(122 days)
No
The device description and performance studies focus on the mechanical and material properties of a balloon catheter, with no mention of AI or ML.
Yes
The device is indicated for "balloon catheter dilatation of the stenotic portion of a native coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion," which is a therapeutic intervention.
No
This device is a balloon catheter used for angioplasty, which is a therapeutic procedure to open narrowed arteries, not a diagnostic procedure to identify a condition.
No
The device description clearly outlines a physical medical device (catheter with balloon, shaft, markers, coating) and the performance studies focus on physical and mechanical properties, not software validation.
No, 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 Function: The FOXTROT™ NC PTCA Balloon Catheter is a medical device used within the body (in vivo) to physically dilate narrowed coronary arteries or bypass grafts. It is a therapeutic device, not a diagnostic one.
- Intended Use: The intended use clearly states "balloon catheter dilatation of the stenotic portion of a native coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion" and "post-delivery expansion of balloon expandable stents." These are interventional procedures, not diagnostic tests performed on samples.
- Device Description: The description details a physical catheter with a balloon, radiopaque markers, and a hydrophilic coating, all designed for insertion and manipulation within the circulatory system.
- Performance Studies: The performance studies focus on the physical and mechanical properties of the catheter and balloon, as well as biocompatibility, which are relevant to an implantable or interventional device, not an IVD.
The device is used in conjunction with imaging (fluoroscopy) to guide its placement, but the device itself is not performing a diagnostic test on a biological sample.
N/A
Intended Use / Indications for Use
The FOXTROT™ NC PTCA Balloon Catheters are indicated for the balloon catheter dilatation of the stenotic portion of a native coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion. FOXTROT™ NC PTCA Balloon Catheters are also indicated for the post-delivery expansion of balloon expandable stents.
Product codes
LOX
Device Description
The FOXTROT NC PTCA Balloon Catheter device is a sterile, single-use, rapid exchange percutaneous transluminal coronary angioplasty catheter. The design is an integrated shaft system with a balloon near the distal tip. The balloon is designed to provide an inflatable segment of known diameter and length at recommended pressures. Two radiopaque markers aid in positioning the balloon catheter under fluoroscopy during the procedure. The distal portion of the shaft is coated with a hydrophilic coating to provide lubrication. The effective length of the FOXTROT NC device is 145 cm and it is compatible with a 0.014" guide wire. The FOXTROT NC PTCA balloon catheter is available with balloon diameters of 2.5-4.0 mm and balloon lengths of 10 mm and 15 mm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Fluoroscopy
Anatomical Site
Native coronary artery or bypass graft
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
Biocompatibility Testing:
The biocompatibility evaluation for the FOXTROT NC device was conducted in accordance with current standards and included the following tests:
- Cytotoxicity
- Sensitization
- Irritation/Intracutaneous Reactivity
- Systemic Toxicity
- Pyrogenicity
- Hemolysis
- Complement Activation
- Partial Thromboplastin Time
- Thrombogenicity
Bench Testing:
Mechanical testing was performed per the FDA Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters (September 2010) on both the subject device and the predicate device. The tests included the following:
- Dimensional Verification
- Balloon Preparation, Deployment and Retraction
- Balloon Rated Burst Pressure
- Balloon Fatigue
- Balloon Compliance
- Balloon Inflation and Deflation Time
- Catheter Bond Strength
- Tip Pull Test
- Flexibility and Kink Test
- Torque Strength
- Radiopacity
- Coating Integrity
- Particulate Evaluation
- Balloon Rated Burst Pressure (in Stent)
- Balloon Fatigue (in Stent)
- Corrosion Resistance
- Smoothness of the guidewire lumen
Key Results:
The data provided support the safety of the FOXTROT NC device and the mechanical testing results demonstrate that the device should perform as intended in the specified use conditions. Non-clinical tests demonstrate that the FOXTROT NC device is substantially equivalent to the predicate device which is currently marketed for the same intended use.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.5100 Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter.
