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The Robotic Surgical Instruments, Permanent Cautery Hook (470183) and Permanent Cautery Spatula (470184), are reusable, non-sterile instruments intended for use with the da Vinci X/Xi Surgical System - Intuitive Surgical, Inc. The Permanent Cautery Spatula and Permanent Cautery Hook are intended to be used with the da Vinci Xi System or the da Vinci X System for precise dissection and division of tissue with monopolar cautery.

The Intuitive Surgical Endoscopic Instrument Control System (da Vinci Surgical System, Model IS4000) is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, forceps/pick-ups, needle holders, endoscopic retractors, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, and delivery and placement of microwave and cryogenic ablation probes and accessories, during urologic surgical procedures, general laparoscopic surgical procedures, gynecologic laparoscopic surgical procedures, general thoracoscopic surgical procedures and thoracoscopically assisted cardiotomy procedures. The system can also be employed with adjunctive mediastinotomy to perform coronary anastomosis during cardiac revascularization. The system is indicated for adult and pediatric use. It is intended to be used by trained physicians in an operating room environment in accordance with the representative, specific procedures set forth in the Professional Instructions for Use.

The Robotic Surgical Instruments, Permanent Cautery Hook (470183) and Permanent Cautery Spatula (470184), are reusable, non-sterile instruments intended for use with the da Vinci X/Xi Surgical System – Intuitive Surgical, Inc. The Permanent Cautery Spatula and Permanent Cautery Hook are intended to be used with the da Vinci Xi System or the da Vinci X System for precise dissection and division of tissue with monopolar cautery.

Each instrument consists of four primary components: the housing, shaft, wrist, and tip. The shaft and wrist enable multiple axes of articulation, while the tip is designed for direct interaction with tissue. When operated in conjunction with the appropriate robotic system, these instruments provide enhanced dexterity and a greater range of motion than the human hand, facilitating precise tissue manipulation and dissection in minimally invasive procedures.

The remanufactured devices are intended for up to ten (10) additional clinical use cycles beyond the OEM-cleared use life, as supported by validated reprocessing and performance testing. The design, materials, and intended use are identical to the Predicate Device (K131861) in form, fit, and function. The mechanism of action is unchanged and remains based on the same fundamental mechanical architecture and dimensions.

There are no changes to:

• The indications for use
• Clinical applications
• Patient population
• Performance specifications
• Method of operation

In accordance with the Design Control process, a comprehensive risk analysis was conducted to evaluate the impact of remanufacturing. The remanufacturing process includes validated inspection, repair, testing, and cleaning procedures to ensure safety and effectiveness. Design verification and validation activities confirmed that the Subject Devices meet all applicable design input requirements. The following evaluations were performed, or rationales were provided where testing was not required, consistent with applicable standards and FDA guidance:

• Biocompatibility (per ISO 10993)
• Functional performance testing (mechanical and electrical)
• Cleaning validation (including protein, hemoglobin, and TOC residue analysis)
• Electrical safety testing (per IEC 60601-1 and relevant clauses)

Test results support that the remanufactured instruments are as safe and effective as the Predicate Devices and meet all required specifications for intended use.

Additionally, FDA-cleared Reference Device (K203632) is cited to support the validated cleaning and reprocessing methods associated with the proposed ten (10) reuse cycles.

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AutoContour is intended to assist radiation treatment planners in contouring and reviewing structures within medical images in preparation for radiation therapy treatment planning.

As with AutoContour Model RADAC V4, the AutoContour Model RADAC V5 device is software that uses DICOM-compliant image data (CT or MR) as input to: (1) automatically contour various structures of interest for radiation therapy treatment planning using machine learning based contouring. The deep-learning-based structure models are trained using imaging datasets consisting of anatomical organs of the head and neck, thorax, abdomen, and pelvis for adult male and female patients, (2) allow the user to review and modify the resulting contours, and (3) generate DICOM-compliant structure set data that can be imported into a radiation therapy treatment planning system.

AutoContour Model RADAC V5 consists of 3 main components:

1. A .NET client application designed to run on the Windows Operating System, allowing the user to load image and structure sets for upload to the cloud-based server for automatic contouring, perform registration with other image sets, as well as review, edit, and export the structure set.
2. A local "agent" service designed to run on the Windows Operating System that is configured by the user to monitor a network storage location for new CT and MR datasets that are to be automatically contoured.
3. A cloud-based automatic contouring service that produces initial contours based on image sets sent by the user from the .NET client application.

