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The Micro Catheter is intended for the delivery of interventional devices or contrast media into the vasculature of the peripheral and neuro anatomy.

The Micro Catheter is a sterile, single-use, single lumen, variable stiffness, composite catheter. The Micro Catheter is available in three inner diameters (0.017″, 0.021″ and 0.027″), and two working lengths (150cm and 155cm). All models are designed with a straight tip, and are steam shapeable by the user. Single or dual radiopaque markers at the distal end facilitate fluoroscopic visualization. The outer surface of the catheter is coated with a hydrophilic coating to increase lubricity. The proximal end of Micro Catheter incorporates a standard luer adapter to facilitate the attachment of accessories. The catheter body has a semi-rigid proximal end which transitions into the flexible distal end to facilitate the advancement of the catheter in the tortuous vasculature. The Micro Catheter is compatible with ≤ 0.014″ guidewires and 5F or larger guide catheters.

The PRORAD ATLAS ULTRAPORTABLE Digital X-ray system is intended to deliver high-quality, diagnostic radiographic images of the body extremities. It utilizes a portable X-ray unit, flat-panel detector and image acquisition software to produce clear digital images, enabling fast and accurate diagnosis. The portable X-ray unit is intended to be used only when stand/tripod mounted. The PRORAD ATLAS ULTRAPORTABLE X-ray digital system is predominantly employed in various settings, including health-care centres, temporary and emergency health centres (established, especially in pandemic circumstances), outreach and field interventions (such as mobile clinics/vans, screening campaigns, and home care), and tele-radiology solutions in remote areas. The primary users anticipated for the system include radiographers, radiological technologists, and medical professionals who are trained in safety, radiation protection, and image management. The PRORAD ATLAS ULTRAPORTABLE PLUS Digital X-ray system is intended to deliver high-quality, diagnostic radiographic images of the body extremities. It utilizes a portable X-ray Unit, flat-panel detector and real-time image processing using software to produce clear digital images, enabling fast and accurate diagnosis. The portable X-ray unit is intended to be used only when stand/tripod mounted. The PRORAD ATLAS ULTRAPORTABLE PLUS X-ray digital system is predominantly employed in various settings, including health-care centres, temporary and emergency health centres (established, especially in pandemic circumstances), outreach and field interventions (such as mobile clinics/vans, screening campaigns, and home care), and tele-radiology solutions in remote areas. The primary users anticipated for the system include radiographers, radiological technologists, and medical professionals who are trained in safety, radiation protection, and image management.

The PRORAD ATLAS X-Ray system includes the ULTRAPORTABLE and ULTRAPORTABLE PLUS, which are portable diagnostic X-ray systems with fixed 70kV and 2mA tube current. These systems are intended to produce anatomical X-rays of the body extremities in both pediatric and adult patients. The PRORAD ATLAS X-Ray system was designed, developed, and manufactured by Prognosys Medical Systems Private Limited. The model numbers are listed below. | Model Number | Model Name | Model Description | |--------------|------------|-------------------| | A86-ATL-0001 | PRORAD ATLAS ULTRAPORTABLE | These are ultraportable X-ray systems designed to generate diagnostic, high-quality X-ray images | | A87-ATL-0001 | The PRORAD ATLAS ULTRAPORTABLE PLUS | | The PRORAD ATLAS X-ray system is a sophisticated, battery-powered X-ray generator offered in two versions: PRORAD ATLAS ULTRAPORTABLE and ULTRAPORTABLE PLUS. The main distinction between these models lies in their exposure time ranges and target anatomical areas. The ULTRAPORTABLE model provides exposure times ranging from 0.01 to 1.30 seconds, while the ULTRAPORTABLE PLUS model offers an extended exposure range of 0.01 to 2.5 seconds. Both models share identical internal components, software, algorithms, and operational features and are intended for imaging body extremities. The system includes a high-voltage tank with an X-ray tube mounted on an adjustable tripod stand, allowing users to adjust the height to the specific imaging area. Exposure parameters are configured through the X-ray generator's graphical user interface (GUI). After setting the parameters and positioning the patient on the detector, the X-ray is activated via an exposure switch. The detector captures the radiation, converts it into a digital signal, and transmits the data wirelessly to a computer equipped with compatible software. The images are processed and displayed on the computer for diagnostic review. The PRORAD ATLAS system is compatible with several 510(k)-cleared detectors and their associated software, listed below in Table 1. Prognosys includes one detector and its pre-configured software in the package, depending on availability. Fully battery-operated, the system does not support direct power connection but can seamlessly integrate with multiple detectors and compatible software as part of the package.

