(49 days)
Not Found
No
The device description and summary of performance studies focus on the physical characteristics and material safety of the tube, with no mention of AI or ML capabilities.
No.
Explanation: The device is intended for emergency intubation, difficult intubation, or general anesthesia intubation, providing ventilation, which are acute interventions rather than long-term therapeutic treatments.
No
The device is an intubation tube designed for ventilation, not for diagnosing conditions.
No
The device description clearly details a physical, hardware-based medical device (a tube with lumens, cuffs, and valves) and does not mention any software component.
Based on the provided information, the Rüsch Easy Tube is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for emergency intubation, difficult intubation, or general anesthesia intubation. This is a direct intervention on the patient's airway for ventilation, not a test performed on samples taken from the body.
- Device Description: The device is a physical tube designed to be inserted into the body. It has cuffs and lumens for ventilation. This is characteristic of a medical device used for treatment or support, not for diagnostic testing.
- Lack of Diagnostic Elements: There is no mention of the device being used to analyze biological samples (like blood, urine, tissue, etc.) or to provide information about a patient's health status based on such analysis.
- Anatomical Site: The anatomical sites mentioned (oro- and nasopharynx, esophagus, trachea) are where the device is physically placed, not where samples are collected for analysis.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. The Rüsch Easy Tube does not fit this description. It is a medical device used for airway management.
N/A
Intended Use / Indications for Use
The Rüsch Easy Tube is a sterile single patient use, combination esophageal/tracheal tube intended to be used for emergency intubation, difficult intubation or general anesthesia intubation. The device will provide sufficient ventilation whether the airway is placed into the esophagus or into the trachea.
Product codes
BTR
Device Description
The Rüsch Easy Tube consists of a 28 Fr (Small) or 41 Fr (Large), clear, twin lumen tube with a radiopaque stripe and graduated centimeter markings. The 28 Fr size is for use with patients 90 - 130 cm in height. The 41 Fr size is for use with patients over 130 cm in height.
The device is designed to occlude the oro- and nasopharynx. The tube has a PVC high volume, low pressure, inflatable distal esophageal cuff and a larger proximal oropharyngeal cuff. Both cuffs are provided with self-sealing luer connector valves. A color-coded pilot balloon is provided for each of the color coding facilitates identification of the cuff/pilot balloon relationship. The clear pilot balloon corresponds with the clear distal cuff. The blue pilot balloon corresponds with the green proximal cuff. The shaft for the proximal cuff is also color-coded with a matching blue sleeve.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
oro- and nasopharynx, esophagus, trachea
Indicated Patient Age Range
The 28 Fr size is for use with patients 90 - 130 cm in height. The 41 Fr size is for use with patients over 130 cm in height.
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
All materials used in the fabrication of the Rüsch Easy Tube were evaluated through biological qualification safety tests as outlined in ISO 10993 Part 1 "Biological Evaluation of Medical Devices". Comparative testing was performed. The materials used were also tested in accordance with industry recognized test methods and were found to be acceptable for the intended use.
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 the logo for Teleflex Medical. The logo is in black and white. The word "Teleflex" is in a bold, sans-serif font, and the word "MEDICAL" is in a smaller, sans-serif font below the word "Teleflex."
JAN - 7 2005
Teleflex Medical Group Headquarters 2345 Waukegan Road Bannockburn, IL 60015 USA 847-572-8002 Phone: Fax: 847-572-8001 www.teleflex.com
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Rüsch Easy Tube
A. Name, Address, Phone and Fax Number of Applicant
Teleflex Medical Group Headquarters 2345 Waukegan Road Bannockburn, IL 60015 USA Phone: 847-572-8002 Fax: 847-572-8001
B. Contact Person
Lori Hays Senior Manager, Regulatory Affairs
C. Date Prepared
November 18, 2004
D. Device Name
Trade Name: Rüsch Easy Tube
Common Name: Tracheal Tube
Classification Name: Tube, Tracheal (w/wo Connector)
Product Code: BTR
Regulation Number: 868.5730
Class: Il
E. Device Description
The Rüsch Easy Tube consists of a 28 Fr (Small) or 41 Fr (Large), clear, twin lumen tube with a radiopaque stripe and graduated centimeter markings. The 28 Fr size is for use with patients 90 - 130 cm in height. The 41 Fr size is for use with patients over 130 cm in height.
