(30 days)
Not Found
No
The device description focuses on mechanical components and procedural steps, with no mention of AI or ML.
Yes
The device is described as an "Introducer Set/Tray" and "Exchange Set" intended for "percutaneous dilational tracheostomy for management of the airway" and "tracheostomy tube exchange," which are procedures used to manage and restore normal respiratory function, thus making it a therapeutic device.
No
Explanation: The devices described are intended for "percutaneous dilational tracheostomy for management of the airway" and "adult tracheostomy tube exchange," which are interventional and therapeutic procedures, not diagnostic ones.
No
The device description explicitly lists physical components such as dilators, catheters, and wire guides, indicating it is a hardware-based medical device. There is no mention of software as a component or the primary function.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "percutaneous dilational tracheostomy for management of the airway in adults only" and "adult tracheostomy tube exchange." These are surgical/procedural interventions performed directly on the patient's body.
- Device Description: The device components are instruments used for a surgical procedure (dilators, catheters, wire guide).
- Lack of Diagnostic Purpose: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide diagnostic information. This device is a surgical tool used for a therapeutic procedure.
N/A
Intended Use / Indications for Use
Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Set/Tray is intended for percutaneous dilational tracheostomy for management of the airway in adults only. Tube the technique described herein, should be performed in a controlled setting (e.g., ICU or operating room) with the assistance of trained personnel.
Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set/Tray is intended for percutaneous dilational tracheostomy for management of the airway in adults only. Tube the technique described herein, should be performed in a controlled setting (e.g., ICU or operating room) with the assistance of trained personnel.
Weinmann-Multi 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 devices Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Set/Tray and the Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set/Tray are designed for percutaneous dilational tracheostomy for management of the airway. The devices allow for single-stage dilation, which is achieved with a single rhino-horn-shaped dilator using an in-andout motion. Sets and trays include a Blue Rhino G1 Dilator or Blue Rhino G2 Dilator, loading dilators (6.5, 7.0, 7.5, 8.0, 8.5, 9.0, and 10.0 mm) an 8 Fr guiding catheter, a 14 Fr access dilator, and a wire guide. Sets and trays are available in multiple configurations, which include various set and tray components associated with the procedure and/or for gaining percutaneous access.
The Blue Rhino G1 Dilator is manufactured as a 38-Fr tracheostomy dilator with a length of 20 cm. This dilator has a depth marking to indicate the skin level, which is placed 11 cm from the distal tip. Another feature of the device is the presence of hydrophilic coating on the distal 11 cm of the device.
The Blue Rhino G2 Dilator is identical to the Blue Rhino G1 Dilator with additional surface modifications, which include a diamond (crosshatched) pattern along the proximal 8 cm of the dilator (handle), and longitudinal grooves covering the distal 10 cm curved portion of the device to the distal tip.
The loading dilators are manufactured in 6.5 to 10.0 mm with a length of 20 cm and are curved at the distal end.
The 8 Fr guiding catheter measures 29 cm in length and is designed with an end hole, a distal ridge, and proximal markings.
The 14 Fr access dilator is manufactured in a length measurement of 6.5 cm.
The wire guide measures 55 cm in length, is manufactured of stainless steel, and is designed with a "J" tip with a 3 mm curve.
The subject device Weinmann-Multi Tracheostomy Exchange Set is comprised of a Blue Rhino G1 Dilator, loading dilators (7.0, 7.5, 8.0, 8.5, and 9.0 mm), an 8 Fr Cook Airway Exchange Catheter, and two Rapi-Fit Adapters.
The Blue Rhino G1 Dilator supplied with the Weinmann-Multi Tracheostomy Exchange Set is identical to the Blue Rhino G1 Dilator supplied with the Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Set/Tray.
The loading dilators are manufactured in 7.0 to 9.0 mm with a length of 20 cm and are curved at the distal end, and are identical to the tracheostomy tube loading dilators sized 7.0, 7.5, 8.0, 8.5, and 9.0 mm supplied with the Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Set/Tray and Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set/Tray.
