(270 days)
The Percu-Pro™ Guidewire is intended to facilitate the placement of devices during diagnostic and interventional vascular procedures in the peripheral vasculature. The guidewire is not intended for use in coronary arteries or for neurovascular use.
The Percu-Pro™ GuideWire is constructed of a stainless steel core wire The proximal end of the core and is finished with a PTFE jacket. The coil covered distal end of the core is tapered to a ribbon tip to increase flexibility and is finished with a silver brazed ball tip. The guidewire is provided sterile and is a single use device.
The provided 510(k) summary for the Percu-Pro™ GuideWire (K094062) describes pre-clinical safety and performance testing but does not include acceptance criteria or a study with specific performance metrics for the device itself against established criteria. Instead, it states that "No performance standards have been established under Section 514 of the Food, Drug and Cosmetic Act for these devices."
The submission focuses on demonstrating substantial equivalence to predicate devices (TechDevice Guidewire K053251 and TFX Guidewire K963320) based on "intended use, design, materials, technology, and performance," asserting that "There are no differences between devices which would raise new issues of safety or effectiveness."
Therefore, I cannot fulfill the request to provide a table of acceptance criteria and reported device performance, or details about a study proving the device meets those criteria, as such information is not present in the provided document.
However, I can extract information about the pre-clinical testing conducted, which supports the safety and performance claims for substantial equivalence:
Pre-Clinical Safety and Performance Testing Information (from the 510(k) Summary):
- Type of Testing: Biocompatibility and hemocompatibility, tensile strength, torque strength, resistance to fracture, torqueability, and tip flexibility.
- Methodology: Conducted "in accordance with protocols based on the requirements of industry standards and guidance documents."
Missing Information (Not available in the provided document):
- Table of Acceptance Criteria and Reported Device Performance: Not specified.
- Sample Size for Test Set and Data Provenance: Not specified for any performance testing.
- Number of Experts and Qualifications for Ground Truth: Not applicable, as performance testing against specific criteria is not detailed.
- Adjudication Method: Not applicable.
- Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not applicable (this is a medical device, not an AI diagnostic tool).
- Standalone Performance Study (Algorithm only): Not applicable (this is a medical device, not an AI algorithm).
- Type of Ground Truth Used: Not applicable, as performance testing against specific criteria is not detailed.
- Sample Size for Training Set: Not applicable (this is a medical device, not an AI algorithm).
- How Ground Truth for Training Set was Established: Not applicable.
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K04662
SEP 27 2010
510(k) Summary
As required by section 807.92
| Company Name | Cardiosolutions Inc. |
|---|---|
| Address | 75 Mill St.Stoughton, MA 02072Phone: 781-344-0801Fax: 781-344-0803 |
| Contact Person | Michele Lucey |
| Date | September 23, 2010 |
| Trade Name | Percu-Pro™ GuideWire |
| Common Name | Cardiovascular Guidewire |
| Classification Name | Catheter Guidewire |
| Product Code | DQX |
| Regulation # | 21 CFR 870.1330 |
| Class | 2 |
| Panel | Circulatory System Devices Panel |
| Predicate Devices | TechDevice Guidewire (K053251)TFX Guidewire (K963320) |
| Device Description | The Percu-Pro™ GuideWire is constructed of a stainless steel core wire The proximalend of the core and is finished with a PTFE jacket. The coil covered distal end of thecore is tapered to a ribbon tip to increase flexibility and is finished with a silver brazedball tip. The guidewire is provided sterile and is a single use device. |
| Intended Use | The Percu-Pro™ GuideWire is intended to facilitate the placement of devices duringdiagnostic and interventional vascular procedures in the peripheral vasculature. Theguidewire is not intended for use in coronary arteries or for neurovascular use. |
| Pre-Clinical Safetyand PerformanceTesting | No performance standards have been established under Section 514 of the Food, Drugand Cosmetic Act for these devices, However, pre-clinical safety and performancetesting was conducted in accordance with protocols based on the requirements ofindustry standards and guidance documents. Preclinical testing conducted includedbiocompatibility and hemocompatibility, tensile strength, torque strength, resistance tofracture, torqueability, and tip flexibility. |
| SubstantialEquivalence | The Percu-Pro™ GuideWire is equivalent to the predicate devices in terms of intendeduse, design, materials, technology, and performance. There are no differencesbetween devices which would raise new issues of safety or effectiveness. |
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Image /page/1/Picture/1 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 representing the agency's mission to promote health, well-being, and human services. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Cardiosolutions, Inc. c/o Ms. Michele Lucey Vice President, Regulatory Affairs & Quality Assurance 75 Mill Street Stoughton, MA 02072
SEP 2 7 - 2010
Re: K094062
Trade/Device Name: Percu-Pro™ GuideWire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II (two) Product Code: DOX Dated: September 6, 2010 Received: September 8, 2010
Dear Ms. Lucey:
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 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.
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Page 2 - Ms. Michele Lucey
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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"
(21CFR 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 (240) 276-3150 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
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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INDICATIONS FOR USE
K 09 4062
SEP 2 7 2010
510(k) Number (if known):
Device Name: Percu-Pro™ Guidewire
Indications for Use:
The Percu-Pro™ Guidewire is intended to facilitate the placement of devices during diagnostic and interventional vascular procedures in the peripheral vasculature. The guidewire is not intended for use in coronary arteries or for neurovascular use.
Prescription Use _____________________________________________________________________________________________________________________________________________________________
AND/OR
Over-The_Counter Use_ ________________________________________________________________________________________________________________________________________________________
(PLEASE DO NOTR WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
W.M.S.d
510(k) Number K054062
§ 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.