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

Device Description

The Peripheral Cutting Balloon (PCB) is available in nominal balloon diameters of 5.0 mm to 8.0 mm (Table 1). The device features a non-compliant balloon with four Atherotomes (microsurgical blades) mounted longitudinally on its outer surface. The proximal end of the balloon is equipped with a stainless folding spring to enhance balloon refold. The spring consists of a collar, proximal to the balloon cone; and four fingers that extend across the balloon cone and terminate before the pads that hold the atherolomes to the surface of the balloon. 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. Radiopaque markers are placed on the guidewire tubing at the ends of the atherotomes to provide visual reference points for balloon positioning within the vessel.

AI/ML Overview

The provided text describes the 510(k) summary for the Boston Scientific Peripheral Cutting Balloon. It includes information on performance testing (bench and biocompatibility) and a clinical study (Cutting EDGE trial). However, the information provided focuses on the substantial equivalence to predicate devices rather than specific acceptance criteria thresholds the device had to meet. The study's primary purpose was to compare the Peripheral Cutting Balloon to conventional angioplasty, not to prove the device met predetermined acceptance criteria against a specific numerical benchmark.

Therefore, I cannot populate all the requested fields as the document does not explicitly state "acceptance criteria" for the device's performance in the way a traditional validation study might. Instead, it presents comparative efficacy and safety data against a control group (conventional angioplasty) and references general guidelines (KDOQI) for expected patency rates.

However, I can extract information related to the clinical study and its findings.

Here's the information based on the provided text, with "N/A" for criteria not explicitly stated:

Acceptance Criteria and Device Performance

Acceptance Criteria (Stated or Implied)	Reported Device Performance (Peripheral Cutting Balloon - PCB)
Primary Patency (6 months)	47.9% PCB vs. 40.5% PTA (p=0.37)
For stenosed grafts	51.3% PCB vs. 46.9% PTA (p=0.84)
For thrombosed grafts	43.1% PCB vs. 32.0% PTA (p=0.15)
Procedural Success	Not significantly different from PTA (p=0.24)
Hemodialysis Access Circuit Patency (6 months)	Not significantly different from PTA (p=0.45)
Mean Number of Target Lesion Reinterventions (6 months)	Not significantly different from PTA (p=0.22)
For thrombosed grafts	0.7 PCB vs. 1.0 PTA (marginally significant, p=0.06)
Device-Related Adverse Events (Dissections)	1.7% (3/173) PCB vs. 0% PTA
Device-Related Adverse Events (Perforations)	2.9% (5/173) PCB vs. 0% PTA
Overall Safety and Effectiveness	Not significantly different from conventional angioplasty

Notes on Acceptance Criteria:

The document implies that "not significantly different from conventional angioplasty in overall safety and effectiveness" was a key criterion for demonstrating substantial equivalence.
For patency rates, the document references KDOQI guidelines as benchmarks for "achievable" or "typical" rates, suggesting these were considered relevant for comparison. For example, for stenosed grafts, KDOQI suggests ~50% at 6 months, and the PCB achieved 51.3%. For thrombosed grafts, KDOQI suggests ~40% at 3 months and 20% at 6 months; the PCB's 43.1% at 6 months was noted as "more than double the expected rate."
For complication rates, the document compares the PCB's perforation rate (2.9%) to literature-based expected rates of 2% to 4%, indicating that falling within this range was acceptable.

Study Details

Sample Size used for the test set and the data provenance:
- Sample Size: 340 patients (173 in Peripheral Cutting Balloon arm, 167 in PTA arm).
- Data Provenance: The study was a "prospectively randomized clinical trial," and data was collected from "27 centers in the US."
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not explicitly stated for specific ground truth establishment.
- Qualifications of Experts: An "Adverse events were adjudicated by a CEC" (Clinical Events Committee), and a "DSMB reviewed safety information throughout the enrollment portion of the study." Specific qualifications of CEC or DSMB members are not detailed.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- "Adverse events were adjudicated by a CEC" (Clinical Events Committee). The specific method (e.g., 2+1) is not provided.
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 was a clinical trial comparing a device (Peripheral Cutting Balloon) to another medical intervention (conventional angioplasty - PTA), not an MRMC study involving human readers or AI. So, N/A.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This information pertains to an AI/algorithm. This device is a physical medical device. So, N/A.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The study used outcomes data, specifically "primary patency through 6 months post-procedure," "access circuit primary patency," "procedural success," "number of target lesion reinterventions," and "occurrence of adverse events."
- Adverse events were "adjudicated by a CEC."
The sample size for the training set:
- This document describes a clinical trial for substantial equivalence, not a machine learning study. Therefore, there's no "training set" in the context of an algorithm. So, N/A.
How the ground truth for the training set was established:
- As there is no training set for an algorithm, this question is N/A.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with outstretched wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the emblem.

