BLUperc Percutaneous Dilation Tracheostomy Kit with BLUselect tube, BLUperc Percutaneous Dilation Tracheostomy Kit with BLUselect Suctionaid tube, BLUgriggs Percutaneous Dilation Tracheostomy Kit with BLUselect tube, BLUgriggs Percutaneous Dilation Tracheostomy Kit with BLUselect Suctionaid tube

Q: Who is the manufacturer of BLUperc Percutaneous Dilation Tracheostomy Kit with BLUselect tube, BLUperc Percutaneous Dilation Tracheostomy Kit with BLUselect Suctionaid tube, BLUgriggs Percutaneous Dilation Tracheostomy Kit with BLUselect tube, BLUgriggs Percutaneous Dilation Tracheostomy Kit with BLUselect Suctionaid tube?

Smiths Medical Asd, Inc. filed the 510(k) submission for BLUperc Percutaneous Dilation Tracheostomy Kit with BLUselect tube, BLUperc Percutaneous Dilation Tracheostomy Kit with BLUselect Suctionaid tube, BLUgriggs Percutaneous Dilation Tracheostomy Kit with BLUselect tube, BLUgriggs Percutaneous Dilation Tracheostomy Kit with BLUselect Suctionaid tube (K173912).

Q: What is the FDA product code for BLUperc Percutaneous Dilation Tracheostomy Kit with BLUselect tube, BLUperc Percutaneous Dilation Tracheostomy Kit with BLUselect Suctionaid tube, BLUgriggs Percutaneous Dilation Tracheostomy Kit with BLUselect tube, BLUgriggs Percutaneous Dilation Tracheostomy Kit with BLUselect Suctionaid tube?

JOH. It is classified under 21 CFR 868.5800 as a Class 2 device in the Anesthesiology panel.

Q: What is the regulatory pathway for BLUperc Percutaneous Dilation Tracheostomy Kit with BLUselect tube, BLUperc Percutaneous Dilation Tracheostomy Kit with BLUselect Suctionaid tube, BLUgriggs Percutaneous Dilation Tracheostomy Kit with BLUselect tube, BLUgriggs Percutaneous Dilation Tracheostomy Kit with BLUselect Suctionaid tube?

510(k) clearance (submission type: Traditional).

Q: Who can help prepare an FDA 510(k) submission like BLUperc Percutaneous Dilation Tracheostomy Kit with BLUselect tube, BLUperc Percutaneous Dilation Tracheostomy Kit with BLUselect Suctionaid tube, BLUgriggs Percutaneous Dilation Tracheostomy Kit with BLUselect tube, BLUgriggs Percutaneous Dilation Tracheostomy Kit with BLUselect Suctionaid tube?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

K173912 · Smiths Medical Asd, Inc. · JOH · May 8, 2018 · Anesthesiology

Device Facts

Record ID	K173912
Device Name	BLUperc Percutaneous Dilation Tracheostomy Kit with BLUselect tube, BLUperc Percutaneous Dilation Tracheostomy Kit with BLUselect Suctionaid tube, BLUgriggs Percutaneous Dilation Tracheostomy Kit with BLUselect tube, BLUgriggs Percutaneous Dilation Tracheostomy Kit with BLUselect Suctionaid tube
Applicant	Smiths Medical Asd, Inc.
Product Code	JOH · Anesthesiology
Decision Date	May 8, 2018
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 868.5800
Device Class	Class 2
Attributes	Therapeutic

Indications for Use

Controlled, elective, subcricoid percutaneous insertion of a tracheostomy tube for airway management using a Seldinger guidewire dilation technique. Controlled, elective subcricoid percutaneous insertion of a tracheostomy tube for airway management using a Seldinger technique to guide the specially designed Guidewire Dilating Forceps into the trachea, which are then used to dilate the trachea.

Device Story

Procedural kits/trays for percutaneous dilation tracheostomy (PDT) in adult patients. BLUperc uses Seldinger guidewire technique with a dilator to expand subcutaneous/tracheal tissue. BLUgriggs uses Griggs Forceps technique, where closed forceps are advanced over a guidewire and opened to create a stoma. Kits include tracheostomy tube, guidewire, dilator/forceps, and various procedural components (sutures, scalpels, needles, dressings). Used in hospital environments by physicians/healthcare staff to establish artificial airway. Output is a surgically placed tracheostomy tube for ventilation/airway management. Benefits include standardized procedural workflow and reduced time for airway access.

