(85 days)
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No
The summary describes a physical guide wire and makes no mention of software, algorithms, or AI/ML capabilities.
No
The device is a guide wire used to introduce and position other devices; it does not directly treat a medical condition.
No
The device is a guide wire used to introduce and position other devices. It does not perform diagnostic functions itself.
No
The device description and intended use clearly describe a physical guide wire used in medical procedures, not a software application.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for use in angiographic procedures to introduce and position devices within the peripheral vasculature. This describes a device used in vivo (within the living body) for a procedural purpose.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections. The device described does not perform any such testing on bodily samples.
Therefore, the Hi-Torque Flex-T Guide Wire is a medical device used for interventional procedures within the body, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Hi-Torque Flex-T Guide Wire is intended for use in angiographic procedures to introduce and position diagnostic and interventional devices within the peripheral vasculature during percutaneous procedures. The wire can be torqued to facilitate navigation through tortuous vessels.
The Hi-Torque Flex-T Guide Wire is not intended for use in coronary or neurovasculature.
Product codes
DQX
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
peripheral vasculature
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, along with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the eagle. The eagle is black, and the text is in a simple, sans-serif font.
MAR 1 1 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Abbott Vascular c/o Ms. Nadine Smith Regulatory Affairs Associate 3200 Lakeside Drive Santa Clara, CA 95054
Re: K083738
Trade/Device Name: HI-Torque Flex-T Guide Wire Common Name: Catheter guide wire Regulation Number: 21 CFR 870.1330 Regulatory Class: II Product Code: DQX Dated: February 10, 2009 Received: February 11, 2009
Dear Ms. Smith:
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. Nadine Smith
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 vours. 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 Statement
510(k) Number (if known): K083738
Device Name: Hi-Torque Flex-T Guide Wire
Indications for Use:
The Hi-Torque Flex-T Guide Wire is intended for use in angiographic procedures to introduce and position diagnostic and interventional devices within the peripheral vasculature during percutaneous procedures. The wire can be torqued to facilitate navigation through tortuous vessels.
The Hi-Torque Flex-T Guide Wire is not intended for use in coronary or neurovasculature.
Prescription Use ХХ (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
or
Concurrence of CDRH, Office of Device Evaluation (ODE)
eamall
(Division Sign-Off) Division of Cardiovascular Devices K083738 510(k) Number
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