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510(k) Data Aggregation
(36 days)
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(120 days)
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(89 days)
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(58 days)
CAPRI is indicated for use in dermatology: incision, excision, ablation, and vaporization with hemostasis of soft tissue,
- Treatment of back acne
- Treatment of atrophic acne scars
- Treatment of facial wrinkles
- Treatment of mild to moderate acne vulgaris
- Treatment of Sebaceous Hyperplasia.
CAPRI is a diode laser which delivers energy at a wavelength of 1450 nm and it is indicated for use in dermatology: incision, excision, ablation, and vaporization with hemostasis of soft tissue. Laser energy is delivered through an optical fiber that is attached to the handpiece. Laser guide tip is attached to the handpiece ensures that the spot is focused on the skin and serves as the laser beam aiming device.
CAPRI consists of the following components:
- Main Unit
- Accessories:
- Handpiece & Laser Guide Tip
- Foot Switch
- Remote Interlock Connector
- Gas Spray (HFC-134)
- Key Switch
- Eye Protection Goggle
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(196 days)
The Cara System is intended for preplanning and guidance of medical interventions in an area known to contain or be adjacent to the cardiac conduction system, such as percutaneous or surgical procedures, for example, transcatheter aortic valve replacement (TAVR), as well as medical procedures where the physician desires to deliver therapy to the patient's cardiac conduction system or to a targeted location within it (CSP).
The Cara System uses computed tomography angiography (CTA)-based and user manually marked landmarks to identify the cardiac conduction axis and generate a three-dimensional (3D) map of the individual patient's cardiac conduction system. The system also overlays the anatomical location of the cardiac conduction system (generated by the Cara Metis Simulator using pre-procedure CT data) onto live fluoroscopic images.
The software utilizes AI/ML algorithms to provide OCR detection, automated segmentation of anatomical structures, and detection of catheters.
The CARA System is intended for use in adult patients (18 years of age and older).
The CARA System is a medical device comprising two integrated functions. The CARA System device components include the CARA Metis Simulator and the CARA Atlas Navigator. Both components provide diagnostic imaging software and hardware functions that identify the personalized anatomical location of the cardiac conduction system in relation to other heart anatomies based on a patient's computed tomographic angiography (CTA). The former is intended for preplanning (1) a medical intervention in an area known to contain or be adjacent to the cardiac conduction system or (2) a medical procedure(s) where the physician desires to deliver therapy to the patient's cardiac conduction system. The latter identifies the personalized anatomical location of the cardiac conduction system overlaid on real-time, intra-procedural, fluoroscopic imaging and provides guidance during interventional structural heart disease procedures in an area known to contain or be adjacent to the cardiac conduction system or where the physician desires to deliver therapy to the patient's cardiac conduction system.
The CARA Metis Simulator uses computed tomography angiography (CTA)-based landmarks to accurately identify the cardiac conduction axis and run a simulation generating the personalized three-dimensional (3D) map of the individual patient's cardiac conduction system.
This 3D map is then utilized by the clinical operator to plan any procedure to either target, as in direct pacing, or avoid as in structural heart disease interventions, the cardiac conduction system. As described below, this technology is based on methodical translational studies investigating the 3D location of the cardiac conduction system relative to cardiac structures visible by clinical imaging with initial assessment and validation in the clinical setting.
The CARA Atlas Navigator is designed to overlay the personalized anatomical location of the cardiac conduction system (generated by the Cara Metis Simulator using pre-procedure CT data) onto live fluoroscopic images. This functionality assists clinicians during fluoroscopy-guided interventional heart procedures.
The Cara Atlas Navigator consists of both software and hardware components:
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Fluoroscopy Splitter (F-Splitter) – This device splits the live fluoroscopy image for integration with the CARA System.
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CARA Box – A standard workstation that receives live fluoroscopy images from the Fluoroscopy Splitter and enhances them by adding anatomical landmarks. The CARA Box acts as the system's central processing unit, handling data analysis and image processing. It is equipped with user interface devices, such as a mouse and keyboard.
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CARA Monitor – Displays the enhanced fluoroscopy images, including the analysis performed by the CARA Box. This monitor is typically located in the control room. The same output is also projected onto the main display in the operating room.
