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1. Persyst 15 EEG Review and Analysis Software is intended for the review, monitoring and analysis of EEG recordings made by electroencephalogram (EEG) devices to aid neurologists in the assessment of EEG. This device is intended to be used by qualified medical practitioners who will exercise professional judgment in using the information.

2. The Seizure Detection and Seizure Probability component of Persyst 15 is intended to mark previously acquired sections of the adult (greater than or equal to 18 years) EEG recordings that may correspond to electrographic seizures, in order to assist qualified clinical practitioners in the assessment of EEG traces. EEG recordings should be obtained with a full scalp montage according to the standard 10/20 system. Alternatively, the Seizure Detection can operate using reduced set of electrodes including Fp1, F7, T3, T5, O1, Fp2, F8, T4, T6, O2, but will have decreased sensitivity for seizures due to its limited spatial sampling.

3. The Persyst software's Electrographic Status Epilepticus (ESE) component is indicated for the diagnosis of Electrographic Status Epilepticus in patients greater than or equal to 18 years of age who are at risk for seizure. The (ESE) Component analyzes EEG waveforms and identifies patterns that may be consistent with electrographic status epilepticus as defined in the "(American Clinical Neurophysiology Society's Guideline 14)". EEG recordings used with this feature should be obtained with a full scalp montage (10/20 system) or a reduced set of electrodes (Fp1, F7, T3, T5, O1, Fp2, F8, T4, T6, O2). Using the reduced set of electrodes will result in some decrease in sensitivity and specificity for the detection of ESE in comparison to the full montage due to decreased spatial sampling.

   The (ESE) Component is intended to be used as an aid for determining patient treatment in acute-care environments. Detections from the (ESE) Component provide one input for the clinician that is intended to be used in conjunction with other elements of clinical practice to determine the appropriate treatment course for the patient. The (ESE) Component is intended for detection of electrographic status epilepticus only. The (ESE) Component does not substitute for the review of the underlying EEG by a qualified clinician with respect to any other types of pathological EEG patterns. The (ESE) Component is not intended for use in Epilepsy Monitoring Units or non-acute care environments.

4. The Neonatal Seizure Detection component of Persyst 15 is intended to mark previously acquired sections of neonatal patients' (defined as near-term or term neonates of conceptional age between 36 and 44 weeks and less than two weeks of chronologic age) EEG recordings that may correspond to electrographic seizures, in order to assist qualified clinical practitioners in the assessment of EEG traces. EEG recordings should be obtained with scalp-recorded EEG using the standard International 10-20 system electrode placement, modified for neonates (this includes electrode sites Fp1/2 or alternate F1/2, C3/4, T3/4, O1/2, and Cz, optionally including Fz). Alternatively, the Neonatal Seizure Detection component can operate using a more reduced set of electrodes including C3/4, Fp1/2 (F1/2), and O1/2 (recorded in such a manner to allow creation of montage C3-4, Fp1-O1, Fp2-O2), or an even more simplified electrode set including only C3/4 and Cz (arranged as C3-Cz and C4-Cz), but the three-electrode montage will have decreased sensitivity for seizures due to its limited spatial sampling.

5. The Spike Detection component of Persyst 15 is intended to mark previously acquired sections of the patient's EEG recordings that may correspond to spikes, in order to assist qualified clinical practitioners in the assessment of EEG traces. The Spike Detection component is intended to be used in patients at least one month old. Persyst 15 Spike Detection performance has not been assessed for intracranial recordings.

6. Persyst 15 EEG Review and Analysis Software includes the Persyst Imaging Workflow (PIW), an imaging viewer. It is intended for use by qualified clinical practitioners on both adult and pediatric subjects at least 12 years of age to interpret EEG data in conjunction with any type of neuroimaging including magnetic resonance imaging (MRI) or computed tomography scans (CT). Persyst Imaging Workflow is not intended to provide diagnostic information.

