The subject device, the Weinmann Tracheostomy Exchange Set, includes a Ciaglia Blue Rhino Percutaneous Tracheostomy Dilator (cleared under K133597), five Ciaglia loading dilators (21-, 24-, 26-, 27-, and 28-Fr; cleared under K133597), an 8-Fr Cook Airway Exchange Catheter (cleared under K162729), and two Rapi-Fit Adapters (cleared under K162729).

The Ciaglia Blue Rhino Percutaneous Tracheostomy Dilator is designed to be advanced over an airway exchange catheter into an existing tracheostomy tube to dilate the stoma, to be prepared for replacement of a new tracheostomy tube. The dilator is 38.0-Fr in outer diameter and 20 centimeters long. This dilator has a depth marking to indicate the skin level, which is placed 11 centimeters from the distal tip. Another feature of the device is the presence of hydrophilic coating on the distal 11 centimeters of the device.

The Ciaglia loading dilators are designed to be inserted into a new tracheostomy tube to facilitate dilation of the stoma and placement of the tube in the airway. The dilators are available in outer diameter of 21 to 28 Fr; all dilators are 20 centimeters long and curved at the distal end.

The airway exchange catheter is designed to be inserted into the previously existing tracheostomy tube in patients prior to removal. The airway exchange catheter keeps the airway open during dilation and placement of a new tracheostomy tube. The airway exchange catheter is 8.0 Fr in outer diameter and 45 centimeters long. The distal end of the airway exchange is a blunt tip with rounded edges.

Two Rapi-Fit adapters (one with a 15-mm connector, and one with a Luer lock connector) are provided to be used with the airway exchange catheter for oxygenation when the requirement for oxygen is high in patients but the tracheostomy tube is not in place. The 15 mm Rapi-Fit adapter is designed for attachment to traditional ventilator sources that are low pressure sources, or so-called continuous positive airway pressure (CPAP) ventilators. The Luer Lock Rapi-Fit adapter is designed for attachment to a highpressure jet ventilation oxygen source. The Luer Lock connection is a male Luer Lock that is compatible with the standard Luer fitting of an oxygen tube which is connected to an oxygen source.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Weinmann Tracheostomy Exchange Set (K180034), structured to answer your specific questions:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly present a table of quantitative acceptance criteria for the Weinmann Tracheostomy Exchange Set, nor does it provide specific numerical performance metrics. Instead, the acceptance is based on demonstrating substantial equivalence to a predicate device through:

Identical intended use and similar indications for use.
Similar technological characteristics, method of operation, and materials of construction.
Satisfactory results from non-clinical testing.

Based on the available text, here's a conceptual table:

Acceptance Criteria Category	Reported Device Performance
Intended Use	Intended for adult tracheostomy tube exchange. (Identical to predicate in purpose, though predicate is for initial placement).
Indications for Use	For adult tracheostomy tube exchange. (Similar to predicate, specifically for exchange vs. initial placement, but determined not to raise different questions of safety/effectiveness).
Technological Characteristics - General	Same regulation, product code, and classification (Class II). One-time use. Recommended insertion site and placement method are similar. Limited duration of use (≤ 24 hours).
Technological Characteristics - Dilator	Length: 20 cm. Outer Diameter: 38 Fr (max). Material: Polyurethane. Depth Marking: Yes. Hydrophilic Coating: Yes. (All identical to predicate).
Technological Characteristics - Loading Dilators	Sizes: 21, 24, 26, 27, and 28 Fr (Predicate had more sizes: 18, 21, 24, 26, 27, 28, 32, 36, and 38 Fr). Tip: Tapered and curved. Material: Polyurethane (Predicate: Vinyl and Polyurethane). Ink Marking: Yes.
Technological Characteristics - Exchange Catheter & Adapters	The device includes an 8-Fr Cook Airway Exchange Catheter and two Rapi-Fit Adapters. These components were previously cleared under K162729. (Performance implicitly derived from their prior clearance).
Sterilization Method	Ethylene Oxide (Identical to predicate).
Packaging	Tyvek® Pouch (Predicate: Thermoform tray with a Tyvek® lid).
Biocompatibility	All materials are biocompatible. (Leveraged data from K133597 and K162729).
Dimensional and Compatibility	Testing performed on Accelerated/Real Time Aged devices. Results show the device meets design input requirements based on intended use. (Specific quantitative results not provided).
Safety and Effectiveness	The differences in indication for use and technological characteristics do not raise different questions of safety or effectiveness. Testing supports the conclusion that the device does not raise different questions of safety or effectiveness and is substantially equivalent to the predicate device.

