EXTRACTOR PRO RX RETRIEVAL BALLONS, EXTRACTOR PRO XL RETRIEVAL BALLONS, EXTRACTOR PRO DL RETRIEVAL BALLONS MODEL M005470

K102082 · Boston Scientific Corp · FGE · Aug 23, 2010 · Gastroenterology, Urology

Device Facts

• Record ID: K102082
• Device Name: EXTRACTOR PRO RX RETRIEVAL BALLONS, EXTRACTOR PRO XL RETRIEVAL BALLONS, EXTRACTOR PRO DL RETRIEVAL BALLONS MODEL M005470
• Applicant: Boston Scientific Corp
• Product Code: FGE · Gastroenterology, Urology
• Decision Date: Aug 23, 2010
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 876.5010
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Extractor™ Pro Retrieval Balloon Catheters are indicated for use endoscopically to remove stones from the biliary system, or to facilitate injection of contrast medium while occluding the duct with the balloon.

Device Story

Extractor™ Pro Retrieval Balloon Catheters are endoscopic biliary stone retrieval devices. The catheter is inserted into the biliary system, with or without a 0.035 in. (0.89 mm) guidewire. The device features an inflatable balloon used to occlude the duct; this occlusion facilitates the injection of contrast medium through integrated ports. The device is operated by a physician during endoscopic procedures. The output is the physical removal of stones and the delivery of contrast for imaging. The device benefits patients by enabling minimally invasive stone extraction and diagnostic visualization of the biliary tract.

Clinical Evidence

Bench testing only. In-vitro testing performed on all components and subassemblies confirmed that the device met all required specifications.

Technological Characteristics

Biliary stone retrieval balloon catheter; compatible with 0.035 in. (0.89 mm) guidewires; includes injection ports for contrast medium; design and materials are similar to predicate devices (K041606, K931619).

Indications for Use

Indicated for endoscopic removal of biliary stones and facilitation of contrast medium injection via duct occlusion in patients requiring biliary intervention.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Extractor™ RX Retrieval Balloon (K041606)
• Endoscopic Biliary Stone Retrieval Catheter (K931619)
• Tri-Ex Extraction Balloon with Multiple Sizing (K040129)

Submission Summary (Full Text)

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# K102082

SECTION 5 510(k) SUMMARY

# 510(k) SUMMARY

# 1. Submitter:

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

Contact: Laurie Pannella, RAC Regulatory Affairs Specialist Date Prepared: July 23, 2010

#### 2. Proposed Device:

Trade Name: Extractor™ Pro RX Retrieval Balloon, Extractor™ Pro XL Retrieval Balloon, and Extractor™ Pro DL Retrieval Balloon Classification Name: Endoscopic Biliary Stone Retrieval Balloon Catheter (Catheter, Biliary, Diagnostic) Regulation Number: 876.5010 Product Code: FGE Classification: Class II

## 3. Predicate Device:

1

Trade Name: Extractor™ RX Retrieval Balloon Manufacturer and Clearance Number: Boston Scientific Corporation, K041606 Classification Name: Endoscopic Biliary Stone Retrieval Balloon Catheter Regulation Number: 876.5010 Product Code: FGE Classification: Class II

Trade Name: Endoscopic Biliary Stone Retrieval Catheter Manufacturer and Clearance Number: Boston Scientific Corporation, K931619 Classification Name: Catheter, Biliary, Surgical Regulation Number: 876.5010 Product Code: GCA Classification: Class II

Trade Name: Tri-Ex Extraction Balloon with Multiple Sizing Manufacturer and Clearance Number: Wilson-Cook Medical, K040129 Classification Name: Catheter, Biliary, Surgical Regulation Number: 876.5010 Product Code: GCA . . Classification: Class II

AUG 2 3 2010

000013

Special 510(k) Premarket Notification, Extractor™ Pro Retrieval Balloon Catheters

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## 4. Proposed Device Description:

Extractor™ Pro Retrieval Balloon Catheters are a stone retrieval balloon catheter used for biliary stone retrieval.

