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BD Enteric Bacterial Panel for BD COR™ System

BD Enteric Bacterial Panel for BD COR™ System is an automated in vitro diagnostic test for the direct qualitative detection and differentiation of enteric bacterial pathogens. BD Enteric Bacterial Panel for BD COR™ System detects nucleic acids from:

• Salmonella spp.
• Campylobacter spp. (C. jejuni and C. coli)
• Shigella spp. / Enteroinvasive Escherichia coli (EIEC)
• Shiga toxin 1 (stx1) / Shiga toxin 2 (stx2) genes (found in Shiga toxin-producing Escherichia coli [STEC]) as well as Shigella dysenteriae, which can possess a Shiga toxin gene (stx) that is identical to the stx1 gene of STEC.

Testing is performed utilizing the BD Fecal Collection and Transport Kit. Unpreserved soft to diarrheal stool specimens from symptomatic patients with suspected acute gastroenteritis, enteritis or colitis are probed using the flocked swab and material is transferred to the BD Fecal Collection and Transport tube containing modified Cary-Blair medium. The test is performed utilizing real-time polymerase chain reaction (PCR) for the amplification of specific sequences of target DNA. The test utilizes fluorogenic sequence-specific hybridization probes for detection of the amplified DNA.

This test is intended for use, in conjunction with clinical presentation, laboratory findings, and epidemiological information, as an aid in the differential diagnosis of Salmonella, Shigella/EIEC, Campylobacter, and Shiga toxin-producing E. coli (STEC). Results of this test should not be used as the sole basis for diagnosis, treatment, or other patient management decisions. Positive results do not rule out co-infection with other organisms that are not detected by this test and may not be the sole or definitive cause of patient illness. Negative results in the setting of clinical illness compatible with gastroenteritis may be due to infection by pathogens that are not detected by this test or non-infectious causes such as ulcerative colitis, irritable bowel syndrome, or Crohn's disease.

BD Enteric Bacterial Panel plus for BD COR™ System

BD Enteric Bacterial Panel plus for BD COR™ System is an automated in vitro diagnostic test for the direct qualitative detection and differentiation of enteric bacterial pathogens. BD Enteric Bacterial Panel plus for BD COR™ System detects nucleic acids from:

• Salmonella spp.
• Campylobacter spp. (C. jejuni and C. coli)
• Shigella spp. / Enteroinvasive Escherichia coli (EIEC)
• Shiga toxin 1 (stx1) / Shiga toxin 2 (stx2) genes (found in Shiga toxin-producing Escherichia coli [STEC]) as well as Shigella dysenteriae, which can possess a Shiga toxin gene (stx) that is identical to the stx1 gene of STEC.
• Plesiomonas shigelloides
• Vibrio spp. (V. vulnificus, V. parahaemolyticus, and V. cholerae)
• Enterotoxigenic Escherichia coli (ETEC) heat-labile enterotoxin (LT) / heat-stable enterotoxin (ST) genes
• Yersinia enterocolitica

Testing is performed utilizing the BD Fecal Collection and Transport Kit. Unpreserved soft to diarrheal stool specimens from symptomatic patients with suspected acute gastroenteritis, enteritis or colitis are probed using the flocked swab and material is transferred to the BD Fecal Collection and Transport tube containing modified Cary-Blair medium. The test is performed utilizing real-time polymerase chain reaction (PCR) for the amplification of specific sequences of target DNA. The test utilizes fluorogenic sequence-specific hybridization probes for detection of the amplified DNA.

This test is intended for use, in conjunction with clinical presentation, laboratory findings, and epidemiological information, as an aid in the differential diagnosis of Salmonella, Shigella/EIEC, Campylobacter, Shiga toxin-producing E. coli (STEC), Plesiomonas shigelloides, Vibrio spp. (V. vulnificus, V. parahaemolyticus, and V. cholerae), Enterotoxigenic Escherichia coli (ETEC) LT/ST, and Yersinia enterocolitica. Results of this test should not be used as the sole basis for diagnosis, treatment, or other patient management decisions. Positive results do not rule out co-infection with other organisms that are not detected by this test and may not be the sole or definitive cause of patient illness. Negative results in the setting of clinical illness compatible with gastroenteritis may be due to infection by pathogens that are not detected by this test or non-infectious causes such as ulcerative colitis, irritable bowel syndrome, or Crohn's disease.

Enteric Bacterial Panel Diluent for BD COR™ System

The Enteric Bacterial Panel Diluent for BD COR™ System is intended to be used in clinical settings according to instructions provided for aliquoting into Molecular Aliquot Tubes by the BD COR™ System. The Enteric Bacterial Panel Diluent for BD COR™ System is only for use with BD Fecal Collection and Transport Kit specimens tested on BD COR™ Systems.

