(110 days)
Not Found
No
The summary describes a mechanical device for airway management and secretion removal, with no mention of AI or ML capabilities. The performance studies are bench-top and biocompatibility testing, not related to algorithmic performance.
Yes.
The device is used for airway management and removal of secretions, which are therapeutic interventions.
No
The device is an endotracheal tube used for airway management and secretion removal, which are therapeutic and management functions, not diagnostic.
No
The device description clearly outlines a physical, disposable endotracheal tube with a separate lumen and suction valve, indicating it is a hardware device. There is no mention of software as the primary component or function.
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.
- Device Description: The description details a physical tube inserted into the trachea with a suctioning mechanism. This is a medical device used for treatment and management, not for testing samples outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis. The device's function is purely mechanical and therapeutic.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
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 (comma separated list FDA assigned to the subject device)
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 Eve. They include a separate lumen with a dorsal opening above the cuff to provide access to the subglottic space. The subglottic space is reached via a normally open suction valve which 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 sizes
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 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
Clinical testing was not conducted.
All results of testing met acceptance criteria and demonstrate no concerns of safety or effectiveness for the modified device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
K131 254
510(K) SUMMARY
Kimberly-Clark Corporation
June 17, 2013
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, RAC, CBA
Technical Leader, Regulatory Affairs
Tel: 770.587.8566
Fax: 920.380.6351
email: marcia.johnson@kcc.com |
| Trade Name: | Kimberly-Clark* KimVent* Microcuff* Subglottic Suctioning Endotracheal Tubes |
| Classification
Name: | Tracheal tube |
| Device
Classification
and Product
Code | Class II per 21 CFR §868.5730
Product Code - BTR |
| Predicate Device | The Kimberly-Clark* KimVent* Microcuff* Subglottic Suctioning
Endotracheal Tubes subject of this submission are substantially |
AUG 2 0 2013Endotracheal Tubes subject of this submission are substantially equivalent to the KimVent* Microcuff* Subglottic Suctioning Endotracheal Tubes cleared in 510(k) K120985.
| Device | KimVent* Microcuff* Subglottic Suctioning Endotracheal Tubes are |
|---|---|
| Description: | available in adult sizes 7.0, 7.5, 8.0, 8.5 and 9.0mm with a Murphy |
Special 510(k): Device Modification Kimberly-Clark* Microcuff* Subglottic Suctioning ET Tubes
1
Eve. They include a separate lumen with a dorsal opening above the cuff to provide access to the subglottic space. The subglottic space is reached via a normally open suction valve which 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.
KimVent* Microcuff* Subglottic Suctioning Endotracheal Tubes Intended Use: are indicated for airway management by oral intubation of the trachea and for removal of secretions that accumulate in the subglottic space.
Both the modified Kimberly-Clark* KimVent* Microcuff* Technological Subglottic Suctioning Endotracheal Tubes and the predicate Characteristics KimVent* Microcuff* Subglottic Suctioning Endotracheal Tubes have the same basic fundamental technological characteristics. Both are polyvinylchloride tubes with a barrel-shaped polyurethane inflatable cuff and a suction lumen. Both incorporate a suction valve with integrated rinse port to aid in removing secretions that accumulate in the subglottic space. The only difference in the endotracheal tube is the change in a raw material used to bond the cuff to the endotracheal tube. Below is a comparison table that summarizes the technological characteristics of the subject and predicate tubes.
| | Kimberly-Clark*
KimVent* Microcuff*
Subglottic Suctioning
Endotracheal Tubes
(120985) | Device subject
of this
submission |
|---------------------------|---------------------------------------------------------------------------------------------------------|-----------------------------------------|
| Materials | | |
| Endotracheal
Tube | PVC tube w/Barium
Sulphate Radiopaque
line | Same |
| Pilot Balloon
Assembly | PVC Pilot Balloon
One-way valve (Bespak
Check Valve) = PVC,
Nitizile/Acetal/stainless
steel | Same |
| | Inflation Tube/tail = PVC | |
2
| Materials | | Device subject
of this
submission |
|---------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Kimberly-Clark*
KimVent* Microcuff*
Subglottic Suctioning
Endotracheal Tubes
(120985) | |
| Inflatable
Pressure Cuff | Polyurethane with a
barrel-shape | Same |
| Suction
System/Flush
Port | PVC Tube with
Acrylonitrile Butadiene
Styrene (ABS) Valve | Same |
| Vent
Connector | Polypropylene | Same |
| Ink | All inks were confirmed
to be non-cytotoxic, non-
irritating and non-
sensitizing through
appropriate ISO 10993
testing. | Same |
| Adhesives | UV-Cure Adhesives,
Cyanoacrylate Adhesive | Same, except
the adhesive
used to bond
the cuff to the
tube has
changed from
an adhesive to a
solvent based
blend of
materials. |
| Sizes | 7.0, 7.5, 8.0, 8.5, 9.0
(mm) | Same |
| Shelf-life | 2 years | Same |
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 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
3
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
Clinical testing was not conducted.
All results of testing met acceptance criteria and demonstrate no concerns of safety or effectiveness for the modified device.
Conclusion:
The modified Kimberly-Clark* KimVent* Microcuff* Subglottic Suctioning Endotracheal Tubes are substantially equivalent to the predicate device, Kimberly-Clark* KimVent* Microcuff* Subglottic Suctioning Endotracheal Tubes (K120985), in intended use, design, performance, principles of operation, and both are intended for single use. Test results confirm that the device is as safe and effective and performs as well as or better than the predicate device.
4
Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird with three wing-like shapes, suggesting movement or flight. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Conter - WO66-G609 Silver Spring, MD 20993-0002
August 20. 2013
Kimberly-Clark Corporation Ms. Marcia Johnson, RAC, CBA Technical Leader, Regulatory 1400 Holcomb Bridge Road ROSWELL GA 30076
Re: K131254
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: June 20, 2013 Received: June 21, 2013
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 10 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 r no general comanufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRI-1 does not evaluate information related to contract liability warrantics. 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 Eederal 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 (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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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,
Tejashri Purohit-Sheth, M.D.
Clinical Deputy Director
DAGRID
FOR
Kwame Ulmer M.S. Acting Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
INDICATIONS FOR USE
510(k) Number (if known): 长13/254
Device Name:_ Kimberly-Clark* 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.
AND/OR X 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. Schulthels Jr
2013.08.19 12:26:38 -04'00' (Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
Page I of ____________________________________________________________________________________________________________________________________________________________________ 510(k) Number:
Special 510(k): Device Modification Kimberly-Clark" Microcuff" Subglottic Suctioning ET Tubes
Section 2 - Indications for Use
Page 6 of 54