Rüsch Crystal Clear Tracheostomy Set, Cuffed:
The Rüsch Crystal Clear Tracheostomy Set, Cuffed consists of a polyvinylchloride (PVC) tracheostomy tube with high volume/low pressure cuff, pilot balloon and tapered tip to facilitate insertion, a PVC flexible neck plate with a Nylon 15mm swivel connector and a polyethylene obturator with a tapered tip to facilitate insertion. The flange on this device is not adjustable. In addition, a PVC disposable inner cannula will be offered separately as an accessory.
This set will be offered in a range of sizes from 3.5mm - 10.5mm in 0.5mm increments. The size determinations are the Inside Diameter (I.D.) of the tracheostomy tube.

Rüsch Crystal Clear Tracheostomy Set, Cuffless:
The Rüsch Crystal Clear Tracheostomy Set, Cuffless consists of a polyvinylchloride (PVC) tracheostomy tube with a tapered tip to facilitate insertion, a PVC flexible flange with a PVC turn lock fastener neck plate with a Nylon 15mm swivel connector and a polyethylene obturator with a tapered tip to facilitate insertion. The flange on this device is not adjustable. In addition, a PVC disposable inner cannula will be offered separately as an accessory.
This set will be offered in a range of sizes from 3.5mm - 10.5mm in 0.5mm increments. The size determinations are the Inside Diameter (I.D.) of the tracheostomy tube.

Each Rüsch Crystal Clear Tracheostomy Set, Cuffed and Cuffless will be provided sterile, by either Gamma Irradiation or Ethylene Oxide, inside a protective inner pouch in a blister pack sheet with a Tyvek paper seal to provide a sterility barrier. Each pack will be individually labeled. The device will then be packaged, five units per carton, in a labeled outer cardboard carton. The inner cannulae will be marketed separately as accessories under separate part numbers.

AI/ML Overview

The provided text describes a 510(k) Pre-market Notification for a medical device (Rüsch Crystal Clear Tracheostomy Sets, Cuffed and Cuffless) seeking substantial equivalence to a predicate device. This type of submission** does not typically include a detailed study proving performance against acceptance criteria in the way a clinical trial for a novel device would.**

Instead, the submission focuses on demonstrating that the new device has substantially equivalent technological characteristics and intended use to a previously cleared device. Therefore, many of the requested elements for a detailed acceptance criteria study are not present in this document.

Here's an analysis based on the provided text:

1. Table of acceptance criteria and reported device performance:

This document does not explicitly state quantitative acceptance criteria or provide performance data from a study designed to meet such criteria. The "performance" being demonstrated here is the substantial equivalence to an existing predicate device, not the achievement of specific, novel performance metrics.

2. Sample size used for the test set and the data provenance:

Not applicable in this document. The assessment is based on a comparison of device characteristics and intended use.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. The ground truth for a 510(k) submission is typically the established safety and effectiveness of the predicate device, not a new, expert-adjudicated dataset for the new device.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This is not an AI-enabled device, and no MRMC study is mentioned.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

The "ground truth" implicitly used for this type of submission is the established safety and effectiveness of the existing predicate device (Rüsch Crystal Tracheostomy Set - K972546). The claim is that the new device shares similar technological characteristics and intended use, and therefore can be presumed to be as safe and effective as the predicate.

8. The sample size for the training set:

Not applicable. This device does not involve machine learning or a training set.

9. How the ground truth for the training set was established:

Not applicable.

Summary of the "study" that proves the device meets "acceptance criteria" (within the context of a 510(k) submission):

The "study" or justification for equivalence is described in section "6. Summary of Technological Characteristics."

Acceptance Criteria (implicit for 510(k) Substantial Equivalence): The device must be deemed "substantially equivalent" to a legally marketed predicate device in terms of intended use and technological characteristics, such that it raises no new questions of safety or effectiveness.
Device Performance / Proof of Equivalence:
- Basis of claim: The Rüsch Crystal Clear Tracheostomy Sets are claimed to be substantially equivalent in design and materials to the predicate device, Rüsch Crystal Tracheostomy Set (K972546).
- Technological Characteristics Comparison: "The Rüsch Crystal Clear Tracheostomy Sets are identical in materials and sizes to the 510(k) # K972546, Rüsch Crystal Tracheostomy Set, which was determined to be substantially equivalent on April 14, 1998." (Page 3, Section 6)
- Materials: Both the new device and the predicate are described as being made of polyvinylchloride (PVC) for the tube, pilot balloon, and flexible neck plate; Nylon for the 15mm swivel connector; and polyethylene for the obturator.
- Sizes: The new device is offered in a range of sizes from 3.5mm - 10.5mm in 0.5mm increments. The document notes that "The 3.0mm and 11.0mm sizes indicated in K972546 have been removed from the current product line" for the new device, implying a slight modification in available sizes but not a fundamental change in the technology or intended use.
- Intended Use: Both the new device and the predicate device (by virtue of the claim of equivalence) are intended "for airway management of tracheostomized patients."

