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510(k) Data Aggregation
(91 days)
The UniSpace® TPLIF Cage is indicated for intervertebral body fusion at one level or two contiguous levels in the lumbar spine from L2 to S1 in patients with degenerative disc disease (DDD) with up to Grade I spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. The UniSpace® TPLIF Cage is to be used with supplemental internal spinal fixation. Additionally, the UniSpace® TPLIF Cage is to be used with autograft bone and/or allogenic bone graft comprised of cancellous or corticocancellous bone graft.
The UniSpace® TPLIF Cage is a product for lumbar spinal column stability. The implants of the UniSpace® TPLIF Cage are made of ASTM F3001 titanium alloy (Ti6Al4V ELI) and manufactured using an additive manufacturing method (3D printing), specifically Direct Metal Laser Sintering (DMLS). The UniSpace® TPLIF Cage is available in various heights, widths, lengths, and lordotic angles, and features an open architecture designed to accommodate autograft bone and/or allogenic bone graft comprised of cancellous or corticocancellous bone graft. The cages are provided in a variety of sizes to accommodate individual patients' anatomical requirements. The implants of the UniSpace® TPLIF Cage are provided as a sterile pack. The UniSpace® TPLIF Cage is implanted by using instruments manufactured from stainless steel material (ASTM F899) and/or Ti6Al4V ELI (ASTM F136).
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(24 days)
The UV5000W Handle is to be used with UroViu Cannula Uro-G HD, Uro-G, Uro-V, Uro-N, and Hystero-V and is intended to be used to permit viewing of the urethra and bladder or cervical canal and uterine cavity for the purpose of performing diagnostics.
The UroViu Cannula Uro-G HD, Uro-G, Uro-V, Uro-N, and Hystero-V connect to the UV5000W Handle to become an endoscopic system that is intended to allow visualization of the urethra and bladder or cervical canal and uterine cavity for the purpose of performing diagnostics. This 510(k) discloses the modifications made to the UV5000 Handle (K250797) with the capability of transmitting the images captured wirelessly to an external monitor.
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(118 days)
Uterine Aspiration Set is used with the vacuum system to aspirate transcervically the products of conception or menstruation from the uterus.
The Uterine Aspiration Set consists of rigid/flexible uterine aspiration curette and uterine aspiration tubing set(Composed of uterine aspiration tubing, swivel handle and other components). Rigid/flexible uterine aspiration curette and uterine aspiration tubing set(including uterine aspiration tubing and swivel handle) are all disposable and supplied sterile.
Rigid/Flexible Uterine Aspiration Curette
The rigid/flexible uterine aspiration curette is mainly used to scrape and remove tissues in the endometrium or uterine cavity. Its tip is suitable for entering the uterine cavity and performing scraping operations.
Uterine Aspiration Tubing Set
The uterine aspiration tubing set is mainly used to generate negative pressure during the surgical process. It is usually connected at one end to a Rigid/Flexible Uterine Aspiration Curette for scraping operations, and at the other end to a suction device, and tissues are sucked out by negative pressure. The suction force can be adjusted by sliding the ring on the vacuum control hole.
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(281 days)
This device is intended for use only in adult patients.
Therapeutic Ultrasound
Application of therapeutic deep heat for the treatment of selected sub-chronic and chronic medical conditions such as:
- Pain relief, muscle spasms and joint contractures.
- Relief of pain, muscle spasms and joint contractures that may be associated with:
- Adhesive capsulitis
- Bursitis with slight calcification
- Myositis
- Soft tissue injuries
- Shortened tendons due to past injuries and scar tissues
- Relief of sub-chronic, chronic pain and joint contractures resulting from:
- Capsular tightness
- Capsular scarring
For TENS, Interferential, premodulated (IFC), NMS and Microcurrent:
- Symptomatic relief of chronic intractable pain
- Post-traumatic acute pain
- Post-surgical acute pain
Additionally for NMS, NMS Burst, Hi-Volt and Russian:
- Relaxation of Muscle spasms
- Prevention or retardation of disuse atrophy
- Increasing local blood circulation
- Muscle re-education
- Maintaining or increasing range of motion
- Immediate postsurgical stimulation of calf muscles to prevent venous thrombosis
For DC Continuous Mode
- Relaxation of muscle spasm
The Ultrasound Therapy Workstation (model: XMS-UET2) is an AC-powered device designed to use electrical stimulation and therapeutic ultrasound. Key features include ultrasound output and electrical stimulation output. This device is intended for use in healthcare environments such as hospitals, rehabilitation centers, community health service centers, and clinics.
