to provide intermittent or continuous flow of parenteral fluids to the patient. Parenteral fluids may include all standard fluids and/or medications indicated for infusion as well as blood and blood products.

The WellDoc BlueStar® System is indicated for use by healthcare providers (HCPs) and their patients - aged 18 years and older - who have type 1 or type 2 diabetes. The BlueStar System is intended to provide secure capture, storage, and transmission of blood glucose data as well as information to aid in diabetes self-management. The BlueStar® System analyzes and reports blood glucose test results and supports medication adherence. In addition, the BlueStar System provides coaching messages (motivational, behavioral, and educational) based on real-time blood glucose values and trends. It includes software intended for use on mobile phones or personal computers in the home or in professional healthcare settings. The software also allows for entry of other diabetes-related healthcare information and provides educational information. The BlueStar® System is not intended to replace the care provided by a licensed healthcare professional, including prescriptions, diagnosis, or treatment. The WellDoc BlueStar® Rx System is indicated for use by healthcare providers (HCPs) and their patients - aged 18 years and older - who have type 1 or type 2 diabetes. The BlueStar® Rx System is intended to provide secure capture, storage, and transmission of blood glucose data as well as information to aid in diabetes self-management. The BlueStar® Rx System analyzes and reports blood glucose test results and supports medication adherence. In addition, the BlueStar® Rx System provides coaching messages (motivational, behavioral, and educational) based on real-time blood glucose values and trends. It includes software intended for use on mobile phones or personal computers in the home or in professional healthcare settings. The software also allows for entry of other diabetes-related healthcare information and provides educational information. BlueStar® Rx includes an insulin dose calculator to allow patients to use their prescribed regimen to calculate a dose of insulin for a given amount of carbohydrates and/or blood glucose value. The BlueStar® Rx System is not intended to replace the care provided by a licensed healthcare professional, including prescriptions, diagnosis, or treatment.

WellDoc® BlueStar® is a stand-alone software system intended to be used by healthcare providers (HCPs) and their patients - aged 18 years and older - who have Type 1 or Type 2 Diabetes. The system is intended to assist Type 1 and Type 2 Diabetes patients to self-manage their disease, as cleared under K162532. Patients receive guidance on diabetes self-management and are encouraged to reach out to their healthcare team when needed. There are two versions of BlueStar® - BlueStar® and BlueStar® Rx - which differ in the availability of the insulin dose calculator, which is restricted to a prescription from a licensed HCP with prescribing authority. BlueStar® and BlueStar® Rx are implemented through an enterprise such as a health plan or large physician group in tandem with a patient's healthcare team and are comprised of the following applications: - Enterprise Director Portal - HCP Service - Patient Mobile Application - Patient Web Portal The Enterprise Director application is used for administrative purposes. The HCP Service houses the Medication Reconciliation feature, which allows for the process of identifying the most accurate list of all medications that the patient is taking, including name, dosage and frequency, by comparing the medical record to an external list of medications obtained from a patient, hospital, or other provider (cleared under K141273). The Patient Web Portal and the Patient Mobile application have a similar feature set. Data (including blood glucose values, medications, carbohydrates, and activity) entered into these applications are stored in the database and can be retrieved for display in either application. Both applications require the initial web- or mobile-based registration before the patient can access them. On the patient applications (Mobile and Web), BlueStar® and BlueStar® Rx function as an (1) information repository (logbook and Personal Health Record) and (2) diabetes education resource (learning library and health tips) and provide (3) motivational, behavioral, and educational coaching based on real-time blood glucose values and trends, (4) a secure communication system (Message Center), (5) medication information (dose and schedule), and (6) workflow and decision support for healthcare providers. In BlueStar® Rx, the patient web portal and mobile application also provide an insulin calculator to allow patients to use their prescribed regimen to calculate a dose of insulin for a given amount of carbohydrates and/or blood glucose value. This submission introduces Insulin on Board to be considered in the calculation. The insulin dose calculator is indicated for prescription-use only. Furthermore, as cleared under K162225, BlueStar® and BlueStar® Rx have the ability to connect to the One Touch Verio Flex Blood Glucose Meter (K150214) via Bluetooth. This will allow users to send data from their meter to the BlueStar® Rx app, which will provide coaching messages (motivational, behavioral, and educational) based on the real-time blood glucose values and trends. The BlueStar Server will also have the ability to transmit data to the OneTouch Reveal Server. With this application, 3-hour delayed continuous glucose monitoring device data can be accessed via API and uploaded for data visualization purposes only. These modifications do not change the fundamental scientific technology of the device.

The Lockbox is intended to hold a Perfusor® Space PCA Infusion Pump and provide reasonably secure access to the medication syringe contained within.

The Lockbox is a lockable, clear plastic enclosure designed to house a B. Braun Perfusor® Space PCA Syringe Infusion Pump and secure it onto a vertical IV pole. The Lockbox consists of a two part polycarbonate enclosure consisting of a front housing and a rear housing. The rear housing has two guide rails which position the pump in the Lockbox. The left guiderail contains a detent which serves to hold the pump in place. The rear housing contains three openings, one to allow for the release of the pump from the detent in the left guide rail, one that allows for connection of the power and PCA cables, and slotted openings allowing for alarms to be heard while the infusion pump is in the Lockbox. A front housing is connected to the rear case by means of a full length hinge designed into the polycarbonate material. When closed, the Lockbox is secured by a keyed lock preventing access to the syringe contents contained within the infusion pump. A cut-out in the front housing provides a clinician direct access to the user interface keys and display screen. An aluminum pole clamp, designed to operate with a vertical IV pole is attached to the Lockbox. Once attached to the IV pole, the pole clamp can be locked to prevent the Lockbox from being removed from the pole.

