(261 days)
Not Found
No
The summary describes a mechanical device for airway management and secretion removal, with no mention of AI or ML capabilities.
Yes.
The device is used for airway management and removal of secretions, which are therapeutic interventions.
No
The device is an endotracheal tube designed for airway management and secretion removal, which are therapeutic and management functions, not diagnostic ones.
No
The device description clearly details a physical, disposable endotracheal tube with a separate lumen and suction valve, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for airway management and removal of secretions from the subglottic space. This is a direct intervention on the patient's body for therapeutic and management purposes.
- Device Description: The device is an endotracheal tube with a suctioning mechanism. This is a physical device used within the body.
- Lack of Diagnostic Purpose: There is no mention of the device being used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
IVD devices are used to perform tests on samples (like blood, urine, tissue) taken from the body to diagnose or monitor a condition. This device is used in the body for treatment and management.
N/A
Intended Use / 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.
Product codes
BTR
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
trachea, subglottic space
Indicated Patient Age Range
adult
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-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
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.
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
23 Kimberly-Clark Corporation
Section 3 - 510(K) Summary
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:
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.
Section 3 - 510(K) Summary
Page 1 of 4 ·
1
දිනු Kimberly-Clark Corporation
Intended 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.
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-Clark*
KimVent* Microcuff*
Subglottic
Suctioning
Endotracheal Tubes |
|-----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|
| Materials | | |
| Endotracheal Tube | Polyvinylchloride Tube
(PVC) with Radiopaque
line | PVC tube
w/Barium Sulphate
Radiopaque line |
| Pilot Balloon
Assembly | Plasticol or PVC Pilot
Balloon
One-way valve (Bespak
valve) = PVC, Plastic
Acetal copolymer, Nitrile
Rubber, stainless steel
Inflation Tail = PVC | PVC Pilot Balloon
One-way valve
(Bespak Check Valve)
= PVC, Nitizile/Acetal/
stainless steel
Inflation Tube/Tail =
PVC |
| Inflatable Pressure
Cuff | PVC with a tapered-
shape | Polyurethane with a
barrel-shape |
| Suction System | PVC | PVC Tube with
Acrylonitrile Butadiene
Styrene (ABS) valve |
| Vent Connector | PVC | Polypropylene |
Section 3 - 510(K) Summary
Page 2 of 4
2
| Predicate Device - | Subject Device - | |
|---|---|---|
| TaperGuard Evac™ | ||
| Endotrachael Tubes | ||
| (K090352) | Kimberly-Clark* | |
| KimVent* Microcuff* | ||
| Subglottic | ||
| Suctioning | ||
| Endotracheal Tubes | ||
| Ink | Medical Grade Ink | All inks were confirmed |
| to be non-cytotoxic, | ||
| non-irritating and non- | ||
| sensitizing through | ||
| appropriate ISO 10993 | ||
| testing. | ||
| Adhesives | Solvents used for | |
| assembly: | ||
| Cyclohexanone, Balloon | ||
| Glue, | ||
| Cyclohexanone/Scanning | ||
| compound No. 5. | UV-Cure Adhesives, | |
| Cyanoacrylate | ||
| Adhesive | ||
| 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-year | ||
| using established | ||
| protocols |
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
3
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
4
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.
5
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
6
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