(85 days)
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.
Not Found
The provided document is a 510(k) premarket notification letter from the FDA for a medical device called the "HI-Torque Flex-T Guide Wire." This type of letter generally does not include detailed study results, acceptance criteria, or performance data beyond stating that the device is substantially equivalent to a predicate device.
Therefore, most of the requested information cannot be extracted from this document. The letter focuses on the regulatory clearance process rather than specific clinical trial or performance study details.
Here's what can be inferred or stated based on the document:
-
A table of acceptance criteria and the reported device performance:
- Cannot be provided. The document does not specify acceptance criteria (e.g., specific thresholds for tensile strength, torque transmission, or clinical success rates) or detailed reported device performance against such criteria. The letter primarily states that the device is "substantially equivalent" to a predicate device, implying that its performance is considered acceptable based on that comparison, but the specific metrics are not present here.
-
Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Cannot be provided. The document does not describe a test set, sample sizes, or data provenance from a specific study.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
- Cannot be provided. This information pertains to a study, which is not detailed in this regulatory clearance letter.
-
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Cannot be provided. This information is typically found in study protocols and reports, not in an FDA clearance letter.
-
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Cannot be provided. This device is a guide wire, a physical medical instrument, not an AI-assisted diagnostic tool. Therefore, an MRMC study related to AI assistance would not be applicable or expected.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. As stated above, this is a physical medical device, not an algorithm or software.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Cannot be provided. Pertains to a study not detailed here. For a guide wire, "ground truth" might relate to physical properties, in vitro testing, or clinical outcomes, but the specifics are not in this document.
-
The sample size for the training set:
- Cannot be provided. Pertains to an AI/machine learning model, which this device is not.
-
How the ground truth for the training set was established:
- Not applicable. Pertains to an AI/machine learning model, which this device is not.
Summary based on the provided document:
The document is an FDA 510(k) clearance letter for the "HI-Torque Flex-T Guide Wire." It confirms that the device is substantially equivalent to legally marketed predicate devices. The letter specifies the "Indications for Use" stating that the guide wire is intended for "angiographic procedures to introduce and position diagnostic and interventional devices within the peripheral vasculature during percutaneous procedures," and "The wire can be torqued to facilitate navigation through tortuous vessels." It also explicitly states limitations: "The Hi-Torque Flex-T Guide Wire is not intended for use in coronary or neurovasculature."
This letter does not include the detailed technical or clinical study data, acceptance criteria, or performance metrics that would typically be found in a comprehensive study report. The substantial equivalence determination by the FDA implies that the manufacturer demonstrated sufficient evidence (often non-clinical testing and comparison to predicates) to meet regulatory requirements, but the specifics of that evidence are not in this summary letter.
{0}------------------------------------------------
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
{1}------------------------------------------------
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
{2}------------------------------------------------
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
13
§ 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.