(156 days)
The Vdrive™ system is intended to stabilize, navigate and remotely control:
• 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.
• 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.
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-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 Duo™ is an optional accessory intended for remotely controlling the Vdrive™ system when one arm of the device is equipped with a V-Loop™ disposable set and the other arm is equipped with the V-Sono™ disposable set. During the procedure, the Vdrive Duo™ allows selection between the disposable sets (V-Loop™ or V-Sono™).
The Vdrive™ with V-Loop™ is provides a remote method of controlling the advancement, retraction, rotation, tip deflection, and loop size of a LASSO® Circular Mapping catheter during electrophysiology 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 1) Tableside Controller and 2) dedicated Vdrive™ Controller,
- V-Loop™ Disposable Kit – Handle Clamps (w/catheter inserts), Telescoping Catheter Support and Drape. These components are disposable, sterile, single use devices, and
- V-Sono™ Disposable Kit (K122659) if Vdrive Duo™ will be used.
The STERETAXIS Vdrive™ with V-Loop™ and Vdrive Duo™ system is a catheter control system designed to stabilize, navigate, and remotely control compatible loop mapping catheters and Intracardiac Echocardiography (ICE) catheters during electrophysiological and cardiac procedures, respectively. The following information details the acceptance criteria and the study proving the device meets these criteria.
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state quantitative acceptance criteria in a table format. However, based on the performance data section, the implicit acceptance criteria are:
| Acceptance Criteria Category | Implicit Acceptance Criteria | Reported Device Performance/Conclusion |
|---|---|---|
| Software Verification & Validation | Software functions as intended and meets specifications. | Performance data includes "software verification and validation data." While specific metrics are not detailed, the overall conclusion is that this data contributed to establishing substantial equivalence. |
| Bench Performance Testing | Device meets all specified bench performance requirements (e.g., control of advancement, retraction, rotation, tip deflection, loop size, variable speed, continuous movement, emergency stop). | Performance data includes "bench performance testing to verify that specifications were met." No specific quantitative results are provided for individual functions, but the overall statement implies successful fulfillment of these technical specifications. |
| Electrical Safety | Device is electrically safe. | "Performance testing was conducted for electrical safety." (Implied successful) |
| EMC Compatibility | Device is electromagnetically compatible. | "Performance testing was conducted for...EMC compatibility." (Implied successful) |
| Sterilization & Shelf Life | Disposable components can be effectively sterilized and maintain sterility over their shelf life, and packaging is adequate. | "Performance testing was conducted for...sterilization and shelf life and packaging." (Implied successful) |
| Animal Testing (Safety & Effectiveness) | Device safely and effectively performs navigation, electrogram generation, mapping, and pacing during navigation; meets product usability and extremes of use requirements in an animal model. | "This study demonstrated that Vdrive™ with V-Loop™ met its performance and user requirements." |
| Clinical Efficacy (Non-Inferiority to Manual Navigation) | Vdrive™ with V-Loop™ system is non-inferior to conventional manual methods for navigation of circular mapping (loop) catheters in terms of efficacy. | "Results of the efficacy analysis demonstrated that the Stereotaxis Vdrive™ with V-Loop™ is effective when used to control a circular mapping system catheter when compared to manual navigation; the Vdrive™ with V-Loop™ is non-inferior to the manual procedure." Specific metrics for non-inferiority are not provided in this summary, but the conclusion states it was met. |
| Clinical Safety | The device does not introduce an unacceptable rate or type of adverse events compared to manual methods. | "The safety analysis led to the conclusion that similar adverse events between groups, and that the low rate of adverse events was unrelated to use of the Vdrive™ system." |
| Vdrive Duo™ Performance | Vdrive Duo™ effectively controls two different disposables (V-Loop™ and V-Sono™). | "Vdrive Duo™ was used to control two different disposables in a total of 33 subjects in the VERSATILE trial." (Implied successful, as it contributes to the overall safety and effectiveness conclusion). |
2. Sample Size Used for the Test Set and Data Provenance
The primary clinical study supporting efficacy and safety was a prospective, randomized multi-center clinical trial.
- Sample Size: A total of 137 subjects were randomized.
- Vdrive Group: 77 subjects
- Control (Manual) Group: 43 subjects
- (Note: The total of 77 + 43 = 120 subjects is less than the stated 137 randomized subjects. This may indicate some exclusions post-randomization or that 137 was the total randomized and 120 subjects actually underwent the procedure for data collection).
- Vdrive Duo™ specific performance: 33 subjects used Vdrive Duo™ in the VERSATILE trial.
- Data Provenance:
- Country of Origin: Not explicitly stated, but given the FDA review and the company being based in St. Louis, MO, USA, it is highly likely the clinical sites were in the United States.
- Retrospective or Prospective: Prospective. The study is described as a "prospective, randomized multi-center clinical trial."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not describe the establishment of a "ground truth" in the typical sense of expert annotation for an AI device. This is a medical device for catheter control, and the "ground truth" for its performance would be the clinical outcomes and procedural success, evaluated by the participating physicians.