The CARA System utilizes a specific on-premises workflow to ensure data integrity and clinical accuracy. Prior to physician use, a certified CARA Clinical Expert (CCE) must be physically present on-site. The CCE logs into the CARA Box workstation to prepare the CARA Metis pre-planning process. This includes initiating the automated segmentation, verifying the anatomical output, annotating landmarks, and saving the results to the local storage.
The physician subsequently logs into the same workstation using distinct credentials to load, review, and confirm the pre-planned case. This workflow ensures that all generated outputs are professionally prepared and verified before clinical review.
The CARA System utilizes AI/ML algorithms to provide OCR (Optical Character Recognition), automated segmentations and device tracking:
- OCR detection - is used to automatically extract metadata from the live feed of the fluoroscopy machine (e.g., c-arm position, focal distance, etc.).
- Segmentations - the system utilizes deep learning models to automatically generate anatomical segmentations of the heart chambers and aorta.
- Device Detection - using a segmentation model the system detects the distal tips of specific interventional devices (e.g., Pigtail catheters, CS catheters, pacing leads) within the fluoroscopic image to support real-time tracking and present overlay.
AI-based segmentations are provided to assist the workflow but may contain inaccuracies. The AI output should not be used as the sole basis for clinical decision-making. Clinical oversight is mandatory.
Here's a breakdown of the acceptance criteria and study details for the CARA System, based on the provided FDA 510(k) clearance letter:
Acceptance Criteria and Device Performance Study for the CARA System
The CARA System's performance was evaluated through non-clinical, AI/ML validation, and retrospective clinical performance testing to demonstrate substantial equivalence to the predicate device, Cydar EV (K212442).
1. Acceptance Criteria and Reported Device Performance
| Feature / Metric | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Non-Clinical Performance | ||
| CT-to-fluoroscopy registration error | Mean ≤ 2.0 mm; Max ≤ 3.0 mm | Mean registration error ≤ 2.0 mm; Maximum error ≤ 3.0 mm |
| System latency (95% upper bound) | ≤ 133 ms | ≤ 133 ms |
| Image fidelity (PSNR) | ≥ 35 dB | ≥ 35 dB |
| Image fidelity (SSIM) | ≥ 0.95 | ≥ 0.95 |
| AI/ML Performance | ||
| OCR Error rate | 0 errors (≤5% upper 95% CI bound) | 0 failures observed |
| Anatomical Segmentation (Cardiac Chambers) - Dice Similarity Coefficient (DSC) | ≥ 0.85 | All evaluated structures met criteria |
| Anatomical Segmentation (Cardiac Chambers) - Average Surface Distance (ASD) | ≤ 1.5 mm | All evaluated structures met criteria |
| Aortic Segmentation (DSC) | ≥ 0.85 | Mean DSC = 0.962 |
| Catheter & Lead Detection - Median distal tip localization error | ≤ 0.9 mm | All evaluated catheter types met criteria |
| Clinical Performance | ||
| TAVR Cohort: Association between CARA-visualized CSA and Permanent Pacemaker Implantation (PPI) rates | Association observed consistent with clinical expectations | Implantation above CARA-visualized CSA: 11.2% PPI vs. 33.9% PPI when not above |
| CSP Cohort: Association between CARA-visualized LBBP and LVEF improvement | Association observed consistent with clinical expectations | Pacing at CARA-identified LBBP: +11.2% LVEF improvement vs. +0.3% for non-specific septal pacing |
2. Sample Size and Data Provenance for AI/ML Test Set
- OCR Test Set: 61 fluoroscopic images (retrospective, multi-site clinical datasets).
- Anatomical Segmentation (Cardiac Chambers) Test Set: 50 retrospective CT scans (retrospective, multi-site clinical datasets).
- Aortic Segmentation Test Set: 480 fluoroscopic images (retrospective, multi-site clinical datasets).
- Catheter & Lead Detection Test Set: 2,139 fluoroscopic images (retrospective, multi-site clinical datasets).
The specific country of origin for the retrospective, multi-site clinical datasets is not detailed in the provided information.
3. Number and Qualifications of Experts for Ground Truth
- Anatomical Segmentation (Cardiac Chambers) Ground Truth: Manual segmentation by trained technologists, adjudicated by a U.S. Board-Certified Interventional Cardiologist.
- Aortic Segmentation Ground Truth: Manual contour annotation, adjudicated by a U.S. Board-Certified Interventional Cardiologist.
