(99 days)
No
The summary describes a mechanical catheter used for guidewire support and exchange. There is no mention of AI, ML, image processing, or any computational analysis of data. The performance studies are focused on mechanical and material properties.
No
The device explicitly states, "The CenterCross Ultra Catheter in and of itself does not provide therapeutic benefit beyond simple facilitation of guidewire and device support." It is an access and support tool for other interventional devices that may provide therapeutic benefit.
No
Explanation: The device description states that the CenterCross ULTRA Catheter is used to facilitate placement and exchange of guidewires and other interventional devices for therapeutic purposes, and explicitly says it "in and of itself does not provide therapeutic beyond simple facilitation of guidewire and device support." It does not mention any diagnostic capabilities or functions.
No
The device description clearly details a physical catheter with mechanical components (outer shaft, inner shaft, expandable nitinol structure) and mentions extensive bench testing on the physical device, indicating it is a hardware medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is used in conjunction with steerable guidewires to access discrete regions of the coronary and peripheral vasculature and to facilitate placement and exchange of guidewires and other interventional devices. This describes a device used within the body for procedural support, not for testing samples outside the body to diagnose conditions.
- Device Description: The description details a physical catheter with an expandable structure used for support within the vasculature. This aligns with an interventional medical device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, etc.), detecting analytes, or providing diagnostic information based on laboratory testing.
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 purely mechanical and procedural within the body.
N/A
Intended Use / Indications for Use
The CenterCross ULTRA 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
DQY
Device Description
The CenterCross Ultra Catheter is a sterile, 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 Ultra Catheter consists of an outer shaft and a removable handle/inner shaft assembly that allows for manual device manipulation. A key element of the device is an expandable and retractable nitinol structure, which, when deployed by the physician, expands to the artery wall 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 Ultra Catheter in and of itself does not provide therapeutic beyond simple facilitation of guidewire and device support. The CenterCross Ultra Catheter is similar in its design and achieves its intended use by means of the same mechanisms as the predicate device.
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
physician
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 Ultra Catheter to evaluate the performance of the device and to support a determination of substantial equivalence to the predicate device. Non-clinical testing assessed the following aspects of the device:
- Dimensional Inspection.
- Expansion Force.
- Simulated Use.
- Hydrophilic Coating.
- Leak.
- Contrast Flush Injection.
- Tip Flexibility & Kink Resistance
- Torque Strength
- Tensile Strength.
- Particulate
- Radiopacity.
- Corrosion
- LAL.
- EO Residuals
- Packaging and Shelf-Life.
- Biocompatibility.
All testing was performed in accordance with recognized standards. The collective results of the non-clinical testing demonstrate that the CenterCross Ultra Catheter meets the established specifications necessary for consistent performance for its intended use and is substantially equivalent to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
CenterCross Ultra Catheter (K152456)
Reference Device(s)
Turnpike Catheter (Vascular Solutions, Inc., K142065), MicroCross Catheter (Roxwood Medical, Inc., K151082)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure or a bird in flight, composed of three overlapping profiles.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 17, 2016
Roxwood Medical, Inc Cathy Mantor Director. Quality & Regulatory 400 Seaport Ct. Suite 103 Redwood City, California 94063
Re: K160681
Trade/Device Name: CenterCross Ultra Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: May 19, 2016 Received: May 20, 2016
Dear Cathy Mantor:
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 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.
1
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,
Kenneth J. Cavanaugh -S
for
for Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K160681
Device Name CenterCross Ultra Catheter
Indications for Use (Describe)
The CenterCross ULTRA 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.
| 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
SECTION 5. 510(k) SUMMARY
510(k) Notification K160681
GENERAL INFORMATION
Applicant: Roxwood Medical, Inc. 400 Seaport Court, Suite #103 Redwood City, CA 94063, USA Establishment Registration: #3010034168
Contact Person:
Cathy Mantor Director, Quality & Regulatory Phone: (510) 499-0253 Fax: (650) 779-4554
Date Prepared: March 9, 2016
DEVICE INFORMATION
The CenterCross Ultra Catheter is a percutaneous catheter for use in the coronary and peripheral vasculature.
| Trade Name: | CenterCross Ultra Catheter |
|---|---|
| Generic/Common Name: | Percutaneous Catheter |
| Classification: | 21 CFR§870.1250, Class II |
| Product Code: | DQY |
PREDICATE DEVICE(S)
CenterCross Ultra Catheter (K152456) The predicate has not been subject to a design-related recall.
REFERENCE DEVICE(S)
Turnpike Catheter (Vascular Solutions, Inc., K142065) MicroCross Catheter (Roxwood Medical, Inc., K151082)
INDICATIONS FOR USE
The CenterCross ULTRA 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.
The Indications for Use statement is identical to the predicate device.
4
PRODUCT DESCRIPTION
The CenterCross Ultra Catheter is a sterile, 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 Ultra Catheter consists of an outer shaft and a removable handle/inner shaft assembly that allows for manual device manipulation. A key element of the device is an expandable and retractable nitinol structure, which, when deployed by the physician, expands to the artery wall 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 Ultra Catheter in and of itself does not provide therapeutic beyond simple facilitation of guidewire and device support. The CenterCross Ultra Catheter is similar in its design and achieves its intended use by means of the same mechanisms as the predicate device.
TECHNOLOGICAL CHARACTERISTICS
The technological characteristics of the CenterCross Ultra Catheter are similar to the predicate device. The differences arise from minor modifications to the handle, prime port, scaffold diameter, and shaft materials. Performance data is provided to support the determination of substantial equivalence.
SUBSTANTIAL EQUIVALENCE
The CenterCross Ultra Catheter is substantially equivalent to its predicate device. The minor design and labeling modifications outlined in this Special 510(k) do not 1) affect the intended use nor 2) alter the fundamental scientific technology of the predicate device. The modified device shares the same intended use, indications for use, and principles of operation as the predicate device. Any differences in the technological characteristics between the devices do not raise any new issues of safety or effectiveness. Thus, the CenterCross Ultra Catheter is substantially equivalent to the predicate device.
TESTING IN SUPPORT OF SUBSTANTIAL EQUIVALENCE DETERMINATION
Extensive bench testing was conducted on the CenterCross Ultra Catheter to evaluate the performance of the device and to support a determination of substantial equivalence to the predicate device. Non-clinical testing assessed the following aspects of the device:
- Dimensional Inspection .
- Expansion Force .
- Simulated Use .
5
- Hydrophilic Coating .
- Leak .
- Contrast Flush Injection .
- Tip Flexibility & Kink Resistance ●
- Torque Strength ●
- Tensile Strength .
- . Particulate
- Radiopacity .
- Corrosion ●
- LAL .
- . EO Residuals
- Packaging and Shelf-Life .
- Biocompatibility .
All testing was performed in accordance with recognized standards. The collective results of the non-clinical testing demonstrate that the CenterCross Ultra Catheter meets the established specifications necessary for consistent performance for its intended use and is substantially equivalent to the predicate device.
CONCLUSION
The CenterCross Ultra Catheter is a percutaneous vascular catheter and shares its design and mechanism of action with the identified predicate device. The results of the performance testing confirm that the CenterCross Ultra Catheter functions to its specifications and intended use and exhibit the appropriate characteristics of a percutaneous vascular catheter. The CenterCross Ultra Catheter is substantially equivalent to the predicate device in terms of technological characteristics, intended use and performance. No new issues of safety or effectiveness are raised by the CenterCross Ultra Catheter.
SUMMARY
The CenterCross Ultra Catheter is substantially equivalent to the predicate device.