The Kimberly-Clark* MICROCUFF Pediatric ET Tubes are available in sizes 3.0 to 4.5 in increments of 0.5 mm. They are available as Magill and pre-formed, made with an ultra thin polyurethane cuff, referred to as the MicroCuff.

AI/ML Overview

This 510(k) summary describes a traditional medical device (tracheal tubes). It does not include information about artificial intelligence (AI) and therefore, does not provide the details required for some of your questions, particularly those related to AI model performance, training sets, and expert evaluations in the context of AI.

However, I can extract the available information regarding the device's acceptance criteria and the studies performed to demonstrate its equivalence.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria Category	Reported Device Performance
Bench Testing	Demonstrated that the modified Kimberly-Clark* MICROCUFF Pediatric ET Tubes performs the same function as the predicate device, and any minor differences would have a positive impact on safety or efficacy.
Biocompatibility	Met acceptance criteria.
Sterilization	Met acceptance criteria.
Functional Tests	Met acceptance criteria.

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

The document mentions "bench testing," "biocompatibility," "sterilization," and "functional test results" but does not specify the sample sizes used for these tests. It also does not provide information on data provenance (e.g., country of origin, retrospective or prospective) as these are bench tests and not clinical data sets.

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

This information is not provided in the document. The tests described are laboratory-based and do not involve "ground truth" derived from expert consensus in the way an AI model's performance on clinical images would.

4. Adjudication Method for the Test Set:

This information is not applicable/not provided. Adjudication methods are typically relevant for human-interpreted data, especially in clinical trials or AI model evaluations, where discrepancies between readers or outputs need resolution. The tests here are objective measurements.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of an intervention (like AI assistance) on human reader performance, which is not applicable to a physical medical device like an endotracheal tube.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

No, a standalone algorithm performance study was not done. This device is a physical endotracheal tube, not an algorithm or AI system.

7. The Type of Ground Truth Used:

The "ground truth" for this device's performance is established by objective measurements and industry standards for tracheal tube function, biocompatibility, and sterility, as demonstrated through the bench, biocompatibility, sterilization, and functional tests. It's not based on expert consensus, pathology, or outcomes data in the way an AI diagnostic device would be.

8. The Sample Size for the Training Set:

This information is not applicable. The device is a physical medical product, not an AI algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established:

This information is not applicable. (See point 8).

Summary

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K 080821

APR 2 2 2 2000

510(K) Summary

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	Sherry SauriniAssociate Director, Regulatory AffairsTel: 770.587.8502Fax: 920.969.3455email: sherry.saurini@kcc.com
TRADE NAME:	KIMBERLY-CLARK* MICROCUFF Pediatric ET Tubes
CLASSIFICATIONNAME:	Tracheal tubes
DEVICE	Class II per 21 CFR §878.5730
CLASSIFICATIONAND PRODUCTCODE	Product Code - BTR

SUBSTANTIAL EQUIVALENCE:

The modified Kimberly-Clark* MICROCUFF Pediatric ET Tubes (3.0, 3.5, 4.0, 4.5mm) are substantially equivalent to the Pediatric Cuffed and Uncuffed ET Tubes: Standard cleared under K050803. Both the Kimberly-Clark* MICROCUFF Pediatric ET Tubes and the predicate device have the same intended use and basic scientific technology.

Bench testing has demonstrated that the modified Kimberly-Clark* MICROCUFF Pediatric ET Tubes 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.

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DESCRIPTION OF THE DEVICE:

INDICATIONS FOR USE:

The Kimberly-Clark* MICROCUFF Pediatric Endotracheal Tubes are designed for oral / nasal intubation and are indicated for airway management

PERFORMANCE DATA:

Biocompatibility, sterilization and functional test results met acceptance criteria and demonstrate that the device is safe and effective for use in humans. A sterilization summary can be found in Attachment D. Biocompatibility summaries can be found in Attachment E.

CONCLUSION:

Based on the performance testing, it can be concluded that the modified Kimberly-Clark* MICROCUFF Pediatric ET Tubes (3.0, 3.5, 4.0, 4.5mm) are equivalent to the predicate, Pediatric Cuffed and Uncuffed ET Tubes (K050803).

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird-like figure.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 2 2008

Ms. Sherry Saurini Associate Director, Regulatory Affairs Kimberly-Clark Corporation 1400 Holcomb Bridge Road Roswell, Georgia 30076

Re: K080821

Trade/Device Name: Kimberly-Clark* MICROCUFF Pediatric ET Tubes Regulation Number: 21 CFR 868.5730 Regulation Name: Tracheal Tube Regulatory Class: II Product Code: BTR Dated: March 21, 2008 Received: March 25, 2008

Dear Ms. Saurini:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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. Saurini

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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours,

Chin-Lin, Ph.D.

Chiu Lin, Ph.D. 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* MICROCUFF Pediatric ET Tubes

Indications For Use:

The Kimberly-Clark* MICROCUFF Pediatric Endotracheal Tubes are designed for oral / nasal intubation and are indicated for airway management.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

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)

signature

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

1180821

510(k) Number:

Page 1 of __ 1________________________________________________________________________________________________________________________________________________________________

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).