(26 days)
Not Found
No
The summary describes a mechanical catheter with a manually controlled expandable structure. There is no mention of AI, ML, image processing, or data-driven decision making.
No
The device is described as a support catheter used to facilitate the placement and exchange of guidewires and other interventional devices, rather than directly treating a condition or disease.
No
The device is described as a catheter used to access regions of the peripheral vasculature and facilitate the placement and exchange of guidewires and other interventional devices. Its function is to provide support during interventional procedures, not to diagnose a medical condition.
No
The device description clearly outlines a physical catheter with an outer shaft, inner shaft assembly, and an expandable/retractable nitinol structure, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The description clearly states that the CenterCross ULTRA LV Catheter is a device used within the peripheral vasculature to facilitate access, placement, and exchange of other devices. It is a tool used during an interventional procedure, not a test performed on a sample outside the body.
- Lack of IVD Characteristics: The document does not mention any analysis of biological samples, detection of biomarkers, or diagnostic testing.
Therefore, the CenterCross ULTRA LV Catheter is an interventional medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The CenterCross ULTRA LV Catheter is intended to be used in conjunction with steerable guidewires to access discrete regions of the 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 Ultra LV 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 peripheral vasculature to facilitate exchange of guidewires and other interventional devices.
The CenterCross Ultra LV 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 LV Catheter in and of itself does not provide therapeutic benefit beyond simple facilitation of guidewire and device support. The CenterCross Ultra LV 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
peripheral vasculature
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physician / 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 and evaluations were conducted or assessed for the CenterCross Ultra LV Catheter to evaluate the performance of the device and to support a determination of substantial equivalence to the predicate device. Non-clinical testing and assessments include the following:
- Dimensional Inspection
- Expansion Force
- Simulated Use
- Leak
- Torque Strength
- Tensile Strength
All testing was performed in accordance with recognized standards and/or internal test methods. The collective results of the non-clinical testing demonstrate that the CenterCross Ultra LV 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): 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
§ 870.1250 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
Public Health Service
Image /page/0/Picture/2 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 a stylized image of three human profiles facing to the right, with flowing lines representing hair or clothing.
March 7, 2017
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Roxwood Medical, Inc. Mr. Mehrdad Farhangnia President & CEO 400 Seaport Court. Suite 103 Redwood City, CA 94063
Re: K170403
Trade/Device Name: CenterCross Ultra LV Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: February 8, 2017 Received: February 9, 2017
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 device
1
related 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.
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,
Fernando
Aguel-S
Fernando Aguel
for Bram D. Zuckerman, M.D. 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)
K170403
Device Name CenterCross Ultra LV Catheter
Indications for Use (Describe)
The CenterCross ULTRA LV Catheter is intended to be used in conjunction with steerable guidewires to access discrete regions of the 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) |
Dver-The-Counter Use (21 CFR 801 Subpart C)
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3
SECTION 5. 510(k) SUMMARY
510(k) Notification K170403
GENERAL INFORMATION
Applicant:
Roxwood Medical, Inc. 400 Seaport Court, Suite #103 Redwood City, CA 94063, USA Establishment Registration: #3010034168
Contact Person:
Mehrdad Farhangnia President & CEO Phone: (650) 779-4559 Fax: (650) 779-4554
Date Prepared: February 8, 2017
DEVICE INFORMATION
The CenterCross Ultra LV Catheter is a percutaneous catheter for use in the peripheral vasculature.
| Trade Name: | CenterCross Ultra LV Catheter |
|---|---|
| Generic/Common Name: | Percutaneous Catheter |
| Classification: | 21 CFR§870.1250, Class II |
| Product Code: | DQY |
PREDICATE DEVICE(S)
CenterCross Ultra Catheter (K160681) The predicate has not been subject to a design-related recall.
INDICATIONS FOR USE
The CenterCross Ultra LV Catheter is intended to be used in conjunction with steerable guidewires to access discrete regions of the peripheral vasculature. It may be used to facilitate placement and exchange of guidewires and other interventional devices.
PRODUCT DESCRIPTION
The CenterCross Ultra LV 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 peripheral vasculature to facilitate exchange of guidewires and other interventional devices.
4
The CenterCross Ultra LV 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 LV Catheter in and of itself does not provide therapeutic benefit beyond simple facilitation of guidewire and device support. The CenterCross Ultra LV 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 LV Catheter are the same as the predicate device. Performance data is provided to support the determination of substantial equivalence.
| Feature | CenterCross Ultra LV | CenterCross Ultra |
|---|---|---|
| Working Length | 100cm | 90cm & 125cm |
| Scaffold Diameter | 8.1mm | 4.5mm |
| Scaffold Apposition Length | 8mm | 10mm |
| Visual Length Indicators | No | Yes |
Differences of Modified Device to Predicate Device
SUBSTANTIAL EQUIVALENCE
The CenterCross Ultra LV 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 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 LV is substantially equivalent to the predicate device.
5
TESTING AND EVALUATIONS IN SUPPORT OF SUBSTANTIAL EQUIVALENCE DETERMINATION
Extensive bench testing and evaluations were conducted or assessed for the CenterCross Ultra LV Catheter to evaluate the performance of the device and to support a determination of substantial equivalence to the predicate device. Non-clinical testing and assessments include the following:
- Dimensional Inspection ●
- Expansion Force .
- Simulated Use .
- Leak .
- Torque Strength ●
- Tensile Strength .
All testing was performed in accordance with recognized standards and/or internal test methods. The collective results of the non-clinical testing demonstrate that the CenterCross Ultra LV 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 LV 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 LV Catheter functions to its specifications and intended use and exhibits the appropriate characteristics of a percutaneous vascular catheter. The CenterCross Ultra LV 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 LV Catheter.
SUMMARY
The CenterCross Ultra LV Catheter is substantially equivalent to the predicate device.