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BELLUS-Q, Q switched Nd:YAG Laser System is indicated for the incision, excision, ablation, vaporization of soft tissues for general dermatology, dermatologic and general surgical procedures for coagulation and hemostasis.

1064 nm wavelength in Q-switched mode:

• Removal of dark (black, blue, brown) tattoo ink
• Treatment of nevus of ota
• Treatment of common nevi
• Removal and lightening of unwanted hair
• Skin resurfacing procedures for the treatment of acne scars and wrinkles
• Treatment of melasma
• General dermatology indications: Incision, excision, ablation and vaporization of soft tissue

1064 nm wavelength in GENESIS mode:

• Treatment of wrinkles
• Treatment of mild to moderate inflammatory acne vulgaris

532 nm wavelength in Q-switched mode (nominal delivered energy of 585 nm and 650 nm with the optional 585 nm and 650 nm dye converter handpieces):

• Red, tan, purple and orange tattoo ink removal
• Sky blue (light) tattoo ink removal
• Green tattoo ink removal
• Treatment of benign pigmented lesions including, but not limited to: cafe-au-lait birthmarks, solar lentigines, senile lentigines, senile lentigines, Becker's nevi, freckles, common nevi, nevus spilus
• Treatment of benign vascular lesion including, but not limited to: port wine birthmarks, telangiectasias, spider angioma, cherry angioma, spider nevi
• Seborrheic Keratosis
• Treatment of post-inflammatory hyperpigmentation
• Skin resurfacing procedures for the treatment of acne scars and wrinkles
• Removal of epidermal pigmented lesions

The system consists of a power supply, laser resonator, touch LCD monitor, articulated arm, handpieces, foot switch, and laser protective eyewear. The system includes several safety features, including use of key switch, an interlock, emergency stop button, and need to press a footswitch in order to activate the laser. The main body transmits the laser energy through the articulating arm to the handpiece which is positioned above or in contact with the treatment area. Five different handpieces can be attached to the articulated arm, the Zoom handpiece, Collimated handpiece, MLA handpiece, 585 Dye handpiece, and the 650 Dye handpiece. In addition, the system can operate in different modes, including single pulse, PTP, 3-pulse, 6-pulse, and genesis modes. Each handpiece integrates and aiming beam that shows the treatment area.

The Nd:YAG laser surgical system utilizes a solid-state laser medium of Nd:YAG at 1064 nm and KTP at 532 nm. The 1064 nm and 532 nm wavelengths interact with targeted skin cells or tissues, primarily leveraging the Photothermolysis Effect in Q-switched nanosecond pulse modes. This selective photothermolysis mechanism enables controlled thermal absorption within target chromophores, leading to coagulation, denaturation, or vaporization of melanin-containing cells while preserving surrounding tissues. The laser energy is effectively absorbed by pigmented lesions, allowing for precise and efficient treatment in dermatological applications.

The system also supports Dye handpieces, which enable the use of 585 nm and 650 nm wavelengths by converting 532 nm light. These wavelengths have greater absorption for different specific pigment-related lesions, expanding the system's versatility in medical and aesthetic procedures.

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The BCM2 is intended for use, under the direction of a physician, for the noninvasive intermittent measurement of fluid status in patients with end-stage kidney disease (ESKD) including those receiving maintenance dialysis.

The device does not generate any real-time alarms and outputs from the device should be used in the context of all clinical data to assess a patient's fluid status.

The device is intended for use in patients 18 years and older.

The BCM2 is a multifrequency bioimpedance device that can be used by a clinician for the noninvasive intermittent measurement of fluid status in patients with end-stage kidney disease, including those receiving maintenance dialysis. A physician or designated healthcare professional is responsible for interpreting data from the device to determine what action is required as a result of changes in the measurements.

To assess a patient's hydration status, the BCM2 measures impedance by applying a low-level signal (50–800 µA) for less than 10 seconds at 50 different frequencies from 5 kHz to 1,000 kHz. Measurements are performed by dialysis clinicians (e.g., dialysis nurses, patient care technicians) in a healthcare environment such as a dialysis clinic or hospital.

In the normal clinical workflow, the BCM2 provides the following output parameters:

• Overhydration (OH)
• Urea distribution volume (V)

The following calculated and derived parameters are also available:

• Extracellular water (ECW)
• Intracellular water (ICW)
• Total body water (TBW)

The BCM2 system consists of the BCM2 touchscreen console and the electrode set. The BCM2 console powers and measures the bioimpedance spectroscopy frequencies to assess fluid parameters. The device can also be operated in battery mode. Battery mode provides flexibility when moving between patients. The battery charge status is shown in the upper corner of the display regardless of which power source is being used. The power supply connection is located on the rear of the console.

