The CRE™ Wireguided Balloon Dilatation Catheter is indicated for use in adult and adolescent populations to endoscopically dilate strictures of the alimentary tract. It is also indicated in adults for endoscopic dilatation of the Sphincter of Oddi with or without prior sphincterotomy.

Device Description

The CRE™ Wireguided Balloon Dilatation Catheter is capable of 3 distinct and progressively larger size diameters via controlled radial expansion. Specific balloon sizes are printed on each package and hub label.

The CRETM Wireguided Balloon Dilatation Catheter is designed to pass through a 2,8mm or greater working channel of an endoscope and a 3.2 or 4.2 mm (depending on the balloon) or greater working channel of a duodenoscope. It will also accept a 0.035 in (0.89 mm) guidewire through its guidewire lumen. This catheter comes packaged with a 0.035 in (0.89 mm), floppy tip guidewire preloaded in the guidewire lumen. The guidewire is 25 cm longer than the balloon catheter with the excess length extending from the hub end of the catheter.

A guidewire locking device is attached to the guidewire hub of the catheter. The locking device will be packaged in the "OFF" or unlocked position. The guidewire may only be advanced or removed from the catheter when the switch on the locking device is in the "OFF" position. The guidewire may be held in place within the catheter by moving the switch to the "ON" position.

AI/ML Overview

Here's an analysis of the provided text regarding the CRE Dilatation Balloon, focusing on the acceptance criteria and the study used to demonstrate its performance:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria	Reported Device Performance	Comments
Mechanical/Physical Performance	Meets required specifications for all components, subassemblies, and/or full devices.	"In-vitro testing has been performed and all components, subassemblies, and/or full devices met the required specifications for the completed tests."	The specific "required specifications" are not detailed in the document. This is a general statement that the device passed internal benchmarks.
Safety and Effectiveness	Supports the safety and effectiveness for indicated uses (dilation of strictures of the biliary tree and Sphincter of Oddi).	"A clinical literature search was conducted and the resulting data supports the safety and effectiveness of the CRE™ Wireguided Balloon Dilatation Catheter for dilation of strictures of the biliary tree and the Sphincter of Oddi with or without prior sphincterotomy."	The device's safety and effectiveness were supported by reviewing existing clinical literature, implying no new clinical trials were conducted for this 510(k) submission.
Substantial Equivalence	Identical in design, materials, and manufacturing processes to a predicate device.	"The proposed CRE™ Wireguided Balloon Dilatation Catheter is identical in design, materials, and manufacturing processes to the predicate CRE™ Wireguided Balloon Dilatation Catheter (K110833)."	This is a primary acceptance criterion for 510(k) clearances. The device is claimed to be identical to a previously cleared model for these key aspects.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: The document does not specify a sample size for a test set involving the new CRE™ Wireguided Balloon Dilatation Catheter. The primary performance demonstration relies on in-vitro testing and a clinical literature search.
Data Provenance:
- In-vitro testing: Performed internally by Boston Scientific Corporation. No country of origin is specified, but it can be inferred as originating from the manufacturer's own labs. This is typically prospective in nature for a new device's engineering verification.
- Clinical Literature Search: This implies the use of existing published data from various sources (not specified). This would be retrospective data from prior studies on similar devices or the predicate device itself.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Not applicable. The document does not describe a clinical study where a "test set" with ground truth established by experts was used for the new device. The clinical literature review likely synthesized findings from multiple studies, where individual studies might have involved expert assessments, but this is not broken down here. For the in-vitro testing, "ground truth" would be the engineering specifications and performance metrics.

4. Adjudication Method for the Test Set

Not applicable. As no clinical "test set" requiring expert adjudication is described for the new device itself beyond the literature review, no adjudication method is mentioned.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. An MRMC study was not performed for this 510(k) submission. The document relies on in-vitro testing and a clinical literature review for performance data.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Not applicable. This device is a medical instrument (balloon catheter), not an algorithm or AI system. Therefore, the concept of "standalone algorithm performance" is not relevant here. The device's performance is inherently tied to its physical interaction and use by a human clinician.

7. The Type of Ground Truth Used

For the in-vitro testing: The ground truth would be defined by engineering specifications and performance criteria established prior to testing.
For the clinical literature search: The "ground truth" is inferred from the collective findings and conclusions of the peer-reviewed scientific literature regarding the safety and effectiveness of similar dilatation catheters. This most closely aligns with expert consensus or outcomes data reported in those studies.

8. The Sample Size for the Training Set

Not applicable. This 510(k) pertains to a medical device, not an AI/ML algorithm that requires a "training set."

9. How the Ground Truth for the Training Set Was Established

Not applicable. As this is not an AI/ML algorithm, there is no "training set" or corresponding ground truth establishment process to describe.

