(79 days)
Not Found
No
The 510(k) summary describes a physical guiding catheter and does not mention any software, algorithms, or AI/ML capabilities.
No
The device is described as providing a pathway for other therapeutic devices, rather than being therapeutic itself.
No
The device is a guiding catheter, designed to create a pathway for other therapeutic devices. It does not perform any diagnostic function such as identifying, measuring, or monitoring a disease or condition.
No
The device description clearly states it is a "single lumen catheter with an atraumatic tip," which is a physical hardware component.
Based on the provided information, the Medtronic Guiding Catheter is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "provide a pathway through which therapeutic devices are introduced" into the coronary or peripheral vascular system. This describes a device used in vivo (within the body) for a procedural purpose, not for testing samples in vitro (outside the body).
- Device Description: The description of a "single lumen catheter with an atraumatic tip" further supports its use as a tool for accessing and navigating within blood vessels, not for analyzing biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information based on sample analysis
- Reagents or assays
- Laboratory testing
Therefore, the Medtronic Guiding Catheter is a medical device used for interventional procedures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Medtronic Guiding Catheter is designed to provide a pathway through which therapeutic devices are introduced. The guiding catheter is intended to be used in the coronary or peripheral vascular system.
Product codes
DOY
Device Description
The 6F Taiga™ Guiding Catheter is a single lumen catheter with an atraumatic tip, which provides a pathway for therapeutic devices to be introduced into the coronary or peripheral vascular system.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
coronary or peripheral vascular system
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)
Non-clinical Data: passed all design verification and validation testing.
Summary of Clinical Data: No clinical investigation has been performed for this device.
Conclusion from Data: Medtronic Vascular has demonstrated that the 6F Taiga Guiding Catheter is substantially equivalent to the predicate devices based on its indications for use and fundamental scientific technology.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Medtronic 6F Sherpa NX (Z4) Guiding Catheter, K042489
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
510(k) Summary
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:
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FEB - 6 2009
| FEB - 5 2009 | |
|---|---|
| Submitter: | Medtronic Vascular |
| 37A Cherry Hill Drive | |
| Danvers, MA 01923 | |
| Contact Person: | Vic Zhang |
| Regulatory Affairs Specialist | |
| Phone: (978) 739-3080 | |
| Fax: (978) 777-0390 | |
| Email: vic.zhang@medtronic.com | |
| Date Prepared: | November 14, 2008 |
| Trade Name: | Medtronic 6F Taiga™ Guiding Catheter |
| Common Name: | Guiding Catheter |
| Classification | |
| Name: | Percutaneous Catheter |
| Predicate Device: | Medtronic 6F Sherpa NX (Z4) Guiding Catheter, K042489 |
| Device | |
| Description: | The 6F Taiga™ Guiding Catheter is a single lumen catheter |
| with an atraumatic tip, which provides a pathway for | |
| therapeutic devices to be introduced into the coronary or | |
| peripheral vascular system. | |
| Statement of | |
| Intended Use: | Provide a pathway through which therapeutic devices are |
| introduced. The guiding catheter is intended to be used in | |
| the coronary or peripheral vascular system. | |
| Summary of | |
| Technological | |
| Characteristics: | Luer hub: Allows interfacing of the catheter with other devices. |
| Outer jacket: The outer jacket provides the catheter with its ability to retain its curve, and also provides additional support. | |
| Wire braided shaft: Provides the catheter with torque response and crush resistance. | |
| Inner liner: Provides sufficient lumen lubricity for therapeutic device to pass through. | |
| Distal segments: Allow a transition of catheter stiffness from the proximal catheter shaft to the soft distal tip. | |
| Soft tip: Minimizes the potential for vessel trauma when the catheter is advanced in the vasculature system. | |
| Summary of | Medtronic 6F Taiga™ Guiding Catheter has successfully |
:
.
1
Non-clinical Data:
passed all design verification and validation testing.
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: 上一篇:
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Summary of Clinical Data:
Conclusion from Data:
Medtronic Vascular has demonstrated that the 6F Taiga
No clinical investigation has been performed for this device.
Guiding Catheter is substantially equivalent to the predicate devices based on its indications for use and fundamental scientific technology. ·
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB - 6 2009
Medtronic Vascualr c/o Vic Zang, Ph.D. Regulatory Affairs Specialist 37A Cherry Hill Drive Danvers, MA 01923
Re: K083422
Medtronic 6F Taiga™ Guiding Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Catheter, Percutaneous Regulatory Class: Class II Product Code: DOY Dated: January 8, 2009 Received: January 9, 2009
Dear Dr. Zang:
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.
3
Page 2 – Vic Zang, Ph.D.
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 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 Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding 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.
Sincerelv vours.
R-Vulner
A 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):
Device Name: Medtronic 6F Taiga™ Guiding Catheter
Indications for Use:
The Medtronic Guiding Catheter is designed to provide a pathway through which therapeutic devices are introduced. The guiding catheter is intended to be used in the coronary or peripheral vascular system.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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Division
Division of Cigh-Oir)
Division or Cardiovascular Devices
510(k) Number K083422
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