7. The Persyst ESI component of Persyst 15 is intended for use by a trained/qualified EEG technologist or physician on both adult and pediatric subjects at least 3 years of age for the visualization of human brain function by fusing a variety of EEG information with rendered images of an individualized head model and an individualized MRI image.

8. The Persyst 15 sleep state feature provides the user with output concerning wake-sleep states (wake or sleep,) present in an EEG recording as an aid in assessing which states are present and when they are present. The EEG being assessed for sleep state should utilize standard 10-20 system electrode recording positions and contain the expected EEG patterns of typical wake and sleep, with no major persistent pathological alterations. The sleep state output is subject to user confirmation via EEG waveform review and is not intended for the diagnosis of sleep disorders (e.g.: sleep apnea, narcolepsy, restless leg syndrome). The sleep state feature is intended for adult and pediatric subjects at least 13 years and older.

9. Persyst 15 includes the calculation and display of a set of quantitative measures intended to monitor and analyze the EEG waveform. These include FFT, Rhythmicity, Peak Envelope, Artifact Intensity, Amplitude, Relative Symmetry, and Suppression Ratio. Automatic event marking is not applicable to quantitative measures. These quantitative EEG measures should always be interpreted in conjunction with review of the original EEG waveforms.

10. Persyst 15 displays physiological signals, including the calculation and display of a heart rate measurement based on the ECG channel in the EEG recording, which are intended to aid in the analysis of an EEG. Heart rate measurement of Persyst 15 is not applicable to patients with pacemaker and/or active implantable devices.

11. The aEEG functionality included in Persyst 15 is intended to monitor the state of the brain. The automated event marking function of Persyst 15 is not applicable to aEEG.

12. Persyst 15 provides notifications for seizure detection, quantitative EEG and aEEG that can be used when processing a record during acquisition. These include an on screen display and the optional sending of an email message. Delays of up to several minutes can occur between the beginning of a seizure and when the Persyst 15 notifications will be shown to a user. Persyst 15 notifications cannot be used as a substitute for real time monitoring of the underlying EEG by a trained expert.

13. Persyst 15 AR (Artifact Reduction) is intended to reduce EMG, eye movement, and electrode artifacts in a standard 10-20 EEG recording. AR does not remove the entire artifact signal, and is not effective for other types of artifacts. AR may modify portions of waveforms representing cerebral activity. Waveforms must still be read by a qualified medical practitioner trained in recognizing artifact, and any interpretation or diagnosis must be made with reference to the original waveforms.

14. This device does not provide any diagnostic conclusion about the patient's condition to the user.

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The ClotTriever Thrombectomy System is indicated for:

• The non-surgical removal of thrombi and emboli from blood vessels.
• Injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel.

The ClotTriever Thrombectomy System is intended for use in the peripheral vasculature including deep vein thrombosis (DVT).

The Protrieve Sheath is indicated for use as a conduit for the insertion of endovascular devices into the vasculature while minimizing blood loss associated with such insertions.

The Protrieve Sheath is a sterile, single-use over-the-wire introducer sheath with a hydrophilic coating, distal self-expanding funnel, aspiration port, and proximal hub. A dilator is provided to aid insertion and positioning of the sheath. Other provided accessories include a 60cc large bore syringe that provides a vacuum source and collects aspirated contents. Radiopaque markers aid sheath positioning under fluoroscopic visualization. The dilator tip is radiopaque, and there is a radiopaque marker band near the distal end of the sheath. Target vessels include, but are not limited to, the iliofemoral, upper and lower extremity, inferior vena cava (IVC), and superior vena cava (SVC).

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The PrecisePath Radiofrequency Puncture Generator and Footswitch (optional accessory) is indicated for use in general surgical procedures to cut and coagulate soft tissues.

The PrecisePath Radiofrequency (RF) Puncture Generator is indicated for use in general surgical procedures to cut and coagulate soft tissue. It is designed to be used by trained medical professionals, to provide radiofrequency (RF) current for creating controlled punctures with compatible Baylis RF devices in a monopolar mode. This continuous or pulsed RF current is output at a fixed frequency within 450 kHz to 480 kHz.

