The Gladiator 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 Gladiator 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 Gladiator™ 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 markerbands 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 Gladiator Balloon Dilatation Catheter will be available with balloon diameters 3.0 mm to 12.0 mm, balloon lengths 20 mm to 100 mm, and with shaft lengths of 40 cm and 75 cm.

AI/ML Overview

The provided text focuses on the 510(k) summary for the Boston Scientific Gladiator™ PTA Balloon Dilatation Catheter, demonstrating its substantial equivalence to a predicate device. This type of submission relies on comparisons to an already approved device rather than clinical trials with specific acceptance criteria as might be seen for novel devices or AI/ML-based systems.

Therefore, many of the requested categories (such as sample size for test sets, expert qualifications, MRMC studies, training set details, etc.) are not applicable to this 510(k) submission document.

Here's an analysis of the available information:

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

The document does not present specific quantitative acceptance criteria in numerical form, as would be typical for performance specifications for new devices or AI models. Instead, it relies on demonstrating that the Gladiator device is substantially equivalent to the predicate device (Mustang PTA Balloon Dilatation Catheters, K103751) based on technological characteristics and performance data from bench and biocompatibility testing.

Here's a summary derived from the "Comparison of Technological Characteristics" and "Performance Data" sections:

Acceptance Criteria Category	Reported Device Performance (Gladiator PTA Balloon Dilatation Catheter)
Technological Characteristics	Substantially equivalent to predicate (Mustang PTA Balloon Dilatation Catheters, K103751) in all characteristics:- Manifold Hub: Same material (different colorant/additive), same design, same function.- Bumper Tip: Same material (different colorant), same design, same function.- Strain Relief: Same material, same design, same function.- Proximal Dual Lumen Shaft: Same material, same design, same function.- Proximal Shaft Outer Diameter: Same.- Balloon: Same balloon material, same design, same function, same fundamental technology.- Balloon Protector: Same material, similar design, same function.- Pinch-off Tube: Same material, same design, same function.- Markerbands: Same component, same function.- Coating: Same coating, same function.- Packaging Design: Similar design, same function (same carrier tube materials, different configuration).- Sterilization Method: Same method.- SAL (Sterility Assurance Level): Same level of assurance.- Lumens: Same lumens, same function.- Recommended Guidewire: Same compatibility.- Balloon Diameters: Same.- Balloon Lengths: Within range of predicate.- Effective Length: Within range of predicate.- Rated Burst Pressure (RBP): Same.
Biocompatibility Testing	All tests completed successfully:- MEM Elution Cytotoxicity- Guinea Pig Maximization Sensitization- Intracutaneous Reactivity- Acute Systemic Toxicity- Materials Mediated Rabbit Pyrogen- Bacterial Mutagenicity (Ames Assay)- Mouse Lymphoma Assay- Hemolysis Direct Contact and Extract- Partial Thromboplastin Time- In Vitro Hemocompatibility Assay- Complement Activation- USP Physicochemical- Natural Rubber Latex
Bench/Performance Testing	Performed to assure conformance for intended use. (No new safety or performance issues raised.)
Sterilization	Performed to assure conformance for intended use.

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

This document discusses bench testing and biocompatibility testing, not clinical studies with "test sets" of patient data. The sample sizes for these engineering and lab tests are not specified in the summary. Data provenance for such engineering tests typically refers to laboratory conditions rather than patient data origin.

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)

Not applicable. Ground truth for clinical data is not relevant to a device submission based on substantial equivalence through engineering and biocompatibility testing. The "ground truth" here is adherence to engineering specifications and biological safety standards.

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

Not applicable. Adjudication methods are used in clinical studies, not for the type of testing described here.

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 is for a physical medical device (balloon catheter), not an AI/ML system that assists human readers.

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

Not applicable. This is for a physical medical device.

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

For the Gladiator device, the "ground truth" relates to:

Engineering Specifications: The design and material characteristics of the predicate device (Mustang PTA Balloon Dilatation Catheters) serve as the benchmark for comparison.
Biocompatibility Standards: Established international and national standards for biocompatibility testing (e.g., ISO 10993 series) define the "ground truth" for safety in this area.
Performance Standards: Industry-accepted test methods and performance criteria (e.g., for Rated Burst Pressure, guidewire compatibility) define the "ground truth" for bench testing.

