(26 days)
The Micro Guide Catheter XP accessory is to be used with the Frontrunner® XP CTO Catheter. The Frontrunner XP CTO Catheter is intended to facilitate the intraluminal placement of conventional guide wires beyond the stenotic lesions (including chronic total occlusions) in the peripheral vasculature prior to further percutaneous intervention.
The Micro Guide Catheter XP is a single lumen, braided guide catheter with a PTFE liner. The Micro Guide Catheter has a 4.5 French profile, an inner diameter of 0.042" and overall lengths of 82 cm and 132 cm.
The Micro Guide Catheter XP is provided sterile (via Ethylene Oxide sterilization) and is intended for single use only.
The provided text is related to a 510(k) submission for a medical device called the "Micro Guide Catheter XP." This document focuses on demonstrating substantial equivalence to predicate devices through non-clinical in-vitro bench testing and biocompatibility testing. It does not involve a study to establish performance against specific acceptance criteria in the context of an AI/algorithm-driven device for diagnostic or prognostic purposes, which is what your questions are geared towards.
Therefore, I cannot extract the information you requested about acceptance criteria, sample sizes for test/training sets, expert involvement, adjudication methods, or MRMC studies, as these aspects are not present in the provided 510(k) summary for this type of medical device.
The document states:
- Summary of Testing and Conclusion: "The Micro Guide Catheter XP is substantially equivalent to the predicate devices. The substantial equivalence to the predicate devices has been demonstrated via data collected from non-clinical in-vitro bench testing."
- Biocompatibility testing: "Biocompatibility testing was conducted per ISO 10993-1 (2003)(E): 'Biological Evaluation of Medical Devices. Part 1: Evaluation and Testing'."
These types of tests are physical or chemical evaluations of the device itself, rather than studies assessing diagnostic or prognostic performance with human input or an algorithm.
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ACE.2473 phase ia 2
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AUG 2 5 2008
Image /page/0/Picture/2 description: The image shows the logo for Cordis, a Johnson & Johnson company. The word "Cordis" is written in a bold, stylized font. Below the company name, the text "a Johnson & Johnson company" is written in a smaller font.
510(k) Summary
| Submitter | Cordis Corporation, a Johnson & Johnson Company7 Powder Horn DriveWarren, New Jersey 07059 |
|---|---|
| ContactPerson | Karen WilkRegulatory Affairs ManagerPhone: 908-412-7257Fax: 908-412-3008 |
| DateSummaryPrepared | August 20, 2008 |
| GeneralInformation | Trade Name: Micro Guide Catheter XPCommon/Usual Name: Percutaneous CatheterDevice Classification: Class II, 21 CFR 870.1250 Catheter, PercutaneousProduct Code: DQY |
| Name ofPredicateDevices | The device is substantially equivalent to:• Cordis Micro Guide Catheter XP (510(k) # K035335)• Cordis Vista Brite Tip® Guiding Catheter (510(k) #K021593) |
| DeviceDescription | The Micro Guide Catheter XP is a single lumen, braided guide catheter with a PTFE liner. The Micro Guide Catheter has a 4.5 French profile, an inner diameter of 0.042" and overall lengths of 82 cm and 132 cm.The Micro Guide Catheter XP is provided sterile (via Ethylene Oxide sterilization) and is intended for single use only. |
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510(k) Summary (Continued)
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| Indication forUse | The Micro Guide Catheter XP accessory is to be used with the Frontrunner®XP CTO Catheter. The Frontrunner XP CTO Catheter is intended tofacilitate the intraluminal placement of conventional guide wires beyond thestenotic lesions (including chronic total occlusions) in the peripheralvasculature prior to further percutaneous intervention. |
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| Summary ofTesting andConclusion | The Micro Guide Catheter XP is substantially equivalent to the predicatedevices. The substantial equivalence to the predicate devices has beendemonstrated via data collected from non-clinical in-vitro bench testing. |
| Summary ofTesting andConclusion | Biocompatibility testing was conducted per ISO 10993-1 (2003)(E):"Biological Evaluation of Medical Devices. Part 1: Evaluation and Testing'. |
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and the comments of the comments of the comments of
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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The symbol is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The text is written in a simple, sans-serif font.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Cordis Corporation Ms. Karen Wilk Regulatory Affairs Manager 7 Power Horn Drive Warren, NJ 07059
Re: K082143
Trade/Device Name: Micro Guide Catheter XP Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: PDU Dated: July 29, 2008 Received: July 30, 2008
SEP 1 8 2013
Dear Ms. Wilk:
This letter corrects our substantially equivalent letter of August 25, 2008.
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
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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 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/ResourcesforYou/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/ReportalProblem/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/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Zin. Zin
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
510(k) Number (if known): K08Ziy 3
Device Name: Frontrunner Micro Guide Catheter XP
Indication for Use: The Micro Guide Catheter XP accessory is to be used with the Frontrunner® XP CTO Catheter. The Frontrunner XP CTO Catheter is indicated to facilitate the intraluminal placement of conventional guidewires beyond the stenotic lesions (including chronic total occlusions) in the peripheral vasculature prior to further percutaneous intervention.
Prescription Use X (Part 21 CFR 801 Subpart D
Over-The-Counter Use AND/OR (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)
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ovascular Devices
Ko82143 510(k) Number
§ 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).