Here's a structured summary of the acceptance criteria and study details for the AutoContour Model RADAC V5, based on the provided FDA 510(k) clearance letter:

Acceptance Criteria and Device Performance Study for AutoContour Model RADAC V5

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for each structure model varied based on its size (Large, Medium, Small) and whether it was a new model, an updated model, or an unchanged existing model. The performance was primarily evaluated through Dice Similarity Coefficient (DSC) and Likert Qualitative Review for new/updated models, and DSC and Hausdorff Distance for existing models.

Note: The document provides specific DSC values for many individual structures. The table above shows aggregated or illustrative examples from the tables provided.

2. Sample Size for Test Set and Data Provenance

• CT Test Sets: An average of 49 testing image sets per CT structure model (approximately 10% of training data). Specific examples include:
  • A_Aorta_Asc (Update): 60 testing sets
  • A_Carotid_L/R (Update): 83 testing sets
  • A_Celiac: 44 testing sets
• MR Test Sets:
  • Brain models: 58 testing image sets (e.g., Amygdala_L/R: 133, CorpusCallosum: 15)
  • Pelvis models: 50 testing image sets (e.g., Rectal_Spacer: 26)
• External Clinical Test Sets:
  • CT: 20 (A_Aorta), 37 (A_Carotid_L/R), 24 (A_Celiac), etc.
  • MR: 20 (Amygdala_L), 45 (Bladder_Trigone), 7 (HDR_Bowel), etc.
• Data Provenance (Training and Testing): Data was gathered from several institutions in several different countries (not specifically enumerated but mentioned for CT and MR). Specific external clinical datasets for CT included TCIA - Pelvic-Ref, TCIA - Head-Neck-PET-CT, TCIA - Pancreas-CT-CB, TCIA - NSCLC data. MR external datasets included "MR - Renown," "Gold Atlas Pelvis," "SynthRad," "MRLinac Pelvis," "Female HDR MR Pelvis," and "MR Pelvis Barrigel," some of which were open-source or shared by clinical partners/institutions in Canada, Spain, Australia, and the United States. The images used for testing were sequestered from the original training and validation data population and removed from the training dataset pool before model training began.

3. Number of Experts and Qualifications for Ground Truth

• Number of Experts: Six (6) clinically experienced experts.
• Qualifications: 2 radiation therapy physicists, 1 radiation dosimetrist, and 3 radiation therapists with specialized training in radiation therapy contouring.

4. Adjudication Method for the Test Set

The ground truthing of each test dataset was generated manually using consensus (NRG/RTOG/ESTRO) guidelines as appropriate. While a specific (e.g., 2+1, 3+1) adjudication method for individual cases or disagreements is not explicitly stated, the use of "consensus" guidelines by multiple experts implies a form of adjudicated agreement for final ground truth.

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

• The document does not explicitly describe a conventional MRMC comparative effectiveness study comparing human readers with AI assistance versus without AI assistance.
• Instead, it measures the AI's standalone performance against expert-generated ground truth and uses a qualitative review by external experts (average rating 1-5 where >3 means beneficial, 5 means no edits needed) to assess the clinical appropriateness and required modifications for the AI-generated contours. This qualitative review serves as an indirect assessment of human interaction with AI output, but not a formal MRMC study as typically defined for reader performance improvement with assistance.

6. Standalone Performance (Algorithm Only without Human-in-the-loop)

• Yes, standalone performance was done. The primary performance metrics (Dice Similarity Coefficient - DSC and Hausdorff Distance) directly evaluate the algorithm's output against the expert-generated ground truth without human intervention in the contour generation process. The "Training DSC Evaluation" and "External Dataset DSC Evaluation" explicitly refer to the model's direct output.
• The qualitative review by external experts, while involving human assessment, is done after the algorithm has generated its standalone contours, effectively evaluating the standalone output's clinical utility.

7. Type of Ground Truth Used

• Expert Consensus: Ground truth for both training and test sets was established manually by six clinically experienced experts following consensus guidelines (NRG/RTOG/ESTRO).

8. Sample Size for the Training Set

• CT Training Sets: An average of 459 training image sets per CT structure model. Specific examples:
  • A_Aorta_Asc (Update): 240
  • A_Carotid_L/R (Update): 328
  • A_Celiac: 435
• MR Training Sets:
  • Brain models: An average of 259 training image sets.
  • Pelvis models: An average of 243 training image sets.
  • Specific examples: Amygdala_L/R: 493, CorpusCallosum: 56, Rectal_Spacer: 233.

9. How Ground Truth for Training Set was Established

• The ground truth for the training set was established manually by the same group of six clinically experienced experts (2 radiation therapy physicists, 1 radiation dosimetrist, and 3 radiation therapists with specialized training in radiation therapy contouring) using consensus guidelines (NRG/RTOG/ESTRO).

