2CM PERIPHERAL CUTTING BALLOON, SMALL PERIPHERAL CUTTING BALLOON WITH MONORAIL AND OVER-THE-WIRE DELIVERY SYSTEMS by BOSTON SCIENTIFIC

The Peripheral Cutting Balloon catheters are indicated for percutaneous transluminal angioplasty of obstructive lesions of synthetic or native arteriovenous dialysis fistulae.

Device Description

The family of Peripheral Cutting Balloon (PCB) Catheters has features of a conventional angioplasty catheter with advanced microsurgical capabilities. The PCB family features a balloon with 3 or 4 atherotomes (microsurgical blades) mounted longitudinally on its outer surface. The device is inserted over a guidewire and delivered to the target lesion. When the PCB device is inflated, the atherotomes score the plaque, creating initiation sites for crack propagation. Percutaneous Angioplasty (PTA) with the PCB device allows dilatation of the target lesion with less pressure, minimizing barotrauma.

AI/ML Overview

This document is a 510(k) summary for the Boston Scientific Peripheral Cutting Balloon catheters. It details the device's indications for use, its description, and its substantial equivalence to previously cleared predicate devices.

Acceptance Criteria and Device Performance Study:

The document does not describe acceptance criteria or a study that proves the device meets specific acceptance criteria in terms of performance metrics like sensitivity, specificity, accuracy, or any clinical outcomes for the peripheral cutting balloon.

Instead, the submission focuses on demonstrating substantial equivalence to existing, legally marketed predicate devices. This means that the device is considered as safe and effective as the predicate device because it has the same intended use and the same technological characteristics, or, if there are differences in technological characteristics, those differences do not raise different questions of safety and effectiveness.

Here's a breakdown of the requested information based on the provided document:

Table of Acceptance Criteria and Reported Device Performance:
This information is not present in the provided 510(k) summary. The summary focuses on showing equivalence rather than meeting pre-defined performance criteria for a new type of device.
Sample size used for the test set and the data provenance:
The document does not describe a specific test set, its sample size, or data provenance for performance evaluation. The substantial equivalence argument relies on the inherent similarity to predicate devices. The "proposed device" in the table (Page 3) is the one under review, which is essentially the same as the "predicate device" with minor labeling changes.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable/provided as there is no mention of a test set with ground truth established by experts.
Adjudication method for the test set:
This information is not applicable/provided as there is no mention of a test set.
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:
This is not applicable. The device described is a medical device (a catheter), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study related to AI assistance would not be relevant.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This is not applicable. The device is a physical medical device, not a standalone algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
This information is not applicable/provided as there is no specific performance study requiring ground truth in this submission. The "ground truth" for substantial equivalence is the historical safety and effectiveness data of the predicate devices.
The sample size for the training set:
This information is not applicable/provided. No training set for an algorithm is mentioned.
How the ground truth for the training set was established:
This information is not applicable/provided. No training set for an algorithm is mentioned.

Summary of the Document's Content Regarding Equivalence:

The core of this 510(k) submission is the assertion of substantial equivalence based on the following:

Identical Intended Use: The "Indications for Use" for the proposed device (Peripheral Cutting Balloon catheters for percutaneous transluminal angioplasty of obstructive lesions of synthetic or native arteriovenous dialysis fistulae) are the same as those of its predicate devices.
Identical Technological Characteristics (with minor changes): The document states: "There are no changes in design, composition, function or indication of any of the proposed PCB devices compared to their respective predicates." The only change being proposed is "adding a new contraindication and a new warning in the DFU (Directions For Use)." Such labeling changes are generally considered minor and do not alter the fundamental safety and effectiveness of the device itself, thus maintaining substantial equivalence.

Therefore, for this specific 510(k) submission, the "study" demonstrating that the device meets criteria is the comparison to predicate devices, showing that it is fundamentally the same and incorporates only minor, non-performance-altering changes.