The BD Enteric Bacterial Panel for BD COR™ System (BD EBP for BD COR™ System) simultaneously detects pathogens responsible for gastroenteritis due to Salmonella spp., Campylobacter spp. (C. jejuni and C. coli), Shigella spp./EIEC, stx/stx1/stx2 found in Shiga toxin-producing E. coli and in Shigella dysenteriae, and an internal Sample Processing Control. The BD Enteric Bacterial Panel plus for BD COR™ Systems (BD EBP plus for BD COR™ System) additionally detects Plesiomonas shigelloides, Vibrio (V. vulnificus, V. parahaemolyticus, and V. cholerae), Enterotoxigenic E. coli (ETEC) LT/ST, Yersinia enterocolitica and an internal Sample Processing Control with a second master mix. The assays automate the testing process and minimize operator intervention from the time the sample is placed onto the BD COR™ System until results are available.

The BD COR™ System is comprised of a single BD COR™ PX System attached to a BD COR™ MX Analyzer as described in K210585 and K224653. Once the specimens are loaded, the BD COR™ PX System performs the necessary pre-analytical steps such as vortexing, aliquoting into a diluent filled molecular aliquot tube, sorting/grouping of the secondary samples for testing by assay, pre-warming and cooling of the sample (where required), and transport of the sample into the BD COR™ MX Analyzer, where extraction, amplification and detection take place.

Additionally, the steps of ordering tests on the instrument for specific samples will be managed directly by the user interaction with the Laboratory Information System (LIS), which communicates directly with the instrument.

Once the clinical specimens are received in the laboratory and loaded into the transport racks, the user will not be required to directly handle the specimen again prior to result reporting and removal from the system.

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The device is intended to be used with endoscopic accessories such as a biopsy forceps and Electronic Endoscope Image Processor for endoscopy and endoscopic surgery within urinary tract and interior of the ureter and kidney.

The Flexible Ureterorenoscope System consists of a sterile Flexible Ureterorenoscope and an Electronic Endoscope Image Processor with its accessories power adapter. The Flexible Ureterorenoscope is provided sterile (sterilized by EO) and is single use.

The Flexible Ureterorenoscope consists of a head section, bending section, insertion section, operating section, electrical connection section, and built-in LED light source. The Electronic Endoscope Image Processor is powered by the main line.

The Flexible Ureterorenoscope is an endoscope instrument and is intended to be used with the Electronic Endoscope Image Processor during endoscopic procedures. The handle section features several key components, including a control lever, a handle for manipulation, a button for capturing photos or video, and a Luer port for the insertion of accessories or irrigation to the working channel.

The insertion section houses a working channel and wiring to transmit the image signals to the image processor. The distal bending section of the insertion section contains a camera lens for real-time image capture, an LED light source for illumination, and a distal outlet for the working channel.

The Electronic Endoscope Image Processor is a video processor which is intended and designed for use during endoscopic procedures. It receives and processes image signals from the endoscope and outputs signals to an external medical monitor for display.

The Electronic Endoscope Image Processor has integrated software to control the operation of the device and is a reusable device that does not require sterilization before use, as there is no direct/in-direct patient contact material. The image processor is intended to be cleaned and disinfected before use, the cleaning and disinfection method is validated and recommend in the User Manual.

The equipment is for use in a hospital or qualified medical institution. It is only to be used by skilled physicians trained in clinical endoscopic techniques and procedures.

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Diode Laser Hair Removal Machine (Model: GLD01) is intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI), including tanned skin.

Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.

The Diode Laser Hair Removal Machine (Model: GLD01) consists with the power system, microprocessor controller system, operation and screen system, cooling system, laser module and security alarm system. The microprocessor control the laser power, which can provide the constant current for the laser module. The inner high energy diode, from the laser module, transform the electronic to light energy, which output the constant laser with wavelength.The laser light on the skin by leaded crystal, penetrate into the deep tissue of the skin. The light energy is absorbed and then turned into the thermal energy, which can destroy the hair follicle tissue, make it gone and never grow again.

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The GripTract-GI Endoscopic Tissue Manipulator (GripTract) Upper GI Model is an accessory intended to assist in positioning the distal end of an endoscope from the mucosal surface and assist with optical visualization, diagnosis, and endoscopic treatment.

GripTract Upper GI Model is indicated for use in the upper gastrointestinal tract with any standard endoscope as follows:

The GripTract-GI™ Endoscopic Tissue Manipulator (GripTract) Upper GI Model GT-GS100 is a disposable, non-sterile accessory intended to assist in positioning the distal end of an endoscope from the mucosal surface and assist with optical visualization, diagnosis, and endoscopic treatment.

The GripTract Handpiece attaches to the endoscope control body just below the working channel. The soft End Cap with two integrated Fingers for tissue manipulation is placed on the distal end of the endoscope. Two Control Knobs on the Handpiece each operate a corresponding Finger, permitting the User to rotate and extend/retract the Fingers for tissue manipulation and visualization independent of the endoscope's movement or the presence of other tools in the endoscope's working channel.

