BAL CATH BRONCHIAL ASPIRATE SAMPLING CATHETER

K112562 · Kimberly-Clark · OYI · Dec 15, 2011 · Anesthesiology

Device Facts

• Record ID: K112562
• Device Name: BAL CATH BRONCHIAL ASPIRATE SAMPLING CATHETER
• Applicant: Kimberly-Clark
• Product Code: OYI · Anesthesiology
• Decision Date: Dec 15, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.6810
• Device Class: Class 1

Intended Use

The Kimberly-Clark* KimVent* BAL Cath* Bronchial Aspirate Sampling Catheter is used in the diagnosis of diffuse lung disease by allowing collection of bronchoalveolar lavage (BAL) specimens from deep within the lung. The use of a bronchoscope is not necessary. This catheter is used in adult intubated patients.

Device Story

Sterile, single-use catheter kit for non-bronchoscopic bronchoalveolar lavage (mini-BAL). Designed for adult intubated patients undergoing mechanical ventilation. Enables collection of lung specimens from deep within the lung without requiring a bronchoscope. Clinicians insert the catheter to aspirate samples for diagnostic purposes. Device features a smaller diameter compared to the predicate. Bench testing confirms physical performance and substantial equivalence.

Clinical Evidence

Bench testing only. Physical performance testing demonstrated substantial equivalence to the predicate device and conformance to ISO 594-2:1998, ISO 10993-5:2009, ISO 10993-7:2008, ISO 10993-10:2010, ISO 11135-1:2007, and ISO 5356-1:2004.

Technological Characteristics

Sterile, single-use catheter kit. Smaller diameter than predicate. Conforms to ISO 594-2 (conical fittings), ISO 10993 (biocompatibility: cytotoxicity, ethylene oxide residuals, irritation/sensitization), ISO 11135-1 (sterilization), and ISO 5356-1 (conical connectors).

Indications for Use

Indicated for adult intubated patients requiring collection of bronchoalveolar lavage (BAL) specimens for the diagnosis of diffuse lung disease without the use of a bronchoscope.

Regulatory Classification

Identification

A tracheobronchial suction catheter is a device used to aspirate liquids or semisolids from a patient's upper airway.

Predicate Devices

• BAL Cath* (K923487)

Submission Summary (Full Text)

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

DEC 1 5 2011

## K 112562 510(K) Summary November 22, 2011

| 510(k) Submitter: | David M. Lee, J.D.<br>Associate Director of Regulatory Affairs<br>Kimberly-Clark Health Care<br>1400 Holcomb Bridge Road<br>Roswell, GA 30076<br>Ph: 770.587.7167<br>FAX: [phone]<br>Email: [e-mail] |
|-------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|-------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

| Primary Contact<br>for this 510(k)<br>Submission: | David M. Lee, J.D. |
|---------------------------------------------------|------------------------------------------|
| | Associate Director of Regulatory Affairs |
| | Kimberly-Clark Health Care |
| | 1400 Holcomb Bridge Road |
| | Roswell, GA 30076 |
| | Ph: 770.587.7167 |
| | FAX: [phone] |
| | Email: [e-mail] |

BAL Cath*

OYI, Class I

(21 CFR 868.6810)

Kimberly-Clark* KimVent* BAL Cath* Bronchial Aspirate Sampling Device Trade Catheter (Product Code 143) Name:

Device Common names

Date Summary was

Prepared:

Device Product Codes and Classification Names:

- Predicate Devices The Kimberly-Clark* KimVent* BAL Cath* Bronchial Aspirate Sampling Catheter is substantially equivalent to the predicate device, BAL Cath* (K923487).
Catheters, suction, tracheobronchial

- Sterile, single use, catheter kit for performing non-bronchoscopic Device Brochoalveolar Lavage (BAL) in adult patients undergoing Description: mechanical ventilation. (also known as mini-BAL)
1

. .

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

------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

| Intended Use: | The Kimberly-Clark* KimVent* BAL Cath* Bronchial Aspirate<br>Sampling Catheter is used in the diagnosis of diffuse lung disease<br>by allowing collection of bronchoalveolar lavage (BAL) specimens<br>from deep within the lung. The use of a bronchoscope is not<br>necessary. This catheter is used in adult intubated patients. |
|---------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Technological<br>Characteristics and<br>Substantial<br>Equivalence: | The performance testing of the Kimberly-Clark* KimVent* BAL<br>Cath* Bronchial Aspirate Sampling Catheter demonstrates that it<br>is substantially equivalent to the predicate device, BAL Cath*<br>(K923487) in intended use, design, packaging, manufacturing,<br>biocompatibility, and performance. The Kimberly-Clark* KimVent*<br>BAL Cath* Bronchial Aspirate Sampling Catheter incorporates a<br>smaller catheter diameter. This difference in diameter raises no<br>new issues of safety and efficacy. |
| Summary of<br>Testing: | The Kimberly-Clark* KimVent* BAL Cath* Bronchial Aspirate<br>Sampling Catheter has been tested for physical performance by<br>bench testing demonstrating substantial equivalence to the<br>predicate device and conformance to the applicable sections of<br>the following standards: ISO 594-2:1998, ISO 10993-5:2009, ISO<br>10993-7:2008, ISO 10993-10:2010, ISO 11135-1:2007, and ISO<br>5356-1:2004.<br>All results of testing met acceptance criteria. |

*Registered Trademark or Trademark of Kimberly-Clark Worldwide, Inc.

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

## DEPARTMENT OF HEALTH & HUMAN SERVICES

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

Mr. David M. Lee, J.D. Associate Director of Regulatory Affairs Kimberly-Clark Healthcare 1400 Holcomb Bridge Road Roswell. Georgia 30076

DEC 1 5 2011

Re: K112562

Trade/Device Name: Kimberly-Clark* KimVent *BAL Cath* Bronchial Aspirate Sampling Catheter Regulation Number: 21 CFR 868.6810 Regulation Name: Tracheobronchial Suction Catheter Regulatory Class: 1 Product Code: OYI Dated: August 31, 2011 Received: September 26, 2011

Dear Mr. Lee:

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.

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

Page 2 - Mr. Lee

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 (OS) 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,

Anthony D. anovan

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

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

Kimberly-Clark" Corporation 510(k) for the Kimberly-Clark" KimVent* BAL Cath* Bronchial Aspirate Sampling Catheter

## Indications for Use

------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Kimberly-Clark* KimVent* BAL Cath* Bronchial Aspirate Sampling Catheter

Indications for Use:

The Kimberly-Clark* KimVent* BAL Cath* Bronchial Aspirate Sampling Catheter is used in the diagnosis of diffuse lung disease by allowing collection of bronchoalveolar lavage (BAL) specimens from deep within the lung. The use of a bronchoscope is not necessary. This catheter is used in adult intubated patients.

Prescription Use ___ x (Part 21 CFR 801 Subpart D)

Over - The - Counter Use (21 CFR 801 Subpart C)

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

urrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Division of Anesthesiology, General Hospital

Infection Control, Dental Devices

510(k) Number: K112562

5