- Catheter & Lead Detection Ground Truth: Manual distal tip annotation, adjudicated by a U.S. Board-Certified Interventional Cardiologist.
- OCR Ground Truth: Manual verification of extracted parameters (no specific expert qualifications mentioned beyond "manual verification").
The number of experts (U.S. Board-Certified Interventional Cardiologists) used for adjudication is not specified (e.g., whether it was one individual or a panel).
4. Adjudication Method for the Test Set
The adjudication method clearly states "adjudicated by a U.S. Board-Certified Interventional Cardiologist." This implies a single expert review of the preliminary ground truth established by trained technologists/manual annotators. It does not indicate a 2+1 or 3+1 consensus method.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was mentioned in the provided document. The study described focuses on the device's standalone performance and a retrospective clinical correlation, not on comparing human reader performance with and without AI assistance.
6. Standalone Performance Study
Yes, a standalone (algorithm only without human-in-the-loop performance) study was done for the AI/ML algorithms. The "AI/ML Performance Summary" table directly details the performance of the OCR, anatomical segmentation, and catheter/lead detection algorithms on independent test datasets, measured against ground truth.
7. Type of Ground Truth Used
- AI/ML Algorithms: Expert consensus (adjudication by a U.S. Board-Certified Interventional Cardiologist) applied to initial manual annotations by trained technologists for anatomical segmentations and catheter/lead detection. Manual verification for OCR.
- Clinical Performance Data: Retrospective clinical outcomes data (Permanent Pacemaker Implantation rates, Left Ventricular Ejection Fraction improvement) associated with the CARA-visualized Conduction System Axis and Left Bundle Branch Pacing.
8. Sample Size for the Training Set
The document states, "Algorithms were trained using retrospective, multi-site clinical datasets," but does not specify the sample size used for the training set. It only mentions that "Training and test datasets were independent."
9. How the Ground Truth for the Training Set was Established
The document states, "Algorithms were trained using retrospective, multi-site clinical datasets." While it describes how ground truth was established for the validation/test set (manual segmentation by trained technologists with physician adjudication), it does not explicitly detail how the ground truth for the training set was established. It is implied that similar methods would have been used, but it's not directly stated.
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(179 days)
CaseBio™ Culture w/HSA is intended for use for culture of embryos from fertilization to the blastocyst stage. This device can be used for transfer of embryos to the uterus.
CaseBio™ Handling w/HSA is intended for use in short-term handling and manipulating gametes and embryos, including washing and intracytoplasmic sperm injection (ICSI). This medium is not intended for transferring embryos to the uterine cavity.
CaseBio™ Culture w/HSA (CMH5) and CaseBio™ Handling w/HSA (WHH5) are intended for use during in vitro procedures for gamete/embryo culture and one step media.
CaseBio™ Culture w/HSA is intended for use for culture of embryos from fertilization to the blastocyst stage. This device is a one-step media and can be used for transfer of embryos to the uterus.
CaseBio™ Handling w/HSA is intended for use in short-term handling and manipulation of gametes and embryos, including washing and intracytoplasmic sperm injection (ICSI). This medium is not intended for transferring embryos to the uterine cavity.
CaseBio™ Culture w/HSA (CMH5) and CaseBio™ Handling w/HSA (WHH5) have almost identical composition with differences in amount of NaHCO3 and Phenol red and presence of HEPES in CaseBio™ Handling w/HAS. Both formulations contain gentamicin and human serum albumin.
The two solutions are aseptically filtered (storage vials sterilized by radiation) and provided in PETG square media bottles with HDPE screw-style caps. They have a shelf-life of 90 days when stored at 2-8°C. Media in the vials can be used for up to seven days after vial opening.
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(156 days)
The intended use of the CARTO™ 3 System is catheter-based cardiac electrophysiological (EP) procedures. The CARTO™ 3 System provides information about the electrical activity of the heart and about catheter location during the procedure. The system can be used on patients who are eligible for a conventional electrophysiological procedure. The system has no special contraindications.
The CARTO™ 3 EP Navigation System V8.4, is a catheter-based atrial and ventricular mapping system designed to acquire and analyze navigation catheter's location and intracardiac ECG signals and use this information to display 3D anatomical and electro anatomical maps of the human heart. The location information needed to create the cardiac maps and the local electrograms are acquired using specialized mapping catheters and reference devices. The CARTO™ 3 System uses two distinct types of location technology – magnetic sensor technology and Advanced Catheter Location (ACL) technology.
