(309 days)
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.
The Stereotaxis Cardiodrive™ is a tool that provides the physician with the ability and the choice 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.
The provided text describes a 510(k) submission for the Stereotaxis Cardiodrive™, a device intended for automatically advancing and retracting a specific electrophysiology catheter in the right side of the heart.
This document is a 510(k) summary and approval letter, which typically focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific clinical study results with acceptance criteria. Therefore, much of the requested information regarding detailed acceptance criteria, study design parameters (like sample size for test sets, number of experts, adjudication methods, MRMC studies, standalone performance), and ground truth establishment for either training or test sets is not present in this document.
Here's an analysis of the information that can be extracted from the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not provide a table of quantitative acceptance criteria. Instead, it makes a qualitative claim about performance equivalence:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Substantial equivalence to predicate device (Jomed Trak Back K990271 and IntraLuminal Therapeutics ILT Catheter K001992) | "Bench testing and animal testing demonstrate that the Stereotaxis Cardiodrive™ performs in an equivalent manner to the Jomed Trak Back predicate device." |
| Intended Use | "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." |
2. Sample size used for the test set and the data provenance
The document mentions "Bench testing and animal testing," but it does not specify the sample sizes for these tests for either the device or the predicate. The data provenance (country of origin, retrospective/prospective) is also not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. The statement "Bench testing and animal testing" suggests engineering and animal model evaluations, not necessarily clinical studies involving expert clinicians establishing ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document.
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
This document describes a device for catheter manipulation, not an AI-assisted diagnostic or interpretative tool for human readers. Therefore, an MRMC comparative effectiveness study is not applicable to this device's function, and no such study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device itself is an automated system for advancing and retracting a catheter, which inherently operates "standalone" in performing its mechanical function. The performance claim is that it "performs in an equivalent manner" to predicate devices, through "bench testing and animal testing." The document does not explicitly use the term "standalone performance" in the context of an algorithm, but the device's function is mechanistic.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For "bench testing," ground truth would likely be based on physical measurements (e.g., accuracy of advancement/retraction, force exerted, speed, reliability). For "animal testing," ground truth might involve direct observation of catheter movement within the heart, physiological measurements, and potentially necropsy findings, which could be considered a form of "outcomes data" or direct observation of the device's interaction with biology. However, the specific methods for establishing ground truth are not detailed.
8. The sample size for the training set
The document describes "Bench testing and animal testing" for performance evaluation, but it does not mention a "training set" in the context of machine learning or AI models. This device is a mechanical system, not an AI algorithm that requires a training set.
9. How the ground truth for the training set was established
As there is no mention of a "training set" for an AI model, this question is not applicable.
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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
—
$\lambda$
APR 0 8 2003
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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
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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
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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 - ✓
§ 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).