CIAGLIA PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET/TRAY, CIAGLIA BLUE RHINO PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET/TRAY

{0}------------------------------------------------ COOK INCORPORATED. 750 DANIELS WAY, P.O. BOX-489 BLOOMINGTON, IN 47402-0489 U.S.A. NONE 812.339.2235 TOLL FREE: 800.457.4500- WWW.COOKMEDICAL.COM Image /page/0/Picture/1 description: The image shows information about the Ciaglia Percutaneous Tracheostomy Introducer Set. It also mentions the Ciaglia Blue Rhino Percutaneous Tracheostomy Introducer Set/Tray and the Ciaglia Blue Rhino G2 Advanced Percutaneous Tracheostomy Introducer Set/Tray. The image includes the reference 21 CFR §807.92 and states that the date prepared was April 15, 2014, with an additional date of APR 18 2014. Submitted Bv: Applicant: Contact: Applicant Address: Contact Phone Number: Contact Fax Number: #### Device Information: Trade names: Ciaglia Percutaneous Tracheostomy Introducer Set Ciaglia Blue Rhino® Percutaneous Tracheostomy Introducer Set/Tray Ciaglia Blue Rhino® G2 Advanced Percutaneous Tracheostomy Introducer Set/Tray | Common name: | Tracheostomy Introducers | |----------------------|---------------------------------| | Classification Name: | Tracheostomy tube and tube cuff | | Regulation: | 21 CFR §868.5800 | | Product Code: | JOH | Cook Incorporated Sean Spence, RAC Cook Incorporated 750 Daniels Way (812) 332-0281 Bloomington, IN 47404 (812) 335-3575 x105127 #### Predicate Device: K041348: Portex® Ultraperc® Percutaneous Dilation Tracheostomy kit with Serial Dilators or Single Stage Dilator, Blue Line Ultra Tracheostomy Tube and Introducer ## Device Description: The Cook Ciaglia percutaneous tracheostomy devices are designed for percutaneous dilational tracheostomy for management of the airway. More specifically, the devices allow for two approaches to the dilation of the stoma: serial dilation (Ciaglia Percutaneous Tracheostomy Introducer Set) or single-stage dilation (Blue Rhino® and Blue Rhino® G2 Advanced Percutaneous Tracheostomy Introducer Set). Serial dilation is achieved using numerous progressively larger dilators. Single-stage dilation is achieved with a single rhino-horn-shaped dilator using an in-and-out motion. {1}------------------------------------------------ Image /page/1/Picture/0 description: The image shows the logo for Cook Medical. The logo is white text on a black background. The word "COOK" is on the top line, and the word "MEDICAL" is on the bottom line. The Cook Ciaglia percutaneous tracheostomy devices are sold sterile for single use. There are multiple configurations that include various set and tray components (Table 1) associated with the procedure and/or in gaining percutaneous access. | Components | | | |------------------|----------------------|-----------------------------| | Loading dilators | Gauze sponges | Endotracheal tube accessory | | Guiding catheter | Introducer needles | Suture & needle | | Access dilators | Catheter needles | Tracheostomy tube holder | | Wire guide | Needle holder cup | Drape | | Scalpels | Clamp | Split dressing | | Syringes | Infiltration needles | Antiseptic skin prep | | Lubricated jelly | Filter straw | Local anesthetic | | Ointment | | | # Table 1: Set/Tray Components ## Indications for Use: - The Ciaglia Percutaneous Tracheostomy Introducer Set is intended for percutaneous a. 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 Ciaglia Blue Rhino® 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. - The Ciaglia Blue Rhino® G2 Advanced Percutaneous Tracheostomy Introducer C. 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. #### Substantial Equivalence: The Cook Ciaglia percutaneous tracheostomy devices are substantially equivalent in indications for use to the predicate. Both state their purpose as percutaneous dilational tracheostomy for management of the airway. The predicate specifically lists components used (e.g., wire guide, dilator) but those are implied whenever referencing percutaneous access. These differences do not raise new concerns and support a conclusion of substantial equivalence. {2}------------------------------------------------ Image /page/2/Picture/0 description: The image shows the logo for Cook Medical. The word "COOK" is in large, bold, white letters on a black background. Below "COOK" is the word "MEDICAL" in smaller, white letters. # Table 2: Substantial Equivalence Comparison - Ciaglia and Serial Dilator Predicate | | SUBJECT DEVICES | PREDICATE | |-----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Ciaglia Percutaneous Tracheostomy<br>Introducer Set | Portex® Ultraperc® Percutaneous Dilation<br>Tracheostomy Kit with Serial Dilators or<br>Single Stage Dilator, Blue Line Ultra<br>Trach. Tube and Introducer | | 510(k) | Subject of this submission | K041348 | | Regulation | 21 CFR §868.5800, Tracheostomy tube<br>and tube cuff | Same | | Product Code | JOH, tracheostomy tube and tube cuff | BTO, tube, tracheostomy (w/wo<br>connector) | | Classification | II | Same | | Indications for Use | ... is intended for percutaneous dilational<br>tracheostomy for management of the<br>airway in adults only<br>... should be performed in a controlled<br>setting... | Indicated to create a percutaneous<br>dilational tracheostomy using guidewire<br>dilators and components of these kits that<br>allow for tracheal access for airway<br>management for use in adults only | | Recommended Insertion Site | Between the first and second tracheal<br>cartilages or between the second and thirdtracheal cartilages | Same | | Duration of Use | Limited duration (≤ 24 hours) | Same | | Placement | Percutaneous technique | Same | | Patient Population | Adult patients requiring prolonged<br>ventilatory support | Same | | Sterilization | EtO | EtO | | Shelf-Life | 3 years | UNKNOWN | | Packaging | Thermoform tray with a Tyvek® lid | Polymer bag with Tyvek opening | | Tracheostomy Tube | Not sold with tracheostomy tube | Sold with tracheostomy tube in primary<br>packaging | | Serial Dilator Overview | 18, 21, 24, 28, 32, 36, and 38 French<br>Image: Serial dilator overview | 17, 25, 32, and 37 French<br>Image: Serial dilator overview | | Material | Vinyl | UNKNOWN | | Black Ink Markings | Single skin level mark | Multiple specific depth marks | | Tip Configuration | Tapered and curved | Tapered and straight | | Tracheostomy Tube Loading | Serial dilators serve as tracheostomy tube<br>loading dilators for final placement | Separate tracheostomy tube loading dilator<br>included | | | SUBJECT DEVICES | PREDICATE | | | Ciaglia Blue Rhino, and Ciaglia Blue<br>Rhino G2 Advanced Percutaneous<br>Tracheostomy Introducer Sets | Portex® Ultraperc® Percutaneous Dilation<br>Tracheostomy Kit with Serial Dilators or<br>Single Stage Dilator, Blue Line Ultra<br>Trach. Tube and Introducer | | 510(k) | Subject of this submission | K041348 | | Regulation | 21 CFR §868.5800, Tracheostomy tube<br>and tube cuff | Same | | Product Code | JOH, tracheostomy tube and tube cuff | BTO, tube, tracheostomy (w/wo<br>connector) | | Classification | II | Same | | Indications for Use | .... is intended for percutaneous dilational<br>tracheostomy for management of the<br>airway<br>...should be performed in a controlled<br>setting... | Indicated to create a percutaneous<br>dilational tracheostomy using guidewire<br>dilators and components of these kits that<br>allow for tracheal access for airway<br>management for use in adults only | | Contraindicated for Pediatrics | Yes | Same | | Recommended Insertion Site | Between the first and second tracheal<br>cartilages or between the second and third<br>tracheal cartilages | Same | | Duration of Use | Limited duration (≤ 24 hours) | Same | | Placement | Percutaneous technique | Same | | Patient Population | Adult patients requiring prolonged<br>ventilatory support | Same | | Sterilization | EtO | EtO | | Shelf-Life | 3 years | UNKNOWN | | Packaging | Thermoform tray with a Tyvek® lid | Plastic bag with Tyvek® opening | | Tracheostomy Tube | Set or Tray sold individually and co-<br>packaged with a tracheostomy tube | Tracheostomy tube present in primary<br>packaging | | Single-Staged Dilator<br>Overview | Image: Blue Rhino Curved Single-Staged Dilator | Image: Sigmoid Curved Single-Staged Dilator | | | Blue Rhino | | | | Blue Rhino G2 | | | Material | Blue radiopaque polyurethane | UNKNOWN | | Surface Characteristics | Blue Rhino = Smooth<br>Blue Rhino G2 = Crosshatch Handle and<br>Longitudinally Grooved Distal Portion | Texture Handle Portion and Smooth Distal<br>Portion | | Tip Configuration | Tapered and curved | Same | | Black Ink Markings | Single skin level mark | Same | | Hydrophilic Coating | PVP based Hydrophilic Coating | UNKNOWN base Hydrophilic Coating | {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the logo for Cook Medical. The word "COOK" is in large, bold, white letters on a black background. Below the word "COOK" is the word "MEDICAL" in smaller, white letters. # Table 3: Substantial Equivalence Comparison – Ciaglia Blue Rhino / Blue Rhino