ASPIRA PLEURAL DRAINAGE SYSTEM

K110409 · C.R. Bard, Inc. · DWM · May 11, 2011 · Cardiovascular

Device Facts

• Record ID: K110409
• Device Name: ASPIRA PLEURAL DRAINAGE SYSTEM
• Applicant: C.R. Bard, Inc.
• Product Code: DWM · Cardiovascular
• Decision Date: May 11, 2011
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.5050
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Aspira* Pleural Drainage System is intended for long-term intermittent drainage of pleural fluid accumulated in the pleural cavity for the purpose of relieving symptoms associated with pleural effusion.

Device Story

System provides home-based relief for pleural effusion symptoms. Components include indwelling pleural catheter, drainage bag, dressing kit, valve assembly, and adapters. Catheter provides long-term access to pleural cavity; fluid drains into bag or via external suction/vacuum sources. Used by patients or caregivers in home or clinical settings. Output is drained pleural fluid; clinical benefit is symptom relief (dyspnea, chest discomfort).

Clinical Evidence

Bench testing only. No clinical data presented. Verification and validation activities confirmed device performance against predetermined specifications using standards including ISO 10993-1, ISO 10993-7, ISO 594-1/2, EN 1617, EN 1618, ISO 11607-1/2, ISTA-1G, BS EN 550, and ISO 11135-1.

Technological Characteristics

Catheter-based drainage system. Materials evaluated per ISO 10993-1. Features Luer/Universal adapters (ISO 594-1/2). Sterilized via Ethylene Oxide (ISO 11135-1, ISO 10993-7). Mechanical design includes valve assembly for flow control. No electronic or software components.

Indications for Use

Indicated for intermittent drainage of recurrent, symptomatic pleural effusions in patients requiring long-term pleural cavity access to relieve dyspnea and chest discomfort associated with malignant or other recurrent effusions.

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.

Predicate Devices

• Aspira* Pleural Drainage System (K071095)

Submission Summary (Full Text)

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

Bard Access Systems, Inc. Aspira* Pleural Drainage System Special 510(k) Premarket Notification

K110409

Page 16 of 92

.

MAY 1 1 2011

# 510(k) Summary 21 CFR 807.92

# Aspira* Pleural Drainage System

| General<br>Provisions | Submitter Name:<br>Submitter Address: | Bard Access Systems, Inc.<br>605 North 5600 West<br>Salt Lake City, UT 84116 |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Contact Person: | Henry Boland<br>Regulatory Affairs Specialist<br>[e-mail]<br>801.522.5000 ext. 5428<br>801.522.5425 fax |
| | Date of Preparation: | 9 February 2011 |
| Subject Device | Trade Name: | Aspira* Pleural Drainage System |
| | Classification Name: | Patient Care Suction Apparatus<br>21 CFR 870.5050 - Class II<br>DWM - Patient care suction apparatus |
| Predicate<br>Device | Trade Name: | Aspira* Pleural Drainage System |
| | Classification Name: | Patient Care Suction Apparatus<br>21 CFR 870.5050 - Class II<br>DWM - Patient care suction apparatus |
| | Premarket Notification: | K071095, concurrence date 18 May 2007 |
| | Manufacturer: | Bard Access Systems, Inc. |
| Device<br>Description | The Aspira* Pleural Drainage System provides patients with a convenient<br>method to relieve pleural effusion symptoms at home. The primary<br>components of the Aspira* Pleural Drainage System are the Aspira* Pleural<br>Drainage Catheter and the Aspira* Drainage Bag. | |
| Intended Use | The Aspira* Pleural Drainage System is intended for long-term intermittent<br>drainage of pleural fluid accumulated in the pleural cavity for the purpose of<br>relieving symptoms associated with pleural effusion. | |
| Indications for<br>Use | The Aspira* Pleural Drainage System is indicated for intermittent drainage of<br>recurrent and symptomatic pleural effusions. The catheter is intended for long-term<br>access to the pleural cavity in order to relieve symptoms such as dyspnea and<br>chest discomfort associated with malignant pleural effusion and other recurrent<br>effusions. | |
| | | |
| The Aspira* Drainage Bag is indicated for use only with the Aspira* Drainage<br>Catheter for intermittent drainage. | | |
| The Aspira* Dressing Kit is indicated for dressing of a catheter and exit site. | | |
| The Aspira* Luer/Universal Adapter is intended to provide access to the Aspira*<br>Drainage Catheter. It is used to drain fluid using standard wall suction, water seal<br>drainage system, glass vacuum bottle, syringe or other appropriate method. | | |
| The Aspira* Valve Assembly attaches to the Aspira* Drainage Catheter. The<br>Aspira* Repair Kit is for the repair of the Aspira* Drainage Catheter and<br>replacement of the Aspira* Valve Assembly. | | |
| Technological<br>Characteristics | Technological characteristics of the subject Aspira* Pleural Drainage System are<br>equivalent with respect to the basic catheter design and function to those of the<br>predicate devices. Differences do not raise any new questions regarding safety<br>and effectiveness. | |
| Safety &<br>Performance<br>Tests | Verification and validation activities were designed and performed to<br>demonstrate that the subject Aspira* Pleural Drainage System met<br>predetermined performance specifications. The following guidance<br>documents and standards in conjunction with in-house protocols were used to<br>determine appropriate methods for evaluating the performance of the device: | |
| | ISO 10993-1:2009 | Biological Evaluation of Medical Devices Part 1:<br>Evaluation and Testing |
| | ISO 10993-7:2008 | Biological Evaluation of Medical Devices Part 7:<br>Ethylene Oxide Sterilization Residuals |
| | ISO 594-1:1986 | Conical Fittings with 6% (Luer) Taper for Syringes,<br>Needles and Certain Other Medical Equipment –<br>Part 1: General Requirements |
| | ISO 594-2:1998 | Conical Fittings with 6% (Luer) Taper for Syringes,<br>Needles and Certain Other Medical Equipment –<br>Part 2: Lock Fittings |
| | EN 1617:1997 | Sterile Drainage Catheters and Accessory Devices<br>for Single Use |
| | EN 1618:1997 | Catheters Other Than Intravascular Catheters –<br>Test Methods for Common Properties |
| | ISO 11607-1,2:2006 | Packaging for Terminally Sterilized Medical Devices |
| | ISTA -1G:2005 | International Safe Transit Authority Procedure 1G |
| | BS EN 550:1994 | Sterilization of Medical Devices – Validation and<br>Routine Control of Ethylene Oxide Sterilization |
| | ISO 11135-1:2007 | Sterilization of health care products- Ethylene<br>Oxide – Validation and Routine Control of<br>Sterilization Processes for Medical Devices |
| | AAMI TIR 19:1998 | Guidance for ANSI/AAMI/ISO 10993-7:1995,<br>Biological Evaluation of Medical Devices - Part 7:<br>Ethylene Oxide Sterilization Residuals - Replaces<br>AAMI ST29 and AAMI ST30; Cited as relevant<br>guidance to FDA-recognized standard<br>ANSI/AAMI/ISO 10993-7 |
| | The subject device met all pre-determined acceptance criteria and<br>demonstrated substantial equivalence as compared to the predicate device. | |
| Summary of<br>Substantial<br>Equivalence | Based on the indications for use, technological characteristics, safety, and<br>performance testing, the subject Aspira* Pleural Drainage System meets the<br>pre-determined requirements under 21 CFR 820.30, Design Controls, and<br>demonstrates that the subject device is substantially equivalent to the<br>predicate device. | |

