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 Description

KimVent* Microcuff* Subglottic Suctioning Endotracheal Tubes are available in adult sizes 7.0, 7.5, 8.0, 8.5, and 9.0mm with a Murphy Eye. They include a separate lumen with a dorsal opening above the cuff to provide access to the subglottic space. The subglottic space is accessed via a normally open suction valve that 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.

AI/ML Overview

The Kimberly-Clark* KimVent* Microcuff* Subglottic Suctioning Endotracheal Tubes were studied to confirm suctioning efficiency and adherence to various standards.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Bench-top performance testing:	Results of all testing met acceptance criteria.
* Suctioning efficiency	Confirmed
* Conformance to ISO 5356-1:2004 (Anesthetic and respiratory equipment -Conical connectors: Part 1: Cones and sockets)	Conformance demonstrated
* Conformance to ISO 5361:1999 (Anesthetic and respiratory equipment - Tracheal tubes and connectors)	Conformance demonstrated
Biocompatibility testing:	Results of all testing met acceptance criteria.
* Conformance to ANSI/AAMI/ISO 10993-3: 2003 (Biological Evaluation of Medical Devices - Part 3: Tests for Genotoxicity, Carcinogenicity, and Reproductive Toxicity)	Conformance demonstrated
* Conformance to ANSI/AAMI/ISO 10993-5:2009 (Biological evaluation of medical devices - Part 5: Tests for In Vitro cytotoxicity)	Conformance demonstrated
* Conformance to ANSI/AAMI/ISO 10993-6, 2007 (Biological Evaluation of Medical Devices - Part 6: Tests for Local Effects After Implantation)	Conformance demonstrated
* Conformance to ANSI/AAMI/ISO 10993-10: 2010 (Biological evaluation of medical devices - Part 10:Tests for Irritation and Skin Sensitization)	Conformance demonstrated
Sterilization validation:	Validated.
* According to ANSI/AAMI/ISO 10993-7:2008 (Biological evaluation of medical devices, Part 7: Ethylene oxide sterilization residuals, Section 4.3.3 Prolonged Exposure Devices)	Validated
* According to ANSI/AAMI/ISO 11135-1:2007 (Sterilization of health care products - Ethylene oxide - Part 1: Requirements for development, validation, and routine control of a sterilization process for medical devices)	Validated
* According to ANSI/AAMI/ISO 11607-1 2006 (Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems)	Validated

2. Sample Size and Data Provenance for Test Set

The document describes "bench-top performance testing," "biocompatibility testing," and "sterilization validation." It specifies that bench-top testing was conducted to confirm suctioning efficiency and conformance to ISO standards. Biocompatibility testing was conducted to assure conformance to ISO 10993 series standards. Sterilization validation was done according to ISO 10993-7, ISO 11135-1, and ISO 11607-1.
The specific sample sizes for each type of test or the provenance of any data (e.g., country of origin, retrospective/prospective) are not detailed in the provided text. The testing appears to be primarily laboratory/pre-clinical in nature for device performance and safety, rather than clinical data from human subjects.

3. Number and Qualifications of Experts for Ground Truth

This information is not provided in the document. The studies mentioned are primarily engineering/bench-top performance, biocompatibility, and sterilization validation, which typically rely on standardized tests and measurements rather than expert human interpretation for establishing ground truth in the way a diagnostic AI system would.

4. Adjudication Method for Test Set

This information is not applicable or provided. The described studies are not based on human-interpreted "test sets" requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study was not conducted or described for this device. This device is an endotracheal tube, not an AI-assisted diagnostic tool for which human reader improvement would be measured.

6. Standalone Performance Study

The studies described are for the "standalone" performance of the device itself as a medical product (endotracheal tube), evaluating its physical properties, biological safety, and sterilization effectiveness. It is not an algorithm, so "standalone" in the context of AI performance (algorithm without human-in-the-loop) is not applicable here. The device's performance was evaluated inherently without human intervention beyond conducting the tests.

7. Type of Ground Truth Used

The ground truth used for these studies is based on:
- Defined performance specifications: For suctioning efficiency.
- International and national standards: ISO and ANSI/AAMI/ISO standards for physical properties, biocompatibility, and sterilization.
- Laboratory measurements and assays: To demonstrate conformance to these standards (e.g., cytotoxicity tests, irritation tests, ethylene oxide residual measurements).

8. Sample Size for Training Set

The concept of a "training set" is not applicable here. This is a physical medical device (endotracheal tube), not a software algorithm that undergoes machine learning training.

9. How Ground Truth for Training Set Was Established

This question is not applicable as there is no training set for this device.

Summary

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23 Kimberly-Clark Corporation

Section 3 - 510(K) Summary

K120985

DEC 1 9 2012

Date Summary was Prepared:

December 19, 2012

510(k) Submitter:

Marcia Johnson, RAC Technical Leader, Regulatory Affairs Kimberly-Clark Health Care 1400 Holcomb Bridge Road Roswell, GA 30076 Ph: 770.587.8566 FAX: 920.380.6351 Email: marcia.johnson@kcc.com

Primary Contact for this 510(k) Submission:

Marcia Johnson, RAC Technical Leader, Regulatory Affairs Kimberly-Clark Health Care 1400 Holcomb Bridge Road Roswell, GA 30076 Ph: 770.587.8566 FAX: 920.380.6351 Email: marcia.johnson@kcc.com

Device Trade Name: KimVent* Microcuff* Subglottic Suctioning Endotrachea! Tubes

Device Common names:

Endotracheal Tubes

Device Product Codes and Classification Names:

BTR Class II Endotracheal Tubes (21 CFR 868.5730)

Predicate Devices:

The Kimberly-Clark* KimVent* Microcuff* Subglottic Suctioning Endotracheal Tubes are substantially equivalent to the predicate device, TaperGuard Evac™ Endotrachael Tubes (K090352).