The airway exchange catheter is manufactured as an 8.0 Fr catheter measuring 45 cm in length. The distal end of the airway exchange is characterized by 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 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 socalled continuous positive airway pressure (CPAP) ventilators. The Luer Lock Rapi-Fit adapter is designed for attachment to a high-pressure jet ventilation oxygen source. The Luer Lock is compatible with a variable connector or the standard Luer fitting of an oxygen tube which is connected to an oxygen source.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
airway
Indicated Patient Age Range
adults only
Intended User / Care Setting
controlled setting (e.g., ICU or operating room) with the assistance of trained personnel.
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 following tests were performed to demonstrate that the minor dimensional modifications, the additional sizes, the ink material modification of the size-designation statement of the loading dilators, and the packaging dimensions of the subject devices met applicable design and performance requirements and support a determination of substantial equivalence.
- Simulated Use
- Security of Attachment Testing: performed in accordance with BS EN ISO 5366:2016. The pre-determined acceptance criteria were met.
- Verification of the outer diameter.
- Compression Force Testing. The pre-determined acceptance criteria were met.
- Tensile Strength Testing. The pre-determined acceptance criteria were met.
- Biocompatibility Testing, ISO Acute Systemic Injection Testing: performed in compliance with ISO 10993-11:2017; ISO 10993-12:2012.
- Biocompatibility Testing, ISO MEM Elution Using L-929 Mouse Fibroblast Cells (GLP): performed in compliance with ISO10993-5:2009 and ISO 10993-12:2012.
- Biocompatibility Testing, ISO Intracutaneous Irritation Testing: performed in compliance with ISO10993-10:2010 and ISO 10993-12:2012.
- Biocompatibility Testing, ISO Materials Mediated Rabbit Pyrogen: performed in compliance with US Pharmacopeia Section 151 USP - current version.
- Biocompatibility Testing, ISO Guinea Pig Maximization Sensitization Test: performed in compliance with ISO 10993-10:2013 and ISO 10993-12:2012.
- Packaging simulated distribution testing: per ASTM D4169-16.
- Packaging seal strength, simulated use testing: per ASTM F188/F1886M-16.
- Packaging bubble leak testing: per ASTM F209611.
- Packaging seal strength testing: per F88/F88M-15.
- Bioburden: per ISO 11737-1:2006.
- EO/ECH Residual: performed in compliance with ISO 10993-7:2008.
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.
Not Found
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.
Cook Incorporated Irasema Rivera Regulatory Affairs Specialist 750 Daniels Way Bloomington, Indiana 47404
Re: K193133
Trade/Device Name: Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Set/Trav Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set/Tray Weinmann-Multi Percutaneous Tracheostomy Exchange Set Regulation Number: 21 CFR 868.5800 Regulation Name: Tracheostomy Tube and Tube Cuff Regulatory Class: Class II Product Code: JOH Dated: November 8, 2019 Received: November 12, 2019
Dear Irasema Rivera:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Todd Courtney Assistant Director DHT1C: Division of ENT, Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name
Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Set/Tray Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set/Tray
Indications for Use (Describe)
Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Set/Tray is intended for percutaneous dilational tracheostomy for management of the airway in adults only. Tube the technique described herein, should be performed in a controlled setting (e.g., ICU or operating room) with the assistance of trained personnel.
Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set/Tray is intended for percutaneous dilational tracheostomy for management of the airway in adults only. Tube the technique described herein, should be performed in a controlled setting (e.g., ICU or operating room) with the assistance of trained personnel.
Type of Use (Select one or both, as applicable)
| ☒ 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
Indications for Use
510(k) Number (if known)
Device Name
Weinmann-Multi Tracheostomy Exchange Set
Indications for Use (Describe)
Weinmann-Multi 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."
4
Image /page/4/Picture/2 description: The image is a logo for Cook Medical. The logo consists of the word "COOK" in white, bold, sans-serif font, stacked on top of the word "MEDICAL" in a smaller, white, sans-serif font. The words are set against a red background. The word "MEDICAL" is placed on a red shape that is angled.
