(130 days)
Not Found
No
The device description and intended use are purely mechanical, and there is no mention of AI, ML, image processing, or data-driven performance metrics.
No.
The device is indicated for percutaneous entry into a vessel using the Seldinger technique, which is a diagnostic or interventional access procedure, not a therapeutic treatment itself.
No
The device description indicates it is a guide wire used for percutaneous entry into a vessel, which is a procedural tool and not used for diagnosing medical conditions.
No
The device description clearly states it is a physical guide wire made of stainless steel with a coating, indicating it is a hardware device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "percutaneous entry into vessel using the Seldinger technique." This describes a procedure performed directly on a patient's body, not on a sample of bodily fluid or tissue in vitro (outside the body).
- Device Description: The description details a physical guide wire used for navigating within blood vessels. This is a surgical/interventional device, not a diagnostic reagent or instrument used to analyze samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information based on laboratory testing.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device is a tool used during a medical procedure on a patient.
N/A
Intended Use / Indications for Use
The Medtronic Angiographic Guide Wires are indicated for percutaneous entry into vessel using the Seldinger technique.
Product codes
DOX
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vessel
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
The proposed Medtronic Angiographic Guide Wires has successfully passed all applicable testing.
Key Metrics
Not Found
Predicate Device(s)
Medtronic Angiographic Guide Wires, Pre-Amendment, K772021, K780438
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
KO82873
.
FEB - 6 2009 ´
510(k) Summary
:
the submit and the submit of the subsequence in
:
.
| Submitter: | Medtronic Vascular
37A Cherry Hill Drive
Danvers, MA 01923-5186 |
|-------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Tara N. Turney, RAC
Regulatory Affairs Specialist
Phone: 978-739-6654
Fax: 978-777-0390
tara.n.turney@medtronic.com |
| Date Prepared: | September 26, 2008 |
| Trade Name: | Medtronic Angiographic Guide Wires |
| Common Name: | Angiographic Guide Wires |
| Classification
Name: | Catheter Guide Wire |
| Predicate Device: | Medtronic Angiographic Guide Wires, Pre-Amendment,
K772021 and K780438 |
| Device
Description: | 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. |
| Statement of
Intended Use: | The Medtronic Angiographic Guide Wires are indicated for
percutaneous entry into vessel using the Seldinger technique. |
| Summary of
Technological
Characteristics: | 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. |
| Summary of Non-
clinical Data: | The proposed Medtronic Angiographic Guide Wires has
successfully passed all applicable testing. |
| Conclusion from
Data: | Medtronic has demonstrated that the Angiographic Guide
Wires are substantially equivalent to the predicate device
based upon indications for use, design, test results and
fundamental scientific technology. |
57
1
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
2
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
3
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
Page 1 of /
(Division Sign-Off) (Division Sign-Olf)
Division of Cardiovascular Devices Division of Cardiovascular Cardiovascular
510(k) Number K082873
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