KIMVENT MICROCUFF SUBGLOTTIC SUCTIONING ENDOTRACHEAL TUBE

K131254 · Kimberly-Clark Corp. · BTR · Aug 20, 2013 · Anesthesiology

Device Facts

• Record ID: K131254
• Device Name: KIMVENT MICROCUFF SUBGLOTTIC SUCTIONING ENDOTRACHEAL TUBE
• Applicant: Kimberly-Clark Corp.
• Product Code: BTR · Anesthesiology
• Decision Date: Aug 20, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5730
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

KimVent* Microcuff* Subglottic Suctioning Endotracheal Tubes are indicated for airway management by oral intubation of the trachea and for removal of secretions that accumulate in the subglottic space.

Device Story

Device is a sterile, single-use endotracheal tube featuring a barrel-shaped polyurethane cuff and a dedicated suction lumen with a dorsal opening. It includes a suction valve with an integrated rinse port for sterile saline irrigation or air bolus administration to maintain lumen patency. Used by clinicians for airway management and subglottic secretion removal. The device functions by providing a conduit for ventilation while allowing for the aspiration of accumulated secretions above the cuff to reduce potential complications. The modification involves a change in the adhesive material used to bond the cuff to the tube.

Clinical Evidence

No clinical data. Bench-top performance testing conducted to verify suctioning efficiency and conformance to ISO 5361:1999. Biocompatibility testing performed per ANSI/AAMI/ISO 10993 parts 3, 5, 6, and 10.

Technological Characteristics

PVC tube with barium sulphate radiopaque line; polyurethane barrel-shaped cuff; PVC pilot balloon assembly; ABS suction valve; polypropylene vent connector. Adhesive changed to solvent-based blend. Sterilized, single-use. Conforms to ISO 5361:1999.

Indications for Use

Indicated for airway management via oral tracheal intubation and subglottic secretion removal in patients requiring endotracheal intubation.

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

• KimVent* Microcuff* Subglottic Suctioning Endotracheal Tubes (K120985)

Submission Summary (Full Text)

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K131 254

510(K) SUMMARY

# Kimberly-Clark Corporation

June 17, 2013

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, RAC, CBA<br>Technical Leader, Regulatory Affairs<br>Tel: [phone]<br>Fax: [phone]<br>email: [e-mail] |
| Trade Name: | Kimberly-Clark* KimVent* Microcuff* Subglottic Suctioning Endotracheal Tubes |
| Classification<br>Name: | Tracheal tube |
| Device<br>Classification<br>and Product<br>Code | Class II per 21 CFR §868.5730<br>Product Code - BTR |
| Predicate Device | The Kimberly-Clark* KimVent* Microcuff* Subglottic Suctioning<br>Endotracheal Tubes subject of this submission are substantially |

AUG 2 0 2013Endotracheal Tubes subject of this submission are substantially equivalent to the KimVent* Microcuff* Subglottic Suctioning Endotracheal Tubes cleared in 510(k) K120985.

| Device | KimVent* Microcuff* Subglottic Suctioning Endotracheal Tubes are |
|--------------|---------------------------------------------------------------------|
| Description: | available in adult sizes 7.0, 7.5, 8.0, 8.5 and 9.0mm with a Murphy |

Special 510(k): Device Modification Kimberly-Clark* Microcuff* Subglottic Suctioning ET Tubes

8.

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Eve. They include a separate lumen with a dorsal opening above the cuff to provide access to the subglottic space. The subglottic space is reached via a normally open suction valve which includes a one-way port for rinsing the subglottic space with sterile saline (0.9% Sodium Chloride solution) or administering an air bolus to assist in maintaining a patent suction lumen patency. These devices are sold as disposable, sterile, single use, devices.

KimVent* Microcuff* Subglottic Suctioning Endotracheal Tubes Intended Use: are indicated for airway management by oral intubation of the trachea and for removal of secretions that accumulate in the subglottic space.

Both the modified Kimberly-Clark* KimVent* Microcuff* Technological Subglottic Suctioning Endotracheal Tubes and the predicate Characteristics KimVent* Microcuff* Subglottic Suctioning Endotracheal Tubes have the same basic fundamental technological characteristics. Both are polyvinylchloride tubes with a barrel-shaped polyurethane inflatable cuff and a suction lumen. Both incorporate a suction valve with integrated rinse port to aid in removing secretions that accumulate in the subglottic space. The only difference in the endotracheal tube is the change in a raw material used to bond the cuff to the endotracheal tube. Below is a comparison table that summarizes the technological characteristics of the subject and predicate tubes.

