(30 days)
Not Found
No
The device description and intended use focus on the physical characteristics and function of an endotracheal tube, with no mention of AI or ML capabilities.
No
The device is described as assisting in airway management and drainage, which are supportive functions rather than direct therapeutic treatments for a disease or condition. Its purpose is to maintain an open airway or remove substances.
No
The device is described as an endotracheal tube used for airway management and subglottic drainage, with no mention of diagnosing conditions or processing medical images.
No
The device description clearly describes a physical, sterile, single-use endotracheal tube with various hardware components like lumens, a cuff, a valve, a pilot balloon, and a radiopaque line. There is no mention of software as a component or the primary function of the device.
Based on the provided information, the SealGuard Evac Endotracheal tube is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for airway management by oral/nasal intubation and evacuation/drainage of the subglottic space. This is a direct intervention on a patient's body to maintain an airway, not a test performed on samples taken from the body.
- Device Description: The description details a physical tube inserted into the trachea with features for airway management and drainage. It does not describe any components or processes related to analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing blood, urine, tissue, or any other biological sample. There is no mention of reagents, assays, or diagnostic testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The SealGuard Evac Endotracheal tube is a therapeutic and management device, not a diagnostic one.
N/A
Intended Use / Indications for Use
The SealGuard 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 SealGuard Endotracheal tube is a device inserted into a patient's trachea via the nose or mouth to maintain an open airway.
Product codes
BTR
Device Description
The SealGuard and the SealGuard Oral 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 features a unique ultra thin high volume low pressure cuff and self sealing valve with attached pilot balloon. The unique cuff material of the SealGuard products ideally gives an improved sealing performance over historical PVC cuffed product. The tube incorporates a Magill curve, a hooded tip with 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)
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
KORAS20
OCT 02 2008
Special 510(k) Summary
1. Company Identification
Covidien, (formerly Nellcor Puritan Bennett, Inc.) 6135 Gunbarrel Avenue Boulder, CO 80301
Establishment Registration: 2936999
2. Contact Person
Scott Dickerhoff Director, Regulatory Affairs Phone: (303) 305-2382 Fax: (303) 305-2212 Email: scott.dickerhoff(@covidien.com
- 510(k) Preparation Date
July 15, 2008
4. Device Name
SealGuard Endotracheal Tube and SealGuard Evac Endotracheal Tubes. Trade Name: Common Name: Endotracheal Tube, Tracheal Tube
5. Device Classification
Class II per 21 CFR 878.5730
6. Indications for Use
The SealGuard 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 SealGuard Endotracheal tube is a device inserted into a patient's trachea via the nose or mouth to maintain an open airway.
1
7. Description of Device
SealGuard™ Endotracheal Tube (5.0, 5.5, 6.0, 6.5, 7.0, 7.5, 8.0, 8.5, 9.0, 10mm)
SealGuard™ Evac Endotracheal Tube - Oral (6.0, 6.5, 7.0, 7.5, 8.0, 8.5, 9.0mm)
The SealGuard™ and the SealGuard™ Oral 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 features a unique ultra thin high volume low pressure cuff and self sealing valve with attached pilot balloon. The unique cuff material of the SealGuard products ideally gives an improved sealing performance over historical PVC cuffed product. The tube incorporates a Magill curve, a hooded tip with Murphy Eye and a Tip-To-Tip™ radiopaque line to assist in radiographic visualization.
8. Substantial Equivalence
The predicate devices to which we claim equivalence are the Hi-Lo Cuffed Tracheal Tube (K871204), and the Hi-Lo Evac Endotracheal Tubes (K965132).
The SealGuard Endotracheal tube and the SealGuard EVAC Endotracheal tubes maintain the same intended use as the predicate device. It is a device inserted into the trachea through the mouth or nose to facilitate breathing.
The SealGuard Endotracheal tube & SealGuard EVAC Endotracheal tubes and the predicate device consist of the same fundamental technology.
The SealGuard Endotracheal tube and the SealGuard EVAC Endotracheal tubes differ from the predicate device in that the cuff material is PU (polyurethane) and the predicate device cuff is PVC (polyvinylchloride). In addition, the shape of the cuff is modified from a barrel shape to a tapered shape.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 02 2008
Mallinckrodt Medical C/O Mr. Scott Dickerhoff Director, Regulatory Affairs Covidien 6135 Gunbarrel Avenue Boulder, Colorado 80301
Re: K082520
Trade/Device Name: ScalGuard Tracheal Tubes and SealGuard Evac Tracheal Tubes Regulation Number: 21 CFR 868.5730 Regulation Name: Tracheal Tube Regulatory Class: II Product Code: BTR Dated: August 29, 2008 Received: September 2, 2008
Dear Mr. Dickerhoff:
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.
3
Page 2 - Mr. Dickerhoff
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,
MAnuels Sedimts foell
Chiu Lin, Ph.D. 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: _
Device Name: SealGuard Tracheal Tubes and SealGuard Evac Tracheal Tubes
Indications for Use:
The SealGuard 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 SealGuard Endotracheal tube is a device inserted into a patient's trachea via the nose or mouth to maintain an open airway.
fr. Aciup.
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K080620
Prescription Use _ X (Part 21 CFR 801 Subpart D) AND/OR
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)
Covidien
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