(179 days)
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No
The description focuses on the mechanical components and procedural steps of the device, with no mention of AI, ML, or related concepts. The performance studies also report procedural success rates and safety endpoints, not metrics typically associated with AI/ML performance.
No.
The device facilitates central venous access for patients with venous occlusions. It does not directly treat a disease or condition; rather, it provides a means for other therapeutic interventions (e.g., catheter insertion for drug delivery or fluid administration) to occur.
No
The device is intended to obtain central venous access by facilitating catheter insertion, which is a therapeutic or procedural action, not a diagnostic one. While it uses imaging modalities like fluoroscopy to guide the procedure, its primary purpose is not to diagnose a condition.
No
The device description clearly outlines multiple hardware components including a Workstation Sheath, Surfacer Device (with Needle Wire and Needle Guide), Exit Target, and a Peel-able Introducer Sheath. This is a physical medical device system, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "obtain central venous access to facilitate catheter insertion into the central venous system." This describes a surgical/interventional procedure to gain access to a blood vessel, not a test performed on a sample taken from the body.
- Device Description: The description details a system of catheters, wires, and sheaths used to physically navigate and create a path within the venous system. It does not describe any components or processes for analyzing biological samples (like blood, urine, tissue, etc.).
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analysis of biological samples.
- Detection or measurement of substances in samples.
- Diagnosis, monitoring, or screening of diseases based on sample analysis.
- Reagents, calibrators, or controls used in laboratory testing.
The Surfacer Inside-Out Access Catheter System is a medical device used for a procedural intervention, specifically to facilitate central venous access in challenging cases. It is not designed to perform diagnostic testing on biological samples.
N/A
Intended Use / Indications for Use
The Surfacer Inside-Out Access Catheter System is intended to obtain central venous access to facilitate catheter insertion into the central venous system for patients with upper body venous occlusions or other conditions that preclude central venous access by conventional methods.
Product codes
QJH
Device Description
The Surfacer Inside-Out Access Catheter System (Figure 1) is used to gain central venous access by directing a needle from inside the vein to skin, as opposed to the traditional approach of inserting a needle inwards. The Surfacer Device is percutaneously introduced into the right femoral vein. It is advanced up the inferior vena cava, via the superior vena cava (SVC), to the location of the occlusion. When the occlusion has been visualized under fluoroscopy, a needle wire is oriented to advance through or to cross the occlusion and to exit to a pre-determined external target. A new central venous catheter is then back-loaded into a peel-able introducer sheath and positioned below the occlusion for central venous access.
The Surfacer Inside-Out Access Catheter System is comprised of four components: A Workstation Sheath for percutaneous access via the femoral vein; a Surfacer Device, comprising (b)(4). | Needle Wire and Needle Guide, which is advanced to the supraclavicular al space; an Exit Target, which provides fluoroscopic guidance to mark the exit point; and a | 10(4) (D) (4) Peel-able Introducer Sheath, which is introduced over the Needle Wire to access the central venous system. Once the access is obtained and a catheter is in place, the Surfacer System is removed. Please refer to the Instructions for Use for additional details.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
Fluoroscopy
Anatomical Site
Central Venous System, Right Femoral Vein, Inferior Vena Cava, Superior Vena Cava, Right Atrium, Iliac Vein, Internal Jugular Vein, Subclavian Vein, Brachiocephalic Vein
Indicated Patient Age Range
18 - 80 years of age
Intended User / Care Setting
Physicians who have received appropriate training and are familiar with the principles, clinical applications, complications, side effects and hazards commonly associated with interventional procedures. Use only in institutions where emergency surgery can be performed and where blood transfusions can be performed.
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
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Summary of Performance Studies
United States SAVE-US IDE Study:
Study Type: Prospective, single-arm, multi-center study.
Sample Size: 30 subjects at 7 centers in the United States.
