DENVER PLEURAL EFFUSION SHUNT AND DENVER PLEURAL EFFUSION SHUNT WITH EXTERNAL PUMP CHAMBER

K012235 · Denver Biomedical, Inc. · KPM · Oct 4, 2001 · Gastroenterology, Urology

Device Facts

• Record ID: K012235
• Device Name: DENVER PLEURAL EFFUSION SHUNT AND DENVER PLEURAL EFFUSION SHUNT WITH EXTERNAL PUMP CHAMBER
• Applicant: Denver Biomedical, Inc.
• Product Code: KPM · Gastroenterology, Urology
• Decision Date: Oct 4, 2001
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 876.5955
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The Denver Pleural Effusion Shunt with external pump chamber is used to palliate symptoms of recurrent pleural effusion, an accumulation of fluid in the cavity around the lungs.

Device Story

Device consists of two 15.5 Fr silicone catheters and a valved pump chamber; used to palliate recurrent pleural effusion. One catheter implanted in pleural space; second catheter terminates in abdominal cavity. Pump chamber (implanted or external) manually compressed by patient to transfer fluid from pleural space to peritoneum. Polyester cuffs included on catheters for externalized pump chamber models. Device facilitates fluid drainage to manage symptoms. No electronic components or software.

Clinical Evidence

Bench testing only. Biocompatibility testing performed on raw silicone elastomer and finished devices. Bonding verification testing conducted to ensure compatibility with existing shunt components.

Technological Characteristics

Materials: Silicone rubber, polyester cuff. Dimensions: 15.5 Fr catheters. Principle: Manual valved pump chamber for fluid transfer. Energy source: None (manual). Connectivity: None. Sterilization: Not specified.

Indications for Use

Indicated for adult, pediatric, and neonatal patients with chylothorax or intractable pleural effusion.

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.

Submission Summary (Full Text)

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KO12235

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# OCT - 4 2001

## 510(k) Summary

### Sponsor Information

Denver Biomedical, Inc. 14998 W. 6th Ave., Bldg. E700 Golden, CO 80401 303-279-7500

Contact Person: Jeff Hill, RA/QA Coordinator

This 510(k) summary was prepared on March 30, 2001.

### Device Identification

This special 510(k) is for a modification to the Denver Pleural Effusion Shunt and Pleural Effusion Shunt with External Pump Chamber. The modification is a change in the supplier of the silicone tubing used to fabricate the catheters. The new tubing is very similar to the existing tubing, and the modified devices have been found to be substantially equivalent to the original devices.

#### Intended Use

The Denver Pleural Effusion Shunt with external pump chamber is used to palliate symptoms of recurrent pleural effusion, an accumulation of fluid in the cavity around the lungs.

#### Device Description

The Denver Pleural Effusion Shunt with External Pump Chamber has three major components:

- 1. A 15.5 Fr silicone catheter, which is implanted in the pleural space and collects the accumulated pleural effusion fluid. In the shunt with the externalized pump chamber, the catheter is tunneled subcutaneously and incorporates a polyester cuff.
- 2. A valved pump chamber, which is either implanted or remains external to the body. The patient compresses the pump chamber to transfer fluid from the pleural space to the peritoneum.
- A second 15.5 Fr. silicone catheter, similar to the first, which terminates in the abdominal cav-3. ity. This catheter also bears a polyester cuff in the shunt with the externalized pump chamber.

Except for the polyester cuff, all components of the shunt are made of silicone rubber.

#### Summary of the change

The change that was the subject of the special 510(k) was a change in the silicone tubing used to manufacture the catheters. The original silicone tubing is no longer available. The specifications of the originl material have been matched as closely as possible. Testing has verified that the tubing bonds well to the other components of the shunts. Biocompatibility testing has been carried out on the raw elastomer of the silicone tubing and on the finished devices.

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Image /page/1/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a stylized eagle or bird-like symbol with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol. The text is in all capital letters and is evenly spaced around the circle.

#### Public Health Service

OCT - 4 2001

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Denver® Biomedical, Inc. c/o Nancy Sauer, RAC RDD Consultants, Inc. 401 Spruce Street LOUISVILLE CO 80027

- Re: K012235 Trade/Device Name: Denver® Pleural Effusion Shunt and Denver® Pleural Effusion Shunt with External Pump Chamber Regulation Number: 21 CFR §876.5955 Regulation Name: Peritoneo-venous shunt Regulatory Class: II Product Code: 78 KPM Dated: September 11, 2001 Received: September 17, 2001
Dear Ms. Sauer:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your becamined 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); 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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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 nredicate 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 11 you accirce 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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Page

510(k) Number (if known): KO12235

Device Name: Demier Plaural Effusion Shunts

Indications For Use:

The Denver Pleural Effusion Shunt is indicated for use in patients with

• chylothorax

.

• intractable aseptic pleural effusion

The Denver Pleural Effusion Shunt with External Pump Chamber is indicated for adult, pediatric, and neonatal patients with:

• chylothorax

· intractable pleural effusion

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Carolyn Y. Neiland

Radiological Devices
510(k) Number K01223

(Optional Format 3-10-98)

**Prescription Use** ✓