COOK INCORPORATED 750 DANIELS WAY, P.O. BOX 489 BLOOMINGTON, IN 47402-0489 U.S.A. E: 812.339.2235 TOLL FREE: 800.457.4500 WWW.COOKMEDICAL.COM
510(k) SUMMARY K193133 Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Set/Tray Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set/Tray Weinmann-Multi Tracheostomy Exchange Set 21 CFR §807.92 Date Prepared: December 2, 2019
| Submitted By: | |
|---|---|
| Applicant: | Cook Incorporated |
| Contact: | Irasema Rivera |
| Rohini Patel | |
| Applicant Address: | 750 Daniels Way |
| Bloomington, IN 47404 | |
| Phone: (812) 335-3575 x105166 | |
| Fax: (812) 332-0281 | |
| Device Information: | |
| Trade Names: | Blue Rhino G1-Multi Percutaneous Tracheostomy |
| Introducer Set/Tray, | |
| Blue Rhino G2-Multi Advanced Percutaneous | |
| Tracheostomy Introducer Set/Tray, and | |
| Weinmann-Multi Tracheostomy Exchange Set | |
| Regulation Number: | 21 CFR §868.5800 |
| Regulation Names: | Tube Tracheostomy and Tube Cuff |
| Product Code: | JOH |
| Device Class: | II |
| Review Panel: | Anesthesiology |
| Office of Device Evaluation: | Division of Anesthesiology, General Hospital, Respirator |
| Infection Control, and Dental Devices (DAGRID) | |
| Anesthesiology Devices Branch (ADB) |
5
Image /page/5/Picture/2 description: The image shows the logo for Cook Medical. The logo consists of a red rectangle with the word "COOK" in white, sans-serif font in the top half of the rectangle. Below "COOK" is the word "MEDICAL" in a smaller, white, sans-serif font. The "COOK" text also has a registered trademark symbol next to it.
COOK INCORPORATED
Predicate Devices:
- . The Ciaglia Blue Rhino Percutaneous Tracheostomy Introducer Set and Ciaglia Blue Rhino G2 Advanced Percutaneous Tracheostomy Introducer Set/Tray were cleared under K133597 on April 18, 2014.
- The Weinmann Tracheostomy Exchange Set was cleared under K180034 on May 7, . 2018.
Comparison to Predicate:
The proposed Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Set/Tray and Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set/Tray compared to the predicate devices, Ciaglia Blue Rhino Percutaneous Tracheostomy Introducer Set/Tray and Ciaglia Blue Rhino G2 Advanced Percutaneous Tracheostomy Introducer Set/Tray (K133597), are identical in intended use, principles of operation, technological characteristics, design, and nearly identical in materials of construction and dimensions.
The predicate submissions offered five loading dilators in five French sizes. The set components of the Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Set/Tray and Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set/Tray subjects of this submission offer a total of seven loading dilators in millimeter sizes. The ink material used to mark the millimeter size of the tracheostomy tube loading dilator has changed, and the outer diameter has changed slightly for three loading dilators. The content of product labeling has changed slightly. The dimensions of the product labels and of the marketing carton of the sets/trays supplied with separately packaged tracheostomy tubes have also changed. The safety and/or effectiveness of the subject device for the modifications to the loading dilators that include two new sizes and outer dimeter changes, and the package and labeling changes are supported by performance testing; and the ink material change supported by biocompatibility testing.
Additionally, predicate submission K133597 offered access dilators in 14 French size and measuring 4.5 or 6.5 centimeters in length. The subject devices Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Set/Tray and Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set/Tray will standardize the access dilator to the 14 French size and 6.5 centimeter length access dilator.
6
Image /page/6/Picture/2 description: The image shows the logo for Cook Medical. The logo consists of the word "COOK" in white, sans-serif font, stacked on top of the word "MEDICAL" in a smaller, sans-serif font. The words are set against a red background, with the word "MEDICAL" on a separate, slightly darker red rectangle.