- The study was a randomized clinical trial comparing the device to manual navigation. The clinical outcomes (e.g., efficacy of PV isolation, safety profile) were the direct measures of performance, as assessed by the clinical trial investigators.
- The qualifications of the experts (physicians) performing the procedures and assessing outcomes are implicitly assumed to be board-certified electrophysiologists, as they are conducting complex EP studies and ablation procedures. However, their specific qualifications (e.g., years of experience) are not detailed in this summary.
4. Adjudication Method for the Test Set
The document does not describe an explicit "adjudication method" for the clinical trial data in the way one might for image interpretation studies (e.g., 2+1, 3+1). Clinical trial data for efficacy and safety would typically be collected and analyzed according to a predefined statistical analysis plan, with internal and external monitoring to ensure data integrity. Adverse events would be reported and reviewed by the investigators and potentially an independent Data Safety Monitoring Board (DSMB), but this is not typically referred to as "adjudication" in the same context as ground truth establishment for AI.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not conducted in the context of human readers improving with AI assistance. The study was a clinical trial comparing a device-assisted procedure (Vdrive™ with V-Loop™) directly against a manual procedure, not an evaluation of how AI assistance impacts human interpretation. Therefore, there is no mention of an effect size for human readers improving with AI vs. without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, this is a robotic catheter control system, not an AI algorithm for diagnostic interpretation. The device's function is to assist in real-time catheter manipulation. Therefore, a "standalone algorithm only" performance evaluation is not relevant or applicable for this type of medical device. The device's performance is inherently tied to its use by a human operator in a procedural context.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance was established through:
- Clinical Outcomes/Procedural Success: In the randomized clinical trial, the effectiveness was measured by the ability to achieve the procedural goal (e.g., PV isolation where a circular mapping catheter is used to evaluate PVs), with non-inferiority to the manual method as the success criterion.
- Safety Profile: Comparison of adverse events between the device and control groups.
- Performance Requirements: Meeting specific technical "performance and user requirements" evaluated in bench and animal testing.
It is a performance-based ground truth, not an "expert consensus," "pathology," or "outcomes data" in the typical AI diagnostic context, but rather a direct assessment of the device's ability to perform its intended function safely and effectively in a clinical setting compared to standard of care.
8. The Sample Size for the Training Set
This document describes a premarket notification (510(k)) for a medical device that is not an AI/ML-driven diagnostic or therapeutic algorithm that relies on a "training set" of data for its core function. The device is a robotic control system. Therefore, the concept of a "training set" as it applies to machine learning models is not relevant here, and no such sample size is reported.
The "training" for this device would refer to the developmental and testing phases, including bench testing, animal studies, and the clinical trial, which validate its mechanical and software functions as designed.
9. How the Ground Truth for the Training Set Was Established
As explained in point 8, the concept of a "training set" and its "ground truth" in the context of machine learning does not apply to this robotic catheter control system as described in the provided document. The device's functionality is based on engineering principles and validated through a traditional medical device development pathway (bench, animal, and human clinical studies) rather than a data-driven model learning from a labeled training set.
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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
September 3, 2014
Stereotaxis. Inc. % Diane Horwitz, Ph.D., Rac Safis Solutions LLC 2995 Steven Martin Dr. Fairfax, Virginia 22031
Re: K140804
Trade/Device Name: Vdrive With V-loop/ Vdrive Duo Regulation Number: 21 CFR 870.1290 Regulation Name: System, Catheter Control, Steerable Regulatory Class: Class II (two) Product Codes: DXX, DOX Dated: July 29, 2014 Received: July 30, 2014
Dear Diane Horwitz,
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.
FDA
forBram 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) K140804
Device Name Vdrive™ with V-Loop Vdrive Duo™
Indications for Use (Describe)
The Vdrive™ system is intended to stabilize, navigate and remotely control:
· 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. · 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.
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-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 Duo™ is an optional accessory intended for remotely controlling the Vdrive™ system when one arm of the device is equipped with a V-Loop™ disposable set and the other arm is equipped with the V-Sono™ disposable set. During the procedure, the Vdrive Duo™ allows selection between the disposable sets (V-Loop™ or V-Sono™).
| Type of Use (Select one or both, as applicable) | ||
|---|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D)☐ Over-The-Counter Use (21 CFR 801 Subpart C) | ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ||
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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Image /page/4/Picture/0 description: The image shows the logo for Stereotaxis. 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, there is a tagline that reads "Improving Life with Robotic Precision and Safety."
