(159 days)
Not Found
No
The summary describes a mechanical and radiofrequency guidewire for creating a channel in occluded vessels. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The performance summary focuses on substantial equivalence to predicate devices, not on AI/ML performance metrics.
Yes.
The device is intended to create a channel through occlusive material in vessels, thereby alleviating the occlusion, which is a therapeutic action. It allows for the introduction of other therapeutic devices/therapies.
No
Explanation: The device is intended to create a channel through occlusive material in vessels, which is a therapeutic function, not a diagnostic one. It facilitates the introduction of other devices/therapies.
No
The device description clearly states it is a "sterile, single use, magnetically steerable endovascular guidewire," which is a physical hardware component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Function: The PowerAssert™ Radiofrequency Guidewire (PARG) is an endovascular guidewire used within the body to mechanically or with radiofrequency energy create a channel through occlusions in peripheral vessels. It is a therapeutic device, not a diagnostic one that analyzes samples.
- Intended Use: The intended use clearly states it's for "recanalization of occluded peripheral vessels," which is a treatment procedure.
The description and intended use of the PARG align with a therapeutic medical device used for intervention within the body, not a device used for testing samples outside the body.
N/A
Intended Use / Indications for Use
The PowerAssert™ Radiofrequency Guidewire (PARG) is intended for use with a Stereotaxis Niobe Magnetic Navigation System for the recanalization of occluded peripheral vessels.
Product codes
DOX
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral vessels, coronary and peripheral vasculature
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Appendix 1: 510(k) Summary per 21CFR §807.92 AUG 1 2 2008
| Submitter's
information | Stereotaxis, Inc.
4320 Forest Park Ave, Suite 100
St. Louis, MO 63108
Contact: Dennis Pozzo, Regulatory Affairs Specialist
Phone: 314-678-6136
February 27, 2008 |
|-----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device/
classification
name | • 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 |
| 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. |
| Intended use | The PowerAssert™ Radiofrequency Guidewire (PARG) is intended for use with a
Stereotaxis Niobe Magnetic Navigation System for the recanalization of occluded
peripheral vessels. |
| | Continued on next page |
1
KCECE 37 For John
Appendix 1: 510(k) Summary per 21CFR §807.92, Continued
| Device Characteristic | Proposed PARG
K080637 | Predicate Baylis RF
Tunneler Wire
K051670 | Predicate Stereotaxis
Cronus® & Assert™
Guidewires
K042854 & K043457 |
|----------------------------------|--------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The PowerAssert™
Radiofrequency
Guidewire is intended
for use in recanalization
of occluded peripheral
vessels. | The RF Tunneler Wire
is intended to create a
channel in totally
occluded peripheral
vessels 3mm or greater. | The guidewires are
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. |
| 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 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.
1 1
2
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
3
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
4
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)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page | of |
Duna R. Vuchner
(Division Sign-Off) (Division of Cardiovascular Devices
510(k) Number_Ko80637