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Elcam's High and Medium Pressure Stopcocks and High and Premium High Pressure Manifolds are intended to serve as flow control and delivery devices for I.V fluids injection to the patient's vascular system. The devices are indicated for medium and high pressure injection of fluids such as, but not limited to, fluids used during angiography and angioplasty and during interventional radiology and cardiology procedures. Devices indication for medium and high pressure does not preclude its use for low pressure procedures. The High and Medium Pressure Stopcocks and High and Premium High Pressure Manifolds are intended for single use only.

Stopcocks and Manifolds are generally used for administration of fluids into the human. body. There is a wide use of Stopcocks as flow controls and sampling sites in I.V sets, critical care applications and monitoring kits. Stopcocks are used individually or in the form of Manifolds, units comprised of several Stopcocks joined together ("gang"). High pressure Stopcocks and Manifolds are used in cardiac angiography and angioplasty procedures in which fluids are administered under pressure. These procedures require stopcocks and manifolds which are robust under high pressures. The line of pressure resistant Stopcocks and Manifolds presented in this file includes four (4) products: i. High Pressure (HP) Stopcocks ii. Medium Pressure (MP) Stopcocks High Pressure (HP) Manifolds iii. Premium High Pressure (PHP) Manifolds iv.

Elcam Vital Signs Wireless System is indicated for use on patients requiring pressure monitoring. Elcam Vital Signs Wireless System is intended to perform wireless transmission of pressure information to remote patient monitors from disposable pressure transducers.

Elcam Vital Signs Wireless System utilizes the Bluetooth® communications Protocol in order to eliminate the multi-conductor, fixed length and shielded reusable cables that typically acts as the interface between the patient's bedside monitor and disposable transducer. The disposable transducer will simply plugs into the system's remote transmitter unit, which sends its output signal to the system's receiver unit affixed to the bedside monitor. The wireless system is intended to operate at varying distances to accommodate typical layouts that exist within hospital operating rooms, critical care units, emergency rooms and catheterization lab suites.

Elcam Disposable Integrated Pressure Transducer is intended for direct measurement and monitoring of blood pressure. The disposable Transducer is intended for single use only. Indications for the Disposable Integrated Pressure Transducer (DIPT) include: Direct arterial blood pressure monitoring - central and peripheral Pulmonary artery monitoring Venous pressure monitoring Left atrial monitoring when used with an air eliminator Cardiac catheterization

The disposable Transducer in an extravascular blood pressure transducer that convert mechanical changes in pressure into electrical current that can be input into a pressure monitor. The disposable Transducer consists of an extravascular pressure transducer module that interfaces between an intravascular catheter and pressure monitor. One of the major components that the transducer include is an integral flush valve and Luer connector that can connect a flashing fluid source to the intravascular catheter.

The Flexi-Q DV Auto-injector is indicated for the transfer and automated subcutaneous injection of FDA approved drugs and biologics in compatible vials. The Flexi-Q DV Auto-injector is intended for use in the home environment by the patient or care-giver after training by a Health Care Professional.

The Flexi-Q DV Auto-injector (also called: FUDAI DV)) is designed to allow people with or without minor dexterity problems (or with a help of a care giver) to aspirate a drug in solution form from a standard 13mm vial and automatically inject themselves subcutaneously with the drug. The device is comprised of the following parts; - -Housing: The outer shell/covering of the device. The Housing which encloses and protects the inner components including the syringe, is designed to be used while held with one hand and provides the user with visibility of the solution/ drug before, during and after injection via a window. - -Syringe: A standard 1mL long glass syringe is assembled within the Housing. The syringe includes a staked 1/2 27G needle and an elastomeric syringe piston. The syringe is marked with a single graduation line indicating the dose volume to be aspirated and delivered (any dosage between 0.3 to 1.0mL is possible; e.g., 0.3 or 0.4 or 0.5 or 0.6 etc. up to 1.0mL). i.e., different Flexi-Q Auto-injector versions will be available, each for a single dosage volume, and according to physician prescription, the patient will use the Flexi-Q Auto-injector version specifically marked for his/her prescribed dose volume. The "single dose - single device" Flexi-Q auto-injectors are illustrated in page 11-13, Figure I. The syringe needle is used to penetrate the Vial Adaptor septum (for solution/reconstituted drug aspiration) and then to administer the subcutaneous injection to the patient. - -Needle Shield: The needle shield covers the needle before injection. When depressed against the skin, the shield "unlocks" the Trigger Button to allow activation and injection. After the injection is completed, the shield locks in place, keeping the needle from being accessible and helping protect the user from accidental needle stick injury. - Plunger Rod: A rigid rod that is connected to the syringe piston and protrudes out of the Auto-injector's Housing. The Plunger Rod is used to aspirate the solution/reconstituted drug into the syringe and adjust the volume to be injected to the predefined dosage. - Trigger Button (Red INJECT Button): This button enables the user to activate the injection process after is has been unlocked by the user pressing the shield against the skin at the injection site. Once pressed the device advances the injection needle into the subcutaneous tissue followed by injection of the drug. - One Vial Adaptor (Gray Connector): The Sterile, Single use Vial Adaptor . functions as a connector between the Auto-injector and the drug vial and provides a fluid path to enable aspiration of the drug. The syringe needle penetrates a septum (assembled inside the Vial Adaptor) made of thermoplastic elastomer while a plastic spike (part of the Vial Adaptor) penetrates the vial stopper. While attached to the Auto-injector, the Vial Adaptor conceals the Needle Shield and thus preventing inadvertent activation. In certain cases when additional vial may be used (per drug prescription), additional sterile vial adaptor(s), may be used.

