MULTIPURPOSE, NEPHROSTOMY AND BILIARY DRAINAGE CATHETERS

K093392 · Navilyst Medical, Inc. · FGE · Dec 31, 2009 · Gastroenterology, Urology

Device Facts

• Record ID: K093392
• Device Name: MULTIPURPOSE, NEPHROSTOMY AND BILIARY DRAINAGE CATHETERS
• Applicant: Navilyst Medical, Inc.
• Product Code: FGE · Gastroenterology, Urology
• Decision Date: Dec 31, 2009
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 876.5010
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Multipurpose Drainage Catheters are intended for percutaneous drainage of fluid in the chest, abdomen and pelvis, e.g., abscesses, cysts, biliary, nephrostomy, urinary, pleural empyemas, lung abscess, and mediastinal collections. Nephrostomy Drainage Catheters are intended for percutaneous drainage of fluid collections in the urinary system. Biliary Drainage Catheters are intended for percutaneous drainage of the biliary tree.

Device Story

Percutaneous drainage catheter; flexible tube with open distal tip, drainage holes, and lubricious surface. Distal end features pigtail or J-Tip configuration; some models include radiopaque marker for placement visualization. Proximal hub provides Luer lock connection for fluid collection devices. Accessories include metal or plastic stiffening cannulas and optional trocars. Used by clinicians for percutaneous drainage of fluid collections in chest, abdomen, pelvis, urinary system, and biliary tree. Device facilitates fluid removal, aiding in treatment of abscesses, cysts, and empyemas.

Clinical Evidence

Bench testing only. Biocompatibility testing performed in accordance with ISO 10993-1. Performance testing compared subject device to predicate devices to demonstrate substantial equivalence.

Technological Characteristics

Flexible tube with open distal tip, drainage holes, and lubricious surface. Pigtail or J-Tip distal configuration. Radiopaque marker on some models. Luer lock proximal hub. Accessories: metal/plastic stiffening cannulas, trocar. Biocompatibility per ISO 10993-1.

Indications for Use

Indicated for percutaneous drainage of fluid collections in the chest, abdomen, pelvis, urinary system, and biliary tree in patients requiring drainage of abscesses, cysts, empyemas, or other fluid collections.

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

• Boston Scientific Corporation Flexima Drainage Catheter (K023870)
• Boston Scientific Corporation Flexima Drainage Catheter (K944290)
• Angiodynamics Total Abscession Biliary Drainage Catheter (K060023)

Submission Summary (Full Text)

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# DEC 31 2009

## 510(k) SUMMARY

### A. Sponsor

Navilyst Medical, Inc 26 Forest Street Marlborough, MA 01752

### B. Contact

Wanda Carpinella Acting Project Manager, Global Regulatory Affairs

C. Device Name

Trade Name: Common/Usual name: Classification Name:

### D. Predicate Device(s)

Common/Usual name: Classification Name: Regulation Number: Premarket Notification:

Lorraine M. Hanley Director, Global Regulatory Affairs

To be determined Percutaneous Drainage Catheter FGE-Catheter, Biliary, Diagnostic 21CFR§876.5010, Class II LJE-Catheter, Nephrostomy Pre-Amendment, Unclassified, GBO-Catheter, Nephrostomy, General & Plastic Surgery 21CFR§878.4200, Class I GBX-Catheter, Nephrostomy, General & Plastic Surgery 21CFR§878.4200, Class I

Boston Scientific Corporation Flexima Drainage Catheter FGE-Catheter, Biliary, Diagnostic 21CFR&876.5010, Class II K023870 Boston Scientific Corporation Flexima Drainage Catheter FFA-Tube, Drainage, Subrapubic 21CFR 8876.5090, Class II K944290 Angiodynamics Total Abscession Biliary Drainage Catheter FGE-Catheter, Biliary, Diagnostic 21CFR§876.5010, Class II K060023

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#### E. Device Description

The proposed percutaneous drainage catheter consists of a flexible tube with an open distal tip, drainage holes and a lubricious surface. The distal end of the device has either a pigtail or J-Tip configuration. Some catheter models have a radiopaque marker to aid the user in placement. The proximal hub assembly of the device provides a Luer lock hub to allow the user to connect to a fluid collection device. Accessories include a Metal Stiffening Cannula and Plastic Stiffening Cannula and some sets include an additional Trocar.

#### F. Intended Use

.

- Multipurpose Drainage Catheters are intended for percutaneous drainage of fluid in the chest, . abdomen and pelvis, e.g., abscesses, cysts, biliary, nephrostomy, urinary, pleural empyemas, lung abscess, and mediastinal collections.
- Nephrostomy Drainage Catheters are intended for percutaneous drainage of fluid collections . in the urinary system.
- Biliary Drainage Catheters are intended for percutaneous drainage of the biliary tree. .

#### G. Technology Characteristics

The proposed device has similar materials, design and components and technological characteristics as currently marketed drainage catheters.

#### H. Performance Data

The proposed drainage catheters were tested and compared to predicate devices. Results of this testing demonstrate safety and effectiveness of the proposed device and substantial equivalence. Results of biocompatibility testing performed in accordance with ISO 10993-1 demonstrate the proposed device is acceptable for its intended use.

#### Conclusion l.

Based on responses to questions posed in the FDA's Decision Making Tree, the proposed devices are substantially equivalent.

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

## DEC 3 1 2009

Ms. Wanda Carpinella Acting Project Manager, Global Regulatory Affairs Navilyst Medical, Inc. 26 Forest Street MARLBOROUGH MA 01752

Re: K093392

Trade/Device Name: Percutaneous Drainage Catheter Regulation Number: 21 CFR §876.5010 Regulation Name: Biliary catheter and accessories Regulatory Class: II Product Code: FGE Dated: October 29, 2009 Received: October 30, 2009

Dear Ms. Carpinella:

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.

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 (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 [phone] or [phone] or at its Internet address

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

Sincerely yours,

Janine M. Morris

Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Abbreviated 510(K) NMI PDC 29-October-2009 Abbreviated 510(K) NMI PDC 29-October-2009

Indications for Use

510(k) Number (if Known):

Device Name:

Percutaneous Drainage Catheter

Indications for Use:

Multipurpose Drainage: Catheters are intended for percutaneous drainage of fluid in the chest, abdomen and pelvis, e.g., abscesses, cysts, biliary, nephrostomy, urinary, pleural empyemas, lung abscesses, and mediastinal collections.

Nephrostomy Drainage: Catheters are intended for percutaneous drainage of fluid collections in the urinary system.

Biliary Drainage: Catheters are intended for percutaneous drainage of the biliary tree.

Prescription Use (21 CFR 801 Subpart D)

区 And/Or

AND/OR Over-The-Counter Use: (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)


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

4-2