DENVER PLEURX DRAINAGE KIT AND DENVER PLEURX VACUUM BOTTLE WITH DRAINAGE LINE

K051084 · Denver Biomedicals, Inc. · DWM · Jun 13, 2005 · Cardiovascular

Device Facts

• Record ID: K051084
• Device Name: DENVER PLEURX DRAINAGE KIT AND DENVER PLEURX VACUUM BOTTLE WITH DRAINAGE LINE
• Applicant: Denver Biomedicals, Inc.
• Product Code: DWM · Cardiovascular
• Decision Date: Jun 13, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.5050
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Pleurx Drainage Kits are used in conjunction with the Pleural Catheter. The devices are intended for long-term, intermittent drainage of symptomatic, recurrent, please of off usings, including malignant pleural effusions and other pleural effusions that do not respond to treamma of the underlying disease.

Device Story

Pleurx Drainage Kit facilitates intermittent, long-term removal of accumulated pleural fluid. System consists of vacuum bottle with drainage line connecting to indwelling pleural catheter. Vacuum mechanism draws fluid from pleural space into bottle. Procedure pack contains supplies for drainage and dressing changes. Used in clinical or home settings; operated by healthcare providers or patients/caregivers. Output is physical removal of fluid, providing symptomatic relief of dyspnea and promoting pleurodesis. Modification includes updated bottle size, material, shape, sealing mechanism, and drainage line dimensions.

Clinical Evidence

Bench testing only. Verification of flow rate and bottle design specifications performed to ensure performance equivalence to the predicate.

Technological Characteristics

Vacuum-based drainage system. Components include vacuum bottle, drainage line, and procedure pack. Modifications include changes to bottle material, shape, and sealing/vacuum access mechanism. Sterilization approach updated for drainage line; vacuum bottle interior not sterilized. Flow rate is the primary safety-critical performance parameter.

Indications for Use

Indicated for patients with symptomatic, recurrent pleural effusion, including malignant pleural effusion and other recurrent effusions unresponsive to medical management. Used for palliation of dyspnea and to provide pleurodesis.

Regulatory Classification

Identification

A patient care suction apparatus is a device used with an intrathoracic catheter to withdraw fluid from the chest during the recovery period following surgery.

Submission Summary (Full Text)

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KOS1084

# JUN 1 3 2005

## 6. 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 17, 2005.

#### Device Identification

This special 510(k) is for a modification to the Denver Pleurx Drainage Kit.

#### Intended Use

The Pleurx Drainage Kits are used in conjunction with the Pleural Catheter. The devices are intended for long-term, intermittent drainage of symptomatic, recurrent, please of off usings, including malignant pleural effusions and other pleural effusions that do not respond to treamma of the underlying disease.

#### Device Description

The Pleurx Drainage Kit includes a vacuum bottle with drainage line that is connected to the Pleurx catheter for removing fluid that has accumulated in the chest. It also includes a rooedure pack that includes all the supplies needed to perform the drainage procedure and to replace the dressing over the catheter.

#### Summary of the change

The special 510(k) addresses changes in the vacuum bottle/drainage line assembly. These changes include

- A larger bottle size has been introduced .
- A change in material �
- A change in shape .
- A change in the sealing/vacuum access mechanism .
- A change in the length and diameter of the drainage line .
- A change in the sterilization approach, which will maintain sterility of the drainage line � but will not sterilize the interior of the vacuum bottle.

This 510(k) also identified minor changes that had been made previously, including a change in the skin antiseptic from povidone-iodine to 70% alcohol.

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### Substantial Equivalence to Currently Marketed Device

The sponsor used the following techniques to determine that the modified design is substantially equivalent to that of the currently marketed product.

- Verifying that the key safety-critical performance parameter, flow rate, was within the . specification for the currently marketed device.
- Verifying that other aspects of the revised bottle design met the specifications set for . them.
- Applying risk management techniques to assess the potential impact of the changes on . device safety, and adopting appropriate risk control measures.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle is facing to the right. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

JUN 1 3 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Denver Biomedical, Incorporated C/O Ms. Nancy Sauer Director, Regulatory Affairs Quality Assurance Evergreen Research, Incorporated 433 Park Point Drive, Suite 140 Golden, Colorado 80401

Re: K051084

Trade/Device Name: Pleurx Catheter and Drainage Kits/Vacuum Bottle Regulation Number: 870.5050 Regulation Name: Patient Care Suction Apparatus Regulatory Class: II Product Code: DWM Dated: May 26, 2005 Received: May 31, 2005

Dear Ms. Sauer:

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 such 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.

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Page 2 - Ms. Sauer

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.

This letter will allow you to begin marketing your device as described in your Section 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 [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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,

Jennie H. Michie Omd.

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known):

Device Name: __ PLEURX CATHETER AND DRAINAGE KITS/VACUUM BOTTLE

Indications for Use:

The Denver Pleurx Catheter Kit and the Denver Pleurx Drainage Kit/Vacuum Bottle are indicated for intermittent long term drainage of symptomatic, recurrent pleural effusion, including malignant pleural effusion and other recurrent effusions that do not respond to medical management of the underlying disease. The devices are indicated for 1) the palliation of dyspnea due to pleural effusion and 2) providing pleurodesis (resolution of the pleural effusion).

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)

Quattie H. Michie Dms.

(Division Sign-Off Division of Anesthesiology, General Hospital, Infection Control, Dental Devices

510(k) Number:_KO51084

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(Posted November 13, 2003)