Conclusion:

This 510(k) summary demonstrates substantial equivalence by comparing the new device's materials, design, and intended use directly to a previously cleared predicate device. It does not involve a traditional clinical study with defined acceptance criteria and performance metrics for the new device itself, but rather leverages the established safety and effectiveness of the predicate. The FDA's letter (Page 3-4) confirms their review led to a finding of "substantial equivalence" based on this comparison.

Summary

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MAR 2 8 2003

Image /page/0/Picture/1 description: The image shows the logo for RUSCH International Group Regulatory Affairs. The word "RUSCH" is in large, bold, black letters at the top of the image. Below that, in smaller letters, is "INTERNATIONAL Group Regulatory Affairs". At the bottom of the image, it says "A Subsidiary of Teleflex Incorporated (USA)".

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

K023918

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 Crystal Clear Tracheostomy Proprietary Name: Set, Cuffed Rüsch Crystal Clear Tracheostomy Set, Cuffless

3. Identification of the legally marketed device to which the submitter claims equivalence:

Rüsch Crystal Clear Tracheostomy Sets are substantially The equivalent in design and materials to:

Rüsch Crystal Tracheostomy Set - K972546

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Page 2

4 . Description of the Device:

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

The Rüsch Crystal Clear Tracheostomy Sets will be offered in two (2) versions - Cuffed and Cuffless. Descriptions are:

Rüsch Crystal Clear Tracheostomy Set, Cuffed:

The Rüsch Crystal Clear Tracheostomy Set, Cuffed consists of a polyvinylchloride (PVC) tracheostomy tube with high volume/low pressure cuff, pilot balloon and tapered tip to facilitate insertion, a PVC flexible neck plate with a Nylon 15mm swivel connector and a polyethylene obturator with a tapered tip to facilitate insertion. The flange on this device is not adjustable. In addition, a PVC disposable inner cannula will be offered separately as an accessory.

This set will be offered in a range of sizes from 3.5mm - 10.5mm in 0.5mm increments. The size determinations are the Inside Diameter (I.D.) of the tracheostomy tube.

Rüsch Crystal Clear Tracheostomy Set, Cuffless:

The Rüsch Crystal Clear Tracheostomy Set, Cuffless consists of a polyvinylchloride (PVC) tracheostomy tube with a tapered tip to facilitate insertion, a PVC flexible flange with a PVC turn lock fastener neck plate with a Nylon 15mm swivel connector and a polyethylene obturator with a tapered tip to facilitate insertion. The flange on this device is not adjustable. In addition, a PVC disposable inner cannula will be offered separately as an accessory.

This set will be offered in a range of sizes from 3.5mm - 10.5mm in 0.5mm increments. The size determinations are the Inside Diameter (I.D.) of the tracheostomy tube.

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Page 3

Each Rüsch Crystal Clear Tracheostomy Set, Cuffed and Cuffless provided sterile, by either Gamma Irradiation or will be Ethylene Oxide, inside a protective inner pouch in a blister pack sheet with a Tyvek paper seal to provide a sterility Each pack will be individually labeled. The device barrier. will then be packaged, five units per carton, in a labeled outer cardboard carton. The inner cannulae will be marketed separately as accessories under separate part numbers.

Intended Use of the Device: 5.

The Rüsch Crystal Clear Tracheostomy Sets, Cuffed and Cuffless are intended for airway management of tracheostomized patients.

୧ . Summary of Technological Characteristics:

Rüsch Crystal Clear Tracheostomy Sets are identical The in materials and sizes to the 510(k) # K972546, Rüsch Crystal Tracheostomy Set, which was determined to be substantially equivalent on April 14, 1998. The 3.0mm and 11.0mm sizes indicated in K972546 have been removed from the current product line.

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Image /page/3/Picture/1 description: The image is a logo for the U.S. Department of Health & Human Services. The logo features a stylized representation of a human figure in profile, with three overlapping heads suggesting a sense of community or interconnectedness. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the figure.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 8 2003

Mr. Rick Lykins Group RA Manager Rüsch International 50 Plantation Drive Jaffrey, New Hampshire 03452

Re: K023918

Trade/Device Name: Rusch Crystal Clear Tracheostomy Sets, Cuffed and Cuffless Regulation Number: 21 CFR 868.5800 Regulation Name: Tracheostomy Tube and Tube Cuff Regulatory Class: II Product Code: 73 JOH Dated: November 21, 2002 Received: November 25, 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.

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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 vou 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,

Susan Runner

Susan Runner, DDS, MA Interim 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 of 1

510(k) Number (if known): ¥023918

Rüsch Crystal Clear Tracheostomy Sets, Cuffed and Device Name: Cuffless

Indications for Use:

The Rüsch Crystal Clear Tracheostomy Sets, Cuffed and Cuffless intended for airway management of tracheostomized are 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)

Over-The-Counter Use

(Optional Format 1-2-96)

Susan Ransor

(Division Sign-Off) Division of Anesthesiolo Infection Control. De

510(k) Number:

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.