The device has a color touchscreen display and a control knob with light ring. The screen display shows system information to the user. Both display screen and control knob can assist the user in selecting or adjusting parameters. All controls and indicators are controlled by software.
Three non-invasive therapeutic methods are available: electrotherapy, ultrasound therapy and combination therapy (ultrasound plus electrical stimulation). For each method, the device is configured with protocols and manual operation, which can facilitate users to choose pre-set protocols or adjust parameters to suit individual needs.
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(90 days)
The Electrosurgical & Ultrasonic Generator (USG-410) is intended to be used with the THUNDERBEAT Transducer, the SONICBEAT Transducer, the THUNDERBEAT or the SONICBEAT for open, laparoscopic (including single-site surgery), and endoscopic surgery to cut (dissect) or coagulate soft tissue or to ligate (seal and cut) vessels.
The Reusable Cordless Transducer (TD-410) is intended to be used for open, laparoscopic (including single-site surgery), and endoscopic surgery to cut (dissect) or coagulate soft tissue or to ligate (seal and cut) vessels.
The THUNDERBEAT II Shears with Ultrasonic Mode (TB2-0520FC, TB2-0525FC, TB2-0535FC, TB2-0545FC) are intended to be used for open, laparoscopic, and endoscopic surgery to cut, seal, coagulate, grasp, and dissect.
The THUNDERBEAT II Shears with Ultrasonic Mode are indicated for general, plastic and reconstructive, gynecologic, urologic, thoracic, and other open, laparoscopic and endoscopic procedures.
The THUNDERBEAT II Shears with Ultrasonic Mode have been designed to seal and cut vessels up to and including 7mm in diameter, tissue bundles and lymphatics using with the Seal & Cut mode or the Seal mode.
The THUNDERBEAT II shears with Ultrasonic Mode have been designed to seal and cut vessels up to and including 3mm in diameter, tissue bundles and lymphatics using with the Ultrasonic mode.
The following devices are the subject of this premarket (510(k)) submission:
• THUNDERBEAT II (Model Numbers: TB2-0545FC, TB2-0535FC, TB2-0525FC, TB2-0520FC) – Hand instruments used with an ultrasonic generator and transducer capable of sealing, cutting, grasping and dissecting vessels, tissue bundles, and lymphatic tissue up to 7mm in diameter during open, laparoscopic, and endoscopic surgical procedures. THUNDERBEAT II hand instruments are available in four (4) shaft sizes: 20cm, 25cm, 35cm, and 45cm.
• Reusable Cordless Transducer (Model Number: TD-410) – A transducer used with the THUNDERBEAT II hand instruments and ultrasonic generator to dissect and/or coagulate soft tissue, or ligate (seal and cut) soft tissue.
• Ultrasonic Bipolar Generator (Model Number: USG-410) – An ultrasonic bipolar generator used with the compatible hand instruments and transducers to dissect and/or coagulate soft tissue, or ligate (seal and cut) soft tissue. Identical and unchanged from K211838, but modified when accessory MAJ-2467 is used to upgrade USG-410 software version to allow compatibility with THUNDERBEAT II hand instruments.
- Update Tool for USG-410 (Model Number: MAJ-2467) – A function activation portable memory key accessory used to upgrade the software version of USG-410 to allow compatibility with THUNDERBEAT II hand instruments.
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(30 days)
Upper Arm Electronic Blood Pressure Monitor, Models FC-BP107, FC-BP123, FC-BP125, FC-BP126,FC-BP127, FC-BP116 are intended to measure the systolic and diastolic blood pressure and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm. The devices' features include irregular pulse rhythm detection during measurement, and will display a alert signal with the reading when irregular heartbeat is detected.
The subject device, Upper Arm Electronic Blood Pressure Monitor, is an automatic non-invasive blood pressure monitor which can be driven by 4 AA batteries / 4×AAA batteries or type-C USB (optional). It uses an inflatable cuff which is wrapped around the patient's upper arm to measure the systolic and diastolic blood pressure as well as the pulse rate of adult at household, not for neonate or pregnancy.
The unit uses the oscillometric method of blood pressure measurement. It means the unit detects the movement of your blood through your brachial artery, and converts your blood pressure into a digital reading. The unit is simple to use because a stethoscope is not needed while using an oscillometric monitor.
