(28 days)
Not Found
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on mechanical advancement/retraction controlled via a user interface, with no mention of learning or intelligent decision-making processes.
No
The device is described as advancing and retracting an electrophysiology catheter, and its function relates to controlling the movement of another device (the catheter). It does not directly provide a therapeutic effect itself.
No
The Stereotaxis Cardiodrive® is described as a device that automatically advances and retracts an electrophysiology catheter. Its function is to manipulate the catheter, not to diagnose a condition.
No
The device description explicitly states that the Cardiodrive® advances or retracts a catheter, indicating a physical, hardware component responsible for mechanical movement. While it has a user interface (UI), the core function involves hardware manipulation of a medical device.
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, tissue) to provide information about a person's health. This testing is done outside of the body ("in vitro").
- Cardiodrive® Function: The description clearly states the Cardiodrive® is intended for "automatically advancing and retracting only the Stereotaxis Tangent® Electrophysiology Catheter... in the right side of the heart only." This is a device used within the body ("in vivo") to manipulate a catheter during a medical procedure.
The function of the Cardiodrive® is to physically control a catheter inside a patient's heart, which is the opposite of how IVD devices operate.
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)
DQX
Device Description
The Cardiodrive® advances or retracts a compatible magnetic electrophysiology [EP] catheter, through a hemostasis introducer, remotely via a User Interface (UI) located either at the patient table or in the control room.
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
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 and pre-clinical testing demonstrate that the Stereotaxis Cardiodrive® performs in an equivalent manner to the currently marketed Cardiodrive® 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
§ 870.1330 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
| Appendix 1 - 510(k) Summary of Safety and
| Effectiveness | JUN 2 3 2005 |
|---|---|
| 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] 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 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. |
| Technological
characteristics | The Stereotaxis Cardiodrive® consists of an electrical controller, motor
assembly, and user controls, plus sterile, single-use advancer unit, horizontal
patient mounting bracket, flexible drive shaft, and hemostasis introducer
adapter. |
| Device
comparisons | The modified Stereotaxis Cardiodrive® consists of minor design
modifications of the currently marketed Stereotaxis Cardiodrive®. The new
Cardiodrive® has a modified Hemostasis Introducer Adapter and a new
horizontal patient mounting bracket to better accommodate the use of larger
guiding sheaths. |
Continued on next page
1
| Stereotaxis, Inc. | |
|---|---|
| Special 510(k): Cardiodrive® and Disposable Accessories |
May 23, 2005 Page 50
| | Appendix 1 - 510(k) Summary of Safety and
Effectiveness, Continued | JUN 2 3 2005 |
|---------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| Physical testing | The Stereotaxis Cardiodrive® was designed and tested in compliance with
Stereotaxis design control procedures. The device met design input criteria
and was substantially equivalent to the currently marketed predicate device. | |
| Performance
data | Bench testing and pre-clinical testing demonstrate that the Stereotaxis
Cardiodrive® performs in an equivalent manner to the currently marketed
Cardiodrive® predicate device. | |
| Clinical
performance
data | No clinical studies were needed to support the modifications described herein. | |
| Conclusion | The modified Cardiodrive® is substantially equivalent to the Cardiodrive®
(K021802) predicate device. The modifications described herein do not affect
the intended use of the device or alter the fundamental scientific technology
associated with the device. | |
| Contact | Kelly Rowland
Regulatory Affairs Specialist | |
| Date | May 6, 2005 | |
2
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 3 2005
Stereotaxis, Inc. c/o Ms Kelly Rowland Regulatory Affairs Specialist 4041 Forest Park Avenue St Louis, MO 63108
Re: K051374
Trade Name: Cardiodrive Catheter Advancement System Regulation Number: 21 CFR 870.1330 Regulation Name: Wire, Guide, Catheter Regulatory Class: Class II (two) Product Code: DQX Dated: May 24, 2005 Received: May 26, 2005
Dear Ms. Rowland:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bection of 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 encreaty to togens and ment date of the Medical Device Amendments, or to commence price to May 20, 1978, are excordance with the provisions of the Federal Food, Drug, devices mat have been recuire approval of a premarket approval application (PMA). allo Cosmetic Act (71ct) that do not require to the general controls provisions of the Act. The I ou may, dicrerore, manel and 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 is classified (600 above) of ols. Existing major regulations affecting your device can inay oc subject to sach additions, Title 21, Parts 800 to 898. In addition, FDA may be found in the Overnments concerning your device in the Federal Register.
3
Page 2 – Ms Kelly Rowland
Please be advised that FDA's issuance of a substantial equivalence determination does not mean r loas be actived 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 or any 1 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 Of It 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) I market notification. The FDA finding of substantial equivalence of your device to a legally promated 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 it you dobil o specific at Compliance at (240) 276-0295. 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 other general informational 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/industry/support/index.html.
Sincerely yours,
A. Wesley B. Boan
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
510(k) Number (if known): K__________________________________________________________________________________________________________________________________________________
Device Name: Cardiodrive® Catheter Advancement System (CAS)
Indications for Use: The Stereotaxis Cardiodrive® is intended for automatically advancing and retracting only the Stereotaxis Tangent® Electrophysiology Catheter 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.
ズ AND/OR Prescription Use _ (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)
Rhummer
(Division Sign-Off)
Division of Cardiovascular Devices
Page | of |
510(k) Number K051374
The information herein is considered CONFIDENTIAL to STEREOTAXIS, Inc. in accordance with the provisions and expectations of 21 CFR §20.61, 21 CFR §812.38, and 21 CFR §814.9