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 Duo™Classification/Common name: System, Catheter Control, SteerableClassification Number: 870.1290Product Code: DXX, DQXClassification Panel: CardiovascularCurrently Marketed Substantially Equivalent Device: Vdrive™ with V-Sono™ (K122659) | ||
| Devicedescription | The Vdrive™ with V-Loop™ is provides a remote method of controlling theadvancement, retraction, rotation, tip deflection, and loop size of a LASSO® CircularMapping catheter during electrophysiology procedures and is comprised of fourmajor components:1. Vdrive™ Hardware - control box, adjustable arm, drive unit and supportstructure or Vdrive Duo™ (K133396), with two adjustable arms,2. Vdrive™ User Interface – combination of software-driven 1) TablesideController and 2) dedicated Vdrive™ Controller,3. V-Loop™ Disposable Kit – Handle Clamps (w/catheter inserts),Telescoping Catheter Support and Drape. These components aredisposable, sterile, single use devices, and4. V-Sono™ Disposable Kit (K122659) if Vdrive Duo™ will be used. | ||
| Intended use | The Vdrive™ system is intended to stabilize, navigate and remotely control:• 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™system.• 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.The Vdrive™ with V-Loop™ disposable is indicated to remotely control theadvancement, retraction, rotation, tip deflection and loop size of compatible loopcatheters inserted across the septum into the left atrium using conventionalprocedures. Compatible catheters at this time include Biosense Webster Lasso 2515and Lasso 2515 NAV Circular Mapping Catheters. Other models of loop cathetershave not been tested with the Vdrive™ system. |
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Image /page/5/Picture/0 description: The image is a logo for Stereotaxis. 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.
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 Duo™ is an optional accessory intended for remotely controlling the Vdrive™ system when one arm of the device is equipped with a V-Loop™ disposable set and the other arm is equipped with the V-Sono™ disposable set. During the procedure, the Vdrive Duo™ allows selection between the disposable sets (V-Loop™ or V-Sono™).
Technological characteristics
| DeviceCharacteristic | ProposedVdrive™ with V-Loop™,Vdrive Duo™ | Currently MarketedVdrive™ with V-Sono™ |
|---|---|---|
| Location ofCatheter tip | Right side of heart | Right or left side of heart |
| Initial Placementof catheter | Manual placement by cardiacelectrophysiologist | Manual placement by cardiacelectrophysiologist |
| Catheter Movement | Mechanical | Mechanical |
| Variable Speed | Yes | Yes |
| Catheter Movement | Continuous | Continuous |
| Emergency StopOption | Manual | Manual |
| Manual Override | Yes | Yes |
| Single Use | Disposable is single use | Disposable is single use |
| SterilizationMethod | EtO | EtO |
| Control of cathetermovement | Mechanical | Mechanical |
| CompatibleCatheters | LASSO® 2515 VariableCircular Mapping Catheter,LASSO® 2515 NAVLASSO ® 2515 ECO NAVVariable Circular MappingCatheter (Biosense Webster) | Soundstar™ 3D UltrasoundCatheters (Biosense Webster)AcuNav™ UltrasoundCatheters (AcuNav) |
| Cathetermovements | Advancement-retractionRotationTip deflectionLoop size | Advancement-retractionRotationAnterior-posterior deflection |
Continued on next page
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Image /page/6/Picture/0 description: The image is a logo for Stereotaxis. The logo features a stylized orange graphic on the left, resembling two leaves or petals enclosing a teal dot. To the right of the graphic is the company name, "STEREOTAXIS," in a bold, sans-serif font. Below the company name is the tagline, "Improving Life with Robotic Precision and Safety," in a smaller, lighter font.
| DeviceCharacteristic | ProposedVdrive™ with V-Loop™,Vdrive Duo™ | Currently MarketedVdrive™ with V-Sono™ |
|---|---|---|
| Control Room UserInterface | Yes | Yes |
| SW driven | Yes | Yes |
| Simultaneous Useof two Vdrive™Disposables | Yes | No |
Performance data
Performance data established the substantial equivalence of the Vdrive™ with V-Loop™ compared to the predicate device. Performance data included software verification and validation data, bench performance testing to verify that specifications were met, animal testing, and 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.
Animal Testing: Stereotaxis performed an animal study in a porcine model to evaluate the safety and effectiveness of the Vdrive™ with V-Loop™ to perform navigation, electrogram generation, mapping and pacing during navigation, product usability and extremes of use. This study demonstrated that Vdrive™ with V-Loop™ met its performance and user requirements.
Clinical Testing: Stereotaxis performed a prospective, randomized multi-center clinical trial of the Vdrive™ with V-Loop™ system in navigation of circular mapping (loop) catheters compared to conventional manual methods of navigation. A total of 137 subjects were randomized 2:1 (Vdrive™: Control) at five (5) clinical sites. Actual enrollment was 77 Vdrive™ and 43 control group subjects who were scheduled to undergo electrophysiology (EP) studies and a planned ablation procedure for pulmonary vein (PV) isolation, and who required the use of a circular mapping catheter to evaluate the PVs. Results of the efficacy analysis demonstrated that the Stereotaxis Vdrive™ with V-Loop™ is effective when used to control a circular mapping system catheter when compared to manual navigation; the Vdrive™ with V-Loop™ is non-inferior to the manual procedure. The safety analysis led to the conclusion that similar adverse events between groups, and that the low rate of adverse events was unrelated to use of the Vdrive™ system. Vdrive Duo™ was used to control two different disposables in a total of 33 subjects in the VERSATILE trial.
Based upon the documentation presented in this 510(k) it has been demonstrated that the Vdrive™ with V-Loop™ device is safe and effective for its intended use.
Date summary prepared: September 3, 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).