(86 days)
Rüsch Oral/Nasal Tracheal Tube, Cuffed, Magill/Murphy is a device inserted into a patient's trachea via the nose or mouth and used to maintain an open airway.
The Rüsch Oral/Nasal Tracheal Tube, Cuffed, Magill/Murphy consists of a clear PVC, implant tested, PVC tracheal tube with radiopaque (BaSO4) stripe. The radiopaque stripe runs the entire length of the Tracheal Tube. The cuff is inflated via a valved pilot balloon using lock-The main tube is graduated tip or luer taper syringe. multiple centimeter markings to allow easv with determination of intubation length. A black positioning ring is present on the tube to aid in visualization of An optional Murphy eye provides an alternative the tube. opening. The device is for nasal and oral use.
This 510(k) submission, K993786, for the Rüsch Oral/Nasal Tracheal Tube, Cuffed, Magill/Murphy, does not contain information about specific acceptance criteria, a study proving the device meets those criteria, or performance data in the format requested.
The document is a traditional 510(k) summary, which focuses on establishing substantial equivalence to a predicate device based on design, materials, and intended use, rather than presenting detailed performance validation studies with specific acceptance criteria and statistical analysis.
Therefore, I cannot provide the requested information. The document primarily identifies the device, its intended use, and its substantial equivalence to previously marketed devices.
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FEB 2 2000
Image /page/0/Picture/1 description: The image shows the logo for RUSCH International Group Regulatory Affairs, a subsidiary of Teleflex Incorporated (USA). The logo is in black and white and features the word "RUSCH" in large, bold letters. Below the word "RUSCH" is the text "INTERNATIONAL Group Regulatory Affairs" in a smaller font. The text "A Subsidiary of Teleflex Incorporated (USA)" is located below the previous line in an even smaller font.
Tall Pines Park Jaffrey, NH 03452 (603) 532-7706 FAX (603) 532-8211 or 6108
510 (k) Summar
K99 3786
Submitter Name, Address: 1.
Karenann J. Brozowski Group Regulatory Affairs Director Rüsch International Tall Pines Park Jaffrey, New Hampshire 03452
Telephone: (603) 532-7706 Facsimile: (603) 532-8211 E-Mail: 73451.1040@compuserve.com Contact: Same as above
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- Name of the Device, Common, Proprietary (if Known), and Classification.
Classification Name: Tube, Tracheal (w/wo Connector 73BTR)
- Name of the Device, Common, Proprietary (if Known), and Classification.
Common/Usual Name: Tracheal Tube, or Endotracheal Tube
Proprietary Name: Rüsch Oral/Nasal (Safety Clear Plus™) Tracheal Tube, cuffed, Magill/Murphy, Sterile
3. Identification of the legally marketed device to which the submitter claims equvalence:
The Rüsch Oral/Nasal Tracheal Tube, Cuffed, Magill/Murphy is substantially equivalent to Baxter Lo-Pro/Lo-Contour Tracheal Tube, Sheridan High Volume Tapered Low Pressure Cuff and Rüsch Safety Clear Plus Oral/Nasal Tracheal Tube, Cuffed, size 4.5-11.00mm.
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Description of the Device: 4 .
The Rüsch Oral/Nasal Tracheal Tube, Cuffed, Magill/Murphy consists of a clear PVC, implant tested, PVC tracheal tube with radiopaque (BaSO4) stripe. The radiopaque stripe runs the entire length of the Tracheal Tube. The cuff is inflated via a valved pilot balloon using lock-The main tube is graduated tip or luer taper syringe. multiple centimeter markings to allow easv with determination of intubation length. A black positioning ring is present on the tube to aid in visualization of An optional Murphy eye provides an alternative the tube. opening. The device is for nasal and oral use.
5 . Intended Use of the Device:
Rüsch Oral/Nasal Tracheal Tube, Cuffed, Magill/Murphy is a device inserted into a patient's trachea via the nose or mouth and used to maintain an open airway.
6. Summary of Technological Characteristics
The device is equivalent in design and intended use with Baxter Lo-Pro/Lo-Contour Tracheal Tube, Sheridan High Volume Tapered Low Pressure Cuff (K822082) and Rüsch Safety Clear Plus Oral/Nasal Tracheal Tube, Cuffed, size 4.5-11.00mm, K961837. The products are clear PVC tube, Cuffed, with/without eye, with luer activated valve.
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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a circular design with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird with its wings spread, composed of three curved lines that suggest the feathers and form of the bird.
Public Health Service
2 2000 FEB
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Karenann J. Brozowski RUSH INTL. Tall Pines Park Jaffrey, NH 03452
Re: K993786 Rusch Oral/Nasal (Safety Clear Plus) Tracheal Tube, cuffed, Migill/Murphy Sterile Regulatory Class: II (two) Product Code: 73 BTR Dated: November 3, 1999 November 8, 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 leqally 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, Druq, 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 895. A substantially equivalent determination assumes compliance with 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 Failure to comply with the GMP regulation may result in assumptions. 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.
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Page 2 - Ms. Karenann J. Brozowski
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. 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 regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,
Nuttij C. Brogdon for
Celia M. Witten, Ph.D., M.D. Acting Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): Rüsch Oral/Nasal (safety Clear Plus™) Tracheal Tube, Cuffed, Magill/Murphy Device Name:_
Indications For Use:
Rüsch Oral/Nasal Tracheal Tube, Cuffed, Magill/Murphy is a device inserted into a patient's trachea via the nose or mouth and used to maintain an open airway.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF ·NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Christy Foreman
Division of Cardiovascular, Respira and Neurological Devices 510(k) Numbe Gounter Use
(Division Sign-Off)
(Optional Format 1-2-96)
Prescription Use_U (Per 21 CFR 801.109)
§ 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).