(211 days)
The Stereotaxis Endovascular Guide Wire is intended to introduce and position over-the-wire catheters and other over-the-wire therapeutic devices within the coronary and peripheral vasculature during PTCA or other intravascular interventional procedures.
The Stereotaxis Endovascular Guide Wire is a steerable guide wire that has a nominal diameter of 0.014 in/ 0.36mm and a nominal length of 210/300 cm. The guide wire is designed only for use in conjunction with the Stereotaxis Magnetic Navigation System. The wire is configured with a tapered distal tip and an embedded magnet, which is used for navigating the wire through the vasculature. A hydrophilic coating extends from the base of the distal coil to the proximal end of the wire. This device is sterilized with 100% ethylene oxide.
The Endovascular Guide Wire is a conventional 0.014" hydrophilically coated endovascular guide wire modified to accommodate magnetic actuation and control. It is designed to navigate within the vasculature to deliver a suitable catheter or interventional device to a desired site.
The finished length of the Endovascular Guide Wire is 210cm to 300cm. A taper runs 30cm proximal to the distal tip. The pushable shaft is a continuous wire that allows axial force, applied at the proximal end, to be transmitted to the tip of the guide wire. The Endovascular Guide Wire is used with an introducer sheath to access the human vasculature.
The provided text describes the Stereotaxis Endovascular Guide Wire and its 510(k) summary, aiming for substantial equivalence to predicate devices rather than establishing specific acceptance criteria and proving performance against them through a clinical study with detailed metrics.
Based on the provided information, I can extract the following:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied by Substantial Equivalence Claim) | Reported Device Performance (from "Performance data" section) |
|---|---|
| Equivalence in performance to predicate devices (BSC Choice Guide Wire and ACS BMW Guide Wire) | "Bench testing and preclinical in-vivo testing demonstrate that the Stereotaxis Endovascular Guide Wire performs in an equivalent manner to both the BSC Choice Guide Wire and the ACS BMW Guide Wire predicate devices." |
| Safety and effectiveness for its intended use (introducing and positioning over-the-wire catheters and therapeutic devices within the coronary and peripheral vasculature during PTCA or other intravascular interventional procedures). | Implied by the successful completion of bench and preclinical in-vivo testing and the FDA's determination of substantial equivalence. |
2. Sample Size Used for the Test Set and Data Provenance
The provided text does not specify the sample size used for the test set (number of devices, test cases, or animal subjects). It only mentions "Bench testing and preclinical in-vivo testing." The data provenance is not explicitly stated in terms of country of origin, but "preclinical in-vivo testing" suggests animal studies, and "bench testing" refers to laboratory-based evaluations. It's likely prospective for the testing conducted for this submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not provide any information about experts used to establish ground truth or their qualifications. The evaluation relies on "bench testing and preclinical in-vivo testing," which would typically involve engineering and scientific evaluation rather than expert clinical consensus on a test set.
4. Adjudication Method for the Test Set
The document does not specify any adjudication method. Given the nature of bench and preclinical testing for a guidewire, a formal adjudication process with multiple experts is generally not applicable in the same way it would be for diagnostic AI.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not reported. The information focuses on device performance and substantial equivalence, not on human reader performance with or without AI assistance. This device is a medical instrument, not an AI diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
N/A. This device is a physical medical instrument, not an algorithm. Standalone performance as it applies to AI algorithms is not relevant here.
7. The Type of Ground Truth Used
The "ground truth" for this guidewire's performance would be established through objective measurements and observations during:
- Bench testing: Measuring physical properties, mechanical performance, maneuverability, and other relevant characteristics against pre-defined specifications or predicate device performance.
- Preclinical in-vivo testing: Observing the guidewire's ability to navigate vasculature, facilitate catheter delivery, and its interaction with biological systems in an animal model, often assessed against control or predicate devices. This would involve surgical observations and potentially imaging.
8. The Sample Size for the Training Set
N/A. This is a physical medical device. The concept of a "training set" is relevant for machine learning algorithms, not for the development and testing of a guidewire in this context.