- . The catheter may be placed with or without the aid of a guidewire.
- . The catheter is capable of accepting a 0.035 in. (0.89 mm) guidewire
- Injection ports for contrast are set either below or above the retrieval balloon. .

## 5. Intended Use:

The Extractor™ Pro Retrieval Balloon Catheters are indicated for use endoscopically to remove stones from the biliary system, or to facilitate injection of contrast medium while occluding the duct with the balloon.

#### 6. Technological Characteristics:

The proposed Extractor™ Pro Retrieval Balloon Catheters are similar in design, materials, and manufacturing processes to the predicate Extractor™ RX Retrieval Balloon (K041606) and Endoscopic Biliary Stone Retrieval Catheter (K931619).

# 7. Performance Data:

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

## 8. Conclusion:

Boston Scientific Corporation has demonstrated that the proposed Extractor™ Pro Retrieval Balloon Catheters are substantially equivalent to Boston Scientific Corporation's currently marketed Extractor™ RX Retrieval Balloon (K041606) and Endoscopic Biliary Stone Retrieval Catheter (K931619).

# 000014

Special 510(k) Premarket Notification, Extractor™ Pro Retrieval Balloon Catheters

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# SECTION 6 TRUTHFUL AND ACCURACY STATMENT

# Premarket Notification Truthful and Accurate Statement (As Required by 21 CFR 807.87(k))

I certify that, in my capacity as a Regulatory Affairs Specialist at Boston Scientific Corporation, I believe to the best of my knowledge that all data and information submitted in this premarket notification are truthful and accurate and that no material fact has been omitted.

\$\lim_{x \to \infty} \frac{x^2}{e^x} = 0\$

\$\lim_{x \to \infty} \frac{x^n}{e^x} = 0\$

\$\lim_{x \to \infty} \frac{\ln x}{x} = 0\$

\$\lim_{x \to 0^+} x \ln x = 0\$

\$\lim_{x \to \infty} x^{1/x} = 1\$

\$\lim_{x \to 0} (1+x)^{1/x} = e\$

\$\lim_{x \to \infty} (1+\frac{1}{x})^x = e\$

\$\lim_{n \to \infty} \sqrt[n]{n} = 1\$

\$\lim_{n \to \infty} \frac{x^n}{n!} = 0\$

\$\lim_{n \to \infty} (1-\frac{1}{n})^n = \frac{1}{e}\$

Laurie Pannella, RAC Regulatory Affairs Specialist Boston Scientific Corporation

July 23, 2010 Date

000015

Special 510(k) Premarket Notification, Extractor™ Pro Retrieval Balloon Catheters Proprietary and Confidential Information of Boston Scientific Corporation

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Image /page/3/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo is circular and features an abstract image of an eagle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is written around the perimeter of the circle.

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

Ms. Laurie Pannella Regulatory Affairs Specialist Boston Scientific Corporation 100 Boston Scientific Way MARLBOROUGH MA 01752

AUG 2 3 2010

Re: K102082

Trade/Device Name: Extractor™ Pro Retrieval Balloon Catheter Regulation Number: 21 CFR& 876,5010 Regulation Name: Biliary catheter and accessories Regulatory Class: II Product Code: FGE Dated: July 23, 2010 Received: July 26, 2010

Dear Ms. Pannella:

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 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 Part 801); medical device reporting of medical device-related

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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/CDRH0ffices/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 [phone] or [phone] or at its Internet address

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

Sincerely yours.

Hubert Lenoir MD

Herbert P. Lerner, M.D., Director (Acting) Division of Reproductive. Gastro-Renal and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

#### Enclosure

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K102082

# SECTION 4 INDICATIONS FOR USE STATEMENT

510(k) Number (if known):

To Be Determined

Device Name:

Indications For Use:

Extractor™ Pro Retrieval Balloon Catheter

The Extractor™ Pro Retrieval Balloon Catheters are indicated for use endoscopically to remove stones from the biliary system, or to facilitate injection of contrast medium while occluding the duct with the balloon.

102002

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)

1

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devic 510(k) Number

000012

Special 510(k) Premarket Notification, Extractor™ Pro Retrieval Balloon Catheters