(29 days)
Not Found
No
The 510(k) summary describes a standard medical device (endotracheal tubes) and does not mention any AI or ML components, algorithms, or related functionalities. The performance studies focus on bench testing and biocompatibility, not AI/ML performance metrics.
No.
The device is indicated for airway management, acting as a tool for intubation rather than providing a therapeutic effect on a medical condition.
No
The device is an endotracheal tube designed for airway management, acting as a therapeutic or supportive device rather than one used to diagnose a medical condition.
No
The device description clearly indicates it is a physical medical device (endotracheal tubes) and does not mention any software components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "oral / nasal intubation and are indicated for airway management." This is a procedure performed directly on a patient to manage their airway, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The description details an endotracheal tube, which is a medical device used to maintain an open airway. This is a therapeutic/supportive device, not a diagnostic one.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening
The device is clearly a medical device used for a procedural intervention (intubation) related to airway management.
N/A
Intended Use / Indications for Use
The Kimberly-Clark* MICROCUFF Pediatric Endotracheal Tubes are designed for oral / nasal intubation and are indicated for airway management.
Product codes
BTR
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
airway
Indicated Patient Age Range
Pediatric
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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 Road
Roswell, GA 30076 |
|---------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|
| OFFICIAL
CORRESPONDENT | Sherry Saurini
Associate Director, Regulatory Affairs
Tel: 770.587.8502
Fax: 920.969.3455
email: sherry.saurini@kcc.com |
| TRADE NAME: | KIMBERLY-CLARK* MICROCUFF Pediatric ET Tubes |
| CLASSIFICATION
NAME: | Tracheal tubes |
| DEVICE | Class II per 21 CFR §878.5730 |
| CLASSIFICATION
AND PRODUCT
CODE | 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.
1
DESCRIPTION OF THE DEVICE:
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.
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).
2
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.
3
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
4
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:
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