(26 days)
Not Found
No
The document describes a physical medical device (a guide catheter) and its intended use. There is no mention of software, algorithms, or any technology that would suggest the use of AI or ML. The performance studies are based on bench testing and biocompatibility, not algorithmic performance.
No
A therapeutic device is one that treats, ameliorates, or cures a disease or condition. This device, the Micro Guide Catheter XP, is an accessory used to facilitate the placement of guide wires for further percutaneous intervention, rather than directly treating a condition.
No
The device is a guide catheter intended to facilitate the intraluminal placement of guidewires, which is an interventional/therapeutic function, not a diagnostic one. Its purpose is to aid in treatment delivery by guiding other instruments, not to identify or characterize a disease or condition.
No
The device description clearly states it is a physical catheter, a hardware component, and mentions sterilization and physical dimensions.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used to facilitate the placement of guide wires within the peripheral vasculature for percutaneous intervention. This is an in vivo procedure, meaning it is performed within a living organism.
- Device Description: The description details a physical catheter designed for insertion into blood vessels.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) outside of the body to provide information about a physiological state, health, or disease.
IVD devices are used to perform tests on samples taken from the body, not to directly interact with the body internally for therapeutic or interventional purposes.
N/A
Intended Use / Indications for Use
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.
Product codes
DQY, PDU
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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
The substantial equivalence to the predicate devices has been demonstrated via data collected from non-clinical in-vitro bench testing. Biocompatibility testing was conducted per ISO 10993-1 (2003)(E): "Biological Evaluation of Medical Devices. Part 1: Evaluation and Testing'.
Key Metrics
Not Found
Predicate Device(s)
Cordis Micro Guide Catheter XP (510(k) # K035335), Cordis Vista Brite Tip® Guiding Catheter (510(k) #K021593)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
ACE.2473 phase ia 2
:
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 Company
7 Powder Horn Drive
Warren, New Jersey 07059 |
|---------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact
Person | Karen Wilk
Regulatory Affairs Manager
Phone: 908-412-7257
Fax: 908-412-3008 |
| Date
Summary
Prepared | August 20, 2008 |
| General
Information | Trade Name: Micro Guide Catheter XP
Common/Usual Name: Percutaneous Catheter
Device Classification: Class II, 21 CFR 870.1250 Catheter, Percutaneous
Product Code: DQY |
| Name of
Predicate
Devices | The device is substantially equivalent to:
• Cordis Micro Guide Catheter XP (510(k) # K035335)
• Cordis Vista Brite Tip® Guiding Catheter (510(k) #K021593) |
| Device
Description | 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. |
1
510(k) Summary (Continued)
くことで
.
.
.. . Par . .
| 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 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. |
|-----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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. |
| Summary of
Testing and
Conclusion | Biocompatibility testing was conducted per ISO 10993-1 (2003)(E):
"Biological Evaluation of Medical Devices. Part 1: Evaluation and Testing'. |
.
. . . . .
and the comments of the comments of the comments of
.
2
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
3
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
4
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)
edmee
ovascular Devices
Ko82143 510(k) Number