(68 days)
The NC Quantum Apex™ Monorail™ PTCA Dilatation Catheter is intended for dilatation of stenosis in coronary arteries or bypass grafts and for post-delivery expansion of balloon expandable stents (bare metal and drug-eluting.)
The NC Quantum Apex™ Monorail™ 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. NC Quantum Apex Monorail PTCA Dilatation Catheters are also indicated for the post-delivery expansion of balloon expandable stents (bare metal and drug-eluting).
The Boston Scientific NC Quantum Apex™ Monorail™ PTCA Dilatation Catheter is a sterile, single-use, intravascular medical device. 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. There are 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 Quantum Apex Monorail PTCA Dilatation Catheter is available with balloon diameters of 2.00 mm to 5.00 mm and balloon lengths of 6 mm to 30 mm.
The provided text describes a 510(k) premarket notification for a medical device, the NC Quantum Apex™ Monorail™ PTCA Dilatation Catheter. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study with acceptance criteria and performance metrics typically seen for AI/ML devices. Therefore, much of the requested information regarding AI/ML study components (sample sizes for test/training sets, ground truth establishment, expert qualifications, MRMC studies, standalone performance) is not applicable or cannot be extracted from this document.
However, I can extract information related to the device's technical specifications and the non-clinical performance testing conducted to support its substantial equivalence.
Device Acceptance Criteria and Reported Performance (Non-Clinical Testing)
The acceptance criteria for this device are implicitly tied to demonstrating "substantial equivalence" to the predicate device, meaning its performance should be comparable to or within acceptable limits of the predicate. The document lists various non-clinical tests performed. While specific numeric acceptance criteria and reported performance values are not provided in the summary, the successful completion of these tests suggests the device met the pre-defined criteria for substantial equivalence.
| Acceptance Criteria Category (Implicit) | Reported Device Performance (Implied by successful testing for substantial equivalence) |
|---|---|
| Physical and Mechanical Performance | |
| Effective Length | Met requirements comparable to predicate and reference devices. |
| Proximal Shaft Profile | Met requirements comparable to predicate and reference devices. |
| Shaft and Bond Burst Pressure | Met requirements comparable to predicate and reference devices. |
| Catheter Bond Strength | Met requirements comparable to predicate and reference devices. |
| Flexibility and Kink | Met requirements comparable to predicate and reference devices. |
| Balloon Deflation Time | Met requirements comparable to predicate and reference devices. |
| Corrosion Resistance | Met requirements comparable to predicate and reference devices. |
| Torque Strength | Met requirements comparable to predicate and reference devices. |
| Particulate Evaluation | Met requirements comparable to predicate and reference devices. |
| Biocompatibility | |
| Biocompatibility | Met requirements for biological safety. |
Information Regarding AI/ML Study Components (Not applicable to this 510(k))
As this submission is for a physical medical device (PTCA Dilatation Catheter) and not an AI/ML algorithm, the following sections are not relevant and the requested information cannot be found in the provided text:
- Sample sizes used for the test set and the data provenance: Not applicable. This is not an AI/ML study.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for AI/ML analysis is not relevant here.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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: Not applicable.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
Nature of the Study and Device
The K121667 submission describes a PTCA Dilatation Catheter, which is a physical, invasive medical device used in coronary angioplasty. The "study" referenced in the document is a non-clinical design verification testing program aimed at demonstrating substantial equivalence to an existing predicate device (NC Quantum Apex™ PTCA Dilatation Catheter) and reference devices (Emerge™ PTCA Dilatation Catheter and Quantum™ Maverick™ PTCA Dilatation Catheter).
The document explicitly states: "Design verification testing was performed to demonstrate that the performance of the modified NC Quantum Apex Monorail PTCA Dilatation Catheter remains substantially equivalent to the predicate device." This means the purpose of the testing was to confirm that the minor modifications to the device (related to the hypotube, midshaft component, proximal shaft marks, and removal of accessory kit components) did not negatively impact its safety and effectiveness compared to the already approved devices.
The tests conducted are typical for mechanical and material aspects of a catheter: Effective Length, Proximal Shaft Profile, Shaft and Bond Burst Pressure, Catheter Bond Strength, Flexibility and Kink, Balloon Deflation Time, Corrosion Resistance, Torque Strength, Particulate Evaluation, and Biocompatibility. The successful completion of these tests formed the basis for the FDA's determination of substantial equivalence.
