(192 days)
The Vdrive® system is intended to stabilize, navigate and remotely control:
· Compatible Intracardiac Echocardiography (ICE) catheters to facilitate visualization of cardiac structure during the performance of cardiac procedure when used in conjunction with the V-Sono™ disposable sets in the Vdrive® system,
· Compatible loop (circular) mapping catheters to facilitate movement of the catheter during the performance of electrophysiological procedures when used in conjunction with the V-Loop™ disposable sets in the Vdrive® system, and
· Compatible fixed curve transseptal sheaths and catheters to facilitate movement of the sheath and catheter when used in conjunction with the V-CAS™ disposable sets in the Vdrive® system and with the Niobe® Magnetic Navigation System (MNS).
The Vdrive® with V-Sono™ disposable is indicated for remotely controlling the advancement, retraction, rotation and anterior-posterior deflection of compatible ultrasound catheters inserted into the right atrium. Compatible catheters at this time include Biosense Webster, Inc. Soundstar™ 3D Ultrasound Catheters and AcuNav™ Ultrasound Catheters. Other models of ICE catheters have not been tested with the Vdrive™ system.
The Vdrive® with V-Loop™ disposable is indicated to remotely control the advancement, retraction, tip deflection and loop size of compatible loop catheters inserted across the septum into the left atrium using conventional procedures. Compatible catheters at this time include Biosense Webster Lasso 2515 NAV Circular Mapping Catheters. Other models of loop catheters have not been tested with the Vdrive® system.
The Vdrive® with V-CAS™ disposable is indicated for remotely controlling the advancement, retraction, and rotation of compatible fixed curve transseptal sheaths, and the advancement and retraction of compatible magnetic electrophysiology (EP) mapping and ablation catheters inside the patient's heart when used in conjunction with a Stereotaxis Magnetic Navigation System. Compatible fixed curve sheaths at this time include the St. Jude Medical® Transseptal Sheath and Swartz™ Braided Transseptal Sheath. Other models of transseptal sheaths and mapping/ablation catheters have not been tested with the Vdrive® system. Vdrive® with V-CAS™ is contraindicated for vascular access sites other than the groin. It is not intended to advance the EP mapping and ablation catheters through the coronary vasculature nor the coronary sinus. The transseptal sheath is not to be moved while the EP catheter is actively delivering therapy.
The Vdrive Duo™ is an optional accessory intended for remotely controlling the Vdrive® system when one arm of the device is equipped with one disposable set (V-Sono™, V-Loop™ or V-CAS™) and the other arm is equipped with a different available disposable set. During the procedure, the Vdrive Duo™ allows selection between the disposable sets.
Vdrive® with V-CAST™ is intended to control a compatible fixed curve transseptal sheath and catheter during diagnostic and therapeutic cardiac procedures and is comprised of four major components:
- Vdrive® Hardware - control box, adjustable arm, drive unit and support structure or Vdrive Duo™ (K133396) - with two adjustable arms
- Vdrive® User Interface – combination of software-driven (a) Tableside Controller and (b) dedicated Vdrive® Controller
- V-CAST™ Disposable Kit – Handle Clamps, Catheter Support Tube and Drape. These components are disposable, sterile, single use devices.
- V-Loop™ Disposable Kit (K140804)
- V-Sono™ Disposable Kit (K122659)
The provided text appears to be a 510(k) summary for the Stereotaxis Vdrive, Vdrive with V-CAS, and Vdrive Duo systems. This document describes the device's intended use and performance data used to establish substantial equivalence to predicate devices, rather than a study designed to prove the device meets specific acceptance criteria in the context of an in-depth clinical performance evaluation for a high-risk device or AI/ML algorithm.
Specifically, the document outlines a premarket notification for a Class II medical device, which typically relies on demonstrating substantial equivalence to legally marketed predicate devices, often through non-clinical performance testing (bench, animal) and, if applicable, a review of existing clinical data or small, confirmatory clinical studies. The level of detail regarding acceptance criteria and ground truth establishment is much less stringent than what would be expected for a novel AI/ML device requiring robust clinical validation.
Based on the provided text, here's an attempt to answer your request, focusing on the information available:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly define a table of acceptance criteria with numerical targets for device performance in the same way an AI/ML study might, such as specific sensitivity, specificity, or AUC targets. Instead, it mentions that the device "met its performance and user requirements" through various tests and that the clinical study "supported the safety and effectiveness" of the system.
