(53 days)
K863137/A
No
The summary describes a physical catheter used for delivering substances and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes.
The device's Intended Use states that it "delivers radiopaque media and therapeutic agents to selected sites in the vascular system." The ability to deliver therapeutic agents indicates it can be used in therapeutic procedures.
Yes
Explanation: The device is used in angiographic procedures to deliver radiopaque media. Angiography is a diagnostic imaging technique used to visualize blood vessels. Therefore, a catheter used for this purpose is a diagnostic device.
No
The device description clearly outlines a physical catheter made of materials like stainless steel mesh and polyurethane polyamide elastomer, with a soft tip. The performance studies also focus on physical properties and tests like tensile strength, rigidity, and flow rate, which are characteristic of a hardware medical device. There is no mention of software as the primary component or function.
Based on the provided information, the RADIFOCUS® Optitorque Angiographic Catheter is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for "angiographic procedures" to "deliver radiopaque media and therapeutic agents to selected sites in the vascular system." This describes a device used within the body for imaging and treatment, not a device used to test samples outside the body.
- Device Description: The description details the physical construction of a catheter designed to be inserted into blood vessels.
- Lack of IVD characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is entirely procedural and therapeutic/imaging-related within the vascular system.
N/A
Intended Use / Indications for Use
The RADIFOCUS® Optitorque Angiographic Catheter is intended for use in angiographic procedures. It delivers radiopaque media and therapeutic agents to selected sites in the vascular system.
Product codes (comma separated list FDA assigned to the subject device)
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. The soft tip is approximately 0.51.5 mm long on the 4Fr. Optitorque Catheter. It is approximately 1.02.5mm long on the 5 and 6Fr. Optitorque Catheters.
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)
The following verification tests were performed to demonstrate the substantial equivalence of the Optitorque Angiographic Catheter to the Angiographic Catheter, K863137/A:
- Tensile strength on the shaft, hub and soft tip .
- Rigidity .
- Maximum Pressure Test
- Torque Transmission Test .
- Flow Rate Test .
- . Tip Flexibility Test
- Delivery of Therapeutic Agents .
- Biocompatability Tests .
None of the data raises any new issues of safety and effectiveness. Additionally, a risk analysis was conducted and there were no new issues of safety and effectiveness. Therefore the performance of the Optitorque Angiographic Catheter is substantially equivalent to the performance of the Angiographic Catheter, cleared under K863137/A.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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.
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).
Not Found
§ 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
AUG 10 1999
SUMMARY AND CERTIFICATION II.
SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION PERTAINING TO SUBSTANTIAL EQUIVALENCE
A. Device Name
RADIFOCUS® Optitorque Proprietary Name:
Classification Name: Angiographic Catheter
Common Name: Angiographic Catheter
B. Intended Use
The RADIFOCUS® Optitorque Angiographic Catheter is intended for use in angiographic procedures. It delivers radiopaque media and therapeutic agents to selected sites in the vascular system.
Note: This is the same intended use as the RADIFOCUS® Angiographic Catheter, K863137/A.
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. The soft tip is approximately 0.51.5 mm long on the 4Fr. Optitorque Catheter. It is approximately 1.02.5mm long on the 5 and 6Fr. Optitorque Catheters.
D. Substantial Equivalence
The RADIFOCUS® Optitorque Angiographic Catheter submitted in this 510(k) is substantially equivalent in intended use, design, technology/principles of operation, materials, and performance to the cleared RADIFOCUS® Angiographic Catheter, (K863137/A), the Terumo Angiographic Catheter (K915414) and the Cordis Infiniti Angiographic Catheter (K960975).
E. Principle Of Operation / Technology
The RADIFOCUS® Optitorque Angiographic Catheter is operated manually or by a manual process.
F. Design / Materials
Differences in materials between the RADIFOCUS® Optitorque Angiographic Catheter and the RADIFOCUS® Angiographic Catheter, K863137/A, raise no new issues of safety and effectiveness.
1
G. Specifications
| | Optitorque Angiographic
Catheter | Angiographic Catheter,
K863137/A |
|-------------------------------|----------------------------------------------------|--------------------------------------------------------------------------|
| Available Sizes | 4 - 6 Fr. | 5 – 8 Fr. |
| Catheter Length | 650 - 1200 mm | 500 – 1300 mm |
| Maximum Injection
Pressure | 4 Fr.: 750 psi
5, 6 Fr.: 1000 psi
-- | --
5, 6 Fr.: 1000 psi
7 Fr.: 800 psi
8 Fr.: 700 psi |
H. Performance
The following verification tests were performed to demonstrate the substantial equivalence of the Optitorque Angiographic Catheter to the Angiographic Catheter, K863137/A.
- Tensile strength on the shaft, hub and soft tip .
- Rigidity .
- Maximum Pressure Test ●
- Torque Transmission Test .
- Flow Rate Test .
- . Tip Flexibility Test
- Delivery of Therapeutic Agents .
- Biocompatability Tests .
None of the data raises any new issues of safety and effectiveness. Additionally, a risk analysis was conducted and there were no new issues of safety and effectiveness.
Therefore the performance of the Optitorque Angiographic Catheter is substantially equivalent to the performance of the Angiographic Catheter, cleared under K863137/A.
l. Additional Safety Information
・..
Manufacturing controls include visual, functional (which including dimensional), chemical, biological and sterility tests.
The Optitorque Angiographic Catheter is classified as an Externally Communicating Device, Circulating Blood, Limited Contact (≤24 hrs). The device's 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". Results of the testing demonstrate that the blood contacting materials are biocompatible.
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J. Conclusion
The RADIFOCUS® Optitorque Angiographic Catheter is substantially equivalent in intended use, design, technology / principles of operation, materials and performance to the RADIFOCUS® Angiographic Catheter (K863137/A), the Terumo Angiographic Catheter (K915414) and the Cordis Infiniti Angiographic Catheter (K960975). Differences between the devices do not raise any significant issues of safety or effectiveness. . . - -
| Date Prepared: | June 17, 1999 |
|---|---|
| Prepared By: | Yuk-Ting Lewis |
| Senior Regulatory Specialist | |
| Prepared For: | Terumo Medical Corporation |
| 125 Blue Ball Road | |
| Elkton, MD 21921 | |
| Phone: (410) 392-7213 or (410) 392-7231 | |
| Fax: (410) 398-6079 |
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Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 10 1999
Ms. Yuk-Ting Lewis Senior Requlatory Specialist Terumo Medical Corporation 125 Blue Ball Road Elkton, MD 21921
Re : K992051
RADIFOCUS® Optitorque™ Angiographic Catheter Trade Name: Requlatory Class: II Product Code: DQO Dated: July 12, 1999 Received: July 13, 1999
Dear Ms. Lewis:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 A substantially equivalent determination assumes compliance with 895. the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation
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Page 2 - Ms. Yuk-Ting Lewis
you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4586. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,
Thomas J. Callahon
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory and Neuroloqical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Note: This is the same intended use as the unmodified device, K863137/A
510(k) Number (if known):
RADIFOCUS® Optitorque™ Angiographic Catheter Device Name:
Indications For Use:
The RADIFOCUS® Optitorque Angiographic Catheter is intended for use in angiographic procedures. It delivers radiopaque media and therapeutic agents to selected sites in the vascular system.
Ohtyr M. for Callahan.
ring Off Fascilla: Respiratory, 510(k) Number
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)