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510(k) Data Aggregation
(103 days)
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(271 days)
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(95 days)
IDENTIFY is indicated for adult patients undergoing radiotherapy treatment simulation and/or delivery. IDENTIFY is indicated for positioning of patients, and for monitoring patient motion including respiratory patterns. It allows for data output to radiotherapy devices to synchronize image acquisition or treatment delivery with the acquired motion information.
IDENTIFY uses surface guidance technology to monitor patient motion during radiotherapy treatment simulation and delivery. Its high precision SGRT cameras support:
- Positioning of the patient for treatment delivery
- Monitoring of the patient position during treatment delivery
- Respiratory motion management during simulation and treatment delivery
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(267 days)
The VaporShield™ is a sterile, single-use, closed system transfer device (CSTD), incorporating a preassembled Drug Vial holder (DVH) and Syringe (1mL, 22GA). The preassembled device is intended for medication draw from a drug vial only. After medication draw, the DVH is removed from the syringe, and the syringe is used for direct injection of hazardous and non-hazardous medication via subcutaneous or intramuscular administration. The syringe incorporates a safety mechanism which automatically retracts the needle inside the device for drug containment, and prevention of accidental needlesticks and device reuse. The VaporShield mechanically prevents drug transfer external to the device to minimize individual and environmental drug exposure. The VaporShield is intended for use by medical professionals who prepare/administer injection(s) to adults and adolescents in healthcare facilities. The device is not intended for neonates (<28 days old), infants (< 2 yrs old), or children (> 2 yrs. old – 12 yrs. old). The VaporShield Device is not intended for Compounding, Reconstitution, Phlebotomy, Intravenous injection, Intraperitoneal injection, or Intrathecal injection.
The VaporShield closed system transfer device (CSTD) is sterile, for single use, and is intended for direct injection of hazardous or nonhazardous drugs. A single configuration includes a 1 mL syringe, 22G cannula, and is pre-assembled with a Drug Vial Holder (DVH). Preassembly of the syringe and drug vial holder components are interlocked via a flex tab snap-fit connection. During drug draw, the DVH ensures a stable connection between the drug vial and syringe. The VaporShield has three (3) settings, two for needle length, and one (1) for safety. The DVH can be removed from the syringe when the syringe is placed in locked setting.
The VaporShield includes a safety mechanism that is manually activated by full plunger depression. When activated, the safety mechanism retracts the needle inside the plunger rod for containment, preventing accidental needlestick, and disallowing device reuse.
Syringe is intended for parenteral injection (subcutaneous / intramuscular).
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(125 days)
The Vektor Computational ECG Mapping System (vMap®) is intended for the analysis, display, and storage of cardiac electrophysiological data and maps for analysis by a physician.
vMap is a standalone Software as a Medical Device (SaMD) application. vMap receives electrocardiogram (ECG) data (from other FDA-authorized medical devices) acquired non-invasively from the patient's body surface and processes these signals using proprietary algorithms to transform body surface measurements into cardiac electrical data. vMap utilizes this data to generate 2D cardiac information and 3D color maps that illustrate cardiac electrical features for physician analysis. vMap is intended for use in clinical environments, including electrophysiology (EP) laboratories and hospital settings.
vMap includes a main user application that provides an intuitive user interface to guide clinicians through the mapping workflow. vMap enables users to:
a. Create and manage mapping cases through an organized case management system.
b. Upload ECG data acquired from compatible recording systems.
c. Identify arrhythmias to be mapped, including marking arrhythmic beats on ECG plots.
d. Generate two-dimensional (2D) and three-dimensional (3D) heatmaps representing likely arrhythmia source locations.
e. View and interact with mapping results within the software interface.
f. Export results for integration with external electroanatomic mapping systems (e.g., Carto™, Ensite™)
g. Produce detailed case reports summarizing the mapping session and findings.
vMap SaMD operates on compatible general-purpose computing hardware that includes an off-the-shelf processing unit, monitor, keyboard and mouse. The vMap software is compatible with equivalent hardware components.