COOK INCORPORATED 750 DANIELS WAY, P.O. BOX 489 BLOOMINGTON, IN 47402-0489 U.S.A. 812.339.2235 TOLL FREE: 800.457.4500 WWW.COOKMEDICAL.COM
A comparison between the predicate devices and the subject proposed Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Set/Tray and Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set/Tray is detailed in Table 1.
| Table 1: Substantial Equivalence Comparison Table, Blue Rhino Multi Percutaneous Tracheostomy Introducer Devices | ||||
|---|---|---|---|---|
| PREDICATE DEVICE | SUBJECT DEVICE | |||
| Ciaglia Blue Rhino Percutaneous | ||||
| Tracheostomy Introducer Set/Tray; | Blue Rhino G1-Multi Percutaneous | |||
| Tracheostomy Introducer Set/Tray; | ||||
| Ciaglia Blue Rhino G2 Advanced | ||||
| Percutaneous Tracheostomy Introducer | ||||
| Set/Tray | ||||
| (K133597) | Blue Rhino G2-Multi Percutaneous | |||
| Tracheostomy Introducer Set/Tray | ||||
| Regulation | 21 CFR §868.5800, Tracheostomy tube and | |||
| tube cuff | IDENTICAL | |||
| Product Code | JOH, tracheostomy tube and tube cuff | IDENTICAL | ||
| Classification | II | IDENTICAL | ||
| Indications for Use | Intended for percutaneous dilational | |||
| tracheostomy for management of the airway | ||||
| in adults only. | ||||
| Tube placement, using the technique | ||||
| described herein, should be performed in a | ||||
| controlled setting (e.g., ICU or operating | ||||
| room) with the assistance of trained | ||||
| personnel. | IDENTICAL | |||
| Contraindicated for | ||||
| Pediatrics | Yes | IDENTICAL | ||
| Recommended Insertion Site | Between the first and second tracheal | |||
| cartilages or between the second and third | ||||
| tracheal cartilages | IDENTICAL | |||
| Duration of Use | Limited duration (≤ 24 hours) | IDENTICAL | ||
| Placement | Percutaneous technique | IDENTICAL | ||
| Patient Population | Adult patients requiring prolonged | |||
| ventilatory support | IDENTICAL | |||
| Sterilization | EtO, SAL 10-6 | IDENTICAL | ||
| Shelf-Life | 3 years | IDENTICAL | ||
| Packaging | Thermoform tray with a Tyvek® lid | IDENTICAL | ||
| Tracheostomy Tube | Set or Tray sold individually and co- | |||
| packaged with a tracheostomy tube | IDENTICAL | |||
| Blue | ||||
| Rhino G1 | ||||
| and Blue | ||||
| Rhino G2 | ||||
| Dilator | ||||
| (single-staged) | Surface | |||
| Characteristics | Blue Rhino G1 = Smooth | |||
| Blue Rhino G2 = Crosshatched handle and | ||||
| longitudinally-grooved distal portion | IDENTICAL | |||
| Length | 20 cm | IDENTICAL | ||
| Outer Diameter | 38 Fr (max) | IDENTICAL | ||
| Material | Polyurethane | IDENTICAL | ||
| Depth Markings | Yes | IDENTICAL | ||
| Hydrophilic | ||||
| Coating | Yes | IDENTICAL | ||
| Tracheostomy Introducer Devices (continued) | ||||
| PREDICATE DEVICE | SUBJECT DEVICE | |||
| Ciaglia Blue Rhino Percutaneous | ||||
| Tracheostomy Introducer Set/Tray; | Blue Rhino G1-Multi Percutaneous | |||
| Ciaglia Blue Rhino G2 Advanced | Tracheostomy Introducer Set/Tray; | |||
| Percutaneous Tracheostomy | Blue Rhino G2-Multi Percutaneous | |||
| Introducer Set/Tray | Tracheostomy Introducer Set/Tray | |||
| (K133597) | ||||
| 6.5 mm LOADING DILATOR ONLY | ||||
| NOT FOR CREATION OF STOMA | ||||
| -- | ||||
| 21 Fr LOADING DILATOR ONLY NOT | ||||
| FOR CREATION OF STOMA | 7.0 mm LOADING DILATOR ONLY | |||
| NOT FOR CREATION OF STOMA | ||||
| 24 Fr LOADING DILATOR ONLY NOT | ||||
| FOR CREATION OF STOMA | 7.5 mm LOADING DILATOR ONLY | |||
| NOT FOR CREATION OF STOMA | ||||
