The PowerAssert™ Radiofrequency Guidewire (PARG) is intended for use with a Stereotaxis Niobe Magnetic Navigation System for the recanalization of occluded peripheral vessels.

Device Description

The PARG is a sterile, single use, magnetically steerable endovascular guidewire intended to create a channel through occlusive material in vessels using mechanical or radiofrequency energy. Once a channel is created this will allow the introduction of adjunct devices/therapies to more completely alleviate the occlusion.

AI/ML Overview

This document describes a 510(k) premarket notification for the PowerAssert™ Radiofrequency Guidewire (PARG). The submission aims to demonstrate substantial equivalence to previously cleared predicate devices, not to establish new performance criteria through a standalone study. Therefore, most of the requested information regarding acceptance criteria, sample sizes, expert ground truthing, and clinical study details (like MRMC or standalone performance) is not applicable or provided in this type of regulatory submission.

The document focuses on comparing the technological characteristics of the PARG to its predicates to assert substantial equivalence.

Here's a breakdown of the available information based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

This type of 510(k) summary does not typically include a table of formal acceptance criteria and reported device performance in the way one might expect from a clinical trial or algorithm validation study. Instead, substantial equivalence is claimed by demonstrating that the new device shares similar technological characteristics and intended use with legally marketed predicate devices, and that any differences do not raise new questions of safety or effectiveness.

The document implicitly treats the characteristics of the predicate devices as the "acceptance criteria" for demonstrating substantial equivalence. The "reported device performance" is the list of characteristics of the PARG itself.

Device Characteristic	Proposed PARG (K080637)	Predicate Baylis RF Tunneler Wire (K051670)	Predicate Stereotaxis Cronus® & Assert™ Guidewires (K042854 & K043457)
Intended Use	Recanalization of occluded peripheral vessels with Stereotaxis Niobe Magnetic Navigation System	Create a channel in totally occluded peripheral vessels 3mm or greater	Introduce and position over-the-wire catheters and other over-the-wire therapeutic devices within coronary and peripheral vasculature during PTCA or other intravascular interventional procedures
RF Capable	Yes	Yes	No
Magnetic Navigation Capable	Yes	No	Yes
Wire Diameter	0.018"	0.035"	0.014"
Wire Length(s)	185 and 300 cm	250 cm	180, 210, 235 & 300 cm
Max. RF Power	25 watts	25 watts	NA
RF Dwell Time	3 seconds	99 seconds	NA
Sterilization Method	EtO	EtO	EtO
Single Use	Yes	Yes	Yes
Distal Tip Lubricious Coating	Hydrophilic	Hydrophilic	Hydrophilic
Energy Source	Baylis' RF Generator	Baylis' RF Generator	NA

The "Performance" section explicitly states: "Based upon the objective evidence presented in this 510(k) it has been demonstrated that the PARG is substantially equivalent to the predicate data devices it has been compared to in this submission." This is the primary "proof" of meeting the implicit acceptance criteria (i.e., substantial equivalence).

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. This 510(k) summary does not describe a clinical study with a test set of patient data to validate an algorithm or device performance in that manner. The "test set" here refers to the engineering and design characteristics of the device being compared against predicate devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This is not an AI/algorithm validation study requiring expert ground truth. Ground truth for device characteristics is based on manufacturing specifications and testing.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This is not an AI/algorithm validation study.

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

Not applicable. This device is a guidewire, not an AI diagnostic or assistive tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a guidewire, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For a device like this, the "ground truth" for demonstrating substantial equivalence is primarily based on:

Engineering specifications and design: The physical and operational characteristics of the device.
Bench testing: Laboratory tests to verify performance aspects like power output, dwell time, and coating properties.
Comparison to predicate devices: The established safety and effectiveness of legally marketed predicate devices.

No clinical "ground truth" from patients or experts in the sense of diagnostic accuracy is discussed here.

8. The sample size for the training set

Not applicable. This is a medical device, not an AI algorithm requiring a training set.