Outcome Measures:
Primary Safety Endpoint: Acute device safety, defined as the absence of procedural complications (hemopericardium, hemothorax, blood transfusion, resuscitation, emergency post-procedural intervention, transfer to an intensive care unit, and death) at discharge and 7 days post-procedure.
Primary Effectiveness Endpoint: Rate of safe insertion and patency of central venous catheters (CVCs) created across venous occlusions.
Secondary Endpoints (Safety): Rate of conversion to alternative central vein placement techniques.
Secondary Endpoints (Effectiveness): Surfacer System clinical utility assessed by the ability of the Surfacer System to facilitate central venous access placement.
Key Results:
Primary Safety Endpoint: 86.7% (26/30) subjects without serious procedural complications at discharge and 7 days post procedure (95% CI: 69.3%, 96.2%). Procedure-related adverse events were observed in 4/30 subjects (13.3%). No anticipated or unanticipated device related adverse events were reported.
Primary Effectiveness Endpoint: 100% success rate (27/27) in the per protocol (PP) population. 90% (27/30) subjects obtained central venous access in the intent-to-treat (ITT) population (95% CI: 73.5%, 97.9%).
Secondary Safety Endpoint (Technique Conversion): 10.0% (3/30) subjects with conversion (95% CI: 2.1%, 26.5%). Reason for conversion was distorted anatomy.
Secondary Effectiveness Endpoints: Surfacer System was advanced from entry in the femoral vein to supraclavicular exit in 27/30 (90%) of ITT and 27/27 (100%) of PP treated subjects.
International Post Market SAVE Registry:
Study Type: Prospective, single-arm, post market, multicenter, international registry.
Sample Size: 30 subjects at 5 centers in Germany, Italy, Austria and Paraguay.
Outcome Measures:
Primary Safety Endpoint: Safety evaluation at end of procedure and at discharge. Acute device safety, defined as the absence of device related SAEs.
Primary Performance Endpoint: Success rate defined as the ability to facilitate placement of CVCs using the Surfacer System to establish a transient passage across venous occlusions.
Secondary Endpoints (Safety): Rate of technique conversion and causes, and the rate of CV Access catheter malposition.
Secondary Endpoints (Performance): Assessment of the ability of the Surfacer System to be advanced from the femoral vein to subclavicular exit to facilitate CVC placement.
Key Results:
Primary Performance Endpoint: 29 (96.7%) subjects received placement of a central venous catheter.
Primary Safety Endpoint: 29 (100%) subjects had freedom from complications and absence of device related SAEs. No serious device-related adverse events or procedure related adverse events reported.
Secondary Safety Endpoints: 1 (3.3%) conversion to alternative access method due to significant vascular anatomical tortuosity. 0 (0%) CV Access catheter malposition.
Secondary Performance Endpoints: Visualization of the needle guide and needle wire exit under fluoroscopy, placement of patent CVC using the exit introducer, was confirmed in 29 treated subjects. Surfacer advancement from femoral vein to sub-clavicular exit was 29 (96.7%).
Key Metrics
United States SAVE-US IDE Study:
Primary Safety Endpoint Success Rate: 86.7% (26/30) in ITT population.
Primary Effectiveness Endpoint Success Rate (PP): 100% (27/27).
Primary Effectiveness Endpoint Success Rate (ITT): 90.0% (27/30).
Technique Conversion Rate: 10.0% (3/30).
International Post Market SAVE Registry:
Procedural Success Rate: 96.7% (29/30).
Safety (Freedom from complications and absence of device related SAEs): 100% (29/29).
Surfacer advancement from femoral vein to sub-clavicular exit: 96.7% (29/30).
Technique Conversion Rate: 3.3% (1/30).
CV Access catheter malposition: 0% (0/30).
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1342 Reverse central venous recanalization system.
