(29 days)
P860019
Not Found
No
The 510(k) summary describes a mechanical device (balloon catheter) and does not mention any software, algorithms, or data processing that would suggest the use of AI/ML. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
Yes
The device is described as a "balloon catheter ... indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft for the purpose of improving myocardial perfusion," which is a direct treatment of a medical condition.
No
The device is a balloon catheter used for dilatation of stenotic coronary arteries or bypass grafts, and for post-delivery expansion of balloon expandable stents, which are interventional/therapeutic applications, not diagnostic ones.
No
The device description clearly describes a physical medical device (a balloon catheter) with hardware components (catheter, balloon, corewire). It is not solely software.
Based on the provided information, the Maverick XL balloon catheter is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for balloon dilatation of coronary arteries or bypass grafts and post-delivery expansion of stents. This is a therapeutic procedure performed directly on the patient's body.
- Device Description: The device is a catheter with a balloon, designed for mechanical intervention within the body.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) taken from the human body to provide information about a physiological state, health, or disease. The Maverick XL does not perform this function.
Therefore, the Maverick XL balloon catheter is a medical device used for interventional procedures, not an IVD.
N/A
Intended Use / Indications for Use
The Maverick XL balloon catheter is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft for the purpose of improving myocardial perfusion. The Maverick XL balloon catheter is also indicated for the post delivery expansion of balloon expandable stents.
Product codes
LOX
Device Description
The Maverick XL Percutaneous Transluminal Coronary Angioplasty PTCA (Maverick XL) dilatation catheter is a Monorail catheter with a balloon near the distal tip. The distal catheter segment is dual lumen and coaxial, characteristic of all monorail style catheters. The balloon is located at the distal end of the catheter and is designed to provide an inflatable segment of known diameter and length at recommended pressures.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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
Bench testing and first article testing were performed to support a determination of substantial equivalence. The results of these tests provide reasonable assurance that the proposed device with the modified corewire 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.
Key Metrics
Not Found
Predicate Device(s)
P860019
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
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 14, 2016
Boston Scientific Corporation Ka Zoua Xiong Regulatory Affairs Specialist One Scimed Place Maple Grove, Minnesota 55311-1566
Re: K163200
Trade/Device Name: Maverick XL Percutaneous Transluminal Coronary Angioplasty Monorail Dilatation Catheter Regulation Number: 21 CFR 870.5100 Regulation Name: Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter Regulatory Class: Class II (Special Controls) Product Code: LOX Dated: November 14, 2016 Received: November 15, 2016
Dear Ka Zoua Xiong:
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) 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" (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,
Brian D. Pullin -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) K163200
Device Name
Maverick™ XL Percutaneous Transluminal Coronary Angioplasty Monorail™ Dilatation Catheter
Indications for Use (Describe)
The Maverick XL balloon catheter is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft for the purpose of improving myocardial perfusion. The Maverick XL balloon catheter is also indicated for the post delivery expansion of balloon expandable stents.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
510(k) Summary
Per 21 CFR §807.92
| Common or Usual
| Name | PTCA Dilatation Catheter | |
|---|---|---|
| Trade Name(s) | Maverick™ XL Percutaneous Transluminal Coronary Angioplasty | |
| Monorail™ Dilatation Catheter | ||
| Product Code | LOX - Catheters, Transluminal Coronary Angioplasty, | |
| Percutaneous | ||
| Classification of | ||
| Device | Class II (special controls) - 21 CFR 870.5100 | |
| Submitter's Name | ||
| and Address | Boston Scientific Corporation | |
| One Scimed Place | ||
| Maple Grove, MN 55311-1566 | ||
| Contact Name and | ||
| Information | Ka Zoua Xiong | |
| Regulatory Affairs Specialist | ||
| Phone: 763-494-2970 | ||
| Fax: 763-494-2222 | ||
| Email: Kazoua.Xiong@bsci.com | ||
| Date Prepared | 11 November 2016 | |
| Section 514 of the | ||
| Act Performance | ||
| Standards | The special control for this device is FDA's "Class II Special | |
| Controls Guidance Document: Percutaneous Transluminal | ||
| Coronary Angioplasty (PTCA) 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: | BSC Coventry | |
| 8 Industrial Drive | ||
| Coventry, RI 02816 | ||
| USA | ||
| Predicate Devices | P860019 - Maverick™ XL Percutaneous Transluminal Coronary | |
| Angioplasty Monorail™ Dilatation Catheter, date reclassified | 08 October 2010 |
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| Device Description | The Maverick XL Percutaneous Transluminal Coronary Angioplasty
PTCA (Maverick XL) dilatation catheter is a Monorail catheter with a
balloon near the distal tip. The distal catheter segment is dual
lumen and coaxial, characteristic of all monorail style catheters. The
balloon is located at the distal end of the catheter and is designed
to provide an inflatable segment of known diameter and length at
recommended pressures. |
|---------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use/
Indications for Use | The Maverick XL balloon catheter is indicated for balloon dilatation
of the stenotic portion of a coronary artery or bypass graft for the
purpose of improving myocardial perfusion. The Maverick XL
balloon catheter is also indicated for the post delivery expansion of
balloon expandable stents. |
| Comparison of
Required
Technological
Characteristics | The proposed Maverick XL is substantially equivalent to the existing
Maverick XL approved under premarket approval P860019, which
have since been down-classified by FDA on 08Oct2010. Maverick
XL has the same intended use, scientific technology, design (with
the exception of the corewire design), materials, sterilization
method, and packaging materials as the applicable predicate
device. |
| Summary of Non-
Clinical Test
Summary | Bench testing and first article testing were performed to support a
determination of substantial equivalence. The results of these tests
provide reasonable assurance that the proposed device with the
modified corewire 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. |
| Conclusion | Based on the indications for use, technological characteristics, and
safety and performance testing, the proposed Maverick XL with the
modified corewire has been shown to be appropriate for its
intended use and is considered to be substantially equivalent to its
predicate (P860019). |