Safeport Manifold is indicated to serve as a flow control and a conduit device for I.V fluids delivery to the patient's vascular system. The product is intended for delivering 1.V drugs or fluids, allowing gravity feed, sampling, bolus injection and elimination of reflux of fluids during operation

Modified SafePort Manifold (or Stopcock) is a redesign of Induction & Sampling Manifold (or Stopcock). It has the same appearance and intended use while several design modifications were introduced in order to contribute to the device's convenience of use and robustness. The device will be available in two (2) versions swabable or standard ports configurations. The first version, standard port configuration is similar to the predicate device but with more robust design. The second version, besides of the design changes have an additional feature. The feature is the swabable valves which can be incorporated into the female side ports and function as a closed luer activate valve. The swabable valve enables the female port (luer) to be closed when it is not in use and saves the need to close it with a cap in order to avoid leakage and/ or port's contamination and serves as a needleless injection site integrated in the stopcock. Devices having the swabable valves have been demonstrated in a 510(k) submission for Elcam's Closed Stopcock. SafePort Manifold or Stopcock is composed of the following components: - -One piece injected body having a side female ports. (with or without swabable valves according to the end user request) - Handles assembled into the female side ports. ー - -Elastomer placed between each handle and side female port body, which is placed to function as a pressure activated valve activated valve. - Rotor assembled to the male port (connected toward the patient ) for . " connection locking. - -Check valve assembled to the male port which is connected toward the patient in order to enable connection locking. (this part will not be included, unless otherwise requested by the end user) - Port covers and colored buttons. (if requested by an end user) -

The Haskal™ Torque Device is intended to facilitate steering of guidewires during interventional procedures.

The Haskal™ Torque Device is a one-piece molded unit with rows of interlocking "teeth". When the sides of the device are squeezed, the "teeth" line up and a groove is exposed in the center. The device is then positioned with the guidewire in the groove. When the sides are released, the device "teeth" close onto the guidewire to secure it firmly. The Haskal™ accommodates guidewires with diameters between 0.010 inches to 0.038 inches. The Haskal™ is designed to be mounted onto the guidewire from the side with one hand, eliminating the need for threading along the wire starting from the distal end. It can also be released from the guide wire or repositioned as the guide wire advances by squeezing it on both sides to release the wire. The Haskal™ is a sterile, non-pyrogenic single use device. It is manufactured in several colors.

Elcam Antimicrobial Closed Stopcocks (DSS and TSS) are indicated for fluid flow directional control and for providing access port(s) for administration of solutions. Typical uses include pressure monitoring, intravenous fluid administration and transfusion. Both configurations have a feature of an antimicrobial agent using a compound containing silver. The inclusion of an antimicrobial agent into the material formulation is intended to prevent/reduce the growth of contaminants on the device. The device is NOT intended to be used as a treatment for patient infections.

Elcam Medical's Antimicrobial Closed Stopcocks (DSS and TSS) are a similar version of Elcam legally marketed stopcocks, cleared under 510(k) numbers K053405 and K060231, as identified in paragraph number 3 above. Our Antimicrobial DSS and TSS combine two or three features of our legally marketed devices into one product contains these two or three protection lines as following described: The Double Safe Stopcock (DSS) consists of our antimicrobial stopcock combined with our closed swabable luer-activated valve stopcock. The closed swabable valve functions as a microbial barrier and the antimicrobial agent, impregnated in the stopcock body acts to prevent/reduce the growth of contaminants. This configuration presents a stopcock with two protection lines; (1) impregnated antimicrobial agent; (2) closed swabable valve. The Triple Safe Stopcock (TSS) consists of the same platform of the antimicrobial stopcock together with our legally marketed MRVLS (Minimal Residual Volume Luer-activated Swabable stopcock) design. The two protection lines described above for the DSS exist in the TSS yet, the TSS has a third protection line which is the unique design of the MRVLS handle enables fluid flow around the handle and thus enables more thorough and continuous flushing of the entire stopcock fluid path. This configuration presents a stopcock with three protetion lines: (1) impregnated antimicrobial agent; (2) closed swabable valve; (3) MRVLS handle unique design.

