(179 days)
No
The summary describes a physical medical device (endotracheal tube) and its performance characteristics, with no mention of software, algorithms, or AI/ML terms.
No
This device is for airway management, facilitating ventilation and preventing aspiration, which are supportive functions rather than direct therapeutic actions to treat a disease.
No
The device is an endotracheal tube, used for airway management, not for diagnosing medical conditions. Its function is to facilitate breathing, not to detect or monitor diseases.
No
The device description clearly describes a physical medical device (endotracheal tubes) made of materials like polyurethane and polyvinyl chloride, and the performance studies focus on bench testing of the physical tube's function and materials. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "airway management by nasal or oral intubation of the trachea in adult patients." This describes a procedure performed directly on a patient's body to manage their airway.
- Device Description: The device is an endotracheal tube, which is a physical device inserted into the trachea.
- Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not interact with or analyze such specimens.
Therefore, the KIMVENT* MICROCUFF* Endotracheal Tubes for Adults are a medical device used for a therapeutic/procedural purpose, not an in vitro diagnostic purpose.
N/A
Intended Use / 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.
Product codes
BTR
Device Description
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*.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
trachea
Indicated Patient Age Range
adult patients
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
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.
Functional test results met acceptance criteria and demonstrate that the device is safe and effective for use in humans.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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
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 Road
Roswell, GA 30076 |
|-------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------|
| OFFICIAL
CORRESPONDENT | Marcia Johnson
Technical Leader, Regulatory Affairs
Tel: 770.587.8566
Fax: 920.380.6351
email: marcia.johnson@kcc.com |
| TRADE NAME: | Kimberly-Clark* KimVent* Microcuff* Endotracheal Tubes fo
Adults |
| CLASSIFICATION
NAME: | Tracheal tubes |
| DEVICE
CLASSIFICATION
AND PRODUCT
CODE | Class II per 21 CFR §868.5730
Product 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
1
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*.
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
2
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.
3
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
4
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
Page 1 of 1
510(k) Number: 1133333