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

·

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

* Aspira is the trademark and/or registered trademark of C.R. Bard, Inc. or an affiliate.

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird symbol, composed of three curved lines that suggest wings and a body. The bird is positioned to the right of a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA". The text is arranged around the circumference of the circle, with the bird symbol placed centrally within the circle's right side.

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

MAY 1 1 2011

Mr. Henry Boland Regulatory Affairs Specialist C.R. Bard, Incorporated 605 North 5600 West Salt Lake City, Utah 84116

Re: K110409

Trade/Device Name: Aspira Pleural Drainage System Regulation Number: 21 CFR 870.5050 Regulation Name: Patient Care Suction Apparatus Regulatory Class: II Product Code: DWM Dated: April 8, 2011 Received: April 11, 2011

Dear Mr. Boland:

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. 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.

{4}------------------------------------------------

### Page 2- Mr. Boland

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 (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/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/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 yours,

h for

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

#### Enclosure

{5}------------------------------------------------

Bard Access Systems, Inc. Aspira* Pleural Drainage System Special 510(k) Premarket Notification

## Indications for Use Statement

510(k) Number (if known):

# Device Name: Aspira® Pleural Drainage System

Indications for Use:

The Aspira® Pleural Drainage System is indicated for intermittent drainage of recurrent and symptomatic pleural effusions. The catheter is intended for long-term access to the pleural cavity in order to relieve symptoms such as dyspnea and chest discomfort associated with malignant pleural effusion and other recurrent effusions.

The Aspira® Drainage Bag is indicated for use only with the Aspira® Drainage Catheter for intermittent drainage.

The Aspira® Dressing Kit is indicated for dressing of a catheter and exit site.

The Aspira® Luer/Universal Adapter is intended to provide access to the Aspira® Drainage Catheter. It is used to drain fluid using standard wall suction, water seal drainage system, glass vacuum bottle, syringe or other appropriate method.

The Aspira® Valve Assembly attaches to the Aspira® Drainage Catheter. The Aspira® Repair Kit is for the repair of the Aspira® Drainage Catheter and replacement of the Aspira® Valve Assembly.

Prescription Use × Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

L. Schulthess

(Division Sign-Off) )ivision of Anesthesiology, General Hospital ifection Control, Dental Devices

510(k) Number: K110409