Elcam Antimicrobial Stopcock [or Manifold] is indicated for fluid flow directional control and for providing access port(s) for administration of solutions. Typical uses include pressure monitoring, intravenous fluid administration and transfusion. Elcam Antimicrobial Stopcock [or Manifold] has a feature of an antimicrobial agent using a compound containing silver. The inclusion of an antimicrobial agent into the material formulation is intended to prevent/reduce the growth of contaminants on the device. The device is NOT intended to be used as a treatment for patient infections.

Elcam Antimicrobial Stopcock [or Manifold] is identical to Elcam conventional legally marketed Stopcocks. A model of typical Stopcock is illustrated in Figure 1, section 11, page 33 of this submission. Stopcocks and Manifolds have port(s) that provide access for medications injection, IV administration and blood sampling. The Stopcock usually has three ports and a handle that directs the fluid flow. It has one female side port that is used for medication injection or blood sampling. Both opposite ports (female/male) are connected to the IV line. The Manifold is assembled from two to five stopcocks bonded to each other to create a "stopcocks line" so the Manifold can have between two to five side ports for injection or sampling. Naturally, when the port is open, it can be a potential portal of entry for microorganisms into the device fluid path. Elcam's Antimicrobial Stopcock [or Manifolds] provides an effective solution in preventing/reducing bacterial colonization in the device. The antimicrobial agent is based on silver like in Medex's antimicrobial stopcock legally marketed device, cleared by 510(k) number K954970. All body/fluid contact materials that composed the Antimicrobial Stopcock were tested widely for chemical and biocompatibility in accordance to FDA's Memorandum - #G95 1, May 1, 1995 and ISO 10993-1:2003 - Biological evaluation of medical devices - Part 1: Evaluation and testing with acceptable results.

Elcam Closed Swabable Stopcock and MRVLS is indicated for fluid flow directional control and for providing access port(s) for administration of solutions. Typical uses include pressure monitoring, intravenous fluid administration and transfusion.

Elcam Medical's Closed Swabable Stopcock and MRVLS is a similar version of Elcam legally marketed stopcock. cleared under 510(k) number K022895. The Closed Swabable Stopcock includes an addition of a component that functions as a closed luer-activated valve. The valve enables the female port (luer) to be closed when it is not in use and saves the need to close it with a cap, in order to avoid leakage and/or port's contamination. Once a male luer is introduced into the closed port the fluid path automatically opens to allow injection or blood sampling. Once the male luer is taken out, the female port is automatically closed. The valve actually serves as a needleless injection site integrated in the stopcock. The only change from the end user point of view is the need to swab the valve's top (injection site) with aseptic fluid such as alcohol prior to male luer insertion. The MRVLS (Minimal Residual Volume Luer-activated Swabable-stopcock) feature, is an additional option that can be added to the Closed Swabable Stopcock, described above, and provides a stopcock with a minimal residual volume. Conventional stopcocks are made of a body and a handle with a fluid path bore that allows the fluid to flow only through the handle. Therefore, it leaves other areas in the stopcock without a continuous flow through the stopcock fluid path and especially through the side port female luer. The MRVLS feature enables fluid flow around the handle so the fluid constant flow accesses the entire stopcock's internal volume and enables a continuous flow through the stopcock fluid path and through the side female luer during the medical procedure. This feature significantly reduces the "residual volume" in the stopcock and helps to keep the cleanliness of the stopcock's fluid path when it is in use. The feature of minimal residual volume is achieved thanks to a modification in the stopcock handle design, which changes the fluid path and a flow guide formed therein. The minimal residual volume design, together with the luer-activated valve creates the Minimal Residual Volume Luer-activated Swabable-stopcock (MRVLS).

The device is an Angiographic accessory intended for use as self-sealing Hemostatic luer activated valve for angiography and other high-pressure applications.

The H-Flow Valve developed by Elcam Medical ACAL can be connected, by a standard male luer-lock, to any standard Angiographic catheter. The device has a septum that prevents blood loss when nothing is connected to the female port of the device. Common guide-wires (in diameter of 0.014" to 0.038") can be introduced via the device (through the slit septum) without the need to open the valve and without bleeding due to the intra-catheter human arterial pressure. When connecting a standard male luer to the device's female port (for injection of contrast media or flushing with saline), the septum opens (with the aid of the actuator) to allow fluid flow. An accessory called 'Stylet' is added to the device and has two purposes: a) to make sure the slit is open prior to initial use. b) To aid with insertion of small and angled guide wires.