The Medtronic Angiographic Guide Wires are stainless steel guide wires that are constructed of an inner core wire, a safety wire and an outer spring coil. They have a polytetrafluoroethlyene coating and are available in a variety of configurations of length, diameter and other features.

AI/ML Overview

The provided text is a 510(k) summary for the Medtronic Angiographic Guide Wires. It states that the submission does not contain information about studies proving the device meets acceptance criteria.

Instead, the summary explicitly states:

"There are no changes to the technological characteristics of the Medtronic Angiographic Guide Wires with this submission; characteristics such as product performance, design and intended use have remained the same."

And, crucially:

"The proposed Medtronic Angiographic Guide Wires has successfully passed all applicable testing."

Therefore, the submission relies on the concept of "substantial equivalence" to a predicate device (Medtronic Angiographic Guide Wires, Pre-Amendment, K772021 and K780438), rather than presenting new clinical study data to establish performance against acceptance criteria.

Based on the provided text, I cannot complete the requested information regarding acceptance criteria and a study proving the device meets them because such details are not present. The submission indicates that all applicable testing has been passed, but it does not specify what those tests were, their acceptance criteria, or the results.

If this were a submission for a novel device or one with significant changes, this information would be expected. However, for a 510(k) relying on substantial equivalence for an unchanged device, the focus is on demonstrating that the new device is fundamentally the same as a previously cleared predicate device.

Summary

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KO82873

FEB - 6 2009 ´

510(k) Summary

the submit and the submit of the subsequence in

Submitter:	Medtronic Vascular37A Cherry Hill DriveDanvers, MA 01923-5186
Contact Person:	Tara N. Turney, RACRegulatory Affairs SpecialistPhone: 978-739-6654Fax: 978-777-0390tara.n.turney@medtronic.com
Date Prepared:	September 26, 2008
Trade Name:	Medtronic Angiographic Guide Wires
Common Name:	Angiographic Guide Wires
ClassificationName:	Catheter Guide Wire
Predicate Device:	Medtronic Angiographic Guide Wires, Pre-Amendment,K772021 and K780438
DeviceDescription:	The Medtronic Angiographic Guide Wires are stainless steelguide wires that are constructed of an inner core wire, a safetywire and an outer spring coil. They have apolytetrafluoroethlyene coating and are available in a varietyof configurations of length, diameter and other features.
Statement ofIntended Use:	The Medtronic Angiographic Guide Wires are indicated forpercutaneous entry into vessel using the Seldinger technique.
Summary ofTechnologicalCharacteristics:	There are no changes to the technological characteristics ofthe Medtronic Angiographic Guide Wires with thissubmission; characteristics such as product performance,design and intended use have remained the same.
Summary of Non-clinical Data:	The proposed Medtronic Angiographic Guide Wires hassuccessfully passed all applicable testing.
Conclusion fromData:	Medtronic has demonstrated that the Angiographic GuideWires are substantially equivalent to the predicate devicebased upon indications for use, design, test results andfundamental scientific technology.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services, USA. The seal features a stylized eagle with outstretched wings, symbolizing protection and service. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle.

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 (240) 276-0210. 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 (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Duna R. Weiner

Image /page/2/Picture/5 description: The image shows a simple, abstract line drawing. It features a curved line that forms a loop at the top, resembling a stylized head or upper body. Below the loop, there are a few short, angular lines that could be interpreted as arms or legs, giving the impression of a figure in motion or a simplified human form.

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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Regulation Number and Section

§ 870.1330 Catheter guide wire.

(a)
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.(b)
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.