(269 days)
The Medtronic® Angiographic Catheter is designed to be used for delivering radiopaque media and making pressure measurements in selected coronary sites within the vascular system.
The Medtronic® Angiographic Catheters are 4F, 5F, 6F and 7F in diameter with a braided proximal shaft, non-braided distal segment and a variety of tip configurations.
This submission for the Medtronic® Angiographic Catheter (K980973) is a 510(k) premarket notification. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than providing extensive clinical trial data or detailed performance studies that would typically be required for a novel device.
Therefore, the provided text does not contain the detailed acceptance criteria or a comprehensive study report as would be expected for a product with complex software or AI components. The information is limited to a general statement about meeting specifications and substantial equivalence.
Here's an analysis based on the provided text, while acknowledging the limitations for your specific request:
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| All applicable specifications | "Test results verified that the Medtronic® Angiographic Catheter meets all of the applicable specifications and is deemed adequate for the intended use." |
| Biocompatibility | "All appropriate biocompatibility tests were successfully performed on the materials used for the Medtronic® Angiographic Catheters." |
| Substantial Equivalence | The device is considered substantially equivalent to the Medtronic Cascade® Angiographic Catheter and USCI® Angiographic Catheter. |
Study Information (Based on the provided text)
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
* Not explicitly stated. The submission refers to "Test results" generally, implying laboratory or engineering testing rather than a clinical human subject study with a "test set" as typically understood in AI/medical imaging contexts.
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/Not stated. This submission does not involve an AI device requiring expert-established ground truth for image interpretation or diagnosis. The "ground truth" for a physical device like a catheter would be its physical properties, dimensions, material integrity, and functionality, which are assessed through engineering and materials testing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
* Not applicable/Not stated. This is relevant for studies involving human interpretation (e.g., radiologists reviewing images) where disagreements need resolution. For a physical medical device, testing typically involves objective measurements against established engineering standards.
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
* No. This device is a diagnostic intravascular catheter, not an AI or imaging interpretation system. MRMC studies are not relevant for this type of product.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
* Not applicable. This device is a physical catheter, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
* Not explicitly detailed, but implied to be engineering specifications and material standards. For a catheter, ground truth would relate to its physical dimensions, material strength, biocompatibility, flow rates, pressure measurement accuracy, and resistance to kinking, all measured against predetermined engineering and safety standards.
8. The sample size for the training set
* Not applicable. This is a physical device, not an AI model requiring a "training set."
9. How the ground truth for the training set was established
* Not applicable. This is a physical device, not an AI model.
Summary of Limitations for your Request:
This 510(k) submission for a physical medical device (catheter) precedes the era of widespread AI in medical devices and therefore does not provide the type of detailed information on AI algorithm performance, test set characteristics, expert involvement, or ground truth establishment that your questions are designed to elicit. The "study" mentioned is likely a series of laboratory and engineering tests to ensure the catheter meets its design specifications and is safe and effective for its stated indications for use, in comparison to existing predicate devices.
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Medtronic® Angiographic Catheter
DEC 1 0 1998 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS (Pursuant to Section 12, Safe Medical Devices Act of 1990)
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- The trade or proprietary name of the device is the Medtronic® Angiographic Catheter. Models offered in this product line include Medtronic® 4F Angiographic Catheter, Medtronic® 5F Angiographic Catheter, Medtronic® 6F Angiographic Catheter and Medtronic® 7F Angiographic Catheter. The classification name is Diagnostic Intravascular Catheter.
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- The Medtronic® Angiographic Catheter is designed to be used for delivering radiopaque media and making pressure measurements in selected coronary sites within the vascular system.
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- The Medtronic® Angiographic Catheters are 4F, 5F, 6F and 7F in diameter with a braided proximal shaft, non-braided distal segment and a variety of tip configurations.
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- All appropriate biocompatibility tests were successfully performed on the materials used for the Medtronic® Angiographic Catheters.
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- Test results verified that the Medtronic® Angiographic Catheter meets all of the applicable specifications and is deemed adequate for the intended use. The line of angiographic catheters is considered to be substantially equivalent to the following devices:
- . Medtronic Cascade® Angiographic Catheter
- . USCI® Angiographic Catheter
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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract image of a stylized bird or human figure, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 0 1998
Mr. Mark Chartier Quality Assurance and Regualtory Affairs Manager Medtronic Interventional Vascular, Inc. 37A Cherry Hill Drive Danvers, MA 01923
Re : K980973 Trade Name: Medtronic® Angiographic Catheter Regulatory Class: II Product Code: DQO Dated: September 11, 1998 Received: September 14, 1998
Dear Mr. Chartier:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to A substantially equivalent determination assumes compliance with 895. the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obliqation
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Page 2 - Mr. Mark Chartier
you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4586. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Thomas J. Callehan
Thomas J. Callahe Director Division of Cardiovascular, Respiratory And Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE
| 510(k) Number: | To be assigned by FDA |
|---|---|
| Device Name: | Medtronic® Angiographic Catheter |
| Indications for Use: | The Medtronic® Angiographic Catheter is designed to beused for delivering radiopaque media and making pressuremeasurements in selected coronary sites within the vascularsystem. |
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PACGE IF NEEDED.
Concurrence of CDRH, Office of Device Evaluation (ODE)
ice Evaluation (ODE)
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Device x 510(k) Number _
Prescription Use
(21 CFR 801.109)
Over-The-Counter Use OR
(Per 21 CFR 801.109)
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§ 870.1200 Diagnostic intravascular catheter.
(a)
Identification. An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.(b)
Classification. Class II (performance standards).