The PrecisePath Footswitch (optional accessory) may be used as an alternative to the on/off button on the generator user interface by which the user can start and stop the delivery of RF energy.

The PrecisePath RF Puncture Generator is compatible with separately cleared Baylis radiofrequency devices and connector cables, off-the-shelf return (dispersive) electrodes that meet or exceed IEC 60601-2-2:2017, and the PrecisePath footswitch (optional accessory).

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The Patriot Duo in the CW mode is intended for Open and endoscopic surgery (incision, excision, resection, ablation, vaporization, Coagulation and hemostasis) of soft tissues including:

Urology
Open and endoscopic surgery (incision, excision, resection, ablation, vaporization, Coagulation and hemostasis) including: Urethral Strictures, Bladder Neck Incisions (BNI), Ablation and resection of Bladder Tumors, Uretheral Tumors and Ureteral Tumors, Ablation of Benign Prostatic Hypertrophy (BHP), Transurethral incision of the prostate (TUIP), Laser Resection of the Prostrate (HoLRP), Laser Enuculeation of the Prostate (HoLEP), Laser Ablation of the Prostate (HoLAP), Condylomas and Lesions of external genitalia.

Gastroenterology
Open and endoscopic gastroenterology surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) including: Appendectomy, Polyps, Biopsy, Gall Bladder calculi, Biliary/Bile duct calculi, Ulcers, Gastric ulcers, Duodenal ulcers, Non Bleeding Ulcers, Pancreatitas, Hemorrhoids, Cholecystectomy, Benign and Malignant Neoplasm, Angiodysplasia, Colorectal cancer, Telangiectasias, Telangiectasias of the Osler-Weber-Renu disease, Vascular Malformation, Gastritis, Esophagitis, Esophageal ulcers, Varices, Colitis, Mallory-Weiss tear, Gastric Erosions

Thoracic and Pulmonary
Open and endoscopic thoracic and pulmonary surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) of soft tissue including: Laryngeal Lesions, Airway obstructions including carcinoma, Polyps and Granulomas, Palliation of obstructing carcinomas of the tracheobronchial tree

Gynecology
Open and laparoscopic gynecological surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis), Intra-uterine treatment of submucous fibroids, benign endometrial polyps, and uterine septum by incision, excision, ablation and or vessel coagulation, Soft tissue excision procedures such as excisional conization of the cervix

ENT
Endoscopic endonasal surgery (incision, excision, resection, ablation,vaporization, coagulation and hemostasis of soft tissue) including: Endonasal/sinus Surgery, Partial turbinectomy, Polypectomy, Dacryocystorhinostomy, Frontal Sinusotomy, Ethmoidectomy, Maxillary antrostomy, Functional endoscopic sinus surgery, Lesions or tumors of the oral, nasal, glossal, pharyngeal and, laryngeal, Tonsillectomy, Adenoidectomy

Dermatology and Plastic Surgery
Incision, excision, resection, ablation, vaporization, coagulation and hemostasis of soft, mucosal, fatty and cartilaginous tissue, in therapeutic plastic, dermatologic and aesthetic surgical procedures including: Basal Cell Carcinomas, Lesions of skin and subcutaneous tissue, Skin tags, Plantar warts

General Surgery
Open laparoscopic and endoscopic surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) including: Cholecystectomy, Lysis of adhesion, Appendectomy Biopsy, Skin incision, Tissue dissection, Excision of external tumors and lesions, Complete or partial resection of internal organs, tumors and lesions, Mastectomy, Hepatectomy Pancreatectomy, Splenectomy, Thyroidectomy, Parathyroidectomy, Herniorrhaphy, Tonsillectomy, Lymphadenectomy, Partial Nephrectomy, Pilonidal Cystectomy, Resection of lipoma, Debridement of Decubitus Ulcer, Hemorrhoids, Debridement of Statis Ulcer, Biopsy

