(179 days)
Not Found
P960042, P910001
No
The device description and performance studies focus on the physical mechanism of laser ablation and clinical outcomes, with no mention of AI or ML technologies.
Yes
The device is intended for the ablation of tissue to remove IVC filters, which is a direct treatment or therapy.
No
The device is described as an ablation tool for tissue removal, intending to treat a condition (failed IVC filter retrieval), not to diagnose one.
No
The device description clearly details a physical laser sheath and its interaction with a laser generator, indicating it is a hardware device that utilizes energy for tissue ablation.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the ablation of tissue in the removal of IVC filters. This is a therapeutic procedure performed directly on the patient's tissue.
- Device Description: The device is a laser sheath that transmits energy to ablate tissue. This is a physical intervention, not a test performed on a sample taken from the body.
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
This device is a therapeutic medical device used for a surgical procedure, not a diagnostic test.
N/A
Intended Use / Indications for Use
The CavaClear Laser Sheath is indicated as follows: The device is intended for the ablation of tissue in the removal of IVC filters that have failed a previous retrieval method.
Product codes
QRJ
Device Description
The CavaClear Laser Sheath is a 14Fr or 16 Fr laser sheath that transmits ultraviolet energy in (b)(4) pulse durations from Spectranetics' Excimer Laser generators to the tissue at the distal tip of the device. When the laser activates, a small amount of the tissue is ablated through photochemical, photothermal, and photomechanical interaction, vaporizing tissue overgrowth in order to allow for inferior vena cava (IVC) filter removal. The CavaClear Laser Sheath operates at repetition rates of 25-80Hz and fluence of 30-60mJ/mm2.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Inferior Vena Cava (IVC)
Indicated Patient Age Range
The average patient age at the time of procedure in both the single and multi-center experience datasets was 52 ± 16 years.
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The safety and effectiveness of the CavaClear Laser Sheath for removal of IVC filters has been established through a retrospective analysis of real-world evidence.
Title: Multicenter, real-world study of Excimer laser sheath assisted retrieval of embedded inferior vena cava (IVC) Filters
Purpose: The study aimed to evaluate the safety and performance of utilizing an excimer laser sheath as an advanced technique during IVC filter removal procedures.
Methods: This retrospective, multicenter, real-world evidence, observational trial enrolled 265 subjects at 7 sites in the US, with 139 subjects representing data from the single-center experience and 126 subjects from 6 sites representing the multi-center experience. All cases where the laser was utilized during an IVC filter removal procedure completed between March 2012 and February 2021 were captured following abstraction of the medical records with respect to the multi-center experience or from the existing published dataset with respect to the single center experience. The study populations included all-comer patients presenting with IVC filters that were refractory to alternate removal techniques, which included 10 different filter types with an upper dwell limit of over 21 years.
Results: The primary safety endpoint for the study was met with device related major complication rates of 2.9% (95% CL=0.8%, 7.2%), and 4.0% (95% CL=1.3%, 9.0%) demonstrated by the single and multi-center experience datasets, respectively. The upper confidence limits (UCLs) for both the single and multi-center experience datasets were below the Primary Safety Performance Goal (PG) of 10%.
The primary efficacy endpoint for the study was met with procedural technical success rates of 95.7% (95% CL=90.8%. 98.4%), and 95.2% (95% CL=89.9%. 98.2%) for the single and multi-center clinical experience datasets, respectively. The lower confidence limits (LCLs) for both the single and multi-center experience datasets were above the Primary Efficacy Performance Goal (PGs) of 89.4%.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Primary Safety Endpoint: Device related major complication rates:
Single-center: 2.9% (95% CL=0.8%, 7.2%)
Multi-center: 4.0% (95% CL=1.3%, 9.0%)
Primary Efficacy Endpoint: Procedural technical success rates:
Single-center: 95.7% (95% CL=90.8%. 98.4%)
Multi-center: 95.2% (95% CL=89.9%. 98.2%)
Predicate Device(s)
Not Found
Reference Device(s)
P960042, P910001
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
DE NOVO CLASSIFICATION REQUEST FOR CAVACLEAR LASER SHEATH
REGULATORY INFORMATION
FDA identifies this generic type of device as:
Laser-powered inferior vena cava filter retrieval catheter. A laser-powered inferior vena cava (IVC) filter retrieval catheter is a percutaneous catheter that uses a laser to ablate tissue and is intended to facilitate in the detachment and removal of indwelling IVC filters.
