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

Device Description

The PCB: small MR and OTW features a balloon with 3 or 4 atherotomes (microsurgical blades) mounted longitudinally on its outer surface. 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.

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. The Rated Burst Pressure (RBP) is 12 atm. The devices are available in nominal balloon diameters from 2.0 mm to 4.0 mm and 1.5 cm length.

The OTW devices are attached to a Y-connector at one end; the MR is attached to a female luer. The catheter body for the PCB: small OTW has two lumens. The outer lumen is the balloon inflation lumen. The inner lumen is used to pass the catheter over a guidewire.

The proximal shaft for the PCB:small MR is a hypotube. This hypotube contains the balloon inflation lumen. The distal shaft is made of Pebax material and has a lumen for balloon inflation as well as a guidewire lumen. The guidewire lumen is colored green for case of guidewire insertion. The guidewire exit port is 24 cm from the catheter tip. This port facilitates rapid exchange of the catheter. The PCB:small MR and OTW are coated with Bioslide BL at the distal section.

AI/ML Overview

This document is a 510(k) summary for a medical device called the "Peripheral Cutting Balloon (PCB): small Monorail and Over-the-Wire Delivery systems". It is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to legally marketed predicate devices.

The document does not describe the acceptance criteria and a study that proves the device meets specific acceptance criteria in the way you've outlined. Instead, it describes a submission seeking substantial equivalence to predicate devices based on bench testing and biocompatibility testing. This is a different regulatory pathway than proving performance against specific clinical efficacy or safety endpoints using a standalone or comparative effectiveness study.

Therefore, many of the requested fields cannot be directly extracted from this document, as the information is not present. Here's what can be inferred or stated based on the provided text:

1. A table of acceptance criteria and the reported device performance

This document does not provide a table of acceptance criteria with specific performance metrics (e.g., sensitivity, specificity, accuracy, etc.) for a diagnostic or AI device. It mentions "Performance Testing" which consists of "Bench testing and biocompatibility testing" to support substantial equivalence. The specific results or defined acceptance criteria for these tests are not detailed.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

Not applicable. The submission is based on bench testing and biocompatibility testing, not a clinical test set with patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

Not applicable. Ground truth as typically understood for diagnostic performance is not relevant to bench and biocompatibility testing of a physical medical device.

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

Not applicable. There is no mention of a test set requiring adjudication in the context of diagnostic performance.

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

Not applicable. This is a physical device (a catheter) and not an AI or diagnostic imaging device involved in human interpretation or a MRMC study.

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

Not applicable. This is a physical device, not an algorithm.

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

For the "Performance Testing" mentioned (bench and biocompatibility), the "ground truth" would be established by standard engineering and biological testing protocols and criteria. Specific details are not provided in this summary.

8. The sample size for the training set

Not applicable. This device does not involve a "training set" in the context of an AI or machine learning model.

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

Not applicable. See point 8.

Summary based on the document:

This document describes a 510(k) submission for a medical device (a peripheral cutting balloon catheter) seeking to establish substantial equivalence to legally marketed predicate devices.

Acceptance Criteria & Device Performance: The document states that "Bench testing and biocompatibility testing support a determination of substantial equivalence." No specific quantitative acceptance criteria or performance metrics are provided in this summary. The device's performance is, implicitly, "substantially equivalent" to the predicate devices in terms of design, fundamental technology, and intended use.
Study Type: The "study" mentioned for demonstrating equivalence involved "Bench testing and biocompatibility testing." These are laboratory-based evaluations rather than clinical trials with patient data.
Purpose: The goal was to show that the new device is as safe and effective as pre-existing devices, not to establish novel efficacy or superior performance through clinical trials.

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 consists of a stylized eagle-like symbol with three curved lines representing wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.

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 3574 Ruffin Road San Diego, CA 92123

Re: K052038

Trade/Device Name: Peripheral Cutting Balloon Small Monorail Over-The-Wire Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II (two) Product Code: PNO Dated: July 27, 2005 Received: July 28, 2005

Dear Ms. Krishnan:

This letter corrects our substantially equivalent letter of August 16, 2005.

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 - Ms. Renuka S. Krishnan

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):

K052038

Device Name:

Peripheral Cutting Balloon™: small Monorail and Over-the-Wire Delivery systems

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: 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)

Blumermon
Myles Sign Off

(Division Sign-Off) Division of Cardiovascular Deviges 510(k) Number KO5dD

Page 1 of 1

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K052038

AUG i 6 2005

510(k) SUMMARY

Boston Scientific Corporation Submitter's Name and Address 3574 Ruffin Road San Diego, CA 92123 Renuka Krishnan Contact Person Principal Specialist, Regulatory Affairs (858)203-1812 PTA catheter Common or Usual Name LIT Product Code Classification Class II Peripheral Cutting Balloon: small Monorail Proprietary Names and Over-the-Wire Delivery Systems (PCB: small MR and OTW).

Predicate Devices

Boston Scientific small Peripheral Cutting Balloon; K051254 Boston Scientific 1 cm Peripheral Cutting Balloon; K051254 and K040155 Boston Scientific 2 cm Peripheral Cutting Balloon; K051254 and K041993

Device Description

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Nom. Diameter (mm)	Over-the-Wire	Monorail
2.00	PCBO2015140F	PCBM2015140F
2.50	PCBO2515140F	PCBM2515140F
3.00	PCBO3015140F	PCBM3015140F
3.50	PCBO3515140F	PCBM3515140F
4.00	PCBO4015140F	PCBM4015140F

Table 1. Model Numbers, PCB:small MR and OTW

Catheter length: 140 cm.

Intended Use

The Peripheral Cutting Balloons are indicated for Percutaneous Transluminal Angioplasty of obstructive lesions of synthetic or native arteriovenous dialysis fistulae.

Substantial Equivalence

The PCB: small MR and OTW will incorporate a substantially equivalent design, fundamental technology and intended use as those featured in predicate devices.

Performance Testing

Bench testing and biocompatibility testing support a determination of substantial equivalence. The results of these tests provide reasonable assurance that the proposed devices have been designed and tested to assure conformance to the requirements for its intended use.

Conclusion

The PCB: small MR and OTW have been shown to be Substantially Equivalent to the predicate devices.

Page. of 2

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).