Arthroscopy
Arthroscopy/Orthopedic surgery (excision, ablation and coagulation of soft and cartilaginous tissue), Ablation of soft and cartilaginous tissue in Minimal Invasive Spinal Surgery including: Percutaneous Laser Disc Decompression/Discectomy, Foraminoplasty, Ablation and coagulation of soft vascular and non vascular tissue, In minimally invasive spinal surgery

The Patriot Duo in the Quasi-CW (SuperPulse) mode is intended for:

Urology
Ablation of Benign Prostatic Hypertrophy (BPH), Laser Resection of the Prostrate (LRP), Laser Enucleation of the Prostate (LEP), Laser Ablation of the Prostate (LAP), Transurethral Incision of the Prostate (TUIP), Condylomas, Urethral strictures, Lesions of external genitalia, Bladder neck incisions (BNI), Ablation and resection of bladder tumors, urethral tumors, and ureteral tumors, Endoscopic fragmentation of urethral, ureteral, bladder, and renal calculi, Treatment of distal impacted fragments remaining in the ureters following lithotripsy.

Lithotripsy and Percutaneous Urinary Lithotripsy Indications
Endoscopic fragmentation of urethral, ureteral, bladder and renal calculi including cystine, calcium oxalate, monohydrate and calcium oxalate dehydrate stones.

Gastroenterology
Open and endoscopic gastroenterology surgery (incision, excision, resection, ablation, vaporization, coagulation and haemostasis) including: Appendectomy, Polyps, Biopsy, Gall Bladder calculi, Biliary/Bile duct calculi, Ulcers, Gastric ulcers, Duodenal ulcers, Non Bleeding Ulcers, Pancreatitis, Haemorrhoids, Cholecystectomy, Benign and Malignant Neoplasm, Angiodysplasia, Colorectal cancer, Telangiectasias, Telangiectasias of the Osler-Weber-Renu disease, Vascular Malformation, Gastritis, Esophagitis, Esophageal ulcers, Varices, Colitis, Mallory-Weiss tear, Gastric Erosions

Gynecology
Open and laparoscopic gynecological surgery (incision, resection, ablation, vaporization, coagulation and hemostasis) of the soft tissue.

Note: The Patriot Duo for CW mode is only cleared for BPH when using over 150 W

Patriot Laser is seeking to introduce the Patriot Duo Laser, fibers and related accessories into commerce using fibers provided by InnovaQuartz, LLC, previously cleared by the FDA via the Premarket 510(k) notification process K180140, the InnovaQuartz LLC side fire fiber was previously cleared by the Premarket 510(k) notification process K233157.

The Patriot Duo Laser, fibers and related accessories are substantially equivalent to the predicate devices, The U.S. Laser Worx Patriot 1 Family of Lasers, fibers and associated accessories (K162334) and the Olympus Surgical Technologies America Soltive Preimum SuperPulse Laser, Laser fibers and accessories (K183647). The Patriot Duo is essentially the exact same device in the CW mode of operation as the as the Patriot 1 Family of Lasers. The Patriot Duo also employs a Quasi CW (SuperPulse) module allowing the Patriot Duo to operate in both the CW and Quasi CW (SuperPulse) modes to expand the Indications for Use (IFU's) to include Laser Lithotripsy and a variety of other clinical indications in the Quasi CW (SuperPulse) mode.

In the Patriot Duo each mode of operation is completely independent and may not be used at the same time or simultaneously, hence Patriot Laser LLC is simply requesting FDA Premarket Approval of two previously cleared modalities to be available in one system.

The U.S. Laser Worx Patriot 1 Family of lasers and accessories received FDA Premarket clearance April 27, 2017 (K162334) and the Olympus Surgical Technologies America Soltive Preimum SuperPulse Laser, Laser fibers and accessories received FDA Premarket clearance August 10, 2019 (K183647) for its Quasi CW (SuperPulse) Thulium Fiber Laser. Patriot Laser is simply combining two previously cleared technologies into the same console making it more beneficial for the medical community to treat more patients and a wider array of medical conditions using the same device.