(a)
Identification. A reverse central venous recanalization system is a prescription device for obtaining central venous access to facilitate catheter insertion into the central venous system. Reverse recanalization involves the initiation of an access path from within the vein and then progressing to the skin for patients with upper body venous occlusions or other conditions that preclude central venous access by other methods.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Clinical performance testing must fulfill the following:
(i) Demonstrate the ability to safely deliver, deploy, and remove the device; and
(ii) Evaluate all adverse events including death, bleeding, damage to non-target tissue and organs, blood vessel perforation or rupture, and hematoma.
(2) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested:
(i) Simulated-use testing in a clinically relevant bench anatomic model to assess the delivery, deployment, and retrieval of the system;
(ii) Compatibility with other devices labeled for use with the device;
(iii) Tensile strengths of joints and components;
(iv) Kink resistance of system components;
(v) Radiopacity of components used to monitor procedure under fluoroscopy;
(vi) Characterization and verification of all dimensions; and
(vii) Leakage of air or fluid.
(3) All patient contacting components of the device must be demonstrated to be biocompatible.
(4) Performance data must demonstrate the sterility of the device components intended to be provided sterile.
(5) Performance data must support the shelf life of the device by demonstrating continued sterility, package integrity, and device functionality over the identified shelf life.
(6) Labeling for the device must include:
(i) Instructions for use, including a description of compatible devices;
(ii) A detailed summary of the clinical testing conducted and;
(iii) Shelf life and storage conditions.
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DE NOVO CLASSIFICATION REQUEST FOR SURFACER INSIDE-OUT ACCESS CATHETER SYSTEM
REGULATORY INFORMATION
FDA identifies this generic type of device as:
Reverse central venous recanalization system. A reverse central venous recanalization system is a prescription device for obtaining central venous access to facilitate catheter insertion into the central venous system. Reverse recanalization involves the initiation of an access path from within the yein and then progressing to the skin for patients with upper body venous occlusions or other conditions that preclude central venous access by other methods.
NEW REGULATION NUMBER: 21 CFR 870.1342
CLASSIFICATION: Class II
PRODUCT CODE: QJH
BACKGROUND
DEVICE NAME: Surfacer Inside-Out Access Catheter System
SUBMISSION NUMBER: DEN190038
DATE DE NOVO RECEIVED: August 15, 2019
SPONSOR INFORMATION:
Bluegrass Vascular Technologies, Inc. 12500 Network Boulevard, Suite 308 San Antonio. Texas 78249
INDICATIONS FOR USE
The Surfacer Inside-Out Access Catheter System is intended to obtain central venous access to facilitate catheter insertion into the central venous system for patients with upper body venous occlusions or other conditions that preclude central venous access by conventional methods.
LIMITATIONS
The sale, distribution, and use of the Surfacer Inside-Out Access Catheter System are restricted to prescription use in accordance with 21 CFR 801.109.
1
Only physicians who have received appropriate training and are familiar with the principles, clinical applications, complications, side effects and hazards commonly associated with interventional procedures should use this device.
This device should be used only in institutions where emergency surgery can be performed and where blood transfusions can be performed.
The Surfacer Inside-Out Access Catheter System is contraindicated for patients with an occlusion of the right femoral vein, right iliac vein or inferior vena cava, or acute thrombosis within any vessel to be crossed by the Surfacer Inside-Out Access Catheter System. Special precautions may be required for patients with coagulation disorders or on anti-coagulation therapy.
The Surfacer Inside-Out Access Catheter System is not intended for use in the coronary or cerebral vasculature. This device is not to be used in the arterial system.
PLEASE REFER TO THE LABELING FOR A COMPLETE LIST OF WARNINGS. PRECAUTIONS AND CONTRAINDICATIONS.
DEVICE DESCRIPTION
The Surfacer Inside-Out Access Catheter System (Figure 1) is used to gain central venous access by directing a needle from inside the vein to skin, as opposed to the traditional approach of inserting a needle inwards. The Surfacer Device is percutaneously introduced into the right femoral vein. It is advanced up the inferior vena cava, via the superior vena cava (SVC), to the location of the occlusion. When the occlusion has been visualized under fluoroscopy, a needle wire is oriented to advance through or to cross the occlusion and to exit to a pre-determined external target. A new central venous catheter is then back-loaded into a peel-able introducer sheath and positioned below the occlusion for central venous access.
