(79 days)
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.
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.
The provided text describes the 510(k) summary for the Medtronic 6F Taiga™ Guiding Catheter, which is a medical device, not an AI/ML-enabled diagnostic device. Therefore, the requested information regarding acceptance criteria, study details, and AI-specific metrics (like MRMC studies, standalone performance, training sets) is not applicable to this document.
The document explicitly states: "No clinical investigation has been performed for this device."
Instead, the submission for this device relies on non-clinical data and demonstrating substantial equivalence to a predicate device.
Here's a breakdown of what is relevant from the provided text:
1. A table of acceptance criteria and the reported device performance:
Since this is not an AI/ML diagnostic device, there are no "acceptance criteria" in the sense of performance metrics like sensitivity, specificity, or AUC. The acceptance criteria for this device would have been related to engineering and non-clinical performance (e.g., integrity, deliverability, lubricity), which are summarized as:
| Acceptance Criterion (Implied) | Reported Device Performance |
|---|---|
| Design verification and validation testing | Successfully passed all design verification and validation testing. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
Not applicable. No clinical investigation or test set for performance evaluation was conducted. The evaluation was based on non-clinical (engineering) tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
Not applicable. There was no clinical test set requiring expert ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. No clinical test set.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This is not an AI/ML-enabled device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an AI/ML-enabled device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
Not applicable for clinical performance. The "ground truth" for this device's evaluation would be defined by engineering standards and specifications, confirmed through non-clinical testing.
8. The sample size for the training set:
Not applicable. This is not an AI/ML-enabled device.
9. How the ground truth for the training set was established:
Not applicable. This is not an AI/ML-enabled device.
Study that proves the device meets the acceptance criteria:
The study proving the device meets the acceptance criteria is summarized as "Non-clinical Data: passed all design verification and validation testing." This indicates a series of engineering tests (e.g., mechanical tests, material compatibility, dimensional verification, flow rate, torque response, etc.) were conducted to ensure the device performs as intended and meets its specifications. The specific reports for these tests are not detailed in this summary but would be part of the full 510(k) submission.
Conclusion from Data:
Medtronic Vascular concluded that the 6F Taiga™ Guiding Catheter is substantially equivalent to the predicate devices based on its indications for use and fundamental scientific technology, supported by the successful completion of non-clinical design verification and validation testing.
{0}------------------------------------------------
510(k) Summary
. .
:
.
FEB - 6 2009
| FEB - 5 2009 | |
|---|---|
| Submitter: | Medtronic Vascular37A Cherry Hill DriveDanvers, MA 01923 |
| Contact Person: | Vic ZhangRegulatory Affairs SpecialistPhone: (978) 739-3080Fax: (978) 777-0390Email: vic.zhang@medtronic.com |
| Date Prepared: | November 14, 2008 |
| Trade Name: | Medtronic 6F Taiga™ Guiding Catheter |
| Common Name: | Guiding Catheter |
| ClassificationName: | Percutaneous Catheter |
| Predicate Device: | Medtronic 6F Sherpa NX (Z4) Guiding Catheter, K042489 |
| DeviceDescription: | The 6F Taiga™ Guiding Catheter is a single lumen catheterwith an atraumatic tip, which provides a pathway fortherapeutic devices to be introduced into the coronary orperipheral vascular system. |
| Statement ofIntended Use: | Provide a pathway through which therapeutic devices areintroduced. The guiding catheter is intended to be used inthe coronary or peripheral vascular system. |
| Summary ofTechnologicalCharacteristics: | 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.
.
: 上一篇:
. . . . . . . . . . . 1:40 pm 1 1 - 1 - 1 - 1 - 1 - 1 :
..
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)
$\frac{D}{((Division Sign-Off)}$
Division
Division of Cigh-Oir)
Division or Cardiovascular Devices
510(k) Number K083422
Page 1 of )
§ 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).