Sapphire Primary Sets are indicated for the delivery of fluids from a container to a patient's vascular system. Sapphire Blood Sets are indicated for the delivery of fluids including but not limited to blood and blood products to a patient's vascular system. Sapphire Epidural Sets are indicated for the delivery of fluids from a container to a patient's epidural space.

Sapphire Sets are intended for use with the Sapphire Infusion System. Sapphire sets are comprised of various components including the following: male luer adapter with cap, female luer with cap, piercing pin connector, sapphire cassette, tubing, flow control device, filter, in-line adapter, injection site assembly, check valve, pressure activated valve and blood chamber. Sapphire sets are configured to ensure the intended use of the device is met. The sets are disposable devices for single patient use.

The WellDoc BlueStar® System is indicated for use by healthcare providers (HCPs) and their adult patients - aged 21 years and older - who have type 2 diabetes. The BlueStar System is intended to provide secure capture, storage, and transmission of blood glucose data as well as information to aid in diabetes self-management. The BlueStar® System analyzes and reports blood glucose test results and supports medication adherence. In addition, the BlueStar System provides coaching messages (motivational, behavioral, and educational) based on real-time blood glucose values and trends. It includes software intended for use on mobile phones or personal computers in the home or in professional healthcare settings. The software also allows for entry of other diabetes-related healthcare information and provides educational information. The BlueStar® System is not intended to replace the care provided by a licensed healthcare professional, including prescriptions, diagnosis, or treatment. The WellDoc BlueStar® Rx System is indicated for use by healthcare providers (HCPs) and their adult patients - aged 21 years and older - who have type 2 diabetes. The BlueStar Rx System is intended to provide secure capture, storage, and transmission of blood glucose data as well as information to aid in diabetes self-management. The BlueStar® Rx System analyzes and reports blood glucose test results and supports medication adherence. In addition, the BlueStar Rx System provides coaching messages (motivational, behavioral, and educational) based on real-time blood glucose values and trends. It includes software intended for use on mobile phones or personal computers in the home or in professional healthcare settings. The software also allows for entry of other diabetes-related healthcare information and provides educational information. BlueStar® Rx includes an insulin dose calculator to allow patients to use their prescribed regimen to calculate a dose of insulin for a given amount of carbohydrates and/or blood glucose value. The BlueStar® Rx System is not intended to replace the care provided by a licensed healthcare professional, including prescriptions, diagnosis, or treatment.

WellDoc® BlueStar® is a stand-alone software system intended to be used by healthcare providers (HCPs) and their adult patients – aged 21 years and older - who have Type 2 Diabetes. The system is intended to assist Type 2 Diabetes patients to self-manage their disease, as cleared under K100066. Patients receive guidance on diabetes self-management and are encouraged to reach out to their healthcare team when needed. There are two versions of BlueStar® -BlueStar® and BlueStar® Rx - which differ in the availability of the insulin dose calculator, which is restricted to a prescription from a HCP. BlueStar® and BlueStar® Rx are implemented through an enterprise such as a health plan or large physician group in tandem with a patient's healthcare team and are comprised of the following applications: - Enterprise Director Portal - HCP Service - Patient Mobile Application - Patient Web Portal The Enterprise Director application is used for administrative purposes (unchanged since cleared under K100066). The HCP Service houses the Medication Reconciliation feature, which allows for the process of identifying the most accurate list of all medications that the patient is taking, including name, dosage and frequency, by comparing the medical record to an external list of medications obtained from a patient, hospital, or other provider (cleared under K141273). The Patient Web Portal and the Patient Mobile application have a similar feature set (unchanged since cleared under K100066). Data (including blood glucose values, medications, carbohydrates, and activity) entered into these applications is stored in the database and can be retrieved for display in either applications require the initial web- or mobilebased registration before the patient can access them. On the patient applications (Mobile and Web), BlueStar® and BlueStar® Rx function as an (1) information repository (logbook and Personal Health Record) and (2) diabetes education resource (learning library and health tips) and provide (3) motivational, behavioral, and educational coaching based on real-time blood glucose values and trends, (4) a secure communication system (Message Center), (5) medication information (dose and schedule), and (6) workflow and decision support for healthcare providers. In BlueStar® Rx, the patient web portal and mobile application also provide an insulin dosing calculator to allow patients to use their prescribed regimen to calculate a dose of insulin for a given amount of carbohydrates and/or blood glucose value. The insulin dose calculator is restricted to prescription-use only. Furthermore, as cleared under K16225 (reference device), BlueStar® and BlueStar® Rx have the ability to connect to the One Touch Verio Flex Blood Glucose Meter (K150214) via Bluetooth. This will allow users to send data from their meter to the BlueStar® Rx app, which will provide coaching messages (motivational, behavioral, and educational) based on the real-time blood glucose values and trends. The BlueStar Server will also have the ability to transmit data to the OneTouch Reveal Server. These modifications do not change the fundamental scientific technology of the device.

Hospira Sapphire Sets are indicated for the delivery of fluids from a container to a patient's vascular system.

Hospira Sapphire Sets are intended for use with the Sapphire Infusion System. Hospira Sapphire sets are comprised of various components including the following: male luer adapter with cap, female luer with cap, piercing pin connector, sapphire cassette, tubing, flow control device, in-line adapter, injection site assembly, check valve, and burette chamber. Hospira Sapphire sets are configured to ensure the intended use of the device is met. The sets are disposable devices for single patient use.