(110 days)
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.
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.
The provided text describes a 510(k) premarket notification for a modification to an existing medical device, the Kimberly-Clark* KimVent* Microcuff* Subglottic Suctioning Endotracheal Tubes. This is not a study proving device meets acceptance criteria in the sense of a new AI/software medical device.
The original device (K120985) was already cleared, and this submission (K131254) is for a "Special 510(k): Device Modification" where the only change is the raw material used to bond the cuff to the endotracheal tube. Therefore, the "acceptance criteria" and "study" are focused on demonstrating that this change does not negatively impact the safety and effectiveness, and that the modified device remains substantially equivalent to the predicate.
Here's an analysis based on the provided text, structured to answer your questions where applicable, and noting where the information is not relevant to this type of submission (e.g., AI/software specific criteria):
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria/Standard | Reported Device Performance Description of How Met |
|------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------|
| Functional Performance | Suctioning Efficiency | Confirmed efficient suctioning. | Bench-top performance testing was conducted to confirm suctioning efficiency. |
| | ISO 5361:1999 (Anesthetic and respiratory equipment Tracheal tubes and connectors) | Conformance to standard. | Additional bench-top testing was conducted to assure conformance to this standard. |
| Biocompatibility | ANSI/AAMI/ISO 10993-3: 2003 (Biological Evaluation of Medical Devices - Part 3: Tests for Genotoxicity, Carcinogenicity, and Reproductive Toxicity) | Conformance to standard. | Biocompatibility testing was conducted to assure conformance to this standard. |
| | ANSI/AAMI/ISO 10993-5:2009 (Biological evaluation of medical devices - Part 5: Tests for In Vitro cytotoxicity) | Conformance to standard. | Biocompatibility testing was conducted to assure conformance to this standard. |
| | ANSI/AAMI/ISO 10993-6, 2007 (Biological Evaluation of Medical Devices - Part 6: Tests for Local Effects After Implantation) | Conformance to standard. | Biocompatibility testing was conducted to assure conformance to this standard. |
| | ANSI/AAMI/ISO 10993-10: 2010 (Biological evaluation of medical devices - Part 10: Tests for Irritation and Skin Sensitization) | Conformance to standard. | Biocompatibility testing was conducted to assure conformance to this standard. |
| Overall Conclusion | Demonstrating no concerns of safety or effectiveness for the modified device and substantial equivalence to the predicate. | "All results of testing met acceptance criteria and demonstrate no concerns of safety or effectiveness for the modified device." "Test results confirm that the device is as safe and effective and performs as well as or better than the predicate device." | Based on bench-top and biocompatibility testing against relevant standards. |
2. Sample Size Used for the Test Set and the Data Provenance
This is not a study involving a "test set" in the context of an AI/software medical device. The "testing" refers to standard medical device verification and validation activities (bench-top and biocompatibility testing) on the physical device. The exact sample sizes for these tests are not provided in the summary, but they would be determined by the requirements of the specific ISO/ANSI/AAMI standards referenced. Data provenance is not applicable as this is not a data-driven AI study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. There is no "ground truth" establishment by experts in the context of an AI/software algorithm for this physical device modification. The "ground truth" for device performance is based on meeting the specifications of the referenced standards and internal engineering requirements.
4. Adjudication Method for the Test Set
Not applicable. There is no expert adjudication for this type of physical device testing.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is not an AI-assisted device. No MRMC study was conducted.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/software algorithm.
7. The Type of Ground Truth Used
The "ground truth" in this context refers to the established performance requirements and safety profiles defined by:
- International Standards: ISO 5361:1999 (functional), ANSI/AAMI/ISO 10993 series (biocompatibility).
- Predicate Device Performance: The modified device must perform "as well as or better than" the predicate device (K120985).
8. The Sample Size for the Training Set
Not applicable. This is not an AI/machine learning device; therefore, there is no training set.
9. How the Ground Truth for the Training Set was Established
Not applicable. There is no training set. The "ground truth" for the overall device acceptability is based on compliance with established medical device standards and demonstrating substantial equivalence to the predicate device through bench-top and biocompatibility testing.
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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 RoadRoswell, GA 30076 |
|---|---|
| OfficialCorrespondent | Marcia Johnson, RAC, CBATechnical Leader, Regulatory AffairsTel: 770.587.8566Fax: 920.380.6351email: marcia.johnson@kcc.com |
| Trade Name: | Kimberly-Clark* KimVent* Microcuff* Subglottic Suctioning Endotracheal Tubes |
| ClassificationName: | Tracheal tube |
| DeviceClassificationand ProductCode | Class II per 21 CFR §868.5730Product Code - BTR |
| Predicate Device | The Kimberly-Clark* KimVent* Microcuff* Subglottic SuctioningEndotracheal 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
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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 SuctioningEndotracheal Tubes(120985) | Device subjectof thissubmission | |
|---|---|---|
| Materials | ||
| EndotrachealTube | PVC tube w/BariumSulphate Radiopaqueline | Same |
| Pilot BalloonAssembly | PVC Pilot BalloonOne-way valve (BespakCheck Valve) = PVC,Nitizile/Acetal/stainlesssteel | Same |
| Inflation Tube/tail = PVC |
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| Materials | Device subjectof thissubmission | |
|---|---|---|
| Kimberly-Clark*KimVent* Microcuff*Subglottic SuctioningEndotracheal Tubes(120985) | ||
| InflatablePressure Cuff | Polyurethane with abarrel-shape | Same |
| SuctionSystem/FlushPort | PVC Tube withAcrylonitrile ButadieneStyrene (ABS) Valve | Same |
| VentConnector | Polypropylene | Same |
| Ink | All inks were confirmedto be non-cytotoxic, non-irritating and non-sensitizing throughappropriate ISO 10993testing. | Same |
| Adhesives | UV-Cure Adhesives,Cyanoacrylate Adhesive | Same, exceptthe adhesiveused to bondthe cuff to thetube haschanged froman adhesive to asolvent basedblend ofmaterials. |
| 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.
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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
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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
§ 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).