Summary

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

May 31, 2016

Boston Scientific Corporation c/o Mr. Brian Park Principal Regulatory Affairs Specialist 3574 Ruffin Road San Diego, CA 92123

Re: K070951

Trade/Device Name: Peripheral Cutting Balloon Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: PNO Dated: April 3, 2007 Received: April 4, 2007

Dear Mr. Park:

This letter corrects our substantially equivalent letter of June 4, 2007.

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 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

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Page 2 - Mr. Brian Park

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 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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Misti L. Malone -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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ll. INDICATIONS FOR USE STATEMENT

Kozo95) 510(k) Number:

Device Names: 2cm Peripheral Cutting Balloon® small Peripheral Cutting Balloon® with Monorail Delivery System small Peripheral Cutting Balloon® with Over-the-Wire Delivery System

Indications for Use:

The Peripheral Cutting Balloon catheters are indicated for percutaneous transluminal angioplasty of obstructive lesions of synthetic or native arteriovenous dialysis fistulae.

Prescription Use × (part 21 CFR 801 Subpart D) AND/OR

Over-the-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division of Cardio)
Division of Cardiovasc
510(k) Number K070695

Page 1 of ____________________________________________________________________________________________________________________________________________________________________

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510(k) SUMMARY lll.

JUN -- 4 2007

Submitter's Nameand Address	Boston Scientific Corporation3574 Ruffin RoadSan Diego, CA 92123
Contact Name andInformation	Brian ParkPrincipal Regulatory Affairs SpecialistPhone: (858) 503-1822Fax: (858) 292-8381
Date Prepared	April 3, 2007
ProprietaryNames	2cm Peripheral Cutting Balloon®small Peripheral Cutting Balloon® with Monorail Delivery Systemsmall Peripheral Cutting Balloon® with Over-the-Wire Delivery System
Common Name	PTA Catheter
Product Code	LIT
Classification ofDevice	Class II, 21 CFR Part 870.1250
Predicate Device	2cm Peripheral CuttingBalloon®	K041993 K051254	August 16, 2004June 22, 2005
	Small Peripheral CuttingBalloon® with Monorail DeliverySystem	K052038 K062387	August 16, 2005October 5, 2006
	Small Peripheral CuttingBalloon® with Over-the-WireDelivery System	K052038	August 16, 2005
DeviceDescription	The family of Peripheral Cutting Balloon (PCB) Catheters hasfeatures of a conventional angioplasty catheter with advancedmicrosurgical capabilities. The PCB family features a balloon with3 or 4 atherotomes (microsurgical blades) mounted longitudinallyon its outer surface. The device is inserted over a guidewire anddelivered to the target lesion. When the PCB device is inflated,the atherotomes score the plaque, creating initiation sites for crackpropagation. Percutaneous Angioplasty (PTA) with the PCBdevice allows dilatation of the target lesion with less pressure,minimizing barotrauma.
Intended Use ofDevice	PCB catheters are indicated for percutaneous transluminalangioplasty of obstructive lesions of synthetic or nativearteriovenous dialysis fistulae.
Support ofSubstantialEquivalence	There are no changes in design, composition, function or indicationof any of the proposed PCB devices compared to their respectivepredicates:
	Proposed Device	Predicate Device	510(k)	Clearance Date
	2cm PCB	2cm PCB	K041993	August 16, 2004
			K051254	June 22, 2005
	small PCB withMonorail DeliverySystem	small PCB withMonorail DeliverySystem	K052038	August 16, 2005
			K062387	October 5, 2006
	small PCB withOTW DeliverySystem	small PCB withOTW DeliverySystem	K052038	August 16, 2005
	The only change being proposed is adding a new contraindicationand a new warning in the DFU.
Conclusion	Based on the indications for use and the technologicalcharacteristics, the PCB has been shown to be equivalent inintended use and is considered to be substantially equivalent totheir respective predicate PCBs (K041993, cleared August 16,2004; K051254, cleared June 22, 2005; K052038, cleared August16, 2005; and K062387, cleared October 5, 2006.)

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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).