The Calibration Box employs different resistors to calibrate the entire range of the BCM2's measurement (5 kHz to 1,000 kHz). Impedance measurements are performed for each resistor for all frequencies and the data is verified against an expected tolerance range. After the BCM2 has been calibrated, the Test Box is used to verify that the device is functioning properly.

The BCM2 will be available in one (1) configuration for sale within the U.S.

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BEE HA cages are intended for intervertebral body fusion devices in skeletally mature patients for the treatment of cervical disc degeneration and/or cervical spinal instability as confirmed by imaging studies (radiographs, CT, MRI) that results in radiculopathy, myelopathy and/or pain at one or more contiguous levels from C2-T1. These patients should have had at least six weeks of nonoperative treatment. BEE HA cages are to be used with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion and in combination with supplemental fixation indicated for cervical fusion procedures.

The subject BEE HA cage is an anterior cervical interbody fusion device. BEE HA cage is manufactured from PEEK-OPTIMA™ HA Enhanced. The subject device has a hollow chamber to permit packing with bone graft to facilitate fusion. The superior and inferior surfaces of the device have a pattern of teeth to provide increased stability and to help prevent movement of the device. Additionally, the device contains four (4) titanium alloy (Ti6Al4V per ASTM F136) pins to provide imaging visibility for device positioning.

BEE HA cages are offered in several adaptive sizes with varying footprints and lordotic angles to accommodate patient anatomy. The caudal side is flat, the cranial side is domed and the implant is formed conically from anterior to posterior. In the lateral view, the implant has a slightly lordotic form.

BEE HA cage is intended for single use only and is provided sterile, using gamma irradiation.

The purpose of this traditional 510k is to expand the size range offerings for the previously cleared BEE HA.

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The Biomoneta Avata Rx is an over-the-counter (OTC) medical recirculating air cleaner intended to remove particles for medical purposes. The device is intended for indoor use only.

The Biomoneta Avata Rx has been demonstrated to reduce Staphylococcus epidermidis, Klebsiella aerogenes, and MS2 bacteriophage by > 5 log when operated at its highest fan speed for 60 minutes.

Note: The designation "Rx" in the product name is part of the trade name and does not indicate prescription status.

Performance was validated in controlled test chambers measuring 9.1 ft × 9.1 ft × 7 ft (bioaerosol) and 12 ft × 12.5 ft × 15 ft (particle reduction).

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The BrainsWay Deep TMS™ System is indicated for the treatment of depressive episodes and for decreasing anxiety symptoms for those who may exhibit comorbid anxiety symptoms in adult patients suffering from Major Depressive Disorder (MDD) and who failed to achieve satisfactory improvement from previous antidepressant medication treatment in the current episode.

The BrainsWay Deep TMS™ System is also indicated as an adjunct for the treatment of Major Depressive Disorder (MDD) in adolescent patients (age 15-21 years).

The BrainsWay Deep TMS™ System enables direct non-invasive activation of deep brain structures. Transcranial magnetic stimulation (TMS) is a non-invasive technique used to apply brief magnetic pulses to the brain. The pulses are administered by passing high currents through an electromagnetic coil placed adjacent to a patient's scalp. The pulses induce an electric field in the underlying brain tissue. When the induced field is above a certain threshold and is directed in an appropriate orientation relative to the brain's neuronal pathways, localized axonal depolarizations are produced, thus activating neurons in the targeted brain structure.

The BrainsWay Deep TMS™ System is composed of the following main components:

1. Cart
   a) TMS Neurostimulator
   b) Cooling System
   c) Positioning Device
2. Helmet
   a) Aiming Apparatus (i.e., ruler/grid)
   b) Electromagnetic Coil (H Coil)
   c) Cap

The BrainsWay Deep TMS™ System is identical to the previously cleared BrainsWay Deep TMS™ Systems.

The purpose of this 510(k) submission is to enable modifications to the device software and for use as an adjunct for the treatment of Major Depressive Disorder (MDD) in adolescent patients (age 15-21 years).

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BriefCase-Triage is a radiological computer aided triage and notification software indicated for use in the analysis of abdominal CT images in adults or transitional adolescents aged 18 and older. The device is intended to assist hospital networks and appropriately trained medical specialists in workflow triage by flagging and communication of suspected positive findings of Intra-abdominal free gas (IFG) pathologies.

BriefCase-Triage uses an artificial intelligence algorithm to analyze images and highlight cases with the detected findings in parallel to the ongoing standard of care image interpretation. The user is presented with notifications for cases with suspected findings. Notifications include compressed preview images that are meant for informational purposes only and not intended for diagnostic use beyond notification. The device does not alter the original medical image and is not intended to be used as a diagnostic device.

The results of BriefCase-Triage are intended to be used in conjunction with other patient information and based on their professional judgment, to assist with triage/prioritization of medical images. Notified clinicians are responsible for viewing full images per the standard of care.

Briefcase-Triage is a radiological computer-assisted triage and notification software device.

