(149 days)
Not Found
No
The summary describes a mechanical catheter with a manually deployed scaffold and does not mention any AI/ML components or functions.
No
The device is described as a support catheter used to access vasculature and for guidewire exchange, which are diagnostic and interventional support functions, not direct therapeutic interventions. Its function "to aid the user in establishing greater support near the treatment site" suggests it facilitates a procedure rather than directly treating a disease or condition.
No
Explanation: The device description and intended use indicate that the MultiCross Support Catheter is a tool for accessing vasculature and guidewire exchange, not for diagnosing medical conditions. It aids in procedures rather than identifying diseases.
No
The device description clearly outlines physical components like an inner shaft, outer shaft, proximal handle, and a nitinol scaffold, indicating it is a hardware device. The performance studies also focus on bench testing of physical attributes.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "access discrete regions of the coronary or peripheral vasculature and for guidewire exchange." This describes a device used within the body for a procedural purpose, not a device used to examine specimens outside the body to provide diagnostic information.
- Device Description: The description details a physical catheter with mechanical components (inner shaft, outer shaft, handle, expandable scaffold) designed for manipulation within blood vessels. This aligns with an interventional or procedural device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on in vitro testing.
IVDs are devices used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device clearly falls outside of that definition.
N/A
Intended Use / Indications for Use
The MultiCross Support Catheter is intended to be used in conjunction with steerable guidewires to access discrete regions of the coronary or peripheral vasculature and for guidewire exchange.
Product codes
DQY
Device Description
The MultiCross Catheter consists of an inner shaft, outer shaft, 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 an expandable and retractable nitinol scaffold, which, when deployed by the physician, expands to the artery wall to aid the user in establishing greater support near the treatment site.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
coronary or 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
Extensive bench testing was conducted on the MultiCross 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:
- Catheter Inspection
- Open/Close Force
- Simulated Use
- Tensile Strength
- Particulate
- EO Residuals
All testing was performed in accordance with recognized standards. The collective results of the non-clinical testing demonstrate that the MultiCross Catheter meets the established specifications necessary for consistent performance for its intended use and is substantially equivalent to the predicate device.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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).
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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" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, layered on top of each other to create a sense of depth and unity.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 4, 2016
Roxwood Medical, Inc. Grace Li Director, OA 400 Seaport Ct. Suite #103 Redwood City, California 94063
Re: K152957
Trade/Device Name: MultiCross Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: February 3, 2016 Received: February 4, 2016
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 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
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K152957
Device Name MultiCross Catheter
Indications for Use (Describe)
The MultiCross Support Catheter is intended to be used in conjunction with steerable guidewires to access discrete regions of the coronary or peripheral vasculature and for guidewire exchange.
| 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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SECTION 5. 510(k) SUMMARY
510(k) Notification K152957
GENERAL INFORMATION
Applicant:
Roxwood Medical, Inc. 400 Seaport Court, Suite #103 Redwood City, CA 94063 Phone: (650) 779-4555 Fax: (650) 779-4554
Contact Person:
Grace Li Roxwood Medical, Inc. 400 Seaport Court, Suite #103 Redwood City, CA 94063 Phone: (650) 779-4559 Fax: (650) 779-4554
Date Prepared: October 6, 2015
DEVICE INFORMATION
The MultiCross Catheter is a percutaneous catheter for use in the coronary and peripheral vasculature.
Trade Name:
MultiCross Catheter
Generic/Common Name:
Percutaneous Catheter
Classification:
21 CFR§870.1250, Class II
Product Code: DQY
PREDICATE DEVICE(S)
MultiCross Catheter (K121763) This predicate has not been subject to a design-related recall.
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INDICATIONS FOR USE
The MultiCross Support Catheter is intended to be used in conjunction with steerable guidewires to access discrete regions of the coronary or peripheral vasculature and for guidewire exchange.
The Indications for Use statement is identical to the predicate device.
PRODUCT DESCRIPTION
The MultiCross Catheter consists of an inner shaft, outer shaft, 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 an expandable and retractable nitinol scaffold, which, when deployed by the physician, expands to the artery wall to aid the user in establishing greater support near the treatment site.
Subsequent to conventional guidewire placement, interventional tools such as angioplasty, stent, and atherectomy devices, may be used to provide therapeutic benefit. The MultiCross Catheter in and of itself does not provide therapeutic benefit beyond simple facilitation of guidewire support. The MultiCross 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 MultiCross Catheter are similar to the predicate device. Performance data is provided to support the determination of substantial equivalence.
SUBSTANTIAL EQUIVALENCE
The MultiCross Catheter is substantially equivalent to its predicate device. The minor design modifications outlined in this Special 510(k) do not 1) affect the indications for use or 2) alter the fundamental scientific technology of the predicate device. The modified device shares the same intended use, the same technological characteristics and 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 MultiCross Catheter is substantially equivalent to the predicate device.
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TESTING IN SUPPORT OF SUBSTANTIAL EQUIVALENCE DETERMINATION
Extensive bench testing was conducted on the MultiCross 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:
- . Catheter Inspection
- Open/Close Force .
- Simulated Use ●
- Tensile Strength ●
- Particulate ●
- EO Residuals .
All testing was performed in accordance with recognized standards. The collective results of the non-clinical testing demonstrate that the MultiCross Catheter meets the established specifications necessary for consistent performance for its intended use and is substantially equivalent to the predicate device.
CONCLUSION
The MultiCross 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 MultiCross Catheter functions to its specifications and intended use and exhibit the appropriate characteristics of a percutaneous vascular catheter. The MultiCross 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 MultiCross Catheter.
SUMMARY
The MultiCross Catheter is substantially equivalent to the predicate device.