(a)
Standard PTCA Catheter —(1)Identification. A PTCA catheter is a device that operates on the principle of hydraulic pressurization applied through an inflatable balloon attached to the distal end. A PTCA balloon catheter has a single or double lumen shaft. The catheter features a balloon of appropriate compliance for the clinical application, constructed from a polymer. The balloon is designed to uniformly expand to a specified diameter and length at a specific pressure as labeled, with well characterized rates of inflation and deflation and a defined burst pressure. The device generally features a type of radiographic marker to facilitate fluoroscopic visualization of the balloon during use. A PTCA catheter is intended for balloon dilatation of a hemodynamically significant coronary artery or bypass graft stenosis in patients evidencing coronary ischemia for the purpose of improving myocardial perfusion. A PTCA catheter may also be intended for the treatment of acute myocardial infarction; treatment of in-stent restenosis (ISR) and/or post-deployment stent expansion.(2)
Classification. Class II (special controls). The special control for this device is “Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters.” See § 870.1(e) for the availability of this guidance document.(b)
Cutting/scoring PTCA Catheter —(1)Identification. A cutting/scoring PTCA catheter is a balloon-tipped catheter with cutting/scoring elements attached, which is used in those circumstances where a high pressure balloon resistant lesion is encountered. A cutting/scoring PTCA catheter is intended for the treatment of hemodynamically significant coronary artery stenosis for the purpose of improving myocardial perfusion. A cutting/scoring PTCA catheter may also be indicated for use in complex type C lesions or for the treatment of in-stent restenosis.(2)
Classification. Class III (premarket approval). As of May 28, 1976, an approval under section 515 of the act is required before this device may be commercially distributed. See § 870.3.
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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 border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized symbol featuring three abstract human profiles facing to the right, stacked one in front of the other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 5, 2015
Shanghai Microport Medical (group) Co., Ltd Erika Huffman Medical Research Manager, Regulatory 4050 Olson Memorial Highway. Minneapolis, Minnesota 55422
Re: K143160 Trade/Device Name: FOXTROT NC PTCA Balloon Catheter Regulation Number: 21 CFR 870.5100 Regulation Name: Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter Regulatory Class: Class II Product Code: LOX Dated: February 2, 2015 Received: February 5, 2015
Dear Erika Huffman,
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,
Melissa A. Torres -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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known)
K143160
Device Name FOXTROTTM NC PTCA Balloon Catheter
Indications for Use (Describe)
The FOXTROT™ NC PTCA Balloon Catheters are indicated for the balloon catheter dilatation of the stenotic portion of a native coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion. FOXTROT™ NC PTCA Balloon Catheters are also indicated for the post-delivery expansion of balloon expandable stents.
| 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."
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ு Micro Port
5.0 510(k) Summary
| Submitter: | Shanghai MicroPort Medical (Group) Co., Ltd
501 Newton Road
ZJ Hi-Tech Park
Shanghai, China
201203 |
|----------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Erika Huffman
Medical Research Manager, Regulatory
NAMSA
4050 Olson Memorial Hwy.
Suite 450
Minneapolis, MN 55422
USA
Phone: +1-763-588-9857
Fax: +1-763-287-3836
ehuffman@namsa.com |
| Date Prepared: | October 30, 2014 |
| Trade Name: | FOXTROT™ NC PTCA Balloon Catheter |
| Common Name: | Percutaneous Transluminal Coronary Angioplasty (PTCA)
Catheter |
| Classification: | Class II, 21 CFR Part 870.5100 |
| Product Code: | LOX |
| Predicate Device: | K121667 - NC Quantum Apex™ Monorail PTCA Dilatation
Catheter (Boston Scientific)
This predicate device has not been subject to a design-related
recall. |
| Reference Devices: | • K111544 - Glider™ PTCA Balloon Catheter (TriReme
Medical, Inc.)
