(159 days)
Not Found
Not Found
No
The device description and intended use describe a physical medical device (endotracheal tube) with no mention of software, algorithms, or AI/ML capabilities. The "Mentions AI, DNN, or ML" and "Mentions image processing" sections are explicitly marked as "Not Found".
No.
The device, an endotracheal tube, is used for airway management and intubation, which are supportive functions rather than direct therapeutic treatments for a disease or condition.
No
Explanation: The device is an endotracheal tube used for airway management and intubation, which is a therapeutic rather than a diagnostic procedure.
No
The device description clearly states it is a physical tube made of PVC and stainless steel, which are hardware components.
Based on the provided information, the Rüsch Reinforced Endotracheal Tube is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "oral or nasal intubation and are indicated for airway management." 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 tube inserted into the airway, not a reagent, instrument, or system used for testing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing samples, detecting substances, or providing diagnostic information based on in vitro testing.
Therefore, the Rüsch Reinforced Endotracheal Tube is a medical device used for airway management, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Rüsch Reinforced Endotracheal Tube is designated for oral or nasal intubation and are indicated for airway management. The product may be used to reduce the potential for kinking whenever an unusual positioning of the head or neck is required following intubation.
Product codes (comma separated list FDA assigned to the subject device)
BTR
Device Description
The Rusch Reinforced Endotracheal Tube consists of a specially designed, clear PVC tube with stainless steel reinforcing spiral. The tube is graduated with multiple centimeter markings to allow easy determination of intubation length, and is terminated with a connector. An optional Murphy eye provides an alternative opening. This eye is the difference between the Murphy (with eye) and the Magill (without eye) tracheal tube. The device is for nasal/oral use.
The Rusch Reinforced Endotracheal tube, cuffed is fitted with a cuff, which is inflated through an inflation line and a lumen in the wall of the tube.
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 (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.
Not Found
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/1 description: The image shows the logo for RUSCH International Group Regulatory Affairs, a subsidiary of Teleflex Incorporated (USA). At the top right of the logo is the number K990619. The word RUSCH is in a large, bold font. The words International Group Regulatory Affairs are in a smaller font below the word RUSCH.
Tall Pines Park Jaffrey, NH 03452 (603) 532-7706 FAX (603) 532-8211 or 6108
510(k) Summary
1. Submitter Name, Address, and Date of Submission.
Karenann J. Brozowski Group Regulatory Affairs Director Rüsch International Tall Pines Park Jaffrey, New Hampshire 03452
Telephone: (603) 532-7706 Facsimile: (603) 532-8211
Contact: Same as above
- Classification Name: Tube, Tracheal (with/without connector) 2.
Common Name: Tracheal Tube, or Endotracheal Tube
Proprietary Name: Rüsch Reinforced Endotracheal Tube Cuffed and Uncuffed of Murphy/Magill, sterile
-
- ldentification of the legally marketed device to which the submitter claims equivalence.
The Rusch Reinforced Endotracheal Tube is substantially equivalent to the Willy Rüsch Reinforced Tracheal Tube, Cuffed, Sheridan Reinforced Cuffed Tracheal Tube, SIMS/Portex Reinforced Cuffed Silicone Tracheal Tube and NCC/Mallinckrodt Reinforced Tracheal Tube Cuffed.
- ldentification of the legally marketed device to which the submitter claims equivalence.
-
- Description of the Device.
The Rusch Reinforced Endotracheal Tube consists of a specially designed, clear PVC tube with stainless steel reinforcing spiral. The tube is graduated with multiple centimeter markings to allow easy determination of intubation length, and is terminated with a connector. An optional Murphy eye provides an alternative opening. This eye is the
- Description of the Device.
1
difference between the Murphy (with eye) and the Magill (without eye) tracheal tube. The device is for nasal/oral use.
The Rusch Reinforced Endotracheal tube, cuffed is fitted with a cuff, which is inflated through an inflation line and a lumen in the wall of the tube.
Intended Use of the Device 5.
Rüsch Reinforced Endotracheal Tube is designated for oral or nasal intubation and are indicated for airway management. The product may be used to reduce the potential for kinking whenever an unusual positioning of the head or neck is required following intubation.
Summary of Technological Characteristics 6.
The device is equivalent in design and intended use with Willy Rüsch Reinforced Tracheal Tube and alternative predicates. The products are spiral PVC tubes, cuffed and uncuffed, with or without (uncuffed) luer activated valve.
2
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. Inside the circle is a stylized image of three human profiles facing right, with flowing lines beneath them.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG - 3 1999
Ms. Karenann J. Brozowski Group Requlatory Affairs Director Rusch International Tall Pines Park Jaffrey, NH 03452
K990619 Re: Rusch Reinforced Endotracheal (or Tracheal) Tube Trade Name: Cuffed or Uncuffed, Murphy/Magill, Sterile Requlatory Class: II Product Code: BTR Dated: April 30, 1999 May 5, 1999 Received:
Dear Ms. Brozowski:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 A substantially equivalent determination assumes compliance with 895. the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
3
Page 2 - Ms. Karenann J. Brozowski
This letter will allow you to beqin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a leqally 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4586. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the requlation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,
Thomas J. Cillelon
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number (il known): ___
Ocvice Name:Rusch Reinforced Endotracheal (or Tracheal) Tube
Cuffed or Uncuffed, Murphy/Magill Indications I-or Use:
Rusch Reinforced Endotracheal Tube is designated for oral or nasal intubation and are indicated for airway management. The product may be used to reduce the potential for kinking wherever an unusual positioning of the head or neck is required following intubation.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED!
Concurrence of CDRH, Office of Device Evaluation (ODE) ruscepüren Use ೧೧ Over The-Counter Use____________ 12cc 21 CFR 801 1091
(Optional Format 1-2-96)