FLEXIMA BILIARY CATHETER

K023870 · Boston Scientific/Medi-Tech · FGE · Dec 20, 2002 · Gastroenterology, Urology

Device Facts

• Record ID: K023870
• Device Name: FLEXIMA BILIARY CATHETER
• Applicant: Boston Scientific/Medi-Tech
• Product Code: FGE · Gastroenterology, Urology
• Decision Date: Dec 20, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 876.5010
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Flexima Biliary Catheter is designed for external and internal percutaneous drainage of the biliary system.

Device Story

The Flexima Biliary Catheter is a medical device designed for the percutaneous drainage of the biliary system, supporting both internal and external drainage applications. The device assembly consists of a drainage catheter, a metal stiffening cannula, a flexible stiffening cannula, and a luer cap. It is intended for use by healthcare professionals in a clinical setting to manage biliary drainage. By providing a pathway for fluid, the catheter assists in the decompression or drainage of the biliary tract, potentially benefiting patients with biliary obstructions or related conditions.

Clinical Evidence

Bench testing only.

Technological Characteristics

The device consists of a drainage catheter, metal stiffening cannula, flexible stiffening cannula, and luer cap. It is a Class II biliary catheter (Product Code: 78 FGE).

Indications for Use

Indicated for patients requiring external or internal percutaneous drainage of the biliary system.

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

• Flexima Biliary Catheter

Submission Summary (Full Text)

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Special 510(k) Flexima™ Biliary Catheter Boston Scientific Corporation

DEC 2 0 2002

## Summary of Safety and Effectiveness

This 510(k) summary is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.

| General<br>Information | Submitter: Boston Scientific Corporation<br>780 Brookside Drive<br>Spencer, IN 47460<br>Contact Person: Nicholas Condakes |
|-------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| General<br>Provisions | Trade Name: Flexima Biliary Catheter<br>Classification Name: Biliary Catheter and Accessories |
| Name of<br>Predicate<br>Devices | Flexima Biliary Catheter |
| Classification | Class II |
| Performance<br>Standards | Performance Standards have not been established by FDA under Section 514<br>of the Food, Drug and Cosmetic Act |
| Intended Use<br>and Device<br>Description | The<br>Flexima Biliary Catheter is designed for external and internal<br>percutaneous drainage of the biliary system. The major components of the<br>Flexima Biliary Catheter are the drainage catheter, metal stiffening cannula,<br>flexible stiffening cannula and luer cap. |
| Summary of<br>Substantial<br>Equivalence | The Flexima Biliary Catheters have been tested and compared to the predicate<br>device. All data gathered demonstrate this device as substantially equivalent.<br>No new issues of safety or efficacy have been raised. |

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three overlapping profiles, suggesting a sense of community and service.

#### Public Health Service

DEC 2 0 2002

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Nicholas Condakes Regulatory Affairs Specialist II Boston Scientific Medi-Tech® Boston Scientific Corporation One Boston Scientific Place NATICK MA 01760-1537

Re: K023870

Trade/Device Name: Flexima™ Biliary Drainage Catheter Regulation Number: 21 CFR §876.5010 Regulation Name: Biliary catheter and accessories Regulatory Class: II Product Code: 78 FGE Dated: November 19, 2002 Received: November 20, 2002

Dear Mr. Condakes:

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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

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); 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.

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Page 2

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

| 8xx.1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/cdrh/dsma/dsmamain.html.

Sincerely yours,

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Special 510(k) Flexima™ Biliary Catheter Boston Scientific Corporation

K023870 0-0 0 0 6 3

・

# Indications For Use

| 510(k) Number (if known) | |
|--------------------------|-----------------------------------------------------------------------------------------------------------------|
| Device Name: | Flexima™ Biliary Catheter |
| Indications for Use | The Flexima Biliary Catheter is designed for external and internal percutaneous drainage of the biliary system. |

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Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use (Per 21 CFR 801.109) | <div> <div style="text-align:center;">OR</div> Over-The Counter Use (Optional Format 1-2-96) </div> |
|---------------------------------------|--------------------------------------------------------------------------------------------------------------|
|---------------------------------------|--------------------------------------------------------------------------------------------------------------|

(Division Sign Off)

Division of Reproductive, Abdominal,

and Peripheral Devices

| 510(k) Number | k023870 |
|---------------|---------|
|---------------|---------|

Confidential

Boston Scientific Corporation