.014 PTA Balloon Dilatation Catheter is indicated for Percutaneous Transluminal Angioplasty (PTA) in the peripheral vasculature, including iliac, femoral, infrapopliteal, popliteal, renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

Device Description

The .014 PTA Balloon Dilatation Catheters have a coaxial shaft design. The outer lumen is used for inflation of the balloon, and the wire lumen permits the use of guidewires 0.014 in (0.36 mm) to facilitate advancement of the catheter to and through the stenosis to be dilated. The balloon is designed to provide an inflatable segment of known diameter and length at recommended pressures. The catheter includes a tapered tip to facilitate advancement of the catheter. The working lengths of the balloon catheter are 90 cm and 150 cm.

AI/ML Overview

This is a medical device submission for a .014 Monorail and OTW PTA Balloon Dilatation Catheter. This type of submission (510k) focuses on demonstrating "substantial equivalence" to a predicate device, rather than proving novel effectiveness. Therefore, the "acceptance criteria" and "study" are framed around this concept.

Here's an analysis of the provided text based on your requested information:

Acceptance Criteria and Device Performance

The core of the acceptance criteria is demonstrating substantial equivalence to existing predicate devices. This is achieved by showing that the new device has similar technological characteristics, materials, manufacturing processes, and performance data, and that it raises no new safety or performance issues.

Acceptance Criteria Category	Description of How Met (Reported Device Performance)
Technological Characteristics	Substantially equivalent in design, materials, packaging, fundamental technology, manufacturing processes, sterilization processes, and intended use as predicate devices (Sterling ES and Sterling SL). Specific comparisons were made for manifold, strain relief, catheter shafts, bumper tip, balloon, bonding method, forming process, marker bands, coating, balloon protector, and proximal shaft outer diameter.
Material & Manufacturing	Demonstrated substantial equivalence to predicate devices for all components mentioned above. Any differences were deemed minor or serving the same function.
Balloon & Catheter Dimensions	Similar or same balloon diameters, balloon lengths, rated burst pressure (RBP), catheter length, recommended introducer sheath compatibility, and recommended guidewire as predicate devices.
Sterilization & Packaging	Same sterilization method, same sterility assurance level (SAL), and same packaging material and configuration as predicate devices.
Biocompatibility	Completed a comprehensive set of biocompatibility tests (MEM Elution / Cytotoxicity, Hemolysis / Direct Contact, Guinea Pig Maximization Sensitization, Complement Activation, Intracutaneous Reactivity, Partial Thromboplastin Time, Acute Systemic Toxicity, In Vitro Hemocompatibility, Materials Mediated Rabbit Pyrogen). Results provided reasonable assurance of conformance.
In-vitro Performance	Completed a comprehensive set of in-vitro performance tests (Balloon Multiple Inflation, Distal Shaft Profile, Balloon Compliance (Distension), Flexibility and Kink Test, Balloon Diameter at Nominal Pressure, Folded Balloon Crossing Profile, Balloon Length Dimensions (mm), Particulates Evaluation, Balloon Rated Burst Pressure, Proximal Shaft Profile MR, Bond Tensile, Proximal Shaft Profile OTW, Burst Mode, Radiopacity, Catheter Length Dimensions, Sheath Insertion and Withdrawal Force, Distal Inner Shaft ID). Results provided reasonable assurance of conformance.
No New Safety/Performance Issues	Testing confirmed that no new safety or performance issues were raised.

Study Details for Acceptance Criteria

The provided document describes bench testing and biocompatibility testing to support the claim of substantial equivalence. This is not a clinical study in the typical sense (e.g., comparing patient outcomes).

Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated. The document lists types of tests (biocompatibility and in-vitro performance), implying laboratory-based testing on device samples, not patient data. The number of individual devices or components tested for each specific test (e.g., how many balloons for burst pressure) is not provided.
- Data Provenance: Not applicable in the context of country of origin of data or retrospective/prospective, as this describes lab testing, not human or observational data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. "Ground truth" in this context would be defined by engineering specifications, material standards, and regulatory requirements, not expert consensus on clinical cases. The tests are designed to verify adherence to these predefined criteria.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods are relevant for subjective interpretations of clinical data or images. These are objective engineering and biological tests conducted in a laboratory setting against established pass/fail criteria.
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:
- No MRMC or comparative effectiveness study was done, nor is it relevant for this type of device submission. This is a medical device for angioplasty, not an AI or imaging device involving human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an AI or software algorithm; it is a physical medical device. The "standalone" performance refers to the device's functional integrity as demonstrated through bench and biocompatibility tests.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this submission are objective, pre-defined engineering specifications, material standards, and regulatory requirements (e.g., ISO standards for biocompatibility). Performance is measured against these established quantitative and qualitative criteria.
The sample size for the training set:
- Not applicable. This is not a machine learning or AI device. There is no concept of a "training set."
How the ground truth for the training set was established:
- Not applicable, as there is no training set for this device.

Summary

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K111295 page 1 of 4

MAY 3 1 2011

510(k) Summary

Submitter:	Boston Scientific CorporationOne Scimed Place Maple Grove, MN 55311
Contact Person:	Mark Murphy
Phone Number:	763-494-2377
Fax Number:	763-494-2222
Date Prepared:	May 6, 2011
Device Trade Name:	.014 Monorail and OTW PTA Balloon Dilatation Catheters
Common Name:	Percutaneous Transluminal Angioplasty Dilatation Catheter
Device Classification:	Class II, 21 CFR 870.1250 Product Code: LIT

Predicate Devices

Sterling SL Monorail and OTW PTA Balloon Dilatation Catheters and Sterling ES Monorail and OTW PTA Catheters.

