(90 days)
No
The summary describes a physical medical device (a balloon catheter) and its performance testing, with no mention of software, algorithms, image processing, or AI/ML terms.
Yes
This device is a therapeutic device because its intended use is for the balloon catheter dilatation of stenotic coronary arteries or bypass grafts to improve myocardial perfusion, and for the post-delivery expansion of balloon expandable stents. These actions are direct medical treatments aimed at restoring or improving physiological function.
No
Explanation: The device is a PTCA Dilatation Catheter, indicated for "balloon catheter dilatation of the stenotic portion of a native coronary artery or bypass graft stenosis" and "post-delivery expansion of balloon expandable stents." These are treatment procedures, not diagnostic ones.
No
The device description and performance studies clearly indicate this is a physical medical device (catheter) and not software.
No, 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 catheter dilatation of coronary arteries and bypass grafts, and post-delivery expansion of stents). This is a direct intervention on the patient's body.
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens (like blood, urine, tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. This device does not involve the analysis of such specimens.
- Device Description (or lack thereof): While the description is "Not Found," the intended use is the primary indicator.
- Other Sections: The other sections like "Mentions image processing," "Mentions AI," "Input Imaging Modality," and the focus on performance studies related to the physical properties and biocompatibility of the catheter further support that this is a medical device used for a procedure, not an IVD.
Therefore, based on the provided information, the NC Quantum Apex™ PTCA Dilatation Catheter is a therapeutic medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
NC Quantum Apex™ 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™ PTCA Dilatation Catheters are also indicated for the post-delivery expansion of balloon expandable stents (bare metal and drug-eluting).
Product codes
LOX
Device Description
Not Found
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)
Bench testing was 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 device testing. The following performance tests were completed on the NC Quantum Apex™ PTCA Dilatation Catheter: Corrosion Resistance, Proximal Shaft Marks, Midshaft Bond Tensile, Proximal Mark Abrasion Resistance, Repeat Inflation, Shaft and Bond Burst Pressure. The following biocompatibility and chemical characterization tests were completed on the NC Quantum Apex™ PTCA Dilatation Catheter: Cytotoxicity, Sensitization, Intracutaneous Reactivity, Acute Systemic Injection, Materials Mediated Pyrogenicity, Mutagenicity, Hemolysis, Partial Thromboplastin Time, In Vitro Hemocompatibility, Complement Activation, USP Physicochemical, Latex Assay, Nonvolatile Residue, SEM.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
NC Quantum Apex™ PTCA Dilatation Catheter, K121667
Reference Device(s)
NC Emerge™ PTCA Dilatation Catheter, K141236
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized image of three human profiles facing right, stacked on top of each other to create a sense of depth and unity. The profiles are rendered in a dark color, contrasting with the white background. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the image.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 23, 2016
Boston Scientific Corporation Jane Horan Senior Regulatory Affairs Specialist One Scimed Place Maple Grove, Minnesota 55311
Re: K160823
Trade/Device Name: NC Quantum Apex PTCA Dilatation Catheter Regulation Number: 21 CFR 870.5100 Regulation Name: Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter Regulatory Class: Class II Product Code: LOX Dated: May 23, 2016 Received: May 24, 2016
Dear Jane Horan:
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 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.
1
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" (21 CFR 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/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Kenneth J. Cavanaugh -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): K160823
Device Name:
NC Quantum Apex™ PTCA Dilatation Catheter
Indications for Use:
NC Quantum Apex 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 PTCA Dilatation Catheters are also indicated for the post-delivery expansion of balloon expandable stents (bare metal and drugeluting).
