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

The provided text is a 510(k) summary for the Charger™ PTA Balloon Dilatation Catheters. This type of document is for a medical device seeking market clearance based on substantial equivalence to an existing predicate device, not for a novel diagnostic algorithm or AI. Therefore, much of the requested information regarding acceptance criteria and studies for AI/diagnostic devices (e.g., sample sizes for test/training sets, experts for ground truth, MRMC studies, standalone performance) is not applicable to this submission.

The "acceptance criteria" in this context refer to the demonstration of substantial equivalence through comparison to a predicate device and performance testing relevant to the device's function and safety.

Here's the information that can be extracted from the provided text, structured as closely as possible to your request, with explicit notes about what is not applicable:

Acceptance Criteria and Device Performance for Charger™ PTA Balloon Dilatation Catheters

This submission is a 510(k) for a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter. The acceptance criteria are primarily focused on demonstrating substantial equivalence to a predicate device (Mustang™ PTA Balloon Dilatation Catheters) and confirming that the device meets safety and performance requirements through biocompatibility and bench testing.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria/Tests Performed	Reported Device Performance/Outcome
I. Substantial Equivalence to Predicate Device	Technological Characteristics Comparison:- Manifold material & design- Strain Relief material & design- Catheter Proximal Shaft / Distal Outer material & design- Catheter Inner Shaft material & design- Bumper Tip material & design- Balloon material, design, function, fundamental technology- Balloon Bonding Method- Balloon Forming Process- Marker Bands- Coating- Balloon Protector material & design- Proximal Shaft Outer Diameter- Balloon Diameters - Balloon Lengths- Rated Burst Pressure (RBP)- Catheter Length- Recommended Introducer Sheath Compatibility- Recommended Guidewire- Sterilization Method- SAL- Packaging Material and Configuration	Substantially Equivalent- Most characteristics are "Same" or "Same material/design serving same function," though some material colorants/additives differ, these are considered not to impact substantial equivalence.- RBP and Introducer Sheath Compatibility are "Similar."- Guidewire compatibility is "Same."
II. Biocompatibility Testing	- 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 Physicochemical Latex	Passed. "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."
III. In-vitro Performance Testing	- Bond Tensile	Passed. "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."

2. Sample Size Used for the Test Set and Data Provenance

Not Applicable. This is a medical device 510(k) submission, not a study evaluating an AI/diagnostic algorithm using a test set of patient data. The "test set" here refers to the physical devices and materials undergoing bench and biocompatibility testing. The data provenance is internal laboratory testing and material characterization.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not Applicable. Ground truth, in the context of AI or diagnostic studies, is typically established by medical experts reviewing patient data. For medical device testing like this, the "ground truth" is adherence to established engineering standards, material specifications, and regulatory requirements, assessed by qualified engineers and scientists in laboratory settings.

4. Adjudication Method for the Test Set

Not Applicable. Adjudication methods like 2+1 or 3+1 are used for resolving disagreements among multiple expert readers in diagnostic image interpretation studies. This is not relevant to the bench and biocompatibility testing performed for a PTA balloon catheter.

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. An MRMC study is relevant for evaluating the impact of AI on human reader performance in diagnostic tasks. This submission is for a physical medical device (a catheter), not a diagnostic AI.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not Applicable. This device is a physical catheter, not a software algorithm.

7. The Type of Ground Truth Used

For biocompatibility testing: Established biological safety standards (e.g., ISO 10993 series) and specific test methodologies (e.g., MEM Elution, Guinea Pig Maximization Sensitization).
For in-vitro performance testing (Bond Tensile): Engineering specifications and validated test methods to ensure the device performs as intended and is safe.
For substantial equivalence: Comparison against the predicate device's documented characteristics and performance specifications.

8. The Sample Size for the Training Set

Not Applicable. Training sets are used for machine learning algorithms. This is a physical medical device.

9. How the Ground Truth for the Training Set Was Established

Not Applicable. See point 8.

Summary

{0}------------------------------------------------

Premarket Notification - Special 510(k) Charger™ PTA Balloon Dilatation Catheters

510(k) Summary

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 Balloon Dilatation Catheters Common Name: Percutaneous Transluminal Angioplasty Dilatation Catheter Device Classification: Class II 21 CFR 876.5010 Product Code: FGE

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 Catheters with bailoons up to 120 mm in length are indicated for the treatment of biliary strictures.

Substantial Equivalence

The Charger PTA Balloon Dilatation Catheters design, materials, manufacturing process and intended use are substantially equivalent to the predicate device Mustanny proboon Dilatation Catheters (K110122).

{1}------------------------------------------------

K112701
pg 2 of 4

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 (K110122).

Comparison to Predicate Devices in Materials and ManufacturingA . A . A . A . A
-------------------------------------------------------------------------------------	--	--

Characteristic	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

{2}------------------------------------------------

K 11270)
pg 3 of 4

Comparison to Predicate Devices Characteristics
-------------------------------------------------	--

Characteristic	Mustang predicate
Balloon Diameters	Same balloon diameterrange serving same function
Balloon Lengths	Same balloon length rangesserving same function
Rated Burst Pressure(RBP)	Similar rated burst pressure
Catheter Length	Same catheter lengthranges serving samefunction
RecommendedIntroducer SheathCompatibility	Similar ranges andcompatibilities
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

{3}------------------------------------------------

K112701
pg. 4 of 4

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 (K110122).

{4}------------------------------------------------

Image /page/4/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around it. Inside the circle is a stylized image of an eagle or bird-like figure with three lines representing its wings or feathers.

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

Mr. Glenn Jacques Principal, Regulatory Affairs Boston Scientific One Scimed Place MAPLE GROVE MN 55311

OCT 2 5 2011

Re: K112701

Trade/Device Name: Charger™ PTA Balloon Dilatation Catheters Regulation Number: 21 CFR$ 876.5010 Regulation Name: Biliary catheter and accessories Regulatory Class: II . Product Code: FGE Dated: September 21, 2011 Received: September 28, 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 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 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 of medical device-related

{5}------------------------------------------------

Page 2

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.

Sincerely yours,

Hubert Lemmer 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

{6}------------------------------------------------

Indications for Use Statement

510(k) Number (if known)	K112701
Device Name	Charger TM PTA Balloon Dilatation Catheters
Indications for Use	Charger Balloon Dilatation Catheters with balloons up to 120 mm in 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)

Aorn M Wh

(Division Sign-Off) Division of Reproductive, Gastro-Renal, and Urological Devices 510(k) Number

Page 1 of 1

Regulation Number and Section

§ 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.