G2 and Portex Single-Stage Predicate {4}------------------------------------------------ Image /page/4/Picture/1 description: The image shows the logo for Cook Medical. The word "COOK" is in large, bold, white letters on a black background. Below "COOK" is the word "MEDICAL" in smaller, white letters, also on a black background. As shown in Table 2, differences in the subject serial dilators and the predicate serial dilators are packaging, presence or absence of a tracheostomy tube, range of serial dilators, material, tracheostomy tube loading, curvature at the distal tip, and depth markings. Table 3 shows differences in the subject single-stage dilators and the predicate are packaging, presence or absence of a tracheostomy tube, shape, material and texture. The differences in characteristics do not raise new concerns and support a conclusion of substantial equivalence. This conclusion was derived by comparing the product literature, specifications, and by performance testing. # Summary of Non-Clinical Testing: The following tests were performed to demonstrate that the Cook Ciaglia tracheostomy devices met applicable design and performance requirements and support a determination of substantial equivalence. - Tracheostomy Tube Fit / Removal Testing showed that the appropriate loading dilator . can successfully be inserted into the intended tracheostomy tube and will not fall out under its own weight, and can be successfully removed - . Tensile - Testing showed that the peak tensile load of each test article was greater than or equal to the acceptance criterion - Compression - Testing showed that the test article will withstand the axial peak compressive load without kinking - B Flexibility with Guiding Catheter - Testing showed the mean force to displace the tip of the guiding catheter was less than the mean to displace the dilator - 피 Fracture - Testing showed the test article met the predetermined acceptance criteria - 1 Durability - Testing showed the test article met the predetermined acceptance criteria - I 3 Point Bend - Testing showed the load to deflect the dilators was less than or equal to the load of the predicate - I Insertion Force - Testing showed the average insertion load of the test article was less than or equal to the predicate - . Performance following aging - Testing showed the subject devices continue to meet applicable design input requirements following aging - . Biocompatibility - The proposed devices were classified as external communicating devices with Tissue/Bone/Dentin contact for ≤ 24 hours. The following tests were completed and the biocompatibility was deemed acceptable: Cytotoxicity, Sensitization, Intracutaneous Reactivity, and Pyrogenicity. In addition, human factors hazard analysis and simulated use testing (usability study) were conducted. {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the logo for Cook Medical. The word "COOK" is in large, bold, white letters on the top line. Below that, the word "MEDICAL" is in smaller, white letters. COOK INCORPORATED 750 DANIELS WAY, P.O. BOX 489 LOOMINGTON, IN 47402-0489 U.S.A. 12.389.2235 TOLLERIS BOD.457.4500 WWW.COOKMEDICAL.COM ## Summary of Clinical Performance: Clinical tests were not required to demonstrate substantial equivalence of the Cook Ciaglia percutaneous tracheostomy devices as compared to the predicate devices. However, since the subject devices have a well-established history of clinical use, an evaluation of published clinical evidence was used to substantiate a history of safe and effective use. A total of 24 articles. incorporating 8,726 patients treated with Cook devices, were summarized. Limited clinical evidence on the predicate Portex Ultraperc® Percutaneous Dilation Tracheostomy kit was also found in 4 articles, incorporating 1,036 patients. Overall, the clinical evidence demonstrates that the subject devices are as safe and effective as the predicate device when used in percutaneous dilational tracheostomy for management of the airway. #### Conclusion: Based on the comparison information, non-clinical performance testing, and published clinical evidence, the Cook Ciaglia percutaneous tracheostomy are substantially equivalent to the predicate Portex® Ultraperc® Percutaneous Dilation Tracheostomy kit with Serial Dilators or Single Stage Dilator, Blue Line Ultra Tracheostomy Tube and Introducer (K041348). Portex® and Ultraperc® are registered trademarks of Smiths Medical {6}------------------------------------------------ Image /page/6/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized emblem featuring three abstract shapes that resemble a person with outstretched arms. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 April 18. 2014 Cook Incorporated Mr. Scan Spence, RAC Regulatory Affairs Team Lead Official Correspondent 750 Daniels Way, P.O. Box 489 Bloomington, IN 47402 Re: K133597 Trade/Device Name: Ciaglia Percutaneous Tracheostomy Introducer Set Ciaglia Blue Rhino® Percutaneous Tracheostomy Introducer Set/Trav Ciaglia Blue Rhino® G2 Advanced Percutaneous Tracheostomy Introducer Set/Tray Regulation Number: 21 CFR 868.5800 Regulation Name: Tracheostomy Tube Regulatory Class: Class II Product Code: JOH Dated: March 17th. 2014 Received: March 18th, 2014 Dear Mr. Spence: 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. {7}------------------------------------------------ Page 2 - Mr. Spence 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 (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); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/Safetv/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Sincerely yours. Image /page/7/Picture/8 description: The image shows a signature or stamp with the text "Tejashri Purohit-Sheth, M.D., Clinical Deputy Director, DAGRID, FOR". The text is arranged in a stacked format, with the name and title at the top, followed by the department and a label. The signature or stamp appears to be stylized and may be used for official purposes. Erin I. Keith, M.S. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {8}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K133597 #### Device Name Ciaglia Blue Rhino® Percutaneous Tracheostomy Introducer Set/Tray #### Indications for Use (Describe) The Ciaglia Blue Rhino Percutaneous Tracheostomy Introducer SetTray 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. Type of Use (Select one or both, as applicable) 2 Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) ## PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED. FOR FOR FDA USE ONLY FALL r, 1+32-2- Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) Image /page/8/Picture/14 description: The image shows a logo with the letters FDA in a stylized font. Above the letters, there is a signature or handwritten text that appears to be part of the logo. The overall design is simple and monochromatic. .17 16:21:45 -04'00' 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." Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below. {9}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K133597 Device Name Ciaglia Percutaneous Tracheostomy Introducer Set Indications for Use (Describe) The Ciaglia Percutaneous Tracheostomy Introducer Set 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 operaling 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) ## PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED. FOR FOR FOR FOR FOR FOR FOR FOR FOR THE FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FO Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) Image /page/9/Picture/14 description: The image shows two logos and a timestamp. The first logo on the left is "FDA" in a stylized font. To the right of the logos is the text "Maria Jison -S 2014.04.17 16:21:27 -04'00'". The second logo is also "FDA" in a stylized font. 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." Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below. {10}------------------------------------------------ #### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration ## Indications for Use 510(k) Number (if known) K133597 Device Name Ciaglia Blue Rhino® G2 Advanced Percutaneous Tracheostomy Introducer Set/Tray #### Indications for Use (Describe) The Ciaglia Blue Rhino G2 Advanced Percutaneous Tracheostomy Introducer SetTray 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. Type of Use (Select one or both, as applicable) 2 Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) # PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED. IT THE THE FOR FOR FOR FOR FOR FOR THE TO THE Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) Image /page/10/Picture/14 description: The image shows a logo with the letters FDA in a stylized, geometric font. Above the letters, there is a word written in a cursive script, which is difficult to read due to the image quality. The logo appears to be a representation of the Food and Drug Administration. .17 16:22:14 -04'00' 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." Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.