The Charger 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.
The Charger 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 Charger™ Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter is an over-the-wire (OTW) balloon catheter with a dual lumen shaft design. One lumen marked "WIRE" is used to pass the catheter over 0.035" (0.89mm) guidewires. The second lumen marked "BALLOON" 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 two radiopaque marker bands located under -the balloon shoulders to aid in positioning the system during the procedure. A coating is applied to the balloon to enhance insertion and withdrawal performance. The tip of the catheter is gradually tapered to facilitate advancement of the catheter through the stenosis.
The Charger™ Balloon Dilatation Catheter will be available with balloon diameters 3.0 mm to 12.0 mm, balloon lengths 20 mm to 200 mm and with shaft lengths of 40 cm, 75 cm, and 135 cm.

AI/ML Overview

This document is a 510(k) summary for the Boston Scientific Charger™ PTA Balloon Dilatation Catheter. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with acceptance criteria for a new performance claim. Therefore, much of the requested information regarding acceptance criteria and a study proving those criteria are met is not directly applicable or available in this submission.

Here's a breakdown of the available information:

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

The document does not explicitly state "acceptance criteria" in the traditional sense of a clinical or algorithm performance study with specific thresholds (e.g., sensitivity, specificity, AUC). Instead, it relies on demonstrating substantial equivalence to a predicate device (Mustang™ Balloon Dilatation Catheters, K103751) through comparison of technological characteristics and performance data. The "acceptance criteria" here are implicitly that the new device performs equivalently or comparably to the predicate device in various engineering and biological tests, without raising new safety or performance issues.

The reported device performance for the Charger PTA Balloon Dilatation Catheter is that it "has been designed and tested to assure conformance to the requirements for its intended use" and that "No new safety or performance issues were raised during the testing." This implies the Charger device met the same or similar performance standards as the predicate.

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

The document primarily describes bench testing and biocompatibility testing.

Test Set Sample Size: Not explicitly stated for each test, but standard engineering and biological testing typically involve specific sample sizes per test article/batch. These are generally much smaller than clinical study sample sizes.
Data Provenance: The tests are described as "Biocompatibility testing and bench testing were performed," implying these were conducted by Boston Scientific Corporation (USA, where the submitter is located) within a controlled laboratory setting. This would be considered prospective testing for the purpose of this submission.
The comparison data for the predicate device (Mustang™) is inherent in its marketing clearance (K103751).

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 is not applicable to this type of submission. The ground truth for bench testing (e.g., tensile strength, burst pressure) and biocompatibility testing (e.g., cytotoxicity, pyrogenicity) is established by adherence to recognized international standards (e.g., ISO, ASTM, USP) and laboratory protocols, rather than expert clinical consensus.

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

Not applicable. Adjudication methods like 2+1 or 3+1 refer to agreement among multiple human readers for diagnostic interpretation, which is not part of this device's performance evaluation for 510(k) clearance based on substantial equivalence. Performance is measured against engineering specifications and biological safety standards.

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

Not applicable. This device is a Balloon Dilatation Catheter, a physical medical device, not an AI software or diagnostic imaging tool. Therefore, MRMC studies and the concept of human readers improving with/without AI assistance are irrelevant.

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

Not applicable. See point 5. This is a physical medical device, not an algorithm.

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

The "ground truth" for the performance evaluation in this 510(k) is based on:

Engineering Specifications: Adherence to defined physical and mechanical properties (e.g., bond tensile strength, burst pressure, dimensions).
Biological Safety Standards: Conformance to established limits for biocompatibility (e.g., non-cytotoxic, non-sensitizing, non-pyrogenic).
Predicate Device Performance: The established safety and effectiveness of the legally marketed predicate device (Mustang™) set the de facto standard for substantial equivalence.

8. The sample size for the training set

Not applicable. This is a physical medical device, not a machine learning algorithm that requires a training set.

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

Not applicable. See point 8.

Summary

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510(k) Summarv

Submitter: Boston Scientific Corporation One Scimed Place Maple Grove. MN 55311 Contact Person: Glenn Jacques Phone Number: 763-494-1152 Fax Number: 763-494-2222 Date Prepared: September 15, 2011 Device Trade Name: Charger PTA Balloon Dilatation Catheters Common Name: Percutaneous Transluminal Angioplasty Dilatation Catheter Device Classification: Class II 21 CFR 870.1250 Product Code: LIT, DQY

NOV 3 0 2011

Predicate Devices

Mustang PTA Balloon Dilatation Catheters

Device Description

The Charger™ Balloon Dilatation Catheter will be available with balloon diameters 3.0 mm to 12.0 mm, balloon lengths 20 mm to 200 mm and with shaft lengths of 40 cm, 75 cm, and 135 cm.

Indications for Use

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

Substantial Equivalence

The Charger PTA Balloon Dilatation Catheters design, materials, manufacturing process and intended use are substantially equivalent to the predicate device Mustang™ Balloon Dilatation Catheters (K103751).

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Comparison of Technological Characteristics

The Charger PTA Balloon Dilatation Catheter incorporates substantially equivalent device materials and design, packaging materials and design, fundamental technology, manufacturing processes, sterilization processes and intended use as those featured in the Boston Scientific predicate device Mustang™ Balloon Dilatation Catheters (K103751).

