Rüsch TracheoFix Set, Cuffed:
The Rüsch TracheoFix Set, Cuffed consists of a polyvinylchloride (PVC) outer tube with low pressure cuff and pilot balloon, a PVC flexible flange with a PVC turn lock fastener. The flange on this device is not adjustable. In addition, the set will also include a polyethylene cannula with standard taper and a replacement cannula which will be offered separately as an accessory, a polyethylene introducer, a standard nylon connector, a Velcro head band also offered separately as an accessory, an ABS phonation valve, an ABS cough cap and an ABS sealing cap.
This set will be offered in a variety of sizes from 7.0mm, to 11.0mm in 0.5mm increments. The size determinations are the Inside Diameter (I.D.) of the outer tube.

Rüsch TracheoFix Set, Uncuffed:
The Rüsch TracheoFix Set, Uncuffed consists of a polyvinylchloride (PVC) outer tube, a PVC flexible flange with a PVC turn lock fastener. The flange on this device is not adjustable. In addition, the set will also include a polyethylene inner tube with standard taper and a replacement inner tube which will be offered separately as an accessory, a polyethylene introducer, a standard nylon connector, a Velcro head band which will also be offered as an accessory, an ABS phonation valve, an ABS cough cap and an ABS sealing cap.
This set will be offered in a variety of sizes from 7.0mm, to 11.0mm in 0.5mm increments. The size determinations are the Inside Diameter (I.D.) of the outer tube.

Each Rüsch TracheoFix Set, Cuffed and Uncuffed will be provided sterile, by either Gamma Irradiation or Ethylene Oxide, in a clear plastic thermoformed tray with a Tyvek barrier/label. Each pack will be individually labeled. The device will then be packaged in a labeled outer cardboard carton. The device will be marketed one unit per box. The Velcro headband and the inner cannula will be marketed separately as accessories under separate part numbers. Both accessories will be marketed sterile, individually packaqed and labeled, ten (10) units per box .

AI/ML Overview

The provided text is a 510(k) Summary for a medical device (Rüsch TracheoFix Set, Cuffed and Uncuffed tracheostomy tube). It focuses on establishing substantial equivalence to existing legally marketed devices, rather than presenting a performance study with acceptance criteria.

Therefore, this document does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria, specifically:

A table of acceptance criteria and reported device performance.
Sample sizes, data provenance, number and qualifications of experts, or adjudication methods for a test set.
Multi-reader multi-case (MRMC) comparative effectiveness study results.
Standalone (algorithm only) performance.
Details on the type of ground truth used.
Sample size for the training set or how ground truth for the training set was established.

The 510(k) summary explains the device, its intended use, and claims substantial equivalence to predicate devices based on design and materials, effectively stating that its performance is implicitly acceptable because it is similar to already approved devices. It does not describe an independent performance study with defined acceptance criteria and results.

Summary

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(JUL 2 3 2002

Image /page/0/Picture/1 description: The image shows the logo for Rusch International, along with the text "Group Regulatory Affairs" and "A Subsidiary of Teleflex Incorporated (USA)". Above the logo is the number K021765. The Rusch logo is in bold, black font, with the word "INTERNATIONAL" in a smaller font size below it. The text below the logo is in a smaller, regular font.

(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, Tracheostomy (W/WO Connector) Common Name: Tracheostomy Tube Rüsch TracheoFix Set, Cuffed Proprietary Name:

Rüsch TracheoFix Set, Uncuffed

1. Identification of the legally marketed device to which the submitter claims equivalence:
  Rüsch TracheoFix Set is substantially equivalent in design The and materials to:
Mallinckrodt Shiley DCT Tracheostomy Tube . The Cuffed and Uncuffed
Smiths Industries (SIMS Concord-Portex) ● The D.I.C. (Disposable Inner Cannula) Tracheostomy Tubes, Cuffed and Uncuffed
Technologies AIRE-CUF® Tracheostomy The Bivona Medical Tube (Predicate to Rüsch cuffed version only)
Rüsch Crystal Tracheostomy Tube (Predicate to Rüsch cuffed version only)