Kerecis® Marigen Wound Extra Autologous Hydration, Kerecis Silicone Autologous Hydration and Kerecis Parvus Autologous Hydration Management of wounds including: - Partial thickness wounds - Full thickness wounds - Pressure ulcers - Venous ulcers - Chronic vascular ulcers - Diabetic ulcers - Trauma wounds (abrasions, lacerations, partial thickness burns, skin tears) - Surgical wounds (donor sites/grafts, post-Mohs surgery, post-laser surgery, podiatric, wound dehiscence) - Draining wounds

All three subject devices of this bundled submission are part of a family of devices manufactured by Kerecis Limited. The subject devices can be seen in Table 1. They are lyophilized, terminally sterilized, fish skin medical devices comprised of biocompatible, resorbable fish skin (Wild North Atlantic Cod) for wound management. The devices are intended for single use only. The devices are applied to the wound bed to maintain a moist wound environment. The primary predicate device is Marigen Wound Extra (K190528) and the additional predicate devices are Kerecis Silicone (K213231), and Kerecis Parvus (K241080). Marigen Wound Extra is commercially available under the names Kerecis MariGen, Kerecis GraftGuide, and Kerecis SurgiClose. Kerecis Silicone is commercially available under the names Kerecis Shield and Kerecis SurgiClose Silicone. For clarity, this submission will refer to the devices under their commercially available names, except when specifically referring to the primary predicate device. This information is also shown in Table 1. Although the subject devices differ from each other in terms of device indications and dimensional specifications, each one remains physically identical to its primary predicate device, both in design and packaging, as well as for indications for use. The only difference between each subject device and its respective primary predicate device is in the device labeling, with the subject devices having additional rehydration fluid options included in their instructions for use (IFUs).

The Jewel Soft Tissue Reinforcement Device is a single-use device intended for reinforcement of soft tissues that are undergoing reconstruction surgery, utilizing autograft or allograft soft tissue grafts, or are to be repaired by suture or other fixation devices during ligament repair surgery. This includes reinforcement of extra-articular ligaments such as, but not limited to, medial collateral ligament, lateral collateral ligament, spring ligament, deltoid ligament, and ulnar collateral ligament. The Jewel Soft Tissue Reinforcement Device is not intended to replace normal body structure or provide the full mechanical strength to support the medial collateral ligament, lateral collateral ligament, spring ligament, deltoid ligament, ulnar collateral ligament or other extra-articular ligaments. Sutures, or other fixation devices, used to attach the tissue to the bone, provide mechanical strength for the reconstruction or repair.

The Jewel Soft Tissue Reinforcement Device is a woven tubular implantable device intended to provide support for soft tissues where weakness exists including soft tissues that have been repaired using suture or other fixation devices during ligament repair surgery. The tubular structure of the implant is designed to allow insertion of an allograft or autograft inside the mesh structure; or alternately for reinforcement of the native tissue. The Jewel Soft Tissue Reinforcement Device is a gamma sterilized, single use, permanent implant manufactured from Polyester (Polyethylene Terephthalate; PET) a nonabsorbable material that has a long history of use in the orthopedic market. The Jewel Soft Tissue Reinforcement Device is treated with an atmospheric gas plasma process to improve surface wettability of the mesh structure. The Jewel Soft Tissue Reinforcement Device is MRI safe.

For implantation to reinforce soft tissue where weakness exists in patients requiring soft tissue repair, or reinforcement in plastic or reconstructive surgery.

Kerecis SurgiBind (50241) is a part of a family of devices manufactured by Kerecis® Limited. The device is lyophilized, terminally sterilized, fish skin medical device comprised of biocompatible, resorbable fish skin (Wild North Atlantic Cod). The device is intended for single use only.

Rapid2 Magnetic Stimulators (Magstim Rapid2, Magstim Super Rapid2, Magstim Super Rapid2 Plus1) are intended to stimulate peripheral nerves for relief of chronic intractable, post-traumatic and post-surgical pain for patients 18 years or older.

The Magstim Rapid2, Magstim Super Rapid2, Magstim Super Rapid2 Plus1 (herein collectively referred to as "Rapid2 Magnetic Stimulators") are computerized, electromechanical medical devices that provide brief and focused magnetic pulses in order to non-invasively stimulate peripheral nerves for relief of chronic intractable, post-traumatic and post-surgical pain for patients 18 years or older. The subject device is intended to be used in hospitals and clinics such as pain management clinics. Rapid2 Magnetic Stimulators are integrated systems consisting of a combination of hardware, software, and accessories. Rapid2 Magnetic Stimulators are offered in multiple configurations: - Rapid2 - Super Rapid2 - Super Rapid2 Plus1 All three configurations have identical intended use/indications for use, common specifications, equivalent performance characteristics and equivalent composition to each other. Specifically, Rapid2 and Super Rapid2 have received prior clearance under K051864 for Peripheral Nerve Stimulation (Product Code: GWF, Regulation 21 CFR 882.1870). All Rapid2 Magnetic Stimulators are made up of components that have received prior clearance under K051864 (e.g., the 3190-00, 3192-00 and 3193-00 coils) and components which have received prior clearance under K051864 but have received modifications due to aspects like obsolescence (Mainframe, Power Supply etc.). All Rapid2 Magnetic Stimulators are composed from the following main components: - Stimulating Unit & Power Supply - User Interface - Stimulating Coil - System and Stimulating Coil Cart and Holding Arm Rapid2 Magnetic Stimulators include temperature monitoring via two independent temperature sensors to ensure surfaces of the coils do not reach unacceptable levels. The cut-off is set to act at 40°C at which point the system will automatically be disabled. Over-temperature conditions are also communicated on the User Interface (UI) via a temperature gauge and alarm system. Rapid2 Magnetic Stimulators also includes the 3910-00 air-cooled coil to further mitigate any temperature conditions. The 3910-00 air-cooled coil comes with all 3 configurations (Rapid2, Super Rapid2 and Super Rapid2 Plus1) as standard.