Principles of Operation:
vMap receives electrocardiographic signals acquired non-invasively from the body surface. The ECG signals are used in proprietary algorithms to transform the measured body surface signals into cardiac signals. These algorithms leverage simulated focal or rotor activity from simulated source locations across the entire heart. vMap analyzes focal-based mechanisms for focal-type and anatomical reentry-type arrhythmias (Focal Atrial Tachycardia, Premature Atrial Complex, Atrial Pacing, Ventricular Tachycardia, Premature Ventricular Complex, Ventricular Pacing, and Atrioventricular Reentrant Tachycardia, Typical Atrial Flutter and Atypical Atrial Flutter), and rotor-based mechanisms for fibrillation-type arrhythmias (Atrial Fibrillation and Ventricular Fibrillation). vMap software utilizes this data to provide various 2D cardiac information and interactive 3D color maps, including cardiac electrical features, for analysis by a physician.
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(271 days)
The GentleBeam is a low energy x-ray system, with imaging capability, intended for superficial radiotherapy treatments of primary malignant epithelial neoplasms of the skin and keloids. Applications include: (a) basal cell carcinoma; (b) squamous cell carcinoma; (c) Metatypic carcinoma; (d) cutaneous appendage carcinoma (e) Kaposi's Sarcoma; and (f) the treatment of keloids. Keloids are benign fibrous growths that arise from proliferation of dermal tissue typically arising from injuries to skin tissue.
The imaging capability, employed in a non-diagnostic mode, is used to assist the physician in the selection of the correct treatment area. The imaging component is a laser induced ultrasound scanning system used to visualize the layers of skin, including blood vessels, and to make approximate measurements of dimensions in layers of skin and blood vessels, by detecting laser pulse generated ultrasound waves.
The GentleBeam Radiation Therapy System is a mobile low-energy superficial radiotherapy device for treating skin cancer lesions and keloids. The X-ray source, delivers radiation emission in the low energy therapy ranges of 50kV, 70kV and 100 kV (a total of 3 energies) and is held in place by a manually guided robotic arm. The X-ray source uses single target collimators with a fixed SSD. The robotic arm is manually operated by the user and contains no automated functions, its sole purpose is to support the x-ray head and hold it steady so operator can deliver treatment to the patient. It does not move unless hand guided by the operator to position it. The imaging head produces an ultrasound image, generated using laser induced ultrasound (LIUS, branded as Photosonic) imaging technology for acquisition of internal structures of the skin.
The GentleBeam System includes the following major components:
- Preparation Console – Located on the base of the system to enter patient information, perform simulation and imaging.
- Treatment Console – Located outside the room to control radiation delivery.
- Robotic Arm – Holds the treatment head. Buttons on the robotic arm allows operator to position the arm precisely at the treatment site using hand-guided mode. No automated motions happen on the arm. All movement is through manual user movement.
- Treatment Head – Contains the x-ray source and collimated applicator for precise delivery of radiation treatment using a single focal spot. No multiple focal spots are on the applicators.
- Imaging Head – Ultrasound imaging unit for lesion depth measurement.
- Red Diode Positioning Laser - System uses a laser‐pointing apparatus to assist the operator for a visual guide for positioning purposes of the x-ray source, located on the treatment head.
- Collimators/Applicators - Collimators (also called applicators) are used to collimate the X-ray beam output. The layout of each collimator consists of a single field and flattening filter, which is always used for treatment. The system contains the following applicators:
- 50kV, 5cm SSD, 1.5cm/2cm/3cm/4cm/5cm diameter – single target
- 70kV, 5cm SSD, 1.5cm/2cm/3cm/4cm/5cm diameter – single target
- 100kV, 5cm SSD, 1.5cm/2cm/3cm/4cm/5cm diameter – single target
- QC Applicator for daily quality assurance checks.
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(65 days)
Vitalograph VitaloJAK Clinic Model 7100 is indicated for use to aid in the assessment of cough in adults and pediatric patients aged 8 years and older under supervision presenting with suspected Chronic Cough.
The Vitalograph VitaloJAK Clinic Model 7100 is a non-invasive battery-operated device intended to acquire, record and store ambulatory cough sounds from patients. The device stores the data on internal memory for later playback, review, and analysis on a windows-based PC.
The Vitalograph VitaloJAK Clinic Model 7100 is a non-invasive battery-operated device intended to acquire, record and store ambulatory cough sounds from patients. The device stores the data on a removable memory card or internal memory for later playback, review, and analysis on a windows-based PC.
