(6 days)
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No
The summary describes a physical medical device (catheter) and its materials, intended use, and performance studies focused on substantial equivalence to a predicate device. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
No
The device delivers therapeutic agents but is not itself a therapeutic agent or a device that directly performs a therapeutic action; it is a delivery and guidance tool.
No
Explanation: The device is an angiographic catheter used to deliver media and agents within the vascular system during procedures, not to diagnose a condition.
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.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to deliver substances and other devices within the vascular system for diagnostic and therapeutic procedures. This is an in vivo application (within a living organism).
- Device Description: The description details the physical construction of a catheter designed for insertion into blood vessels.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue) outside of the body to provide information about a physiological state, health, or disease.
IVD devices are used to perform tests on samples taken from the body, while this device is used to interact directly with the body's internal structures.
N/A
Intended Use / Indications for Use
The Radifocus Optitorque Angiographic Catheter is intended for cardiac and vascular procedures. It is designed to dcliver radiopaque media, guide wires, catheters, and therapeutic agents to sclected sites in the vascular system. The different shapes are designed to selectively engage arteries from access sites such as the femoral, radial, and brachial artery.
Product codes
DQO
Device Description
The Radifocus Optitorque Angiographic Catheter 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. The Catheter has a "soft-tip" whose purpose is to minimize trauma to the vessel wall. The soft-tip is a flexible, supple polyurethane tip that is permanently welded to the catheter shaft.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
vascular system; arteries from access sites such as the femoral, radial, and brachial artery
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
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 Optitorque Angiographic Catheter is substantially equivalent to the performance of the Radifocus Optitorque Angiographic Catheter cleared under K992051.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc)
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§ 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
Image /page/0/Picture/0 description: The image shows a sequence of handwritten digits and letters. The sequence is "K082736". The characters are written in black ink on a white background.
SEP 2 4 2008 Terumo Corporation Premarket Notification - Radifocus® Optitorque™ Angiographic Catheter Section II. 510(k) Summary
SECTION II. 510(K) SUMMARY
A. Device Name
| Proprietary Name: | Radifocus® Optitorque™ Angiographic Catheter |
|---|---|
| Classification Name: | Angiographic Catheter |
| Common Name: | Angiographic Catheter |
B. Intended Use
The Radifocus Optitorque Angiographic Catheter is intended for cardiac and vascular procedures. It is designed to dcliver radiopaque media, guide wires, catheters, and therapeutic agents to sclected sites in the vascular system. The different shapes are designed to selectively engage arteries from access sites such as the femoral, radial, and brachial artery.
C. Device Description
The Radifocus Optitorque Angiographic Catheter 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. The Catheter has a "soft-tip" whose purpose is to minimize trauma to the vessel wall. The soft-tip is a flexible, supple polyurethane tip that is permanently welded to the catheter shaft.
D. Principle Of Operation / Technology
The Radifocus Optitorque Angiographic Catheter is operated manually or by a manual process.
E. Design / Materials
The Radifocus Optitorque Angiographic Catheter in this submission is the same device that was cleared under K992051. There are no changes in the design or materials.
1
F. Specifications
| Available Sizes | 4 - 6 Fr. |
|---|---|
| Catheter Length | 650 – 1200 mm |
| Maximum Injection | |
| Pressure | 4 Fr.: 750 psi |
| 5, 6 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 Optitorque Angiographic Catheter is substantially equivalent to the performance of the Radifocus Optitorque Angiographic Catheter cleared under K992051.
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 (