Firefighter™ NC Pro PTCA Balloon Catheter

K223189 · Shanghai MicroPort Medical (Group) Co., Ltd. · LOX · Jul 21, 2023 · Cardiovascular

Device Facts

• Record ID: K223189
• Device Name: Firefighter™ NC Pro PTCA Balloon Catheter
• Applicant: Shanghai MicroPort Medical (Group) Co., Ltd.
• Product Code: LOX · Cardiovascular
• Decision Date: Jul 21, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5100
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Firefighter™ NC Pro PTCA Balloon Catheter is indicated to be used for: Balloon dilatation of the stenotic portion of a native coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion; Balloon dilatation of post-delivery expansion of balloon expandable stents (models 2.00-5.00mm).

Device Story

Rapid exchange PTCA balloon catheter; non-compliant balloon at distal tip; two radiopaque platinum-iridium marker bands on inner lumen for positioning; hydrophilic coating on distal section to reduce friction. Used in coronary interventions; operated by physicians. Input: guide wire (≤ 0.014 inch). Operation: catheter advanced through guiding catheter to target lesion; balloon inflated to dilate stenosis or expand stents. Output: mechanical dilatation of vessel or stent. Benefits: improved myocardial perfusion via vessel patency.

Clinical Evidence

Bench testing only. Testing included biocompatibility (cytotoxicity, sensitization, irritation, systemic toxicity, pyrogenicity, haemocompatibility, in vivo canine thrombogenicity) and mechanical performance (dimensional verification, balloon preparation/deployment/retraction, rated burst pressure, fatigue, compliance, inflation/deflation time, bond strength, tip pull, flexibility/kink, torque, radiopacity, coating integrity, particulate evaluation, and in-stent performance).

Technological Characteristics

Rapid exchange PTCA catheter; 145cm length; 2.00-5.50mm balloon diameters; 6-30mm lengths. Materials include platinum-iridium marker bands. Hydrophilic coating. Mechanical sensing/actuation via hydraulic inflation. Sterile, single-use. No software or electronic components.

Indications for Use

Indicated for patients requiring balloon dilatation of stenotic native coronary arteries or bypass grafts to improve myocardial perfusion, and for post-delivery expansion of balloon-expandable stents (2.00-5.00mm).

Regulatory Classification

Identification

Standard PTCA Catheter: 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. Cutting/scoring PTCA Catheter: 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.

Special Controls

*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.

Predicate Devices

• NC Emerge™ Monorail™ PTCA Dilatation Catheter (K141236)

Submission Summary (Full Text)

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July 21, 2023

Shanghai MicroPort Medical (Group) Co., Ltd. % Yutian Yang Advanced Supervisor of Regulatory Affairs Department MicroPort Sinica Co., Ltd. 1601 ZhangDong Rd, ZJ Hi-Tech Park Shanghai, Shanghai 201203 China

Re: K223189

Trade/Device Name: Firefighter™ NC Pro 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: June 14, 2023 Received: June 15, 2023

Dear Yutian Yang:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Digitally signed by Gregory W. Gregory W. O'connell -O'connell -S Date: 2023.07.21 09:23:39 -04'00

Gregory O'Connell Assistant Director DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K223189

Device Name Firefighter™ NC Pro PTCA Balloon Catheter

Indications for Use (Describe)

Firefighter™ NC Pro PTCA Balloon Catheter is indicated to be used for:

Balloon dilatation of the stenotic portion of a native coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion;

Balloon dilatation of post-delivery expansion of balloon expandable stents (models 2.00-5.00mm).

| Type of Use (Select one or both, as applicable) |
|-------------------------------------------------|
|-------------------------------------------------|

| <span style="font-size: 16px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) |
|--------------------------------------------------------------------------------------|
| <span style="font-size: 16px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) |

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| | 510(k) Summary |
|--|----------------|
|--|----------------|

| Sponsor: | Shanghai MicroPort Medical (Group) Co., Ltd<br>1601 Zhangdong Road, ZJ Hi-Tech Park,<br>201203 Shanghai,<br>PEOPLE'S REPUBLIC OF CHINA |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Xia Tian<br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
| Date Prepared: | July 17th, 2023 |
| Trade Name: | Firefighter™ NC Pro PTCA Balloon Catheter |
| Common Name: | Percutaneous Transluminal Coronary Angioplasty (PTCA)<br>Catheter |
| Classification: | Class II, 21 CFR Part 870.5100 |
| Product Code: | LOX |
| Predicate Device: | K141236 – NC Emerge™ Monorail™ PTCA Dilatation<br>Catheter ( Boston Scientific Corporation)<br>This predicate device has not been subject to a design-related<br>recall. |
| Device Description: | Firefighter™ NC Pro PTCA Balloon Catheter is a rapid exchange<br>catheter, with a non-compliant balloon near the distal tip. Two<br>radiopaque marker bands are located underneath the balloon and<br>fixed on the inner lumen to position the balloon. The hydrophilic<br>coating is located on the whole distal section to reduce friction<br>and enhance the crossing capability. The effective length of the<br>catheter is 145cm, the inner lumen of catheter permits the use of<br>guide wire ≤ 0.014 inch (0.36mm). Firefighter™ NC Pro is<br>available with balloon diameters of 2.00-5.50mm and balloon<br>lengths of 6, 10, 15, 20, 25 and 30mm. 5F Guiding catheter is used<br>for the delivery of Firefighter™ NC Pro with 2.00-4.00mm<br>balloon diameter. 6F Guiding catheter is used for the delivery of<br>Firefighter™ NC Pro with 4.50-5.50mm balloon diameter. |
| Indications for Use: | Firefighter™ NC Pro PTCA Balloon Catheter is indicated to be<br>used for:<br>Balloon dilatation of the stenotic portion of a native coronary<br>artery or bypass graft stenosis for the purpose of improving<br>myocardial perfusion;Balloon dilatation of post-delivery expansion of balloon<br>expandable stents (models 2.00-5.00mm). |