The Vitalograph VitaloJAK Clinic Model 7100 is indicated for use in cough recording sessions. It provides the means to sense voice and cough activity from a subject, record this information and store it on an SD memory card. The Vitalograph VitaloJAK Clinic Model 7100 is not life supporting equipment, it does not screen, treat or prevent any condition or disease. The subjects may be of any user population, weight range, health, or condition.
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(55 days)
The NeVa PV Thrombectomy Device is indicated for:
- The non-surgical removal of thrombus burden from coronary blood vessels,
- Use with adjunctive aspiration and with the injection or infusion of contrast media and other fluids.
The NeVa PV Thrombectomy Device ("NeVa") is a mechanical thrombectomy device that is temporarily inserted into the coronary vasculature under angiographic visualization in order to remove emboli and thrombus to restore blood flow to occluded vessels. The overall design of NeVa is similar to other commercially mechanical thrombectomy devices that use a self-expanding nitinol basket attached to a core pusher wire. To optimize emboli and thrombus removal, NeVa employs a capture cell design within the nitinol basket structure that incorporates a proprietary drop zone pattern. This proprietary drop zone design maximizes clot retrieval efficiency without changing the mechanism of action used by mechanical thrombectomy devices. As with other mechanical thrombectomy devices, NeVa is intended to be delivered through a compatible commercially available microcatheter to the target vessel. NeVa is intended to be retrieved into a guiding catheter with adjunctive aspiration to reduce potential emboli. NeVa is provided sterile and intended for single-use only. To accommodate different vessel diameters and clot sizes, NeVa is provided in multiple expandable tip sizes and configurations.
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(70 days)
The Guided Aarhus Applicator Set is indicated for use for cancer treatment of the vagina, vaginal stump, cervix, uterus, and endometrium using HDR brachytherapy.
The Guided Aarhus Applicator Set is an applicator for intracavitary/interstitial brachytherapy.
Brachytherapy is a form of radiotherapy using Gamma rays from a radioactive source placed at locations close to or within a tumor or other treatment area to a predefined treatment plan. The treatment plan defines the positions and times for the source to ensure the correct dose for the treatment area. The applicator acts to guide the radioactive source to the correct location or locations for treatment.
Brachytherapy is a form of radiotherapy using Gamma rays from a radioactive source placed at locations close to or within a tumor or other treatment area to a predefined treatment plan. The treatment plan defines the positions and times for the source to ensure the correct dose for the treatment area. The applicator acts to guide the radioactive source to the correct location or locations for treatment.
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(223 days)
NeVasc Aspiration Catheter:
As part of the NeVasc Aspiration System, the NeVasc Aspiration Catheter with the Vesalio Aspiration Tubing Set and a compatible aspiration pump is indicated for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral - M1 and M2 segments, basilar, and vertebral arteries) within 8 hours of symptom onset. Patients who are ineligible for thrombolytic drug therapy or who failed thrombolytic drug therapy are candidates for treatment.
Vesalio Aspiration Tubing Set:
As part of the NeVasc Aspiration System, the Vesalio Aspiration Tubing Set is indicated to connect the NeVasc Aspiration Catheter to a compatible aspiration pump.
The NeVasc Aspiration System consists of 1) NeVasc Aspiration Catheter, 2) Peel Away Introducer Sheath and 3) Vesalio Aspiration Tubing Set.
The NeVasc Aspiration Catheter is a single-lumen, reinforced, flexible, variable stiffness composite catheter that facilitates the removal of thrombus from the neurovasculature when connected to a compatible aspiration pump and the Vesalio Aspiration Tubing Set. The catheter distal shaft has an external hydrophilic coating aimed at reducing friction during use. The distal end of the catheter shaft is radiopaque for fluoroscopic visualization, and the proximal end contains a luer hub that allows attachment of accessories for flushing and aspiration.
The peel-away introducer sheath is provided in the package to facilitate the insertion of the NeVasc Aspiration Catheter's distal tip into an appropriate vascular sheath.
The Vesalio Aspiration Tubing Set is provided in a separate package and is made of common medical grade polymers. It comprises of a hollow cylindrical tube that is bonded to a standard male rotator fitting on one end. The male rotator allows the tubing to connect to a rotating hemostasis valve (RHV) or the female luer hub of the NeVasc Aspiration Catheter. The other end of the tubing consists of a hose fitting to enable connection with an aspiration pump. A flow switch is connected in line to provide vacuum control.
The NeVasc Aspiration System is provided sterile, non-pyrogenic, and is intended for single use only.
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