The Mustang™ Balloon Dilatation Catheter is indicated for percutaneous transluminal angioplasty (PTA) in the peripheral vasculature including iliac, femoral, popliteal, tibial, peroneal, subclavian, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This catheter is not for use in coronary arteries.

The Mustang™ Balloon Dilatation Catheter is also indicated for post-dilatation of balloon expandable and self-expanding stents in the peripheral vasculature.

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 20 cm and with shaft lengths of 40 cm, 75 cm, and 135 cm.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Mustang™ Balloon Dilatation Catheter. It focuses on demonstrating substantial equivalence to predicate devices through comparisons of technological characteristics and performance data from bench and biocompatibility testing. The submission does not include a study involving human subjects or AI.

Here's an analysis based on your requested information:

1. A table of acceptance criteria and the reported device performance

The submission does not explicitly state "acceptance criteria" in a quantitative manner as would be typical for a clinical study with specific endpoints. Instead, it relies on demonstrating that the device meets safety and performance requirements through various tests and by comparing its characteristics to predicate devices. The "reported device performance" is essentially that the device passed all these tests.

Test Category	Specific Tests Performed	Reported Performance / Acceptance Criteria (Implied)
Biocompatibility	Cytotoxicity, Sensitization, Intracutaneous Reactivity, Acute Systemic Toxicity, Materials Mediated Pyrogenicity, Latex, Direct Contact Hemolysis, Complement Activation, Partial Thromboplastin Time, In Vitro Hemocompatibility, Ames Mutagenicity, Mouse Lymphoma Assays, USP Physicochemical	The submission states: "The following biocompatibility tests were completed on the Mustang™ Balloon Dilatation Catheter... No new safety or performance issues were raised during the testing." This implies that the device met the established safety standards for biocompatibility according to the methods used (e.g., ISO 10993 standards, although not explicitly stated). Specific numerical pass/fail criteria are not detailed in this summary.
In-vitro Performance	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	The submission states: "The following in-vitro performance tests were completed of the Mustang™ Balloon Dilatation Catheter... 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." This implies the device passed these functional and mechanical tests. For example, for "Rated Burst Pressure (RBP)", it notes: "tested to meet rated pressures with 95% confidence on 99.9% population." This indicates a specific statistical criterion was met for RBP, but exact numerical values for other tests are not provided in this summary. The implicit acceptance criteria are that the device performs equivalently or better than predicate devices in these aspects.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size: Not explicitly stated for each test. For "Rated Burst Pressure (RBP)", it mentions "95% confidence on 99.9% population," which is a statistical threshold rather than a raw sample size. For other tests, sample sizes are not provided in this summary.
Data Provenance: The tests are described as "Bench testing" and "biocompatibility testing." This indicates the data is from laboratory settings (in-vitro), not from human or animal studies. The country of origin of the testing is not specified, but the submitter is Boston Scientific Corporation in Maple Grove, MN, USA.
Retrospective or Prospective: These are laboratory tests, not clinical studies, so the terms retrospective or prospective do not directly apply.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This section is not applicable. The submission describes testing of a physical medical device (balloon catheter) in a laboratory setting, not an AI or diagnostic imaging device that requires expert interpretation to establish ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This section is not applicable for the same reasons as #3.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

There was no MRMC study done as this submission is for a physical medical device (balloon catheter), not an AI or diagnostic imaging device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This section is not applicable as the submission is for a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

This section is not applicable in the context of an AI device requiring ground truth. For the physical device, the "ground truth" is defined by established engineering and material science standards, specifications, and performance criteria that the device must meet (e.g., maximum burst pressure, tensile strength, biocompatibility standards).

8. The sample size for the training set

This section is not applicable as there is no AI algorithm being trained.

9. How the ground truth for the training set was established

This section is not applicable as there is no AI algorithm being trained.

