COAXIAL ACCORDION ERCP DEVICE, MODELS C0AC19001, COAC20005, COAC22003

K090485 · Percutaneous Systems, Incorporated · LQR · Jul 22, 2009 · Gastroenterology, Urology

Device Facts

• Record ID: K090485
• Device Name: COAXIAL ACCORDION ERCP DEVICE, MODELS C0AC19001, COAC20005, COAC22003
• Applicant: Percutaneous Systems, Incorporated
• Product Code: LQR · Gastroenterology, Urology
• Decision Date: Jul 22, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5010
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Coaxial Accordion ERCP Device is intended to be used for endoscopic removal of stones in the biliary system and for contrast injection.

Device Story

Biliary catheter device used during endoscopic retrograde cholangiopancreatography (ERCP). Consists of a catheter with an attached film membrane. Used by physicians for stone removal from the biliary system and for contrast injection. Operates as a mechanical tool for biliary intervention.

Clinical Evidence

No clinical data; performance data not required.

Technological Characteristics

Biliary catheter featuring a film membrane attached to the catheter body. Mechanical device; no electronic components or software.

Indications for Use

Indicated for endoscopic removal of biliary stones and contrast injection in patients requiring ERCP procedures.

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

• Coaxial Accordion Stone Management Device (Percutaneous Systems, Inc.)
• Fusion Extraction Balloon with Multiple Sizing (Cook Medical)

Submission Summary (Full Text)

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K090485
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JUL 2 2 2009

# 510(k) Summary

# Percutaneous Systems, Inc.'s Coaxial Accordion ERCP Device

# Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared

Percutaneous Systems, Inc. 3260 Hillview Avenue Suite 100 Palo Alto, CA 94304

| Phone: | (650) 493 - 4200 |
|------------|------------------|
| Facsimile: | (650) 493 - 4201 |

Contact Person: Thomas Lawson

Date Prepared: February 20, 2009

# Common or Usual Name

Biliary Catheter

# Classification Name

Biliary Catheter and Accessories

#### Predicate Devices

Coaxial Accordion Stone Management Device, Percutaneous Systems, Inc. Fusion Extraction Balloon with Multiple Sizing, Cook Medical

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K090485
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### Intended Use

The Coaxial Accordion ERCP Device is intended to be used for endoscopic removal of stones in the biliary system and for contrast injection.

# Technological Characteristics

The Coaxial Accordion ERCP Device consists of a film membrane attached onto a catheter.

# Performance Data

Not required.

# Substantial Equivalence

The Coaxial Accordion ERCP Device has the same intended use, indications for use, and principles of and very similar technological characteristics as the predicate devices. Thus, the Coaxial Accordion ERCP Device is substantially equivalent to the cleared predicate devices.

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Image /page/2/Picture/0 description: The image shows the seal for the Department of Health & Human Services. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 2 2 2009

Thomas Lawson, Ph.D. VP, Clinical & Regulatory Affairs Percutaneous Systems, Inc. 3260 Hillview Avenue Suite 100 PALO ALTO CA 94304

K090485 Re:

> Trade/Device Name: Coaxial Accordion ERCP Device Regulation Number: 21 CFR §876.5010 Regulation Name: Biliary catheter and accessories Regulatory Class: II Product Codes: LQR, GCA and FGE Dated: July 13, 2009 Received: July 15, 2009

Dear Dr. Lawson:

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 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/cdrl/mdr/ 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/cdrh/industry/support/index.html.

Sincerely yours,

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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# Indications for Use

510(k) Number (if known): Ko90485

Device Name: Coaxial Accordion ERCP Device

Indications for Use:

The Coaxial Accordion ERCP Device is intended to be used for endoscopic removal of stones in the biliary system and for contrast injection.

X Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

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

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