(127 days)
Not Found
Not Found
No
The summary describes a physical medical device (a guiding catheter) and does not mention any software, algorithms, or AI/ML capabilities.
No
The device is a guiding catheter that provides a pathway for the introduction of therapeutic devices, rather than being a therapeutic device itself.
No
Explanation: The device description states its purpose is to provide a pathway for therapeutic devices, and there is no mention of diagnostic functions, image processing, or AI/ML for analysis.
No
The device description clearly states it is a physical catheter with specific construction details (braided shaft, inner liner, soft distal tip, lubricious coating), indicating it is a hardware medical device.
Based on the provided information, the Medtronic® Zuma™ Guiding Catheter is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to "provide a pathway through which therapeutic devices are introduced" within the coronary or peripheral vascular system. This describes a device used in vivo (within the body) for a therapeutic procedure, not a device used in vitro (outside the body) to examine specimens from the body for diagnostic purposes.
- Device Description: The description details the physical construction of a catheter designed to be inserted into blood vessels. This aligns with an in vivo medical device.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any other typical components or processes associated with in vitro diagnostics.
Therefore, the Medtronic® Zuma™ Guiding Catheter is a medical device used for interventional procedures within the vascular system, not an IVD.
N/A
Intended Use / Indications for Use
The Medtronic® Zuma™ 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 Medtronic® Zuma™ Guiding Catheters will be available in a 6F outer diameter size. The catheter is constructed with a braided proximal shaft with an inner liner and a soft distal tip. The inner lumen of the catheter has a thin lubricious coating. The Zuma™ Guiding Catheter has a larger inner lumen diameter and a stiffer shaft.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
coronary or peripheral vascular system
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Test results verified that the Medtronic® Zuma™ Guiding Catheters meets all of the applicable specifications and is deemed adequate for the intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Medtronic® Vector™ X Guiding Catheter, Cordis® Brite Tip® Guiding Catheter
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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) Notification
Medtronic® Zuma™ Guiding Catheter
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® Zuma™ Guiding Catheter. The Medtronic® Zuma™ Guiding Catheter will be available in the 6F size and in curve styles similar to the current Medtronic Guiding Catheters.
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- The Medtronic® Zuma™ 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 Medtronic® Zuma™ Guiding Catheters will be available in a 6F outer diameter size. The catheter is constructed with a braided proximal shaft with an inner liner and a soft distal tip. The inner lumen of the catheter has a thin lubricious coating. TThe Zuma™ Guiding Catheter has a larger inner lumen diameter and a stiffer shaft.
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- All appropriate Biocompatibility tests were successfully performed on the materials used for the Medtronic® Zuma™ Guiding Catheter.
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- Test results verified that the Medtronic® Zuma™ Guiding Catheters meets all of the applicable specifications and is deemed adequate for the intended use. The quide catheters is considered to be substantially equivalent to the following device:
- Medtronic® Vector™ X Guiding Catheter .
- Cordis® Brite Tip® Guiding Catheter .
1
Image /page/1/Picture/2 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized image of three human profiles facing to the right, with three curved lines above them. The profiles are stacked on top of each other, creating a sense of depth and unity. The overall design is simple and modern, with a focus on conveying the department's mission of promoting health and well-being.
AUG - 7 1998
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Mark Chartier Quality Assurance and Regulatory Affairs Manager Medtronic Interventional Vascular, Inc. 37 A Cherry Hill Drive Danvers, MA 01923
K981198/S1 Re: Medtronic® 6F Zuma™ Guiding Catheter Trade Name: Requlatory Class: II Product Code: DOY Dated: June 24, 1998 Received: June 25, 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, labelinq, and prohibitions aqainst 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 Please note: this response to your premarket Federal Register. notification submission does not affect any obligation you might have under sections 531 through 542 of the Act
2
Page 2 - Mr. Mark Chartier
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 requlation 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. Callahon
Thomas J. Callah Director Division of Cardiovascular, Respiratory and Neuroloqical Health Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
INDICATIONS FOR USE
510(k) Number: To be assigned by FDA
(
Medtronic® Zuma™ Guiding Catheter Device Name: The Medtronic® Zuma™ Guiding Catheter is designed to provide a Indications for Use: The Medifornio & Lama - Gapeutic devices are introduced. The Zuma pathway through whiler thused in the coronary or peripheral vascular system.
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED.
Concurrence of CDRH, Office of Device Evaluation (ODE)
| | (Division Sign-Off)
Division of Cardiovascular, Respiratory,
and Neurological Devices |
|---------------|---------------------------------------------------------------------------------------------|
| 510(k) Number | K981198 |
| Prescription Use
| (Per 21 CFR 801.109) | OR | Over-The-Counter Use |
|---|---|---|
| ------------------------------------------ | ---- | ---------------------- |