(18 days)
K/DEN number not found.
Not Found
No
The summary describes a physical medical device (guiding catheter) and its construction, with no mention of software, algorithms, image processing, AI, or ML.
No
Explanation: The device description states that the Medtronice ZumaTM Guiding Catheter "is designed to provide a pathway through which therapeutic devices are introduced" and is intended to be used in the coronary or peripheral vascular system. This indicates it is a guiding catheter, meant to facilitate the use of other therapeutic devices, rather than being a therapeutic device itself.
No
The device is described as a "Guiding Catheter" designed to "provide a pathway through which therapeutic devices are introduced," indicating it is an access tool for treatment, not for diagnosis.
No
The device description clearly describes a physical catheter with specific dimensions, materials, and construction, indicating it is a hardware medical device.
Based on the provided information, the Medtronic ZumaTM Guiding Catheter is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the device is designed 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 procedural purpose, not for testing samples in vitro (outside the body) to diagnose a condition.
- Device Description: The description details the physical construction of a catheter, which is a medical device used for insertion into the body.
- Lack of IVD Characteristics: There is no mention of the device being used to analyze biological samples (blood, urine, tissue, etc.) or to provide diagnostic information based on such analysis.
Therefore, the Medtronic ZumaTM Guiding Catheter is a medical device used for interventional procedures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Medtronice ZumaTM Guiding Catheter is designed to provide a pathway through which therapeutic devices are introduced. The Zuma™ catheter is intended to be used in the coronary or peripheral vascular system
Product codes
DQY
Device Description
The Medtronic® Zuma™ Guiding Catheter will be available in 6F- 8F sizes and in curve styles similar to the current Medtronic Guiding Catheters. The Medtronic® Zuma™ Guiding Catheters will be available in 6F, 7F and 8F outer diameters. The 6F catheter is constructed with a braided proximal shaft with an inner liner and a soft distal tip. The 7F and 8F catheters are manufactured with a braided proximal and segmented shaft with an inner liner and a soft distal tip. The inner lumen of the 22ma™ catheter (6F-8F) has a thin lubricious coating. The Zuma™ Guiding Catheter has a larger inner lumen diameter and a stiffer shaft than its predicate devices.
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
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
Not Found
Predicate Device(s)
Medtronic® 6F Zuma™ Guiding Catheter, Medtronic® Vector™ Guiding Catheter, Cordis® Brite Tip® Guiding Catheter
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
- 4 1000
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS (Pursuant to Section 12, Safe Medical Devices Act of 1990)
- 】. The trade or proprietary name of the device is the Medtronic® Zuma™ Guiding Catheter The Medtronic® Zuma™ Guiding Catheter will be available in 6F- 8F sizes and in curve styles similar to the current Medtronic Guiding Catheters.
- 2: 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 6F, 7F and 8F outer 3. diameters. The 6F catheter is constructed with a braided proximal shaft with an inner liner and a soft distal tip. The 7F and 8F catheters are manufactured with a braided proximal and segmented shaft with an inner liner and a soft distal tip. The inner lumen of the 22ma™ catheter (6F-8F) has a thin lubricious coating. The Zuma™ Guiding Catheter has a larger inner lumen diameter and a stiffer shaft than its predicate devices.
- All appropriate Biocompatibility tests were successfully performed on the materials used for এ the Medtronic® Zuma™ Guiding Catherer.
- Test results verified that the Medtronic® Zuma™ Guiding Catheters meets all of the 5. applicable specifications and is deemed adequate for the intended use. The Zuma™ guide catheter is considered to be substantially equivalent to the following device:
- Medtronic® 6F Zuma™ Guiding Catheter .
- . Medtronic® Vector™ Guiding Catheter
- . Cordis® Brite Tip® Guiding Catheter
1
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of a human figure. The figure is composed of three wavy lines that represent the head, body, and legs.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 0 1998
Mr. Mark Chartier Medtronic Interventional Vascular, Inc. 37A Cherry Hill Drive Danvers, MA 01923
K982883 Re : 7F and 8F Zuma™ Guide Catheter Trade Name: Regulatory Class: II Product Code: DQY Dated: August 14, 1998 Received: August 17, 1998
Dear Mr. Chartier:
This letter corrects our substantially equivalent letter of September 4, 1998 regarding an error with the trade name and the classification number .
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is che antially 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 Incelbeate commerce 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 gencial 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 edditional controls. Existing major regulations affecting your device additions consider and Federal Regulations, Title 21, Parts 800 can be 10 substantially equivalent determination assumes compliance with the Good Manufacturing Practice requirements, as set forth in the with the Good Nandralon (QS) for Medical Devices: General (QS) regulation (21 CFR Part 820) and that, through periodic QS inspections, FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, the che enr regulacion and Deal (FDA) may publish further announcements
2
Page 2 - Mr. Mark Chartier
concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation 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. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at their toll free number (800) 638-2041 or at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Thomas J. Gillehan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
directed 7 mm
INDICATIONS FOR USE
510(k) Number: To be assigned by FDA
Device Name:
r
Medtronice Zuma™ Guiding Catheter
Indications for Use:
The Medtronice ZumaTM Guiding Catheter is designed to provide a pathway through which therapeutic devices are introduced. The Zuma™ catheter is intended to be used 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)
Prescription Use (Per 21 CFR 801.109) OR Over-The-Counter Use
M. Puga
ion Sign Off
n of Cardiovascular, Respiratory
rological Devices
number 6782883