The Surfacer Inside-Out Access Catheter System is comprised of four components: A Workstation Sheath for percutaneous access via the femoral vein; a Surfacer Device, comprising (b)(4). | Needle Wire and Needle Guide, which is advanced to the supraclavicular al space; an Exit Target, which provides fluoroscopic guidance to mark the exit point; and a | 10(4) (D) (4) Peel-able Introducer Sheath, which is introduced over the Needle Wire to access the central venous system. Once the access is obtained and a catheter is in place, the Surfacer System is removed. Please refer to the Instructions for Use for additional details.
2
Image /page/2/Figure/0 description: The image shows a medical device with several labeled components. The components include a needle guide, main sheath, handle, and needle wire. The needle guide is circled in red, and arrows point to each of the labeled components.
Figure 1: The Surfacer Inside-Out Access Catheter System
SUMMARY OF NONCLINICAL/BENCH STUDIES
BIOCOMPATIBILITY/MATERIALS
The Surfacer Inside-Out Access Catheter System is an externally communicating device in contact with circulating blood with limited contact duration (Performance (N=30) | |
| Procedural success rate: ability to facilitate placement of
CVC's using the Surfacer to establish a transient passage
across venous occlusions. | 29 (96.7%) |
| Safety (N=29*) | |
| Safety evaluation at end of procedure and at discharge.
Freedom from complications. | 29 (100%) |
| Acute device safety, defined as the absence of device related
SAEs. | 29 (100%) |
| SECONDARY Endpoints | |
| Performance (N=30) | |
| Surfacer advancement from femoral vein to sub-clavicular
exit to facilitate CVC placement assessed by: | 29 (96.7%) |
| Ability of Needle Guide and Needle Wire to exit
superior vena cava as visualized fluoroscopically | |
| Ability of exit introducer to facilitate placement of
CVC | 29 (96.7%) |
| Safety (N=30) | |
| Technique Conversion rate | 1 (3.3%) |
| CV Access catheter malposition | 0 (0%) |
Table 12: Endpoints Evaluation
*Includes subjects with Surfacer System only
Conclusions:
The results obtained for subjects enrolled in the SAVE Registry support the safety and efficacy of the Surfacer Inside-Out procedure when used for restoring a right-sided central venous access in subjects with central venous occlusions.
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EU Vigilance Reports
Since receipt of CE Mark, four (4) European vigilance reports were filed with events such as bleeding, blood vessel/vein damage; and arterial damage. Two events resulted in patient death. One subject tolerated access of the central venous system with the Surfacer device, but died of acute bleeding into the pleural space after the tract was dilated with an angioplasty balloon to insert a HeRO catheter. None of the vigilance reports were related to device malfunction. Bleeding is a known and anticipated risk of Surfacer System use. Users should follow the instructions/warnings provided in the labeling.
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.
POSTMARKET EVALUATION
A postmarket evaluation will be required to obtain a more comprehensive safety profile of the device by collecting short-term safety data associated with real-world US use of the device in the absence of proctors. Safety and effectiveness data will be collected and compared to the pivotal study data that supported this De Novo application.
LABELING
The Surfacer Inside-Out Access Catheter System 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 description of compatible devices; 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.
Please see the Limitations section above for important warnings and presented in the device labeling.
