(70 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and function of a balloon catheter, with no mention of AI or ML capabilities.
Yes
The device is used for the treatment of biliary strictures, which indicates a therapeutic purpose.
No
The device is indicated for the "treatment of biliary strictures" and its description details its function in inflating and deflating a balloon to dilate strictures, which is a therapeutic intervention, not a diagnostic one.
No
The device description clearly outlines a physical catheter with lumens, a balloon, a Y-connector manifold, luer lock fittings, radiopaque marker bands, and a silicone coating. This is a hardware device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "treatment of biliary strictures." This is a therapeutic procedure performed directly on the patient's body.
- Device Description: The description details a physical catheter with a balloon designed for mechanical dilation within the biliary system. This is an interventional device.
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. This device does not involve testing samples outside the body.
The information provided clearly describes a medical device used for a therapeutic intervention, not a diagnostic test performed in vitro.
N/A
Intended Use / Indications for Use
The Mustang ™ Balloon Dilatation Catheters with balloons up to 120mm in length are indicated for the treatment of biliary strictures.
Product codes (comma separated list FDA assigned to the subject device)
FGE
Device Description
Mustang Balloon Dilatation Catheters are over-the-wire balloon catheters with a dual lumen shaft design. One lumen is used to pass the catheter over 0.035" guidewires. The second lumen communicates with the balloon and is used to inflate and deflate the balloon during the procedure. The guidewire lumen and the balloon lumen terminate at the proximal end of the catheter in a Y-connector manifold with luer lock fittings. There are radiopaque marker bands located under the balloon to aid in positioning the system during the procedure. A silicone coating is applied to the balloon to enhance insertion and withdrawal performance.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Biliary strictures
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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 testing and therefore, these devices may be considered substantially equivalent to the predicate devices.
The following in-vitro performance tests were completed on the Mustang Balloon Dilatation Catheter:
- Balloon Compliance
- Balloon Nominal Diameter
- Balloon Crossing Profile
- Sheath Insertion and Withdrawal Force
- Balloon Rated Burst Pressure
- Balloon Burst Mode
- Balloon Protector (Wingtool removal Force)
- Balloon Multiple Inflation
- Proximal Bond Tensile
- Balloon Multiple Inflation in a Stent
- Initial Sheath insertion Force
- Sheath Withdrawal
- Crossing Profile
- Burst in a stent
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.
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.
Not Found
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
§ 876.5010 Biliary catheter and accessories.
(a)
Identification. A biliary catheter and accessories is a tubular flexible device used for temporary or prolonged drainage of the biliary tract, for splinting of the bile duct during healing, or for preventing stricture of the bile duct. This generic type of device may include a bile collecting bag that is attached to the biliary catheter by a connector and fastened to the patient with a strap.(b)
Classification. Class II (special controls). The device, when it is a bile collecting bag or a surgical biliary catheter that does not include a balloon component, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.
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 circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure in profile, with three overlapping faces.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 22, 2014
Boston Scientific Corporation Melanie Raska Director, Regulatory Affairs One Scimed Place Maple Grove, MN 55311-1566
Re: K141597
Trade/Device Name: Mustang™ Balloon Dilation Catheter Regulation Number: 21 CFR§ 876.5010 Regulation Name: Biliary catheter and accessories Regulatory Class: II Product Code: FGE Dated: August 5, 2014 Received: August 6, 2014
Dear Melanie Raska,
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.
1
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/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Benjamin R. Fisher -S
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use Statement
510(k) Number K141597 (if known) Device Name Mustang ™ PTA Balloon Dilatation Catheters Indications for The Mustang ™ Balloon Dilatation Catheters with balloons up to 120mm in Use length are indicated for the treatment of biliary strictures.