| Loading | ||||
| Dilators | Ink Markings | 26 Fr LOADING DILATOR ONLY NOT | ||
| FOR CREATION OF STOMA | 8.0 mm LOADING DILATOR ONLY | |||
| NOT FOR CREATION OF STOMA | ||||
| 27 Fr LOADING DILATOR ONLY NOT | ||||
| FOR CREATION OF STOMA | 8.5 mm LOADING DILATOR ONLY | |||
| NOT FOR CREATION OF STOMA | ||||
| 28 Fr LOADING DILATOR ONLY NOT | ||||
| FOR CREATION OF STOMA | 9.0 mm LOADING DILATOR ONLY | |||
| NOT FOR CREATION OF STOMA | ||||
| -- | 10.0 mm LOADING DILATOR ONLY | |||
| NOT FOR CREATION OF STOMA | ||||
| -- | (6.5 mm) 0.268 in | |||
| Outer | ||||
| Diameter | (21 Fr) 0.273 in | (7.0 mm) 0.288 in | ||
| (24 Fr) 0.308 in | IDENTICAL | |||
| (26 Fr) 0.327 in | IDENTICAL | |||
| (27 Fr) 0.345 in | (8.5 mm) 0.349 in | |||
| (28 Fr) 0.375 in | (9.0 mm) 0.366 in | |||
| -- | (10.0 mm) 0.412 in | |||
| Endhole | ||||
| Diameter | 0.110 in | IDENTICAL | ||
| Material | Polyurethane | IDENTICAL | ||
| Ink Material | Black, TP 247/65-NT | Black, 71860 | ||
| Guiding | Size | 8 Fr | IDENTICAL | |
| Catheter | Material | Fluorinated ethylene propylene | IDENTICAL | |
| Ink | #3112 Polyking Black Ink | IDENTICAL | ||
| Access | Size | 14 Fr, 4.5 cm and 14 Fr, 6.5 cm | 14 Fr, 6.5 cm only | |
| Dilator | Material | Polyethylene | IDENTICAL | |
| Wire | Size | 0.052 in | IDENTICAL | |
| Guide | Material | Stainless Steel / PTFE | IDENTICAL |
Table 1: Substantial Equivalence Comparison Table, Blue Rhino Multi
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Image /page/7/Picture/2 description: The image shows the Cook Medical logo. The logo is a red rectangle with the word "COOK" in white, bold letters on the top. Below the word "COOK" is the word "MEDICAL" in smaller, white letters. The bottom left corner of the red rectangle is cut off at an angle.
COOK INCORPORATED 750 DANIELS WAY, P.O. BOX 489 BLOOMINGTON, IN 47402-0489 U.S.A. PHONE: 812.339.2235 TOLL FREE: 800.457.4500 WWW.COOKMEDICAL.COM
Table 1: Substantial Equivalence Comparison Table, Blue Rhino Multi Percutaneous Tracheostomy Introducer Devices (continued)
8
Image /page/8/Picture/2 description: The image shows the logo for Cook Medical. The logo consists of the word "COOK" in white, with the word "MEDICAL" underneath it in a smaller font. The background of the logo is a dark red color. The logo is simple and professional, and it is likely used on Cook Medical's products and marketing materials.
COOK INCORPORATED 50 DANIFIS WAY P.O. BOX 489 MINGTON, IN 47402-0489 U.S.A. 235 TOLL FREE: 800.457.4500 WWW.COOKMEDICAL.COM
The proposed Weinmann-Multi Tracheostomy Exchange Set compared to the Weinmann Tracheostomy Exchange Set (K180034) is identical in intended use, principles of operation, basic technological characteristics, design, and nearly identical in materials of construction and dimensions.
The predicate submissions offered five loading dilators in five French sizes. The set components of the Weinmann-Multi Tracheostomy Exchange Set subject of this submission offers five loading dilators in millimeter sizes. The ink material used to mark the millimeter size of the tracheostomy tube loading dilator has changed, the outer diameter has changed slightly for three loading dilators and the contents of the product labeling has changed slightly. The safety and/or effectiveness of the subject device, specifically for the modifications to the loading dilators are supported by performance testing; and the ink material change supported by biocompatibility testing.
