(276 days)
Not Found
No
The description focuses on the mechanical features of the tracheal tube, specifically the articulating tip, and there is no mention of AI or ML in the text, performance studies, or key metrics.
No.
The device is described for airway management during anesthesia and mechanical ventilation, which are supportive functions, not therapeutic treatments for a disease or condition.
No
The device is intended for airway management (intubation), which is a treatment or intervention, not a diagnostic process. It does not collect or analyze data to identify a disease, condition, or its cause.
No
The device description clearly states it is a physical tracheal tube made of materials, with a beveled tip, cuff, inflation system, and connector. It is a hardware device.
Based on the provided information, the EndoFlex Tracheal Tube is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is "airway management by oral/nasal intubation." This is a procedure performed directly on a patient to manage their airway, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The description details a physical device used for intubation, including features like a beveled tip, cuff, and articulating tip. These are all components of a medical device used for a procedure, not for in vitro testing.
- Lack of IVD Characteristics: There is no mention of the device being used to analyze biological samples (blood, urine, tissue, etc.) or to provide diagnostic information based on such analysis.
Therefore, the EndoFlex Tracheal Tube is a medical device used for airway management, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The EndoFlex Tracheal Tube is intended for airway management by oral/nasal intubation.
Product codes
BTR
Device Description
The EndoFlex Tracheal Tube is sterile, single use device for airway management during anesthesia and mechanical ventilation. The tube is made in fifteen sizes; 3.0mm through 10.0mm in 0.5 mm increments. The EndoFlex Tracheal tube is identical to the predicate devices in terms of material composition, biocompatibility, and sterilization. The EndoFlex Tracheal tube has a beveled tip, high volume/low pressure cuff, inflation system, and 15mm connector equivalent to the predicate devices. The EndoFlex Tracheal tube differs from the predicate device in the following ways:
- The EndoFlex Tracheal tube has an articulating tip that can be flexed to facilitate . intubation. The flexing tip eliminates the need for intubation stylets.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
airway
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
Non-Clinical Performance Data: The EndoFlex Tracheal Tube was evaluated using the ASTM 1242-96 performance standard. The EndoFlex Tracheal Tube conforms to all of the performance standard criteria for materials, cuffs, inflation system, radius of curvature, marking materials, and packaging. The tube passes all performance tests for tube collapse, cuff materals, and paekaging - Netwees we/volume/diameter assessment, radiopaque markers, and leak test.
Clinical Performance Data: To date, no clinical data has been collected.
Key Metrics
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
Image /page/0/Picture/0 description: The image shows a handwritten string of alphanumeric characters, "K031794". The characters are written in a bold, slightly slanted font. The image has a white background.
Section E - 510(k) Summary
June 2, 2003
| Applicant: | Merlyn Associates Inc.
11 Bayleaf Lane
Irvine, CA 92620
Phone: 714 730-3976 Fax: 714 730-3899
Email: jkotin.merlyn@cox.net |
|-----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Application Preparer &
Correspondent | Thomas E. Ferari
Medical Device Consultant
181 Dixon Road
Queensbury, NY 12804
Phone - 518-792-2258 Fax: 518-792-2274
Email - tferari@aol.com |
| Proprietary Device Name: | EndoFlex Tracheal Tube |
| Common Device Name: | Endotracheal Tube |
| Classification Name: | Tracheal Tube (Class II Device Ref 21CFR 868.5730) |
| Predicate Devices: | Cuffed Tracheal Tube
Mallinckrodt Critical Care K871204 |
Device Description: The EndoFlex Tracheal Tube is sterile, single use device for airway management during anesthesia and mechanical ventilation. The tube is made in fifteen sizes; 3.0mm through 10.0mm in 0.5 mm increments. The EndoFlex Tracheal tube is identical to the predicate devices in terms of material composition, biocompatibility, and sterilization. The EndoFlex Tracheal tube has a beveled tip, high volume/low pressure cuff, inflation system, and 15mm connector equivalent to the predicate devices. The EndoFlex Tracheal tube differs from the predicate device in the following ways:
- The EndoFlex Tracheal tube has an articulating tip that can be flexed to facilitate . intubation. The flexing tip eliminates the need for intubation stylets.
Intended Use: The EndoFlex Tracheal Tube is intended for airway management by oral/nasal intubation.
Non-Clinical Performance Data: The EndoFlex Tracheal Tube was evaluated using the ASTM 1242-96 performance standard. The EndoFlex Tracheal Tube conforms to all of the performance standard criteria for materials, cuffs, inflation system, radius of curvature, marking
1
materials, and packaging. The tube passes all performance tests for tube collapse, cuff materals, and paekaging - Netwees we/volume/diameter assessment, radiopaque markers, and leak test.
Clinical Performance Data: To date, no clinical data has been collected.
Substantial Equivalence Assessment: Based on the non-clinical testing of the EndoFlex Substantial Liqurulent to the predicate devices and both safe and effective for clinical usc.
2
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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 2 2004
Merlyn Associates Incorporated c/o Dr. Ching Ching Seah, Ph.D. Amsino International, Incorporated 4501 Brickell Privado Ontario, CA 91761
Re: K031794
Trade/Device Name: EndoFlex Tracheal Tube Regulation Number: 863.5730 Regulation Name: Tracheal Tube Regulatory Class: II Product Code: BTR Dated: January 8, 2004 Received: January 12, 2004
Dear Dr. Seah:
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.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean r hat 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
3
Page 2 - Dr. Ching Ching Seah, Ph.D.
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 (301) 594-4646. 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/dsma/dsmamain.html.
Sincerely yours,
Charles
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
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Section D - Statement of Indications for Use
| 510(k) Number: | K031794 |
|---|---|
| Applicant: | Merlyn Associates Inc. |
| 11 Bayleaf Lane | |
| Irvine, CA 92620 | |
| Phone: 714 730-3976 Fax: 714 730-3899 |
EndoFlex Tracheal Tube Proprietary Device Name:
Intended Use: The EndoFlex Tracheal Tube is intended for airway management by oral/nasal intubation.
Prescription USE
510(k) Number:
fth
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices