(165 days)
Not Found
No
The description focuses on the mechanical and structural aspects of the catheter and its function in supporting guidewire placement. There is no mention of AI or ML in the device description, intended use, or performance studies.
No
The device description explicitly states: "The MultiCross Support Catheter by itself does not provide therapeutic benefit beyond simple facilitation of guidewire support." It is intended to prepare the site for subsequent therapeutic devices.
No
The device description clearly states its purpose is to "access discrete regions of the coronary and peripheral vasculature for guidewire exchange" and that "The MultiCross Support Catheter by itself does not provide therapeutic benefit beyond simple facilitation of guidewire support." It is an access and support tool, not one that gathers information for diagnosis.
No
The device description clearly states it is a physical catheter with multiple lumens, a handle, and a deployable Nitinol scaffold. 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 for accessing and supporting guidewires within the coronary and peripheral vasculature. This is an in vivo (within a living organism) procedure.
- Device Description: The description details a physical catheter designed to be inserted into the body. It facilitates a medical procedure within the patient's circulatory system.
- Lack of IVD Characteristics: There is no mention of the device being used to test samples (blood, urine, tissue, etc.) outside of the body to diagnose a condition. IVDs are typically used in laboratories or point-of-care settings to analyze biological specimens.
The MultiCross Support Catheter is a medical device used for interventional procedures within the body, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The MultiCross Support Catheter is intended to be used in conjunction with a steerable guidewire to access discrete regions of the coronary and peripheral vasculature and for guidewire exchange.
Product codes
DQY
Device Description
The MultiCross Support Catheter is a sterile, single-use, triple lumen, over-the-wire, disposable percutaneous support catheter designed for use in conjunction with a steerable guidewire to access discrete regions of the coronary and peripheral vasculature for guidewire exchange.
The MultiCross Support 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 deployable and retractable distal Nitinol scaffold, which is visible through fluoroscopy when deployed by the user, and expands to the width of the artery to provide an anchoring to aid the user in establishing greater support near the treatment site.
Subsequent to conventional guidewire placement, therapeutic devices such as atherectomy devices, PTCA catheters, and/or stents may be used to provide therapeutic benefit. The MultiCross Support Catheter by itself does not provide therapeutic benefit beyond simple facilitation of guidewire support. The MultiCross Support 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)
Performance Testing - Bench: Extensive bench testing was conducted on the MultiCross Support 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: Catheter Inspection (Visual Inspection/Physical Dimensions), Particulate Testing, Radial Outward Force, Contrast Flush Injection, Simulated Use, Torque Strength, Flexibility and Kink Resistance, Leak: Liquid, Air, Tensile Strength, Corrosion Resistance Test, Coating Integrity. All testing was performed in accordance with recognized standards.
Safety and Performance Testing - Animal: A GLP animal study was performed to evaluate the safety, performance and handling of the MultiCross Support Catheter in the coronary and peripheral vasculature as compared to a control device. Based on pathology and histopathology results, the safety acceptance criteria for the study were met. Performance and handling observations were made based on detailed characteristics of the device. No untoward observations were found by the clinician.
Conclusion of Performance Testing: The collective results of the bench testing and the GLP animal study demonstrate that the MultiCross Support 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)
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).
0
510(k) SUMMARY K121763
NOV 2 7 2012
This summary of the 510(k) premarket notification for the MultiCross Support Catheter is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR8807.92.
GENERAL INFORMATION
Applicant:
Roxwood Medical, Inc. 150 Executive Park Boulevard, Suite 3700 San Francisco, CA 94134 U.S.A. Phone: 408-373-4751 Fax: 415-467-1253
Contact Person:
Mehrdad Farhangnia Chief Executive Officer Roxwood Medical, Inc. 150 Executive Park Boulevard, Suite 3700 San Francisco, CA 94134 U.S.A. Phone: 408-373-4751 Fax: 415-467-1253
Date Prepared: June 13, 2012
DEVICE INFORMATION
The MultiCross Support Catheter is a percutaneous catheter for use in the coronary and peripheral vasculature.