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

May 31, 2016

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

Re: K040155

Peripheral Cutting Balloon Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II (two) Product Code: PNO Dated: April 28, 2004 Received: April 29, 2004

Dear Ms. Krishnan:

This letter corrects our substantially equivalent letter of July 1, 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/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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INDICATIONS FOR USE

510(k) Number (if known): K040155

Device Name:

Peripheral Cutting Balloon"M

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)

(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K040/55/5/

Page I of ____________________________________________________________________________________________________________________________________________________________________

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K04-01-5

'JUL - 1 2004

510(k) SUMMARY

Submitter's Name and Address	Boston Scientific Corporation3574 Ruffin RoadSan Diego, CA 92123
Contact Person	Paul Mason, Ph.DDirector, Regulatory Affairs(858)268-4488 x 2869
Common or Usual Name	PTA catheter
Product Code	LIT
Classification	Class II
Proprietary Name	Peripheral Cutting Balloon™

Predicate Devices

Boston Scientific Ultra-Thin Diamond Balloon Dilatation Catheter, K960501 Polarcath™ Peripheral Balloon Catheter system, K022061 CVSi Peripheral Balloon Catheter system, K030742

Device Description

Nom. Diameter	Catheter Length
	50 cm	90 cm	135 cm
5.0 mm	BP505010	BP905010	BP1355010
5.5mm	BP505510	BP905510	BP1355510
6.0mm	BP506010	BP906010	BP1356010
7.0mm	BP505010	BP907010	BP1357010
8.0 mm	BP508010	BP908010	BP1358010

Table 1. Model Numbers, 1 cm PCB

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Intended Use

The Peripheral Cutting Balloon catheters are recommended for Percutancous 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 cquivalence. 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.

Clinical Experience

The 1 cm Peripheral Cutting Balloon™ was studied in a prospectively randomized clinical trial, Cutting EDGE (CUTTING Balloon HEmoDialysis Access ManaGEment Trial) that compared the Peripheral Cutting Balloon to conventional angioplasty (PTA) in the treatment of stenosed or thrombosed synthetic hemodialysis grafts. The study enrolled 340 patients, 173 in the Peripheral Cutting Balloon arm and 167 in the PTA arm at 27 centers in the US. The primary endpoint was primary patency through 6 months post-procedure. Secondary efficacy endpoints included: access circuit primary patency; procedural success; and the number of target lesion reinterventions through 6 months. Secondary endpoints also included safety: occurrence of adverse events. Adverse events were adjudicated by a CEC; a DSMB reviewed safety information throughout the enrollment portion of the study.

The Peripheral Cutting Balloon is not signficantly different from PTA with respect to the rate of target lesion primary patency through 6 months post-proccdure: 47.9% pcs vs. 40.5% PTA.D=0.37.

The target lesion primary patency rates for subjects with stenosed grafts were not significantly different: 51.3% Kir vs. 46.9% PTA . p = 0.84. The national Kidney Foundation; Kidney Disease Outcome Quality Initiative for Vascular Access (KDOQI) suggests achievable primary patency rates in this group of patients to be about 50% at 6 months.

The PCB target lesion primary patency for thrombosed grafts was greater but not significant: 43.1% PCB vs. 32.0% PTA, p = 0.15. KDOQI guidelines suggest that 40% patency is typical at 3 months; the Quality Improvement Guidelines for Percutancous Management of the Thrombosed or Dysfunctional Dialysis Access suggest that 20% patency is typical at 6 months. The target lesion primary patency rate for subjects

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treated with the Peripheral Cutting Balloon was more than double the expected rate, suggesting a clinical benefit.

Sccondary efficacy endpoints did not differ significantly between treatments: procedural success, p = 0.24; hemodialysis access circuit patency at 6-months, p = 0.45; mean number of target lesion reinterventions through 6 months, n = 0.22. Subjects with thrombosed grafts had fewer target lesion interventions after treatment with the Peripheral Cutting Balloon; the difference between means is marginally significant: 0.7 pcu vs. 1.0 pra, p = 0.06.

Device-related events, limited to dissections and perforations, were significantly more frequent in the Peripheral Cutting Balloon arm: 1.7% (3/173) dissections and 2.9% (5/173) perforations after use of the Peripheral Cutting Balloon vs. no events in the PTA arm (p = 0.007). When the dissection and perforation rates are considered independently, rather than pooled, the rates are not significantly different. Two of the cases (one perforation and one dissection) are protocol deviations because the Peripheral Cutting Balloon was oversized beyond the limits specified in the Directions for Use. The Quality Improvement Guidelines for Percutaneous Management of the Thrombosed or Dysfunctional Dialysis Access, updated in 2003, summarizes published complication rates. Based on the literature, the expected rate of vascular perforations or ruptures from the perculaneous management of hemodialysis is 2% to 4%. The Peripheral Cutting Balloon perforation rate of 2.9% falls within this expected range.

Only PTA balloons were used for reinterventions; 213 reinterventions were recorded during the trial. Among these reintervention procedures, there were two procedurerelated vessel ruptures and two device-related perforations. Although no vessel perforations or ruptures occurred with PTA at the index procedure, these expected events did occur during reinterventions.

In summary, the Peripheral Cutting Balloon™ is not significantly different from conventional angioplasty in overall safety and effectiveness.

Conclusion

The 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).