• K123264 - DK-PTCA Balloon Catheter (Intuit Medical,
LLC) |
| Device Description: | The FOXTROT NC PTCA Balloon Catheter device is a sterile,
single-use, rapid exchange percutaneous transluminal coronary
angioplasty catheter. The design is an integrated shaft system
with a balloon near the distal tip. The balloon is designed to
provide an inflatable segment of known diameter and length at
recommended pressures. Two radiopaque markers aid in
positioning the balloon catheter under fluoroscopy during the
procedure. The distal portion of the shaft is coated with a
hydrophilic coating to provide lubrication. The effective length
of the FOXTROT NC device is 145 cm and it is compatible with
a 0.014" guide wire. The FOXTROT NC PTCA balloon catheter |
| is available with balloon diameters of 2.5-4.0 mm and balloon
lengths of 10 mm and 15 mm. | |
| Indications for Use: | The FOXTROT™ NC PTCA Balloon Catheters are indicated
for the balloon catheter dilatation of the stenotic portion of a
native coronary artery or bypass graft stenosis for the purpose of
improving myocardial perfusion. FOXTROT™ NC PTCA
Balloon Catheters are also indicated for the post-delivery
expansion of balloon expandable stents. |
| Comparison with
Predicate Device: | The FOXTROT NC PTCA Balloon Catheter is similar to the NC
Quantum Apex Monorail PTCA Dilatation Catheter in the
following ways:
Each of the devices are intended to be used for dilatation of stenoses to improve myocardial perfusion. Each of the devices are intended to be used for post-delivery expansion of balloon expandable stents. Each of the devices is compatible with a 0.14" (0.36 mm) guide wire. Each of the devices is designed to be a rapid exchange catheter. Each of the devices is provided sterile. Each of the devices is intended to be single use. Each device has two platinum-iridium radiopaque marker bands to aid in positioning the balloon during a procedure. Each device has markers along the proximal shaft to indicate the depth of catheter insertion. Each of the devices has a hydrophilic coating. Each of the devices is available in balloon diameters ranging from 2.5 mm to 3.5 mm (in 0.25 mm increments). Each of the devices also has an available 4.0 mm balloon diameter. Each of the devices has an available 15 mm balloon length. Each of the devices has a nominal balloon pressure of 12.0 atm. Each of the devices has a rated burst pressure of 20 atm for 2.5-4.0 mm balloon diameters. The following technological differences exist between the subject and predicate devices: Effective length Recommended guide catheter Available balloon lengths |
| Performance Data: | Biocompatibility Testing |
| | The biocompatibility evaluation for the FOXTROT NC device
was conducted in accordance with current standards and
included the following tests: |
| | ● Cytotoxicity |
| | ● Sensitization |
| | ● Irritation/Intracutaneous Reactivity |
| | ● Systemic Toxicity |
| | ● Pyrogenicity |
| | ● Hemolysis |
| | ● Complement Activation |
| | ● Partial Thromboplastin Time |
| | ● Thrombogenicity |
| | Bench Testing |
| | Mechanical testing was performed per the FDA Class II Special
Controls Guidance Document for Certain Percutaneous
Transluminal Coronary Angioplasty (PTCA) Catheters
(September 2010) on both the subject device and the predicate
device. The tests included the following: |
| | ● Dimensional Verification |
| | ● Balloon Preparation, Deployment and Retraction |
| | ● Balloon Rated Burst Pressure |
| | ● Balloon Fatigue |
| | ● Balloon Compliance |
| | ● Balloon Inflation and Deflation Time |
| | ● Catheter Bond Strength |
| | ● Tip Pull Test |
| | ● Flexibility and Kink Test |
| | ● Torque Strength |
| | ● Radiopacity |
| | ● Coating Integrity |
| | ● Particulate Evaluation |
| | ● Balloon Rated Burst Pressure (in Stent) |
| | ● Balloon Fatigue (in Stent) |
| | ● Corrosion Resistance |
| | ● Smoothness of the guidewire lumen |
| Conclusion: | The data provided support the safety of the FOXTROT NC
device and the mechanical testing results demonstrate that the
device should perform as intended in the specified use
conditions. Non-clinical tests demonstrate that the FOXTROT
NC device is substantially equivalent to the predicate device
which is currently marketed for the same intended use. |
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icroPort
5