Search Results

The KARL STORZ Cholangiography Set consists of manually operated reusable surgical devices intended for use by qualified surgeons in minimally invasive intraoperative cholangiography in adults and pediatric patients ≥ 13 years of age.

The KARL STORZ Cholangiography Set are manually operated reusable surgical devices consisting of: Cholangiography Fixation Clamp, Guide Tube for Cholangiocatheter, and BERCI Plastic Stylet. The KARL STORZ Cholangiography Set includes devices which are used to facilitate the execution of cholangiograms (x-ray pictures of the bile ducts) during endoscopic surgery.

The Cholangiography Fixation Clamp, Guide Tube for Cholangiocatheter, and BERCI Plastic Stylet work together to ensure accurate and clear cholangiography during minimally invasive procedures.

• The Cholangiography Fixation Clamp secures the catheter in place after insertion, preventing movement and ensuring proper positioning.
• The Guide Tube provides a smooth, controlled pathway for the catheter during insertion.
• The BERCI Plastic Stylet eliminates metal shadows by remaining in place when the metal trocar sheath is removed, preserving clear X-ray imaging of the biliary system.

The devices facilitate precise catheter placement, reduce interference in imaging, and maintain optimal procedure conditions for successful cholangiography.

N/A

Ask a specific question about this device

The Nuvis Wireless HD Camera System is indicated for use in diagnostic and operative endoscopic procedures, supplying visualization of an interior cavity of the body.

The Nuvis Wireless HD Camera System (or "System" or "Nuvis-2K") consists of two wireless reusable camera heads that can be paired to a wireless base station. When the camera head is attached to an arthroscope/light source (using a C-mount coupler) AND the wireless base station is attached to a clinic supplied video system, arthroscopic examinations can be viewed and pertinent data recorded. A tablet with NuvisCon Application (APP) can be connected to the wireless base station to enter patient and case data. The System can transmit uncompressed video content from the camera head to the wireless base station up to 5 meters (15 feet) away. Recorded video and snapped pictures are saved to an internal storage drive in the wireless base station.

N/A

Ask a specific question about this device

Kii Structural Balloon Access System is indicated for use in patients undergoing laparoscopic surgery requiring a path of entry and/or tissue retraction of the extraperitoneal space.

Applied Medical's Kii Structural Balloon Access System provides a path of entry and/or tissue retraction for laparoscopic procedures in the extraperitoneal space. The system is provided sterile.

The system is composed of four main components:

• An obturator that facilitates insertion of the system through an incision.
• A cannula with bolster and attached balloon, encased within a perforated sheath.
• A seal which maintains insufflation.
• An inflation bulb that is used to manually inflate and deflate the balloon.

N/A

Ask a specific question about this device

Stellar Imaging System is intended to provide real-time visible and near-infrared imaging in minimally invasive procedures.

Upon intravenous administration and use of an ICG agent consistent with its approved label, Stellar Imaging System is used to perform fluorescence imaging visualization of vessels, blood flow and related tissue perfusion, and at least one of the major extra-hepatic bile ducts.

Upon interstitial administration and use of an ICG agent consistent with its approved label, the Stellar Imaging System is used to perform intraoperative fluorescence imaging and visualization of the lymphatic system, including lymphatic vessels and lymph nodes.

Stellar Imaging System comprises Image Processing Unit, Light Source, Camera Head, Laparoscope and relevant accessories. During surgical procedures, Stellar Imaging System is used to provide real-time 3D visible and fluorescence imaging in endoscopic surgery.

The Stellar Imaging System including the laparoscope is designed to work with an approved infrared dye (Indocyanine green (ICG). ICG may be excited at excitation at either 785 or 805 nm. The System provides excitation light to the surgical field to excite the dye molecules and captures emission from the dye via the camera head. Fluorescence imaging with ICG permits the system to visualize blood flow and related tissue circulation, of lymphatic flow, etc.

The System allows the capture of normal (white) light image in parallel with the fluorescence image and displays both to the surgeon to provide a view of the anatomy. In addition, the System permits recording surgical procedures, storing them on removable storage devices, and replaying the procedures.