| | Kimberly-Clark*<br>KimVent* Microcuff*<br>Subglottic Suctioning<br>Endotracheal Tubes<br>(120985) | Device subject<br>of this<br>submission |
|---------------------------|---------------------------------------------------------------------------------------------------------|-----------------------------------------|
| Materials | | |
| Endotracheal<br>Tube | PVC tube w/Barium<br>Sulphate Radiopaque<br>line | Same |
| Pilot Balloon<br>Assembly | PVC Pilot Balloon<br>One-way valve (Bespak<br>Check Valve) = PVC,<br>Nitizile/Acetal/stainless<br>steel | Same |
| | Inflation Tube/tail = PVC | |

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| Materials | | Device subject<br>of this<br>submission |
|---------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Kimberly-Clark*<br>KimVent* Microcuff*<br>Subglottic Suctioning<br>Endotracheal Tubes<br>(120985) | |
| Inflatable<br>Pressure Cuff | Polyurethane with a<br>barrel-shape | Same |
| Suction<br>System/Flush<br>Port | PVC Tube with<br>Acrylonitrile Butadiene<br>Styrene (ABS) Valve | Same |
| Vent<br>Connector | Polypropylene | Same |
| Ink | All inks were confirmed<br>to be non-cytotoxic, non-<br>irritating and non-<br>sensitizing through<br>appropriate ISO 10993<br>testing. | Same |
| Adhesives | UV-Cure Adhesives,<br>Cyanoacrylate Adhesive | Same, except<br>the adhesive<br>used to bond<br>the cuff to the<br>tube has<br>changed from<br>an adhesive to a<br>solvent based<br>blend of<br>materials. |
| Sizes | 7.0, 7.5, 8.0, 8.5, 9.0<br>(mm) | Same |
| Shelf-life | 2 years | Same |

Summary of Testing:

Bench-top performance testing was conducted to confirm suctioning efficiency and additional bench-top testing was conducted to assure conformance to the following standards.

- · ISO 5361:1999, Anesthetic and respiratory equipment Tracheal tubes and connectors.
Biocompatibility testing was conducted to assure conformance to the following standards:

- ANSI/AAMI/ISO 10993-3: 2003 Biological Evaluation of Medical Devices - Part 3: Tests for Genotoxicity, Carcinogenicity, and Reproductive Toxicity,
- · ANSI/AAMI/ISO 10993-5:2009, Biological evaluation of

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medical devices - Part 5: Tests for In Vitro cytotoxicity

- · ANSI/AAMI/ISO 10993-6, 2007 Biological Evaluation of Medical Devices - Part 6: Tests for Local Effects After Implantation
- · ANSI/AAMI/ISO 10993-10: 2010: Biological evaluation of medical devices - Part 10:Tests for Irritation and Skin Sensitization

Clinical testing was not conducted.

All results of testing met acceptance criteria and demonstrate no concerns of safety or effectiveness for the modified device.

#### Conclusion:

The modified Kimberly-Clark* KimVent* Microcuff* Subglottic Suctioning Endotracheal Tubes are substantially equivalent to the predicate device, Kimberly-Clark* KimVent* Microcuff* Subglottic Suctioning Endotracheal Tubes (K120985), in intended use, design, performance, principles of operation, and both are intended for single use. Test results confirm that the device is as safe and effective and performs as well as or better than the predicate device.

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

August 20. 2013

Kimberly-Clark Corporation Ms. Marcia Johnson, RAC, CBA Technical Leader, Regulatory 1400 Holcomb Bridge Road ROSWELL GA 30076

Re: K131254

Trade/Device Name: KimVent* Microcuff* Subglottic Suctioning Endotracheal Tubes Regulation Number: 21 CFR 868.5730 Regulation Name: Tracheal Tube Regulatory Class: II Product Code: BTR Dated: June 20, 2013 Received: June 21, 2013

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 10 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 r no general comanufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRI-1 does not evaluate information related to contract liability warrantics. 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 Eederal 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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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,

Tejashri Purohit-Sheth, M.D.
Clinical Deputy Director
DAGRID
FOR

Kwame Ulmer M.S. Acting Division Director Division of Anesthesiology, General Hospital, Respiratory, 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): 长13/254

Device Name:_ Kimberly-Clark* KimVent* Microcuff* Subglottic Suctioning Endotracheal Tubes.

Indications For Use:

KimVent* Microcuff* Subglottic Suctioning Endotracheal Tubes are indicated for airway management by oral intubation of the trachea and for removal of secretions that accumulate in the subglottic space.

AND/OR X Prescription Use (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)

> Concurrence of CDRH, Office of Device Evaluation (ODE) Lester W. Schulthels Jr

2013.08.19 12:26:38 -04'00' (Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

Page I of ____________________________________________________________________________________________________________________________________________________________________ 510(k) Number:

Special 510(k): Device Modification Kimberly-Clark" Microcuff" Subglottic Suctioning ET Tubes

Section 2 - Indications for Use

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