(224 days)
Not Found
No
The description focuses on mechanical components and manual manipulation, with no mention of AI/ML terms or data processing related to learning or prediction.
No.
The device description explicitly states, "The CenterCross Catheter in and of itself does not provide therapeutic benefit beyond simple facilitation of guidewire support."
No
The device is a support catheter used to facilitate the placement and exchange of guidewires and other interventional devices for therapeutic procedures, not for diagnosis. It does not provide any diagnostic information.
No
The device description clearly details a physical catheter with mechanical components (inner shaft, outer sheath, handle, nitinol structure) and mentions extensive bench testing and an in vivo animal study, indicating it is a hardware device.
Based on the provided information, the CenterCross Catheter is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to access and facilitate procedures within the coronary and peripheral vasculature within the body. This is an in vivo application.
- Device Description: The description details a catheter designed for insertion into blood vessels to support guidewires and other interventional devices. This is a medical device used directly on a patient.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (blood, tissue, etc.) outside of the body to provide information about a patient's health.
IVD devices are specifically designed to be used in vitro (in glass, or outside the body) to diagnose diseases or other conditions. The CenterCross Catheter is clearly designed for in vivo use.
N/A
Intended Use / Indications for Use
The CenterCross Catheter is intended to be used in conjunction with steerable guidewires to access discrete regions of the coronary and peripheral vasculature. It may be used to facilitate placement and exchange of guidewires and other interventional devices.
Product codes (comma separated list FDA assigned to the subject device)
DQY
Device Description
The CenterCross Catheter is a sterile, single-use, single lumen over-the-wire support catheter to be used in conjunction with steerable guidewires to access discrete regions of the coronary and peripheral vasculature to facilitate exchange of guidewires and other interventional devices.
The CenterCross Catheter consists of an inner shaft, outer sheath, and a proximal handle that allows for manual device manipulation and a means for flushing the catheter lumen. A key element of the device is a temporarily expandable and retractable nitinol structure, which when deployed by the physician expands to the width of the artery to aid interventionalists in establishing greater support near the treatment site.
Subsequent to conventional guidewire placement, atherectomy devices, PTCA catheters, and/or stents may be used to provide therapeutic benefit. The CenterCross Catheter in and of itself does not provide therapeutic benefit beyond simple facilitation of guidewire support. The CenterCross Catheter is similar in its design and it achieves its intended use by means of the same mechanisms as the predicate devices.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Coronary and peripheral vasculature
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)
Extensive bench testing was conducted on the CenterCross Catheter to evaluate the performance of the device and to support a determination of substantial equivalence to the predicate devices. Non-clinical testing assessed the following aspects of the device:
- Tensile Strength
- Torque Strength
- Simulated Use
- Catheter Compatibility
- Guidewire Compatibility
- Delivery, Deployment and Retraction
- Durability
- Contrast Injection
- Flexibility & Kink Resistance
- Leak
- Particulate
- Expansion Force
- In vivo animal validation study
- Biocompatibility
- Sterilization Adoption into a validated sterilization process
- Packaging and shelf-life
All testing was performed in accordance with recognized standards. The collective results of the non-clinical testing demonstrate that the CenterCross Catheter meets the established specifications necessary for consistent performance for its intended use and is substantially equivalent to the predicate devices.
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.
Roxwood Medical, MultiCross Support Catheter (K121763), Radius Medical, Prodigy Support Catheter (K130714)
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
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized image of three human profiles facing to the right.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 19, 2014
Roxwood Medical, Inc. Mehrdad Farhangnia President & CEO 400 Seaport Ct. Suite #103 Redwood City, California 94063
Re: K140910 Trade/Device Name: CenterCross Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: November 7, 2014 Received: November 10, 2014
Dear Mr. Farhangnia,
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. 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 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Melissa A. Torres -S
For Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
ROXWOOD MEDICAL, INC.
CenterCross Catheter 510(k) PREMARKET NOTIFICATION
INDICATIONS FOR USE STATEMENT
510(k) Number (if known): K140910
Device Name: CenterCross Catheter
Indications For Use:
The CenterCross Catheter is intended to be used in conjunction with steerable guidewires to access discrete regions of the coronary and peripheral vasculature. It may be used to facilitate placement and exchange of guidewires and other interventional devices.