9. How the ground truth for the training set was established

Not applicable. See point 8.

Summary

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Appendix 1: 510(k) Summary per 21CFR §807.92 AUG 1 2 2008

Submitter'sinformation	Stereotaxis, Inc.4320 Forest Park Ave, Suite 100St. Louis, MO 63108Contact: Dennis Pozzo, Regulatory Affairs SpecialistPhone: 314-678-6136February 27, 2008
Device/classificationname	• Device Name:PowerAssert™ Radiofrequency Guidewire (PARG)• Classification/Common name:Catheter Wire Guide• The marketed device(s) to which substantial equivalence is claimed:– Baylis Medical's RF Tunneler Wire - 510(k), K051670– Cronus Guidewire – 510(k), K042854– Assert Guidewire - 510(k), K043457
Devicedescription	The PARG is a sterile, single use, magnetically steerable endovascularguidewire intended to create a channel through occlusive material in vesselsusing mechanical or radiofrequency energy. Once a channel is created thiswill allow the introduction of adjunct devices/therapies to more completelyalleviate the occlusion.
Intended use	The PowerAssert™ Radiofrequency Guidewire (PARG) is intended for use with aStereotaxis Niobe Magnetic Navigation System for the recanalization of occludedperipheral vessels.
	Continued on next page

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KCECE 37 For John

Appendix 1: 510(k) Summary per 21CFR §807.92, Continued

Device Characteristic	Proposed PARGK080637	Predicate Baylis RFTunneler WireK051670	Predicate StereotaxisCronus® & Assert™GuidewiresK042854 & K043457
Intended Use	The PowerAssert™RadiofrequencyGuidewire is intendedfor use in recanalizationof occluded peripheralvessels.	The RF Tunneler Wireis intended to create achannel in totallyoccluded peripheralvessels 3mm or greater.	The guidewires areintended to introduce andposition over-the-wirecatheters and other over-the-wire therapeuticdevices within thecoronary and peripheralvasculature during PTCAor other intravascularinterventional procedures.
RF Capable	Yes	Yes	No
MagneticNavigation Capable	Yes	No	Yes
Wire Diameter	0.018"	0.035"	0.014"
Wire Length(s)	185 and 300 cm	250 cm	180, 210, 235 & 300 cm
Max. RF Power	25 watts	25 watts	NA
RF Dwell Time	3 seconds	99 seconds	NA
Sterilization Method	EtO	EtO	EtO
Single Use	Yes	Yes	Yes
Distal TipLubricious Coating	Hydrophilic	Hydrophilic	Hydrophilic
Energy Source	Baylis' RF Generator	Baylis' RF Generator	NA

The table below lists device characteristics. Technological characteristics

Performance Based upon the objective evidence presented in this 510(k) it has been demonstrated that the PARG is substantially equivalent to the predicate data devices it has been compared to in this submission.

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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 stylized eagle or bird-like symbol with three curved lines forming its body and wings. To the left of the symbol, the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 2 2008

Stereotaxis, Inc. c/o Mr. Dennis Pozzo 4320 Forest Park Avenue, Suite 100 St. Louis, MO 63108

Re: K080637 Trade/Device Name: PowerAssert Radiofrequency Guidewire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter guide wire Regulatory Class: Class II (two) Product Code: DOX Dated: July 29, 2008 Received: July 30, 2008

Dear Mr. Pozzo:

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. Dennis Pozzo

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

R. V. Anes

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: Indications for Use Statement

Statement The indications for Use Statement:

510(k) Number: K080637

Device Name: PowerAssert™ Radiofrequency Guidewire

The PowerAssert™ Radiofrequency Guidewire (PARG) is intended for use with a Stereotaxis Niobe Magnetic Navigation System for the recanalization of occluded peripheral vessels.

Prescription Use X X AND/OR (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (Part 21 CFR 801 Subpart C)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

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Duna R. Vuchner

(Division Sign-Off) (Division of Cardiovascular Devices

510(k) Number_Ko80637

Regulation Number and Section

§ 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.