(153 days)
No
The 510(k) summary describes a physical medical device (catheter) and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML. The focus is on the physical properties and function of the catheter for delivering contrast and enabling imaging.
No
The device is used for diagnostic visualization (angiography) to provide images of the vasculature, not for treating a disease or condition.
No
The device is an angiographic catheter designed to deliver contrast media for visualization and measurement of the vasculature. It facilitates imaging but does not perform diagnosis itself.
No
The device description clearly describes a physical catheter, a "thin plastic tube," which is a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or treatment.
- This device is a catheter inserted directly into the vascular system of a patient. It is used to deliver contrast media and facilitate imaging within the body, not to analyze a sample outside the body.
The description clearly indicates it's an invasive device used for imaging the vascular system in vivo.
N/A
Intended Use / Indications for Use
Cordis Angiographic Catheters with Marker Bands are designed to provide angiographic visualization and linear measurement of the vasculature when combined with the delivery of radiopaque contrast media to selected sites in the vascular system.
Product codes
DQX, DQO
Device Description
The SUPER TORQUE® MB Angiographic Catheter is a thin plastic tube which is inserted into an artery through a small incision in the skin. The catheter is guided to the area being examined, and contrast material is injected through the tube and images are captured using a small dose of ionizing radiation (x-rays).
Each SUPER TORQUE® MB Angiographic Catheter consists of a braided Polyurethane body and a non-braided Polyurethane tip section having multiple, radiopaque marker bands.
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
Bench Testing: No new testing was required to be conducted due to addition of contraindication in the IFU. However, since the clearance of the original 510(k), minor manufacturing updates were made, additional biocompatibility testing was performed, and additional sterilization facilities were qualified. The testing previously conducted, and the additional testing provided in this 510(k) confirm that the SUPER TORQUE® MB Angiographic Catheter meets established performance characteristics.
Clinical Studies: No clinical data was required in support of the proposed change to the predicate device cleared under K992347.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
February 17, 2022
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Cordis Corporation Vidya Venkataraghavan Principal Specialist, Regulatory Affairs 14201 N.W. 60th Avenue Miami Lakes, Florida 33014
Re: K212977
Trade/Device Name: SUPER TORQUE MB Angiographic Catheter with Radiopaque markerbands Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: DQX Dated: December 20, 2021 Received: December 21, 2021
Dear Vidya Venkataraghavan:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for Lydia Glaw Assistant Director DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K212977
Device Name SUPER TORQUE® MB Angiographic Catheter
Indications for Use (Describe)
Cordis Anglographic Catheters with Marker Bands are designed to provide angiographic visualization and linear measurement of the vasculature when combined with the delivery of radiopaque contrast media to selected sites in the vascular system.
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over The Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ----------------------------------------------------------------------------------------- | ---------------------------------------------------------------------------------------- |
||X| Prescription Use (Part 21 CFR 801 Subpart D)
_ | Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary
I. SUBMITTER
Applicant: Cordis US Corp. 14201 North West 60th Avenue Miami Lakes, Florida 33014 USA Establishment Reqistration: 1016427
Contact: Vidya Venkataraghavan Cordis US Corp. Tel: (408) 718-1348 vidya.venkataraghavan@cordis.com
Date Prepared: December 20, 2021
II. DEVICE
Name of Device: SUPER TORQUE® MB Angiographic Catheter Common Name: Angiographic Catheter Classification Name: Diagnostic Intravascular Catheter (21 CFR 870.1200), Class II Product Code: DQO
III. PREDICATE DEVICE
SUPER TORQUE®MB Angiographic Catheter with Radiopaque Marker Bands cleared on October 8, 1999 under K992347.
IV. DEVICE DESCRIPTION
The SUPER TORQUE® MB Angiographic Catheter is a thin plastic tube which is inserted into an artery through a small incision in the skin. The catheter is guided to the area being examined, and contrast material is injected through the tube and images are captured using a small dose of ionizing radiation (x-rays).
Each SUPER TORQUE® MB Angiographic Catheter consists of a braided Polyurethane body and a non-braided Polyurethane tip section having multiple, radiopaque marker bands.
It is available in the following configurations:
| Catalog Numbers |
|---|
| 532598A |
| 532598B |
| 532598C |
| SRD7040MB |
4
The materials of construction of the SUPER TORQUE® MB Angiographic Catheter are as follows:
| Component | Materials | Patient
Contact |
|---------------|------------------------------------------------------|--------------------|
| Catheter Body | Pellethane, Barium Sulphate, Stainless
steel wire | Direct |
| Catheter Tip | Pellethane, Barium Sulphate | Direct |
| Marker Bands | Gold-alloy marker | Direct |
| Strain Relief | Combination of various polyurethane
grades | Indirect |
| Hub | Isoplast | Indirect |
| Coating | 51-3 solution | Direct |
IV. INDICATIONS FOR USE
Cordis Angiographic Catheters with Marker Bands are designed to provide angiographic visualization and linear measurement of the vasculature when combined with the delivery of radiopaque contrast media to selected sites in the vascular system.
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
The proposed SUPER TORQUE® MB Angiographic Catheter and the predicate device cleared under K992347 are inserted into the artery through a small incision in the skin. Both contain a luer connector, braided catheter body and an atraumatic tip.
The proposed SUPER TORQUE® MB Angiographic Catheter is the same device as that of the currently cleared device with an addition of below labeling contraindication.
'Do not use the SUPER TORQUE MB catheter in procedures where entrapment of the catheter between endovascular devices and the vessel wall may occur, for example endovascular aortic repair (EVAR) procedures. "
VII. PERFORMANCE DATA
Bench Testing
No new testing was required to be conducted due to addition of contraindication in the IFU. However, since the clearance of the original 510(k), minor manufacturing updates were made, additional biocompatibility testing was performed, and additional sterilization facilities were qualified.
5
The testing previously conducted, and the additional testing provided in this 510(k) confirm that the SUPER TORQUE® MB Angiographic Catheter meets established performance characteristics.
Clinical Studies
No clinical data was required in support of the proposed change to the predicate device cleared under K992347.
VIII. CONCLUSIONS
The information presented in this Premarket Notification demonstrates the following for the SUPER TORQUE® MB Angiographic Catheter:
- SUPER TORQUE® MB Angiographic Catheter has a legally-marketed predicate
- SUPER TORQUE® MB Angiographic Catheter has the same Intended Use as the ● predicate
- . SUPER TORQUE® MB Angiographic Catheter incorporates the same fundamental technology as the predicate
- Accepted scientific methods and international standards were used to evaluate substantial equivalence of the SUPER TORQUE®MB Angiographic Catheter relative to the predicate
- . Performance characteristics of the SUPER TORQUE® MB Angiographic Catheter are equivalent to the predicate device.
Based on the intended use, technological characteristics, and safety and performance testing, the SUPER TORQUE® MB Angiographic Catheter has been shown to be appropriate for its intended use and is considered substantially equivalent to the predicate SUPER TORQUE® MB Angiographic Catheter with Radiopaque Marker Bands (K992347).