(75 days)
Indications for Use: The Stereotaxis Assert™ 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 Assert™ Guide Wire is a steerable guide wire that has a nominal diameter of 0.014 in/ 0.36mm and nominal lengths of 180 cm and 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 covers the distal portion of the wire, and a PTFE coating covers the proximal end of the wire. This device is sterilized with 100% ethylene oxide.
The provided document is a 510(k) Summary for the Stereotaxis Assert™ Guide Wire. It describes a medical device, its intended use, technological characteristics, and comparison to a predicate device. It explicitly states that no clinical studies were needed to support the modifications and therefore clinical performance data is not available. This means that the device was not evaluated through a study to meet acceptance criteria in the way envisioned by your request.
Instead, the document details that the device met acceptance criteria based on:
- Physical testing: "The Stereotaxis Assert™ Guide Wire was designed and tested in compliance with the FDA "Coronary and Cerebrovascular Guidewire Guidance" dated January 1995. The device met design input criteria..."
- Preclinical animal performance data: "Testing of the Stereotaxis Assert™ Guide Wire in the swine animal model demonstrated substantial equivalence to the currently marketed predicate device."
Given this, I cannot fill out the requested table for "acceptance criteria and the study that proves the device meets the acceptance criteria" in the traditional sense of a clinical or standalone AI study. The document focuses on demonstrating substantial equivalence to a previously cleared device (K021363) through non-clinical data.
Here's how I can address your request based on the provided text, acknowledging the limitations:
1. A table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria with reported performance values as would be found in a clinical trial. Instead, it states qualitative criteria and that they were met through non-clinical testing.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Design Input Criteria Compliance | "The device met design input criteria" |
| Compliance with FDA Guidance | "designed and tested in compliance with the FDA 'Coronary and Cerebrovascular Guidewire Guidance' dated January 1995." |
| Substantial Equivalence (Animal) | "demonstrated substantial equivalence to the currently marketed predicate device" in a swine animal model. |
2. Sample size used for the test set and the data provenance
The document mentions "testing of the Stereotaxis Assert™ Guide Wire in the swine animal model" but does not specify the sample size for this animal study. It also does not specify the country of origin or whether it was retrospective or prospective, although animal studies are typically prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable or provided. The "ground truth" equivalent in this context would be the successful navigation and performance in the animal model, observed by the researchers/veterinarians conducting the study, rather than expert interpretation of images or clinical outcomes.
4. Adjudication method for the test set
This information is not applicable or provided. Adjudication methods are typically relevant for human-read clinical studies or analyses requiring consensus on diagnoses or outcomes.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
No, an MRMC comparative effectiveness study was not done. The document explicitly states: "No clinical studies were needed to support the modifications."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This concept is not applicable as this is a physical medical device (guide wire), not an AI algorithm. Its performance is inherent in its physical properties and how it functions.
7. The type of ground truth used
For the animal study, the "ground truth" was likely direct observation of the device's performance in vivo within the swine vasculature, assessing its navigability and ability to deliver other devices, in comparison to the predicate device.
8. The sample size for the training set
This is not applicable. There is no "training set" in the context of a physical medical device like a guide wire. Design and engineering principles are applied, followed by non-clinical testing.
9. How the ground truth for the training set was established
This is not applicable for the reasons stated above.
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Appendix 1: 510(k) Summary of Safety and Effectiveness Kod 3457
| 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 isformatted in accordance with the Agency's final rule "...510(k) Summariesand 510(k) Statements..." (21 CFR §807) and can be used to provide asubstantial equivalence summary to anyone requesting it from the Agency. |
|---|---|
| Devicedescription | The Stereotaxis Assert™ Guide Wire is a steerable guide wire that has anominal diameter of 0.014 in/ 0.36mm and nominal lengths of 180 cm and300 cm. The guide wire is designed only for use in conjunction with theStereotaxis Magnetic Navigation System. The wire is configured with atapered distal tip and an embedded magnet, which is used for navigating thewire through the vasculature. A hydrophilic coating covers the distal portionof the wire, and a PTFE coating covers the proximal end of the wire. Thisdevice is sterilized with 100% ethylene oxide. |
| Technologicalcharacteristics | The Assert™ Guide Wire is a conventional 0.014" coated endovascular guidewire modified to accommodate magnetic actuation and control. It is designedto navigate within the vasculature to deliver a suitable catheter orinterventional device to a desired site. |
| The finished lengths of the guide wire are 180cm and 300cm. A taper runsproximal to the distal tip. The pushable shaft is a continuous wire that allowsaxial force, applied at the proximal end, to be transmitted to the tip of theguide wire. The guide wire is used with an introducer sheath to access thehuman vasculature. | |
| Intended use | Indications for Use: The Stereotaxis Assert™ Guide Wire is intended tointroduce and position over-the-wire catheters and other over-the-wiretherapeutic devices within the coronary and peripheral vasculature duringPTCA or other intravascular 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 Assert™ Guide Wires. | |