The CARTO™ 3 System V8.4 consists of the following hardware components:
- Patient Interface Unit (PIU)
- Workstation with Graphic User Interface (GUI)
- Wide-Screen monitors, keyboard, and mouse
- Intracardiac In Port
- Intracardiac Out Port
- Power Supply
- Patches Connection Box and Cables (PU)
- Pedal
- Location Pad (LP)
- Signal Processing Unit (SPU)
All hardware components of the CARTO™ 3 system V8.4 are the same as those found in the predicate device.
The provided FDA 510(k) clearance letter and summary for the CARTO™ 3 EP Navigation System V8.4 details two new AI-powered features: the CARTOSOUND™ REVEAL Module and the LA FAM Module.
Based on the provided document, here's a breakdown of the acceptance criteria and the study information:
1. Acceptance Criteria and Reported Device Performance
The document states that the testing verified and validated that the new features perform according to specifications and that existing features were not negatively affected. However, specific quantitative acceptance criteria (e.g., a specific accuracy percentage, Dice coefficient, etc.) for the AI algorithms in the CARTOSOUND™ REVEAL Module or LA FAM Module are not explicitly provided in the public document. The reported performance is that "All system features were found to perform according to specifications" and "All tests were successfully completed."
Given the lack of specific quantitative metrics in the provided document, I cannot create a table with specific numeric acceptance criteria and reported performance values. The closest information is:
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Overall System Functionality (including new features) | "All system features were found to perform according to specifications." "All tests were successfully completed." |
| Accuracy of CARTO™ 3 System V8.4 design | "The CARTO™ 3 System V8.4 design meets its accuracy specifications." "All tests were successfully completed." |
| Clinical functionality and quality of new modules (CARTOSOUND™ REVEAL and LA FAM) on retrospective data. | "All testing performed were successfully completed." |
| Clinical Workflow under simulated conditions (Animal Testing) | "All test protocol steps were successfully completed and expected results were achieved." |
2. Sample Size Used for the Test Set and Data Provenance
- CARTOSOUND™ REVEAL Module:
- Sample Size: Not explicitly stated as a number. The document mentions "Data for... validation of the DL algorithm was collected from a representative range of LA and LV chamber volumes and geographical locations, using a variety of ultrasound system settings, ULS scanners, and catheters."
- Data Provenance: "geographical locations" implies diverse data sources, but specific countries are not mentioned. The data was collected from "CARTO™ 3 System cases with ultrasound information," suggesting it's retrospective clinical data gathered during past procedures where the CARTO™ 3 system was used.
- LA FAM Module:
- Sample Size: Not explicitly stated as a number. The document mentions "Data for... validation of the DL algorithm consisted of CT and CARTO™ 3 System cases with FAM and was collected from a representative range of LA chamber volumes, geographical locations, and catheters."
- Data Provenance: "geographical locations" implies diverse data sources, but specific countries are not mentioned. The data was collected from "CT and CARTO™ 3 System cases with FAM," suggesting it's a mix of retrospective clinical CT data and retrospective clinical data from past CARTO™ 3 procedures.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
Not explicitly stated in the provided document. The document describes the "anatomical labeling and automatic contouring algorithms" as "developed and tested using CARTO™ 3 System cases with ultrasound information." For the 3D shell model, it was "developed and tested using CT and CARTO™ 3 System cases with FAM." However, the exact number, qualifications (e.g., cardiologist, electrophysiologist, radiologist, years of experience), and process of expert involvement in establishing ground truth for the test set are not detailed.
4. Adjudication Method for the Test Set
Not explicitly stated in the provided document. The document does not describe any specific multi-expert adjudication method (e.g., 2+1, 3+1, none) used for the test set ground truth.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study involving human readers assisting with AI vs. without AI assistance was mentioned. The testing described focuses on the standalone performance of the AI modules and regression testing of the overall system.
6. Standalone Performance (Algorithm Only without Human-in-the-Loop)
Yes, standalone performance was implied for the AI algorithms. The description of CARTOSOUND™ REVEAL and LA FAM modules specifically mentions "locked AI algorithms" for "Automatic identification," "Automatic 2D contours creation," and "Automatic 3D sell creation." The "Retrospective Validation Tests" were performed on "clinical recorded data" to "validate the clinical functionality and quality of the introduced modules," suggesting an evaluation of these automated features.
