(86 days)
No
The device description and performance studies focus on the physical characteristics and mechanical performance of a balloon catheter, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is used for balloon catheter dilatation to improve myocardial perfusion, which is a therapeutic intervention.
No
This device is a PTCA Dilatation Catheter intended for therapeutic purposes (balloon catheter dilatation of stenotic portions of arteries/grafts and post-delivery expansion of stents) rather than for diagnosing a condition.
No
The device description clearly outlines a physical catheter with a balloon, marker bands, and coatings, indicating it is a hardware medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used for a therapeutic procedure (balloon dilatation of coronary arteries and bypass grafts) performed directly on the patient's body.
- Device Description: The description details a physical medical device (catheter with a balloon) designed for insertion into the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used in vitro (outside the body) to analyze samples and provide diagnostic information. This device is used in vivo (inside the body) for a therapeutic intervention.
N/A
Intended Use / Indications for Use
The NC Emerge Over-The-Wire (OTW) and NC Emerge Monorail (MR) 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).
Product codes
LOX
Device Description
The NC Emerge PTCA Dilatation Catheters are sterile, single-use, intravascular medical devices. The catheter consists of a shaft with a balloon near the distal tip. The balloon is designed to provide an inflatable segment of known diameter and length at recommended pressures. The NC Emerge PTCA Dilatation Catheter is offered in both Monorail (MR) and Over-The-Wire (OTW) platforms. There are two (2) radiopaque marker bands located under the balloon to aid in positioning the system during the procedure. Coatings are applied to the balloon and catheter to enhance insertion and withdrawal performance.
The NC Emerge PTCA Dilatation Catheter will be available in select combinations of 2.0-6.0mm diameters and 6-30mm lengths as shown below:
| Length (mm) | |||||||
|---|---|---|---|---|---|---|---|
| 6 | 8 | 12 | 15 | 20 | 30 | ||
| Width (mm) | 2.00 | X | X | X | X | X | X |
| 2.25 | X | X | X | X | X | X | |
| 2.50 | X | X | X | X | X | X | |
| 2.75 | X | X | X | X | X | X | |
| 3.00 | X | X | X | X | X | X | |
| 3.25 | X | X | X | X | X | X | |
| 3.50 | X | X | X | X | X | X | |
| 3.75 | X | X | X | X | X | X | |
| 4.00 | X | X | X | X | X | X | |
| 4.50 | X | X | X | X | X | X | |
| 5.00 | X | X | X | X | X | ||
| 5.50 | X | X | X | X | |||
| 6.00 | X | X | X | X |
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The NC Emerge PTCA Dilatation Catheter was subjected to testing according to the requirements of Guidance for Industry and FDA Staff – Class II Special Controls for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters, 08 September 2010. Bench testing and biocompatibility testing were performed to support a determination of substantial equivalence. The results of these tests provide reasonable assurance that the proposed device has been designed and tested to assure conformance to the requirements for its intended use. No new safety or performance issues were raised during the testing and, therefore, these devices may be considered substantially equivalent to the predicate devices.
The following biocompatibility and chemical characterization tests were completed on the NC Emerge PTCA Dilatation Catheters: Cytotoxicity, Sensitization, Intracutaneous Reactivity, Acute Systemic Toxicity, Materials Mediated Pyrogenicity, USP Physicochemical, Hemolysis (Direct Contact), Hemolysis (Extract Method), Complement Activation, Coagulation, In Vitro Hemocompatibility.
