(49 days)
The Power Wire Radiofrequency Guidewire is intended to create a channel in totally occluded peripheral vessels 3 mm or greater.
The present device, PowerWire Radiofrequency Guidewire consists of a core wire surrounded with a polymer insulation. The wire connects to a radiofrequency puncture generator at the proximal end via a connector cable, and has an active tip at the distal end to deliver radiofrequency energy. The changes made to the device include changes in active tip geometry and material and addition of more radiopaque bands.
The PowerWire Radiofrequency Guidewire is designed to be compatible with most balloon and stent catheters approved for use in peripheral interventional procedures.
The provided text describes a 510(k) summary for the PowerWire Radiofrequency Guidewire. This document primarily focuses on establishing substantial equivalence to a predicate device and detailing non-clinical performance and safety testing. It does not describe a study involving device performance against acceptance criteria in the context of a diagnostic or AI-enabled device, nor does it involve human readers, ground truth establishment by experts, or AI performance metrics.
Therefore, I cannot fulfill the request for information regarding acceptance criteria, reported device performance, sample sizes for test/training sets, data provenance, expert involvement, adjudication methods, MRMC studies, standalone AI performance, or ground truth types as these concepts are not present in the provided text.
The document is a regulatory submission demonstrating the safety and performance of a new version of a guidewire by comparing it to an existing cleared device through a series of non-clinical (bench and biocompatibility) tests. These tests evaluate the physical, electrical, and biological properties of the device against established standards and internal criteria to ensure it performs as intended and is as safe as the predicate device.
Key takeaway based on the provided text: The submission focused on demonstrating substantial equivalence of the new PowerWire Radiofrequency Guidewire to a previously cleared version using a battery of non-clinical tests. This is a common approach for device modifications where clinical efficacy has already been established for the predicate.
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7. 510(k) Summary
Submitter Information
A. Company Name: Baylis Medical Company Inc.
B. Company Address: 2645 Matheson Blvd. East Mississauga, Ontario L4W 5S4 Canada
C. Company Phone: (905) 602-4875; ext 252
D. Company Facsimile: (905) 602-5671
E. Contact Person: Meghal Khakhar
F. Summary Prepared on: June 8, 2010
Device Identification
- A. Device Trade Name: PowerWire Radiofrequency Guidewire
- B. Device Common Name: Catheter Guide Wire
- C. Classification Name: Wire, guide, catheter
- D. Device Class: Class II
E. Device Code: DQX
Identification of Predicate Device
The predicate device is the PowerWire Radiofrequency Guidewire, which is cleared under 510(k) Premarket Notification Number K051670.
Device Description
The present device, PowerWire Radiofrequency Guidewire consists of a core wire surrounded with a polymer insulation. The wire connects to a radiofrequency puncture generator at the proximal end via a connector cable, and has an active tip at the distal end to deliver radiofrequency energy. The changes made to the device include changes in active tip geometry and material and addition of more radiopaque bands.
The PowerWire Radiofrequency Guidewire is designed to be compatible with most balloon and stent catheters approved for use in peripheral interventional procedures.
Appendix C
K101615
JUL 28 2010
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Indications for Use
The Power Wire Radiofrequency Guidewire is intended to create a channel in totally occluded peripheral vessels 3 mm or greater.
Substantially Equivalent Device
The present PowerWire Radiofrequency Guidewire is substantially equivalent to the currently 510(k) cleared PowerWire Radiofrequency Guidewire (K051670).
Brief Comparison Summary
To demonstrate equivalence of the present Power Wire Radiofrequency Guidewire to the predicate device, technological characteristics and performance criteria were evaluated using testing as listed below.
Using FDA guidance documents and appropriate standards for non-clinical testing of medical devices, the following tests were performed:
- fracture resistance
- damage with repeated flexing
- union strength
- . integrity after mechanical shock
- electrical impedance .
- . high frequency dielectric strength
- . mains frequency dielectric withstand
- . bending fatigue
- resistance to user manipulation .
- proximal stiffness �
- distal stiffness ●
- torqueability ●
- torque strength
- corrosion resistance ●
- simulated device use (model bench . testing validation)
- cytotoxicity ●
- sensitization
- . irritation (intracutaneous reactivity)
- acute systemic toxicity �
- hemocompatibility .
- thrombogenicity. ●
The results from these tests demonstrate that the technological characteristics and performance criteria of the present PowerWire Radiofrequency Guidewire are substantially equivalent to the predicate device for the same intended use.
Conclusion (Statement of Equivalence)
The data and information presented in this application, including non-clinical testing, and the device similarities support a determination of substantial equivalence, and therefore market clearance of the present PowerWire Radiofrequency Guidewire through this Special 510(k) Premarket Notification.
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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 caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular pattern around the symbol. The logo is black and white and has a simple, clean design. The caduceus symbol is a common symbol for healthcare and medicine.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Baylis Medical Company Inc. Ms. Meghal Khakhar, MBBS, CerRAP, RAC Regulatory Affairs Manager 2645 Matheson Blvd. East Mississauga. Ontario Canada L4W 5S4
SEP 1 8 2013
Re: K101615
Trade/Device Name: PowerWire Radiofrequency Guidewire Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: PDU Dated: July 15, 2010 Received: July 16, 2010
Dear Ms. Khakhar:
This letter corrects our substantially equivalent letter of July 28, 2010.
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical
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device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803). please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Z.M.Z.
Image /page/3/Picture/9 description: The image contains a handwritten word, "for", in cursive script. The word is written in black ink on a white background. The letter "f" has a loop extending above the main body of the letter, and the "o" and "r" are connected.
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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1 JUL 2,8 2010
Indications for Use
510(k) Number (if known): K (016 / S
Device Name: PowerWire Radiofrequency Guidewire
Indications For Use:
The Power Wire Radiofrequency Guidewire is intended to create a channel in totally occluded peripheral vessels 3 mm or greater.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Omer R. Mc. Innes
Tivision Sign-Off) ision of Cardiovascular Devices
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1(k) Number_KIO)(1,15
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).