(123 days)
No
The device description and performance studies focus on physical components and their mechanical properties, with no mention of AI/ML algorithms or data processing.
No.
The device is intended for the exchange of adult tracheostomy tubes, which is a procedural aid rather than a direct therapeutic intervention for a disease or condition. It facilitates a medical procedure but does not treat, cure, or mitigate a disease intrinsically.
No
The Weinmann Tracheostomy Exchange Set is described as a medical device intended for the exchange of adult tracheostomy tubes, involving dilation and placement. Its components (dilators, catheters, adapters) are all designed for interventional or assistive procedures related to maintaining an airway, not for diagnosing a condition or disease.
No
The device description clearly outlines physical components such as dilators, catheters, and adapters, which are hardware. There is no mention of software as a component of this device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "for adult tracheostomy tube exchange." This describes a surgical or procedural intervention, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The description details instruments used for a medical procedure (dilating a stoma, facilitating tube placement, maintaining an airway, providing oxygen). It does not mention any components or processes related to analyzing biological samples.
- Lack of IVD Indicators: There is no mention of:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Diagnosing, monitoring, or screening for diseases or conditions based on sample analysis
- Reagents, calibrators, or controls typically associated with IVDs
The device is clearly intended for a medical procedure involving the respiratory system, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The Weinmann Tracheostomy Exchange Set is intended for adult tracheostomy tube exchange.
Product codes (comma separated list FDA assigned to the subject device)
JOH
Device Description
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).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
adult
Intended User / Care Setting
Prescription Use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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);
1
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
2
Indications for Use
510(k) Number (if known)
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Image /page/3/Picture/0 description: The image shows the logo for Cook Medical. The logo is set against a red background. The word "COOK" is in large, white, sans-serif font at the top. Below that, the word "MEDICAL" is in a smaller, white, sans-serif font, set against a black background.
510(k) Summary
Weinmann Tracheostomy Exchange Set 21 CFR §807.92 Date Prepared: April 30, 2018
Submitted By:
| Applicant: | Cook Incorporated |
|---|---|
| Contact: | Paul Meyer |
| Hui Ouyang, PhD, RAC | |
| Applicant Address: | Cook Incorporated |
| 750 Daniels Way | |
| Bloomington, 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:
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).
4
Image /page/4/Picture/0 description: The image shows the logo for Cook Medical. The logo consists of the word "COOK" in white, block letters on a red background. Below the word "COOK" is the word "MEDICAL" in white, block letters on a red background that is shaped like a banner.
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.
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,
5
Image /page/5/Picture/0 description: The image shows the logo for Cook Medical. The logo is set against a red background. The word "COOK" is in white, block letters, and the word "MEDICAL" is in smaller, white letters below it.
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 Percutaneous | |||
| Tracheostomy Introducer | |||
| Set, Ciaglia Blue Rhino® | |||
| Percutaneous Tracheostomy | |||
| Introducer Set/Tray | |||
| K133597 | Weimann Tracheostomy | ||
| Exchange Set | |||
| Regulation | 21 CFR § 868.5800, | ||
| Tracheostomy tube and tube | |||
| cuff | IDENTICAL TO PREDICATE | ||
| Product Code | JOH, tracheostomy tube and | ||
| tube cuff | IDENTICAL TO PREDICATE | ||
| Classification | II | IDENTICAL TO PREDICATE | |
| Indication for Use | For percutaneous dilational | ||
| tracheostomy for management | |||
| of the airway in adults only | The Weinmann Tracheostomy | ||
| Exchange Set is intended for | |||
| adult tracheostomy tube | |||
| exchange | |||
| One-time Use | Yes | IDENTICAL TO PREDICATE | |
| Recommended Insertion Site | Between the 1st and 2nd | ||
| tracheal cartilages or between | |||
| the 2nd and 3rd tracheal | |||
| cartilages | IDENTICAL TO PREDICATE | ||
| Placement | Percutaneous technique | IDENTICAL TO PREDICATE | |
| Duration of Use | Limited (≤ 24 hours) | IDENTICAL TO PREDICATE | |
| Ciaglia Blue | |||
| Rhino | |||
| Tracheostomy | |||
| Dilator | Length | 20 cm | IDENTICAL TO PREDICATE |
| Outer | |||
| Diameter | 38 Fr (max) | IDENTICAL TO PREDICATE | |
| Material | Polyurethane | IDENTICAL TO PREDICATE | |
| Depth | |||
| Marking | Yes | IDENTICAL TO PREDICATE | |
| Hydrophilic | |||
| Coating | Yes | IDENTICAL TO PREDICATE | |
| Loading | |||
| Dilators | 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 needles | ||
| Introducer dilator | |||
| Wire guide | |||
| Guiding catheter | Exchange catheter | ||
| Two Rapi-Fit adapters | |||
| Sterilization Method | Ethylene Oxide | IDENTICAL TO PREDICATE | |
| Packaging | Thermoform tray with a | ||
| Tyvek® lid | Tyvek® Pouch |
Table 1: Substantial Equivalence Comparison Table
6
Image /page/6/Picture/0 description: The image shows the logo for Cook Medical. The logo is set against a red background. The word "COOK" is in white, bold, sans-serif font, and is placed on the top portion of the logo. Below "COOK" is the word "MEDICAL" in white, sans-serif font, and is placed on a white banner.
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.