The following in-vitro performance tests were completed and support the NC Emerge PTCA Dilatation Catheters: Effective Length, Shaft Inner and Outer Diameter, Crossing Profile, Balloon Preparation, Deployment, and Retraction, Withdrawal into a Guide Catheter, Rated Burst Pressure, Balloon Fatigue (Repeat Inflations), Balloon Compliance, Balloon Inflation/Deflation Time, Catheter Bond Strength Tensile, Tip Pull Test, Flexibility and Kink, Torque Strength, Radiopacity, Coating Integrity, Particulate Evaluation, Rated Burst Pressure in a Stent, Balloon Fatigue (in Stent), Kissing Balloon Compatibility.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K113220, K121667, P860019/S241 (Prior to reclassification of Balloon Angioplasty Catheters from Class III to Class II with special controls, P860019/S183 (Prior to reclassification of Balloon Angioplasty Catheters from Class III to Class II with special controls)
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.
0
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 7, 2014
Boston Scientific Corporation c/o Ms. Adrienne Hotchkiss Senior Regulatory Affairs Specialist One Scimed Place Maple Grove, MN 55311
Re: K141236
Trade/Device Name: NC Emerge™ PTCA Dilatation Catheter (Monorail and Over-the-Wire) Regulation Number: 21 CFR 870.5100 Regulation Name: Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter Regulatory Class: Class II Product Code: LOX Dated: May 13, 2014 Received: May 14, 2014
Dear Ms. Hotchkiss:
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
1
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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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" (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 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/MedicalDevicesforYou/Industry/default.htm.
Sincerely yours,
Fernando Aguel
Fernando Aguel -S
for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known): K141236
Device Name: NC Emerge™ Monorail™ PTCA Dilatation Catheter NC Emerge™ Over-The-Wire PTCA Dilatation Catheter
Indications for Use:
The NC Emerge Over-The-Wire (OTW) and NC Emerge Monorail (MR) 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).
Prescription Use × (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Fernando Aguel Fernando Aguel -S
3
510(k) Summary
per 21 CFR §807.92
| Submitter's
Name and
Address | Boston Scientific Corporation
Interventional Cardiology Division
One Scimed Place
Maple Grove, MN 55311
Phone: 763-494-1700
Fax: 763-494-2222 | | |
|------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------|-----------------|
| Contact Name
and
Information | Adrienne Hotchkiss
Senior Regulatory Affairs Specialist
Phone: 763-494-1588
Fax: 763-494-2222
e-mail: hotchkia@bsci.com | | |
| Date Prepared | 09 May 2014 | | |
| Proprietary
Name(s) | NC Emerge™ Monorail™ PTCA Dilatation Catheter
NC Emerge™ Over-The-Wire PTCA Dilatation Catheter | | |
| Common Name | Percutaneous Transluminal Coronary Angioplasty (PTCA) Dilatation
Catheter | | |
| Product Code | LOX | | |
| Classification | Class II, 21 CFR Part 870.5100 | | |
| Predicate
Devices | Emerge™ PTCA
Dilatation Catheter
(2.00 - 4.00 mm
diameter Monorail and
Over-the-Wire balloon
models) | K113220 | 22 March 2012 |
| | NC Quantum Apex ™
PTCA Dilatation Catheter
(Monorail) | K121667 | 18 August 2012 |
| | NC Quantum Apex ™
PTCA Dilatation Catheter
(Over-the-Wire) | P860019/S241
(Prior to
reclassification of
Balloon Angioplasty
Catheters from Class
III to Class II with
special controls | 16 April 2010 |
| | Maverick™ XL PTCA
Dilatation Catheter
(Monorail) | P860019/S183
(Prior to
reclassification of
Balloon Angioplasty
Catheters from Class
III to Class II with
special controls) | 24 October 2002 |
4
Device Description
The NC Emerge PTCA Dilatation Catheters are sterile, single-use, intravascular medical devices. The catheter consists of a shaft with a balloon near the distal tip. The balloon is designed to provide an inflatable segment of known diameter and length at recommended pressures. The NC Emerge PTCA Dilatation Catheter is offered in both Monorail (MR) and Over-The-Wire (OTW) platforms. There are two (2) radiopaque marker bands located under the balloon to aid in positioning the system during the procedure. Coatings are applied to the balloon and catheter to enhance insertion and withdrawal performance.
