(51 days)
Not Found
No
The 510(k) summary describes a mechanical device for airway management and subglottic drainage. There is no mention of AI, ML, or any computational analysis of data. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
Yes
The device is used for airway management and evacuation/drainage, which are therapeutic interventions.
No
The device is an endotracheal tube used for airway management and evacuation/drainage, not for diagnosing medical conditions.
No
The device description clearly details physical components like a tube, lumen, connector, and radiopaque line, 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:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Function: The TaperGuard Evac™ Endotracheal tube is a device inserted directly into a patient's airway to maintain an open airway and for drainage. It does not analyze specimens taken from the body.
- Intended Use: The intended use clearly describes a procedure performed directly on the patient for airway management and drainage, not for laboratory testing of specimens.
Therefore, this device falls under the category of a medical device used for direct patient care, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Hi-Lo, Intermediate Hi-Lo, and TaperGuard™ cuffed endotracheal tubes are indicated for oral/nasal intubation of the trachea for anesthesia and for general airway management. Tubes that are pre-cut to special lengths are intended for oral intubation only.
The TaperGuard Evac™ Endotracheal tube is indicated for airway management by oral/nasal intubation of the trachea and for evacuation or drainage of the subglottic space.
The TaperGuard™ Endotracheal tube is a device inserted into a patient's trachea via the nose or mouth to maintain an open airway.
Product codes (comma separated list FDA assigned to the subject device)
BTR
Device Description
TaperGuard™ Endotracheal Tube (5.0, 5.5, 6.0, 6.5, 7.0, 7.5, 8.0, 8.5, 9.0, 9.5, 10mm)
TaperGuard Evac™ Endotracheal Tube - Oral (6.0, 6.5, 7.0, 7.5, 8.0, 8.5, 9.0mm)
The TaperGuard™ and the TaperGuard Evac™ Tracheal Tubes are sterile, single-use devices supplied with a standard 15mm connector. On the Evac tubes, in addition to the main lumen, the tube has a separate Evac lumen which has a dorsal opening above the cuff. Access to the lumen is accomplished via a clear connecting tube with a capped Luer connector. The tube incorporates a Magill curve, a hooded tip with a Murphy Eye and a Tip-To-Tip™ radiopaque line to assist in radiographic visualization.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
trachea
Indicated Patient Age Range
Not Found
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)
Not Found
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
Image /page/0/Picture/0 description: The image contains a sequence of handwritten characters, which appear to be a combination of letters and numbers. The sequence reads as 'K090352'. The characters are written in a bold, black ink, which contrasts with the white background. The style of writing is cursive, with some characters connected to each other.
Special 510(k) Summary
1. Company Identification
Covidien, (formerly Nellcor Puritan Bennett, Inc.) 6135 Gunbarrel Avenue Boulder, CO 80301
APR - 3 2009
Establishment Registration: 2936999
2. Contact Person
Ted Kuhn Regulatory Affairs Associate II Phone: (303) 305-2272 Fax: (303) 305-2212 Email: ted.kuhn@covidien.com
3. 510(k) Preparation Date
February 10, 2009
4. Device Name
TaperGuard™ Endotracheal Tubes and TaperGuard Evac™ Endotracheal Tubes. Trade Name: Endotracheal Tube, Tracheal Tube Common Name:
5. Device Classification
Class II Tracheal Tube (21 CFR 868.5730), classification code 73 BTR
6. Intended Use
The Hi-Lo, Intermediate Hi-Lo, and TaperGuard™ cuffed endotracheal tubes are indicated for oral/nasal intubation of the trachea for anesthesia and for general airway management. Tubes that are pre-cut to special lengths are intended for oral intubation only.
7. Indications for Use
The TaperGuard Evac™ Endotracheal tube is indicated for airway management by oral/nasal intubation of the trachea and for evacuation or drainage of the subglottic space.
The TaperGuard™ Endotracheal tube is a device inserted into a patient's trachea via the nose or mouth to maintain an open airway.
1
8. Claims
TaperGuard™ Endotracheal Tubes;
-
The TaperGuard™ PVC Tapered Cuff Endotracheal tubes reduce micro aspiration by an average of 90%, in comparison to the Hi-Lo Basic Barrel Shaped PVC Cuff Endotracheal tube.