Device Description

Indications for Use

The .014 Balloon Dilatation Catheter is indicated for Percutaneous Transluminal Angioplasty (PTA) in the peripheral vasculature, including iliac, femoral, infrapopliteal, renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

Substantial Equivalence

The .014 PTA Balloon Dilatation Catheters design, materials, manufacturing process and intended use are substantially equivalent to predicate devices Sterling ES (K080982 and K093636), and Sterling SL Monorail and OTW (K093720) PTA Catheters.

Comparison of Technological Characteristics

The .014 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 devices, Sterling ES PTA Balloon Dilatation Catheter (K080982 and K093636) and Sterling SL PTA Balloon Dilatation Catheter (K093720).

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Characteristic	Sterling ES (MR/OTW)	Sterling SL (MR/OTW)
Manifold	Same material. Different colorant.Same design with minordimensional differences but servingsame function	OTW Same material. MR differentmaterial. Same design with minordimensional differences butserving same function
Strain Relief	MR has different material. OTW hassame material. Similar designs withserving same function	Same material, different colorant,different designs but serving samefunction
Catheter Proximal Shaft /Distal Outer	MR different material. OTW similarmaterial. Both designs servingsame function	Similar material and design servingsame function
Catheter Inner Shaft	Same material, different colorantsand serving same function	Similar material, same colorantsand serving same function
Bumper Tip	Different material, same colorantbut serving same function	Different material, differentcolorant but serving same function
Balloon	Difference in balloon material anddesign but serving same functionand fundamental technology	Difference in balloon material anddesign but serving same functionand fundamental technology
Balloon Bonding Method	Same bonding method andfunction	Same bonding method andfunction
Balloon FormingProcess	Same forming method and function	Same forming method and function
Marker Bands	Similar component serving samefunction	Different component serving samefunction
Coating	Same coating serving samefunction	Same coating serving samefunction
Balloon Protector	Same material and similar designboth serving same function.	Same material and similar designboth serving same function
Proximal Shaft OuterDiameter	Similar shaft outer diameters	Similar shaft outer diameters

Comparison to Predicate Devices in Materials and Manufacturing

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Characteristic	Sterling ES (MR/OTW)	Sterling SL (MR/OTW)
Balloon Diameters	Similar balloon diameter rangeserving same function	Same balloon diameter rangeserving same function
Balloon Lengths	Shorter balloon length rangesserving same function	Similar balloon length rangesserving same function
Rated Burst Pressure(RBP)	Similar rated burst pressure	Same rated burst pressure
Catheter Length	Similar catheter length rangesserving same function	Same catheter length rangesserving same function
RecommendedIntroducer SheathCompatibility	Similar ranges and compatibilities	Same ranges and compatibilities
RecommendedGuidewire	Same compatibility.	Same compatibility.
Sterilization Method	Same method.	Same method.
SAL	Same level of assurance	Same level of assurance
Packaging Materialand Configuration	Same design and function	Same design and function

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 .014 PTA Balloon Dilatation Catheter:

MEM Elution / Cytotoxicity	Hemolysis / Direct Contact
Guinea Pig Maximization Sensitization	Complement Activation
Intracutaneous Reactivity	Partial Thromboplastin Time
Acute Systemic Toxicity	In Vitro Hemocompatibility
Materials Mediated Rabbit Pyrogen

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K111295 page 4 of 4

The following in-vitro performance tests were completed for the .014 PTA Balloon Dilatation Catheter:

Balloon Multiple Inflation	Distal Shaft Profile
Balloon Compliance (Distension)	Flexibility and Kink Test
Balloon Diameter at Nominal Pressure	Folded Balloon Crossing Profile
Balloon Length Dimensions (mm)	Particulates Evaluation
Balloon Rated Burst Pressure	Proximal Shaft Profile MR
Bond Tensile	Proximal Shaft Profile OTW
Burst Mode	Radiopacity
Catheter Length Dimensions	Sheath Insertion and Withdrawal Force
	Distal Inner Shaft ID

Conclusion

Based on the indications for use, technological characteristics, and safety and performance testing, the .014 PTA Balloon Dilatation Catheter has been shown to be appropriate for its intended use and is considered to be substantially equivalent to the Boston Scientific Sterling ES PTA Balloon Dilatation Catheter (K080982 and K0936336) and the Sterling SL PTA Balloon Dilatation Catheter (K093720).

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Image /page/4/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name arranged in a circular fashion around a stylized emblem. The emblem consists of a caduceus-like symbol with three parallel lines that curve and converge, representing health and human services.

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

MAY 3 1 2011

Boston Scientific Corporation c/o Mr. Mark Murphy One Scimed Place Maple Grove, MN 55311-1566

Re: K111295

Trade/Device Name: .014 Monorail and Over-The-Wire PTA Balloon Dilatation Catheters Regulation Number: 21 CFR 870.1250 Regulation Name: Percutancous catheter Regulatory Class: Class II (two) Product Code: LIT, DQY Dated: May 6, 2011 Received: May 9, 2011

Dear Mr. Murphy:

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.

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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/CDRH0ffices/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.

érely vou

ram 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 Statement
510(k) Number(if known)	K111295
Device Name	.014 MR & OTW PTA Balloon Dilatation Catheters
Indications forUse	.014 PTA Balloon Dilatation Catheter is indicated for PercutaneousTransluminal Angioplasty (PTA) in the peripheral vasculature, includingiliac, femoral, infrapopliteal, popliteal, renal arteries, and for the treatment oobstructive lesions of native or synthetic arteriovenous dialysis fistulae.

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

signature

(Division Sign-Off) Division of Cardioyascular Devices 510(k) Nui ાંાણા 295

Prescription Use ___X (Per 21 CFR 801.109 OR

Over-The-Counter Use___________________________________________________________________________________________________________________________________________________________________________

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).