The software is based on an algorithm programmed component and is intended to run on a linux-based server in a cloud environment.

The Briefcase-Triage receives filtered DICOM Images, and processes them chronologically by running the algorithms on each series to detect suspected cases. Following the AI processing, the output of the algorithm analysis is transferred to an image review software (desktop application). When a suspected case is detected, the user receives a pop-up notification and is presented with a compressed, low-quality, grayscale image that is captioned "not for diagnostic use, for prioritization only" which is displayed as a preview function. This preview is meant for informational purposes only, does not contain any marking of the findings, and is not intended for primary diagnosis beyond notification.

Presenting the users with worklist prioritization facilitates efficient triage by prompting the user to assess the relevant original images in the PACS. Thus, the suspect case receives attention earlier than would have been the case in the standard of care practice alone.

The algorithm was trained during software development on images of the pathology. As is customary in the field of machine learning, deep learning algorithm development consisted of training on labeled ("tagged") images. In that process, each image in the training dataset was tagged based on the presence of the critical finding.

Here's a detailed breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided FDA 510(k) clearance letter for BriefCase-Triage:

Acceptance Criteria and Reported Device Performance

Note: The document explicitly states that the primary endpoints were "sensitivity and specificity with an 80% performance goal." The reported performance for both sensitivity and specificity (94.2% and 94.6% respectively) significantly exceeds this 80% goal. The time-to-notification for the subject device is significantly faster than the predicate, demonstrating improved "time savings to the standard of care review."

Study Information

1. Sample Size Used for the Test Set and Data Provenance:
* Sample Size: 394 cases
* Data Provenance:
* Country of Origin: US (6 clinical sites)
* Retrospective/Prospective: Retrospective
* Additional Detail: Cases were distinct in time or center from the training data.

2. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
* Number of Experts: 3
* Qualifications: Senior board-certified radiologists

3. Adjudication Method for the Test Set:
* The document states "as determined by three senior board-certified radiologists." While it doesn't explicitly state "2+1" or "3+1," this implies a consensus-based approach among the three experts. Without further detail, it's reasonable to infer a consensus was reached, or a specific rule for disagreement (e.g., majority) was applied.

4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
* No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted to assess how much human readers improve with AI vs. without AI assistance. The study focuses purely on the standalone performance of the AI algorithm.

5. Standalone Performance Study (Algorithm Only):
* Yes, a standalone study was performed. The "Pivotal Study Summary" describes evaluating "the software's performance to the ground truth," indicating a standalone performance assessment of the algorithm without human-in-the-loop performance measurement.

6. Type of Ground Truth Used:
* Expert consensus (as determined by three senior board-certified radiologists).

7. Sample Size for the Training Set:
* The document states, "The algorithm was trained during software development on images of the pathology." However, it does not provide a specific sample size for the training set.

8. How the Ground Truth for the Training Set Was Established:
* "each image in the training dataset was tagged based on the presence of the critical finding." This indicates that human experts (or a similar method to the test set ground truth) labeled the images in the training set for the presence of the pathology. However, the specific number and qualifications of these experts are not explicitly stated for the training set.

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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 BD Alaris™ Pump Infusion Set is indicated for pump use by experienced healthcare professionals within healthcare facilities through intravenous, intra arterial and subcutaneous routes for adults, pediatrics and neonates or irrigation of fluid spaces for adults. Based on clinical discretion these sets can be used for temporary intravenous gravity infusion.

The subject BD Alaris™ Pump Infusion Set is a single-use infusion set incorporating a spiked drip chamber on the proximal end, which is inserted into a fluid container, and a male luer lock connector on the distal end which connects to a patient's access device. The spike cap and the male luer lock cap maintain sterility of the fluid path prior to use. The BD Alaris™ Pump Infusion Set is supplied fluid-path sterile using gamma irradiation and is non-pyrogenic. The subject BD Alaris™ Pump Infusion Set incorporates a pump segment designed to interface with the BD Alaris™ Pump Module for administration of fluids, medications, and parenteral nutrition through clinically acceptable routes of administration.

The BD Alaris™ Pump Infusion Set is available in six (6) configurations incorporating variations of the following components: roller clamp, pinch clamp, slide clamp, SmartSite™ Y-site(s), back check valve, and inline filter.

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The Blood Pressure Monitor is intended to measure the systolic and diastolic blood pressure as well as the pulse rate by using the arm cuff. The device can be used in medical facilities or at home, and only for indoor use. It is supplied for OTC use.

The blood pressure monitor is a fully automatic, non-invasive upper arm measurement device using oscillometric methodology to measure systolic pressure, diastolic pressure and pulse rate. The device features an inflatable cuff that wraps around the arm, with a built-in pressure sensor and transducer that analyze arterial pulsations to determine blood pressure values. Measurement results are clearly displayed on the LCD screen.

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