7. Type of Ground Truth Used
- CARTOSOUND™ REVEAL Module:
- For anatomical labeling and automatic contouring: Ground truth was derived from "CARTO™ 3 System cases with ultrasound information." This likely implies expert consensus or manual annotation by experts reviewing these clinical images.
- For 3D shell model: Ground truth was derived from "CT and CARTO™ 3 System cases with FAM." This suggests CT imaging, potentially combined with expert manual segmentation or annotation from CARTO™ 3 FAM data.
- LA FAM Module:
- Ground truth was derived from "CT and CARTO™ 3 System cases with FAM." This also suggests CT imaging, potentially combined with expert manual segmentation or annotation from CARTO™ 3 FAM data.
In both cases, while not explicitly stated, the generation of "ground truth" for a medical imaging task typically involves expert manual annotation or comparison to a gold standard imaging modality (like CT for anatomical structures).
8. Sample Size for the Training Set
- CARTOSOUND™ REVEAL Module: Not explicitly stated as a number. The document mentions "Data for training... of the DL algorithm was collected from a representative range of LA and LV chamber volumes and geographical locations, using a variety of ultrasound system settings, ULS scanners, and catheters."
- LA FAM Module: Not explicitly stated as a number. The document mentions "Data for training... of the DL algorithm consisted of CT and CARTO™ 3 System cases with FAM and was collected from a representative range of LA chamber volumes, geographical locations, and catheters."
9. How the Ground Truth for the Training Set Was Established
- CARTOSOUND™ REVEAL Module:
- For anatomical labeling and automatic contouring: "The anatomical labeling and automatic contouring algorithms were developed and tested using CARTO™ 3 System cases with ultrasound information." This implies expert annotation or labeling of cardiac structures and contours within these ultrasound images.
- For 3D shell model: "The 3D shell model was developed and tested using CT and CARTO™ 3 System cases with FAM." This implies expert segmentation or model creation/validation based on CT images and CARTO™ 3 FAM data.
- LA FAM Module:
- "Data for training... of the DL algorithm consisted of CT and CARTO™ 3 System cases with FAM." This indicates the ground truth for training was established through expert analysis and annotation of CT scans and CARTO™ 3 Fast Anatomical Maps (FAM).
Similar to the test set, the establishment of ground truth for training data in medical AI typically relies on manual work by qualified experts to delineate structures or confirm labels.
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(31 days)
The intended use of the CARTO™ 3 System is catheter-based cardiac electrophysiological (EP) procedures. The CARTO™ 3 System provides information about the electrical activity of the heart and about catheter location during the procedure. The system can be used on patients who are eligible for a conventional electrophysiological procedure. The system has no special contraindications.
The CARTO™ 3 EP Navigation System V9.0, is a catheter-based atrial and ventricular mapping system designed to acquire and analyze navigation catheter's location and intracardiac ECG signals and use this information to display 3D anatomical and electroanatomical maps of the human heart. The location information needed to create the cardiac maps and the local electrograms are acquired using specialized mapping catheters and reference devices. The CARTO™ 3 System uses two distinct types of location technology – magnetic sensor technology and Advanced Catheter Location (ACL) technology.
The CARTO™ 3 System V9.0 consists of the following hardware components:
- Patient Interface Unit – (PIU Plus or PIU)
- Workstation with Graphic User Interface (GUI)
- Wide-Screen monitors, keyboard, and mouse
- Intracardiac In Port
- Intracardiac Out Port
- Power Supply
- Patches Connection Box and Cables (PU)
- Pedals
- Location Pad (LP)
- Signal Processing Unit (SPU) – supported with PIU only
All hardware components of the CARTO™ 3 system V9.0 are the same as those found in the predicate device, with improved Patient Interface Unit (PIU Plus).
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(173 days)
A patient examination glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. The gloves was tested for use with Chemotherapy Drugs and Fentanyl Citrate as per ASTM D6978, "Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs".
