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The FreedomEdge® Syringe Infusion System consists of the following components:

• FreedomEdge® Infusion Pump
• Precision Flow Rate Tubing™
• High-Flo SubQ Needle Sets™

The FreedomEdge® Syringe Infusion System is indicated for use with the BD® 20 ml syringe (US Reference number: 302830), BD 30 ml syringe (US Reference number: 302832) and Hizentra® 20 ml prefilled syringe (NDC 44206-458-96).

For Immunoglobulin Administration:
The FreedomEdge Infusion System is specifically indicated for the subcutaneous infusion of the following human plasma-derived immunoglobulins in the home, hospital, or ambulatory settings when administered according to the FDA approved biologic labeling:

• Cuvitru®, Immune Globulin Infusion (Human) 20% (manufactured by Takeda®); Gammagard Liquid®, Immune Globulin Infusion (Human) 10% (manufactured by Takeda®);
• Hizentra®, Immune Globulin Subcutaneous (Human) 20% Liquid (manufactured by CSL Behring®)
• Hizentra®, Immune Globulin Subcutaneous (Human) 20% Liquid 20ml Single-use pre-filled syringe (manufactured by CSL Behring®)

For EMPAVELI™ (pegcetacoplan) Administration:
The FreedomEdge Infusion System is specifically indicated for the subcutaneous infusion of EMPAVELI™ (pegcetacoplan) in the home, hospital, or ambulatory setting when administered according to the approved drug product labeling.

For RYSTIGGO® (rozanolixizumab-noli) Administration:
The FreedomEdge Infusion System is specifically indicated for the subcutaneous infusion of RYSTIGGO® (rozanolixizumab-noli) when administered according to the approved drug product labeling.

For Intravenous Antibiotic Administration:
The FreedomEdge Infusion Pump and Precision Flow Rate Tubing are specifically indicated for the intravenous infusion of the following antibiotics when used according to the FDA approved drug product labeling:

• Ertapenem, Meropenem, Oxacillin, and Tobramycin

The FreedomEdge Infusion System is a non-electrically powered, mechanical infusion system which is intended for subcutaneous or intravenous administration of drug products in a home, ambulatory, or clinical setting. The infusion system includes the FreedomEdge Infusion Pump, the High-Flo SubQ Needle Sets, and the Precision Flow Rate Tubing Sets. The infusion system is designed to be used with sterile, single use syringes (not manufactured or sold by Koru Medical Systems) as the drug reservoir. There have been no significant changes to the technological features (e.g., material, design, energy source, packaging, sterility, manufacturing method) since the previous clearance.

The fundamental operating principle of the FreedomEdge Infusion System is based on the Hagen-Poiseuille equation. The syringe containing the drug to be infused is connected to the flow rate control tubing and the subcutaneous needle set or venous access device and inserted into the pump. The syringe pusher of the pump applies a constant force to the plunger of the syringe. The infusion sets generate a defined amount of resistance which determines the flow rate. Flow rates are modeled using the Hagen-Poiseuille equation and verified at the boundary conditions for the system.

The design and operating principles of the system and its components have not been significantly modified since the device was first cleared. The same test methods were used as in prior submissions. Acceptance criteria were generated for Rystiggo using the same flow rate prediction model as used in prior submissions.

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A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.

These gloves were tested for use with chemotherapy drugs, Fentanyl Citrate, Xylazine HCl, and Simulated Gastric Acid as per ASTM D6978-05 (Reapproved 2023) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.

Chemotherapy Drugs Permeation Test:

