(116 days)
Not Found
No
The device description and intended use are purely mechanical and do not mention any computational or analytical capabilities. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
Yes
The device is used for airway management and ventilator support, which are therapeutic interventions.
No
This device, an endotracheal tube, is used for airway management and provides mechanical support (e.g., delivering air for ventilation) rather than diagnosing conditions or diseases.
No
The device description clearly details physical components like a silicone shaft, wire reinforcement, connector, depth marks, ring marks, hooded tip, ACAP, inflatable air cuff, inflation line, luer valve, and pilot balloon. These are all hardware components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "providing airway management by oral intubation of the trachea during anesthesia and during ventilator support of respiration." This is a direct medical intervention on a patient's body to manage their airway.
- Device Description: The description details a physical tube inserted into the trachea, with features like a cuff, inflation line, and connector. These are all components of a device used for direct patient care.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not perform any such analysis of biological specimens.
Therefore, the Arcadia Medical® Silicone Wire Reinforced Endotracheal Tube is a medical device used for airway management, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Endotracheal Tubes are indicated for use in providing airway management by oral intubation of the trachea during anesthesia and during ventilator support of respiration. Wire Reinforced Endotracheal Tubes are indicated for use in procedures requiring flexing of the neck or movement of the patient (lateral or prone position).
Product codes (comma separated list FDA assigned to the subject device)
BTR
Device Description
Arcadia Medical® Silicone Wire Reinforced Endotracheal Tubes are available in Cuffless or Air Cuff styles. All tubes consist of a radiopaque biocompatible wire reinforced silicone shaft and have a standard 15mm connector, depth marks in centimeters and two ring marks behind the cuff for reference in determining the position of the cuff or distal tip in the trachea.
Air Cuff Endotracheal Tubes have a radiopaque hooded tip to ease insertion through the vocal cords. Air Cuff Tubes also have an Above the Cuff Access Port (ACAP)® for removing secretions above the cuff to help prevent aspiration.
Air Cuff Endotracheal Tubes have an inflatable air cuff to seal the trachea. When properly inflated, the air cuff conforms to the shape of the trachea providing an effective seal. The tube has an inflation line with a luer valve and blue pilot balloon to indicate cuff inflation.
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)
Performance Data for the device is shown in Section 11: Performance Standards
Performance Data indicates that the device is substantially equivalent in performance to the predicate 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.
K792035, K830352, K954750, K954754, K991580
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
510(K) SUMMARY [as required by 807.92(c)]
| Date Submitted: | January 6, 2006 | |
|---|---|---|
| Submitter: | Arcadia Medical Corporation | |
| 1450 East American Lane, Suite 1400 | ||
| Schaumburg, IL 60173 USA | ||
| Phone: 847-330-4447 | ||
| Fax: 847-620-2502 | ||
| E-Mail: mfoote@arcadiamedical.com | ||
| Contact Person: | Mr. Mark Foote | |
| Classification Name: | Tube, Tracheal (W/Wo Connector) | |
| Common Device Name: | Tracheal Tube or Endotracheal Tube | |
| Proprietary Name: | Arcadia Medical® Silicone Cuffless Wire Reinforced | |
| Endotracheal Tubes with Murphy Eye | ||
| Arcadia Medical® Silicone Air Cuff Wire Reinforced | ||
| Endotracheal Tubes with Murphy Eye, Hooded Tip and | ||
| Above the Cuff Access Port (ACAP)® | ||
| Regulatory Class: | II | |
| Classification Number: | BTR | |
| Regulation Number: | 868.5730 | |
| Panel: | Anesthesiology |
Legally Marketed Predicate Devices:
- K792035- Fome-Cuf-Wire Reinforced, Aire-Cuf Wire Reinforced Tracheal Tube: Bivona Medical Technologies
- K830352- Reinforced Silicone Tracheal Tube: Portex
- K954750- Pediatric Wire Reinforced Silicone Endotracheal Tube: Unomedical (Euromedical) Sdn Bhd
- ' K954754- Wire Reinforced Silicone Endotracheal Tube: Unomedical (Euromedical) Sdn Bhd
- K991580- ILM Endotracheal Tube: Laryngeal Mask Company, Ltd.
1
510(K) SUMMARY [continued]
Device Description:
Arcadia Medical® Silicone Wire Reinforced Endotracheal Tubes are available in Cuffless or Air Cuff styles. All tubes consist of a radiopaque biocompatible wire reinforced silicone shaft and have a standard 15mm connector, depth marks in centimeters and two ring marks behind the cuff for reference in determining the position of the cuff or distal tip in the trachea.
Air Cuff Endotracheal Tubes have a radiopaque hooded tip to ease insertion through the vocal cords. Air Cuff Tubes also have an Above the Cuff Access Port (ACAP)® for removing secretions above the cuff to help prevent aspiration.
Air Cuff Endotracheal Tubes have an inflatable air cuff to seal the trachea. When properly inflated, the air cuff conforms to the shape of the trachea providing an effective seal. The tube has an inflation line with a luer valve and blue pilot balloon to indicate cuff inflation.
Intended Use:
Endotracheal Tubes are indicated for use in providing airway management by oral intubation of the trachea during anesthesia and during ventilator support of respiration. Wire Reinforced Endotracheal Tubes are indicated for use in procedures requiring flexing of the neck or movement of the patient (lateral or prone position).
Technological Characteristics of Device compared to Predicate Devices:
The device is substantially equivalent to the Predicate devices in all aspects except the following;
The Air Cuff Model has a unique molded tip and a suction port above the cuff to remove secretions.
Performance Data:
Performance Data for the device is shown in Section 11: Performance Standards
Performance Data indicates that the device is substantially equivalent in performance to the predicate device.
Conclusion:
Comparison of the device to the predicate devices supports the conclusion that the device is substantially equivalent in safety and effectiveness and in its intended use to existing legally marketed devices.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three curved lines representing its wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NAV - 8 Julia
Mr. Mark Foote President Arcadia Medical Corporation 1450 East American Lane, Suite 1400 Schaumburg, Illinois 60173
Re: K060094
Trade/Device Name: Arcadia Medical® Silicone Wire Reinforced Endotracheal Tubes Regulation Number: 21 CFR 868.5730 Regulation Name: Tracheal Tube Regulatory Class: II Product Code: BTR Dated: April 29, 2006 Received: May 3, 2006
Dear Mr. Foote:
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. Foote
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 Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
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 Statement
Page 1 of 1
510(k) Number (if known): ¥ 0 6 0 0 % 9 %
Device Name: Arcadia Medical® Silicone Wire Reinforced Endotracheal Tubes
Indications for Use:
Endotracheal Tubes are indicated for use in providing airway management by oral intubation of the trachea during anesthesia and during ventilator support of respiration. Wire Reinforced Endotracheal Tubes are indicated for use in procedures requiring flexing of the neck or movement of the patient (lateral or prone position).
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)
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