A comparison between the predicate devices and the subject proposed Weinmann-Multi Tracheostomy Exchange Set is detailed in Table 2.
| Tracheostomy Exchange Set | |||
|---|---|---|---|
| PREDICATE DEVICE | SUBJECT DEVICE | ||
| Weinmann Tracheostomy Exchange | |||
| Set | |||
| (K180034) | Weinmann-Multi Tracheostomy | ||
| Exchange Set | |||
| Regulation | 21 CFR § 868.5800, Tracheostomy tube | ||
| and tube cuff | IDENTICAL | ||
| Product Code | JOH, tracheostomy tube and tube cuff | IDENTICAL | |
| Classification | II | IDENTICAL | |
| Indications for Use | For adult tracheostomy tube exchange | IDENTICAL | |
| One-time Use | Yes | IDENTICAL | |
| Recommended Insertion Site | Between the 1st and 2nd tracheal | ||
| cartilages or between the 2nd and 3rd | |||
| tracheal cartilages | IDENTICAL | ||
| Placement | Percutaneous technique | IDENTICAL | |
| Duration of Use | Limited (≤ 24 hours) | IDENTICAL | |
| Length | 20 cm | IDENTICAL | |
| Blue | |||
| Rhino G1 | |||
| Dilator | |||
| (single- | |||
| staged) | Outer Diameter | 38 Fr (max) | IDENTICAL |
| Material | Polyurethane | IDENTICAL | |
| Depth Markings | Yes | IDENTICAL | |
| Hydrophilic | |||
| Coating | Yes | IDENTICAL |
Table 2: Substantial Equivalence Comparison Table, Weinmann-Multi
9
Image /page/9/Picture/0 description: The image shows the logo for Cook Medical. The logo consists of the word "COOK" in large, white, sans-serif font on a red background. Below the word "COOK" is the word "MEDICAL" in white, sans-serif font on a red background. The logo is simple and clean, and the red and white color scheme is eye-catching.
COOK INCORPORATED 750 DANIELS WAY, P.O. BOX 489 BLOOMINGTON, IN 47402-0489 U.S.A. 9.2235 TOLL FREE: 800.457.4500 WWW.COOKMEDICAL.COM
| Table 2: Substantial Equivalence Comparison Table, Weinmann-Multi |
|---|
| Tracheostomy Exchange Set (continued) |
| PREDICATE DEVICE | SUBJECT DEVICE | |||
|---|---|---|---|---|
| Weinmann Tracheostomy Exchange | ||||
| Set | ||||
| (K180034) | Weinmann-Multi Tracheostomy | |||
| Exchange Set | ||||
| Loading | ||||
| Dilators | Ink Markings | |||
| 24 Fr LOADING DILATOR ONLY NOT | ||||
| FOR CREATION OF STOMA | 7.5 mm LOADING DILATOR ONLY | |||
| NOT FOR CREATION OF STOMA | ||||
| 26 Fr LOADING DILATOR ONLY NOT | ||||
| FOR CREATION OF STOMA | 8.0 mm LOADING DILATOR ONLY | |||
| NOT FOR CREATION OF STOMA | ||||
| 27 Fr LOADING DILATOR ONLY NOT | ||||
| FOR CREATION OF STOMA | 8.5 mm LOADING DILATOR ONLY | |||
| NOT FOR CREATION OF STOMA | ||||
| 28 Fr LOADING DILATOR ONLY NOT | ||||
| FOR CREATION OF STOMA | 9.0 mm LOADING DILATOR ONLY | |||
| NOT FOR CREATION OF STOMA | ||||
| Outer Diameter | (21 Fr) 0.273 in | (7.0 mm) 0.288 in | ||
| (24 Fr) 0.308 in | ||||
| (26 Fr) 0.327 in | ||||
| (27 Fr) 0.345 in | ||||
| (28 Fr) 0.375 in | ||||
| Endhole | ||||
| Diameter | 0.110 in | IDENTICAL | ||
| Tip | Tapered and curved | IDENTICAL | ||
| Dilator Material | Polyurethane | IDENTICAL | ||
| Ink Material | Black, TP 247/65-NT | Black, 71860 | ||
| Cook | ||||
| Airway | ||||
| Exchange | ||||
| Catheter | Length | 45 cm | IDENTICAL | |
| Outer Diameter | 8 Fr | IDENTICAL | ||
| Material | Polyurethane | IDENTICAL | ||
| Ink | Ink, Amines, C12-14-tert-alkyl | IDENTICAL | ||
| Adapters | Luer Lock and 15 mm Adapter | IDENTICAL | ||
| Sterilization Method | Ethylene Oxide | IDENTICAL | ||
| Packaging | Tyvek® Pouch | IDENTICAL |
Device Description:
Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Set/Tray and the Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set/Tray
The subject devices Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Set/Tray and the Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set/Tray are designed for percutaneous dilational tracheostomy for management of the airway. The devices allow for single-stage dilation, which is achieved with a single rhino-horn-shaped dilator using an in-andout motion. Sets and trays include a Blue Rhino G1 Dilator or Blue Rhino G2 Dilator, loading dilators (6.5, 7.0, 7.5, 8.0, 8.5, 9.0, and 10.0 mm) an 8 Fr guiding catheter, a 14 Fr access dilator,
10
Image /page/10/Picture/2 description: The image shows the Cook Medical logo. The logo is set against a red background. The word "COOK" is in large, white, sans-serif font, stacked above the word "MEDICAL" which is in a smaller, white, sans-serif font. The logo is simple and modern.
COOK INCORPORATED
750 DANIELS WAY, P.O. BOX 489
BLOOMINGTON, IN 47402-0489 U.S.A.
PHONE: 812.339.2235 TOLL FREE: 800.457.4500
WWW.COOKMEDICAL.COM
and a wire guide. Sets and trays are available in multiple configurations, which include various set and tray components (Table 1) associated with the procedure and/or for gaining percutaneous access.
Table 3: Set/Tray Components, Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Set/Tray and Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set/Tray
| Components | |||
|---|---|---|---|
| Scalpels | Catheter needle | Endotracheal tube accessory | Split dressing |
| Syringes | Needle holder cup | Suture & needle | Antiseptic skin pre |
| Lubricating jelly | Clamp | Needle driver | Local anesthetic |
| Gauze sponges | Infiltration needles | Tracheostomy tube holder |
The Blue Rhino G1 Dilator is manufactured as a 38-Fr tracheostomy dilator with a length of 20 cm. This dilator has a depth marking to indicate the skin level, which is placed 11 cm from the distal tip. Another feature of the device is the presence of hydrophilic coating on the distal 11 cm of the device.
The Blue Rhino G2 Dilator is identical to the Blue Rhino G1 Dilator with additional surface modifications, which include a diamond (crosshatched) pattern along the proximal 8 cm of the dilator (handle), and longitudinal grooves covering the distal 10 cm curved portion of the device to the distal tip.
The loading dilators are manufactured in 6.5 to 10.0 mm with a length of 20 cm and are curved at the distal end.
The 8 Fr guiding catheter measures 29 cm in length and is designed with an end hole, a distal ridge, and proximal markings.
The 14 Fr access dilator is manufactured in a length measurement of 6.5 cm.
The wire guide measures 55 cm in length, is manufactured of stainless steel, and is designed with a "J" tip with a 3 mm curve.
Weinmann-Multi Tracheostomy Exchange Set
The subject device Weinmann-Multi Tracheostomy Exchange Set is comprised of a Blue Rhino G1 Dilator, loading dilators (7.0, 7.5, 8.0, 8.5, and 9.0 mm), an 8 Fr Cook Airway Exchange Catheter, and two Rapi-Fit Adapters.
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Image /page/11/Picture/2 description: The image is a logo for Cook Medical. The logo is set against a red background. The word "COOK" is in large, white, sans-serif font, and the word "MEDICAL" is in a smaller, white, sans-serif font below the word "COOK".
COOK
INCORPORATED
750 DANIELS WAY, P.O. BOX 489
BLOOMINGTON, IN 47402-0489 U.S.A.
