Tracheoflex® Fenestrated Tracheostomy Set-Cuffed, Tracheoflex® The Ultra Tracheostomy Set-Uncuffed, Tracheoflex® Fenestrated Tracheostomy Set-Uncuffed, are sterile, disposable, single use cuffed, or uncuffed fenestrated fixed length fenestrated tracheostomy tubes with a fixed flange. The kit may include a radiopaque tube, a tube obturator, a cough cap, a 15 mm airway connector, phonation value, a sealing cap, exchangeable inner cannulas, and a neck band. The inner cannula will be also available as a separate item.

AI/ML Overview

The provided text describes medical device submission for tracheostomy tube kits, not an AI/ML device. Therefore, it does not contain information about acceptance criteria or study data for an AI/ML device.

Specifically, the document states: "No clinical testing was completed." This directly indicates that no study was performed to assess the device's performance against specific acceptance criteria. The submission focuses on demonstrating substantial equivalence to already marketed devices based on features, materials, and dimensions.

Therefore, I cannot provide the requested information.

Summary

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Image /page/0/Picture/0 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 smaller letters. At the top of the image is the number K964056.

Tall Pines Park Jaffrey, NH 03452 (603) 532-7706 FAX (603) 532-8211 or 6108

OCT 10 1997

ATTACHMENT # 1 510(K) SUMMARY Page 1 of 3

510(K) SUMMARY ULTRATRACHEOFLEX®TRACHEOFLEX® TRACHEOSTOMY KITS

Submitter Information/Contact Person:

Neil R. Armstrong Group Regulatory Affairs Manager Rüsch International Tall Pines Park Jaffrey NH 03452 Phone Number: (603) 532-7706 Fax Number: 1603) 532-8211

Fax Number:	(603) 532-8211
Date 510(k) Summary Prepared:	August 29, 1996
Name of the Device:
Trade or Proprietary Name:	Rüsch UltraTracheoflex® FenestratedTracheostomy Kit - Cuffed
	Rüsch Tracheoflex® Tracheostomy Kit -Uncuffed
	Rüsch Tracheoflex® FenestratedTracheostomy Kit - Uncuffed
Common Name:	Fenestrated or unfenestratedTracheostomy Tube Kit - cuffed, oruncuffed fixed length, with connectors.
Classification Name:	Tracheostomy tube and tube cuff, andaccessories: 21 CFR 868.5800

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ATTACHMENT # 1 510(K) SUMMARY Page 2 of 3

Identification of Legally Marketed Device to which the Submitter Claim Equivalence:

The subject devices cuffed are substantially equivalent to the Rüsch UltraTracheoflex® Tracheostomy Kits legally marketed under K955564. These devices are also similar to the Portex Flexible D.I.C. Tracheostomy Tube found substantially equivalent under K934465.

The subject devices are similar or equivalent to the predicates in significant features, materials, dimensions, and intended use.

Description of the Subject Devices:

These devices meet applicable portions of the following voluntary standards:

ISO 5366-1: Tracheostomy Tubes Connectors for Tubes for Adults.
ISO 5366-2: Basic requirements for Tracheostomy Tubes for Adults.
Anesthesia and Respiration Equipment, Conical Connectors, ISO 5356: Cones and Sockets.
ISO 5361-5: Tracheal Tubes, Requirements and Tests for Cuffs and Tubes,

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ATTACHMENT # 1 510(K) SUMMARY Page 3 of 3

Intended Use of Subject Device

These tracheostomy tube kits intended for airway management in a tracheostomized patient.

Technological Characteristics of the Subject Devices

The 510(k) application devices and the predicates have the same technological characteristics except for:

The Tracheoflex® and the fenestrated Tracheoflex® tracheostomy tubes are not 1. cuffed.
The Rüsch predicate is not fenestrated. The UltraTracheoflex® Fenestrated and 2. the Tracheoflex® Uncuffed, Fenestrated are fenestrated tracheostomy tubes. The Portex D.I.C. tube is available fenestrated.

No clinical testing was completed.

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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 features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & H. HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus symbol.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 1 0 1997

Mr. James R. Whitney Rüsch International Tall Pines Park Jaffrey, New Hampshire 03452

Re: K964056 Rüsch Ultra Tracheoflex Fenestrated Kit Cuffed, Uncuffed Requlatory Class: II (two) Product Code: 73 JOH Dated: July 18, 1997 Received: July 21, 1997

Dear Mr. Whitney:

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 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 requlations 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 Requlation (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 requlatory 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 - Mr. James R. Whitney

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 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/dsmamain.html".

Sincerely yours
Thomas J. Callahan

Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Premarket Notification "Indications for Use" Statement

510(k) Number (if known):

K 964056

Device Name:

Rüsch UltraTracheoflex®Tracheoflex® Tracheostomy fenestrated; uncuffed, (cuffed, Tube Kits unfenestrated; uncuffed, fenestrated)

Indications for Use:

The Rusch UltraTracheoflex®Tracheoflex® Tracheostomy Tube Kits are intended for use in airway management of tracheostomized patients.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Ath. A. Ciarkowski.

Division of and Neur 204056 510(k) Num

Perscription Use
OR Over-the-Counter Use
(Per 21 CFR 801.109)

Attachment 2

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.