(114 days)
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.
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.
This document is a 510(k) summary for the Boston Scientific Mustang™ Balloon Dilatation Catheter, a medical device intended for the dilatation of strictures in the biliary system. It is a premarket notification for a Class II device, seeking to demonstrate substantial equivalence to a predicate device.
Here's an analysis of the provided information, focusing on acceptance criteria and the study that proves the device meets those criteria:
1. Table of Acceptance Criteria and the Reported Device Performance:
The document does not explicitly present a table of quantitative acceptance criteria with corresponding performance values for the Mustang™ Balloon Dilatation Catheter. Instead, it describes various tests performed and states that "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."
However, we can infer the types of acceptance criteria indirectly from the tests conducted. The underlying acceptance criterion for all these tests is that the device performs equivalently or better than the predicate device without raising new safety concerns, and meets relevant standards for medical devices of its type.
| Acceptance Criteria Category (Inferred) | Reported Device Performance (Summary) |
|---|---|
| Biocompatibility | All listed biocompatibility tests (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) were completed. The implicit acceptance criterion is that the device materials are biocompatible and do not pose unacceptable biological risks. The reported performance is that these tests support a determination of substantial equivalence, implying the device met the expected biocompatibility profiles. |
| Mechanical Performance (In-vitro) | All listed in-vitro performance tests (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) were completed. The implicit acceptance criterion is that the device's physical and mechanical properties meet specified design requirements and perform comparably to the predicate device. The reported performance is that these tests support a determination of substantial equivalence, implying the device met the expected mechanical performance characteristics. |
| Substantial Equivalence to Predicate Device | The Mustang™ Balloon Dilatation Catheter demonstrated substantially equivalent device materials and design, packaging materials and design, fundamental technology, manufacturing processes, sterilization process, and intended use as the Boston Scientific SC 35 Balloon Dilatation Catheter (K993303). This is the overarching acceptance criterion for a 510(k) submission. |
| Safety and Performance Issues | No new safety or performance issues were raised during the testing. |
2. Sample Size Used for the Test Set and the Data Provenance:
The document describes "bench testing" and "biocompatibility testing." These are laboratory-based studies, not clinical studies involving human patients. Therefore, the concept of a "test set" in the context of clinical data (like patient cases) is not directly applicable here.
- Sample Size: The specific number of devices or material samples used for each bench test or biocompatibility test is not disclosed in this summary.
- Data Provenance: The data provenance is laboratory testing ("bench testing and biocompatibility testing"). Given that Boston Scientific Corporation is based in Maple Grove, MN, USA, it's highly probable that these tests were conducted in the USA, likely at internal Boston Scientific labs or by contracted testing facilities. These are prospective tests performed specifically to support this submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:
Since this submission relies on bench and biocompatibility testing, there is no "test set" of clinical cases that would require expert adjudication for ground truth. The "ground truth" for these tests are the established scientific and engineering principles, material specifications, and validated test methods. The "experts" involved would be the engineers, scientists, and technicians who designed, conducted, and analyzed these tests, following recognized standards (e.g., ISO for biocompatibility). Their qualifications would be in engineering, materials science, toxicology, and other relevant scientific disciplines, but specific numbers and qualifications are not stated in this summary.
4. Adjudication Method for the Test Set:
Not applicable, as there is no clinical test set requiring expert adjudication.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done:
No, an MRMC comparative effectiveness study was not done. This 510(k) submission primarily relies on non-clinical (bench and biocompatibility) data to demonstrate substantial equivalence for a medical device. MRMC studies are typically performed for diagnostic devices where human readers interpret medical images, often with and without AI assistance, to assess performance improvement.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is a physical medical instrument (a balloon dilatation catheter), not an algorithm or AI system. Therefore, the concept of "standalone algorithm performance" does not apply.
7. The type of ground truth used:
- For biocompatibility tests: The ground truth is based on established biological safety standards and validated test methodologies (e.g., ISO 10993 series). The "truth" is whether the materials elicit specific biological responses per the standard.
- For in-vitro performance tests: The ground truth is based on engineering specifications, design requirements, and validated test methods (e.g., measuring dimensions, burst pressures, fatigue cycles against predefined limits). The "truth" is whether the device meets those quantifiable engineering parameters.
8. The sample size for the training set:
Not applicable. This device is a physical medical instrument, not an AI/ML algorithm that requires a "training set" of data.
9. How the ground truth for the training set was established:
Not applicable. As above, there is no training set for this type of device.
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K 110122
pg 1 of 2
MAY 1 2 2011
510(k) Summary
per 21 CFR §807.92
| Submitter'sName andAddress | Boston Scientific CorporationOne Scimed PlaceMaple Grove, MN 55311 | |
|---|---|---|
| Contact Nameand Information | Anne V. RossiManager, Regulatory AffairsPhone: 763-255-0681Fax: 763-494-2222e-mail: rossia@bsci.com | |
| Date Prepared | 14 January 2011 | |
| ProprietaryName | Mustang™ Balloon Dilatation Catheter | |
| Common Name | Balloon Dilatation Catheter | |
| Product Code | FGE | |
| Classification | Class II, 21 CFR Part 876.5010 | |
| PredicateDevice | SC 35 Balloon Dilatation CatheterK993303 23 March 2000 | |
| DeviceDescription | The Boston Scientific Mustang™ Balloon Dilatation Catheter is an over-the-wire balloon catheter with a dual lumen shaft design. One lumen is used topass the catheter over 0.035" guidewires. The second lumen communicateswith the balloon and is used to inflate and deflate the balloon during theprocedure. The guidewire lumen and the balloon lumen terminate at theproximal end of the catheter in a Y-connector manifold with luer lock fittings.There are radiopaque marker bands located under the balloon to aid inpositioning the system during the procedure. A silicone coating is applied tothe balloon to enhance insertion and withdrawal performance.The Mustang™ Balloon Dilatation Catheter will be available with balloondiameters 3.0 mm to 12.0 mm, balloon lengths 2 cm to 12 cm and with shaftlengths of 40 cm, 75 cm, and 135 cm. | |
| Intended Use ofDevice | The Mustang™ Balloon Dilatation Catheters are intended for dilatation ofstrictures in the biliary system. | |
| Indications forUse | The Mustang Balloon Dilatation Catheters with balloons up to 120 mm inlength are indicated for the treatment of biliary strictures. | |
| Comparison ofTechnologicalCharacteristics | The Mustang™ Balloon Dilatation Catheter incorporates substantiallyequivalent device materials and design, packaging materials and design,fundamental technology, manufacturing processes, sterilization process andintended use as those featured in the Boston Scientific predicate device, SC35 Balloon Dilatation Catheter (K993303). | |
| PerformanceData | Bench testing and biocompatibility testing were performed to support adetermination of substantial equivalence. The results of these tests providereasonable assurance that the proposed device has been designed andtested to assure conformance to the requirements for its intended use. Nonew safety or performance issues were raised during the testing. | |
| The following biocompatibility tests were completed on the Mustang™ BalloonDilatation 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 WithdrawalForce | Balloon Rated Burst Pressure inStent | |
| 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 andperformance testing, the Mustang™ Balloon Dilatation Catheter has beenshown to be appropriate for its intended use and is considered to besubstantially equivalent to the Boston Scientific SC 35 Balloon DilatationCatheter (K993303) |
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K110/22
pg 2 of 2
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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
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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
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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
Page I of I
§ 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.