A Division of Teleflex Incorporated
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1
The device is designed to occlude the oro- and nasopharynx. The tube has a PVC high volume, low pressure, inflatable distal esophageal cuff and a larger proximal oropharyngeal cuff. Both cuffs are provided with self-sealing luer connector valves. A color-coded pilot balloon is provided for each of the color coding facilitates identification of the cuff/pilot balloon relationship. The clear pilot balloon corresponds with the clear distal cuff. The blue pilot balloon corresponds with the green proximal cuff. The shaft for the proximal cuff is also color-coded with a matching blue sleeve.
F. Intended Use
The Rüsch Easy Tube is a sterile single patient use, combination esophageal/tracheal tube intended to be used for emergency intubation, difficult intubation or general anesthesia intubation. The device will provide sufficient ventilation whether the airway is placed into the esophagus or into the trachea.
G. Substantial Equivalence
The Rüsch Easy Tube is substantially equivalent to the Kendall Combitube (K844746) in intended use, design and components, materials, and performance characteristics. See Table 1.
| Comparison Point | Easy Tube | Kendall Combitube -
K844746 |
|---------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | To be used for emergency,
difficult or general anesthesia
intubation. The device will
provide sufficient ventilation
whether the airway is placed
into the esophagus or into the
trachea. | To be used for emergency,
difficult or general anesthesia
intubation. The device will
provide sufficient ventilation
whether the airway is placed
into the esophagus or into the
trachea. |
| I.D. Size | Small - 28Fr
Large - 41Fr | Small Adult - 37Fr,
Regular - 41Fr |
| Cuff Style | High Volume, Low Pressure | High Volume, Low Pressure |
| Pilot Balloons -
Color Coded | Yes | Yes |
| Tube Available
Separately | Yes | Yes |
| Graduations | Yes | No |
| Radiopaque Marker | Yes | No |
| Inflation Valve Type | Luer Activated | Luer Activated |
| Sterile | Yes | No |
Table 1
2
H. Summary of Testing
All materials used in the fabrication of the Rüsch Easy Tube were evaluated through biological qualification safety tests as outlined in ISO 10993 Part 1 "Biological Evaluation of Medical Devices". Comparative testing was performed. The materials used were also tested in accordance with industry recognized test methods and were found to be acceptable for the intended use
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract symbol that resembles an eagle or bird-like figure.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN - 7 2005
Ms. Lori Hays Senior Manager, Regulatory Affairs Teleflex Medical Group Headquarters 2345 Waukegan Road Bannockburn, Illinois 60015
Re: K043205
Trade/Device Name: Rüsch Easy Tube Regulation Number: 868.5730 Regulation Name: Tracheal Tube Regulatory Class: II Product Code: BTR Dated: November 18, 2004 Received: November 19, 2004
Dear Ms. Hays:
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.
4
Page 2 - Ms. Hays
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. or the rest of mply 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 and instills (1) CF CF CF 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) rine reter 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), rf you contact the Office of Compliance at (301) 594-0120. 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,
Suitte Michael OMD. for DR. CHIU LIN
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
5
Image /page/5/Picture/0 description: The image shows the logo for Teleflex Medical. The logo is in black and consists of the word "Teleflex" in a bold, sans-serif font, with the word "MEDICAL" in a smaller font size underneath. The logo is simple and modern, and it is likely used to represent the company's brand identity.
Teleflex Medical Group Headquarters 2345 Waukegan Road Bannockburn, IL 60015 USA Phone: 847-572-8002 847-572-8001 Fax: www.teleflex.com
Indications for Use
510(k) Number (if known):
Rüsch Easy Tube Device Name:
Indications For Use:
The Rüsch Easy Tube is a sterile, single use, combination esophageal/ tracheal tube intende to be used for emergency intubation, difficult intubation or general anesthesia intubation. Th to be adou for entilation whether the airway is placed into the esophagus or in the trachea
Jan K. Lemille Smichaelo MD
FOR
sthesiology, General Hospital, ion Control, Dental
510(k) Number:_Koy3205
AND/OR Over-The-Counter Use __________________________________________________________________________________________________________________________________________________ Prescription Use _ X (Part 21 CFR 801 Subpart D) (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)
Page 1 of
A Division of Teleflex Incorporated
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