MEDTRONIC ZUMA GUIDING CATHETER by MEDTRONICS INTERVENTIONAL VASCULAR

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.

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.

AI/ML Overview

The provided text is a 510(k) summary for the Medtronic® Zuma™ Guiding Catheter. It outlines the device's intended use, construction, and provides a statement of substantial equivalence to predicate devices. However, it does not contain specific acceptance criteria, detailed study results, or the comprehensive information required to fill in all aspects of your request.

Here's a breakdown of what can be extracted and what is missing:

The document states:
"Test results verified that the Medtronic® Zuma™ Guiding Catheters meets all of the applicable specifications and is deemed adequate for the intended use."

This confirms that some testing was done to meet specifications, but it doesn't provide the specifications themselves (the acceptance criteria) or the detailed results.

Assuming a hypothetical scenario for a medical device cleared via 510(k) and drawing common practices from such submissions, the following table and explanations are constructed. Please note these are inferred or placeholders where the original text lacks details.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Biocompatibility:
All materials pass ISO 10993 series tests for cytotoxicity, sensitization, irritation.	All appropriate Biocompatibility tests were successfully performed on the materials used.
Physical Performance:
Inner Lumen Diameter: Minimum inner lumen diameter to accommodate therapeutic devices (e.g., 0.070 inches for a 6F catheter).	A larger inner lumen diameter (compared to existing catheters, implied by "Zuma™ Guiding Catheter has a larger inner lumen diameter"). Actual value not specified.
Shaft Stiffness/Pushability: Sufficient stiffness for guided advancement while maintaining flexibility to navigate tortuous anatomy (e.g., quantified by pushability (gf) and deflection angle).	A stiffer shaft (implied by "Zuma™ Guiding Catheter has... a stiffer shaft"). Specific metrics not provided.
Trackability/Torquability: Ability to accurately transmit torque and navigate vessel anatomy (e.g., torque response angle and force to advance through tortuous model).	Implied by "designed to provide a pathway... in the coronary or peripheral vascular system." Specific metrics not provided.
Distal Tip Softness/Atraumaticity: Distal tip atraumaticity to minimize vessel injury (e.g., durometer reading, force to cause vessel damage in a model).	A soft distal tip. Specific metrics not provided.
Lubricity (Inner Lumen): Low friction to facilitate device passage (e.g., coefficient of friction, force to advance device through lumen).	The inner lumen of the catheter has a thin lubricious coating. Specific metrics not provided.
Burst Pressure: Withstand internal pressure from contrast injection (e.g., >1200 psi).	Not specified, but implied by successful performance testing.
Kink Resistance: Maintain patency during navigation (e.g., angle of kink at defined force).	Not specified, but implied by successful performance testing.
Radiopacity: Clear visibility under fluoroscopy.	Not specified, but generally a requirement for guiding catheters.
Functional Equivalence: Performance comparable to predicate devices in relevant in-vivo/in-vitro models.	Deemed substantially equivalent to Medtronic® Vector™ X Guiding Catheter and Cordis® Brite Tip® Guiding Catheter.

(The following sections will contain "Not mentioned in the provided text" for most points, as the 510(k) summary does not include this level of detail. Such information is typically found in the full 510(k) submission, not the public summary.)

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

Sample Size: Not mentioned in the provided text. For physical properties, this would typically be a statistical sample of manufactured units (e.g., n=30 per test). For biocompatibility, it refers to the material samples tested.
Data Provenance: Not mentioned in the provided text. Most likely laboratory testing (in-vitro) and animal studies (if required for certain biocompatibility or preclinical performance aspects), generally conducted in the country of manufacture or a certified lab. The summary implies the data is prospective, generated specifically for this submission.

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 mentioned. This device is a guiding catheter, a physical medical device, not an AI diagnostic tool. Ground truth in this context refers to established engineering specifications and performance benchmarks, not expert consensus on interpretations. Physical tests are carried out by engineers and technicians according to established protocols.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable/Not mentioned. Adjudication methods are relevant for subjective diagnostic tasks, not for objective physical performance testing of a catheter. Testing follows pre-defined pass/fail criteria.

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 a physical medical device (guiding catheter), not an AI diagnostic system. Therefore, MRMC studies and "human readers improving with AI" are irrelevant to this submission.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The ground truth for this type of device is established engineering specifications, mechanical test standards (e.g., ISO, ASTM), and clinical performance criteria derived from predicate devices and intended use. For biocompatibility, the ground truth is the pass/fail criteria of ISO 10993 tests.

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI/machine learning model, so there is no "training set."

9. How the ground truth for the training set was established

Not applicable. As there is no training set for a physical device, this question is not relevant.

Summary of Device Clearance:

The Medtronic® Zuma™ Guiding Catheter was cleared through the 510(k) pathway by demonstrating substantial equivalence to existing legally marketed predicate devices (Medtronic® Vector™ X Guiding Catheter and Cordis® Brite Tip® Guiding Catheter). This means the FDA determined that the new device is as safe and effective as the predicate devices, based on its technological characteristics, intended use, and performance data. The review focuses on demonstrating that the new device does not raise different questions of safety and effectiveness compared to the predicate. The document confirms that "Test results verified that the Medtronic® Zuma™ Guiding Catheters meets all of the applicable specifications and is deemed adequate for the intended use." indicating successful performance testing, though the specifics of those tests and their acceptance criteria are not detailed in this public summary.

Summary

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K981198

510(k) Notification
Medtronic® Zuma™ Guiding Catheter

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS (Pursuant to Section 12, Safe Medical Devices Act of 1990)

1. 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.
1. 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.
1. 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.
1. All appropriate Biocompatibility tests were successfully performed on the materials used for the Medtronic® Zuma™ Guiding Catheter.
1. 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 .

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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

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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

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INDICATIONS FOR USE

510(k) Number: To be assigned by FDA

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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
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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).