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DESS Dental Smart Solutions abutments are intended to be used in conjunction with endosseous dental implants in the maxillary or mandibular arch to provide support for prosthetic restorations.

The purpose of this submission is to expand the DESS Dental Smart Solutions for the DESSLoc Attachment system cleared under K170588, K191986, K212628, K222288, K240208, and K242340 and to:

• include OEM platform compatibilities to the DESSLoc Abutment design that have been previously cleared in other DESS Abutment designs,
• include new OEM platform compatibility for MIS C1 Dental Implant System,
• include attachment components (retention inserts and housing) including reprocessing information in labeling.

The DESSLoc Attachment System consists of abutments and device-specific accessories (retention inserts and denture housings) for resilient attachment of prostheses to endosseous dental implants. There have been no changes to the design of the DESSLoc abutments, the design is the same that has been cleared in the above submissions. The abutments are made of titanium alloy and coated with zirconium nitride (ZrN). The nylon retention insert is manufactured from Polynil® (polyamide 6.6) or Vestamid® Care ML GB30 (polyamide 12). The denture housing is made of titanium alloy with a machined surface or anodized surface. The DESSLoc abutment is compatible with OEM implants, as listed below.

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The Firebird SI Navigation System instruments are intended to be used during the preparation and placement of Orthofix Firebird SI Fusion System screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. The Firebird SI Navigation instruments are specifically designed for use with the Medtronic StealthStation System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a vertebra or pelvis can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks for the anatomy.

The Firebird SI Navigation System consists of manual, surgical instruments for use with the Medtronic StealthStation Navigation System via the NavLock Tracker and SureTrak II Large Passive Fighter to assist surgeons in locating anatomical structures in minimally invasive and open procedures for preparation and placement of Firebird SI Fusion System implants. This surgical imaging technology provides surgeons visualization for complex and MIS procedures and confirms the accuracy of advanced surgical procedures. Use of these navigation systems provides the surgeon access to real-time, multi-plane 3D images (and 2D images) providing confirmation of hardware placement. The Firebird SI Navigation System instruments are manufactured from Stainless Steel per ASTM F899 or ASTM A564.

The Firebird SI Navigation System instruments include the following:

• Screw Driver
• Drills
• MDT Inline Adapter

The Firebird SI Navigation System instruments are to be used with the following FDA cleared SeaSpine Spinal System:

• Firebird SI Fusion System

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Advanced Bipolar: The Voyant electrosurgical generator is indicated for use with advanced bipolar Voyant devices in open and minimally invasive procedures where the ligation of vessels up to and including 7mm in diameter and tissue bundles is desired.

NOTE: For indications specific to each Voyant device used with the Voyant generator, refer to each device's Instructions for Use (IFU).

Monopolar/Bipolar: Intended to provide energy to standard monopolar and bipolar surgical accessories.

The Applied Medical Voyant Electrosurgical Generator (EA030) is a reusable, electrically isolated, microprocessor-controlled power supply intended to deliver radiofrequency (RF) energy for electrosurgical applications. The system provides energy output to compatible monopolar, bipolar, and Voyant advanced bipolar instruments for the cutting, coagulation, and sealing of vessels and tissue bundles. The Voyant EA030 operates outside the sterile field and interfaces with active surgical instruments that operate within the sterile field. The system comprises integrated mechanical, electrical, and software components, constructed from various metals and polymers. It features a front-panel LCD touchscreen that enables users to view, navigate and adjust operating modes and system settings.

Voyant EA030 is designed to function as part of a system that includes optional accessories such as active devices, footswitches, and patient return electrodes. These components work together to ensure safe and effective energy delivery during surgical procedures.

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The Diagnostic Ultrasound System Aplio i900 Model TUS-AI900, Aplio i800 Model TUS-AI800, and Aplio i700 Model TUS-AI700 are indicated for the visualization of structures, and dynamic processes with the human body using ultrasound and to provide image information for diagnosis in the following clinical applications: fetal, abdominal, intra-operative (abdominal), pediatric, small organs (thyroid, breast and testicle), trans-vaginal, trans-rectal, neonatal cephalic, adult cephalic, cardiac (both adult and pediatric), peripheral vascular, transesophageal, musculo-skeletal (both conventional and superficial), laparoscopic and thoracic/pleural. This system provides high-quality ultrasound images in the following modes: B mode, M mode, Continuous Wave, Color Doppler, Pulsed Wave Doppler, Power Doppler and Combination Doppler, as well as Speckle-tracking, Tissue Harmonic Imaging, Combined Modes, Shear wave, Elastography, and Acoustic attenuation mapping. This system is suitable for use in hospital and clinical settings by physicians or appropriately trained healthcare professionals.

