CRE BALLOON DILATATION CATHETER

K110833 · Boston Scientific Corporation · FDT · Apr 20, 2011 · Gastroenterology, Urology

Device Facts

• Record ID: K110833
• Device Name: CRE BALLOON DILATATION CATHETER
• Applicant: Boston Scientific Corporation
• Product Code: FDT · Gastroenterology, Urology
• Decision Date: Apr 20, 2011
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Indicated for use in adult and adolescent populations to endoscopically dilate strictures of the alimentary tract. The recommended application is printed on the package label referring to any combination of esophageal, pyloric and colonic dilatation.

Device Story

CRE Balloon Dilatation Catheter is a medical device designed for endoscopic dilation of alimentary tract strictures. It features a balloon capable of three distinct, progressively larger diameters via controlled radial expansion. The catheter is inserted through the working channel of an endoscope and accommodates a 0.035-inch guidewire. It includes a preloaded floppy-tip guidewire and a guidewire locking device at the hub to secure the wire position during procedures. Operated by physicians in clinical settings, the device allows for mechanical dilation of strictures, potentially improving patient outcomes by relieving obstructions in the digestive tract.

Clinical Evidence

Bench testing only. In-vitro testing performed on components, subassemblies, and full devices confirmed that all met required specifications.

Technological Characteristics

Balloon dilatation catheter with controlled radial expansion capability; supports 0.035-inch guidewire; includes integrated guidewire locking mechanism. Design, materials, and manufacturing processes are consistent with the predicate device.

Indications for Use

Indicated for adult and adolescent patients requiring endoscopic dilation of alimentary tract strictures, including esophageal, pyloric, and colonic regions.

Regulatory Classification

Identification

An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.

Special Controls

*Classification* —(1)*Class II (special controls).* The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.

Predicate Devices

• CRE Balloon Dilatation Catheter (K974788)

Submission Summary (Full Text)

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

May 31, 2016

Boston Scientific Corporation Endoscopy Janis Taranto Regulatory Affairs Specialist 100 Boston Scientific Way Marlborough, MA 01752

Re: K110833

> Trade/Device Name: CRETM Balloon Dilation Catheter Regulation Number: 21 CFR§ 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: II Product Code: FDT, FDF, KNQ Dated (Date on orig SE ltr): March 22, 2011 Received (Date on orig SE ltr): March 25, 2011

Dear Janis Taranto:

This letter corrects our substantially equivalent letter of April 20, 2011

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially (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.

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Page 2 - Janis Taranto

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 CFR Part 807); labeling (21 CFR 801); medical device 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 [phone] or [phone] 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/Safetw/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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

# Benjamin R. Fisher -S

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

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#### SECTION 4 INDICATIONS FOR USE STATEMENT

KII 0833 510(k) Number (if known): To Be Delemined Device Name: CRETM Balloon Dilatation Catheter Indications for Use: Indicated for use in adult and adolescent populations to endoscopically dilate strictures of the alimentary tract. The recommended application is printed on the package label referring to any combination of esophageal, pyloric and colonic dilatation.

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3

Prescription Use X (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)

Heidi Leus

ve, Gastro-Renal, and

Special 510(k) Premarket Notification, CRETM Balloon Dilatation Catheter

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SECTION 5 510(k) SUMMARY

APR 2 0 2011

#### 510(k) SUMMARY

#### 1. Submitter:

Boston Scientific Corporation 100 Boston Scientific Way Marlborough, MA 01752 Telephone: [phone] Fax: [phone]

Contact: Janis F. Taranto, M.S., RAC Regulatory Affairs Specialist Date Prepared: March 21, 2011

#### 2. Proposed Device:

Trade Name: CRE™ Balloon Dilatation Catheter Classification Name: 1) Endoscope and/or accessories 2) Dilator, esophageal Regulation Number: 1) 876.1500 2) 876.5365 Product Code: 1) KOG, 2) KNQ Classification: Class II

#### 3. Predicate Device:

K974788 Trade Name: CRE™ Balloon Dilatation Catheter Classification Name: CRE™ Balloon Dilatation Catheter Regulation Number: 1) -876.1500 2) 876.5365 Product Code: 1) KOG, 2) KNQ Classification: Class II

#### 4. Proposed Device Description:

The proposed CRE™ Balloon Dilatation Catheter is capable of 3 distinct and progressively larger size diameters via controlled radial expansion. It is designed to pass through the working channel of an endoscope and 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.

#### 5. Intended Use:

Indicated for use in adult and adolescent populations to endoscopically dilate strictures of the alimentary tract. The recommended application is printed on the package label referring to any combination of esophageal, pyloric and colonic dilatation.

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Special 510(k) Premarket Notification, CRETM Balloon Dilatation Catheter

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K 110833
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#### 6. Technological Characteristics:

The proposed CRE™ Balloon Dilatation Catheter is nearly identical in design, materials, and manufacturing processes to the predicate CRE™ Balloon Dilatation Catheter (K974788).

#### 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.

#### 8. Conclusion:

Boston Scientific Corporation has demonstrated that the proposed CRB™ Balloon Dilation Catheter is substantially equivalent to Boston Scientific Corporation's currently marketed CRE™ Balloon Dilatation Catheter (K974788).

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Special 510(k) Premarket Notification, CRETM Balloon Dilatation Catheter