(104 days)
Not Found
No
The description focuses on the physical characteristics and function of a catheter for guidewire support and fluid delivery, with no mention of AI or ML.
No.
The device description explicitly states, "The MicroCross Catheter in and of itself does not provide therapeutic benefit beyond simple facilitation of guidewire support."
No
The device is described as a "conduit for the exchange/support of guidewires" and for "infuse and deliver saline and contrast agents," which are supportive functions for interventional procedures, not diagnostic ones. It explicitly states it "in and of itself does not provide therapeutic benefit beyond simple facilitation of guidewire support."
No
The device description clearly outlines a physical catheter with a shaft and hub, intended for insertion into the body. It also details physical characteristics like working length and compatibility with guidewires and sheaths, indicating a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- MicroCross Catheter Function: The description clearly states the MicroCross Catheter is used within the body (in the peripheral and coronary vasculatures) as a conduit for guidewires and to infuse substances like saline and contrast agents. It is an interventional tool used during procedures, not for analyzing samples outside the body.
The intended use and device description align with an interventional medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The MicroCross Catheter is intended for use as a conduit for the exchange/support of guidewires in the peripheral and coronary vasculatures. The MicroCross Catheter is also intended to infuse and contrast agents.
Product codes (comma separated list FDA assigned to the subject device)
DQY
Device Description
The MicroCross Catheter is a sterile, single lumen over-the-wire catheter to be used for the exchange and support of guidewires in the peripheral and coronary vasculatures. The MicroCross Catheter also infuses and delivers saline and contrast agents.
The MicroCross Catheter consists of a catheter shaft and a proximal hub that provides strain relief. The MicroCross Catheter is offered in working lengths of 150cm and 155cm and is compatible with 0.014" diameter guidewires, 5F guide catheters, and 4F introducer sheaths.
Subsequent to conventional guidewire placement, interventional tools such as angioplasty, stent, and atherectomy devices, may be used to provide therapeutic benefit. The MicroCross Catheter in and of itself does not provide therapeutic benefit beyond simple facilitation of guidewire support. The MicroCross Catheter is similar in its design and it 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 and coronary vasculatures
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 MicroCross 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:
Nonclinical Testing Summary:
- . Dimensional Inspection
- Hydrophilic Coating .
- Simulated Use ●
- Contrast Flush Injection .
- Leak ●
- Torque Strength .
- . Kink Resistance & Flexibility
- Pressurized Flow Rate ●
- Tensile Strength .
- Luer Compliance ●
- . Corrosion
- Particulate .
- LAL .
- 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 MicroCross 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
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 a stylized symbol of three human profiles facing right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 14, 2015
Roxwood Medical, Inc. Grace Li Director, QA 400 Seaport Ct. Suite #103 Redwood City, California 94063
Re: K143744 Trade/Device Name: MicroCross Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: March 4, 2015 Received: March 6, 2015
Dear Grace Li,
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,
Bram D. Zuckerman -S
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)
Device Name MicroCross Catheter
Indications for Use (Describe)
The MicroCross Catheter is intended for use as a conduit for the exchange/support of guidewires in the peripheral and coronary vasculatures. The MicroCross Catheter is also intended to infuse and contrast agents.
| 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) |
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3
510(k) SUMMARY
510(k) Notification K143744
GENERAL INFORMATION
Applicant:
Roxwood Medical, Inc. 400 Seaport Ct., Suite #103 Redwood City, CA 94063 Phone: (650) 779-4555 FAX: (650) 779-4554
Contact Person:
Grace Li Roxwood Medical, Inc. 400 Seaport Ct., Suite #103 Redwood City, CA 94063 Phone: (650) 779-4555 FAX: (650) 779-4554
Date Prepared: December 30, 2014
DEVICE INFORMATION
The MicroCross Catheter is a percutaneous catheter for use in the coronary and peripheral vasculature.
Trade Name:
MicroCross Catheter
Generic/Common Name:
Percutaneous Catheter
Classification:
21 CFR§870.1250, Class II
Product Code: DQY
PREDICATE DEVICE(S) Valet Micro Catheter (Volcano Corporation, K112035)
4
INDICATIONS FOR USE
The MicroCross Catheter is intended for use as a conduit for the exchange/support of guidewires in the peripheral and coronary vasculatures. The MicroCross Catheter is also intended to infuse and deliver saline and contrast agents.
PRODUCT DESCRIPTION
The MicroCross Catheter is a sterile, single lumen over-the-wire catheter to be used for the exchange and support of guidewires in the peripheral and coronary vasculatures. The MicroCross Catheter also infuses and delivers saline and contrast agents.
The MicroCross Catheter consists of a catheter shaft and a proximal hub that provides strain relief. The MicroCross Catheter is offered in working lengths of 150cm and 155cm and is compatible with 0.014" diameter guidewires, 5F guide catheters, and 4F introducer sheaths.
Subsequent to conventional guidewire placement, interventional tools such as angioplasty, stent, and atherectomy devices, may be used to provide therapeutic benefit. The MicroCross Catheter in and of itself does not provide therapeutic benefit beyond simple facilitation of guidewire support. The MicroCross Catheter is similar in its design and it achieves its intended use by means of the same mechanisms as the predicate device.
TECHNOLOGICAL CHARACTERISTICS
The technological characteristics of the MicroCross Catheter are similar to the predicate device. Performance data is provided to support the determination of substantial equivalence.
SUBSTANTIAL EQUIVALENCE
The MicroCross Catheter is substantially equivalent to the Valet Micro Catheter (Volcano Corporation, K112035). The subject device and the predicate devices are percutaneous catheters. The proposed indications for the MicroCross Catheter are substantially equivalent to the indications for use for the predicate device. Any differences in the technological characteristics between the devices do not raise any new issues of safety or effectiveness. Thus, the MicroCross Catheter is substantially equivalent to the predicate device.
5
TESTING IN SUPPORT OF SUBSTANTIAL EQUIVALENCE DETERMINATION
Extensive bench testing was conducted on the MicroCross 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:
Nonclinical Testing Summary:
- . Dimensional Inspection
- Hydrophilic Coating .
- Simulated Use ●
- Contrast Flush Injection .
- Leak ●
- Torque Strength .
- . Kink Resistance & Flexibility
- Pressurized Flow Rate ●
- Tensile Strength .
- Luer Compliance ●
- . Corrosion
- Particulate .
- LAL .
- 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 MicroCross Catheter meets the established specifications necessary for consistent performance for its intended use and is substantially equivalent to the predicate device.
CONCLUSION
The MicroCross 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 MicroCross Catheter functions to its specifications and intended use and exhibit the appropriate characteristics of a percutaneous vascular catheter. The MicroCross 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 MicroCross Catheter.
SUMMARY
The MicroCross Catheter is substantially equivalent to the predicate device.