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The Tigertriever 25 Revascularization Device is intended to restore blood flow by removing thrombus from a large intracranial vessel in patients experiencing ischemic stroke within 8 hours of symptom onset. Patients who are ineligible for thrombolytic drug therapy or who failed thrombolytic drug therapy are candidates for treatment.

The Tigertriever 25 Revascularization Device (TRPP7125) is a line extension of the existing Tigertriever 21 Revascularization Device (TRPP7155), cleared as "Tigertriever Revascularization Device" under K203592. The Tigertriever 25 Revascularization Device is a stentriever that is comprised of an adjustable nitinol braided mesh, stainless steel shaft, nitinol core wire and a handle. The shaft connects the mesh and the handle by the core wire that runs inside the shaft from the distal end of the mesh to the slider activation element in the handle. The mesh is expanded when the physician pulls the slider, since the wires of the mesh are completely radiopaque, the physician sees the mesh under fluoroscopy and controls it until it conforms to the vessel diameter. The design of the wire mesh is optimized to penetrate the clot and encapsulate it during retrieval. The Tigertriever 25 revascularization device is supplied sterile and is intended for single-use only by physicians trained in neurointerventional procedures and the treatment of ischemic stroke.

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Strut Suture: The Strut Suture is intended to be used for fixation of bone to bone, and is intended as fixation posts, a distribution bridge, or for distributing suture tension over areas of ligament or tendon repair in ACL/PCL Repair.

No-Tie Button The No-Tie Button is intended to be used for fixation of bone to bone, intended as fixation posts, a distribution bridge, or for distributing suture tension over areas of ligament or tendon repair in ACL/PCL Repair when used with Strut Suture (or equivalent) and soft tissue fixation to bone in the knee for meniscal root repair when used with RootMend MRR (or equivalent).

Strut Suture devices are a suture and button construct composed of uncoated UHMWPE (ultra-high molecular weight polyethylene) with UHMWPE tracer material and an attachable fixation anchor composed of a titanium (Ti-6Al-4V) button. Strut Suture devices will be provided sterile using ethylene oxide, for single use only, and are not to be re-sterilized.

No-Tie Button devices are an attachable fixation anchor composed of a titanium (Ti-6Al-4V) button. No-Tie Button devices will be provided sterile using ethylene oxide, for single use only, and are not to be re-sterilized.

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The Reselute Traditional Tibial Intramedullary Nail is intended to stabilize fractures of the proximal and distal tibia and the tibial shaft, open and closed tibial shaft fractures, certain pre and post isthmic fractures and tibial malunions and non-unions.

The Reselute Tibial Intramedullary Nail System is a single use intramedullary device for the fixation, correction, or stabilization of the tibia. The Reselute Tibial Intramedullary Nail implant system includes a tibial nail offered at various diameters and lengths to accommodate a range of patient anatomies, cross-locking screws to prevent movement of the nail relative to the bone fragments, and optional endcaps for preventing proximal bone ingrowth. Each implant component is manufactured from titanium alloy (Ti-6Al-4V), which conforms to ASTM F136-13 for medical implants.

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The Klär Lite is an Ultraviolet Light Emitting Medical Device. It is intended for use in localized phototherapeutic treatment of dermatologic conditions such as psoriasis, vitiligo, atopic dermatitis (eczema), seborrheic dermatitis and leukoderma on all skin types (I-VI).

The Klär Lite is a narrowband UVB light emitting phototherapy medical device intended for treatment of dermatologic conditions such as psoriasis, vitiligo, atopic dermatitis (eczema), seborrheic dermatitis and leukoderma on all skin types (I-VI).

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The Anti Snoring Mouthpiece is designed to advance the user's lower jaw and maintain this position during use, opening the airway to reduce snoring during sleep. It is intended for adults with at least 18 years old.

The L08 series Anti Snoring Mouthpiece is an intraoral device that is used to maintain the lower jaw in a forward position to increase pharyngeal space so as to improve the ability to exchange air and decrease air turbulence, a causative factor in snoring.

L08 series Anti Snoring Mouthpiece includes three upper trays (A0, A2, A4) and three lower trays (B0, B1, B2). One upper tray and one lower tray are combined together for use. By randomly combining one upper tray with one lower tray, the device can be used for advancing lower jaw from 0mm to 6mm.

Considering that the size of the oral cavity varies among different groups of people, L08 series Anti Snoring Mouthpiece is designed to be available for two size (L and S).

Even though the dimensions of these sizes of Anti Snoring Mouthpiece are different, by positioning the upper protrusion and the lower protrusion at different locations within the upper tray assembly and the lower tray assembly respectively, advancement distance of 0-6 mm can still be realized.

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