(135 days)
The Stereotaxis Cardiodrive is intended for automatically advancing and retracting only compatible magnetic electrophysiology [EP] mapping and ablation catheters inside the patient's heart when used in conjunction with a Stereotaxis Magnetic Navigation System (MNS). It is not intended to advance the EP mapping and ablation catheters through the coronary vasculature nor the coronary sinus.
The Cardiodrive® provides a User Interface to control the motorized navigation of the catheter, in conjunction with the MNS magnetic fields. It is a tool that provides the physician with the ability to advance and retract magnetic EP catheters. The Cardiodrive® is designed only for use with compatible magnetic EP mapping catheters inside the patient's heart steered with a Stereotaxis MNS.
The Stereotaxis Cardiodrive® Catheter Advancement System (CAS) received 510(k) clearance (K071029) based on substantial equivalence to the previously marketed Cardiodrive® Catheter Advancement System. The device is intended for automatically advancing and retracting compatible magnetic electrophysiology (EP) mapping and ablation catheters inside the patient's heart in conjunction with a Stereotaxis Magnetic Navigation System (MNS).
Here's an analysis of the provided information:
1. Table of acceptance criteria and the reported device performance
The provided document does not explicitly state "acceptance criteria" in terms of specific performance metrics with numerical thresholds (e.g., accuracy > 90%). Instead, the substantial equivalence determination is based on the device having no modifications to its technological characteristics compared to the predicate device.
| Device Characteristic | Proposed Cardiodrive® CAS | Predicate Cardiodrive® CAS |
|---|---|---|
| Catheter Retraction/Advancement | Mechanical | Mechanical |
| Variable Speed | Yes | Yes |
| Catheter Movement | Stepped or Continuous | Stepped or Continuous |
| Emergency Stop Option | Mechanical or Manual | Mechanical or Manual |
| Manual Override | Yes | Yes |
| Stop Switch | Yes | Yes |
Reported Device Performance:
The document states: "Based upon the objective evidence presented in this 510(k) it has been demonstrated that any compatible magnetically tipped EP ablation catheter can be used safely and effectively when used with the Cardiodrive® CAS."
This statement serves as the overall conclusion of the device's performance, implying it meets the necessary safety and effectiveness standards, likely through the comparison of technological characteristics and potentially other non-clinical tests (though not detailed here) to demonstrate equivalence.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The provided documents do not mention any specific test set size, data provenance, or the nature of any clinical studies involving human subjects or real-world data. The clearance is based on technological equivalence.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
No information is provided regarding experts, ground truth establishment, or clinical performance studies typically requiring such elements. The submission primarily focuses on technical characteristics for substantial equivalence.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
No information is provided regarding adjudication methods, as there is no mention of a clinical test set requiring expert review.
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 MRMC study was conducted or referenced. This device is a mechanical catheter advancement system, not an AI-powered diagnostic or assistive tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This refers to an algorithm's performance without human interaction. This is a medical device, a catheter advancement system, not a software algorithm. Therefore, "standalone" algorithm performance is not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
No specific "ground truth" as typically defined for diagnostic or predictive algorithms is mentioned. The ground for clearance is based on the technological characteristics being substantially equivalent to a predicate device and a general demonstration of safe and effective use through objective evidence, which predominantly would be engineering tests and comparisons rather than clinical outcomes.
8. The sample size for the training set
No training set is mentioned or applicable, as this device is not an AI/ML model for which training data would be used.
9. How the ground truth for the training set was established
Not applicable, as there is no AI/ML model or training set.
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Appendix 1: 510(k) Summary per 21CFR §807.92
| Submitter'sinformation | Stereotaxis, Inc.4320 Forest Park Ave, Suite 100St. Louis, MO 63108Contact: Dennis Pozzo, Regulatory Affairs SpecialistPhone: 314-678-6136March 30, 2007 | AUG 2 4 2007 |
|---|---|---|
| Device/classificationname | • Device Name:Cardiodrive® CAS• Classification/Common name:Percutaneous Catheter & Wire, Guide, Catheter• The marketed device(s) to which substantial equivalence is claimed:Cardiodrive® Catheter Advancement SystemStereotaxis Cardiodrive® Catheter Advancer SystemStereotaxis Catheter Advancement System (CAS) | |
| Devicedescription | The Cardiodrive® provides a User Interface to control the motorizednavigation of the catheter, in conjunction with the MNS magnetic fields.It is a tool that provides the physician with the ability to advance and retractmagnetic EP catheters. The Cardiodrive® is designed only for use withcompatible magnetic EP mapping catheters inside the patient's heart steeredwith a Stereotaxis MNS. | |
| Intended use | The Stereotaxis Cardiodrive® is intended for automatically advancing andretracting only compatible magnetic electrophysiology [EP] mapping andablation catheters inside the patient's heart when used in conjunction with aStereotaxis Magnetic Navigation System (MNS). It is not intended toadvance the EP mapping and ablation catheters through the coronaryvasculature nor the coronary sinus.Continued on next page |
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Appendix 1: 510(k) Summary per 21CFR §807.92, Continued
| Technologicalcharacteristics | There have been no modifications to the Cardiodrive CAS. The table belowlists device characteristics. | ||
|---|---|---|---|
| Device Characteristic | ProposedCardiodrive® CAS | PredicateCardiodrive® CAS | |
| CatheterRetraction/Advancement | Mechanical | Mechanical | |
| Variable Speed | Yes | Yes | |
| Catheter Movement | Stepped or Continuous | Stepped or Continuous | |
| Emergency Stop Option | Mechanical or Manual | Mechanical or Manual | |
| Manual Override | Yes | Yes | |
| Stop Switch | Yes | Yes |
Performance data
Based upon the objective evidence presented in this 510(k) it has been demonstrated that any compatible magnetically tipped EP ablation catheter can be used safely and effectively when used with the Cardiodrive® CAS.
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Public Health Service
Image /page/2/Picture/2 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the symbol. The text is in all caps and is written in a sans-serif font.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 2 4 2007
Stereotaxis. Inc. c/o Mr. Dennis Pozzo Regulatory Affairs Specialist 4320 Forest Park Ave. Suite 100 St. Louis, MO 63108
Re: K071029
Trade/Device Name: Cardiodrive Catheter Advancement System (CAS) Regulation Number: 21 CFR 870.1330 Regulation Name: Wire, Guide, Catheter Regulatory Class: Class II Product Code: DOX Dated: July 26, 2007 Received: July 27, 2007
Dear Mr. Pozzo:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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
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Page 2 - Mr. Dennis Pozzo
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 Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at 240-276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Duna R. de Luna
b
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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Appendix 2: Indications for Use Statement
Statement The indications for Use Statement:
510(k) Number: K_071029
Device Name: Cardiodrive® Catheter Advancement System (CAS)
The Stereotaxis Cardiodrive is intended for automatically advancing and retracting only compatible magnetic electrophysiology [EP] mapping and ablation catheters inside the patient's heart when used in conjunction with a Stereotaxis Magnetic Navigation System (MNS). It is not intended to advance the EP mapping and ablation catheters through the coronary vasculature nor the coronary sinus.
Prescription Use X = AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (Part 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| R. W. Jones | |
|---|---|
| (Division Sign-Off) |
Division of Čardiovascular Devices____________________________________________________________________________________________________________________________________________
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510(k) Number_Ko7102 9
§ 870.1330 Catheter guide wire.
(a)
Identification. A catheter guide wire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.(b)
Classification. Class II (special controls). The device, when it is a torque device that is manually operated, non-patient contacting, and intended to manipulate non-cerebral vascular guide wires, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.