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

The document describes non-clinical testing, which typically does not involve human subjects. The testing described includes:

Dimensional and Compatibility Evaluation of the subject device (Accelerated/Real Time Aged).
Biocompatibility testing.

The document does not specify a "sample size" in terms of number of patients or cases. For non-clinical device testing, sample size would refer to the number of devices or components tested. This information is not provided in the document.

The data provenance is from Cook Incorporated's internal non-clinical testing, as implied by the reference to "applicable non-clinical testing to ensure reliable design and performance under the specified design requirements." There is no mention of country of origin of data, or if it was retrospective or prospective in the clinical sense, as it refers to device testing, not human trials.

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

This information is not applicable or not provided. Since the study is a non-clinical device performance and substantial equivalence assessment, it does not involve establishing ground truth from expert consensus on patient cases. Decisions are based on engineering and material science testing standards and comparison to a predicate device.

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

This information is not applicable or not provided. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or image review where multiple experts independently assess cases and discrepancies are resolved. This document details non-clinical device component testing.

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

There was no MRMC comparative effectiveness study done. This device is a physical medical device (tracheostomy exchange set), not an AI-powered diagnostic or assistive technology. Therefore, the concept of "human readers improve with AI" does not apply.

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

This question is not applicable. The device is a physical medical instrument, not an algorithm, so an "algorithm only" performance study is irrelevant.

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

The "ground truth" for this regulatory submission is established through:

Engineering specifications and standards: For dimensional, compatibility, and material properties.
Biocompatibility standards: Often ISO 10993 series.
Comparison to a legally marketed predicate device: The Ciaglia Blue Rhino® Percutaneous Tracheostomy Introducer Sets (K133597). The predicate device's safety and effectiveness implicitly serve as a benchmark for substantial equivalence.

8. The sample size for the training set

This information is not applicable or not provided. There is no "training set" in the context of this device's non-clinical testing. Training sets are typically associated with machine learning or AI development.

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

This information is not applicable. As there is no training set for an AI/ML model, the concept of establishing ground truth for it does not apply here.

Summary

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May 7, 2018

Cook Incorporated Paul Mever Regulatory Affairs Specialist 750 Daniels Way, P.O. Box 489 Bloomington, Indiana 47404

Re: K180034

Trade/Device Name: Weinmann Tracheostomy Exchange Set Regulation Number: 21 CFR 868.5800 Regulation Name: Tracheostomy Tube and Tube Cuff Regulatory Class: Class II Product Code: JOH Dated: April 9, 2018 Received: April 10, 2018

Dear Paul Meyer:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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. 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); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);

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and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Geeta K.
Pamidimukkala -S

for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K180034

Device Name Weinmann Tracheostomy Exchange Set

Indications for Use (Describe)

The Weinmann Tracheostomy Exchange Set is intended for adult tracheostomy tube exchange

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

Weinmann Tracheostomy Exchange Set 21 CFR §807.92 Date Prepared: April 30, 2018

Submitted By:

Applicant:	Cook Incorporated
Contact:	Paul MeyerHui Ouyang, PhD, RAC
Applicant Address:	Cook Incorporated750 Daniels WayBloomington, IN 47404
Contact Phone Number:	(812) 339-2235 x105299
Contact Fax Number:	(812) 332-0281
Device Information:
Trade Name:	Weinmann Tracheostomy Exchange Set
Device Common Names:	Tracheostomy tube exchange set
Classification Regulation:	21 CFR 868.5800, JOH
Device Classification:	Class II
Review Panel:	Anesthesiology
Office of Device Evaluation:	Division of Anesthesiology, General Hospital,Respiratory, Infection Control, and Dental Devices(DAGRID) Anesthesiology Devices Branch (ANDB)

Predicate Device:

The Weinmann Tracheostomy Exchange Set is substantially equivalent to the predicate device, the Ciaglia Blue Rhino® Percutaneous Tracheostomy Introducer Sets (Cook Incorporated, K133597), cleared for market by FDA on April 18, 2014.