The NC Emerge PTCA Dilatation Catheter will be available in select combinations of 2.0-6.0mm diameters and 6-30mm lengths as shown below:
| Length (mm) | |||||||
|---|---|---|---|---|---|---|---|
| 6 | 8 | 12 | 15 | 20 | 30 | ||
| Width (mm) | 2.00 | X | X | X | X | X | X |
| 2.25 | X | X | X | X | X | X | |
| 2.50 | X | X | X | X | X | X | |
| 2.75 | X | X | X | X | X | X | |
| 3.00 | X | X | X | X | X | X | |
| 3.25 | X | X | X | X | X | X | |
| 3.50 | X | X | X | X | X | X | |
| 3.75 | X | X | X | X | X | X | |
| 4.00 | X | X | X | X | X | X | |
| 4.50 | X | X | X | X | X | X | |
| 5.00 | X | X | X | X | X | ||
| 5.50 | X | X | X | X | |||
| 6.00 | X | X | X | X |
| Intended Use
of Device | The NC Emerge PTCA Dilatation Catheters are intended to enable dilation of
stenotic small and large lumen coronary vessels. | | |
|-----------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Indications
for Use | 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). | | |
| Substantial
Equivalence /
Comparison of
Technological
Characteristics | The NC Emerge PTCA Dilatation Catheters incorporate substantially
equivalent device materials and design, packaging materials and design,
fundamental technology, manufacturing processes, sterilization process, and
intended use as those featured in the Boston Scientific predicate devices:
Emerge PTCA Dilatation Catheters (K113220), NC Quantum Apex PTCA
Dilatation Catheters (K121667 and P860019/S241), and Maverick XL PTCA
Dilatation Catheters (P860019/S183). | | |
| Performance
Data | The NC Emerge PTCA Dilatation Catheter was subjected to testing according
to the requirements of Guidance for Industry and FDA Staff – Class II Special
Controls for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA)
Catheters, 08 September 2010. Bench testing and biocompatibility testing
were performed to support a determination of substantial equivalence. The
results of these tests provide reasonable assurance that the proposed device
has been designed and tested to assure conformance to the requirements for
its intended use. No new safety or performance issues were raised during the
testing and, therefore, these devices may be considered substantially
equivalent to the predicate devices. | | |
| | The following biocompatibility and chemical characterization tests were
completed on the NC Emerge PTCA Dilatation Catheters:
Cytotoxicity
Sensitization
Intracutaneous Reactivity
Acute Systemic Toxicity
Materials Mediated Pyrogenicity
USP Physicochemical | Hemolysis (Direct Contact)
Hemolysis (Extract Method)
Complement Activation
Coagulation
In Vitro Hemocompatibility | |
| | The following in-vitro performance tests were completed and support the
NC Emerge PTCA Dilatation Catheters:
Effective Length
Shaft Inner and Outer Diameter
Crossing Profile
Balloon Preparation, Deployment,
and Retraction
Withdrawal into a Guide Catheter
Rated Burst Pressure
Balloon Fatigue (Repeat Inflations)
Balloon Compliance
Balloon Inflation/Deflation Time
Catheter Bond Strength Tensile | Tip Pull Test
Flexibility and Kink
Torque Strength
Radiopacity
Coating Integrity
Particulate Evaluation
Rated Burst Pressure in a Stent
Balloon Fatigue (in Stent)
Kissing Balloon Compatibility | |
| Conclusion | Based on the indications for use, technological characteristics, and safety and
performance testing, the NC Emerge PTCA Dilatation Catheters have been
shown to be appropriate for their intended use and are considered to be
substantially equivalent to the Boston Scientific predicate device Emerge
PTCA Dilatation Catheters (2.00 – 4.00 mm diameter) (K121667), NC
Quantum Apex PTCA Dilatation Catheters (K121667 and P860019/S41), and
Maverick XL PTCA Dilatation Catheters (P860019/S183). | | |
5