| Prescription Use | X | AND/OR | Over-The-Counter Use | |
|---|---|---|---|---|
| (Part 21 CFR 801 Subpart D) | (21 CFR 801 Subpart C) | |||
| (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) |
Concurrence of Center for Devices and Radiological Heath (CDRH)
3
510k Summary
Per 21 CFR §807.92
| Common or Usual Name | PTCA Dilatation Catheter |
|---|---|
| Trade Name(s) | NC Quantum Apex™ PTCA Dilatation Catheter |
| Product Code | LOX - Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter |
| Classification of Device | Class II, 21 CFR 870.5100 |
| Submitter's Name and Address | Boston Scientific Corporation |
| One Scimed Place | |
| Maple Grove, MN 55311-1566 | |
| Contact Name and Information | Jane Horan |
| Senior Regulatory Affairs Specialist | |
| Phone: 763-494-2572 | |
| Fax: 763-494-2222 | |
| Email: Jane.Horan@bsci.com | |
| Date Prepared | 01 May 2016 |
| Section 514 of the Act | |
| Performance Standards | No performance standards have been established under |
| Section 514 of the Food, Drug and Cosmetic Act for | |
| percutaneous catheters. | |
| Establishment Registration Numbers | Owner /Operator: |
| Boston Scientific Corporation | |
| 300 Boston Scientific Way | |
| Marlborough, MA 01752 | |
| ERN: 9912058 |
Manufacturing Facility:
Boston Scientific Corporation
Two Scimed Place
Maple Grove, MN 55311
ERN: 2134265
Sterilization Facilities:
Boston Scientific Corporation – Coventry
8 Industrial Drive
Coventry, RI 02816
ERN: 1000121056 |
| Sterilization
Facilities: | STERIS Isomedix Services
3459 South Clinton Avenue
South Plainfield, NJ 07080
ERN: 2246552 |
| | Synergy Health Ireland Ltd.
(Tullamore)
IDA Business & Technology Park
Tullamore, County Offaly
Ireland
ERN: 3002807314 |
| | Synergy Health AST, SRL
B13. 1 Street 4, Avenue 1
El Coyol Free Zone
El Coyol, Alajeula 20102
Costa Rica
ERN: 3010273872 |
| | Synergy Health Venlo
Faunalaan 38
Venlo Limburg, Netherlands
5928 RZ
ERN: 3009337401 |
| Predicate Device | NC Quantum Apex™ PTCA Dilatation Catheter, K121667,
cleared 13 August 2012. |
| Reference
Device | NC Emerge™ PTCA Dilatation Catheter, K141236,
cleared 7 August 2014 |
| Intended Use/
Indications for
Use | NC Quantum Apex™ 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™ PTCA Dilatation
Catheters are also indicated for the post-delivery
expansion of balloon expandable stents (bare metal and
drug-eluting). |
| Comparison of
Required
Technological
Characteristics | The proposed NC Quantum Apex™ PTCA Dilatation
Catheter is substantially equivalent to the existing NC
Quantum Apex™ PTCA Dilation Catheter cleared by FDA
under premarket notification K121667 (August 13, 2012).
NC Quantum Apex™ has the same intended use,
scientific technology, design, sterilization method,
packaging materials, and equivalent materials as the
applicable predicate device. |
4
5
| Summary of Non-
Clinical Test
Summary | Bench testing was 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 device testing. | |
|---------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------|
| | The following performance tests were completed on the
NC Quantum Apex™ PTCA Dilatation Catheter: | |
| | Corrosion Resistance | Proximal Mark Abrasion
Resistance |
| | Proximal Shaft Marks | Repeat Inflation |
| | Midshaft Bond Tensile | Shaft and Bond
Burst Pressure |
| | The following biocompatibility and chemical
characterization tests were completed on the NC
Quantum Apex™ PTCA Dilatation Catheter: | |
| | Cytotoxicity | Partial Thromboplastin
Time |
| | Sensitization | In Vitro Hemocompatibility |
| | Intracutaneous Reactivity | Complement Activation |
| | Acute Systemic Injection | USP Physicochemical |
| | Materials Mediated
Pyrogenicity | Latex Assay |
| | Mutagenicity | Nonvolatile Residue |
| | Hemolysis | SEM |
| Conclusion | Based on the indications for use, technological
characteristics, and safety and performance testing, the
proposed NC Quantum Apex™ PTCA Dilatation Catheter
has been shown to be appropriate for its intended use
and is considered to be substantially equivalent to the NC
Quantum Apex™ PTCA Dilatation Catheter (K121667). | |