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Page 2

Rüsch TracheoFlex Sets (Predicate to Rüsch cuffed version only) ●

4 . Description of the Device:

TracheoFix Sets will be offered in two (2) versions - Cuffed and Uncuffed. Descriptions are as follows:

Rüsch TracheoFix Set, Cuffed:

The Rüsch TracheoFix Set, Cuffed consists of a polyvinylchloride (PVC) outer tube with low pressure cuff and pilot balloon, a PVC flexible flange with a PVC turn lock fastener. The flange on this device is not adjustable. In addition, the set will also include a polyethylene cannula with standard taper and a replacement cannula which will be offered separately as an accessory, a polyethylene introducer, a standard nylon connector, a Velcro head band also offered separately as an accessory, an ABS phonation valve, an ABS cough cap and an ABS sealing cap.

This set will be offered in a variety of sizes from 7.0mm, to 11.0mm in 0.5mm increments. The size determinations are the Inside Diameter (I.D.) of the outer tube.

Rüsch TracheoFix Set, Uncuffed:

The Rüsch TracheoFix Set, Uncuffed consists of a polyvinylchloride (PVC) outer tube, a PVC flexible flange with a PVC turn lock fastener. The flange on this device is not adjustable. In addition, the set will also include a polyethylene inner tube with standard taper and a replacement inner tube which will be offered separately as an accessory, a polyethylene introducer, a standard nylon connector, a Velcro head band which will also be offered as an accessory, an ABS phonation valve, an ABS cough cap and an ABS sealing cap.

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Page 3

This set will be offered in a variety of sizes from 7.0mm, to 11.0mm in 0.5mm increments. The size determinations are the Inside Diameter (I.D.) of the outer tube.

5. Intended Use of the Device:

The Rüsch TracheoFix Set (TFS) is a single patient disposable tracheostomy tube for airway management of tracheostomized patients.

6. Summary of Technological Characteristics:

The Rüsch TracheoFix Set is identical in materials to the 510(k) # K972423, Rüsch TracheoFix Set, which was determined to be substantially equivalent on February 13, 1997. An uncuffed version has been added to this submission.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized symbol of three wavy lines, resembling a caduceus without the snake.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 2 3 2002

Mr. Rick Lvkins Group RA Manager Rusch International Tall Pines Park Jaffrey, New Hampshire 03452

Re: K021764

Trade/Device Name: Rusch TracheoFix Set Regulation Number: 868.5800 Regulation Name: Tracheostomy Tube and Tube Cuff Regulatory Class: II Product Code: BTO Dated: May 28, 2002 Received: May 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 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 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.

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Page 2 - Mr. Lykins

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 (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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), 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.qov/cdrh/dsma/dsmamain.html

Sincerely yours

Timothy Ulatowski

Timot Ulatowski 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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Page 1 of 1

510(k) Number (if known): K021764

Device Name: Rüsch TracheoFix Set

Indications for Use:

The Rusch TracheoFix Set (TFS) is a single patient disposable management of tracheostomized tracheostomy tube for airway patients.

(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
(Division Sign-Off)
Division of Dental, Infection Control,and General Hospital Devices
510(k) Number	K021764

Over-The-Counter Use

(Optional Format 1-2-96)

Regulation Number and Section

§ 868.5800 Tracheostomy tube and tube cuff.

(a)
Identification. A tracheostomy tube and tube cuff is a device intended to be placed into a surgical opening of the trachea to facilitate ventilation to the lungs. The cuff may be a separate or integral part of the tracheostomy tube and is, when inflated, intended to establish a seal between the tracheal wall and the tracheostomy tube. The cuff is used to prevent the patient's aspiration of substances, such as blood or vomit, or to provide a means for positive-pressure ventilation of the patient. This device is made of either stainless steel or plastic.(b)
Classification. Class II.