Comparison to Predicate Devices in Materials and Manufacturing 1 - RETUREA 22 - 1 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 -

Characteristics	Mustang predicate
Manifold	Same material. Differentcolorant. Same designserving same function
Strain Relief	Same material. Samedesign serving samefunction
Catheter Proximal Shaft /Distal Outer	Same material. Differentcolorant/additive. Samedesign serving samefunction
Catheter Inner Shaft	Same material, differentcolorant/additive andserving same function
Bumper Tip	Same material. Differentcolorant. Same designserving same function
Balloon	Same balloon materialand design and servingsame function andfundamental technology
Balloon Bonding Method	Same bonding methodand function
Balloon FormingProcess	Same forming methodand function
Marker Bands	Same component servingsame function
Coating	Same coating servingsame function
Balloon Protector	Same material andsimilar design bothserving same function.
Proximal Shaft OuterDiameter	Same shaft outerdiameters

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Comparison to Predicate Devices Characteristics
Characteristic	Mustang predicate
Balloon Diameters	Same balloon diameter range serving same function
Balloon Lengths	Same balloon length ranges serving same function
Rated Burst Pressure(RBP)	Similar rated burst pressure
Catheter Length	Same catheter length ranges serving same function
RecommendedIntroducer SheathCompatibility	Similar ranges and compatibilities
RecommendedGuidewire	Same compatibility.
Sterilization Method	Same method.
SAL	Same level of assurance
Packaging Materialand Configuration	Same design and function

Performance Data

Biocompatibility testing and bench 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 Charger PTA Balloon Dilatation Catheter:

MEM Elution / Cytotoxicity Guinea Pig Maximization Sensitization Intracutaneous Reactivity Acute Systemic Toxicity Materials Mediated Rabbit Pyrogen Hemolysis Direct Contact and Extract Complement Activation
Partial Thromboplastin Time In Vitro Hemocompatibility Bacterial Mutagenicity (Ames Assay) Mouse Lymphoma Assay USP Physiochemical Latex

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The following in-vitro performance tests were completed for the Charger PTA Balloon Dilatation Catheter as part of a Special 510k:

Bond Tensile

Conclusion

Based on the indications for use, technological characteristics, safety and performance testing, the Charger 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 Catheters (K103751).

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Public Health Service

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

NOV 3 0 2011

Boston Scientific Corporation c/o Glenn Jacques One Scimed Place Maple Grove, MN 55311

Re: K112697

Trade/Device Name: Charger™ PTA Balloon Dilatation Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: Class II Product Code: LIT, DQY Dated: October 28, 2011 Received: October 31, 2011

Dear Mr. Jacques:

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 of ections of ecass In (FWA).
Found in the Golon SE also CE also 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.

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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 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/Resourcesfor You/Industry/default.htm.

Enclosure

Sincerely vours.

M. A. Hillehouse

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

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Indications for Use Statement
-------------------------------

510(k) Number (if known)	K112697
Device Name	Charger™ PTA Balloon Dilatation Catheters
Indications for Use	The Charger 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.The Charger Balloon Dilatation Catheter is also indicated for post-dilatation of balloon expandable and self-expanding stents in the peripheral vasculature.

510(k) Number (if known)

K112697

Device Name

Charger™ PTA Balloon Dilatation Catheters

Indications for Use

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

Prescription Use	X	AND/OR	Over-The-Counter Use
(Per 21 CFR 801 Subpart D)			(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)

	M.Y. Willelrenn
(Division Sign-Off)	Division of Cardiovascular Devices		Page 1 of 1
510(k) Number	K112697

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).

Characteristic	Predicate Device (Mustang) Performance	Charger Device Performance (Implied Acceptance/Equivalence)
Technological Characteristics
Manifold	Same material. Different colorant. Same design serving same function	Same material. Different colorant. Same design serving same function.
Strain Relief	Same material. Same design serving same function	Same material. Same design serving same function.
Catheter Proximal Shaft / Distal Outer Cable	Same material. Different colorant/additive. Same design serving same function	Same material. Different colorant/additive. Same design serving same function.
Catheter Inner Shaft	Same material, different colorant/additive and serving same function	Same material, different colorant/additive and serving same function.
Bumper Tip	Same material. Different colorant. Same design serving same function	Same material. Different colorant. Same design serving same function.
Balloon	Same balloon material and design and serving same function and fundamental technology	Same balloon material and design and serving same function and fundamental technology.
Balloon Bonding Method	Same bonding method and function	Same bonding method and function.
Balloon Forming Process	Same forming method and function	Same forming method and function.
Marker Bands	Same component serving same function	Same component serving same function.
Coating	Same coating serving same function	Same coating serving same function.
Balloon Protector	Same material and similar design both serving same function.	Same material and similar design both serving same function.
Proximal Shaft Outer Diameter	Same shaft outer diameters	Same shaft outer diameters.
Balloon Diameters	Same balloon diameter range serving same function	Same balloon diameter range serving same function.
Balloon Lengths	Same balloon length ranges serving same function	Same balloon length ranges serving same function.
Rated Burst Pressure (RBP)	Similar rated burst pressure	Similar rated burst pressure.
Catheter Length	Same catheter length ranges serving same function	Same catheter length ranges serving same function.
Recommended Introducer Sheath Compatibility	Similar ranges and compatibilities	Similar ranges and compatibilities.
Recommended Guidewire	Same compatibility.	Same compatibility.
Sterilization Method	Same method.	Same method.
SAL	Same level of assurance	Same level of assurance.
Packaging Material and Configuration	Same design and function	Same design and function.
Biocompatibility Testing	Passed (implied in predicate)	Passed (MEM Elution / Cytotoxicity, Sensitization, Intracutaneous Reactivity, Acute Systemic Toxicity, Rabbit Pyrogen, Hemolysis, Complement Activation, Partial Thromboplastin Time, Bacterial Mutagenicity, Mouse Lymphoma Assay, USP Physiochemical Latex)
In-vitro Performance Testing	Passed (implied in predicate)	Passed (Bond Tensile)