PLEURAFLOW CATHETER SYSTEM

K093565 · Clear Catheter Systems · OTK · Dec 3, 2010 · General, Plastic Surgery

Device Facts

• Record ID: K093565
• Device Name: PLEURAFLOW CATHETER SYSTEM
• Applicant: Clear Catheter Systems
• Product Code: OTK · General, Plastic Surgery
• Decision Date: Dec 3, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4780
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The PleuraFlow Catheter is indicated for use as an adjunctive device during open surgical procedures in order to prevent fluid accumulation within the operative site after closure of the surgical wound. The device is indicated for use in thoracic surgical procedures.

Device Story

PleuraFlow Catheter System is a silicone drainage tube (20-32Fr) with an integrated tube clearance apparatus; used in thoracic surgery to prevent post-operative fluid accumulation. The clearance apparatus consists of a PTFE-coated guide wire with a 90-degree looped distal end, magnetically driven by an internal magnet coupled to an external magnet in a shuttle assembly. The device connects to standard suction pumps. Operated by surgeons and ICU nurses, the clearance mechanism is manually activated to clear obstructions within the catheter. This prevents tube blockage, ensuring continuous drainage, reducing the risk of retained fluid, and potentially improving patient outcomes by minimizing complications associated with fluid accumulation.

Clinical Evidence

User preference study of 19 patients undergoing cardiac surgery via median sternotomy. Compared standard chest tube to PleuraFlow system. Evaluated by surgeons, nurses, and residents. Results indicated acceptable assembly time, ease of placement, and ease of use of the clearance mechanism. Concluded the device performed as intended in a clinical setting.

Technological Characteristics

Silicone drainage tube (20-32Fr) with barium stripe; PTFE-coated guide wire clearance apparatus; magnetically driven mechanism; connects to standard suction pumps. No software or electronic components.

Indications for Use

Indicated for patients undergoing open surgical procedures, specifically thoracic surgery, to prevent fluid accumulation at the operative site post-wound closure.

Regulatory Classification

Identification

A powered suction pump is a portable, AC-powered or compressed air-powered device intended to be used to remove infectious materials from wounds or fluids from a patient's airway or respiratory support system. The device may be used during surgery in the operating room or at the patient's bedside. The device may include a microbial filter.

Predicate Devices

• Deutsch Anti-Blockage Wound Drain (K052286)

Submission Summary (Full Text)

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093565

## 510(k) Summary

ﺮ ﺍﻟﻤﺮﺍﺟﻊ

The following information is provided as required by 21 CFR § 807.87 for PleuraFlow Catheter System 510(k) premarket notification. In response to the Safe Medical Devices Act of 1990, the following is a summary of the safety and effectiveness information upon which the substantial equivalence determination is based.

| Applicant: | Clear Catheter Systems<br>2200 NE Neff, Suite 204<br>Bend, Oregon 97701 |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Edward Boyle, MD |
| Contact Person: | Marie Marlow<br>M Squared Associates, Inc.<br>901 King St, Suite 200<br>Alexandria, VA 22314<br>Phone: [phone]<br>Fax: [phone]<br>DEC - 3 2010 |
| Date of Submission: | November 17, 2009 |
| Proprietary Name: | PleuraFlow Catheter System |
| Common Name: | Accessory to powered suction pump |
| Regulatory Class: | II |
| Product Codes: | OTK |
| Predicate Device(s): | The primary predicate device used to demonstrate substantial<br>equivalence is the Deutsch Anti-Blockage Wound Drain<br>(K052286). |
| Device Description: | The PleuraFlow Catheter System is comprised of a silicone<br>drainage tube and a shuttle assembly and guide tube. The<br>PleuraFlow drainage tube is 20 inches in length with<br>graduated measurements in inches from the first side hole<br>and will be available in standard sizes from 20Fr to 32Fr<br>versions. There is a barium stripe in the tube to facilitate<br>visualization. A connector at the proximal end of the device<br>connects to a commercially available drainage system.<br>Within the catheter is a tube clearance apparatus to facilitate<br>clearing of the drainage tube. The tube clearance apparatus is<br>composed of a PTFE-coated guide wire that has a loop set on |

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its distal end, bent at a 90-degree angle. The clearance apparatus is sized such that it cannot exit the end of the drainage tube or the side holes. The tube clearance apparatus is magnetically driven by an attached internal magnet coupled to an external magnet contained within the shuttle assembly.

Indication for use: The PleuraFlow Catheter is indicated for use as an adjunctive device during open surgical procedures in order to prevent fluid accumulation within the operative site after closure of the surgical wound.

> The device is indicated for use in thoracic surgical procedures.

## Substantial Equivalence:

The PleuraFlow Catheter has the same or similar intended use, indications for use, principle of operation, and performance characteristics as predicate devices and is, therefore, substantially equivalent to the predicate devices.

Performance Data: The safety and effectiveness of the PleuraFlow Catheter has been demonstrated through data collected from clinical and nonclinical bench tests and analysis.

> A total of 19 patients were enrolled in a User Preference Study. Patients undergoing cardiac surgery through a median sternotomy had two chest tubes placed in the midline; one standard chest tube and a PleuraFlow system. A study questionnaire was completed by the surgeon placing the chest tube, the nurse taking care of the patient prior to removal of the chest tube, and by the Physician Assistant or Resident who removed the chest tube. Findings from the study indicated that the time for assembly and ease of placement were acceptable to the surgeons, and that ease of use of the clearance mechanism and adequacy of chest tube clearance were acceptable to the ICU nurses. It was concluded that the device was helpful and easy to use, and performed as intended in the clinical setting.

## Conclusion:

The evaluation of the PleuraFlow Catheter does not raise any additional concerns regarding safety and effectiveness and may therefore be considered substantially equivalent to the predicate devices.

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

Clear Catheter Systems % M Squared Associates, Inc. Ms. Monica Early Dougherty 901 King Street, Suite 200 Alexandria, Virginia 22314

Re: K093565

Trade/Device Name: PleuraFlow Catheter System Regulation Number: 21 CFR 878.4780 Regulation Name: Powered suction pump Regulatory Class: Class II Product Code: OTK Dated: October 19, 2010 Received: October 20, 2010

DEC - 3 2010

Dear Ms. Dougherty:

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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

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

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Page 2 - Ms. Monica Early Dougherty

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 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/CDRHQffices/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 vours.

Sincerely yours,

Mark N. Melkerson

Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Section 4: Indications for Use Statement

To be assigned Ko 93 565 510(k) Number:

Device Name: PleuraFlow Catheter System

Indications for Use: The PleuraFlow Catheter is indicated for use as an adjunctive device during open surgical procedures in order to prevent fluid accumulation within the operative site after closure of the The device is indicated for use in surgical wound. thoracic surgical procedures.

| Prescription Use | X |
|-----------------------------|---|
| (Part 21 CFR 801 Subpart D) | |

AND/OR

| Over-The-Counter Use | |
|------------------------|--|
| (21 CFR 807 Subpart C) | |

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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(Division Signical. Orthopedic, and Restorative Devices

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510(k) Number K093565