Trade Name: MultiCross Support Catheter
Generic/Common Name: Percutaneous Catheter
Classification: 21 CFR 870.1250, Class II
Product Code: DQY
1
MULTICROSS SUPPORT CAT 510(k) PREMARKET NOTIFICATION
PREDICATE DEVICE(S)
- Vascular Solutions Twin-Pass™ OTW Dual Access Catheter (K072618) �
- EndoCross ENABLER-P Catheter System (K092174) �
- BridgePoint Medical Stingray Orienting Balloon Catheter (K080987) .
INDICATIONS FOR USE
The MultiCross Support Catheter is intended to be used in conjunction with a steerable guidewire to access discrete regions of the coronary and peripheral vasculature and for guidewire exchange.
PRODUCT DESCRIPTION
The MultiCross Support Catheter is a sterile, single-use, triple lumen, over-the-wire, disposable percutaneous support catheter designed for use in conjunction with a steerable guidewire to access discrete regions of the coronary and peripheral vasculature for guidewire exchange.
The MultiCross Support 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 deployable and retractable distal Nitinol scaffold, which is visible through fluoroscopy when deployed by the user, and expands to the width of the artery to provide an anchoring to aid the user in establishing greater support near the treatment site.
Subsequent to conventional guidewire placement, therapeutic devices such as atherectomy devices, PTCA catheters, and/or stents may be used to provide therapeutic benefit. The MultiCross Support Catheter by itself does not provide therapeutic benefit beyond simple facilitation of guidewire support. The MultiCross Support 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 MultiCross Support Catheter are similar to the predicate devices. Performance data were provided to support the determination of substantial equivalence.
| Feature | MultiCross Support
Catheter
(Subject Device) | Vascular Solutions
Twin-PassTM OTW Dual
Access Catheter | EndoCross
ENABLER-P
Catheter System | BridgePoint Medical
Stingray Orienting
Balloon Catheter |
|------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K_____ | K052257 | K092174 | K080987 |
| Indications for
Use | The MultiCross
Support Catheter is
intended to be used in
conjunction with a
steerable guidewire to
access discrete regions
of the coronary and
peripheral vasculature
and for guidewire | The Twin-Pass Dual
Access Catheter is to be
used in conjunction with
steerable guidewires in
order to access discrete
regions of the coronary
and peripheral arterial
vasculature, to facilitate
placement of guidewires
and other interventional | The ENABLER-P
Catheter System is
intended to be used
in conjunction with a
steerable guidewire
to access discrete
regions of the
peripheral
vasculature and for | The BridgePoint
Medical StingrayTM
Orienting Balloon
Catheters are indicated
for directing, steering,
controlling, and
supporting a
guidewire in order to
access discrete regions |
2
ROXWOOD MEDICAL, INC.
MULTICROSS SUPPORT CATHETER 510(k) PREMARKET NOTIFICATION
| Feature | MultiCross Support
Catheter
(Subject Device)
exchange. | Vascular Solutions
Twin-Pass™ OTW Dual
Access Catheter
devices, and for use
during two guidewire
procedures. | EndoCross
ENABLER-P
Catheter System
guidewire exchange. | BridgePoint Medical
Stingray Orienting
Balloon Catheter
of the coronary and
peripheral vasculature. |
|---------------------------------|--------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------|
| Guide Catheter
Compatibility | 7F | 5F | 7F | 6F |
| Working
Length | 135 cm | 140 cm | 107 cm | 135cm |
| Guidewire
Compatibility | 0.014" Guidewire
compatible;
Up to three guidewires
may be exchanged | 0.014" Guidewire
compatible;
Up to two guidewires
may be exchanged | 0.035" Guidewire
Compatible | 0.014" Guidewire
compatible; |
| Lumen | Triple | Dual | Dual | Triple |
| Distal Shaft
Capability | The Nitinol scaffold
provides distal
anchoring and
supports the
advancement of the
guidewire. | Standard Percutaneous
Catheter Distal Shaft
Structure (no support
mechanism) | The balloon provides
distal anchoring and
supports the
advancement of the
guidewire. | The balloon provides
distal anchoring and
supports the
advancement of the
guidewire. |
SUBSTANTIAL EQUIVALENCE
The MultiCross Support Catheter is substantially equivalent to Vascular Solutions Twin-Pass OTW Dual Access Catheter (K072618), the EndoCross ENABLER-P Catheter System (K092174, and the BridgePoint Medical Stingray Orienting Balloon Catheter (K080987). The subject device and the predicate devices are percutaneous catheters. The proposed indications for use for the MultiCross Support 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 MultiCross Support Catheter is substantially equivalent to the predicate devices.