8. The sample size for the training set

Not applicable. There is no "training set" as this is not an AI/ML device.

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

Not applicable.

Summary

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

K113681

JAN 1 1 2012

510(k) Summary

Submitter	Boston Scientific CorporationOne Scimed Place Maple Grove, MN 55311
Contact Person	Amber R. Johnson
Phone Number	763-494-2643
Fax Number	763-494-2222
Date Prepared	December 14, 2011
Device Trade Name	Gladiator PTA Balloon Dilatation Catheters
Common Name	Percutaneous Transluminal Angioplasty Dilatation Catheter
Device Classification	Class II 21 CFR 870.1250 Product Code: LIT, DQY

Predicate Device

Mustang PTA Balloon Dilatation Catheters

Device Description

· The Gladiator Balloon Dilatation Catheter will be available with balloon diameters 3.0 mm to 12.0 mm, balloon lengths 20 mm to 100 mm, and with shaft lengths of 40 cm and 75 cm.

Indications for Use

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

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

Substantial Equivalence

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

Comparison of Technological Characteristics

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

Characteristic	Mustang predicate
Manifold Hub	Same material. Different colorant/additive. Same designserving same function.
Bumper Tip	Same material. Different colorant. Same design servingsame function.
Strain Relief	Same material. Same design serving same function.
Proximal Dual Lumen Shaft	Same material. Same design serving same function.
Proximal Shaft Outer Diameter	Same shaft outer diameters.
Balloon	Same balloon material. Same design serving samefunction and fundamental technology.
Balloon Protector	Same material and similar design serving same function.
Pinch-off Tube	Same material. Same design serving same function.
Markerbands	Same component serving same function.
Coating	Same coating serving same function.
Packaging Design	Similar design serving same function. Same carrier tubematerials. Different configuration.
Sterilization Method	Same method.
SAL	Same level of assurance.
Lumens	Same lumens serving same function.
Recommended Guidewire	Same compatibility.
Balloon Diameters	Same balloon diameter serving same function.
Balloon Lengths	Within range of predicate serving same function.
Effective Length	Within range of predicate serving same function.
Rated Burst Pressure (RBP)	Same Rated Burst Pressure (RBP).

Comparison to Predicate Device

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

Performance Data

Biocompatibility testing, bench testing, and sterilization 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 testing.

The following biocompatibility tests were completed on the Gladiator PTA Balloon Dilatation Catheter:

MEM Elution Cytotoxicity o
0 Guinea Pig Maximization Sensitization
0 Intracutaneous Reactivity
Acute Systemic Toxicity 0
Materials Mediated Rabbit Pyrogen o
Bacterial Mutagenicity (Ames Assay) 0
Mouse Lymphoma Assay 0
Hemolysis Direct Contact and Extract O
Partial Thromboplastin Time O
In Vitro Hemocompatibility Assay 0
Complement Activation 0
USP Physicochemical O
Natural Rubber Latex 0

Conclusion:

Based on the indications for use, technological characteristics, safety and performance testing, the Gladiator 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).

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

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol, with three curved lines representing the body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the bird symbol.

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

JAN 1 1 2012

Boston Scientific c/o Ms. Amber Johnson One Scimed Place Maple Grove, MN 55311

Re: K113681

Trade/Device Name: Gladiator Balloon Dilatation PTA Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: Class II (two) Product Code: LIT, DQY Dated: December 14, 2011 Received: December 15, 2011

Dear Ms. Johnson:

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.

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

Page 2 - Ms. Amber Johnson

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.

Sincerely yours,

M. A. Killebrew

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

Enclosure

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

Indications for Use Statement

: :

510(k) Number(if known)	K113681
Device Name	Gladiator™ PTA Balloon Dilatation Catheters
Indications forUse	The Gladiator Balloon Dilatation Catheter is indicated forPercutaneous Transluminal Angioplasty (PTA) in the peripheralvasculature, including iliac, femoral, popliteal, tibial, peroneal,subclavian, and renal arteries and for the treatment of obstructivelesions of native or synthetic arteriovenous dialysis fistulae.The Gladiator Balloon Dilatation Catheter is also indicated for post-dilatation of balloon expandable and self-expanding stents in theperipheral vasculature.
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)

signature
MI Allehen (Division Sign-Off) Division of Cardiovascular Devices

510(k) Number_K11 368 l

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).