The closest we get to "performance" in a measurable sense for the V-CAS component is:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Safety and Effectiveness for controlling compatible transseptal sheaths and EP catheters. | Animal Testing: "[Vdrive™ with V-CAS™] met its performance and user requirements."Clinical Testing (V-CAS™ component in Vdrive Duo™): "Analysis of safety data showed that no adverse events related to the Vdrive® system occurred. Electrical PV isolation was achieved in 57/59 (96.6%) of targeted PVs using the ablation catheters controlled by the V-CAS™ disposable in the 15 subjects who underwent the ablation procedure using Vdrive Duo™ with V-CAS™." |
| User Requirements for sheath and catheter movements. | Demonstrated in animal study. |
| Functional Equivalence to existing predicate devices. | Assessed through comparison of technological characteristics and performance data (bench, animal, clinical review) to predicates. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set (Clinical Data for V-CAS™): For the V-CAS™ disposable used with Vdrive Duo™, data was collected from 15 subjects in the VERSATILE Study.
- Data Provenance: The VERSATILE Study was a prospective, randomized multi-center clinical trial. No specific countries of origin are mentioned, but "multi-center" implies multiple clinical sites, likely within the US given the FDA submission. The study is cited with a ClinicalTrials.gov identifier (NCT01656772).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The concept of "ground truth" as typically applied to diagnostic AI/ML algorithms (e.g., expert consensus for image findings) is not directly applicable here. This device is a robotic catheter control system. Therefore, the "ground truth" or primary outcome measure in the clinical study was related to the clinical success of the procedure facilitated by the device and occurrence of adverse events.
- For the V-CAS™ disposable: The outcome was the achievement of electrical pulmonary vein (PV) isolation. This outcome would have been determined by the treating electrophysiologists using established clinical methods (e.g., electrophysiological mapping demonstrating no conduction). The study involved "investigators," who would be qualified medical professionals, most likely electrophysiologists. However, the specific number and qualifications are not detailed beyond "investigators."
4. Adjudication Method for the Test Set
The document does not describe an adjudication method for establishing ground truth as might be done for image-based diagnostic decisions. For a procedural device, the primary "adjudication" would typically involve:
- Clinical assessment by the treating physician: The success of electrical PV isolation would be determined by the electrophysiologist performing the procedure based on real-time physiological data.
- Adverse event reporting and review: Safety outcomes would be documented and reviewed according to study protocols, likely by a clinical events committee or study monitors, but this isn't explicitly detailed as an adjudication method for defining "ground truth" in the diagnostic sense.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve With AI vs Without AI Assistance
No, an MRMC comparative effectiveness study of human readers with vs. without AI assistance was not conducted and is not relevant to this device.
The clinical study (VERSATILE Study) was a prospective, randomized multi-center trial comparing the Vdrive® with V-Loop™ system to conventional manual methods of navigation for circular mapping catheters. This is a comparison of robotic assistance versus manual methods for catheter navigation, not an AI-assisted diagnostic task. The V-CAS™ component (the subject of this 510(k)) was evaluated for safety as part of the Vdrive Duo™ arm of this trial, but the primary comparison was for V-Loop™.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
This device is fundamentally a "human-in-the-loop" system, as it is a remote control system for catheters operated by a physician. Therefore, a "standalone algorithm only" performance evaluation is not applicable. The device's function is to assist human control.
7. The Type of Ground Truth Used
The ground truth or primary outcome for the clinical evaluation of the V-CAS™ component (within the Vdrive Duo™ arm) was the clinical outcome of electrical PV isolation (a physiological/procedural outcome) and the occurrence of adverse events (safety outcome). This is distinct from "expert consensus," "pathology," or "outcomes data" in the sense of an independent, definitive diagnostic label. Rather, it's a measure of procedural success and safety during complex medical procedures.
8. The Sample Size for the Training Set
The document describes a 510(k) submission, which demonstrates substantial equivalence, not the development and training of an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning. The "training" for the device's development would involve engineering design, bench testing, and animal studies.
9. How the Ground Truth for the Training Set Was Established
As there is no AI/ML training set, this question is not applicable. The device's functional integrity and safety were established through a combination of engineering specifications, bench testing, and animal studies.