N/A

Ask a specific question about this device

The VereSee Optical Veres Needle and Endoscopic Camera is intended for:

• Percutaneous insertion into the peritoneal cavity for the purpose of insufflation with carbon dioxide to establish pneumoperitoneum prior to the placement of trocars during laparoscopic surgery

• Use as an endoscopic video camera to provide visible light imaging in a variety of endoscopic and laparoscopic diagnostic and surgical procedures

The VereSee Optical Veres Needle and Endoscopic Camera System consists of two components: 1) VereSee Optical Veres Needle and Endoscopic Camera, and 2) VereSee Camera Control Unit.

The VereSee Optical Veres Needle and Endoscopic Camera consists of a series of three concentric stainless steel cannulas with a handle and an umbilical cable to connect it to the VereSee Camera Control Unit. It is provided sterile, for single patient use. The three concentric stainless steel cannulas include: 1) an Outer Cannula (or Insufflation Cannula), 2) a Central Cannula (or Access Cannula) with a clear, pointed tip for penetration and visualization during body cavity entry, and 3) Inner Cannula (or Camera Cannula) with a CMOS camera surrounded by light fibers at its tip.

The VereSee Camera Control Unit connects the CMOS camera in the VereSee Optical Veres Needle and Endoscopic Camera to HDMI compatible monitors to provide an image for endoscopic procedures. The VereSee Camera Control Unit (CCU) includes an LED driver to power the LED. The CCU connects to the Optical Veres Needle and Endoscopic Camera via an umbilical cable. The CCU converts signals from the CMOS camera in the VereSee Optical Veres Needle and Endoscopic Camera to a format compatible with HDMI display input requirements.

N/A

Ask a specific question about this device

The Arthrex Synergy Vision imaging system is intended to provide visible light imaging in a variety of diagnostic and surgical procedures, including laparoscopy, orthopedic, plastic surgery, sinuscopy, spine, urology, and procedures within the thoracic cavity. The device is also intended to be used as an accessory for microscopic surgery.

The Arthrex Synergy Vision imaging system is indicated for use to provide real-time visible and near-infrared fluorescence imaging. Upon intravenous administration and use of ICG consistent with its approved label, the system enables surgeons to perform open and minimally invasive surgery using standard endoscope visible light as well as visualization of vessels, blood flow and related tissue perfusion, and at least one of the major extra-hepatic bile ducts (cystic duct, common bile duct or common hepatic duct), using near-infrared imaging. Fluorescence imaging of biliary ducts with the Arthrex Synergy Vision imaging system is intended for use with standard of care white light, and when indicated, intraoperative cholangiography. The device is not intended for standalone use for biliary duct visualization. Additionally, the system is indicated for fluorescence imaging of blood flow and tissue perfusion before, during, and after vascular, gastrointestinal, organ transplant, plastic, micro- and reconstructive surgical procedures.

Upon interstitial administration and use of ICG consistent with its approved label, the Arthrex Synergy Vision imaging system is used to perform intraoperative fluorescence imaging and visualization of the lymphatic system, including lymphatic vessels and lymph nodes.

Upon administration and use of pafolacianine consistent with its approved label, the Arthrex Synergy Vision imaging system is used to perform intraoperative fluorescence imaging of tissues that have taken up the drug.

The Arthrex NanoNeedle Scope when used with the Synergy Vision imaging system is intended to be used as an endoscopic video camera to provide visible light imaging in a variety of endoscopic diagnostic and surgical procedures, including laparoscopy, orthopedic, plastic surgery, sinuscopy, spine, urology, and procedures within the thoracic cavity. The device is also intended to be used as an accessory for microscopic surgery. For pediatric patients, the Arthrex NanoNeedle Scope is indicated for laparoscopy and orthopedic procedures.

The Arthrex 4K Open Scope 0° NIR is intended to be used as an accessory with the Synergy Vision imaging system to provide visible light imaging and near-infrared fluorescence imaging during open surgical procedures.

The Synergy Vision Imaging System includes a camera control unit (CCU) console, camera head, scope, and a laser light source. The system provides real-time visible light and near-infrared (NIR) illumination and imaging.