In addition to the aforementioned indications for use, when EUS transducer GF-UCT180 and BF-UC190F are connected, Aplio i800 Model TUS-AI800/E3 provides image information for diagnosis of the upper gastrointestinal tract and surrounding organs, airways, tracheobronchial tree and esophagus.

The Aplio i900 Model TUS-AI900, Aplio i800 Model TUS-AI800 and Aplio i700 Model TUS-AI700, V9.0 are mobile diagnostic ultrasound systems. These systems are Track 3 devices that employ a wide array of probes including flat linear array, convex, and sector array with frequency ranges between approximately 2MHz to 33MHz.

This FDA 510(k) clearance letter details the substantial equivalence of the Aplio i900, Aplio i800, and Aplio i700 Software V9.0 Diagnostic Ultrasound System to its predicate device. The information provided specifically focuses on the validation of new and improved features, with particular attention to the 3rd Harmonic Imaging (3-HI), a new deep learning (DL) enabled filtering process.

Acceptance Criteria and Device Performance for 3rd Harmonic Imaging (3-HI)

Detailed Study Information

1. Acceptance Criteria and Reported Device Performance

(See table above)

2. Sample Size Used for the Test Set and Data Provenance

• 3rd Harmonic Imaging (3-HI) Clinical Evaluation:
  • Sample Size: 30 patients.
  • Data Provenance: Previously acquired data from a U.S. clinical site (retrospective). Patients were selected to ensure diverse demographic characteristics representative of the intended U.S. patient population, including a wide range of body mass indices (18.5-36.3 kg/m²), roughly equivalent numbers of males and females, and ages ranging from 23-89 years old.
• 3rd Harmonic Imaging (3-HI) Phantom Study:
  • Sample Size: Five abdominal phantoms.
  • Data Provenance: Phantom data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

• 3rd Harmonic Imaging (3-HI) Clinical Evaluation:
  • Number of Experts: Three (3).
  • Qualifications: U.S. board-certified radiologists.

4. Adjudication Method for the Test Set

• 3rd Harmonic Imaging (3-HI) Clinical Evaluation:
  • Adjudication Method: Blinded observer study. The three radiologists compared images with 3-HI to images without 3-HI (predicate functionality) using a 5-point ordinal scale. The median score was then compared with the middle score of 3.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• Yes, a MRMC-like comparative effectiveness study was done for 3-HI's clinical evaluation.
• Effect Size: The statistical analysis demonstrated that scores for 3-HI were higher than the middle score of 3 for spatial resolution, contrast resolution, and artifact suppression. This indicates that human readers (radiologists) rated images with 3-HI as improved compared to those without.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance)

• Yes, a standalone study was performed for 3-HI in the phantom study. The phantom studies objectively examined lateral and axial resolution, slice resolution, contrast-to-noise ratio (CNR), reverberation artifact suppression, and frequency spectra without human interpretation.

7. The Type of Ground Truth Used

• 3rd Harmonic Imaging (3-HI) Clinical Evaluation:
  • Type of Ground Truth: Expert consensus (from the three board-certified radiologists) on image quality metrics (spatial resolution, contrast resolution, artifact suppression) through a blinded comparison against predicate functionality. The initial selection of patient images included "representative focal pathologies" suggesting clinical relevance in the images themselves.
• 3rd Harmonic Imaging (3-HI) Phantom Study:
  • Type of Ground Truth: Objective measurements against known physical properties and targets within the phantoms.

8. The Sample Size for the Training Set (for 3-HI)

• The document explicitly states that the "The validation data set [30 patients] was entirely independent of the data set used to train the algorithm during its development." However, the actual sample size for the training set is not provided in the given text.

9. How the Ground Truth for the Training Set Was Established (for 3-HI)

• This information is not provided in the given text, beyond the statement that the algorithm was "locked upon completion of development" and had "no post-market, continuous learning capability."

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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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Phasor GREEN Drill is a re-sterilizable drill driver (for use on one ore more patients, up to 10 total holes), with separately packaged single-use sterilized drill bit assembly -- for use on adult patients during neurosurgical procedures for drilling of cranial bone.

The Phasor™ GREEN Drill is composed of 2 items: (1) a re-sterilizable, non-rechargeable battery-operated Phasor Green Driver (made of plastic housing, capable of drilling up to 10 total holes in one or more patients) in conjunction with (2) a separately packaged, single-use Phasor Green Drill Bit Assembly comprised of a steel bit (of 6.35-mm or less), plastic adapter, and polybag secured using latex-free bands. The device is for drilling cranial or orthopedic bone, by prescription only and used by qualified users, with (1) Drill Driver (provided non-sterile) for sterilization using vaporized hydrogen peroxide (VHP)prior to use at user facility and (2) Drill Bit Assembly provided gamma-sterilized for single-use respectively.

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