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 18, 2014
Stereotaxis. Inc. % Diana Horwitz, Ph.D., Rac Regulatory Consultant 2995 Steven Martin Dr, Fairfax, Virginia 22031
Re: K141530
Trade/Device Name: Vdrive, Vdrive with V-CAS, Vdrive Duo Regulation Number: 21 CFR 870.1290 Regulation Name: Steerable Catheter Control System Regulatory Class: Class II Product Code: DXX. DOX Dated: November 12, 2014 Received: November 12, 2014
Dear Diana Horwitz, Ph.D., Rac,
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR
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Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Melissa A. Torres -S
For Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K141530
Device Name Vdrive® Vdrive® with V-CASTM Vdrive Duo™
Indications for Use (Describe)
The Vdrive® system is intended to stabilize, navigate and remotely control:
· Compatible Intracardiac Echocardiography (ICE) catheters to facilitate visualization of cardiac structure during the performance of cardiac procedure when used in conjunction with the V-Sono™ disposable sets in the Vdrive® system,
· Compatible loop (circular) mapping catheters to facilitate movement of the catheter during the performance of electrophysiological procedures when used in conjunction with the V-Loop™ disposable sets in the Vdrive® system, and
· Compatible fixed curve transseptal sheaths and catheters to facilitate movement of the sheath and catheter when used in conjunction with the V-CAS™ disposable sets in the Vdrive® system and with the Niobe® Magnetic Navigation System (MNS).
The Vdrive® with V-Sono™ disposable is indicated for remotely controlling the advancement, retraction, rotation and anterior-posterior deflection of compatible ultrasound catheters inserted into the right atrium. Compatible catheters at this time include Biosense Webster, Inc. Soundstar™ 3D Ultrasound Catheters and AcuNav™ Ultrasound Catheters. Other models of ICE catheters have not been tested with the Vdrive™ system.
The Vdrive® with V-Loop™ disposable is indicated to remotely control the advancement, retraction, tip deflection and loop size of compatible loop catheters inserted across the septum into the left atrium using conventional procedures. Compatible catheters at this time include Biosense Webster Lasso 2515 NAV Circular Mapping Catheters. Other models of loop catheters have not been tested with the Vdrive® system.
The Vdrive® with V-CAS™ disposable is indicated for remotely controlling the advancement, retraction, and rotation of compatible fixed curve transseptal sheaths, and the advancement and retraction of compatible magnetic electrophysiology (EP) mapping and ablation catheters inside the patient's heart when used in conjunction with a Stereotaxis Magnetic Navigation System. Compatible fixed curve sheaths at this time include the St. Jude Medical® Transseptal Sheath and Swartz™ Braided Transseptal Sheath. Other models of transseptal sheaths and mapping/ablation catheters have not been tested with the Vdrive® system. Vdrive® with V-CAS™ is contraindicated for vascular access sites other than the groin. It is not intended to advance the EP mapping and ablation catheters through the coronary vasculature nor the coronary sinus. The transseptal sheath is not to be moved while the EP catheter is actively delivering therapy.
The Vdrive Duo™ is an optional accessory intended for remotely controlling the Vdrive® system when one arm of the device is equipped with one disposable set (V-Sono™, V-Loop™ or V-CAS™) and the other arm is equipped with a different available disposable set. During the procedure, the Vdrive Duo™ allows selection between the disposable sets.