The following drugs have been tested with these gloves:
| Chemotherapy Drug & Concentration | Minimum Breakthrough Detection Time in Minutes, 0.01 μg/cm2/min: |
|---|---|
| Bendamustine HCl, 5 mg/ml (5,000 ppm) | >240 min |
| Bleomycin Sulfate, 15 mg/ml (15,000 ppm) | >240 min |
| Busulfan, 6 mg/ml (6,000 ppm) | >240 min |
| Carboplatin, 10 mg/ml (10,000 ppm) | >240 min |
| Carmustine 3.3 mg/ml (3,300 ppm) | 10.0 min |
| Chloroquine, 50 mg/ml (50,000 ppm) | >240 min |
| Cisplatin, 1mg/ml (1000 ppm) | >240 min |
| Cyclophosphamide 20mg/ml (20,000 ppm) | >240 min |
| Cytarabine HCl (Cytosine), 100 mg/ml (100,000 ppm) | >240 min |
| Dacarbazine (DTIC), 10 mg/ml (10,000 ppm) | >240 min |
| Doxorubicin HCL, 2 mg/ml (2,000 ppm) | >240 min |
| Epirubicin HCl, 2 mg/ml (2,000 ppm) | >240 min |
| Etoposide, 20 mg/ml (20,000 ppm) | >240 min |
| Fludarabine, 25 mg/ml (25,000 ppm) | >240 min |
| Fluorouracil (5 Flu), 50mg/ml (50,000ppm) | >240 min |
| Gemcitabine HCl, 38 mg/ml (38,000 ppm) | >240 min |
| Idarubicin HCl, 1 mg/ml (1,000 ppm) | >240 min |
| Ifosfamide (IFEX), 50 mg/ml (50,000 ppm) | 80.0 min |
| Mechlorethamine HCl, 1 mg/ml (1,000 ppm) | >240 min |
| Melphalan HCl, 5 mg/ml (5,000 ppm) | >240 min |
| Methotrexate, 25mg/ml (25,000ppm) | >240 min |
| Mitomycin C, 0.5mg/ml (500 ppm) | >240 min |
| Mitoxantrone HCl (2.0 mg/mL) (2000 ppm) | >240 min |
| Oxaliplatin, 5 mg/ml (5,000 ppm) | >240 min |
| Paclitaxel, 6mg/ml (6,000ppm) | >240 min |
| Rituximab, 10 mg/ml (10,000 ppm) | >240 min |
| Thiotepa, l0mg/ml (10,000ppm) | 20.0 min |
| Trisenox (Arsenic Trioxide), 1 mg/ml (1,000 ppm) | >240 min |
| Vincristine sulfate, 1mg/ml (1000 ppm) | >240 min |
| Vinorelbine, 10 mg/ml (10,00 ppm) | >240 min |
| Opioid Drug | Minimum Breakthrough Detection Time in Minutes, 0.01 μg/cm2/min: |
|---|---|
| Fentanyl Citrate Injection, 100mcg/2mg | >240 min |
*Please note that the following drugs have low permeation times:
Carmustine: 10.0 minutes, Thiotepa: 20.0 minutes
Warning: Do not use with Carmustine & Thiotepa.
Caution: Testing showed breakthrough time of 80.0 minutes with Ifosfamide IFEX (50.0 mg/mL).
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(189 days)
The Signature Orthopaedics' Cambridge Partial Knee is designed for a single compartment replacement of the natural knee joint. The Cambridge Partial Knee is indicated for cemented use in partial knee arthroplasty procedures. Partial replacement of the articulating surfaces of the knee is indicated only when only one compartment of the joint is affected due to the compartmental primary degenerative or post-traumatic degenerative disease, previous tibial condyle or plateau fractures, deformity or revision of previous arthroplasty.
The Cambridge Partial Knee is a unicompartmental knee system consisting of a femoral component and tibial component (meniscal insert overmoulded onto the tibial baseplate). The femoral and tibial components are intended for use with bone cement. The implant is for fixed partial knee replacement. Each size tibial implant has two variants, right lateral/left medial (RLLM) and right medial/left lateral (RMLL) condyle.
The femoral component is a spherical, symmetrically designed prosthesis manufactured from cast cobalt chrome (CoCrMo). The meniscal bearing and tibial baseplate are a monobloc fixed tibial bearing consisting of a titanium (Ti6Al4V) baseplate overmoulded with UHMWPE GUR1020-E. The meniscal bearing is moulded over the tibial baseplate and machined to the correct size and geometry.
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