(28 days)
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.
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.
The provided document is a 510(k) Summary of Safety and Effectiveness for the Stereotaxis Cardiodrive® Catheter Advancement System, specifically for modifications made to an already marketed device. As such, it's a submission for clearance, not typically a detailed study report demonstrating acceptance criteria for an entirely new device. The focus is on demonstrating "substantial equivalence" to a predicate device rather than fulfilling new, specific performance acceptance criteria.
However, I can extract information related to the device's performance claims and the study type conducted to support the modifications.
Here's an analysis based on the provided text, addressing your points where information is available:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Device meets design input criteria. | "The Stereotaxis Cardiodrive® was designed and tested in compliance with Stereotaxis design control procedures. The device met design input criteria..." |
| Device is substantially equivalent to the currently marketed predicate device. | "...and was substantially equivalent to the currently marketed predicate device." "Bench testing and pre-clinical testing demonstrate that the Stereotaxis Cardiodrive® performs in an equivalent manner to the currently marketed Cardiodrive® predicate device." "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." |
| No impact on intended use or fundamental scientific technology. | "The modifications described herein do not affect the intended use of the device or alter the fundamental scientific technology associated with the device." |
2. Sample Size Used for the Test Set and Data Provenance
- The document states "Bench testing and pre-clinical testing." It does not specify the sample size for these tests.
- The data provenance (country of origin, retrospective/prospective) is not mentioned. It is implied to be internal testing by Stereotaxis, Inc.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- This information is not provided. The document describes physical and performance testing by the company, not expert-adjudicated test sets for an AI/algorithm.
4. Adjudication Method for the Test Set
- This information is not applicable/provided. There's no mention of an adjudication method as the testing described is primarily physical and pre-clinical performance testing of a mechanical device, not expert review of AI outputs.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
- No, an MRMC comparative effectiveness study was not done. The device is a mechanical catheter advancement system, not an AI or imaging diagnostic tool that would typically involve human readers.
- The document explicitly states: "No clinical studies were needed to support the modifications described herein."
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
- Not applicable. This device is a mechanical system, not an algorithm in the context of AI. Its operation is "intended for automatically advancing and retracting," implying a standalone mechanical function, but not in the AI sense of "algorithm only performance."
7. The Type of Ground Truth Used
- For the physical and performance testing, the "ground truth" would be established by engineering specifications, design input criteria, and comparison to the performance of the legally marketed predicate device. The document states the device "met design input criteria" and "performs in an equivalent manner" to the predicate.
8. The Sample Size for the Training Set
- Not applicable. This device is a mechanical system and does not involve AI or machine learning that would require a "training set."
9. How the Ground Truth for the Training Set was Established
- Not applicable. As there is no training set mentioned or implied for this mechanical device, there's no ground truth to establish for it.
In summary:
This document describes a 510(k) submission for a mechanical device (catheter advancement system) with minor modifications. The "acceptance criteria" revolve around demonstrating that the modified device still meets its design specifications and performs equivalently to its predicate device, without requiring new clinical studies. The testing performed was "bench testing and pre-clinical testing," which are internal validation steps for mechanical devices, not typically involving the extensive data set, expert validation, or AI-specific criteria you've asked about.
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| Appendix 1 - 510(k) Summary of Safety andEffectiveness | JUN 2 3 2005 |
|---|---|
| Statement | Information supporting claims of substantial equivalence, as defined underthe Federal Food, Drug and Cosmetic Act, respecting safety and effectivenessis summarized below.For the convenience of the Reviewer, this summary is formatted inaccordance with the Agency's final rule "...510(k) Summaries and 510(k)Statements..." (21 CFR §807) and can be used to provide a substantialequivalence summary to anyone requesting it from the Agency. |
| Devicedescription | The Cardiodrive® advances or retracts a compatible magneticelectrophysiology [EP] catheter, through a hemostasis introducer, remotelyvia a User Interface (UI) located either at the patient table or in the controlroom. |
| Intended use | The Stereotaxis Cardiodrive® is intended for automatically advancing andretracting only the Stereotaxis Tangent® Electrophysiology Catheter (part#001-001223-1) of 7F shaft diameter and 8F tip. The Cardiodrive® isintended to advance the Stereotaxis Tangent® Electrophysiology Catheter inthe right side of the heart only. It is not intended to advance the Tangent®Electrophysiology Catheter through the coronary vasculature nor the coronarysinus. |
| Technologicalcharacteristics | The Stereotaxis Cardiodrive® consists of an electrical controller, motorassembly, and user controls, plus sterile, single-use advancer unit, horizontalpatient mounting bracket, flexible drive shaft, and hemostasis introduceradapter. |
| Devicecomparisons | The modified Stereotaxis Cardiodrive® consists of minor designmodifications of the currently marketed Stereotaxis Cardiodrive®. The newCardiodrive® has a modified Hemostasis Introducer Adapter and a newhorizontal patient mounting bracket to better accommodate the use of largerguiding sheaths. |
Continued on next page
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| Stereotaxis, Inc. | |
|---|---|
| Special 510(k): Cardiodrive® and Disposable Accessories |
May 23, 2005 Page 50
| Appendix 1 - 510(k) Summary of Safety andEffectiveness, Continued | JUN 2 3 2005 | |
|---|---|---|
| Physical testing | The Stereotaxis Cardiodrive® was designed and tested in compliance withStereotaxis design control procedures. The device met design input criteriaand was substantially equivalent to the currently marketed predicate device. | |
| Performancedata | Bench testing and pre-clinical testing demonstrate that the StereotaxisCardiodrive® performs in an equivalent manner to the currently marketedCardiodrive® predicate device. | |
| Clinicalperformancedata | 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 affectthe intended use of the device or alter the fundamental scientific technologyassociated with the device. | |
| Contact | Kelly RowlandRegulatory Affairs Specialist | |
| Date | May 6, 2005 |
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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.
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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
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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
§ 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.