(93 days)
Not Found
Not Found
No
The summary describes a guidewire, a purely mechanical device used for guiding catheters. There is no mention of any computational or analytical capabilities, let alone AI/ML. The "Not Found" entries for AI/ML mentions and performance studies further support this.
No
The device is a guidewire, used for directing a catheter through a blood vessel, which is a diagnostic or procedural aid, not a device that directly treats a medical condition.
No
The device is described as a guidewire, intended for directing a catheter through a blood vessel, which is a therapeutic or procedural function, not a diagnostic one.
No
The device description explicitly states "The Guidewires are intended to fit inside a percutaneous catheter for the purpose of directing it through a blood vessel or other natural channel," indicating a physical hardware component (guidewires).
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device as a guidewire used to direct a catheter through blood vessels or other natural channels. This is a surgical or interventional device used directly on or within the patient's body.
- IVD Definition: In Vitro Diagnostics (IVDs) are medical devices used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. This device does not perform such an examination of specimens.
- Device Description: The description confirms it's a Class II medical device used in a percutaneous procedure.
Therefore, the function and application of this guidewire clearly fall outside the scope of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The Guidewires are intended to fit inside a percutaneous catheter for the purpose of directing it through a blood vessel or other natural channel - excluding use in coronary arteries and in the neurovasculature.
Product codes
DQX
Device Description
Guidewires have been in commercial use for over 10 years and been found to be safe and effective for the application for which they are intended. No complaints have been reported to Rocket Medical Plc regarding the use or application of the guidewires.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
blood vessel or other natural channel - excluding use in coronary arteries and in the neurovasculature.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
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
Rocket Medical plc - 510(k) Notification IR™ Guidewires
NOV 2 4 2004
Summary of Safety and Effectiveness
This is a class II device, registered by Rocket Medical plc (Establishment number: 8010022/9610632). This device is substantially equivalent to medical devices which are currently in commerce and have been submitted to the FDA
Guidewires have been in commercial use for over 10 years and been found to be safe and effective for the application for which they are intended. No complaints have been reported to Rocket Medical Plc regarding the use or application of the guidewires.
Rocket Medical plc continues to search all appropriate sources for information relating to safety and effectiveness and maintains an in-house reporting system to identify adverse safety and effectiveness information and as such, applicable data is recorded for this product.
CERTIFICATION
I hereby certify that this Summary of Safety and Effectiveness applies for the above indicated device.
16/8/04
Date
Tradura
Signed by Tracy Charlton Regulatory Affairs Manager Rocket Medical plc Wear Industrial Estate, Washington Tyne & Wear, England. NE38 9BZ
Image /page/0/Picture/13 description: The image contains the logo for Rocketmedical. The logo consists of a stylized letter "R" with a plus sign incorporated into its design, positioned above the word "Rocketmedical". The text is in a simple, sans-serif font.
1
Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.
NOV 2 4 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Rocket Medical Plc. c/o Ms. Tracy Charlton RA Manager Factories 2-4, Sedling Road Wear Industrial Estate Washington, Tyne, & Wear NE38 9BZ UNITED KINGDOM
Re: K042264
Trade Name: IR Guidewires Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire. Regulatory Class: II (two) Product Code: DQX Dated: August 13, 2004 Received: August 23, 2004
Dear Ms. Charlton:
We have reviewed your Section 510(k) premarket notification of intent to market the device wo have and have 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.
2
Page 2 - Ms. Tracy Charlton
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 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 Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Duna R. Wehner
A/\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): KD42264
Device Name: Guidewires
Indications for Use:
The Guidewires are intended to fit inside a percutaneous catheter for the purpose of directing it through a blood vessel or other natural channel - excluding use in coronary arteries and in the neurovasculature.
Prescription Use V (Part 21 CFR 801 Subpart D)
and / or
Over-The-Counter Usc (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)
Page 1 of 1
Duna R. Vachner
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number_K642264