Summary

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K10375/

510(k) Summary per 21 CFR §807.92

MAR 2 2 2011

Submitter's Name and Address	Boston Scientific CorporationOne Scimed PlaceMaple Grove, MN 55311
Contact Name and Information	Anne V. RossiManager, Regulatory AffairsPhone: 763-255-0681Fax: 763-494-2222e-mail: rossia@bsci.com
Date Prepared	22 December 2010
Proprietary Name	Mustang™ Balloon Dilatation Catheter
Common Name	PTA Balloon Dilatation Catheter
Product Code	LIT, DQY
Classification	Class II, 21 CFR Part 870.1250
Predicate Devices	SC 35 Balloon Dilatation CatheterBard Dorado™ PTA Balloon Dilatation Catheter	K993305 K072283	10 April 200019 September 2007
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 20 cm and with shaft lengths of 40 cm, 75 cm, and 135 cm.
Intended Use of Device	The Mustang™ Balloon Dilatation Catheter is intended for dilatation of stenosis in the peripheral vascular, for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae and post-deployed stent expansion of self-expanding and balloon expandable peripheral vascular stents.
Indications for Use	The Mustang™ Balloon Dilatation Catheter is indicated for Percutaneous Transluminal Angioplasty (PTA) in the peripheral vasculature including iliac, femoral, popliteal, tibial, peroneal, subclavian, and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This catheter is not for use in coronary arteries.The Mustang™ Balloon Dilatation Catheter is also indicated for post-dilatation of balloon expandable and self-expanding stents in the peripheral vasculature.

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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 (K993305). Mustang™ Balloon Dilatation Catheter incorporates similar design parameters and the same intended use as the Bard Dorado™ PTA Balloon Dilatation Catheter (K072283).

Mustang Characteristic	Synergy	Dorado
Manifold	Same material and design with minor dimensionaldifferences but serving same function.	Unknown
Pinch-Off Tube	Same material, component and function.	Unknown
Strain Relief	Similar designs with same material serving samefunction.	Unknown
Proximal Dual Lumen Shaft	Same material and design serving same function.	Unknown
Distal Guidewire Lumen Shaft	Same design with minor difference in material butserving same function.	Unknown
Bumper Tip	Difference in design. Bumper tip is used inconjunction with the guidewire lumen to provide fora less stiff tip.	Unknown
Balloon	Difference in balloon material and design butserving same function and fundamental technology.The co-extruded design allows for the device toachieve high burst pressures.	Unknown
Balloon Bonding Method	Difference in bonding method but serving samefunction.	Unknown
Marker Bands	Same component serving same function.	Unknown
Coating	Different coating but serving same function.Silicone based coatings have history of use withBSC cleared PTA products.	Unknown
Balloon Protector	Same material and similar design both servingsame function.	Unknown
Sterilization Method	Same method.	Unknown
SAL	Same level of assurance.	Unknown
Packaging	Similar design with the exception of the tray.	Unknown

Comparison to Predicate Devices in Materials and Manufacturing

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Comparison of Technological Characteristics (Continued)

Comparison to Predicate Devices (Synergy and Dorado) Characteristics

Characteristic	Synergy	Dorado
Nominal Balloon Diameters	Same range serving same function.	Same range
Balloon Lengths	Similar range serving same function	Same range
Rated Burst Pressure (RBP)	Different balloon construction. Ratedlower than Mustang, however, tested tomeet rated pressures with 95% confidenceon 99.9% population.	Same high pressure ratedballoon
Effective Lengths	Similar ranges serving same function.	Same ranges
Recommended IntroducerSheath Compatibility	Similar ranges and compatibilities	Same ranges andcompatibilities
Recommended Guidewire	Same compatibility.	Same compatibility

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 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

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Based on the indications for use, technological characteristics, and safety and Conclusion 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 (K993305) and the Bard Dorado™ PTA Balloon Dilatation Catheter (K072283).

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three overlapping wings, representing service to the nation. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room-WO66-G609 Silver Spring, MD 20993-0002

Boston Scientific Corporation C/O Anne V. Rossi Manager, Regulatory Affairs One Scimed Place Maple Grove, MN 55311

MAR 2 2 2011

Re: K103751

Trade/Device Name: Mustang™ Balloon Dilatation Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: LIT, DQY Dated: December 22, 2010 Received: December 23, 2010

Dear Ms. Anne Rossi:

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

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Page 2 - Ms. Anne Rossi

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.html fau 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/Resourcesfor You/Industry/default.htm.

Sincerely vours.

Dvina R. Vahner

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): Kじらみら

Device Name: Mustang™ Balloon Dilatation Catheter

Indications For Use:

The Mustang™ Balloon Dilatation Catheter is also indicated for post-dilatation of balloon expandable and self-expanding stents in the peripheral vasculature.

Prescription Use	✓
(Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (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)

uma R. Vocher

(Division Sign-Off) (Division Sign-Oll)
Division of Cardiovascular Devices

510(k) Number_

×10375

Page 1 of 1

Regulation Number and Section

§ 870.1250 Percutaneous catheter.

(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).