The Peripheral Cutting Balloon™ catheters are indicated for Percutaneous Transluminal Angioplasty of obstructive lesions of synthetic arteriovenous dialysis fistulae.

Device Description

The 2 cm Pcripheral Cutting Balloon (2 cm PCB) is a product line extension to the 1 cm Peripheral Cutting Balloon, and uses longer balloons to support 2 cm blades. It is available in nominal balloon diameters of 5.0 mm (Table 1). The device features a non-compliant balloon with four Atherotomes (microsurgical blades) mounted longitudinally on its outer surface. The catheter body has two lumens. The outer lumen is the balloon inflation lumen. The inner lumen is used to pass the catheter over a guidewire. Radionaque markers are placed on the guidewire tubing at the ends of the atherotomes to provide visual reference points for balloon positioning within the vessel. One end of the catheter is attached to a Y-connector, the other end is attached to the balloon. The Rated Burst Pressure (RBP) of the device is 10 atm. The device is compatible with 0.018" guide wire.

AI/ML Overview

This document is a 510(k) premarket notification for a medical device called the "2 cm Peripheral Cutting Balloon™". It does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria in the way you've outlined for an AI/algorithm-based device.

The document discusses substantial equivalence to predicate devices based on design, fundamental technology, intended use, and general performance and biocompatibility testing. It's a regulatory document for a physical medical device, not a software or AI-based diagnostic tool.

Therefore, I cannot provide the information requested in your prompt as it is not present in the provided text.

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 Ms. Renuka S. Krishnan Principal Specialist, Regulatory Affairs 3574 Ruffin Road San Diego. CA 92123

Re: K041993

2 cm Peripheral Cutting Balloon™ Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II (two) Product Code: PNO Dated: July 22, 2004 Received: July 23, 2004

Dear Ms. Krishnan:

This letter corrects our substantially equivalent letter of August 16, 2004.

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

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Page 2 - Ms. Renuka S. Krishnan

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 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 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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INDICATIONS FOR USE

K041993 510(k) Number (if known):

Device Name:

2 cm Peripheral Cutting Balloon™

Indications For Use:

The Peripheral Cutting Balloon™ catheters are indicated for Percutaneous Transluminal Angioplasty of obstructive lesions of synthetic arteriovenous dialysis fistulae.

Prescription Use: Yes (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use: No (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)

DANA R. Richards

(Division Sign-Off) (Division of Cardiovascular Devices

510(k) Number K041993

Page 1 of 1

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510(k) SUMMARY

Submitter's Name and Address	Boston Scientific Corporation3574 Ruffin RoadSan Diego, CA 92123
Contact Person	Renuka KrishnanPrincipal Specialist, Regulatory Affairs(858)503-1815
Common or Usual Name	PTA catheter
Product Code	LIT
Classification'	Class II
Proprietary Name	2 cm Peripheral Cutting Balloon™

Predicate Devices

Boston Scientific 1 cm Peripheral Cutting Balloon 114, K040155 Boston Scientific Ultra-Thin Diamond Balloon Dilatation Catheter, K960501 Polarcath ™ Peripheral Balloon Catheter system, K030742 CVSi Peripheral Balloon Catheter system, K022061

Device Description

Nom. Diameter (mm)	Catheter Length
	50 cms	90 cms	135 cms
5.0	PCB502050	PCB502090	PCB5020135
6.0	PCB602050	PCB602090	PCB6020135
7.0	PCB702050	PCB702090	PCB7020135
8.0	PCB802050	PCB802090	PCB8020135

Table 1. Model Numbers, 2 cm PCB

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Intended Use

The 2 cm Peripheral Cutting Balloon catheters are recommended for Percutaneous Transluminal Angioplasty of obstructive lesions in synthetic arteriovenous dialysis fistulae.

Substantial Equivalence

The Peripheral Cutting Balloon catheters will incorporate a substantially equivalent design, fundamental technology and intended use as those featured in predicate devices.

Performance Testing

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.

Conclusion

The 2 cm Peripheral Cutting Balloon catheter has been shown to be Substantially Equivalent to the predicate devices.

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).