• Carmustine (BCNU) (3.3 mg/ml): White-Green (30.0 minutes), White-Blue (30.0 minutes)
• Cisplatin (1.0 mg/ml): White-Green (>240), White-Blue (>240)
• Cyclophosphamide (Cytoxan) (20.0 mg/ml): White-Green (>240), White-Blue (>240)
• Cytarabine HCl (100 mg/ml): White-Green (>240), White-Blue (>240)
• Dacarbazine (DTIC) (10.0 mg/ml): White-Green (>240), White-Blue (>240)
• Doxorubicin Hydrochloride (2.0 mg/ml): White-Green (>240), White-Blue (>240)
• Etoposide (20.0 mg/ml): White-Green (>240), White-Blue (>240)
• Fluorouracil (50.0 mg/ml): White-Green (>240), White-Blue (>240)
• Ifosfamide (50.0 mg/ml): White-Green (>240), White-Blue (>240)
• Methotrexate (25.0 mg/ml): White-Green (>240), White-Blue (>240)
• Mitomycin C (0.5 mg/ml): White-Green (>240), White-Blue (>240)
• Mitoxantrone (2.0 mg/ml): White-Green (>240), White-Blue (>240)
• Paclitaxel (Taxol) (6.0 mg/ml): White-Green (>240), White-Blue (>240)
• Thiotepa (10.0 mg/ml): White-Green (60.0 minutes), White-Blue (80.0 minutes)
• Vincristine Sulfate (1.0 mg/ml): White-Green (>240), White-Blue (>240)

Please note that Carmustine (BCNU) and Thiotepa has low permeation times of 30.0 and 60.0 minutes respectively (for White-Green), and 30.0 and 80.0 minutes respectively (for White-Blue).
Warning: Do not use with Carmustine and Thiotepa

Opioid Drugs and Others Permeation Test:

• Fentanyl Citrate Injection (100mcg/2mL): White-Green (>240), White-Blue (>240)
• Simulated Gastric Acid: White-Green (>240), White-Blue (>240)
• Xylazine HCl (100 mg/ml): White-Green (>240), White-Blue (>240)

Non-sterile Powder Free Nitrile Examination Glove, Dual Color (White-Green), Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Xylazine HCl, and Simulated Gastric Acid; Non-sterile Powder Free Nitrile Examination Glove, Dual Color (White-Blue), Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Xylazine HCl, and Simulated Gastric Acid
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.

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Rx use: revyve® Antimicrobial Skin and Wound Cleanser for prescription use is intended for use under the supervision of healthcare professionals for mechanical cleansing, moistening, debriding, and removal of foreign material including microorganisms and debris from wounds, including acute and chronic dermal lesions, such as Stage I - IV pressure ulcers, venous ulcers, leg ulcers, diabetic foot ulcers, post-surgical wounds, first and superficial second degree burns, grafted and donor sites. It is also intended for moistening absorbent wound dressings and cleaning minor cuts, minor burns, superficial abrasions.

OTC use: revyve® Antimicrobial Skin and Wound Cleanser for OTC use is intended for mechanical cleansing wounds and moistening absorbent wound dressings for the management of minor cuts, abrasions, lacerations, and minor burns.

revyve® Antimicrobial Skin and Wound Cleanser is a clear, colorless liquid containing poloxamer 407, EDTA, sodium citrate/citric acid, polyhexanide (PHMB) and glycerol. PHMB at a concentration of 0.1% w/w is added as preservative to prevent microbial growth, within the product during shelf-storage. This skin and wound cleanser will be packaged in 4 fluid oz (118.3 mL) polyethylene squeeze bottle. revyve® Antimicrobial Skin and Wound and Cleanser will be used for mechanically cleaning wounds and for moistening and lubricating absorbent wound dressings for ulcers, first and superficial second-degree burns, post- surgical wounds and abrasions. The mechanical action of moving across the wound provides for the mechanism of action and aids in the removal of foreign material such as dirt, debris, and microorganisms. It will be provided in non-sterile form, labeled for single patient, single use only.

The device will be available as both a Rx and OTC product.

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Permanent obturation of the root canal.
ZenSeal Pro is intended for root canal sealing after the removal of infected or necrotic pulp tissue.

ZenSeal Pro is suitable for use in the warm vertical condensation, single cone, cold lateral condensation and gutta-percha carrier obturator technique.

ZenSeal Pro is a Bioceramic root canal sealer based of calcium silicate making it a bioceramic material. The device is a single syringe barrel, insoluble, radiopaque material, which requires the presence of water to set and harden. It is delivered into the canal with the use of disposable tips provided in the package or it can be delivered via the gutta-percha paper point or file method.

ZenSeal Pro is used for permanent obturation of the root canal space with the aid of obturating points.

It is suitable for use in the warm vertical condensation, single cone, cold lateral condensation and gutta-percha carrier obturator technique.

ZenSeal Pro consists of one (1) syringe with 1.8 grams of paste and twenty (20) single use ZenSeal Pro Trimmable Tips also known as disposable delivery tips. Tips are also offered separately as an accessory.