Device Description:

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Indication for Use:

The Weinmann Tracheostomy Set is intended for adult tracheostomy tube exchange.

Comparison to Predicate:

The subject device is substantially equivalent to the predicate device in that they have the same intended use, which is to assist placement of a tracheostomy tube. Furthermore, they have similar indications for use, technological characteristics, method of operation,

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and materials of construction. The substantial equivalence comparison with the predicate device is provided in Table 1.

		Table 1: Substantial Equivalence Comparison Table
		Predicate Device	Subject Device
		Ciaglia PercutaneousTracheostomy IntroducerSet, Ciaglia Blue Rhino®Percutaneous TracheostomyIntroducer Set/TrayK133597	Weimann TracheostomyExchange Set
Regulation		21 CFR § 868.5800,Tracheostomy tube and tubecuff	IDENTICAL TO PREDICATE
Product Code		JOH, tracheostomy tube andtube cuff	IDENTICAL TO PREDICATE
Classification		II	IDENTICAL TO PREDICATE
Indication for Use		For percutaneous dilationaltracheostomy for managementof the airway in adults only	The Weinmann TracheostomyExchange Set is intended foradult tracheostomy tubeexchange
One-time Use		Yes	IDENTICAL TO PREDICATE
Recommended Insertion Site		Between the 1st and 2ndtracheal cartilages or betweenthe 2nd and 3rd trachealcartilages	IDENTICAL TO PREDICATE
Placement		Percutaneous technique	IDENTICAL TO PREDICATE
Duration of Use		Limited (≤ 24 hours)	IDENTICAL TO PREDICATE
Ciaglia BlueRhinoTracheostomyDilator	Length	20 cm	IDENTICAL TO PREDICATE
	OuterDiameter	38 Fr (max)	IDENTICAL TO PREDICATE
	Material	Polyurethane	IDENTICAL TO PREDICATE
	DepthMarking	Yes	IDENTICAL TO PREDICATE
	HydrophilicCoating	Yes	IDENTICAL TO PREDICATE
	LoadingDilators	Sizes	18, 21, 24, 26, 27, 28, 32, 36,and 38 Fr
		Tip	Tapered and curved
Material		Vinyl and Polyurethane	Polyurethane
Ink Marking		Yes	IDENTICAL TO PREDICATE
Additional Components		Introducer needlesIntroducer dilatorWire guideGuiding catheter	Exchange catheterTwo Rapi-Fit adapters



Sterilization Method		Ethylene Oxide	IDENTICAL TO PREDICATE
Packaging		Thermoform tray with aTyvek® lid	Tyvek® Pouch

Table 1: Substantial Equivalence Comparison Table

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The differences in Indication for Use and technological characteristics between the predicate and subject devices do not raise different questions of safety or effectiveness because:

-Indication for Use: the predicate is used for the initial placement of a tracheostomy tube when no tracheostomy exists. The subject device is used to exchange an existing tracheostomy tube to a new one. Initial placement of the tracheostomy tube as in the predicate device indication requires creating a percutaneous opening into the patient's airway through the tracheal cartilages. This access procedure is not required for the subject device as there is already a tracheostomy tube in place. The exchange aspect of the subject device does not raise different questions of safety or effectiveness as comparing to the predicate.
-Additional components: the exchange catheter and adapters included in the subject device set have been previously cleared under K162729.

Technological Characteristics:

The subject device. Weinmann Tracheostomy Exchange Set, was subjected to applicable non-clinical testing to ensure reliable design and performance under the specified design requirements. Testing includes:

. Dimensional and Compatibility Evaluation of the subject device (Accelerated/Real Time Aged).
. Biocompatibility testing - Data from the Ciaglia Blue Rhino Percutaneous Tracheostomy Introducer Set/Tray cleared under K133597 and the Cook Airway Exchange Catheter cleared under K162729 were leveraged to mitigate biocompatibility testing. Test results indicate that all materials are biocompatible.

The results of these tests show that the subject device meets the design input requirements based on the intended use and support the conclusion that the subject device does not raise different questions of safety or effectiveness and is substantially equivalent to the predicate device.

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.