The Synergy Vision Imaging System uses an integrated LED light to provide visible light illumination and imaging of a surgical site. For NIR imaging, the system interacts with the laser light source to visualize the presence of a fluorescence contrast agent, indocyanine green (ICG) and pafolacianine. The contrast agent fluoresces when illuminated through the scope with NIR excitation light from the laser light source and the fluorescent response is then imaged with the camera, processed, and displayed on a monitor.

N/A

Ask a specific question about this device

The Revolve Surgical System is intended to assist in the control of Revolve Surgical laparoscopic instrument for endoscopic manipulation of tissue, including approximation, ligation, and suturing, during laparoscopic general surgery. It is intended to be used by trained physicians in an operating room environment, in accordance with its Instructions for Use.

The Revolve Surgical System is an electromechanically controlled laparoscopic surgery platform used for minimally invasive surgery in the abdomen comprised of a reusable system arm which mounts to the operating table and several sterile, single-use disposable accessories – instrument, instrument handle, and drape. The device operates under the direct control of the surgeon to manipulate tissues during surgery. Surgeon control is achieved by grasping the instrument handle and moving it to the desired position. The device compensates for gravitational forces applied to the instrument and maintains the instrument position when the surgeon's hand is removed from the device.

N/A

Ask a specific question about this device

It is used to connect with an optical endoscope during the endoscopic diagnosis, treatment, and observation. And to capture, process and transmit images in the human body cavity under the field of view observed by the endoscope to the monitor.

The 4K Endoscopic Camera System consists of a camera control unit and a 4K camera head.
The device is intended to be used to connect with an optical endoscope during the endoscopic diagnosis and/or treatment/surgery, and to capture, process and transmit images in the human body cavity under the field of view observed by the endoscope to the monitor.
There are 4 models of the device. The hardware configuration of the device of 4 models are same, and difference is different functions which opened up through software.

N/A

Ask a specific question about this device

The LaproSac™ Specimen Retrieval Bags is indicated for use in surgical procedures to capture organs or tissue to be removed from the body cavity during Laparoscopic Surgery.

The SPI LaproSac™ Laparoscopic Single-Use Rip-Stop Nylon Specimen Retrieval Systems are sterile single patient use devices, which comprise of a flexible nylon bag with and without a deployment mechanism. The bag consists of a large, easily accessible opening and a closure suture that facilitates closure of the specimen bag after the specimen(s) have been collected. The deployment mechanism consists for an introducer and actuation rod with biasing arms, which allows for insertion through an appropriately sized port and automatic opening of the bag upon deployment.

These devices are not made with natural rubber latex or synthetic derivatives of natural rubber latex.

N/A

Ask a specific question about this device

The Viction Disposable Irrigation and Suction Catheter is indicated for use in conjunction with the handpiece , dual tubing, and probes to provide controlled powered irrigation during Laparoscopic surgery.

The Viction Disposable Irrigation and suction Catheter is constitutes with Suction/irrigation handpiece , dual tubing, Irrigation device that is a battery-powered mechanical pumping system connect with dual tubing(suction tubing and irrigation tubing) to deliver sterile fluids to surgical sites. Control of the irrigation flow is generated by depressing the on-off Control Button on the handpiece. The mechanical pumping system is powered with nine(9) standard AAlkaline Battery.
Hand piece equipped with pistol style attach to Suction irrigation probes and suction tubing . And it should be used with negative pressure device of the hospital.
There are 8 models of the product, models VC-IRA0532, VC-IRA0523, VC-IRB0532, VC-IRB0523, VC-IRC0532,VC-IRC0523,VC-IRD0532, VC-IRD0532. All product's Structure are the same, the length of the irrigation suction tubes is the main difference. It is a single use, disposable device and is sold sterile.

The provided FDA 510(k) clearance letter and summary for the "Viction Disposable Irrigation and Suction Catheter" (K250124) concerns a medical device, specifically an endoscope accessory. It does not involve an AI/ML component for diagnosis or analysis, but rather outlines the substantial equivalence of a physical medical device to a predicate device.

Therefore, many of the requested elements typically relevant to AI/ML software (such as ground truth establishment by experts, adjudication methods, MRMC studies, standalone algorithm performance, training set details, etc.) are not applicable to this submission.

