(68 days)
P860019/S241
K113220, P860019/S182
No
The device description and performance studies focus on the physical characteristics and mechanical performance of a balloon catheter, with no mention of AI or ML.
Yes
The device is intended for the "dilatation of stenosis in coronary arteries or bypass grafts" to "improv[e] myocardial perfusion," which describes a therapeutic action.
No
This device is a PTCA (Percutaneous Transluminal Coronary Angioplasty) dilatation catheter intended for widening stenotic coronary arteries or bypass grafts and for post-delivery expansion of stents. Its purpose is therapeutic intervention, not diagnosis.
No
The device description clearly outlines a physical medical device (catheter with a balloon) and the performance studies focus on physical characteristics and testing of the hardware components. There is no mention of software as the primary or sole component.
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, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The NC Quantum Apex™ Monorail™ PTCA Dilatation Catheter is a medical device used directly within the body (intravascularly) to physically dilate stenotic coronary arteries or bypass grafts and expand stents. It is a therapeutic device, not a diagnostic test performed on a sample.
- Intended Use: The intended use clearly describes a procedure performed in vivo (within a living organism) to improve blood flow.
- Device Description: The description details the physical components of a catheter designed for insertion into blood vessels.
Therefore, the NC Quantum Apex™ Monorail™ PTCA Dilatation Catheter is a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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).
Product codes (comma separated list FDA assigned to the subject device)
LOX
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Coronary arteries or bypass grafts
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 Quantum Apex™ Monorail™ 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, September 8, 2010. 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.
Specifically, the following tests were evaluated to support changes for the modified NC Quantum Apex Monorail PTCA Dilatation Catheter:
- Effective Length
- Proximal Shaft Profile
- Shaft and Bond Burst Pressure
- Corrosion Resistance
- Torque Strength
- Catheter Bond Strength
- Flexibility and Kink
- Particulate Evaluation
- Biocompatibility
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
P860019/S241
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
K113220, P860019/S182
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
K121667
P. 1082
510(k) Summary
per 21 CFR §807.92
AUG 1 3 2012
| Submitter's
Name and
Address | Boston Scientific Corporation
Cardiovascular, Rhythm and Vascular Division
One Scimed Place
Maple Grove, MN 55311
Phone: 763-494-1700
Fax: 763-494-2222 | | |
|------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------|-----------------|
| Contact Name
and
Information | Margo J. Anderson
Principal Regulatory Affairs Specialist
Phone: 763-494-1932
Fax: 763-494-2222
E-mail: Margo.Anderson@bsci.com | | |
| Date Prepared | 19 July 2012 | | |
| Proprietary
Name | NC Quantum Apex™ Monorail™ PTCA Dilatation Catheter | | |
| Common Name | Percutaneous Transluminal Coronary Angioplasty (PTCA) Dilatation
Catheter | | |
| Product Code | LOX | | |
| Classification | Class II, 21 CFR Part 870.5100 | | |
| Predicate
Device | NC Quantum Apex™ PTCA
Dilatation Catheter | P860019
/S241 | 16 April 2010 |
| Reference
Devices | Emerge™ PTCA Dilatation
Catheter | K113220 | 22 March 2012 |
| | Quantum™ Maverick™ PTCA
Dilatation Catheter | P860019
/S182 | 01 October 2002 |
| Device
Description | 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. | | |
| Intended Use
of Device | 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.) | | |
1
| 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 drug-eluting). | |
|---------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|
| Comparison of
Technological
Characteristics | The NC Quantum Apex™ Monorail™ PTCA Dilatation Catheter was
modified to incorporate the same device design for the hypotube, midshaft
component and proximal shaft marks as referenced devices Emerge™
PTCA Dilatation Catheter (K113220, cleared March 22, 2012) and
Quantum™ Maverick™ PTCA Dilatation Catheter (P860019/S182,
approved October 1, 2002).
The modified NC Quantum Apex Monorail PTCA Dilatation Catheter
differs from the Boston Scientific predicate device, NC Quantum Apex™
PTCA Dilatation Catheter (P860019/S241,approved April 16, 2010), by
the removal of an accessory kit pouch, flushing needle and one CLIP-IT™
hypotube clip. Otherwise the NC Quantum Apex Monorail PTCA Dilatation
Catheter incorporates substantially equivalent device materials, design,
packaging materials, fundamental technology, manufacturing processes,
sterilization process and intended use as those featured in the predicate
device. | |
| Summary of
Non-Clinical
Performance
Data | The NC Quantum Apex™ Monorail™ 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,
September 8, 2010. 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.
Specifically, the following tests were evaluated to support changes for the
modified 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 Strength
Flexibility and Kink | Particulate Evaluation |
| | | Biocompatibility |
| Conclusion | Based on the indications for use, technological characteristics, and safety
and performance testing, the NC Quantum Apex™ Monorail™PTCA
Dilatation Catheter has been shown to be appropriate for its intended use
and is considered to be substantially equivalent to the Boston Scientific
predicate device, NC Quantum Apex™ PTCA Dilatation Catheter. | |
quantam?
.
2
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.
3
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
4
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_