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The SurfRider 13 Microcatheter is intended for the introduction of interventional devices, such as embolic coils, or diagnostic agents into the neurovasculature.

The SurfRider 13 Microcatheter is a single-lumen microcatheter with a gradual stiffness change from tip to proximal end, reinforced with a metal braid to facilitate delivery to distal vessels and to serve as a delivery path of contrast media, embolic agents and coils. The distal end has two radiopaque markers to facilitate fluoroscopic visualization, and two types of tips: a straight tip and a pre-shaped tip. The proximal end of the Microcatheter incorporates a standard luer adaptor to facilitate the attachment of accessories. The outer surface of the Microcatheter has a hydrophilic coating to increase lubricity. The Microcatheter is designed to be introduced over a steerable guidewire into the vasculature.

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The KP Protective Face Mask is intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and operating room personnel from transfer of microorganisms, body fluids, and particulate material.

The KP Protective Face Mask is a non-sterile, single-use surgical mask intended to cover the user's nose and mouth, providing a physical barrier to fluids, microorganisms, and particulate matter.

The mask consists of three nonwoven polypropylene layers, including:

• Outer layer: Spunbond non-woven
• Filter layer: Melt-blown polypropylene
• Inner comfort layer: Spunbond non-woven
• Nose wire: Polypropylene-clad adjustable wire
• Attachment: Elastic earloops (A mixture of nylon and polyurethane)

The mask is white, flat-fold style, supplied non-sterile, and packaged in standard pouches.

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• Bonding of indirect restorations made of composite, all-ceramic and metal.
• Bonding of prosthetic devices (crowns, inlays, onlays, bridges, and veneers) to cavities, abutment teeth, or implant abutments.
• Dental core bonding.

The subject device is a dual-cure resin cement for dental adhesion composed of two types of paste: the Catalyst Paste and the Base Paste. Each paste is filled separately in the independent double-barrel syringe and is mixed and dispensed through a dedicated mixing tip attached to the syringe nozzle. To match the color of the prepared tooth structure (dentin and enamel) and the prosthetic restoration, the Base Paste is available in four shades: Translucent, Yellow, White, and Opaque. The accessory tips include iCEM Universal Plus Mixing Tips and iCEM Universal Plus Endo Tips (consisting of Endo Mixing Tips and Extension Tips), which differ in tip diameter and are selected according to the clinical indication. All tips are single-use only. The mixed resin cement cures through both chemical and light polymerization. The subject device can adhere to tooth structure (dentin and enamel) using iCEM Universal Plus Cement, with or without the use of iCEM Universal Plus Primer, depending on the clinical indication:
• Self-Adhesive Mode: Using only iCEM Universal Plus Cement as a self-adhesive resin cement.
• Adhesive Mode: Using iCEM Universal Plus Cement in combination with the dedicated primer, iCEM Universal Plus Primer, as an adhesive resin cement.
When used in the adhesive mode, iCEM Universal Plus Primer contains a portion of the polymerization initiators involved in the chemical polymerization of the subject device. Upon contact with the subject device, these initiators are activated, initiating the polymerization of the monomers and resulting in curing. This combination enhances the bond strength to tooth structure (dentin and enamel) compared to the Self-Adhesive Mode.

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The KLS Martin Pure Pectus System is indicated for use in surgical procedures to repair pectus excavatum. It is indicated for use in adult and pediatric (children and adolescents) populations.

The KLS Martin Pure Pectus system consists of metallic implants comprised of straight and angled pectus bars and connector bars that provide support to the thoracic cavity undergoing repair for pectus excavatum. The implants are provided non-sterile in multiple sizes and are manufactured using traditional manufacturing methods. Pectus bars are manufactured from CP Titanium. Connector bars are manufactured from Ti-6Al-4V. The system also includes the necessary instruments to facilitate placement of the implants.

The purpose of this submission is as follows:

1. Line extension to include longer pectus bar sizes for both angled and straight pectus bars ranging greater than 380 mm and less than/equal to 500 mm

2. Add "MR Conditional" to the device labeling for the angled and straight pectus bars ranging greater than 380 mm and less than/equal to 500 mm used in conjunction with connector bars

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