TESTING IN SUPPORT OF SUBSTANTIAL EQUIVALENCE DETERMINATION
Performance Testing - Bench
Extensive bench testing was conducted on the MultiCross Support 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:
- Catheter Inspection (Visual Inspection/Physical Dimensions) �
- Particulate Testing
- Radial Outward Force .
- Contrast Flush Injection .
- Simulated Use �
- Torque Strength
- Flexibility and Kink Resistance
- Leak: Liquid
- Air
- Leak: Liquid
3
K121763
Page 4 of 4
MULTICROSS SUPPORT CATHETER 510(k) PREMARKET NOTIFICATION
- Tensile Strength .
- Corrosion Resistance Test .
- Coating Integrity .
- In vivo Animal Validation Study .
- . Biocompatibility
- Sterilization Validation .
- Packaging and Shelf-life ♥
All testing was performed in accordance with recognized standards.
Safety and Performance Testing - Animal
A GLP animal study was performed to evaluate the safety, performance and handling of the MultiCross Support Catheter in the coronary and peripheral vasculature as compared to a control device. Based on pathology and histopathology results, the safety acceptance criteria for the study were met.
Performance and handling observations were made based on detailed characteristics of the device. No untoward observations were found by the clinician.
Conclusion of Performance Testing
The collective results of the bench testing and the GLP animal study demonstrate that the MultiCross Support Catheter meets the established specifications necessary for consistent performance for its intended use and is substantially equivalent to the predicate devices.
CONCLUSION
The MultiCross Support Catheter is a percutaneous vascular support catheter and shares its design and mechanism of action with the identified predicate devices. The results of the bench testing and GLP animal study confirm that the MultiCross Support Catheter functions to its specifications, performs as intended and exhibits the appropriate characteristics of a percutaneous support catheter. The MultiCross Support 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 MultiCross Support Catheter.
SUMMARY
The MultiCross Support Catheter is substantially equivalent to the predicate devices.
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name arranged in a circular fashion around a symbol. The symbol is a stylized representation of an eagle or bird with outstretched wings, rendered in a bold, black color.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
Roxwood Medical, Inc. Mr. Mehdrad Farhangnia Chief Executive Officer 150 Executive Park Blvd, Suite 3700 San Francisco, CA 94134
Re: K121763
Trade/Device Name: MultiCross Support Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: November 16, 2012 Received: November 19, 2012
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 or any I vith 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-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
NOV 2 7 2012
5
Page 2 - Mr. Mehdrad Farhangnia
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic in 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours, Matthew G Hillebrenne
for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
ROXWOOD MEDICAL, INC.
510(k) Number (if known): KI21 76 3
Device Name: MultiCross Support Catheter
Indications For Use:
The MultiCross Support Catheter is intended to be used in conjunction with a steerable guidewire to access discrete regions of the coronary and peripheral vasculature and for guidewire exchange.
Prescription Use X (21 CFR Part 801 Subpart D) And/Or
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)
MS Kelli
Division of Cardiovascular Devices
510(k) Number K121763