| Devicecomparisons | The Stereotaxis Assert™ Guide Wire is a minor design modification of thecurrently marketed Stereotaxis Endovascular Guide Wire. The new wire has amodified taper to the core wire profile, has a different hydrophilic coating onthe distal end, and carries a PTFE coating on the proximal end. |
| Physical testing | The Stereotaxis Assert™ Guide Wire was designed and tested in compliancewith the FDA "Coronary and Cerebrovascular Guidewire Guidance" datedJanuary 1995. The device met design input criteria and was substantiallyequivalent to the currently marketed predicate device. |
| Preclinicalanimalperformancedata | Testing of the Stereotaxis Assert™ Guide Wire in the swine animal modeldemonstrated substantial equivalence to the currently marketed predicatedevice. |
| Clinicalperformancedata | No clinical studies were needed to support the modifications. |
| Substantialequivalence | The Assert™ Guide Wire is a substantially equivalent modification of theStereotaxis Endovascular Guide Wire originally cleared under K021363. Themodifications described herein do not affect the intended use of the device oralter the fundamental scientific technology associated with the device. |
| Contact | Gary M. Rauvola, RACDirector, Compliance & Regulatory AffairsStereotaxis, Inc.4041 Forest Park AvenueSt. Louis, Missouri 63108Ph. 314-615-6913Fax 314-615-6912 |
| Date | December 09, 2004 |
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.
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Appendix 1: 510(k) Summary of Safety and Effectiveness,
Continued
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.
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Public Health Service
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wings. The eagle is enclosed within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is written around the upper portion of the circle.
FEB 2 8 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Stereotaxis, Inc. c/o Mr. Gary M. Rauvola Director, Regulatory Affairs for Disposable Products 4041 Forest Park Ave. St. Louis, MO 63108
K043457 Re:
Stereotaxis Assert™ Endovascular Guide Wire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: II Product Code: DQX Dated: February 10, 2005 Received: February 11, 2005
Dear Mr. Rauvola:
We have reviewed your Section 510(k) premarket notification of intent to market the indication We have reviewed your Section 510(x) premainted institution morrototed in interstate referenced and nave decemblicating the arrest over is a section of the marketed in interstate for use stated in the enclosure) to regary mancede provice Americal Device Amendments, or to commerce prior to May 28, 1970, the chance with the provisions of the Federal Food. Drug, devices that have been reciassified in accordance with as proval application (PMA).
and Cosmetic Act (Act) that do not require approval as training of the Act . The and Cosmetic Act (Act) that do not require approval controls provisions of the Act. The You may, merelore, market the devree, seeject of the s
general controls provisions of the Act include requirements for annual registration and general controls provisions of the recentered required of childrens 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 (see above) into entier on a consisted in the program and the can
may be subject to such additional controls. Existing major regulations EDA ma may be subject to such additional controller Extisting the 200 to 898. In addition, FDA may be found in the Code of Feact. Inc.g.
publish further announcements concerning your device in the Federal Register.
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Page 2 -- Mr. Gary M. Rauvola
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that I DA s issuates of a build with other requirements of the Act that I DA has made a actor in and regulations administered by other Federal agencies. You must of any it catal statutes and regulations and limited to: registration and listing (21 Comply with an the Aot 8 requirements, and manufacturing practice requirements as set CTN in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050. product laulation control pro herens (2 seting your device as described in your Section 510(k) This letter will anow you to begin manteeing your antial equivalence of your device to a legally premits that 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 If you desire specific advice 10. your acc)) 276-0120. Also, please note the regulation entitled, Connact the Office of Comparket notification" (21CFR Part 807.97). You may obtain Misbranding by reference to premaintentibilities 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,
Dina R. Vachner
- A 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: Revised Indications for Use Form
Indications for Use Statement
510(k) Number K043457:
Device Name: Assert™ Guide Wires
Indications for Use: Stereotaxis Assert™ Guide Wires are intended to Indications for Osc. 'Stereotains Fisses and other over-the-wire therapeutic devices within the coronary and peripheral vasculature during therapoutie been intravascular interventional procedures.
Contraindications: This guide wire is not intended for use without the Contraincations: "This garos in System. The device is not intended for use Stereotaxis Magnette Navigantes ... Rotational atherectomy devices, and any In the coloral vasodiatere. I Revices, are contraindicated for use with Stereotaxis Assert™ Guide Wires.
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ Prescription Use _____________________________________________________________________________________________________________________________________________________________ AND/OR (Part 21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page | of __
Duna P. Vachon
(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number_k 04 לאר 49
The information herein is considered CONFIDENTIAL to STEREOTAXIS, Inc. in accordance with the provisions and 15 consideres 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.