TaperGuard Evac™ Endotracheal Tubes; -
The TaperGuard PVC Tapered Cuff Evac™ Endotracheal tubes reduce micro aspiration by an ﺎﺭ average of 90%, in comparison to the Hi-Lo Evac Barrel Shaped PVC Cuff Endotracheal tube.
In specific clinical circumstances, use of the TaperGuard Evac™ Endotracheal Tubes has been associated with a decrease in the rate of nosocomial pneumonia (VAP).
9. Description of Device
TaperGuard™ Endotracheal Tube (5.0, 5.5, 6.0, 6.5, 7.0, 7.5, 8.0, 8.5, 9.0, 9.5, 10mm)
TaperGuard Evac™ Endotracheal Tube - Oral (6.0, 6.5, 7.0, 7.5, 8.0, 8.5, 9.0mm)
The TaperGuard™ and the TaperGuard Evac™ Tracheal Tubes are sterile, single-use devices supplied with a standard 15mm connector. On the Evac tubes, in addition to the main lumen, the tube has a separate Evac lumen which has a dorsal opening above the cuff. Access to the lumen is accomplished via a clear connecting tube with a capped Luer connector. The tube incorporates a Magill curve, a hooded tip with a Murphy Eye and a Tip-To-Tip™ radiopaque line to assist in radiographic visualization.
10. Substantial Equivalence
The predicate devices to which we claim equivalence are the Hi-Lo Cuffed Tracheal Tubes (K871204), Hi-Lo Evac™ Endotracheal Tubes (K965132), SealGuard Endotracheal Tubes and SealGuard Evac™ Endotracheal Tubes (K082520).
The TaperGuard™ Endotracheal tubes and the TaperGuard Evac™ Endotracheal tubes maintain the same intended use as the predicate devices. It is a device inserted into the trachea through the mouth or nose to facilitate breathing.
The TaperGuard™ Endotracheal tubes, TaperGuard Evac™ Endotracheal tubes and the predicate devices consist of the same fundamental technology.
The TaperGuard™ device differs from the predicate device, SealGuard, in that the tapered cuff is made of PVC for TaperGuard™ and PU for SealGuard. Both devices have a tapered cuff.
The TaperGuard™ device differs from the predicate device, Hi-Lo, in that the TaperGuard™ has a tapered cuff and the Hi-Lo has a barrel shaped cuff. The cuff material for both devices is PVC.
The TaperGuard™ and TaperGuard Evac™ device in all clinical applications will be identical to the use of predicate devices. From a Human Factors perspective none of the changes in any way affect the operation or usability of the tube or cuff.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
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 stylized eagle with three overlapping bars representing its wings. The eagle faces right and is positioned to the right of a circular text element. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" and is arranged around the circumference of the circle.
Food and Drug Administration 200 Corporate Boulevard Rockville MD 20850
Mr. Ted Kuhn Regulatory Affairs Associate II Respiratory & Monitoring Solutions Covidien 6135 Gunbarrel Avenue Boulder, Colorado 80301
APR - 3 2009
Re: K090352
Trade/Device Name: TaperGuard™ Trachael Tubes and TaperGuard Evac™ Trachael Tubes Regulation Number: 21 CFR 868.5730
Regulation Name: Trachael Tube Regulatory Class: II
Product Code: BTR Dated: March 20, 2009 Received: March 23, 2009
Dear Mr. Kuhn:
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.
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Page 2 – Mr. Kuhn
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Susan Cuomo
Ginette Y. Michaud. M.D. Acting 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: K090352
Device Name: TaperGuard™ Tracheal Tubes and TaperGuard Evac™ Tracheal Tubes
Indications for Use:
The TaperGuard Evac™ Endotracheal tube is indicated for airway management by oral/nasal intubation of the trachea, and for evacuation or drainage of the subglottic space.
The TaperGuard™ Endotracheal tube is a device inserted into a patient's trachea via the nose or mouth to maintain an open airway.
Prescription Use (Part 21 CFR 801 Subpart D) C)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) (Division of Anesthesiology, General Hospital Infection Control, Dental Devices
Infection Control, etc.
Confidential & 510(K) Number: 120810352 - Covidien