(135 days)
Not Found
No
The document describes a motorized catheter advancement system controlled by a user interface and magnetic fields, with no mention of AI, ML, or related concepts.
No
The device is described as a tool that provides the physician with the ability to advance and retract magnetic EP catheters, and based on the intended use, it is designed to manipulate catheters during procedures, not to provide therapy itself.
No.
The document describes the device as a tool for advancing and retracting catheters for mapping and ablation, focusing on navigation and control of the catheter, not on diagnosing conditions or generating diagnostic information itself.
No
The device description explicitly states it provides a "motorized navigation of the catheter" and is a "tool that provides the physician with the ability to advance and retract magnetic EP catheters," indicating a hardware component responsible for physical movement.
Based on the provided information, the Stereotaxis Cardiodrive is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside the body (in vitro).
- Stereotaxis Cardiodrive Function: The Stereotaxis Cardiodrive is a mechanical device used to manipulate a catheter inside the patient's heart. It is used for navigation and positioning of the catheter during a medical procedure.
- Intended Use: The intended use clearly states it's for advancing and retracting catheters inside the patient's heart. This is an in vivo (within the living body) application, not an in vitro one.
Therefore, the Stereotaxis Cardiodrive falls under the category of a medical device used for a therapeutic or interventional procedure, not an IVD.
N/A
Intended Use / Indications for Use
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.
Product codes
DOX
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
inside the patient's heart
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physician
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Image /page/0/Picture/1 description: The image shows the text "K07/029 page 1 of 2" along with the date "April 9, 2007" and "Page 28". The text appears to be handwritten or typed in a simple font. The layout suggests it could be part of a document or report, possibly indicating a page number and date of creation. The text is clear and legible, with a slightly aged or worn appearance.
Appendix 1: 510(k) Summary per 21CFR §807.92
| Submitter's
information | Stereotaxis, Inc.
4320 Forest Park Ave, Suite 100
St. Louis, MO 63108
Contact: Dennis Pozzo, Regulatory Affairs Specialist
Phone: 314-678-6136
March 30, 2007 | AUG 2 4 2007 |
|-----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| Device/
classification
name | • 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 System
Stereotaxis Cardiodrive® Catheter Advancer System
Stereotaxis Catheter Advancement System (CAS) | |
| Device
description | 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. | |
| Intended use | 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.
Continued on next page | |
1
Image /page/1/Picture/1 description: The image shows the text "K071020 Page", "April 9, 2007 2 of 2", and "Page 29". The text appears to be handwritten or typed in a simple font. The date is clearly visible, and the page number is crossed out.
Appendix 1: 510(k) Summary per 21CFR §807.92, Continued
| Technological
characteristics | There have been no modifications to the Cardiodrive CAS. The table below
lists device characteristics. | | |
|----------------------------------|-----------------------------------------------------------------------------------------------------------|------------------------------|-------------------------------|
| | 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 |
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.
2
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
3
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
4
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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