MEDTRONIC 5F & 9F ZUMA GUIDING CATHETERS

K990707 · Medtronics Interventional Vascular · DQY · Mar 22, 1999 · Cardiovascular

Device Facts

• Record ID: K990707
• Device Name: MEDTRONIC 5F & 9F ZUMA GUIDING CATHETERS
• Applicant: Medtronics Interventional Vascular
• Product Code: DQY · Cardiovascular
• Decision Date: Mar 22, 1999
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1250
• Device Class: Class 2

Intended Use

The Medtronic® Zuma™ 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 Story

The Medtronic Zuma Guiding Catheter serves as a conduit for delivering therapeutic devices into the coronary or peripheral vascular system. It consists of a braided proximal shaft, an inner liner, and a soft distal tip, with a lubricious coating on the inner lumen. Available in 5F-9F sizes, the device is used by clinicians in vascular procedures to facilitate access. The catheter provides a pathway for interventional tools; its design features varying stiffness and lumen diameters to accommodate different clinical needs. By providing a stable, lubricious track, it assists the physician in navigating the vasculature to deliver therapy, potentially improving procedural efficiency and patient outcomes.

Clinical Evidence

Bench testing only. Biocompatibility testing was successfully performed on all materials. Performance testing verified that the device meets all applicable specifications.

Technological Characteristics

Braided proximal shaft, inner liner, soft distal tip, and lubricious inner lumen coating. Available in 5F-9F outer diameters. 6F and 9F models are non-segmented; 5F, 7F, 8F, and 9F models are segmented. Mechanical device; no energy source or software.

Indications for Use

Indicated for use as a pathway for the introduction of therapeutic devices into the coronary or peripheral vascular system. For prescription use only.

Regulatory Classification

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.

Predicate Devices

• Medtronic® 6F Zuma™ Guiding Catheter
• Medtronic® 7F, 8F Zuma™ Guiding Catheter
• Medtronic® Vector™ X Guiding Catheter
• Cordis® Brite Tip® Guiding Catheter

Submission Summary (Full Text)

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3/22/99

K990707

510(k) Notification Medtronio® Zuma™ Guiding Catheter

## 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 l . Medtronic® Zuma™ Guiding Catheter will be available in 5F- 9F sizes and in curve styles similar to the current Medtronic Guiding Catheters.
- The Medtronic® Zuma™ Guiding Catheter is designed to provide a pathway through which 2. 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 5F 9F outer diameters. The 6F and 3. 9F (non-segmented) catheter is constructed with a braided proximal shaft with an inner liner and a soft distal tip. The 5F, 7F, 8F and 9F(segmented) Zuma catheters are manufactured with a braided proximal shaft and segments, an inner liner and a soft distal tip. The inner lumen of the Zuma™ catheter has a thin lubricious coating. The Zuma™ Guiding Catheter (6F - 9F) has a larger inner lumen diameter than its predicate devices. The 5F Zuma is comparable in stiffness to a 6F predicate device.
- All appropriate Biocompatibility tests were successfully performed on the materials used for the 4. Medtronic® Zuma™ Guiding Catheter.
- న్. Test results verified that the Medtronic® Zuma™ Ouiding Catheters meet all of the applicable specifications and are 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® 7F. 8F Zuma™ Guiding Catheter
- Medtronic® Vector™ X Guiding Catheter ●
- Cordis® Brite Tip® Guiding Catheter .

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## MAR 2 2 1999

Mr. Mark Chartier Quality Assurance and Regulatory Affairs Director Medtronic Interventional Vascular, Inc. 37A Cherry Hill Drive Danvers, MA 01923

Re: K990707 Medtronic® Zuma™ Guiding Catheter Trade Name: Requlatory Class: II Product Code: DQY Dated: March 3, 1999 Received: March 4, 1999

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 regulation (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 requlation may result in requlatory action. In addition, FDA may publish further announcements concerninq your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation

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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) Additionally, for questions on the promotion and advertising 594-4586. of your device, please contact the Office of Compliance at (301) 594- Also, please note the regulation entitled, "Misbranding by 4639. 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 [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Thomas J. Callehan

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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## INDICATIONS FOR USE

510(k) Number: To be assigned by FDA K996707

Device Name:

Medtronic® Zuma™ Guiding Catheter

Indications for Use:

The Medtronic® Zuma™ 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.

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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

Victor Lam Hu

rdiovascular, Respiratory, 510(k) N