(282 days)
Not Found
No
The 510(k) summary describes a mechanical device (balloon catheter) and its performance is evaluated through standard biocompatibility and bench testing, with no mention of AI/ML components or data-driven performance metrics.
Yes
The device is indicated for balloon dilatation of stenotic coronary arteries or bypass grafts to improve myocardial perfusion, which is a therapeutic intervention.
No.
The Firefighter™ NC Pro PTCA Balloon Catheter is indicated for therapeutic purposes, specifically for balloon dilatation of stenotic coronary arteries or bypass grafts and post-delivery expansion of balloon-expandable stents, not for diagnosing conditions.
No
The device description clearly details a physical catheter with a balloon, radiopaque markers, and hydrophilic coating, indicating it is a hardware medical device.
Based on the provided information, 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 or tissue, to detect diseases or other conditions. They are used to diagnose, monitor, or screen for diseases.
- Device Description and Intended Use: The Firefighter™ NC Pro PTCA Balloon Catheter is a medical device used within the body (in vivo) for mechanical procedures (balloon dilatation) on coronary arteries and bypass grafts. It is a physical tool used to open narrowed blood vessels.
- Lack of Diagnostic Function: The device does not analyze biological samples or provide diagnostic information about a patient's condition. Its function is purely therapeutic and mechanical.
Therefore, the Firefighter™ NC Pro PTCA Balloon Catheter falls under the category of an invasive therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for 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).
Product codes
LOX
Device Description
Firefighter™ NC Pro PTCA Balloon Catheter is a rapid exchange catheter, with a non-compliant balloon near the distal tip. Two radiopaque marker bands are located underneath the balloon and fixed on the inner lumen to position the balloon. The hydrophilic coating is located on the whole distal section to reduce friction and enhance the crossing capability. The effective length of the catheter is 145cm, the inner lumen of catheter permits the use of guide wire ≤ 0.014 inch (0.36mm). Firefighter™ NC Pro is available with balloon diameters of 2.00-5.50mm and balloon lengths of 6, 10, 15, 20, 25 and 30mm. 5F Guiding catheter is used for the delivery of Firefighter™ NC Pro with 2.00-4.00mm balloon diameter. 6F Guiding catheter is used for the delivery of Firefighter™ NC Pro with 4.50-5.50mm balloon diameter.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
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 FirefighterTM NC Pro device was conducted in accordance with current standards and included the following tests: Cytotoxicity Sensitization Irritation/Intracutaneous Reactivity Systemic Toxicity (acute) Pyrogen Study (Material Mediated) Haemocompatibility Direct and Indirect Hemolysis Complement Activation In vivo Thrombogenicity in Canine.
Bench Testing: Mechanical testing was performed per the Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters (issued by FDA in September 2010) on the subject device. The tests included 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 Stent)
- Coating Integrity (in Stent)
- Particulate Evaluation (in Stent)
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.