Type of Use (Select one or both, as applicable)
ال Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary per 21CFR §807.92
| Submitter'sinformation | Stereotaxis, Inc.4320 Forest Park Ave, Suite 100St. Louis, MO 63108Contact: John Nadelin, VP Regulatory & QualityTelephone: 314-678-6130 |
|---|---|
| Device/classificationname | Device Name: Vdrive®, Vdrive® with V-CAST™, Vdrive Duo™Classification/Common name: System, Catheter Control, SteerableClassification Number: 870.1290Product Code: DXX, DQXClassification Panel: CardiovascularPredicate Devices:• Cardiodrive® Catheter Advancement System, K071029 (Stereotaxis)• Vdrive® with V-Loop™, K140804 (Stereotaxis)• Vdrive® with V-Sono™, K122659 (Stereotaxis)• Vdrive Duo™, K133396 (Stereotaxis)• Artisan S Control Catheter, K090365 (Hansen Medical) |
| Devicedescription | Vdrive® with V-CAST™ is intended to control a compatible fixed curve transseptalsheath and catheter during diagnostic and therapeutic cardiac procedures and iscomprised of four major components:1. Vdrive® Hardware - control box, adjustable arm, drive unit and supportstructure or Vdrive Duo™ (K133396) - with two adjustable arms2. Vdrive® User Interface – combination of software-driven(a) Tableside Controller and (b) dedicated Vdrive® Controller3. V-CAST™ Disposable Kit – Handle Clamps, Catheter Support Tube andDrape. These components are disposable, sterile, single use devices.4. V-Loop™ Disposable Kit (K140804)5. V-Sono™ Disposable Kit (K122659) |
| Intended use | The Vdrive® system is intended to stabilize, navigate and remotely control:• Compatible Intracardiac Echocardiography (ICE) catheters to facilitatevisualization of cardiac structure during the performance of cardiacprocedure when used in conjunction with the V-Sono™ disposable sets inthe Vdrive® system,• Compatible loop (circular) mapping catheters to facilitate movement of thecatheter during the performance of electrophysiological procedures whenused in conjunction with the V-Loop™ disposable sets in the Vdrive® |
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Image /page/5/Picture/1 description: The image is a logo for Stereotaxis. The logo features an orange abstract design on the left, followed by the word "STEREOTAXIS" in a bold, sans-serif font. Below the word, there is a tagline that reads "Improving Life with Robotic Precision and Safety" in a smaller font.
system, and
- Compatible fixed curve transseptal sheaths and catheters to facilitate movement of the sheath and catheter when used in conjunction with the V-CASTM disposable sets in the Vdrive® system and with the Niobe® Magnetic Navigation System (MNS).
The Vdrive® with V-Sono™ disposable is indicated for remotely controlling the advancement, retraction, rotation and anterior-posterior deflection of compatible ultrasound catheters inserted into the right atrium. Compatible catheters at this time include Biosense Webster. Inc. Soundstar™ 3D Ultrasound Catheters and Acuson AcuNav™ Ultrasound Catheters. Other models of ICE catheters have not been tested with the Vdrive® system.
The Vdrive® with V-Loop™ disposable is indicated to remotely control the advancement, retraction, rotation, tip deflection and loop size of compatible loop catheters inserted across the septum into the left atrium using conventional procedures. Compatible catheters at this time include Biosense Webster Lasso 2515 and Lasso 2515 NAV Circular Mapping Catheters. Other models of loop catheters have not been tested with the Vdrive® system.
The Vdrive® with V-CAS™ disposable is indicated for remotely controlling the advancement, retraction, and rotation of compatible fixed curve transseptal sheaths, and the advancement and retraction of compatible magnetic electrophysiology (EP) mapping and ablation catheters inside the patient's heart when used in conjunction with a Stereotaxis Magnetic Navigation System. Compatible fixed curve sheaths at this time include the St. Jude Medical® Transseptal Sheath and Swartz™ Braided Transseptal Sheath. Other models of transseptal sheaths and mapping/ablation catheters have not been tested with the Vdrive® system. Vdrive® with V-CASTM is contraindicated for vascular access sites other than the groin. It is not intended to advance the EP mapping and ablation catheters through the coronary vasculature nor the coronary sinus. The transseptal sheath is not to be moved while the EP catheter is actively delivering therapy.
The Vdrive Duo™ is an optional accessory intended for remotely controlling the Vdrive® system when one arm of the device is equipped with one disposable set (V-Sono™, V-Loop™ or V-CAS™) and the other arm is equipped with a different available disposable set. During the procedure, the Vdrive Duo™ allows selection between the disposable sets.
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Image /page/6/Picture/1 description: The image shows the Stereotaxis logo. The logo consists of an orange abstract shape on the left, followed by the word "STEREOTAXIS" in a bold, sans-serif font. Below the word "STEREOTAXIS" is the tagline "Improving Life with Robotic Precision and Safety" in a smaller font.
