KIMBERLY-CLARK KIM VENT MICROCUFF ENDOTRACHEAL TUBE FOR ADULTS

K113333 · Kimberly-Clark Corporation · BTR · May 11, 2012 · Anesthesiology

Device Facts

• Record ID: K113333
• Device Name: KIMBERLY-CLARK KIM VENT MICROCUFF ENDOTRACHEAL TUBE FOR ADULTS
• Applicant: Kimberly-Clark Corporation
• Product Code: BTR · Anesthesiology
• Decision Date: May 11, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5730
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

KIMVENT* MICROCUFF* Endotracheal Tubes for Adults are indicated for airway management by nasal or oral intubation of the trachea in adult patients.

Device Story

Endotracheal tube for airway management in adult patients; inserted via nasal or oral route. Features ultra-thin polyurethane cuff (Microcuff) designed to provide superior tracheal seal across wider range of trachea sizes and pressures compared to standard PVC cuffs. Attached pilot balloon with one-way Luer-slip adapter facilitates cuff inflation. Used by clinicians in clinical settings. Device reduces microaspiration compared to standard PVC cuffed tubes, potentially improving patient outcomes by minimizing aspiration-related complications.

Clinical Evidence

Bench testing only. Performance testing demonstrated superior tracheal seal and reduced microaspiration (at least 93-95% reduction) compared to predicate and reference PVC cuffed tubes. Functional test results met all acceptance criteria.

Technological Characteristics

Polyvinylchloride (PVC) endotracheal tube; polyurethane high-volume low-pressure cuff; attached pilot balloon with one-way Luer-slip adapter. Available in sizes 5.0-10.0 mm. Magill style.

Indications for Use

Indicated for airway management via nasal or oral tracheal intubation in adult patients.

Regulatory Classification

Identification

A tracheal tube is a device inserted into a patient's trachea via the nose or mouth and used to maintain an open airway.

Predicate Devices

• Adult Cuffed ET Tubes; Standard (K050803)

Reference Devices

• Covidien Hi-Lo PVC cuffed tube
• Covidien TaperGuard tube

Submission Summary (Full Text)

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## 510(K) SUMMARY (REVISED)

This 510(k) Summary is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

| APPLICANT | Kimberly-Clark*<br>1400 Holcomb Bridge Road<br>Roswell, GA 30076 |
|-------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------|
| OFFICIAL<br>CORRESPONDENT | Marcia Johnson<br>Technical Leader, Regulatory Affairs<br>Tel: [phone]<br>Fax: [phone]<br>email: [e-mail] |
| TRADE NAME: | Kimberly-Clark* KimVent* Microcuff* Endotracheal Tubes fo<br>Adults |
| CLASSIFICATION<br>NAME: | Tracheal tubes |
| DEVICE<br>CLASSIFICATION<br>AND PRODUCT<br>CODE | Class II per 21 CFR §868.5730<br>Product Code - BTR |

## SUBSTANTIAL EQUIVALENCE:

The modified Kimberly-Clark* KimVent* Microcuff* Endotracheal Tubes for Adults (sizes 5.0, 5.5, 6.0, 6.5, 7.0, 7.5, 8.0, 8.5, 9.0, 10.0 mm) are substantially equivalent to the Adult Cuffed ET Tubes; Standard cleared under K050803. Both the Kimberly-Clark* KimVent* Microcuff* Endotracheal Tubes for Adults and the predicate device have the same intended use and same fundamental scientific technology.

Bench testing has demonstrated that the modified Kimberly-Clark* KimVent* Microcuff* Endotracheal Tubes for Adults performs the same function as the predicate device, and that any minor differences between the modified device and the predicate device would have positive impact to safety or efficacy.

## DESCRIPTION OF THE DEVICE:

K113333 Kimvent* Microcuff* Endotracheal Tubes for Adults

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The Kimberly-Clark* KimVent* Microcuff* Endotracheal Tubes for Adults are available in sizes 5.0, 5.5, 6.0, 6.5, 7.0, 7.5, 8.0, 8.5, 9.0, 10.0 mm. They are available as Magill and made with an ultra-thin polyurethane cuff, referred to as the MicroCuff*.

## INDICATIONS FOR USE:

KIMVENT* MICROCUFF* Endotracheal Tubes for Adults are indicated for airway management by nasal or oral intubation of the trachea in adult patients.

#### TECHNILOGICAL CHARACTERISTICS

KIMVENT* MICROCUFF* Endotracheal Tubes for Adults have the same fundamental technological characteristics as the predicate device, the Adult Cuffed ET Tubes; Standard cleared under K050803. Both are polyvinylchloride (PVC) endotracheal tubes designed with a polyurethane high volume low pressure cuff (referred to as the Microcuff*) and have an attached pilot balloon with a one-way Luer-slip adapter.

#### CLAIMS

- . The Microcuff* tube with its cylindrical shaped polyurethane cuff provides a superior tracheal seal for a wider range of trachea sizes and cuff sealing pressures compared to leading PVC cuffed tubes.
- . KimVent* Microcuff* Endotracheal Tubes reduce microaspiration by at least 95% when compared to the Covidien Hi-Lo PVC cuffed tube and at least 93% when compared to the Covidien TaperGuard tube with a tapered PVC cuff.
- . At 10 cm H2O cuff pressure, the Microcuff* tube demonstrated 96% less microaspiration compared to the Covidien TaperGuard tube.

In benchtop testing, the use of the KimVent Microcuff Endotracheal tubes, with its polyurethane cuff, has also demonstrated superior tracheal seal and less microaspiration when compared to similar endotracheal tubes utilizing a polyvinyl chloride cuff.

#### PERFORMANCE DATA:

Functional test results met acceptance criteria and demonstrate that the device is safe and effective for use in humans.

## CONCLUSION:

Based on the performance testing, it can be concluded that the modified Kimberly-Clark* KimVent* Microcuff* Endotracheal Tubes for Adults are equivalent to the predicate, Adult Cuffed and Uncuffed ET Tubes (K050803).

K113333 Kimvent* Microcuff* Endotracheal Tubes for Adults

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle-like symbol with three curved lines representing the body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.

## DEPARTMENT OF HEALTH & HUMAN SERVICES

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

Ms. Marcia Johnson Technical Leader, Regulatory Affairs Kimberly-Clark Corporation 1400 Holcomb Bridge Road Roswell, Georgia 30076

MAY 1 1 2012

Re: K113333

Trade/Device Name: Kimberly-Clark* Kim Vent Microcuff* Endotracheal Tubes for Adults Regulation Number: 21 CFR 868.5730 Regulation Name: Tracheal tube Regulatory Class: II Product Code: BTR Dated: May 9, 2012 Received: May 10, 2012

Dear Ms. Johnson:

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.

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## Page 2- Ms. Johnson

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,

Antwony D. Martin

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

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# Indications for Use

510(k) Number (if known):

Device Name:_ Kimberly-Clark* KimVent* Microcuff* Endotracheal Tubes for Adults.

Indications For Use:

KIMVENT* MICROCUFF* Endotracheal Tubes for Adults are indicated for airway management by nasal or oral intubation of the trachea in adult 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)

AND/OR

Concurrence of CDRH, Office of Device Evaluation (ODE)

L. Schult

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

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510(k) Number: 1133333