The Sterling OTW PTA Balloon Dilatation Catheter is indicated for Percutaneous Transluminal Angioplasty (PTA) in the peripheral vasculature, including iliac, femoral, popliteal, infra-popliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous fistulae. This device is also indicated for post-dilatation of balloon expandable and self-expanding stents in the peripheral vasculature.

Device Description

The Sterling OTW Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter is a high performance balloon catheter for peripheral indications. The device features an ultra-low profile, semi-compliant balloon combined with a low profile tip. The catheter is compatible with either 0.014 in (0.36 mm) or 0.018 in (0.46 mm) guidewires.

The Sterling OTW PTA Balloon Dilatation Catheter is an Over-The-Wire (OTW) catheter with a semi-compliant balloon fixed at the distal tip. The balloon catheter has a coaxial shaft design. The outer lumen is used for inflation of the balloon, and the wire lumen permits the use of guide wires 0.014 in or 0.018 in 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 to and through the stenosis. Two radiopaque marker bands (one proximal and one distal), in conjunction with fluoroscopy, enable accurate positioning of the balloon.

The effective lengths of the balloon catheter are 90 cm and 150 cm. Markers on the 90 cm effective length catheter indicate the exit of the dilatation catheter tip out of the guiding catheter (one at 50 cm and two at 60 cm). Markers on the 150 cm effective length catheter indicate the exit of the dilatation catheter tip out of the guiding catheter (one at 90 cm and two at 100 cm). The proximal portion of the catheter includes one female Luer-lock port connected to the inflation lumen, and one female Luer-lock port for guidewire lumen.

The balloon lengths are available in 20, 30, 40, 60, 200 and 220 mm sizes with diameters of 1.5, 2.0, 2.5, 3.0, 3.5 and 4.0 mm.

AI/ML Overview

The provided text describes a 510(k) submission for the Sterling™ Over-the-Wire PTA Balloon Dilatation Catheter (K141112). This is a medical device, not an AI/ML device, therefore, many of the requested categories are not applicable.

Here's the analysis based on the provided text:

1. Table of acceptance criteria and the reported device performance:

Since this is a traditional medical device (a balloon catheter), acceptance criteria are typically related to engineering specifications and performance in bench tests, rather than diagnostic accuracy metrics common for AI/ML devices. The "Performance Data" section states that "Bench testing was performed to support a determination of substantial equivalence." It does not provide specific quantitative acceptance criteria or detailed reported performance values for each test. Instead, it states that the tests "provide reasonable assurance that the proposed device 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."

Therefore, specific numerical acceptance criteria and reported device performance (e.g., specific burst pressures, deflation times, crossing profiles) are not provided in this document. The document lists the types of tests performed.

Acceptance Criteria Category (Implied by Test Type)	Reported Device Performance (Summary statement from document)
Balloon Compliance	Bench testing demonstrated conformance to requirements.
Balloon Nominal Diameter	Bench testing demonstrated conformance to requirements.
Balloon Rated Burst Pressure (RBP)	Bench testing demonstrated conformance to requirements.
Burst in a Stent	Bench testing demonstrated conformance to requirements.
Balloon Multiple Inflation	Bench testing demonstrated conformance to requirements.
Balloon Body Length	Bench testing demonstrated conformance to requirements.
Crossing Profile	Bench testing demonstrated conformance to requirements.
Guidewire Movement	Bench testing demonstrated conformance to requirements.
Full Catheter Tensile Extension and Deflation	Bench testing demonstrated conformance to requirements.
Sheath Withdrawal	Bench testing demonstrated conformance to requirements.
Balloon Multiple Inflation in a Stent	Bench testing demonstrated conformance to requirements.
Marker Band to Balloon Alignment	Bench testing demonstrated conformance to requirements.
Proximal Balloon Bond and Shaft Tensile Strength	Bench testing demonstrated conformance to requirements.
Deflation Time	Bench testing demonstrated conformance to requirements.

