(24 days)
The Rüsch Microlaryngeal Tube is a sterile, single-use, oral/nasal tracheal tube intended to be used for airway management during laryngeal procedures.
The Rüsch Microlaryngeal Tube will be offered in three (3) sizes - 4.0mm, 5.0mm and 6.0mm ID. The devices will have a low-pressure/high volume cuff, inflated via a luer activated valve. A pilot balloon will be provided to give a visual indication of cuff status. The Rüsch Microlaryngeal Tube consists of a clear, implant-tested tracheal tube with a radiopaque stripe. The main tube is graduated with multiple centimeter markings to facilitate determination of intubated length.
The provided document is a 510(k) premarket notification for a medical device, the Rüsch Microlaryngeal Tube. It focuses on demonstrating substantial equivalence to pre-existing devices, rather than presenting a performance study with acceptance criteria in the context of an AI/ML powered device.
Therefore, the requested information regarding acceptance criteria, study data, sample sizes, ground truth establishment, expert involvement, and MRMC studies for an AI/ML device is not available in this document.
This document describes a traditional medical device (a tracheal tube) and uses substantial equivalence as its regulatory pathway, which involves comparing its design, materials, and intended use to legally marketed predicate devices. It does not involve any AI/ML components or associated performance studies.
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KO23964
DEC 2 3 2002
Tall Pines Park Jaffrey, NH 03452 (603) 532-7706 FAX (603) 532-8211 or 6108
510 (k) Summary
Submitter Name, Address, and Date of Submission: 1.
Rick Lykins Group RA Manager - US Rüsch International Tall Pines Park Jaffrey, NH 03452 Telephone Number: (603) 532-0204 Fax Number: (603) 532-6179
rlykins@tfx.com E-Mail:
Same as above Contact:
Name of the Device, Common, Proprietary (if known), and 2. Classification:
Classification Name: Tube, Tracheal w/wo Connector
Common Name: Tracheal Tube
Proprietary Name: Rüsch Microlaryngeal Tube
Identification of the legally marketed device to which the ကိ submitter claims equivalence:
The Rüsch Microlaryngeal Tube is substantially equivalent in design and materials to:
Rüsch Safety Tracheal Tubes - Preamendment Rüsch AGT PVC Preformed Nasal Tracheal Tubes - K931163/K931166 Rüsch Oral/Nasal (Safety Clear Plus™) Tracheal Tube, Cuffed, Magill/Murphy, Sterile - K993786 Rüsch Edgar Tube - K021540 Sheridan® (Now Hudson RCI) LTS™ Tracheal Tube for Microlaryngeal Tracheal Surgery - K860176 Mallinckrodt (Now Nellcor) MLT® Microlaryngeal Tracheal Tube -K801005
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Page 2
Description of the Device: 4 .
The Rüsch Microlaryngeal Tube will be offered in three (3) sizes - 4.0mm, 5.0mm and 6.0mm ID. The devices will have a low-pressure/high volume cuff, inflated via a luer activated A pilot balloon will be provided to give a visual valve. indication of cuff status.
The Rüsch Microlaryngeal Tube consists of a clear, implanttested tracheal tube with a radiopaque stripe. The main tube is graduated with multiple centimeter markings to facilitate determination of intubated length.
5 . Intended Use of the Device:
Microlaryngeal Tube is a sterile, single-use, The Rüsch tracheal tube intended to be used for airway oral/nasal management during laryngeal procedures.
Summary of Technological Characteristics: 6.
The following technological characteristics are the same as or equivalent to the predicate devices listed above:
Materials:
The Rüsch Microlaryngeal Tube is manufactured from the same material (trade name Rüschelit) and manufactured by the same processes as the Rüsch Safety Tracheal Tubes which were in interstate commerce prior to May 28, 1976, the Rüsch AGT Preformed Nasal Tubes, K931163 and K931166 which were determined to be substantially equivalent by the Agency June 23, 1993 and June 22, 1993 respectively, the Rüsch Oral/Nasal (Safety Clear Plus™) Tracheal Tube, Cuffed, Magill/Murphy, Sterile, K993786 which was determined to be substantially equivalent by the Agency February 2, 2000 and, most recently, Rüsch Edgar Tube, K021540 which was determined to be the substantially equivalent by the Agency August 1, 2002.
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Page 3
Size Range:
The Rüsch Microlaryngeal Tube will be offered in three (3) sizes - 4.0mm, 5.0mm and 6.0mm ID. Both the Mallinckrodt MLT® Microlaryngeal Tracheal Tube - K801005 and the Sheridan® LTS™ Tracheal Tube for Microlaryngeal Tracheal Surgery - K860176 are marketed in identical sizes.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three human profiles incorporated into its design.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
·Mr. Rick Lykins Group RA Manager Rüsch International 50 Plantation Drive Jaffery, New Hampshire 03452
Re: K023964
Trade/Device Name: Rusch Microlaryngeal Tube Regulation Number: 21 CFR 868.5730 Regulation Name: Tracheal Tube Regulatory Class: II Product Code: 73 BTR Dated: November 26, 2002 Received: November 29, 2002
Dear Mr. Lykins:
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 vour 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.
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Page 2 - Mr. Lykins
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 (OS) 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. 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,
Robert Betz DDS for T.A. Wiatrowski
Timothy A. Ulatowski Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
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510 (k) Number (if kn 023969
Device Name: Rüsch Microlaryngeal Tube
Indications for Use:
The Rüsch Microlaryngeal Tube is single-use sterile a tracheal tube oral/nasal intended for to he used alrway management during laryngeal procedures
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use ✓ (Per 21 CFR 801.109) OR
Over-The-Counter Use
(Optional Format 1-2-96)
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
KC23964 510(k) Number __
§ 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).