NEW REGULATION NUMBER: 21 CFR 870.5125
CLASSIFICATION: Class II
PRODUCT CODE: QRJ
BACKGROUND
DEVICE NAME: CavaClear Laser Sheath
SUBMISSION NUMBER: DEN210024
DATE DE NOVO RECEIVED: June 25, 2021
SPONSOR INFORMATION:
Spectranetics, Inc. 9965 Federal Drive Colorado Springs, Colorado 80921
INDICATIONS FOR USE
The CavaClear Laser Sheath is indicated as follows:
The device is intended for the ablation of tissue in the removal of IVC filters that have failed a previous retrieval method.
LIMITATIONS
The sale, distribution, and use of the CavaClear Laser Sheath are restricted to prescription use in accordance with 21 CFR 801.109.
PLEASE REFER TO THE LABELING FOR A COMPLETE LIST OF WARNINGS, PRECAUTIONS AND CONTRAINDICATIONS.
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DEVICE DESCRIPTION
The CavaClear Laser Sheath is a 14Fr or 16 Fr laser sheath that transmits ultraviolet energy in (b)(4) pulse durations from Spectranetics' Excimer Laser generators to the tissue at the distal tip of the device. When the laser activates, a small amount of the tissue is ablated through photochemical, photothermal, and photomechanical interaction, vaporizing tissue overgrowth in order to allow for inferior vena cava (IVC) filter removal. The CavaClear Laser Sheath operates at repetition rates of 25-80Hz and fluence of 30-60mJ/mm2. Sec Figure 1 below.
Figure 1: CavaClear Laser Sheath
Image /page/1/Figure/3 description: The image shows a medical device with a long, flexible tube. One end of the tube is connected to a T-shaped handle, while the other end is connected to a rectangular connector. The tube is coiled in the middle, and it appears to be made of a gray material. The connector has several metal pins, and it is likely used to connect the device to a medical instrument.
This device is identical in design, materials, and method of construction to the GlideLight Laser Sheath approved for pacemaker and defibrillator cardiac lead removal under P960042 and related supplements.
SUMMARY OF BENCH AND SHELF-LIFE STUDIES
BIOCOMPATIBILITY
The CavaClear Laser Sheath is considered an externally communicating device that is intended to come in direct contact with circulating blood for a limited duration (48 hours); E. Permanent adverse sequelae; F. Death; Minor Complication definition (per SIR grading): A. No therapy, no consequence; B. Nominal therapy, no consequence; includes overnight admission for observation only.
Pediatric Extrapolation
In this De Novo request, existing clinical data were not leveraged to support the use of the device in a pediatric patient population.
TRAINING
Training is required for use of the CavaClear Laser Sheath for IVC filter removal. Training includes the following topics:
- . Device design and key features
- Review of indications and contraindications .
- Review of potential complications .
- Laser sheath preparations .
- . The use of the laser sheath to remove IVC filters
- Post-removal of laser sheath .
LABELING
The labeling consists of Instructions for Use and packaging labels. The Instructions for use include the indications for use; a description of the device, contraindications, warnings, precautions; a detailed summary of the clinical data collected in support of the device; a shelf life; and instructions for the safe use of the device. The labeling satisfies the requirements of 21 CFR 801.109.
RISKS TO HEALTH
The table below identifies the risks to health that may be associated with use of Laser-powered inferior vena cava filter retrieval catheters:
| Identified Risks to Health | Mitigation Measures |
|---|---|
| Infection | Sterilization validation |
| Shelf life testing | |
| Pyrogenicity testing | |
| Labeling |
Identified Risks to Health and Mitigation Measures
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| Identified Risks to Health | Mitigation Measures |
|---|---|
| Adverse tissue reaction | Biocompatibility evaluation |
| Device damage during use resulting in clinical | |
| sequelae such as embolic concern or prolonged | |
| procedure | Non-clinical performance testing |
| Clinical performance testing | |
| Soft tissue damage from laser, such as IVC | |
| injury, extravasation, and perforation | Laser generator compatibility testing |
| In-vivo safety testing, | |
| Clinical performance testing | |
| Labeling | |
| Training | |
| IVF filter damage, including fracture and | |
| embolization, due to laser interaction | Non-clinical performance testing |
| Clinical testing | |
| Labeling | |
| Training |
SPECIAL CONTROLS
In combination with the general controls of the FD&C Act. the laser-powered inferior vena cava (IVC) filter retrieval catheter is subject to the following special controls:
-
- Clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. Testing must include:
- Evaluation of major and minor complications associated with IVC filter i removal; and
- Evaluation of success rates of IVC filter removal. ii.