Device Description:

Section 3 - 510(K) Summary

Page 1 of 4 ·

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දිනු Kimberly-Clark Corporation

Intended Use:

Technological Characteristics Both the Kimberly-Clark* KimVent* Microcuff* Subglottic Suctioning Endotracheal Tubes and the predicate TaperGuard Evac™ Endotracheal Tubes have the same basic fundamental technological characteristics. Both are polyvinylchloride tubes with inflatable cuffs and include a suction lumen. The Kimberly-Clark* KimVent* Microcuff* Subglottic Suctioning Endotracheal Tube incorporates a barrel-shaped polyurethane inflatable cuff while the predicate TaperGuard Evac™ Endotracheal Tubes contain a tapered PVC cuff. The Kimberly-Clark* KimVent* Microcuff* Subglottic Suctioning Endotracheal Tubes incorporate a suction valve with integrated rinse port to aid in removing secretions that accumulate in the subglottic space while the predicate TaperGuard Evac™ Endotracheal Tubes contain a single port for access to the subglottic space. Below is a comparison table that summarizes the technological characteristics of the subject and predicate tubes:

	Predicate Device -TaperGuard Evac™Endotrachael Tubes(K090352)	Subject Device -Kimberly-ClarkKimVent Microcuff*SubglotticSuctioningEndotracheal Tubes
Materials
Endotracheal Tube	Polyvinylchloride Tube(PVC) with Radiopaqueline	PVC tubew/Barium SulphateRadiopaque line
Pilot BalloonAssembly	Plasticol or PVC PilotBalloonOne-way valve (Bespakvalve) = PVC, PlasticAcetal copolymer, NitrileRubber, stainless steelInflation Tail = PVC	PVC Pilot BalloonOne-way valve(Bespak Check Valve)= PVC, Nitizile/Acetal/stainless steelInflation Tube/Tail =PVC
Inflatable PressureCuff	PVC with a tapered-shape	Polyurethane with abarrel-shape
Suction System	PVC	PVC Tube withAcrylonitrile ButadieneStyrene (ABS) valve
Vent Connector	PVC	Polypropylene

Section 3 - 510(K) Summary

Page 2 of 4

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	Predicate Device -	Subject Device -
	TaperGuard Evac™Endotrachael Tubes(K090352)	Kimberly-ClarkKimVent Microcuff*SubglotticSuctioningEndotracheal Tubes
Ink	Medical Grade Ink	All inks were confirmedto be non-cytotoxic,non-irritating and non-sensitizing throughappropriate ISO 10993testing.
Adhesives	Solvents used forassembly:Cyclohexanone, BalloonGlue,Cyclohexanone/Scanningcompound No. 5.	UV-Cure Adhesives,CyanoacrylateAdhesive
Sizes	6.0, 6.5, 7.0, 7.5, 8.0,8.5, 9.0 (mm)	7.0, 7.5, 8.0, 8.5, 9.0(mm)
Shelf-life	5-year	Launch with 2-year,will extend to 5-yearusing establishedprotocols

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 5356-1:2004, Anesthetic and respiratory equipment -Conical connectors: Part 1: Cones and sockets:
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 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

Section 3 ~ 510(K) Summary

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නු Kimberly-Clark Corporation

The product is EO sterilized and validated according to the following standards:

· ANSI/AAMI/ISO 10993-7:2008, Biological evaluation of medical devices, Part 7: Ethylene oxide sterilization residuals, Section 4.3.3 Prolonged Exposure Devices.
· ANSI/AAMI/ISO 11135-1:2007 Sterilization of health care products - Ethylene oxide - Part 1: Requirements for development, validation, and routine control of a sterilization process for medical devices.
· ANSI/AAMI/ISO 11607-1 2006 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems.

Results of all testing met acceptance criteria.

Conclusion:

The Kimberly-Clark* KimVent* Microcuff* Subglottic Suctioning Endotracheal Tubes are substantially equivalent to the predicate device, TaperGuard Evac™ Endotracheal Tubes (K090352), in intended use, design, performance, principles of operation, and both are intended for single use. Test results confirm that the device is as safe, as effective, and performs as well as or better than the predicate device.

Section 3 - 510(K) Summary

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 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 wings or feathers. The symbol is positioned to the right of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA".

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

Public Health Service

December 19. 2012

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

Re: K120985

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: November 26, 2012 Received: November 28, 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 (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 (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Kwame Q. Ulmer

Anthony D. Watson, B.S., M.S., M.B.A. 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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Section 2 - Indications for Use

510(k) Number (if known): 1520985

Device Name: 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.

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. Schultheis Jr 2012.12.19 1,0:59:44 -05′00″

(Division Sign-Off) Division of Anestheslology, General Hospital Infection Control, Dental Devices

510(k) Number;

Section 2 - Indications for Use

Page 8 of 63

Regulation Number and Section

§ 868.5730 Tracheal tube.

(a)
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.(b)
Classification. Class II (performance standards).