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 for Test Set: Not specified in the provided document. The document only mentions "Bench testing."
Data Provenance: Not specified. Bench testing typically involves laboratory-controlled environments and materials, not patient data from specific countries.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Number of Experts: Not applicable. For this type of medical device (catheter), ground truth is established through physical measurements and engineering specifications, often by qualified engineers and technicians, not clinical experts for diagnostic accuracy.
Qualifications of Experts: Not applicable in the context of clinical "ground truth" establishment for diagnostic accuracy.

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

Adjudication method: Not applicable. This concept relates to resolving discrepancies among expert readers in diagnostic studies, which is not relevant for bench testing of a 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:

MRMC Study: No, this is not an AI/ML device, so an MRMC study is not relevant or performed.
Effect size: Not applicable.

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

Standalone Performance: No, this is a physical medical device, not an algorithm.

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

Type of Ground Truth: The ground truth for this device is based on engineering specifications, material properties, and physical performance measurements against established industry standards and internal design requirements. For example, "Rated Burst Pressure" has a defined value that the device must meet during testing.

8. The sample size for the training set:

Sample Size for Training Set: Not applicable. This is not an AI/ML device that requires a training set. The device is designed, manufactured, and then tested against specifications.

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

Ground Truth Establishment for Training Set: Not applicable. As this is not an AI/ML device, there is no "training set" or ground truth established for such a purpose.

Summary

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JUL 1 6 2014

510(k) Summary

per 21 CFR §807.92

Submitter'sName andAddress	Boston Scientific CorporationOne Scimed PlaceMaple Grove, MN 55311
Contact NameandInformation	Carol TiffanySenior Regulatory Affairs SpecialistPhone: 763-494-1106Fax: 763-494-2222e-mail: carol.tiffany@bsci.com
Date Prepared	29 April 2014
ProprietaryName	Sterling™ Over-the-Wire PTA Balloon Dilatation Catheter
Common Name	Percutaneous Catheter
Product Code	LIT - Catheter, Angioplasty, Peripheral, Transluminal
Classification	Class II, 21 CFR Part 870.1250 - Percutaneous Catheter
PredicateDevice(s)	Sterling OTW PTA Balloon Dilatation Catheter K132430 October 17, 2013
DeviceDescription	The Sterling OTW Percutaneous Transluminal Angioplasty (PTA) BalloonDilatation Catheter is a high performance balloon catheter for peripheralindications. The device features an ultra-low profile, semi-compliant ballooncombined with a low profile tip. The catheter is compatible with either 0.014in (0.36 mm) or 0.018 in (0.46 mm) guidewires.The Sterling OTW PTA Balloon Dilatation Catheter is an Over-The-Wire(OTW) catheter with a semi-compliant balloon fixed at the distal tip. Theballoon catheter has a coaxial shaft design. The outer lumen is used forinflation of the balloon, and the wire lumen permits the use of guidewires0.014 in or 0.018 in to facilitate advancement of the catheter to andthrough the stenosis to be dilated. The balloon is designed to provide aninflatable segment of known diameter and length at recommendedpressures. The catheter includes a tapered tip to facilitate advancement ofthe catheter to and through the stenosis. Two radiopaque marker bands(one proximal and one distal), in conjunction with fluoroscopy, enableaccurate positioning of the balloon.The effective lengths of the balloon catheter are 90 cm and 150 cm.Markers on the 90 cm effective length catheter indicate the exit of thedilatation catheter tip out of the guiding catheter (one at 50 cm and two at60 cm). Markers on the 150 cm effective length catheter indicate the exit ofthe dilatation catheter tip out of the guiding catheter (one at 90 cm and twoat 100 cm). The proximal portion of the catheter includes one female Luer-lock port connected to the inflation lumen, and one female Luer-lock portfor guidewire lumen.The balloon lengths are available in 20, 30, 40, 60, 200 and 220 mm sizeswith diameters of 1.5, 2.0, 2.5, 3.0, 3.5 and 4.0 mm. The combinations ofballoon sizes are displayed below.

