(309 days)
Not Found
No
The summary describes a mechanical device for catheter manipulation and does not mention any AI/ML components or functionalities.
No.
The device is used to advance and retract a catheter, but it does not directly treat a disease or condition itself.
No
The device is intended for advancing and retracting a catheter, which is a therapeutic manipulation rather than a diagnostic one. It does not mention recognizing or interpreting physiological signals or anatomical structures for diagnostic purposes.
No
The device description explicitly lists multiple hardware components (Controller, Motor, User Interface, Advancer Unit, Patient Mounting Bracket, Flexible Drive Shaft, Hemostasis Introducer Adapter) in addition to any potential software.
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 (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Cardiodrive™ Function: The description clearly states the Cardiodrive™ is a tool for mechanically advancing and retracting a catheter within the heart. It is used in vivo (within the living body) to manipulate a medical device.
- No Specimen Analysis: There is no mention of the Cardiodrive™ analyzing any biological specimens or providing diagnostic information based on such analysis.
Therefore, the Stereotaxis Cardiodrive™ is 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 the Stereotaxis Tangent™ Electrophysiology Catheter (part # 001-001223-1) of 7F shaft diameter and 8F tip. The Cardiodrive™ is intended to advance the Stereotaxis Tangent™ Electrophysiology Catheter in the right side of the heart only. It is not intended to advance the Tangent™ Electrophysiology Catheter through the coronary vasculature nor the coronary sinus.
Product codes (comma separated list FDA assigned to the subject device)
DQY, DQX
Device Description
The Stereotaxis Cardiodrive™ is a tool that provides the physician with the ability to advance and retract catheters either standing bedside, or from a control room. The Stereotaxis Cardiodrive™ consists of an electrically powered Controller, Motor, and User Interface, plus sterile single-use Advancer Unit, Patient Mounting Bracket, Flexible Drive Shaft, and Hemostasis Introducer Adapter.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
right side of the heart
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physician, bedside or from a control room.
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 and animal testing demonstrate that the Stereotaxis Cardiodrive™ performs in an equivalent manner to the Jomed Trak Back predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
K021802
Appendix A: 510(k) Summary of Safety and Effectiveness (rev. 04-03-03)
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. The Stereotaxis Cardiodrive™ is a tool that provides the physician with the ability description and the choice to advance and retract catheters either standing bedside, or from a control room. The Stereotaxis Cardiodrive™ is intended for automatically advancing and retracting Intended use only the Stereotaxis Tangent™ Electrophysiology Catheter (part # 001-001223-1) of 7F shaft diameter and 8F tip. The Cardiodrive™ is intended to advance the Stereotaxis Tangent™ Electrophysiology Catheter in the right side of the heart only. It is not intended to advance the Tangent™ Electrophysiology Catheter through the coronary vasculature nor the coronary sinus. The Stereotaxis Cardiodrive™ consists of an electrically powered Controller, Motor, Technological and User Interface, plus sterile single-use Advancer Unit. Patient Mounting Bracket, characteristics Flexible Drive Shaft, and Hemostasis Introducer Adapter. Bench testing and animal testing demonstrate that the Stereotaxis Cardiodrive™ Performance performs in an equivalent manner to the Jomed Trak Back predicate device. The Stereotaxis Cardiodrive is substantially equivalent to the Jomed Trak Back
Conclusion (K990271) and the IntraLuminal Therapeutics ILT Catheter (K001992) predicate devices.
Gary M. Rauvola, Director, Regulatory Affairs for Disposable Products Contact
Date
data
Device
April 3. 2003
—
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APR 0 8 2003
1
Image /page/1/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, formed by three overlapping profiles of human faces.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 0 8 2003
Stereotaxis. Inc. c/o Mr. Gary M. Rauvola Director, Regulatory Affairs for Disposable Products 4041 Forest Park Avenue St. Louis, Missouri 63108
Re: K021802
Trade Name: Stereotaxis Cardiodrive Regulation Number: 21 CFR 870.1250 and 870.1330 Regulation Name: Percutaneous Catheter and Catheter Guide Wire Regulatory Class: Class II (two) Product Code: DQY and DQX Dated: January 24, 2003 Received: January 27, 2003
Dear Mr. Rauvola:
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 the Act
2
Page 2 - Mr. Gary M. Rauvola
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 (301) 594-4646. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
D D/Z 1 M.D
Bram D/Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Appendix B: Indications for Use Statement
(rev. 04-03-03)
Indications for Use Statement: Statement
510(k) Number: K021802
Device Name: Stereotaxis Cardiodrive™
Indications for Use: The Stereotaxis Cardiodrive™ is intended for automatically advancing and retracting only the Stereotaxis Tangent™ Electrophysiology Catheter (part # 001-001223-1) of 7F shaft diameter and 8F tip. The Cardiodrive™ is intended (part .. 001 to Stereotaxis Tangent™ Electrophysiology Catheter in the right side of the heart only. It is not intended to advance the Tangent™ Electrophysiology Catheter through the coronary vasculature nor the coronary sinus.
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K021802
Prescription Use - ✓