The unit stores the blood pressure and pulse rate in the memory after completing a measurement each time. 2x120 sets of measurement values can be stored automatically. The earliest record will be deleted automatically to save the latest measurement value when more than the measurement values. The unit also calculates an average reading based on the values of the latest 3 times measurement.
This blood pressure monitor has the function of blood pressure classification, which is convenient for you to judge whether your blood pressure is normal or not.
This blood pressure monitor has voice broadcast function. During measurement and recall the memory, there will be voice operation tips.
During blood pressure measurement, if the body moves excessively, the body motion detection icon will appear on the display.
Sleeve with self-check: Detects whether the cuff is worn correctly. If the pressure can exceed 30mmHg within 15 seconds, this Sleeve with self-check icon will light up.
During the blood pressure measurement decrease process, if a pulse wave is detected, this Pulse Detected Icon will flash at the same frequency as the peak of the pulse wave appears.
The device detects an Irregular HeartBeat (IRB) (a Heartbeat that is more than 25% slower or 25% faster from the average Heartbeat) two or more times during the measurement, the irregular heartbeat Symbol will appear on the display with the measurement values.
The device features a built-in "Bluetooth Data Transmission" function, which enables the device automatically transmit measuring results to paired Bluetooth-enabled device(except model FC-BP107).
There is a maximum pressure safety setting at 300 mmHg, when the pressure is more than 300mmHg, the device will exhaust fast automatically.
No operation for 2 minute the device will shut down automatically.
The device includes model FC-BP107, FC-BP123, FC-BP125, FC-BP126, FC-BP127, FC-BP116. Model FC-BP107 and FC-BP116 can be powered by internal battery (4×AA batteries, 6.0V DC) or Type-C port 5VDC 1A, other models can be powered by internal battery (4×AAA batteries, 6.0V DC) or Type-C port 5VDC 1A.
All models have same MCU, Air pump, Solenoid valve and blood pressure core algorithm except for PCB layout, Display screen, function of the Button, dimension and power supply.
The subject devices (FC-BP107, FC-BP123, FC-BP125, FC-BP126, FC-BP127, FC-BP116) and the predicate devices (FC-BP100, FC-BP101, FC-BP102, FC-BP110, FC-BP111, FC-BP112) share the same schematic, circuitry, critical components, and measurement algorithm.
For the differences between the subject device models, the differences are PCB layout difference (physical board shape and/or component arrangement differences), Display screen, function of the Button, dimension, and power supply.
These changes are mainly cosmetic and do not affect the electrical design, safety, or essential performance of the devices.
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(45 days)
The UltraGuideCTR® image guided soft tissue release system using real-time ultrasound visualization and guidance with integrated safety-engineered Sharps Injury Prevention is indicated for use in minimally invasive soft tissue release:
- Carpal tunnel release in the wrist
The UltraGuideCTR® image guided soft tissue release system with Sharps Injury Prevention feature is comprised of a disposable Handpiece with inflatable Balloons and a Blade assembly (UltraGuideCTR® device) that is utilized with Ultrasound imaging (continuous real-time Ultrasound visualization and guidance). The device is gamma sterilized and intended for single-use only.
Continuous real-time multi-planar ultrasound imaging throughout the procedure enables the user to visually identify pertinent anatomical structures of the hand and wrist and to visualize and navigate the device throughout the procedure. The device design and components enhance the echogenicity and visualization of the device and ensures the device is compatible with any musculoskeletal (MSK) Ultrasound system. The echogenic features of the device include:
- Inflatable Balloons located along the Shaft on either side of the Blade track, which, once inflated with saline, appear under Ultrasound as two dark circles.
- Metal Shaft/Tip of Blade - the Shaft, which houses the recessed blade at the distal Tip, appears as a bright echogenic line, with a visible notch indicating the point where the recessed Blade will be deployed from the Tip of the Shaft.
- After deployment, the Blade appears on Ultrasound as a bright star-shaped structure moving along the track in the Shaft.
Collectively, these echogenic features facilitate visualization and navigation of the device within the critical anatomy throughout the procedure.
The low-profile of the Tip allows the device to be inserted through a single, percutaneous incision in the proximal wrist flexor crease. The device is operated using an ergonomic Handle with separate controls to activate and inflate the integrated Balloons and actuate the Blade. The two inflatable Balloons are integrated on either side of the Blade track in the Shaft and once inflated, function as both anatomical guards and visual confirmation of desired device placement, as well as a safety mechanism before the Blade can be deployed from the Tip.