PHONE: 812.339.2235 TOLL FREE: 800.457.4500
The Blue Rhino G1 Dilator supplied with the Weinmann-Multi Tracheostomy Exchange Set is identical to the Blue Rhino G1 Dilator supplied with the Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Set/Tray.
The loading dilators are manufactured in 7.0 to 9.0 mm with a length of 20 cm and are curved at the distal end, and are identical to the tracheostomy tube loading dilators sized 7.0, 7.5, 8.0, 8.5, and 9.0 mm supplied with the Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Set/Tray and Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set/Tray.
The airway exchange catheter is manufactured as an 8.0 Fr catheter measuring 45 cm in length. The distal end of the airway exchange is characterized by 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 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 socalled continuous positive airway pressure (CPAP) ventilators. The Luer Lock Rapi-Fit adapter is designed for attachment to a high-pressure jet ventilation oxygen source. The Luer Lock is compatible with a variable connector or the standard Luer fitting of an oxygen tube which is connected to an oxygen source.
Indications for Use:
- a. The Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Set/Tray is intended for percutaneous dilational tracheostomy for management of the airway in adults only. Tube placement, using the technique described herein, should be performed in a controlled setting (e.g. ICU or operating room) with the assistance of trained personnel.
- b. The Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set/Tray is intended for percutaneous dilational tracheostomy for management of the airway in adults only. Tube placement, using the technique described herein, should be performed in a controlled setting (e.g. ICU or operating room) with the assistance of trained personnel.
- c. The Weinmann-Multi Tracheostomy Exchange Set is intended for adult tracheostomy tube exchange.
12
Image /page/12/Picture/2 description: The image shows the logo for Cook Medical. The logo consists of the word "COOK" in white, with the word "MEDICAL" underneath it. The background is a solid red color. The logo is simple and clean, and the use of white text on a red background makes it eye-catching.
COOK INCORPORATED
750 DANIELS WAY, P.O. BOX 489
BLOOMINGTON, IN 47402-0489 U.S.A.
PHONE: 812.339.2235 TOLL FREE: 800.457.4500
WWW.COOKMEDICAL.COM
Test Data:
The following tests were performed to demonstrate that the minor dimensional modifications, the additional sizes, the ink material modification of the size-designation statement of the loading dilators, and the packaging dimensions of the subject devices met applicable design and performance requirements and support a determination of substantial equivalence.
- Simulated Use .
- Security of Attachment Testing: performed in accordance with BS EN ISO 5366:2016. . The pre-determined acceptance criteria were met.
- Verification of the outer diameter. ●
- . Compression Force Testing. The pre-determined acceptance criteria were met.
- Tensile Strength Testing. The pre-determined acceptance criteria were met. ●
- . Biocompatibility Testing, ISO Acute Systemic Injection Testing: performed in compliance with ISO 10993-11:2017; ISO 10993-12:2012.
- . Biocompatibility Testing, ISO MEM Elution Using L-929 Mouse Fibroblast Cells (GLP): performed in compliance with ISO10993-5:2009 and ISO 10993-12:2012.
- Biocompatibility Testing, ISO Intracutaneous Irritation Testing: performed in compliance . with ISO10993-10:2010 and ISO 10993-12:2012.
- . Biocompatibility Testing, ISO Materials Mediated Rabbit Pyrogen: performed in compliance with US Pharmacopeia Section 151 USP - current version.
- Biocompatibility Testing, ISO Guinea Pig Maximization Sensitization Test: performed in compliance with ISO 10993-10:2013 and ISO 10993-12:2012.
- . Packaging simulated distribution testing: per ASTM D4169-16.
- Packaging seal strength, simulated use testing: per ASTM F188/F1886M-16. ●
- Packaging bubble leak testing: per ASTM F209611. .
- . Packaging seal strength testing: per F88/F88M-15.
- Bioburden: per ISO 11737-1:2006. .
- EO/ECH Residual: performed in compliance with ISO 10993-7:2008. ●
Conclusion:
In conclusion, these tests support a determination of substantial equivalence of the predicate devices to the devices subject of this submission, and do not raise any new questions of the safety and/or effectiveness of the device.