(663 days)
021802
Not Found
No
The description focuses on automated mechanical movement based on user input, with no mention of AI/ML terms or capabilities like learning, adaptation, or data analysis for decision making.
No
The device is used to advance and retract mapping catheters, which are diagnostic tools, not to provide therapy.
No
The device is described as advancing and retracting EP mapping catheters to perform a function (mapping), but it does not perform any diagnostic analysis of its own. It's an ancillary device for a larger system that might be used for diagnosis.
No
The device description explicitly lists hardware components such as an electrical controller, motor assembly, user controls, advancer unit, patient mounting bracket, flexible drive shaft, and hemostasis valve adapter.
Based on the provided information, the Stereotaxis Cardiodrive® is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In vitro diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Cardiodrive® Function: The Cardiodrive® is a mechanical device used to manipulate a catheter inside the patient's heart. It is used for navigation and positioning of a catheter during an electrophysiology procedure.
- No Specimen Analysis: The description clearly states its function is to advance and retract a catheter within the patient's body. There is no mention of analyzing any biological specimens.
Therefore, the Stereotaxis Cardiodrive® falls under the category of a medical device used for interventional procedures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Stereotaxis Cardiodrive® is intended for automatically advancing and retracting only compatible magnetic electrophysiology [EP] mapping catheters. It is not intended to advance the EP mapping catheter through the coronary vasculature nor the coronary sinus.
The Cardiodrive® is intended for automatically advancing and retracting only compatible magnetic electrophysiology [EP] mapping 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 catheter through the coronary vasculature nor the coronary sinus.
Product codes
DQY
Device Description
The Cardiodrive® advances or retracts a compatible magnetic electrophysiology [EP] mapping catheter, through a hemostasis introducer, remotely via a User Interface (UI) located either at the patient table or in the control room.
The Stereotaxis Cardiodrive® consists of an electrical controller, motor assembly, and user controls, plus sterile, single-use advancer unit, patient mounting bracket, flexible drive shaft, and hemostasis valve adapter.
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
Not Found
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)
Bench testing demonstrates that the Stereotaxis Cardiodrive® performs in an equivalent manner to the Stereotaxis Catheter Advancer System (CAS) predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
021802
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).
0
K042850
Page 1 of 1
Appendix 1 – 510(k) Summary of Safety and Effectiveness
| Statement | Information supporting claims of substantial equivalence, as defined under
the Federal Food, Drug and Cosmetic Act, respecting safety and effectiveness
is summarized below.
For the convenience of the Reviewer, this summary is formatted in
accordance with the Agency's final rule "...510(k) Summaries and 510(k)
Statements..." (21 CFR §807) and can be used to provide a substantial
equivalence summary to anyone requesting it from the Agency. |
|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device
description | The Cardiodrive® advances or retracts a compatible magnetic
electrophysiology [EP] mapping catheter, through a hemostasis introducer,
remotely via a User Interface (UI) located either at the patient table or in the
control room. |
| Intended use | The Stereotaxis Cardiodrive® is intended for automatically advancing and
retracting only compatible magnetic electrophysiology [EP] mapping
catheters. It is not intended to advance the EP mapping catheter through the
coronary vasculature nor the coronary sinus. |
| Technological
characteristics | The Stereotaxis Cardiodrive® consists of an electrical controller, motor
assembly, and user controls, plus sterile, single-use advancer unit, patient
mounting bracket, flexible drive shaft, and hemostasis valve adapter. |
| Performance
data | Bench testing demonstrates that the Stereotaxis Cardiodrive® performs in an
equivalent manner to the Stereotaxis Catheter Advancer System (CAS)
predicate device. |
| Conclusion | The Stereotaxis Cardiodrive® is substantially equivalent to the Stereotaxis
Catheter Advancer System (CAS) (021802) predicate device. |
| Contact | Gary M. Rauvola, Director, Regulatory Affairs for Disposable Products |
| Date | September 20, 2004 |
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG - 9 2006
Stereotaxis, Inc. c/o Mr. Gary Rauvola, RAC Director, Regulatory Affairs - Disposable Products 4320 Forest Park Avenue Suite 100 St. Louis, MO 63108
K042850 Re:
Trade/Device Name: Stereotaxis Cardiodrive® Catheter Advancer System Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II (two) Product Code: DQY Dated: June 12, 2006 Received: June 13, 2006
Dear Mr. Rauvola:
We have reviewed your Section 510(k) premarket notification of intent to market the device w 6 nave review your see determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreate) it itgans)
commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to econiner of the 1125 2011-11-11 in accordance with the provisions of the Federal Food, Drug, de nees that have been receasing t require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The I va may, diciere, mailes of the Act include requirements for annual registration, listing of general controls provisions of ractice, 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 If your device 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 1 Toast of advised that 1197 5 results over device complies with other requirements of the Act that I DA has made a detel regulations administered by other Federal agencies. You must
2
Page 2 - Mr. Gary Rauvola, RAC
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,
Bhimmarfor
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Appendix 2 - Indications for Use Statement
Statement
The indications for Use Statement:
510(k) Number: K042850_______________________________________________________________________________________________________________________________________________________
Device Name: Stereotaxis Cardiodrive®
Stereotaxis Cardiodrive®:
The Cardiodrive® is intended for automatically advancing and retracting only compatible magnetic electrophysiology [EP] mapping 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 catheter through the coronary vasculature nor the coronary sinus.
X ____________________________________________________________________________________________________________________________________________________________________________ Prescription Use 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)
$\nearrow$
S.K. McComber
Julsion Sign-Off) Division of Cardlovascular Devloes 510(k) Number
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