(31 days)
No
The summary describes a physical catheter used for delivering substances and guiding wires, with no mention of software, algorithms, or AI/ML capabilities.
No
The device delivers therapeutic agents, but its primary function is for diagnostic procedures (angiography) and guiding other devices. It does not exert a direct therapeutic effect itself.
No
The device is a catheter used to deliver media and agents, and to lead other instruments. Its function is interventional/delivery, not diagnostic.
No
The device description clearly details a physical catheter constructed from materials like stainless steel mesh and polyurethane polyamide elastomer, 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 clearly states it's for "angiographic procedures" to "deliver radiopaque media and therapeutic agents to selected sites in the vascular system" and to "lead a guide wire or a catheter into the target site." This describes a device used within the body for diagnostic imaging and therapeutic delivery, not for testing samples outside the body.
- Device Description: The description details a catheter with a specific construction and coating designed for insertion into the vascular system. This is consistent with an in-vivo medical device.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or performing tests on these samples to diagnose a condition.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is entirely focused on interacting with the vascular system in vivo.
N/A
Intended Use / Indications for Use
The RADIFOCUS® Glidecath® (or RADIFOCUS Glidecath XP) is intended for use in angiographic procedures. It delivers radiopaque media and therapeutic agents to selected sites in the vascular system. It is also used to lead a guide wire or a catheter into the target site.
Product codes
DQO
Device Description
The RADIFOCUS® Glidecath® (or RADIFOCUS Glidecath XP) is a two-layer construction comprised of a stainless steel mesh sandwiched between layers of polyurethane polyamide elastomer. The polyurethane polyamide elastomer contains barium sulfate for visibility and contrast under fluoroscopy. There is a hydrophilic coating on the distal portion of the device. The length of the coating is determined by the product code number.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vascular system
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)
A risk/hazard analysis was conducted according to EN ISO 14971 Medical Devices -Application of risk management to medical devices. Performance characteristics for this new indication for use were determined. Then it was justified that the performance of the RADIFOCUS® Glidecath® (or RADIFOCUS Glidecath XP) is substantially equivalent to the performance of the Terumo Angiographic Catheter cleared under K915414.
Manufacturing controls include visual, functional, dimensional and sterility tests.
Blood contacting materials were tested in accordance with the tests recommended in the FDA General Program Memorandum #G95-1 (5/1/95): Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part-1: Evaluation and Testing".
The catheter is classified as Externally Communicating Devices, Circulating Blood, limited Contact (
§ 870.1200 Diagnostic intravascular catheter.
(a)
Identification. An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.(b)
Classification. Class II (performance standards).
0
:
FEB = 6 2009
SECTION II. 510(K) SUMMARY
A. Device Name
| Proprietary Name: | RADIFOCUS® Glidecath® (or RADIFOCUS Glidecath XP) |
|---|---|
| Classification Name: | Diagnostic Intravascular Catheter |
| Common Name: | Angiographic Catheter |
B. Intended Use
The RADIFOCUS® Glidecath® (or RADIFOCUS Glidecath XP) is intended for use in angiographic procedures. It delivers radiopaque media and therapeutic agents to selected sites in the vascular system. It is also used to lead a guide wire or a catheter into the target site.
C. Device Description
The RADIFOCUS® Glidecath® (or RADIFOCUS Glidecath XP) is a two-layer construction comprised of a stainless steel mesh sandwiched between layers of polyurethane polyamide elastomer. The polyurethane polyamide elastomer contains barium sulfate for visibility and contrast under fluoroscopy. There is a hydrophilic coating on the distal portion of the device. The length of the coating is determined by the product code number.
D. Principle of Operation / Technology
The RADIFOCUS® Glidecath® (or RADIFOCUS Glidecath XP) is operated manually or by a manual process.
E. Design / Materials
The RADIFOCUS® Glidecath® (or RADIFOCUS Glidecath XP) in this submission is the same device that was cleared under K915414, the Terumo Angiographic Catheter. There are no changes in the design or materials.
1
Terumo Corporation Premarket Notification - RADIFOCUS® Glidecath® (or RADIFOCUS Glidecath XP) Section II. 510(k) Summary
F. Specifications
| Available Sizes | 4 & 5 Fr. |
|---|---|
| Catheter Length | 30 - 150 cm |
| Maximum Injection | |
| Pressure | 4 Fr.: 750 psi |
| 5 Fr.: 1000 psi |
G. Performance
A risk/hazard analysis was conducted according to EN ISO 14971 Medical Devices -Application of risk management to medical devices. Performance characteristics for this new indication for use were determined. Then it was justified that the performance of the RADIFOCUS® Glidecath® (or RADIFOCUS Glidecath XP) is substantially equivalent to the performance of the Terumo Angiographic Catheter cleared under K915414.
H. Additional Safety Information
Manufacturing controls include visual, functional, dimensional and sterility tests.
Blood contacting materials were tested in accordance with the tests recommended in the FDA General Program Memorandum #G95-1 (5/1/95): Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part-1: Evaluation and Testing".
The catheter is classified as Externally Communicating Devices, Circulating Blood, limited Contact ( Trade/Device Name: RADIFOCUS® Glidecath® (or RADIFOCUS Glidecath XP) Common Name: Diagnostic intravascular catheter Regulation Number: 21 CFR 870.1200 Regulatory Class: II Product Code: DQO Dated: January 23, 2008 Received: January 26, 2008
Dear Mr. Job:
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
4
Page 2 - Mr. Mark Job
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. product rainline in 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,
R-vichner
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): K090040
RADIFOCUS® Glidecath® (or RADIFOCUS Glidecath XP) Device Name:
Indications For Use:
The RADIFOCUS® Glidecath® (or RADIFOCUS Glidecath XP) is intended for use in angiographic procedures. It delivers radiopaque media and therapeutic agents to selected sites in the vascular system. It is also used to lead a guide wire or a catheter into the target site.
Prescription Use X (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)
R. Vi. Lunes
(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number_ko 900 40