Summary of Device Performance Study:

The Boston Scientific CRE™ Wireguided Balloon Dilatation Catheter's performance demonstration for 510(k) clearance relied on two primary pillars:

In-vitro testing: This involved laboratory tests to ensure the device components and assemblies met predefined engineering specifications. The specific tests or their results are not detailed, but the document states they "met the required specifications." This type of testing is fundamental for demonstrating the physical integrity and functional performance of a medical device.
Clinical Literature Search: Instead of conducting new clinical trials, the manufacturer performed a literature review. This review compiled existing data and studies on similar or predicate devices to support the safety and effectiveness of balloon dilatation catheters for the specified indications (alimentary tract strictures, Sphincter of Oddi dilatation). This approach is common for 510(k) submissions, particularly when a new device is substantially equivalent to a well-established predicate.

The crucial aspect of this submission, explicitly stated, is that the proposed device is identical in design, materials, and manufacturing processes to a previously cleared predicate device (K110833). This "substantial equivalence" is the cornerstone of its clearance without extensive new clinical data.

Summary

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K112994.
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FEB 1 0 2012

510(k) SUMMARY

1. Submitter

Boston Scientific Corporation 100 Boston Scientific Way Marlborough, MA 01752 Telephone: 508-683-4560 Fax: 508-683-5939

Contact: Janis F. Taranto M.S., RAC Regulatory Affairs Specialist Date Prepared: October 9, 2011

2. Device

Trade Name: CRE Dilatation Balloon Common Name: CRE Wireguided Dilatation Balloon Classification Name: 1) Endoscope and/or accessories, 2) dilator, esophageal, 3) Catheter, Biliary, Diagnostic Regulation Number: 1) 876.5010, 2) 876.5365, 3) 876.5010 Product Code: 1) KOG, 2) KNQ, 3) FGE Classification: Class II

3. Predicate Devices

Trade Name: CRE Dilatation Balloon Manufacturer and Clearance Number: Boston Scientific Corporation, K110833 Classification Name: 1) Endoscope and/or accessories, 2) dilator, esophageal Regulation Number: 1) 876.5010, 2) 876.5365 Product Code: 1) KOG, 2) KNQ Classification: Class II

Trade Name: Hurricane RX Biliary Balloon Dilatation Catheter Manufacturer and Clearance Number: Boston Scientific Corporation K001338 Classification Name: Catheter, Biliary, Diagnostic Regulation Number: 876.5010 Product Code: FGE Classification: II

Trade Name: Maxforce Biliary Manufacturer and Clearance Number: Boston Scientific Corporation, K910931 Classification Name: Catheter, Biliary, Diagnostic Regulation Number: 876.5010 Product Code: FGE Classification: II

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K.112994
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4. Device Description

5. Indication for Use:

The CRETM Wireguided Balloon Dilatation Catheter is indicated for use in adult and adolescent populations to endoscopically dilate strictures of the alimentary tract. It is also indicated in adults for endoscopic dilatation of the Sphincter of Oddi with or without prior sphincterotomy.

6. Technological Characteristics:

The proposed CRE™ Wireguided Balloon Dilatation Catheter is identical in design, materials, and manufacturing processes to the predicate CRE™ Wireguided Balloon Dilatation Catheter (K110833).

7. Performance Data:

In-vitro testing has been performed and all components, subassemblies, and/or full devices met the required specifications for the completed tests.

A clinical literature search was conducted and the resulting data supports the safety and effectiveness of the CRE™ Wireguided Balloon Dilatation Catheter for dilation of strictures of the biliary tree and the Sphincter of Oddi with or without prior sphincterotomy.

8. Conclusion:

Boston Scientific Corporation has demonstrated that the proposed CRETM Wireguided Balloon Dilatation Catheter is substantially equivalent to Boston Scientific Corporation's currently marketed CRE™ Wireguided Balloon Dilatation Catheter (K110833), Hurricane RX Biliary Balloon Dilatation Catheter (K001338) and Maxforce Biliary Balloon Dilatation Catheter (K910931).

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular pattern around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.

Public Health Service

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

Janis F. Taranto, M.S. RAC Regulatory Affairs Specialist Boston Scientific Corporation Endoscopy 100 Boston Scientific Way MARLBOROUGH MA 01752

FEB 1 0 2012

K112994 Re:

Trade Name: CRE™ Wireguided Balloon Dilatation Catheter Regulation Number: 21 CFR §876.5010 Regulation Name: Biliary catheter and accessories Regulatory Class: II Product Code: FGE Dated: February 9, 2012 Received: February 10, 2012

Dear Ms. Taranto:

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 r read or at hose 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

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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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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,

Benjamin R. Civiletti

Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE

STATEMENT

510(k) Number (if known): K112994

Device Name: CRETM Wireguided Balloon Dilatation Catheter

Indications for Use:

Prescription Use _ X (Part 21 CFR 801 Part 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)

Carolyn Y Newland for Herb Lenner

Division of Reproductive, Gastro-Renal, and
Urological Devices
510(k) Number K112994

Regulation Number and Section

§ 876.5010 Biliary catheter and accessories.

(a)
Identification. A biliary catheter and accessories is a tubular flexible device used for temporary or prolonged drainage of the biliary tract, for splinting of the bile duct during healing, or for preventing stricture of the bile duct. This generic type of device may include a bile collecting bag that is attached to the biliary catheter by a connector and fastened to the patient with a strap.(b)
Classification. Class II (special controls). The device, when it is a bile collecting bag or a surgical biliary catheter that does not include a balloon component, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.