(114 days)
No
The description focuses on the mechanical aspects of a balloon catheter and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is intended for the "dilatation of strictures in the biliary system" and "treatment of biliary strictures", which indicates a therapeutic purpose.
No
The device is a balloon dilatation catheter intended for the treatment (dilatation) of strictures in the biliary system, not for diagnosis.
No
The device description clearly details a physical balloon catheter with lumens, a shaft, a Y-connector manifold, luer lock fittings, radiopaque marker bands, and a silicone coating. These are all hardware components, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Description and Intended Use: The description clearly states that the Mustang™ Balloon Dilatation Catheter is used for "dilatation of strictures in the biliary system." This is a procedure performed inside the body (in vivo) to physically open up narrowed passages.
- Lack of Specimen Analysis: The device does not involve the collection or analysis of any biological specimens.
Therefore, based on the provided information, the Mustang™ Balloon Dilatation Catheter is a therapeutic medical device used for an interventional procedure, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Mustang™ Balloon Dilatation Catheters are intended for dilatation of strictures in the biliary system.
The Mustang Balloon Dilatation Catheters with balloons up to 120 mm in length are indicated for the treatment of biliary strictures.
Product codes
FGE
Device Description
The Boston Scientific Mustang™ Balloon Dilatation Catheter is an over-the-wire balloon catheter 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. The Mustang™ Balloon Dilatation Catheter will be available with balloon diameters 3.0 mm to 12.0 mm, balloon lengths 2 cm to 12 cm and with shaft lengths of 40 cm, 75 cm, and 135 cm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
biliary system, biliary strictures
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 and biocompatibility testing were 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.
The following biocompatibility tests were completed on the Mustang™ Balloon Dilatation Catheter: Cytotoxicity, Sensitization, Intracutaneous Reactivity, Acute Systemic Toxicity, Materials Mediated Pyrogenicity, USP Physicochemical, Latex, Direct Contact Hemolysis, Complement Activation, Partial Thromboplastin Time, In Vitro Hemocompatibility, Ames Mutagenicity, Mouse Lymphoma Assays.
The following in-vitro performance tests were completed of the Mustang™ Balloon Dilatation Catheter: Effective Length, Shaft Outer Diameter, Balloon Crossing Profile, Sheath Insertion and Withdrawal Force, Balloon Rated Burst Pressure, Balloon Fatigue, Balloon Compliance & Distension, Coating Integrity, Balloon Inflation/Deflation Time, Device Tensile, Shaft Kink Resistance, Balloon Rated Burst Pressure in Stent, Torque Strength, Balloon Fatigue in Stent, Radiopacity, Particulate Evaluation.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
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K 110122
pg 1 of 2
MAY 1 2 2011
510(k) 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 | Anne V. Rossi
Manager, Regulatory Affairs
Phone: 763-255-0681
Fax: 763-494-2222
e-mail: rossia@bsci.com | |
| Date Prepared | 14 January 2011 | |
| Proprietary
Name | Mustang™ Balloon Dilatation Catheter | |
| Common Name | Balloon Dilatation Catheter | |
| Product Code | FGE | |
| Classification | Class II, 21 CFR Part 876.5010 | |
| Predicate
Device | SC 35 Balloon Dilatation Catheter
K993303 23 March 2000 | |
| Device
Description | The Boston Scientific Mustang™ Balloon Dilatation Catheter is an over-the-
wire balloon catheter 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.
The Mustang™ Balloon Dilatation Catheter will be available with balloon
diameters 3.0 mm to 12.0 mm, balloon lengths 2 cm to 12 cm and with shaft
lengths of 40 cm, 75 cm, and 135 cm. | |
| Intended Use of
Device | The Mustang™ Balloon Dilatation Catheters are intended for dilatation of
strictures in the biliary system. | |
| Indications for
Use | The Mustang Balloon Dilatation Catheters with balloons up to 120 mm in
length are indicated for the treatment of biliary strictures. | |
| Comparison of
Technological
Characteristics | The Mustang™ Balloon Dilatation Catheter incorporates substantially
equivalent device materials and design, packaging materials and design,
fundamental technology, manufacturing processes, sterilization process and
intended use as those featured in the Boston Scientific predicate device, SC
35 Balloon Dilatation Catheter (K993303). | |
| Performance
Data | Bench testing and biocompatibility testing were 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. | |
| | The following biocompatibility tests were completed on the Mustang™ Balloon
Dilatation Catheter: | |
| | Cytotoxicity | Direct Contact Hemolysis |
| | Sensitization | Complement Activation |
| | Intracutaneous Reactivity | Partial Thromboplastin Time |
| | Acute Systemic Toxicity | In Vitro Hemocompatibility |
| | Materials Mediated Pyrogenicity | Ames Mutagenicity |
| | USP Physicochemical | Mouse Lymphoma Assays |
| | Latex | |
| | The following in-vitro performance tests were completed of the Mustang™
Balloon Dilatation Catheter: | |
| | Effective Length | Balloon Inflation/ Deflation Time |
| | Shaft Outer Diameter | Device Tensile |
| | Balloon Crossing Profile | Shaft Kink Resistance |
| | Sheath Insertion and Withdrawal
Force | Balloon Rated Burst Pressure in
Stent |
| | Balloon Rated Burst Pressure | Torque Strength |
| | Balloon Fatigue | Balloon Fatigue in Stent |
| | Balloon Compliance & Distension | Radiopacity |
| | Coating Integrity | Particulate Evaluation |
| Conclusion | 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 SC 35 Balloon Dilatation
Catheter (K993303) | |
1
K110/22
pg 2 of 2
2
Image /page/2/Picture/11 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus. The logo is simple and monochromatic, with a focus on conveying the department's mission and identity.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-Gt Silver Spring, MD 20993-0002
MAY 1 2 2011
Mr. James M. Taufen Regulatory Affairs Manager Boston Scientific Corporation One Scimed Place MAPLE GROVE MN 55311-1566
Re: K110122
Trade/Device Name: Mustang™ Balloon Dilatation Catheter Regulation Number: 21 CFR 876.5010 Regulation Name: Biliary catheter and accessories Regulatory Class: II Product Code: FGE Dated: May 5, 2011 Received: May 6, 2011
Dear Mr. Taufen:
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 indivitions 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, its inc. Act. devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liablity warranties. We remind you, however, that device labeling must be truthful and 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 theart 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
3
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.html 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 Production 807.97). For questions regarding the reporting of adverse events under the MDR regulting (1 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 nomber (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
http://www.fda.gov/MedicalDevices/ResourceforYou/Industry/default.htm.
Sincerely yours.
Stuker Lemur, MD
Herbert P. Lerner, M.D., Director (Acting) Division of Reproductive, Gastro-Renal and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement
510(k) Number (if known): KII0122
Device Name Mustang™ Balloon Dilatation Catheter
Indications for Use
The Mustang Balloon Dilatation Catheters with balloons up to 120 mm in length are indicated for the treatment of biliary strictures.
Prescription Use (Per 21 CFR 801 Subpart D)
OR
Over-The-Counter Use (21 CRF 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
oductive, Gastro-Renal, and
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