The Patriot 1 Family of Lasers, 200, 400, 600 and 1000 micron sterile, disposable, single-use fibers (K162334) are indicated for incision, excision, resection, ablation, vaporization and coagulation of soft tissue encountered urology, gastroenterology, thoracic and pulmonary, gynecology, ENT, dermatology and plastic surgery general surgery and arthroscopy.

The Olympus Surgical Technologies America Soltive Preimum SuperPulse Laser (K183647) is intended for incision, excision, resection, ablation, coagulation, hemostasis, and vaporization of soft tissue, with or without an endoscope, in the following indications: urology, lithotripsy, gastroenterological surgery, and gynecological surgery.

The Patriot Duo Laser, fibers, and related accessories are indicated for incision, excision, resection, ablation, vaporization, and coagulation of soft tissue encountered in urology, lithotripsy, gastroenterology, thoracic and pulmonary, gynecology, ENT, dermatology and plastic surgery general surgery and arthroscopy.

The Patriot Duo, the Patriot 1 Family of Lasers and the Soltive Premium are medical grade, infrared devices, which provide continuous and or Quasi CW (SuperPulse) laser energy at a wavelength 1945.5 nm +/- 8 % and 1920 nm – 1960 nm respectfully. The very slight difference in wavelength is clinically negligible. The Patriot Duo has the same intended uses as the previously cleared devices by the FDA via the 510K Notification process.

A comparison matrix listing the Characteristics and Technical Data of the Patriot Laser Patriot Duo and representative predicate devices is listed below.

The intended use and indications for use of the Patriot Duo Laser, fibers and related accessories are equivalent to the intended use and indications for use of the predicate devices the Patriot 1 Family of Lasers, fibers and related accessories and The Soltive Premium Laser, Laser fibers and accessories.

In addition, similar technological characteristics and principles of operation apply for all three laser systems. The Patriot Duo Laser, fibers and related accessories, components share the same fundamental technology as the previously cleared or predicate devices.

Performance testing was conducted and demonstrated that technological differences in optical and energy outputs of the laser do not alter the safety and effectiveness when compared to the optical and energy outputs of the predicate laser systems.

In regard to safety or effectiveness whereas the Patriot Duo, the Patriot 1 Family of Lasers and the Soltive Premium are very similar products. Patriot Laser believes that the performance characteristics of the Patriot Duo raises no safety concerns.

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Parietene™ flat Sheet Mesh is intended for the reinforcement of abdominal wall soft tissue where a weakness exists, in procedures involving abdominal wall hernias repair.

Parietene™ Flat Sheet Mesh is a Monofilament polypropylene mesh.

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The Picosecond Laser device is intended for use in surgical and aesthetic application in the medical dermatology and general and plastic surgery as follows:

1064nm wavelength:

• Removal of tattoos on all skin type (Fitzpatrick skin types I-VI) with the following tattoo colors: black, brown, green, blue and purple.
• Treatment of benign pigmented lesions on Fitzpatrick skin types I-IV.

532nm wavelength:

• Removal of tattoos on Fitzpatrick skin types I-III with the following tattoo colors: red, yellow and orange.
• Treatment of benign pigmented lesions on Fitzpatrick skin types I-IV.

The Picosecond Laser Device mainly consists of a main unit, a light guide arm, a standard handpiece, a foot switch, a power cord, and other auxiliary treatment accessories.

The main unit includes power supply unit, control unit, laser system, water circulation cooling system.

Accessories include goggles, eye mask, funnel assembly, drainage nozzle, fuse tubes, remote control interlock connector, and keys.

The Picosecond Laser Device is a multi-wavelength, pulsed laser system designed for the treatment of benign pigmented lesions. A key feature of the device is its ability to produce multiple laser wavelengths (1064 nm and 532 nm).

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