MEDTRONIC 7F AND 8F ZUMA GUIDING CATHETER by MEDTRONICS INTERVENTIONAL VASCULAR

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

Device Description

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.

AI/ML Overview

The provided text refers to a 510(k) summary for a medical device called the Medtronic® Zuma™ Guiding Catheter, not a study evaluating an AI-powered device. Therefore, information regarding AI-specific acceptance criteria, test sets, expert ground truth, MRMC studies, or training sets is not available in the provided document.

However, I can extract the general acceptance criteria for this medical device and how it was shown to meet them based on the provided text.

Here's the information parsed from the provided text:

Acceptance Criteria and Device Performance for Medtronic® Zuma™ Guiding Catheter

Acceptance Criteria	Reported Device Performance
Biocompatibility	All appropriate Biocompatibility tests were successfully performed on the materials used.
Functional Specifications	Test results verified that the device meets all applicable specifications and is deemed adequate for the intended use.
Substantial Equivalence to Predicate Devices	The Zuma™ guide catheter is considered to be substantially equivalent to: Medtronic® 6F Zuma™ Guiding Catheter, Medtronic® Vector™ Guiding Catheter, Cordis® Brite Tip® Guiding Catheter.
Intended Use	Designed to provide a pathway for therapeutic devices in the coronary or peripheral vascular system.
Sizes and Design	Available in 6F, 7F, and 8F outer diameters. 6F: braided proximal shaft, inner liner, soft distal tip. 7F/8F: braided proximal and segmented shaft, inner liner, soft distal tip. Inner lumen has a thin lubricious coating. Larger inner lumen diameter and stiffer shaft than predicate devices.

Study Details (as inferable from a 510(k) submission for a non-AI device):

Sample size for the test set and the data provenance: Not applicable in the context of an AI device. For this traditional medical device, testing would involve in-vitro (bench) testing, and potentially animal studies, to demonstrate performance and safety, but not human "test set" data in the AI sense. The provenance would be the laboratory where testing was conducted.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. For a guiding catheter, "ground truth" relates to physical and performance specifications verified through engineering and biocompatibility testing, not expert interpretation of data.
Adjudication method for the test set: Not applicable. Performance is based on objective, quantifiable measurements against pre-defined specifications for physical properties, functionality, and biocompatibility.
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-powered device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI-powered device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): For this type of device, the "ground truth" would be established by engineering specifications, material science standards (for biocompatibility), and established medical device performance criteria.
The sample size for the training set: Not applicable. This is not an AI-powered device and therefore does not have a training set.
How the ground truth for the training set was established: Not applicable. This is not an AI-powered device.

Summary

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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

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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

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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

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directed 7 mm

INDICATIONS FOR USE

510(k) Number: To be assigned by FDA

Device Name:

Medtronice Zuma™ Guiding Catheter

Indications for Use:

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

Regulation Number and Section

§ 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).