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| Comparison with<br>Predicate Device: | The Firefighter™ NC Pro PTCA Balloon Catheter is similar to<br>the predicate device in the components, design, materials,<br>sterility, shelf life and operating principle. The indications for use<br>of the subject device and the predicate device are the same. | | |
|--------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|
| Item | Subject device | Predicate device | Comparison |
| Name | Firefighter™ NC Pro<br>PTCA Balloon Catheter | NC Emerge™ Monorail™<br>PTCA Dilatation Catheter | N/A |
| 510(k) number | K223189 | K141236 | N/A |
| Manufacturer | Shanghai MicroPort<br>Medical (Group) Co., Ltd | Boston Scientific<br>Corporation | N/A |
| Indications for use | Firefighter™ NC Pro<br>PTCA Balloon Catheter is<br>indicated to be used for:<br>• Balloon dilatation of<br>the stenotic portion of<br>a native coronary<br>artery or bypass graft<br>stenosis for the<br>purpose of improving<br>myocardial perfusion;<br>• Balloon dilatation of<br>post-delivery<br>expansion of balloon<br>expandable stents<br>(models 2.00-<br>5.00mm). | The NC Emerge Monorail<br>(MR) and NC Emerge<br>Over-The-Wire (OTW)<br>PTCA Dilatation Catheters<br>are indicated for the<br>balloon catheter dilatation<br>of the stenotic portion of a<br>native coronary artery or<br>bypass graft stenosis for<br>the purpose of improving<br>myocardial perfusion in<br>patients with<br>atherosclerosis.<br>NC Emerge Over-The-<br>Wire and NC Emerge<br>Monorail PTCA Dilatation<br>Catheters (balloon models<br>2.00-5.00 mm) are also<br>indicated for the post-<br>delivery expansion of<br>balloon expandable stents<br>(bare metal and drug-<br>eluting). | Same |
| Catheter effective<br>length | 145 cm | 143 cm | Substantially<br>equivalent |
| Recommended<br>guide catheter | Ø 2.00-4.00mm: 5F<br>Ø 4.50-5.50mm: 6F | Ø 2.00-4.00mm:<br>Minimum I.D. of<br>GC=0.056in (1.42mm)<br>Ø 4.50-5.50mm:<br>Minimum I.D. of<br>GC=0.066in (1.68mm) | Substantially<br>equivalent |
| Recommended<br>guide wire | 0.014" (0.36 mm) | 0.014" (0.36 mm) | Same |
| Rapid exchange<br>design | Yes | Yes | Same |
| Hydrophilic | Yes | Yes | Same |
| Sterility | Sterile | Sterile | Same |
| Shelf life | 2 years | 2 years | Same |
| Single use | Yes | Yes | Same |
| Radiopaque marker<br>bands | Yes (2; platinum iridium) | Yes (2; platinum iridium) | Same |
| Proximal shaft<br>depth markers | Yes | Yes | Same |
| Balloon diameters | 2.00-4.00 mm (in 0.25 mm increments) 4.50 mm 5.00 mm 5.50 mm | 2.00-4.00 mm (in 0.25 mm increments) 4.50 mm 5.00 mm 5.50 mm 6.00 mm | Substantially<br>equivalent |
| Balloon lengths | 6, 10, 15, 20, 25, 30 mm | 6, 8, 12, 15, 20, 30 mm | Substantially<br>equivalent |
| Balloon nominal<br>pressure | 12.0 atm | 12.0 atm | Same |
| Balloon rated burst<br>pressure | 20 atm for 2.00-4.00 mm diameter balloons 18 atm for 4.50-5.50 mm diameter balloons | 20 atm for 2.00-4.00 mm diameter balloons 18 atm for 4.50-6.00 mm diameter balloons | Substantially<br>equivalent |
| <b>Performance Data:</b> | <b>Biocompatibility Testing</b><br>The biocompatibility evaluation for the FirefighterTM NC Pro<br>device was conducted in accordance with current standards and<br>included the following tests: Cytotoxicity Sensitization Irritation/Intracutaneous Reactivity Systemic Toxicity (acute) Pyrogen Study (Material Mediated) Haemocompatibility Direct and Indirect Hemolysis Complement Activation <i>In vivo</i> Thrombogenicity in Canine <b>Bench Testing</b><br>Mechanical testing was performed per the Class II Special<br>Controls Guidance Document for Certain Percutaneous<br>Transluminal Coronary Angioplasty (PTCA) Catheters (issued by<br>FDA in September 2010) on the subject device. The tests included<br>the following: Dimensional Verification | | |
| | ● | Balloon Preparation, Deployment and Retraction | |
| | ● | Balloon Rated Burst Pressure | |
| | ● | Balloon Fatigue (Repeat Balloon Inflations) | |
| | ● | Balloon Compliance (Diameter vs. Pressure) | |
| | ● | 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 (Repeat Balloon Inflations; in Stent) | |
| | ● | Endotoxin | |
| | ● | Freedom from Leakage | |
| | ● | Corrosion Resistance | |
| | ● | Balloon preparation, Deployment and Retraction (in<br>Stent) | |
| | ● | Coating Integrity (in Stent) | |
| | ● | Particulate Evaluation (in Stent) | |
| Conclusion: | Based on the data provided, the Firefighter™ NC Pro PTCA<br>Balloon Catheter does not raise new questions of safety and<br>effectiveness and is substantially equivalent to the predicate<br>device. | | |

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