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Balloon(mm)	Balloon Length (mm)
	20	30	40	60	200	220
1.5	90cm150cm		90cm150cm
2.0	90cm150cm	90cm150cm	90cm150cm	90cm150cm		90cm150cm
2.5	90cm150cm	90cm150cm	90cm150cm	90cm150cm		90cm150cm
3.0	90cm150cm	90cm150cm	90cm150cm	90cm150cm		90cm150cm
3.5	90cm150cm	90cm150cm	90cm150cm	90cm150cm		90cm150cm
4.0					90cm150cm	90cm150cm

Intended Use/ Indications for Use of Device

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Special 510(k) Submission Sterling™ OTW Balloon Dilatation Catheter

Comparison of Technological Characteristics

The Sterling OTW catheter will incorporate a substantially equivalent design, packaging, fundamental technology, manufacturing, materials, sterilization and intended use as those featured in the predicate BSC Sterling OTW Balloon Dilatation Catheter.

Characteristic	Comparison to Sterling OTW Predicate
Manifold	Same material. Same design serving the samefunction.
Strain Relief	Same material. Same design serving the samefunction.
Inner Shaft/Outer Shaft	Same material. Same design serving the samefunction.
Balloon	Same material. Same design serving the samefunction.
Marker Bands	Same component. Same design serving the samefunction.
Proximal Marks	Same material. Same design serving the samefunction.
Coating	Same material. Same design serving the samefunction.
Bumper Tip	Same material. Same design serving the samefunction.
Sterilization Method/SAL	Same method and same level of assurance.
Balloon Diameters	Smaller diameters than the predicate range.
Balloon Lengths	200 and 220 mm are the same as predicate range.Adding balloon lengths of 20, 30, 40, and 60 mm.
Usable Catheter Lengths	Same lengths.
Rated Burst Pressure(RBP)	Same Rated Burst Pressure.
Sheath/GuideCompatibility	Compatibility the same for larger sizes, slightlydifferent compatibility depending on balloondiameters.
Packaging	Same function and design.
Guidewire	Same Compatibility.
Manufacturing	Manufactured on the same manufacturing lines.

Performance Data

Bench testing was 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 and, therefore, these devices may be considered substantially equivalent to the predicate devices.

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The following bench testing was completed on the Sterling™ OTW PTA Balloon Dilatation Catheter:

Bench
Balloon Compliance	Balloon Nominal Diameter
Balloon Rated Burst Pressure (RBP)	Burst in a Stent
Balloon Multiple Inflation	Balloon Body Length
Crossing Profile	Guidewire Movement
Full Catheter Tensile Extensionand Deflation	Sheath Withdrawal
Balloon Multiple Inflationin a Stent	Marker Band to BalloonAlignment
Proximal Balloon Bond andShaft Tensile Strength	Deflation Time

Conclusion

Based on the Indications for Use, technological characteristics, safety and performance testing, the Sterling OTW PTA Balloon Dilatation Catheter has been shown to be appropriate for its intended use and is considered to be substantially equivalent to the Sterling OTW PTA Balloon Dilatation Catheter (K0132430 cleared October 17, 2013).

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized emblem featuring a symbol that resembles three wavy lines or abstract human figures.

Food and Drug Administration 0903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

July 16, 2014

Boston Scientific Ms. Carol Tiffany Regulatory Affairs Specialist One Scimed Place Maple Grove, MN 55311-1566

Re: K141112

. Trade/Device Name: Sterling Over-The Wire PTA Balloon Dilatation Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: LIT Dated: June 13, 2014 Received: June 16, 2014

Dear Ms. Tiffany:

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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Ms. Carol Tiffany

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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 Industry and Consumer Education 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 vour

Kenneth J. Cavanaugh -S

for

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):

Device Name: Sterling™ Over-the-Wire (OTW) PTA Balloon Dilatation Catheter

Indications for Use:

The Sterling OTW PTA Balloon Dilatation Catheter is indicated for Percutaneous Transluminal Angioplasty (PTA) in the peripheral vasculature, including illac, femoral, popliteal, infra-popliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for postdilatation of balloon expandable and self-expanding stents in the peripheral vasculature.

Prescription Use X (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)

Image /page/6/Picture/11 description: The image shows the name "Kenneth J. Cavanaugh -S" in black font. The letters are clearly visible and evenly spaced. In the middle of the name, there is a logo that appears to be the FDA logo.

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).