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
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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) |
|---|
| ------------------------------------------------- |
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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| 510(k) Summary | |
|---|---|
| -- | ---------------- |
| Sponsor: | Shanghai MicroPort Medical (Group) Co., Ltd
1601 Zhangdong Road, ZJ Hi-Tech Park,
201203 Shanghai,
PEOPLE'S REPUBLIC OF CHINA |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Xia Tian
Phone: 86-021-38954600
Fax: 86-021-50801305
Email: Xia.Tian@microport.com |
| Date Prepared: | July 17th, 2023 |
| Trade Name: | Firefighter™ NC Pro PTCA Balloon Catheter |
| Common Name: | Percutaneous Transluminal Coronary Angioplasty (PTCA)
Catheter |
| Classification: | Class II, 21 CFR Part 870.5100 |
| Product Code: | LOX |
| Predicate Device: | K141236 – NC Emerge™ Monorail™ PTCA Dilatation
Catheter ( Boston Scientific Corporation)
This predicate device has not been subject to a design-related
recall. |
| Device Description: | Firefighter™ NC Pro PTCA Balloon Catheter is a rapid exchange
catheter, with a non-compliant balloon near the distal tip. Two
radiopaque marker bands are located underneath the balloon and
fixed on the inner lumen to position the balloon. The hydrophilic
coating is located on the whole distal section to reduce friction
and enhance the crossing capability. The effective length of the
catheter is 145cm, the inner lumen of catheter permits the use of
guide wire ≤ 0.014 inch (0.36mm). Firefighter™ NC Pro is
available with balloon diameters of 2.00-5.50mm and balloon
lengths of 6, 10, 15, 20, 25 and 30mm. 5F Guiding catheter is used
for the delivery of Firefighter™ NC Pro with 2.00-4.00mm
balloon diameter. 6F Guiding catheter is used for the delivery of
Firefighter™ NC Pro with 4.50-5.50mm balloon diameter. |
| Indications for 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). |
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| Comparison with
Predicate Device: | The Firefighter™ NC Pro PTCA Balloon Catheter is similar to
the predicate device in the components, design, materials,
sterility, shelf life and operating principle. The indications for use
of the subject device and the predicate device are the same. | | |
|--------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|
| Item | Subject device | Predicate device | Comparison |
| Name | Firefighter™ NC Pro
PTCA Balloon Catheter | NC Emerge™ Monorail™
PTCA Dilatation Catheter | N/A |
| 510(k) number | K223189 | K141236 | N/A |
| Manufacturer | Shanghai MicroPort
Medical (Group) Co., Ltd | Boston Scientific
Corporation | N/A |
| Indications for 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). | The NC Emerge Monorail
(MR) and NC Emerge
Over-The-Wire (OTW)
PTCA Dilatation 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 in
patients with
atherosclerosis.
NC Emerge Over-The-
Wire and NC Emerge
Monorail PTCA Dilatation
Catheters (balloon models
2.00-5.00 mm) are also
indicated for the post-
delivery expansion of
balloon expandable stents
(bare metal and drug-
eluting). | Same |
| Catheter effective
length | 145 cm | 143 cm | Substantially
equivalent |
| Recommended
guide catheter | Ø 2.00-4.00mm: 5F
Ø 4.50-5.50mm: 6F | Ø 2.00-4.00mm:
Minimum I.D. of
GC=0.056in (1.42mm)
Ø 4.50-5.50mm:
Minimum I.D. of
GC=0.066in (1.68mm) | Substantially
equivalent |
| Recommended
guide wire | 0.014" (0.36 mm) | 0.014" (0.36 mm) | Same |
| Rapid exchange
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
bands | Yes (2; platinum iridium) | Yes (2; platinum iridium) | Same |
| Proximal shaft
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
equivalent |
| Balloon lengths | 6, 10, 15, 20, 25, 30 mm | 6, 8, 12, 15, 20, 30 mm | Substantially
equivalent |
| Balloon nominal
pressure | 12.0 atm | 12.0 atm | Same |
| Balloon rated burst
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
equivalent |
| Performance Data: | Biocompatibility Testing
The biocompatibility evaluation for the FirefighterTM NC Pro
device was conducted in accordance with current standards and
included the following tests: Cytotoxicity Sensitization Irritation/Intracutaneous Reactivity Systemic Toxicity (acute) Pyrogen Study (Material Mediated) Haemocompatibility Direct and Indirect Hemolysis Complement Activation In vivo Thrombogenicity in Canine Bench Testing
Mechanical testing was performed per the Class II Special
Controls Guidance Document for Certain Percutaneous
Transluminal Coronary Angioplasty (PTCA) Catheters (issued by
FDA in September 2010) on the subject device. The tests included
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
Stent) | |
| | ● | Coating Integrity (in Stent) | |
| | ● | Particulate Evaluation (in Stent) | |
| Conclusion: | Based on the data provided, the Firefighter™ NC Pro PTCA
Balloon Catheter does not raise new questions of safety and
effectiveness and is substantially equivalent to the predicate
device. | | |
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