MEDTRONIC ANGIOGRAPHIC GUIDE WIRES

K082873 · Medtronic Vascular · DQX · Feb 6, 2009 · Cardiovascular

Device Facts

• Record ID: K082873
• Device Name: MEDTRONIC ANGIOGRAPHIC GUIDE WIRES
• Applicant: Medtronic Vascular
• Product Code: DQX · Cardiovascular
• Decision Date: Feb 6, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1330
• Device Class: Class 2

Intended Use

The Medtronic Angiographic Guide Wires are indicated for percutaneous entry into vessel using the Seldinger technique.

Device Story

Medtronic Angiographic Guide Wires are stainless steel devices consisting of an inner core wire, a safety wire, and an outer spring coil with a polytetrafluoroethylene (PTFE) coating. Available in various lengths and diameters, these wires are used by clinicians to facilitate percutaneous vascular access via the Seldinger technique. The device acts as a mechanical guide for the placement of catheters within the vascular system. It is a manual, non-powered instrument used in clinical settings.

Clinical Evidence

Bench testing only.

Technological Characteristics

Stainless steel construction; inner core wire, safety wire, and outer spring coil; polytetrafluoroethylene (PTFE) coating; manual operation; various lengths and diameters.

Indications for Use

Indicated for percutaneous entry into a vessel using the Seldinger technique in patients requiring angiographic procedures.

Regulatory Classification

Identification

A catheter guide wire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.

Special Controls

*Classification.* Class II (special controls). The device, when it is a torque device that is manually operated, non-patient contacting, and intended to manipulate non-cerebral vascular guide wires, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.

Predicate Devices

• Medtronic Angiographic Guide Wires (K772021)
• Medtronic Angiographic Guide Wires (K780438)

Submission Summary (Full Text)

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## KO82873

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# FEB - 6 2009 ´

## 510(k) Summary

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| Submitter: | Medtronic Vascular<br>37A Cherry Hill Drive<br>Danvers, MA 01923-5186 |
|-------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Tara N. Turney, RAC<br>Regulatory Affairs Specialist<br>Phone: [phone]<br>Fax: [phone]<br>[e-mail] |
| Date Prepared: | September 26, 2008 |
| Trade Name: | Medtronic Angiographic Guide Wires |
| Common Name: | Angiographic Guide Wires |
| Classification<br>Name: | Catheter Guide Wire |
| Predicate Device: | Medtronic Angiographic Guide Wires, Pre-Amendment,<br>K772021 and K780438 |
| Device<br>Description: | The Medtronic Angiographic Guide Wires are stainless steel<br>guide wires that are constructed of an inner core wire, a safety<br>wire and an outer spring coil. They have a<br>polytetrafluoroethlyene coating and are available in a variety<br>of configurations of length, diameter and other features. |
| Statement of<br>Intended Use: | The Medtronic Angiographic Guide Wires are indicated for<br>percutaneous entry into vessel using the Seldinger technique. |
| Summary of<br>Technological<br>Characteristics: | There are no changes to the technological characteristics of<br>the Medtronic Angiographic Guide Wires with this<br>submission; characteristics such as product performance,<br>design and intended use have remained the same. |
| Summary of Non-<br>clinical Data: | The proposed Medtronic Angiographic Guide Wires has<br>successfully passed all applicable testing. |
| Conclusion from<br>Data: | Medtronic has demonstrated that the Angiographic Guide<br>Wires are substantially equivalent to the predicate device<br>based upon indications for use, design, test results and<br>fundamental scientific technology. |

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

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#### Public Health Service

FEB - 6 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Medtronic Vascular c/o Ms. Tara N. Turney, RAC Regulatory Affairs Specialist 37A Cherry Hill Drive Danvers, MA 01923

Re: K082873

> Trade/Device Name: Medtronic Vascular Angiographic Guide Wires Common Name: Catheter cannula Regulation Number: 21 CFR 870.1330 Regulatory Class: II Product Code: DOX Dated: December 29, 2008 Received: January 2, 2009

Dear Ms. Turney:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set

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#### Page 2 - Ms. Tara N. Turney

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Duna R. Weiner

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Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

#### Enclosure

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## Indications for Use

510(k) Number (if known):

Device Name: Medtronic Angiographic Guide Wires

Indications for Use:

- The Medtronic Angiographic Guide Wires are indicated for percutaneous . entry into vessel using the Seldinger technique.
Prescription Use ਮ (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Duma R.V. Lunes

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(Division Sign-Off) (Division Sign-Olf)
Division of Cardiovascular Devices Division of Cardiovascular Cardiovascular

510(k) Number K082873

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