Prescription Use X And/Or (21 CFR Part 801 Subpart D)
Over the Counter Use (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
3
510(k) SUMMARY
510(k) Notification K
GENERAL INFORMATION
Applicant:
Roxwood Medical, Inc. 400 Seaport Ct., Suite #103 Redwood City, CA 94063 U.S.A. Phone: 408.373.4751 FAX: 650.779.4554
Contact Person:
Mehrdad Farhangnia Roxwood Medical, Inc. 400 Seaport Ct., Suite #103 Redwood City, CA 94063 U.S.A. Phone: 408.373.4751 FAX: 650.779.4554
Date Prepared: April 28, 2014
DEVICE INFORMATION
The CenterCross Catheter is a percutaneous catheter for use in the coronary and peripheral vasculature.
Trade Name: CenterCross Catheter
Generic/Common Name: Percutaneous Catheter
Classification: 21 CFR§870.1250, Class II
Product Code: DQY
4
510(k) SUMMARY (CONT.)
PREDICATE DEVICE(S)
- Roxwood Medical, MultiCross Support Catheter (K121763)
- Radius Medical, Prodigy Support Catheter (K130714) ●
INDICATIONS FOR USE
The CenterCross Catheter is intended to be used in conjunction with steerable guidewires to access discrete regions of the coronary and peripheral vasculature. It may be used to facilitate placement and exchange of guidewires and other interventional devices.
PRODUCT DESCRIPTION
The CenterCross Catheter is a sterile, single-use, single lumen over-the-wire support catheter to be used in conjunction with steerable guidewires to access discrete regions of the coronary and peripheral vasculature to facilitate exchange of guidewires and other interventional devices.
The CenterCross Catheter consists of an inner shaft, outer sheath, and a proximal handle that allows for manual device manipulation and a means for flushing the catheter lumen. A key element of the device is a temporarily expandable and retractable nitinol structure, which when deployed by the physician expands to the width of the artery to aid interventionalists in establishing greater support near the treatment site.
Subsequent to conventional guidewire placement, atherectomy devices, PTCA catheters, and/or stents may be used to provide therapeutic benefit. The CenterCross Catheter in and of itself does not provide therapeutic benefit beyond simple facilitation of guidewire support. The CenterCross Catheter is similar in its design and it achieves its intended use by means of the same mechanisms as the predicate devices.
TECHNOLOGICAL CHARACTERISTICS
The technological characteristics of the CenterCross Catheter are similar to the predicate devices. Performance data is provided to support the determination of substantial equivalence.
SUBSTANTIAL EQUIVALENCE
The CenterCross Catheter is substantially equivalent to the Roxwood Medical MultiCross Support Catheter and the Radius Medical Prodigy Support Catheter. The subject device and the predicate devices are percutaneous catheters. The proposed indications for use for the CenterCross Catheter are substantially equivalent to the indications for use for the predicate devices. Any differences in the technological characteristics between the devices do not raise any new issues of safety or effectiveness. Thus, the CenterCross Catheter is substantially equivalent to the predicate devices.
5
510(k) SUMMARY (CONT.)
TESTING IN SUPPORT OF SUBSTANTIAL EQUIVALENCE DETERMINATION
Extensive bench testing was conducted on the CenterCross Catheter to evaluate the performance of the device and to support a determination of substantial equivalence to the predicate devices. Non-clinical testing assessed the following aspects of the device:
Nonclinical Testing Summary:
- Tensile Strength ●
- Torque Strength .
- . Simulated Use
- · Catheter Compatibility
- · Guidewire Compatibility
- · Delivery, Deployment and Retraction
- · Durability
- Contrast Injection
- Flexibility & Kink Resistance ●
- Leak ●
- Particulate ●
- Expansion Force .
- In vivo animal validation study ●
- Biocompatibility ●
- Sterilization Adoption into a validated sterilization process ●
- Packaging and shelf-life .
All testing was performed in accordance with recognized standards. The collective results of the non-clinical testing demonstrate that the CenterCross Catheter meets the established specifications necessary for consistent performance for its intended use and is substantially equivalent to the predicate devices.
CONCLUSION
The CenterCross Catheter is a percutaneous vascular catheter and shares its design and mechanism of action with the identified predicate devices. The results of the performance testing confirm that the CenterCross Catheter functions to its specifications and intended use and exhibit the appropriate characteristics of a percutaneous vascular support catheter. The CenterCross Catheter is substantially equivalent to the predicate devices in terms of technological characteristics, intended use and performance. No new issues of safety or effectiveness are raised by the CenterCross Catheter.
SUMMARY
The CenterCross Catheter is substantially equivalent to the predicate devices.