(86 days)
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).
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 provided text describes a 510(k) premarket notification for the NC Emerge™ PTCA Dilatation Catheter. It focuses on demonstrating substantial equivalence to existing predicate devices through bench testing and biocompatibility testing. The document explicitly states "No new safety or performance issues were raised during the testing and, therefore, these devices may be considered substantially equivalent to the predicate devices."
However, the provided text does not contain the specific acceptance criteria, reported performance values, or detailed study results (like sample sizes, ground truth establishment, or expert information) that would typically be found in a comprehensive study report. The "Performance Data" section lists the types of tests performed but does not provide quantitative results or explicit acceptance criteria for those tests.
Therefore, many of the requested details cannot be extracted from this document.
Here's a breakdown of what can and cannot be provided based on the input:
1. A table of acceptance criteria and the reported device performance
- Cannot be provided definitively from the text. The document lists the types of performance tests conducted (e.g., Effective Length, Rated Burst Pressure, Balloon Fatigue), but it does not specify the acceptance criteria or quantitative reported performance values for these tests. For example, it doesn't state what the accepted range for "Effective Length" is or what the measured effective length was. It only concludes that the tests supported substantial equivalence.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Cannot be provided from the text. The document mentions "bench testing and biocompatibility testing were performed" but does not specify the sample sizes used for these tests. It also does not provide information on data provenance (country of origin, retrospective/prospective). This is common for 510(k) summaries, which often abstract away detailed test reports.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
- Not applicable / Cannot be provided from the text. This type of information is relevant for studies involving human physiological data or image interpretation where expert consensus forms the ground truth. The tests described are "bench testing" and "biocompatibility testing," which are laboratory tests performed on the device itself, not human subjects. Therefore, the concept of "experts establishing ground truth" in the way described does not apply here.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable / Cannot be provided from the text. Similar to point 3, adjudication methods are typically used for expert review of subjective data (like medical images or clinical outcomes). The described tests are objective laboratory measurements, so adjudication by experts is not relevant.
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
- No. This device is a PTCA Dilatation Catheter, a physical medical device used in interventional cardiology. It is not an AI-powered diagnostic or assistive tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant to this device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- No. This device is a physical medical device, not an algorithm or AI system. Therefore, a standalone algorithm performance study is not relevant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable / Cannot be provided directly as "ground truth" in the requested sense. For the bench and biocompatibility tests, the "ground truth" would be established by physical measurement standards, internationally recognized test methods (e.g., ISO standards), and internal Boston Scientific specifications for device performance. It's not "expert consensus" on an image, for example, but rather adherence to predefined engineering specifications and biological safety standards.
8. The sample size for the training set
- Not applicable / Cannot be provided from the text. Training sets are relevant for machine learning or AI models. This device is a physical medical device, not an AI system. Therefore, there is no "training set" in this context.
9. How the ground truth for the training set was established
- Not applicable / Cannot be provided from the text. As explained in point 8, there is no training set for this type of device.
Summary of available information from the text regarding acceptance criteria and study:
The document outlines that the device was subjected to:
- "bench testing"
- "biocompatibility testing"
These tests were performed "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."
The types of tests completed are listed under "Performance Data":
Biocompatibility and Chemical Characterization Tests:
- Cytotoxicity
- Sensitization
- Intracutaneous Reactivity
- Acute Systemic Toxicity
- Materials Mediated Pyrogenicity
- USP Physicochemical
- Hemolysis (Direct Contact)
- Hemolysis (Extract Method)
- Complement Activation
- Coagulation
- In Vitro Hemocompatibility
In-vitro Performance Tests:
- 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: "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."
In essence, the "study" is a series of laboratory tests demonstrating that the NC Emerge PTCA Dilatation Catheter performs comparably to its predicate devices in accordance with regulatory guidance and relevant standards, ensuring its safety and effectiveness. The specific quantitative acceptance criteria and detailed performance values are not disclosed in this summary document.