-
- Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be evaluated:
- Dimensional testing must demonstrate that the device is compatible with the i. intended anatomy and compatible with all labeled accessories.
- ii. Mechanical testing on all joints must demonstrate that the device can withstand tensile and torsional forces encountered under challenging clinical use conditions.
- iii. Simulated use testing must demonstrate that the device can be inserted, tracked, activated, and removed without device damage and that the device is able to function as intended (e.g., remove IVC filter without damage) under challenging clinical use conditions.
- iv. Performance testing must demonstrate that the product is visible under fluoroscopic techniques.
- Performance testing must demonstrate that the device does not kink when v. subjected to clinically relevant tortuosity.
-
- Compatibility testing with laser generators must include:
- Electrical safety, electromagnetic compatibility (EMC) testing, and i. electromagnetic interference (EMI) testing must be conducted for all devices that contain electrical components.
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- ii. Software verification, validation, and hazard analysis must be conducted for all devices that contain software.
- Laser output characterization and performance testing, including verification iii. of calibration reliability, energy output, and repetition rate, and laser lifetime testing, must be conducted.
-
- All patient-contacting components must be demonstrated to be biocompatible.
-
- Performance data must demonstrate the sterility and non-pyrogenicity of patient contacting components of the device that are provided sterile.
- Performance data must support the shelf life of the device by demonstrating 6) continued sterility, package integrity, and system functionality over the established shelf life.
-
- In vivo safety testing must demonstrate that the device does not cause soft tissue damage or device damage under worst case clinical use conditions.
-
- Labeling must include the following:
- A detailed summary of the device technical parameters and materials of the i. device:
- ii. A summary of the clinical performance testing conducted with the device; and iii. A shelf life.
-
- A training program must be provided to ensure that users can safely and reliably use the device per its instructions for use.
BENEFIT-RISK DETERMINATION
The risks of the device are based on data collected in a clinical study described above.
Risks for use of the CavaClear Laser sheath are low, as demonstrated by the supporting clinical data. The device related major complication rate was observed to be approximately 3-4%, which is similar to the expected rate for other advanced filter extraction techniques. Complications experienced in this study include IVC injury causing extravasation, IVC injury causing hematoma, IVC injury causing perforation, filter fracture, and filter embolization. These complications occurred at expected rates. Device related minor complications, determined to be minor based on SIR grading, were experienced at rates of approximately 10-15% in the clinical study, and were similar in nature to the ones described above. Risks are further mitigated through labeling and a comprehensive training program.
The probable benefits of the device are also based on data collected in a clinical study as described above.
The probable benefits of the CavaClear Laser Sheath are demonstrated by the supporting clinical data, which indicated a technical success rate of approximately 95%. Reasons for failed technical success include inability to grasp filter, failure to ablate tissue, and filter fracture. For chronically embedded IVC filters, the observed technical success rate was high, indicating that the CavaClear Laser Sheath provides clinical benefits to patients with firmly adherent and otherwise difficult to extract devices.
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Additional factors to be considered in determining probable risks and benefits for the CavaClear Laser Sheath include:
This device is intended for patients who have failed previous retrieval attempt(s) and the clinical data shows a high technical success rate in these patients who otherwise may have limited options for IVC filter removal.
The sponsor has made efforts to mitigate risks through labeling and development of a comprehensive training program for new physician users, incorporating best practices for managing potential complications.
For the intended patient population with firmly adherent IVC filters that have failed a previous retrieval method, the benefit risk profile derived from the provided real world evidence has been demonstrated to be acceptable.
Patient Perspectives
This submission did not include specific information on patient perspectives for this device.
Benefit/Risk Conclusion
In conclusion, given the available information above, for the following indication statement:
The device is intended for the ablation tissue in the removal of IVC filters that have failed a previous retrieval method.
The probable benefits outweigh the probable risks for the CavaClear Laser Sheath. The device provides benefits and the risks can be mitigated by the use of general controls and the identified special controls.
CONCLUSION
The De Novo request for the CavaClear Laser Sheath is granted and the device is classified as follows:
Product Code: ORJ Device Type: Laser-powered inferior vena cava filter retrieval catheter Regulation Number: 21 CFR 870.5125 Class: II