9. How the Ground Truth for the Training Set Was Established
N/A. As mentioned above, the concept of a training set and its ground truth establishment is not applicable to this type of device. The development process would involve iterative design, prototyping, and testing against engineering specifications and preclinical models.
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NOV 27 2002
Appendix A: 510(k) Summary of Safety and Effectiveness
| 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 Stereotaxis Endovascular Guide Wire is a steerable guide wire that has anominal diameter of 0.014 in/ 0.36mm and a nominal length of 210/300 cm.The guide wire is designed only for use in conjunction with the StereotaxisMagnetic Navigation System. The wire is configured with a tapered distal tipand an embedded magnet, which is used for navigating the wire through thevasculature. A hydrophilic coating extends from the base of the distal coil tothe proximal end of the wire. This device is sterilized with 100% ethyleneoxide. |
| Intended use | The Stereotaxis Endovascular Guide Wire is intended to introduce andposition over-the-wire catheters and other over-the-wire therapeutic deviceswithin the coronary and peripheral vasculature during PTCA or otherintravascular interventional procedures. |
| Contraindications: This guide wire is not intended for use without theStereotaxis Magnetic Navigation System. The device is not intended for usein the cerebral vasculature. Rotational atherectomy devices, and anyferromagnetic interventional devices, are contraindicated for use with theStereotaxis Endovascular Guide Wire. | |
| Technologicalcharacteristics | The Endovascular Guide Wire is a conventional 0.014" hydrophilicallycoated endovascular guide wire modified to accommodate magnetic actuationand control. It is designed to navigate within the vasculature to deliver asuitable catheter or interventional device to a desired site. |
| The finished length of the Endovascular Guide Wire is 210cm to 300cm. Ataper runs 30cm proximal to the distal tip. The pushable shaft is a continuouswire that allows axial force, applied at the proximal end, to be transmitted tothe tip of the guide wire. The Endovascular Guide Wire is used with anintroducer sheath to access the human vasculature. |
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| Performancedata | Bench testing and preclinical in-vivo testing demonstrate that the StereotaxisEndovascular Guide Wire performs in an equivalent manner to both the BSCChoice Guide Wire and the ACS BMW Guide Wire predicate devices. |
|---|---|
| Conclusion | The Stereotaxis Endovascular Guide Wire is substantially equivalent to theBSC Choice Guide Wire (K970244) and the ACS BMW Guide Wire(K971815) predicate devices. |
| Contact | Gary M. Rauvola, Director, Regulatory Affairs for Disposable Products |
| Date | November 22, 2002 |
.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling three stylized human figures or birds in flight, arranged in a row.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 27 2002
Mr. Garv M. Rauvola Director, Regulatory Affairs for Disposable Products Stereotaxis, Inc. 4041 Forest Park Avenue St. Louis, MO 63108
Re: K021363
Trade/Device Name: Stereotaxis Endovascular Guide Wire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter guide wire Regulatory Class: Class II Product Code: DQX Dated: August 29, 2002 Received: August 30, 2002
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 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
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Page 2 - Mr. Gary M. Rauvola
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) 594-4686. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,
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 L: Revised Indications For Use Statement
Indications for Use Statement
Revised Statement Indications for Use Statement:
510(k) Number: K021363
Device Name: Stereotaxis Endovascular Guide Wire
Indications for Use: The Stereotaxis Endovascular Guide Wire is intended to introduce and position over-the-wire catheters and other over-the-wire therapeutic devices within the coronary and peripheral vasculature during PTCA or other intravascular interventional procedures.
Contraindications: This guide wire is not intended for use without the Stereotaxis Magnetic Navigation System. The device is not intended for use in the cerebral vasculature. Rotational atherectomy devices, and any ferromagnetic interventional devices, are contraindicated for use with the Stereotaxis Endovascular Guide Wire.
Prescription Use
(Per 21 CFR 801.109)
Division of Cardiovascular & Respiratory Devices
510(k) Number K021363
§ 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.