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.

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.

AI/ML Overview

This document describes the FOXTROT™ NC PTCA Balloon Catheter and its non-clinical testing to demonstrate substantial equivalence to a predicate device.

Here's a breakdown of the requested information based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly present a table of acceptance criteria alongside reported device performance values. Instead, it lists the types of tests performed and states that the data supports the safety of the device and that mechanical testing results demonstrate it performs as intended.

Acceptance Criteria Type	Reported Device Performance Summary
Biocompatibility Testing	Evaluation conducted in accordance with current standards.
Cytotoxicity	Not explicitly stated, but implied to meet standards.
Sensitization	Not explicitly stated, but implied to meet standards.
Irritation/Intracutaneous Reactivity	Not explicitly stated, but implied to meet standards.
Systemic Toxicity	Not explicitly stated, but implied to meet standards.
Pyrogenicity	Not explicitly stated, but implied to meet standards.
Hemolysis	Not explicitly stated, but implied to meet standards.
Complement Activation	Not explicitly stated, but implied to meet standards.
Partial Thromboplastin Time	Not explicitly stated, but implied to meet standards.
Thrombogenicity	Not explicitly stated, but implied to meet standards.
Bench Testing (Mechanical)	Performed per FDA Class II Special Controls Guidance Document for Certain PTCA Catheters (September 2010). Results demonstrate the device performs as intended and is substantially equivalent to the predicate device.
Dimensional Verification	Not explicitly stated, but implied to meet standards/comparable to predicate.
Balloon Preparation, Deployment and Retraction	Not explicitly stated, but implied to meet standards/comparable to predicate.
Balloon Rated Burst Pressure	Not explicitly stated, but implied to meet standards/comparable to predicate.
Balloon Fatigue	Not explicitly stated, but implied to meet standards/comparable to predicate.
Balloon Compliance	Not explicitly stated, but implied to meet standards/comparable to predicate.
Balloon Inflation and Deflation Time	Not explicitly stated, but implied to meet standards/comparable to predicate.
Catheter Bond Strength	Not explicitly stated, but implied to meet standards/comparable to predicate.
Tip Pull Test	Not explicitly stated, but implied to meet standards/comparable to predicate.
Flexibility and Kink Test	Not explicitly stated, but implied to meet standards/comparable to predicate.
Torque Strength	Not explicitly stated, but implied to meet standards/comparable to predicate.
Radiopacity	Not explicitly stated, but implied to meet standards/comparable to predicate.
Coating Integrity	Not explicitly stated, but implied to meet standards/comparable to predicate.
Particulate Evaluation	Not explicitly stated, but implied to meet standards/comparable to predicate.
Balloon Rated Burst Pressure (in Stent)	Not explicitly stated, but implied to meet standards/comparable to predicate.
Balloon Fatigue (in Stent)	Not explicitly stated, but implied to meet standards/comparable to predicate.
Corrosion Resistance	Not explicitly stated, but implied to meet standards/comparable to predicate.
Smoothness of the guidewire lumen	Not explicitly stated, but implied to meet standards/comparable to predicate.

2. Sample sizes used for the test set and the data provenance

The document does not specify the sample sizes used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It only states that mechanical testing was performed on "both the subject device and the predicate device."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not applicable. The study described is entirely non-clinical bench testing and biocompatibility testing. There are no human experts involved in establishing ground truth in the context of diagnostic interpretation for this type of device submission.

4. Adjudication method for the test set

This information is not applicable. As stated above, this is a non-clinical study.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This information is not applicable. The device is a PTCA Balloon Catheter, not an AI diagnostic device. No MRMC study was mentioned.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not applicable. The device is a PTCA Balloon Catheter, not an algorithm or AI device.

7. The type of ground truth used

The "ground truth" for this submission is based on established industry standards and regulatory guidance for medical device testing. For biocompatibility, it's the outcome of standardized biological tests. For bench testing, it's the performance against predefined physical and mechanical specifications as outlined in the "FDA Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters (September 2010)." The ultimate "ground truth" for demonstrating substantial equivalence is that the new device performs comparably to the predicate device in these tests.

8. The sample size for the training set

This information is not applicable. There is no "training set" as this is not an AI/machine learning device.

9. How the ground truth for the training set was established

This information is not applicable. There is no "training set" as this is not an AI/machine learning device.

Summary

{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 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

{2}------------------------------------------------

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)

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."

{3}------------------------------------------------

ு Micro Port

5.0 510(k) Summary

Submitter:	Shanghai MicroPort Medical (Group) Co., Ltd501 Newton RoadZJ Hi-Tech ParkShanghai, China201203
Contact Person:	Erika HuffmanMedical Research Manager, RegulatoryNAMSA4050 Olson Memorial Hwy.Suite 450Minneapolis, MN 55422USAPhone: +1-763-588-9857Fax: +1-763-287-3836ehuffman@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 DilatationCatheter (Boston Scientific)This predicate device has not been subject to a design-relatedrecall.
Reference Devices:	• K111544 - Glider™ PTCA Balloon Catheter (TriRemeMedical, 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 coronaryangioplasty catheter. The design is an integrated shaft systemwith a balloon near the distal tip. The balloon is designed toprovide an inflatable segment of known diameter and length atrecommended pressures. Two radiopaque markers aid inpositioning the balloon catheter under fluoroscopy during theprocedure. The distal portion of the shaft is coated with ahydrophilic coating to provide lubrication. The effective lengthof the FOXTROT NC device is 145 cm and it is compatible witha 0.014" guide wire. The FOXTROT NC PTCA balloon catheter
is available with balloon diameters of 2.5-4.0 mm and balloonlengths of 10 mm and 15 mm.
Indications for Use:	The FOXTROT™ NC PTCA Balloon Catheters are indicatedfor the balloon catheter dilatation of the stenotic portion of anative coronary artery or bypass graft stenosis for the purpose ofimproving myocardial perfusion. FOXTROT™ NC PTCABalloon Catheters are also indicated for the post-deliveryexpansion of balloon expandable stents.
Comparison withPredicate Device:	The FOXTROT NC PTCA Balloon Catheter is similar to the NCQuantum Apex Monorail PTCA Dilatation Catheter in thefollowing 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 devicewas conducted in accordance with current standards andincluded 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 SpecialControls Guidance Document for Certain PercutaneousTransluminal Coronary Angioplasty (PTCA) Catheters(September 2010) on both the subject device and the predicatedevice. 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 NCdevice and the mechanical testing results demonstrate that thedevice should perform as intended in the specified useconditions. Non-clinical tests demonstrate that the FOXTROTNC device is substantially equivalent to the predicate devicewhich is currently marketed for the same intended use.

{4}------------------------------------------------

icroPort

{5}------------------------------------------------

9 MicroPort

Regulation Number and Section

§ 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.