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*.

AI/ML Overview

The provided text describes a 510(k) submission for the "Kimberly-Clark* KimVent* Microcuff* Endotracheal Tubes for Adults." It focuses on demonstrating substantial equivalence to a predicate device through bench testing.

Here's an analysis of the acceptance criteria and study information, addressing your specific points:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criterion (Claim/Benchmark)	Reported Device Performance
Superior tracheal seal for a wider range of trachea sizes and cuff sealing pressures compared to leading PVC cuffed tubes.	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. (Stated as a claim, supported by benchtop testing.)
Reduce microaspiration by at least 95% when compared to the Covidien Hi-Lo PVC cuffed tube.	KimVent* Microcuff* Endotracheal Tubes reduce microaspiration by at least 95% when compared to the Covidien Hi-Lo PVC cuffed tube. (Stated as a claim, supported by benchtop testing.)
Reduce microaspiration by at least 93% when compared to the Covidien TaperGuard tube with a tapered PVC cuff.	KimVent* Microcuff* Endotracheal Tubes reduce microaspiration by at least 93% when compared to the Covidien TaperGuard tube with a tapered PVC cuff. (Stated as a claim, supported by benchtop testing.)
At 10 cm H2O cuff pressure, demonstrate less microaspiration compared to the Covidien TaperGuard tube.	At 10 cm H2O cuff pressure, the Microcuff* tube demonstrated 96% less microaspiration compared to the Covidien TaperGuard tube. (Stated as a claim, supported by benchtop testing.)
Perform the same function as the predicate device (Adult Cuffed ET Tubes; Standard cleared under K050803).	Bench testing has demonstrated that the modified Kimberly-Clark* KimVent* Microcuff* Endotracheal Tubes for Adults performs the same function as the predicate device. Functional test results met acceptance criteria. (General statement of equivalence and meeting acceptance criteria.)
Any minor differences between the modified device and the predicate device would have positive impact to safety or efficacy.	Bench testing has demonstrated that any minor differences between the modified device and the predicate device would have positive impact to safety or efficacy. (General statement of positive impact from differences.)
Safe and effective for use in humans.	Functional test results met acceptance criteria and demonstrate that the device is safe and effective for use in humans. (Conclusion based on functional tests.)

2. Sample Size Used for the Test Set and Data Provenance

The document refers to "bench testing" and "benchtop testing" to support its claims. However, it does not specify the sample size used for these tests. There is no information regarding the data provenance (e.g., country of origin, retrospective or prospective) as it's a bench test, not a clinical study with human or animal subjects.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This information is not provided in the document. As the testing appears to be purely mechanical/benchtop, it wouldn't typically involve experts establishing a ground truth in the same way a diagnostic algorithm (e.g., for radiology) would. The "ground truth" here would be the physical measurements and observations from the bench tests.

4. Adjudication Method for the Test Set

This information is not applicable/provided. Bench testing generally does not involve adjudication methods like those used in clinical studies with human evaluators. The "adjudication" would be inherent in the standardized test methods and measurements.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

There is no MRMC comparative effectiveness study mentioned in this document. The device is a medical product (endotracheal tube), not an AI-powered diagnostic tool. Therefore, the concept of "human readers improve with AI" is not relevant to this submission.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is not applicable. The device is an endotracheal tube, not an algorithm, so "standalone algorithm performance" is irrelevant.

7. The Type of Ground Truth Used

The ground truth for the "performance data" mentioned (tracheal seal, microaspiration reduction) was established through bench testing/experimental measurements. This involves controlled laboratory settings to quantitatively assess the physical characteristics and performance of the endotracheal tubes. It's based on objective, quantifiable data rather than expert consensus, pathology, or outcomes data in the traditional sense.

8. The Sample Size for the Training Set

There is no "training set" as this is a medical device (endotracheal tube) and not an AI/machine learning model that requires training data.

9. How the Ground Truth for the Training Set was Established

This question is not applicable as there is no training set mentioned or implied for this type of medical device submission.

Summary

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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*1400 Holcomb Bridge RoadRoswell, GA 30076
OFFICIALCORRESPONDENT	Marcia JohnsonTechnical Leader, Regulatory AffairsTel: 770.587.8566Fax: 920.380.6351email: marcia.johnson@kcc.com
TRADE NAME:	Kimberly-Clark* KimVent* Microcuff* Endotracheal Tubes foAdults
CLASSIFICATIONNAME:	Tracheal tubes
DEVICECLASSIFICATIONAND PRODUCTCODE	Class II per 21 CFR §868.5730Product 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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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 (800) 638-2041 or (301) 796-7100 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

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).