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RISKS TO HEALTH
The table below identifies the risks to health that may be associated with use of a reverse central venous recanalization system.
| Identified Risks to Health | Mitigation Measures |
|---|---|
| Infection | Sterilization validation |
| Shelf life testing | |
| Labeling | |
| Adverse tissue reaction | Biocompatibility evaluation |
| Embolization caused by component fracture | Clinical performance testing |
| Non-clinical performance testing | |
| Death, bleeding, damage to non-target tissue and | |
| organs, blood vessel perforation or rupture, | |
| hematoma; or delays to therapy from failure to | |
| achieve central venous access | Clinical performance testing |
| Non-clinical performance testing | |
| Labeling |
| Table 13: Identified Risks to Health and Mitigation Measures | ||||
|---|---|---|---|---|
SPECIAL CONTROLS
In combination with the general controls of the FD&C Act, the reverse central venous recanalization system is subject to the following special controls:
- (1) Clinical performance testing must fulfill the following:
- Demonstrate the ability to safely deliver, deploy, and remove the device; and (i)
- (ii) Evaluate all adverse events including death, bleeding, damage to non-target tissue and organs, blood vessel perforation or rupture, and hematoma.
- (2) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested:
- (i) Simulated-use testing in a clinically relevant bench anatomic model to assess the delivery, deployment, and retrieval of the system;
- Compatibility of system components with other devices labeled for use with the (ii) device:
- (iii) Tensile strengths of joints and components.
- (iv) Kink resistance of system components;
- (v) Radiopacity of components used to monitor procedure under fluoroscopy;
- (vi) Characterization and verification of all dimensions; and
- (vii) Leakage of air or fluid.
- (3) All patient contacting components of the device must be demonstrated to be biocompatible.
- (4) Performance data must demonstrate the sterility of the device components intended to be provided sterile.
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- (5) Performance data must support the shelf life of the device by demonstrating continued sterility, package integrity, and device functionality over the identified shelf life.
- (6) Labeling for the device must include:
- (i) Instructions for use, including a description of compatible devices:
- (ii) A detailed summary of the clinical testing conducted; and
- (iii) The shelf life and storage conditions.
BENEFIT-RISK DETERMINATION
The risks of the Surfacer Inside-Out Access Catheter System are based on nonclinical laboratory studies as well as data collected in the clinical studies described above. Potential serious and life-threating complications include death, severe bleeding, perforation of the right atrium, pericardial tamponade, hemothorax, tears of the superior vena cava, and lacerations of the main subclavian artery and its branches, any of which can rapidly lead to cardiac collapse and/or exsanguination.
The probable benefits of the device are also based on nonclinical laboratory studies as well as data collected in the clinical studies as described above.
The Surfacer Inside-Out Access Catheter System has been shown in the IDE trial and other supporting clinical data to be effective at establishing right neck central venous access in selected patients with central venous occlusions. Selected patients requiring central venous access for hemodialysis and infusion therapy despite presence of central venous occlusions may benefit from this device. The Surfacer System could benefit patients as an alternative to chronic femoral venous catheters, which may have high infection rates and hinder mobility. Some patients may also benefit from avoiding the need for higher-risk placement of catheters via translumbar and transhepatic routes.
The United States SAVE-US IDE Study had only a limited cohort size (30 subjects) and proctors were present in the vast majority (29/30) of procedures. Consequently, limited information is available that represents treatment of US patients without a proctor present. Therefore, to support a favorable benefit/risk decision, additional Post Market data collection was required to monitor the first patients for Adverse Events and Serious Adverse events that may arise during real-world use of the Surfacer device in a US healthcare setting with both proctored and unproctored cases.
Patient Perspectives
This submission did not include specific information on patient perspectives for this device.
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BENEFIT/RISK CONCLUSION
In conclusion, given the available information above, for the following indication statement:
The Surfacer Inside-Out Access Catheter System is intended to obtain central venous access to facilitate catheter insertion into the central venous system for patients with upper body venous occlusions or other conditions that preclude central venous access by conventional methods.
The probable benefits outweigh the probable risks for the Surfacer Inside-Out Access Catheter System. 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 Surfacer Inside-Out Access Catheter System is granted and the device is classified as follows:
Product Code: OJH Device Type: Reverse central venous recanalization system Regulation Number: 21 CFR 870.1342 Class: II