The Rusch Single Use Crystal Tracheostomy Tube set consists of a polyvinyl chloride tube with a radiopaque stripe, terminated with a flange and connector. The tube is fitted with a high volume cuff inflated through a luer-activated valve, pilot balloon, inflation tube and a lumen in the wall of the main tube. Inner cannulas made of low density polyethylene and specifically designed for use with this tube are individually sterile packed. These cannulas may be boxed with the tracheostomy tube and will be available separately.

AI/ML Overview

The provided text is a 510(k) summary for the Rüsch Single Use Crystal Tracheostomy Tube Set. It describes the device, its intended use, and a summary of performance data. However, it does not contain the detailed information necessary to answer your specific questions related to acceptance criteria, specific study design, sample sizes, ground truth establishment, or AI-related metrics.

Here's an analysis of what can and cannot be answered from the provided text:

What can be extracted:

Device Name: Rüsch Single Use Crystal Tracheostomy Tube Set
Intended Use: "airway management of tracheostomized patients."
Regulatory Class: Class II
Comparison Devices: Rüsch (Warne Surgical Products) Crystal Tracheostomy Tube -Preamendment, Smiths Industries D.I.C. & Portex Blue Line Tracheostomy Tubes - K934465, Bovina Medical Technologies Cuffed Pediatric Tracheostomy Tubes - K913270, K914088.

What cannot be answered from this document:

The provided document is a 510(k) summary, which typically provides a high-level overview for substantial equivalence. It does not include the detailed study protocols, results, acceptance criteria, or ground truth methodologies that would be found in a full study report or the complete 510(k) submission.

Specifically, the document states: "Laboratory bench testing has been completed to demonstrate compliance with appropriate sections of ISO 5366." This indicates that bench testing was performed against a specific standard, but it does not provide:

A table of acceptance criteria or reported device performance metrics in detail.
Sample sizes used for any test set or data provenance. The testing was "lab bench testing," which implies physical device testing, not typically data-driven like AI studies.
Number of experts or their qualifications for establishing ground truth. (Ground truth in this context would likely be defined by the ISO standard itself, or engineering specifications, not expert consensus as in medical image analysis).
Adjudication method for a test set.
Information about a multi-reader multi-case (MRMC) comparative effectiveness study, as this is not an AI device.
Information about standalone (algorithm only) performance, as this is not an AI device.
The type of ground truth used beyond "compliance with appropriate sections of ISO 5366."
Sample size for a training set. (Training sets are relevant for AI/ML, not for this type of physical device).
How the ground truth for the training set was established.

In summary: The document confirms that bench testing was done to meet ISO 5366. To answer your questions, one would need access to the full 510(k) submission, specifically the detailed test reports outlining the methodology, specific acceptance criteria from ISO 5366, and the actual performance results obtained from those tests. This document only states that compliance was demonstrated.

Summary

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Image /page/0/Picture/0 description: The image shows a sequence of handwritten alphanumeric characters, specifically 'K972546'. The characters are written in a simple, clear style, with each digit and letter easily distinguishable. The writing appears to be done with a dark ink or marker on a light background, providing good contrast and readability.

RUSCH.
INTERNATIONAL
Group Regulatory Affairs
A Subsidiary of Teleflex Incorporated (USA)

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

510 (k) SUMARY

APR 1 4 1998

[As required by 21 CFR 807.92]

1. Submitter and Contact Person

James R. Whitney Group Regulatory Affairs Associate Rüsch International Tall Pines Park Jaffrey, NH 03452 Tel: (603)532 7706 Fax: (603)532 8211

Device set Name

Trade Name:

Rüsch Single Use Crystal Tracheostomy Tube set

Common Name:

Tracheostomy Tube

Classification Name:

Tube, Tracheostomy, and Tube Cuff 73 JOH; 21 CFR 868.5800; Class II medical device

3. Comparison Devices

Rüsch (Warne Surgical Products) Crystal Tracheostomy Tube -Preamendment

Smiths Industries D.I.C. & Portex Blue Line Tracheostomy Tubes - K934465

Bovina Medical Technologies Cuffed Pediatric Tracheostomy Tubes - K913270, K914088

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4. Description of Device Set

Inner cannulas made of low density polyethylene and specifically designed for use with this tube are individually sterile packed. These cannulas may be boxed with the tracheostomy tube and will be available separately.

5. Intended Use

The Rusch Single Use Crystal Tracheostomy Tube is indicated for airway management of tracheostomized patients.

Summary of Technological Characteristics 6.

The Rüsch Single Use Crystal Tracheostomy Tube Set has been developed from the Rüsch (formerly Warne Surgical Products) Crystal Tracheostomy Tube, which was in interstate commerce prior to May 28, 1976. The cumulative effect of developments, including modifications introduced to comply with the voluntary ISO 5366 standard, is thought to warrant this premarket notification.

The Rüsch Single Use Crystal Tracheostomy Tube Set will be available with and without an inner cannula, like the Smiths Industries (Portex) product and sizes from 3.0 to 11.0 mm.

7. Summary of Performance Data

Laboratory bench testing has been completed to demonstrate compliance with appropriate sections of ISO 5366.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like symbol with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the symbol in a circular fashion.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 1 4 1998

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

Re : K972546 Rüsch Crystal Tracheostomy Tube Requlatory Class: II (two) Product Code: 73 JOH Dated: November 25, 1997 Received: January 15, 1998

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, 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. 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 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/dsmamain.html".

Sincerely yours,

Thomas J. Callehan

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 972546

Device set Name:

Rüsch Single Use Crystal Tracheostomy Tube Set

Indications for Use:

The Rusch Single Use Crystal Tracheostomy Tube Set is indicated for 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)

ﺳ

Thomas J. Callahor

(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices 6972546

510(k) Number.

Prescription Use
(Per 21 CFR 801.109) /

子

Over-the-Counter Use

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.