The "acceptance criteria" for this device are demonstrated through bench testing, electrical safety, electromagnetic compatibility, biocompatibility, and sterilization performance against predefined criteria and relevant industry standards, establishing substantial equivalence to a legally marketed predicate device.

Here's the information that can be extracted and presented based on the provided document:

Device Acceptance Criteria and Performance (Based on provided 510(k) Summary)

The device, "Viction Disposable Irrigation and Suction Catheter," demonstrates substantial equivalence to its predicate device, CORE E3 Suction/Irrigator (K202303), primarily through non-clinical performance data and design comparisons.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for Test Set and Data Provenance

• Sample Size for Test Set: The document does not specify a numerical "sample size" for the performance tests (e.g., number of devices tested for flow rate, pressure, etc.). It states "All the test results meets the predefined acceptance criteria..." implying that a sufficient number were tested to demonstrate compliance.
• Data Provenance: Not explicitly stated (e.g., in terms of country of origin of testing facilities), but implies internal testing performed by the manufacturer or a contracted lab. The studies were non-clinical bench and lab tests, not human subject data.

3. Number of Experts and Qualifications for Ground Truth

• Not Applicable. This is a physical medical device, not an AI/ML diagnostic tool. "Ground truth" in this context refers to established technical standards (e.g., IEC, ISO) and comparison to a predicate device's established performance specifications. There were no human expert readers establishing "ground truth" labels from medical images or clinical data.

4. Adjudication Method for the Test Set

• Not Applicable. There was no human "adjudication" of test results in the sense of resolving disagreements among experts for a diagnostic task. Performance was measured against technical specifications and standards.

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

• Not Applicable. No MRMC study was conducted or is relevant for this device type. This device is a tool for surgery, not an imaging analysis or diagnostic aid requiring human reader performance evaluation.

6. Standalone (Algorithm Only) Performance

• Not Applicable. There is no standalone algorithm. This is a physical device.

7. Type of Ground Truth Used

• The "ground truth" for this device's performance is established by engineering specifications, international consensus standards (IEC, ISO), and the performance characteristics of the legally marketed predicate device. For example, the "truth" for biocompatibility is conformance to ISO 10993, and the "truth" for electrical safety is conformance to IEC 60601-1.

8. Sample Size for the Training Set

• Not Applicable. This is a physical medical device, not an AI/ML system. There is no "training set."

9. How the Ground Truth for the Training Set was Established

• Not Applicable. There is no training set for this device.

Summary of the Study Proving Device Acceptance:

The "study" proving the device meets acceptance criteria is a comprehensive set of non-clinical performance tests and analyses. These include:

• Electrical Safety & EMC Testing: Following IEC 60601-1 and IEC 60601-1-2 standards to ensure the device is electrically safe and compatible within its intended electromagnetic environment.
• Biocompatibility Testing: Following ISO 10993-1 guidelines, including tests for acute systemic toxicity, skin sensitization, intracutaneous reactivity, pyrogenicity, and in vitro cytotoxicity. This demonstrates the materials used are safe for patient contact.
• Bench Testing: Evaluation of critical functional parameters such as fluid flow rate of the irrigation tube, negative pressure resistance of the suction, and sealing integrity of the irrigation tube. These tests confirm the device performs its intended functions effectively.
• Sterilization Validation: Performance qualification for ethylene oxide sterilization to ensure the device achieves a required Sterility Assurance Level (SAL) of 10⁻⁶, rendering it safe for single use in surgical environments.
• Comparative Analysis: A detailed comparison of technological characteristics (intended use, design, materials, specifications) against the predicate device (CORE E3 Suction/Irrigator, K202303) demonstrated substantial equivalence.

The document states, "All the test results meets the predefined acceptance criteria and complied with the design specification of the subject device throughout the use life. The results of the non-clinical testing demonstrate that the viction disposable irrigation and suction catheter is as safe and effective as the predicate device." This statement serves as the conclusion that the device successfully met its acceptance criteria through these documented non-clinical studies. No clinical testing was deemed applicable or necessary for this submission.

Ask a specific question about this device