DENVER ASCITES SHUNTS, DENVER ASCITES SHUNT PERCUTANEOUS ACCESS KITS

K973129 · Denver Biomaterials, Inc. · KPM · Mar 17, 1998 · Gastroenterology, Urology

Device Facts

• Record ID: K973129
• Device Name: DENVER ASCITES SHUNTS, DENVER ASCITES SHUNT PERCUTANEOUS ACCESS KITS
• Applicant: Denver Biomaterials, Inc.
• Product Code: KPM · Gastroenterology, Urology
• Decision Date: Mar 17, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5955
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

Drainage of persistent ascites from the abdominal cavity into the venous system, for use in patients with: chronic liver disease whose ascites has not responded to surgical correction of their portal hypertension nor to standard medical management persistent ascites who are not considered candidates for portal-venous shunting persistent ascites which is non-responsive to standard medical management primary or metastatic intra-abdominal neoplasms with massive ascites to help relieve intra-abdominal pressure persistent ascites with hepatorenal syndrome, chylous ascites, and idiopathic ascites

Device Story

Peritoneovenous shunt for drainage of persistent ascites from abdominal cavity to venous system. Device consists of shunt and percutaneous access kits. Operates via pressure-driven fluid transfer. Used in clinical settings by physicians. Subject devices feature a specific surface treatment applied during manufacturing; excludes TDMAC-Heparin coating found in previous versions. Intended to relieve intra-abdominal pressure and manage refractory ascites.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and design similarities to predicate devices.

Technological Characteristics

Peritoneovenous shunt system. Materials and dimensions identical to predicate devices. Features a specific surface treatment applied during manufacturing. Does not contain TDMAC-Heparin. Mechanical device; no energy source or software components.

Indications for Use

Indicated for patients with persistent ascites due to chronic liver disease (refractory to surgery/medical management), non-candidates for portal-venous shunting, non-responsive ascites, primary/metastatic intra-abdominal neoplasms, hepatorenal syndrome, chylous ascites, or idiopathic ascites.

Regulatory Classification

Identification

A peritoneo-venous shunt is an implanted device that consists of a catheter and a pressure activated one-way valve. The catheter is implanted with one end in the peritoneal cavity and the other in a large vein. This device enables ascitic fluid in the peritoneal cavity to flow into the venous system for the treatment of intractable ascites.

Special Controls

*Classification.* Class II. The special controls for this device are FDA's:(1) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Devices—Part I: Evaluation and Testing,’ ” (2) “510(k) Sterility Review Guidance of 2/12/90 (K90-1),” and (3) Backflow specification and testing to prevent reflux of blood into the shunt.

Predicate Devices

• Denver® Ascites Shunts (K894756)
• Denver® Ascites Shunt Percutaneous Access Kits (K913728)

Reference Devices

• Smith & Nephew Ventilation Tubes

Submission Summary (Full Text)

{0}------------------------------------------------

K973/29 P½

MAR 17 1998

## Summary of Safety and Effectiveness Denver® Ascites Shunts Denver® Ascites Shunt Percutaneous Access Kits

#### SUBMITTER INFORMATION

Denver Biomaterials, Inc. 14998 W. 6th Avenue, Bldg. E700 Golden, Colorado 80401 USA

Bonnie Vivian Vice President

DEVICE COMMON NAME

Peritoneovenous Shunt

DEVICE CLASSIFICATION NAME

Peritoneo-venous Shunt

IDENTIFICATION OF SUBSTANTIALLY EQUIVALENT DEVICE (S)

The devices are substantially equivalent to the currently marketed Denver® Ascites Shunts and Denver® Ascites Shunt Percutaneous Access Kits. The devices have the same intended use, materials, configuration and dimensional specifications as the currently marketed Denver® Ascites Shunts (K894756) and Denver® Ascites Shunt Percutaneous Access Kits (K913728).

The devices differ in that:

The devices covered by this submission undergo a surface 1) treatment as part of the manufacturing process. No TDMAC-Heparin is applied to the devices covered by this 2) submission.

The devices are also substantially equivalent to Smith & Nephew Ventilation Tubes in that they both undergo this surface treatment as part of the manufacturing process.

The manufacturing process changes that are the subject of this submission should not raise new issues of safety and/or effectivenenss.

#### INTENDED USE

Drainage of persistent ascites from the abdominal cavity into the venous system, for use in patients with:

{1}------------------------------------------------

*chronic liver disease whose ascites has not responded to "chronic fiver dibease whole portal hypertension nor to standard medical management

*persistent ascites who are not considered candidates for portalvenous shunting

*persistent ascites which is non-responsive to standard medical management

*primary or metastatic intra-abdominal neoplasms with massive ascites to help relieve intra-abdominal pressure

*persistent ascites with hepatorenal syndrome, chylous ascites, and idiopathic ascites

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three heads, representing the department's mission to protect the health of all Americans and provide essential human services. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circle around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 7 1998

Ms. Bonnie B. Vivian Vice President Denver Biomaterials, Inc. 14998 W. 6th Avenue, Bldg. E700 Golden, Colorado 80401

Re: K973129 Denver Ascites Shunts and Percutaneous Access Kits December 18, 1997 Dated: Received: December 19, 1998 Regulatory Class: III 21 CFR 876.5955/Product Code: 78 KPM

Dear Ms. Vivian:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions of the Act. However, you are responsible to determine that the medical devices you use as components in the kit have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were legally on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. Please note: If you purchase your device components in bulk (i.e., unfinished) and further process (e.q., sterilize) you must submit a new 510(k) before including these components in your kit. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, and labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval) it may be subject to such additional controls. Existing major regulations affecting your device, , . . can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, the Food and Drug Administration (FDA) may publish further announcements concerning your device in the Federal Register.

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Page - 2 - Ms. Bonnie B. Vivian

Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal Laws or Regulations.

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 the labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll free number [phone] or [phone], or at its Internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Robert R Satting/

\$\xi\$

Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### INDICATIONS FOR USE

# 510(k) Number: к 97 3/29

Denver® Ascites Shunts Device Name: Denver® Ascites Shunt Percutaneous Access Kits

Indications

For Use:

Drainage of persistent ascites from the abdominal cavity into the venous system, for use in patients with: *chronic liver disease whose ascites has not

responded to surgical correction of their portal hypertension nor to standard medical management

*persistent ascites who are not considered candidates for portal-venous shunting

*persistent ascites which is non-responsive to standard medical management

*primary or metastatic intra-abdominal neoplasms with massive ascites to help relieve intraabdominal pressure

*persistent ascites with hepatorenal syndrome, chylous ascites, and idiopathic ascites

-------Concurrence of CDRH, Office of Device Evaluation (ODE)

Robert D. Rathbun

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

Prescription Use: Yes
(Per 21 CFR 801.109)

Over-The-Counter Use: No

OR