Technological Characteristics
| DeviceCharacter-istic | SubjectDeviceVdrive® withV-CASTM.Vdrive Duo™M | Predicate 1Cardiodrive®(K071029) | Predicate 2Vdrive® withV-LoopTM(K140804) | Predicate 3 & 4Vdrive® withV-Sono™(K122659.K133396) | Predicate 5Artisan SControlCatheter(K090365) |
|---|---|---|---|---|---|
| Location ofCatheter tip | Right atriumor left atrium | Same | Same | Right atrium | Same |
| InitialPlacement ofcatheter | Manualplacement byelectrophysiologist underfluoroscopy | Same | Same | Same | Same |
| Type ofProcedure | Diagnostic ortherapeutic EPprocedures | Same | Diagnostic EPprocedures | Cardiac imaging | DiagnosticEPprocedures |
| SheathMovements | Remoteretraction andadvancement.rotation | Does notcontrol sheath(this is donemanually) | N/A(no sheath) | N/A(no sheath) | Remoteretraction,advance-ment, anddeflection |
| CatheterMovements | Advance-retractMagneticsteering | Same | Advance/retract,rotation,deflection,loop size | Advance/ retract,rotation,deflection | None.Catheter iscaptured bysheath |
| Visualiza-tionDuringProcedure | Fluoroscopy,standard ofcare | Same | Same | Same | Same |
| Catheter TipMovement | Niobe(magneticnavigation) | Same | Vdrivemanipulation | Vdrivemanipulation | Articulatingsheathmovescatheter tip |
| Single UseDisposable | Sterile handleclampCatheterSupportDrape | Sterile DriveunitBracket | Same | Same | SheathcassetteIrrigationmanifoldDrape |
Performance data
Performance data establish the substantial equivalence of the Vdrive® with V-CAS™ compared to the predicate devices. Performance data included software verification and validation data, bench performance testing, animal testing, and reference to a prospective randomized multi-center clinical trial of the Vdrive® with V-Loop™ system in navigation of circular mapping catheters compared to conventional manual methods of navigation. Performance testing was conducted for electrical safety, EMC compatibility, sterilization and shelf life and packaging.
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Image /page/7/Picture/1 description: The image is a logo for Stereotaxis. The logo features an orange abstract shape on the left, followed by the word "STEREOTAXIS" in a bold, sans-serif font. Below the word, there is a tagline that reads "Improving Life with Robotic Precision and Safety."
Animal Testing: Stereotaxis performed an animal study in a porcine model to evaluate the safety and effectiveness of Vdrive® with V-CAS™ to perform sheath and catheter movements according to product requirements, product usability and extremes of use. This study demonstrated that Vdrive™ with V-CASTM met its performance and user requirements.
Clinical Testing: Stereotaxis performed a prospective, randomized multi-center clinical trial of the Vdrive® with V-Loop™ system compared to conventional manual methods of navigation in patients who underwent a pulmonary vein (PV) isolation procedure for treatment of atrial fibrillation (The VERSATILE Study, http://clinicaltrials.gov/show/NCT01656772). Out of the 120 enrolled subjects in this trial, investigators employed Vdrive Duo™ in 33 subjects, providing safety data on use of the combinations V-Loop™ + V-Sono™ (n=18) and V-Loop™ + V-CASTM (n=15). V-Sono™ was used to control the Biosense Webster, Inc. Soundstar™ 3D Ultrasound Catheter; V-Loop™ was used to control the Lasso 2515 NAV Circular Mapping Catheter; and V-CAS™ was used to control compatible magnetic electrophysiology mapping and ablation catheters in conjunction with a Stereotaxis Magnetic Navigation System and the St. Jude Medical® Transseptal Sheath or the Swartz™ Braided Transseptal Sheath. Results of this study supported the safety and effectiveness of the Vdrive® system, including the use of Vdrive Duo™ with combinations of two disposables. Analysis of safety data showed that no adverse events related to the Vdrive® system occurred. Electrical PV isolation was achieved in 57/59 (96.6%) of targeted PVs using the ablation catheters controlled by the V-CASTM disposable in the 15 subjects who underwent the ablation procedure using Vdrive Duo™ with V-CASTM.
Based upon the documentation presented in this 510(k) it has been demonstrated that the Vdrive® with V-CAS™ device is safe and effective for its intended use.
Date summary prepared: December 16, 2014
§ 870.1290 Steerable catheter control system.
(a)
Identification. A steerable catheter control system is a device that is connected to the proximal end of a steerable guide wire that controls the motion of the steerable catheter.(b)
Classification. Class II (performance standards).