The Balloons are inflated in the intracarpal space of the carpal tunnel to create additional space and protect the surrounding anatomy while the Blade is actuated to transect the TCL. The design of the Blade includes a safety-engineered Sharps Injury Prevention feature. The Blade remains recessed in the Tip of the device until the Balloons are inflated using the Activation Lever on the Handle. Once the Balloon inflation/Blade interlock safety mechanism is released, the Blade Slider on the Handle is pulled back in a retrograde motion to actuate the Blade in a distal-to-proximal direction along the Blade track in the Shaft to transect the TCL. The Blade must be retracted into the fully recessed position in the Shaft before the Balloons are deflated, and the device is removed.
This integrated design of the Metal Tip/Shaft/Blade and Balloons serves to protect the surrounding anatomy during the palmar pressure that is applied to the device during the insertion, navigation, TCL transection, and removal of the device, and prevents deployment of the Blade prior to inflation and subsequent to deflation of the Balloons.
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(57 days)
The uMR 680 system is indicated for use as a magnetic resonance diagnostic device (MRDD) that produces sagittal, transverse, coronal, and oblique cross sectional images, and spectroscopic images, and that display internal anatomical structure and/or function of the head, body and extremities.
These images and the physical parameters derived from the images when interpreted by a trained physician yield information that may assist the diagnosis. Contrast agents may be used depending on the region of interest of the scan.
The uMR 680 is a 1.5T superconducting magnetic resonance diagnostic device with a 70cm size patient bore. It consists of components such as magnet, RF power amplifier, RF coils, gradient power amplifier, gradient coils, patient table, spectrometer, computer, equipment cabinets, power distribution system, internal communication system, and vital signal module etc. The uMR 680 Magnetic Resonance Diagnostic Device is designed to conform to NEMA and DICOM standards.
This special 510(k) is to request modifications for the cleared uMR 680(K243397). The modifications performed on the uMR 680 in this submission are due to the following changes that include:
(1) Addition of RF coils: Tx/Rx Head Coil.
(2) Addition of a mobile configuration.
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(257 days)
The uWS-Angio Pro is a post-processing software based on the uWS-Angio Basic for viewing, processing, evaluating and analyzing CT, MR, 3D XA images, and overlaying 2D medical images to support image guidance during interventional procedures. It has the following application:
The uWS-Angio Pro uTarget view application is intended to provide tools for adding the trajectory to the lesion. It also supports overlay of 3D datasets on 2D fluoroscopy images.
The uWS-Angio Pro uEmbo View application is intended to provide users with tools for planning and guiding interventional procedures. It offers a suite of features to mark targets, detect feeder vessels, and overlay the 3D image with the feeders and the corresponding anatomical X-ray image. When the overlay function is activated, it supports automatic 2D-3D image registration specifically for head neuroimaging, while the manual registration function is not restricted to any specific anatomical region.
The uWS-Angio Pro uCardiac View application is intended to provide users tools to plan and guide the interventional procedures. This application can use CT angiography images for vascular access analysis, aortic root analysis and angle management, and overlay registration display with 2D XA images.
uWS-Angio Pro is a software intended for viewing, processing, evaluating and analyzing medical images that comply with the DICOM 3.0 protocol. It supports interpretation and evaluation of examinations within healthcare institutions. It can be deployed on independent hardware such as a stand-alone diagnostic review and post-processing workstation. It can also be configured within a network to send and receive DICOM data. Furthermore, it can be deployed on systems of the United Imaging Healthcare Angiography system family.
uWS-Angio Pro contains the following applications:
- uWS-Angio Pro uTarget View
- uWS-Angio Pro uEmbo View
- uWS-Angio Pro uCardiac View
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(28 days)
UniBur is for single use only. This device is designed to be used with electric surgical instruments manufactured by Nakanishi INC. This device is intended for: cutting, drilling, removal, and shaping of bones in the fields of Neuro, Spine and ENT surgery.
The UniBur is a single-use, sterile medical device designed for cutting, drilling, removal, and shaping of bones, used with the Primado2 Total Surgical System (K132264) and used in the fields of neuro, spine, and ENT surgery.
The UniBur is designed to be connected to the slim motor handpiece of the Primado2 Total Surgical System.
The UniBur has 22 types of product variations based on differences in the length (3 types) and bending angle of the bur guard (3 types), the diameter of the bur for bone cutting (from φ0.6 mm to φ4.5 mm), and the grit size of the diamond embedded in the bur.
The UniBur consists of Diamond, Nickel, Stainless steel, Phosphor bronze, Stainless steel, FKM, Polyamide and PTFE.
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