{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'sName andAddress | Boston Scientific CorporationInterventional Cardiology DivisionOne Scimed PlaceMaple Grove, MN 55311Phone: 763-494-1700Fax: 763-494-2222 | ||
|---|---|---|---|
| Contact NameandInformation | Adrienne HotchkissSenior Regulatory Affairs SpecialistPhone: 763-494-1588Fax: 763-494-2222e-mail: hotchkia@bsci.com | ||
| Date Prepared | 09 May 2014 | ||
| ProprietaryName(s) | NC Emerge™ Monorail™ PTCA Dilatation CatheterNC Emerge™ Over-The-Wire PTCA Dilatation Catheter | ||
| Common Name | Percutaneous Transluminal Coronary Angioplasty (PTCA) DilatationCatheter | ||
| Product Code | LOX | ||
| Classification | Class II, 21 CFR Part 870.5100 | ||
| PredicateDevices | Emerge™ PTCADilatation Catheter(2.00 - 4.00 mmdiameter Monorail andOver-the-Wire balloonmodels) | 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 toreclassification ofBalloon AngioplastyCatheters from ClassIII to Class II withspecial controls | 16 April 2010 | |
| Maverick™ XL PTCADilatation Catheter(Monorail) | P860019/S183(Prior toreclassification ofBalloon AngioplastyCatheters from ClassIII to Class II withspecial 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 Useof Device | The NC Emerge PTCA Dilatation Catheters are intended to enable dilation ofstenotic small and large lumen coronary vessels. | ||
|---|---|---|---|
| Indicationsfor Use | The NC Emerge Monorail (MR) and NC Emerge Over-The-Wire (OTW) PTCADilatation Catheters are indicated for the balloon catheter dilatation of thestenotic portion of a native coronary artery or bypass graft stenosis for thepurpose of improving myocardial perfusion in patients with atherosclerosis.NC Emerge Over-The-Wire and NC Emerge Monorail PTCA DilatationCatheters (balloon models 2.00-5.00 mm) are also indicated for the post-delivery expansion of balloon expandable stents (bare metal and drug-eluting). | ||
| SubstantialEquivalence /Comparison ofTechnologicalCharacteristics | The NC Emerge PTCA Dilatation Catheters incorporate substantiallyequivalent device materials and design, packaging materials and design,fundamental technology, manufacturing processes, sterilization process, andintended use as those featured in the Boston Scientific predicate devices:Emerge PTCA Dilatation Catheters (K113220), NC Quantum Apex PTCADilatation Catheters (K121667 and P860019/S241), and Maverick XL PTCADilatation Catheters (P860019/S183). | ||
| PerformanceData | The NC Emerge PTCA Dilatation Catheter was subjected to testing accordingto the requirements of Guidance for Industry and FDA Staff – Class II SpecialControls for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA)Catheters, 08 September 2010. Bench testing and biocompatibility testingwere performed to support a determination of substantial equivalence. Theresults of these tests provide reasonable assurance that the proposed devicehas been designed and tested to assure conformance to the requirements forits intended use. No new safety or performance issues were raised during thetesting and, therefore, these devices may be considered substantiallyequivalent to the predicate devices. | ||
| The following biocompatibility and chemical characterization tests werecompleted on the NC Emerge PTCA Dilatation Catheters:CytotoxicitySensitizationIntracutaneous ReactivityAcute Systemic ToxicityMaterials Mediated PyrogenicityUSP Physicochemical | Hemolysis (Direct Contact)Hemolysis (Extract Method)Complement ActivationCoagulationIn Vitro Hemocompatibility | ||
| The following in-vitro performance tests were completed and support theNC Emerge PTCA Dilatation Catheters:Effective LengthShaft Inner and Outer DiameterCrossing ProfileBalloon Preparation, Deployment,and RetractionWithdrawal into a Guide CatheterRated Burst PressureBalloon Fatigue (Repeat Inflations)Balloon ComplianceBalloon Inflation/Deflation TimeCatheter Bond Strength Tensile | Tip Pull TestFlexibility and KinkTorque StrengthRadiopacityCoating IntegrityParticulate EvaluationRated Burst Pressure in a StentBalloon Fatigue (in Stent)Kissing Balloon Compatibility | ||
| Conclusion | Based on the indications for use, technological characteristics, and safety andperformance testing, the NC Emerge PTCA Dilatation Catheters have beenshown to be appropriate for their intended use and are considered to besubstantially equivalent to the Boston Scientific predicate device EmergePTCA Dilatation Catheters (2.00 – 4.00 mm diameter) (K121667), NCQuantum Apex PTCA Dilatation Catheters (K121667 and P860019/S41), andMaverick XL PTCA Dilatation Catheters (P860019/S183). |
{5}------------------------------------------------
§ 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.