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K121667
P. 1082
510(k) Summary
per 21 CFR §807.92
AUG 1 3 2012
| Submitter'sName andAddress | Boston Scientific CorporationCardiovascular, Rhythm and Vascular DivisionOne Scimed PlaceMaple Grove, MN 55311Phone: 763-494-1700Fax: 763-494-2222 | ||
|---|---|---|---|
| Contact NameandInformation | Margo J. AndersonPrincipal Regulatory Affairs SpecialistPhone: 763-494-1932Fax: 763-494-2222E-mail: Margo.Anderson@bsci.com | ||
| Date Prepared | 19 July 2012 | ||
| ProprietaryName | NC Quantum Apex™ Monorail™ PTCA Dilatation Catheter | ||
| Common Name | Percutaneous Transluminal Coronary Angioplasty (PTCA) DilatationCatheter | ||
| Product Code | LOX | ||
| Classification | Class II, 21 CFR Part 870.5100 | ||
| PredicateDevice | NC Quantum Apex™ PTCADilatation Catheter | P860019/S241 | 16 April 2010 |
| ReferenceDevices | Emerge™ PTCA DilatationCatheter | K113220 | 22 March 2012 |
| Quantum™ Maverick™ PTCADilatation Catheter | P860019/S182 | 01 October 2002 | |
| DeviceDescription | The Boston Scientific NC Quantum Apex™ Monorail™ PTCA DilatationCatheter is a sterile, single-use, intravascular medical device. Thecatheter consists of a shaft with a balloon near the distal tip. The balloonis designed to provide an inflatable segment of known diameter andlength at recommended pressures. There are radiopaque marker bandslocated under the balloon to aid in positioning the system during theprocedure. Coatings are applied to the balloon and catheter to enhanceinsertion and withdrawal performance.The NC Quantum Apex Monorail PTCA Dilatation Catheter is availablewith balloon diameters of 2.00 mm to 5.00 mm and balloon lengths of 6mm to 30 mm. | ||
| Intended Useof Device | The NC Quantum Apex™ Monorail™ PTCA Dilatation Catheter isintended for dilatation of stenosis in coronary arteries or bypass grafts andfor post-delivery expansion of balloon expandable stents (bare metal anddrug-eluting.) |
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| Indications for Use | The NC Quantum Apex™ Monorail™ PTCA Dilatation Catheters areindicated for the balloon catheter dilatation of the stenotic portion of anative coronary artery or bypass graft stenosis for the purpose ofimproving myocardial perfusion. NC Quantum Apex Monorail PTCADilatation Catheters are also indicated for the post-delivery expansion ofballoon expandable stents (bare metal and drug-eluting). | |
|---|---|---|
| Comparison ofTechnologicalCharacteristics | The NC Quantum Apex™ Monorail™ PTCA Dilatation Catheter wasmodified to incorporate the same device design for the hypotube, midshaftcomponent and proximal shaft marks as referenced devices Emerge™PTCA Dilatation Catheter (K113220, cleared March 22, 2012) andQuantum™ Maverick™ PTCA Dilatation Catheter (P860019/S182,approved October 1, 2002).The modified NC Quantum Apex Monorail PTCA Dilatation Catheterdiffers from the Boston Scientific predicate device, NC Quantum Apex™PTCA Dilatation Catheter (P860019/S241,approved April 16, 2010), bythe removal of an accessory kit pouch, flushing needle and one CLIP-IT™hypotube clip. Otherwise the NC Quantum Apex Monorail PTCA DilatationCatheter incorporates substantially equivalent device materials, design,packaging materials, fundamental technology, manufacturing processes,sterilization process and intended use as those featured in the predicatedevice. | |
| Summary ofNon-ClinicalPerformanceData | The NC Quantum Apex™ Monorail™ PTCA Dilatation Catheter wassubjected to testing according to the requirements of Guidance forIndustry and FDA Staff - Class II Special Controls for CertainPercutaneous Transluminal Coronary Angioplasty (PTCA) Catheters,September 8, 2010. Design verification testing was performed todemonstrate that the performance of the modified NC Quantum ApexMonorail PTCA Dilatation Catheter remains substantially equivalent to thepredicate device.Specifically, the following tests were evaluated to support changes for themodified NC Quantum Apex Monorail PTCA Dilatation Catheter: | |
| Effective Length | Balloon Deflation Time | |
| Proximal Shaft Profile | Corrosion Resistance | |
| Shaft and Bond Burst Pressure | Torque Strength | |
| Catheter Bond StrengthFlexibility and Kink | Particulate Evaluation | |
| Biocompatibility | ||
| Conclusion | Based on the indications for use, technological characteristics, and safetyand performance testing, the NC Quantum Apex™ Monorail™PTCADilatation Catheter has been shown to be appropriate for its intended useand is considered to be substantially equivalent to the Boston Scientificpredicate device, NC Quantum Apex™ PTCA Dilatation Catheter. |
quantam?
.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
AUG 1 3 2012
Boston Scientific Corp. Ms. Laura Lind Regulatory Affairs Specialist One Scimed Place Maple Grove, MN 55311
Re: K121667
Trade/Device Name: NC Quantum Apex™ Monorail™ PTCA Dilatation Catheter Regulation Number: 21 CFR 870.5100 Regulation Name: Catheters, Transluminal Coronary Angioplasty, Percutaneous Regulatory Class: Class II Product Code: LOX Dated: July 19, 2012 Received: July 20, 2012
Dear Ms. Lind:
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.
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Page 2 – Ms. Laura Lind
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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
MG Hillen
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K121667
Device Name: NC Quantum Apex "Monorail" PTCA Dilatation Catheter
(
Indications for Use:
The NC Quantum Apex Monorail 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.
NC Quantum Apex Monorail PTCA Dilatation Catheters are also indicated for the post-delivery expansion of balloon expandable stents (bare metal and drugeluting).
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)
CMA Zkillelu
(Division Sign-Off) Division of Cardiovascular Devices
K121667 510(k) Number_
§ 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.