Prescription Use X (Per 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (Per 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)
Boston Scientific Corporation
Page 1
3
510k Summary
Per 21 CFR §807.92
| Submitter's
Name and
Address | Boston Scientific Corporation
One Scimed Place
Maple Grove, MN 55311 | | |
|------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------|--|
| Contact Name
and Information | Elaine Ruddle
Specialist, Regulatory Affairs
Phone: +353 91 517936
Fax: 763-494-2222
e-mail: ruddlee@bsci.com
Or
Melanie Raska
Director, Regulatory Affairs
Phone :763-494 -2212
Fax: 763-494-2222
e-mail: raskam@bsci.com | | |
| Date Prepared | June 12, 2014 | | |
| Proprietary
Name | MustangTM Balloon Dilatation Catheter | | |
| Common Name | Percutaneous Transluminal Angioplasty Dilatation Catheter | | |
| Product Code | FGE - Catheter, Biliary, Diagnostic | | |
| Classification | Class II, 21 CFR Part 876.5010 | | |
| Predicate
Device(s) | MustangTM Balloon Dilatation
Catheter
K110122
Gladiator Elite TM Balloon Dilatation
Catheter
K132810 | 12 May 2011
28 February 2014 | |
| Device
Description | Mustang Balloon Dilatation Catheters are over-the-wire balloon catheters with
a dual lumen shaft design. One lumen is used to pass the catheter over
0.035" guidewires. The second lumen communicates with the balloon and is
used to inflate and deflate the balloon during the procedure. The guidewire
lumen and the balloon lumen terminate at the proximal end of the catheter in a
Y-connector manifold with luer lock fittings. There are radiopaque marker
bands located under the balloon to aid in positioning the system during the
procedure. A silicone coating is applied to the balloon to enhance insertion
and withdrawal performance. | | |
| Intended Use of
Device | The Mustang TM Balloon Dilatation Catheter with balloons up to 120mm in
length are indicated for the treatment of biliary strictures. | | |
| Indications for
Use | The Mustang TM Balloon Dilatation Catheter with balloons up to 120mm in
length are indicated for the treatment of biliary strictures. | | |
Boston Scientific Corporation
Premarket Notification – Special 510(k) Mustang Balloon Dilatation Catheter Attachment 2: 510k Summary
Page 1
4
Comparison of Technological Characteristics
The Mustang Balloon Dilatation Catheter incorporates substantially equivalent device materials , design, catheter configuration, packaging fundamental technology, manufacturing processes, sterilization process and intended use as those featured in the Boston Scientific predicate devices.
| Characteristic | Proposed compared to Predicates | ||
|---|---|---|---|
| Components | Same components, configuration, design and | ||
| function | |||
| Materials | Same materials. Balloon contains an additional | ||
| material not new to the device | |||
| Packaging | Same packaging materials and configuration | ||
| Sterilization Method /SAL | Same method and level of assurance | ||
| Guidewire compatibility | Same compatibility | ||
| Balloon Diameters and | |||
| Lengths | Same sizes | ||
| Effective length | Same length catheters | ||
| Rated Burst Pressure (RBP) | Same RBP | ||
| Performance | |||
| Data | 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 testing and therefore, these devices may be considered | |||
| substantially equivalent to the predicate devices. | |||
| The following in-vitro performance tests were completed on the Mustang | |||
| Balloon Dilatation Catheter: | |||
| Balloon Compliance | Balloon Multiple Inflation | ||
| Balloon Nominal Diameter | Proximal Bond Tensile | ||
| Balloon Crossing Profile | Balloon Multiple Inflation in a Stent | ||
| Sheath Insertion and Withdrawal | |||
| Force | Initial Sheath insertion Force | ||
| Balloon Rated Burst Pressure | Sheath Withdrawal | ||
| Balloon Burst Mode | Crossing Profile | ||
| Balloon Protector (Wingtool removal | |||
| Force ) | Burst in a stent | ||
| Conclusion | Gladiator Elite Balloon Dilatation Catheter. | Based on the indications for use, technological characteristics, and safety and | |
| performance testing, the Mustang Balloon Dilatation Catheter has been shown | |||
| to be appropriate for its intended use and is considered to be substantially | |||
| equivalent to the Boston Scientific Mustang Balloon Dilatation Catheter and |
Comparison to predicate Devices :
Boston Scientific Corporation