Clinical Evidence

Bench testing only. Testing included design verification and validation, packaging validation (ISO 11607), human factors (ISO 62366), sterilization/microbiology validation (ISO 11135, AAMI TIR28, ISO 11737), and biocompatibility assessment (ISO 10993-1).

Technological Characteristics

Medical grade materials; biocompatible per ISO 10993-1. Seldinger or Griggs Forceps dilation principle. Ethylene Oxide (EO) sterile. 15mm connectors for ventilation compatibility. Includes neck strap for tube securement. Single-use, prescription only.

Indications for Use

Indicated for adult patients requiring an artificial airway for breathing due to trauma, medical condition, or airway maintenance.

Regulatory Classification

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.

Predicate Devices

UltraPerc Percutaneous Dilation Kit with Single Stage Dilator, Blue Line Ultra Tracheostomy Tube and Introducer (K041348)
Portex Percutaneous Tracheostomy Kit (K060945)

Reference Devices

Percutaneous Dilation Kit with Single Stage Dilator and Soft Introducer for Sizes 7, 8, & 9 mm Tubes Only, without Tracheostomy Tubes (K040014)

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. May 8, 2018 Smiths Medical ASD, Inc. Donna Semlak Principal Regulatory Affairs Specialist 6000 Nathan Lane North Minneapolis, Minnesota 55442 Re: K173912 Trade/Device Name: BLUperc® Percutaneous Dilation Tracheostomy Procedural Kit or Tray with or without BLUselect Tracheostomy Tube, and BLUgriggs® Percutaneous Dilation Tracheostomy Procedural Kit or Tray with BLUselect® Tracheostomy Tube with or without Forceps Regulation Number: 21 CFR 868.5800 Regulation Name: Tracheostomy Tube and Tube Cuff Regulatory Class: Class II Product Code: JOH Dated: April 6, 2018 Received: April 9, 2018 Dear Donna Semlak: 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 {1}------------------------------------------------ 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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 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 medical devices and radiation-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) #### K173912 Device Name Smiths Medical BLUperc® Percutaneous Dilation Tracheostomy Procedural Kit or Tray without BLUselect® Tracheostomy Tube Indications for Use (Describe) Controlled, elective, subcricoid percutaneous insertion of a tracheostomy tube for airway management using a Seldinger guidewire dilation technique. 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." Confidential {3}------------------------------------------------ # Indications for Use 510(k) Number (if known) #### K173912 Device Name Smiths Medical BLUgrigg® Percutaneous Dilation Tracheostomy Procedural Kit or Tray with BLUselect® Tracheostomy Tube with or without Forceps Indications for Use (Describe) Controlled, elective subcricoid percutaneous insertion of a tracheostomy tube for airway management using a Seldinger technique to guide the specially designed Guidewire Dilating Forceps into trachea, which are then used to dilate the trachea. | 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) | escription 000 (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." Confidential {4}------------------------------------------------ # smiths medical bringing technology to life # 510(k) SUMMARY BLUperc®, and BLUgriggs® Percutaneous Dilation Tracheostomy Procedural Kit or Tray #### Date of Summary Preparation: Submitter: #### Establishment Registration Number: Company Contact (Primary): Trade Name(s): Device Names(s): May 3, 2018 (Revised) Smiths Medical 6000 Nathan Lane Minneapolis, MN 55442 USA 3012307300 (Minneapolis) Donna M. Semlak Principal Regulatory Affairs Specialist Email: donna.semlak@smiths-medical.com Office: 763-383-3076 Tracheostomy Tube - · BLUperc® Percutaneous Dilation Tracheostomy Procedural Kit or Tray with or without BLUselect® Tracheostomy Tube - · BLUgriggs® Percutaneous Dilation Tracheostomy Procedural Kit or Tray with BLUselect® Tracheostomy Tube with or without Forceps Class II 21 CFR § 868.5800 Tracheostomy Tube and Tube Cuff JOH Device Classification: Regulation Number/Name Product Code(s): {5}------------------------------------------------ ## Purpose The purpose of this premarket notification Traditional 510(k) is to obtain FDA clearance for adult patient population requiring an artificial airway for breathing. This submission is submitted to establish substantial equivalence and obtain 510(k) clearance for the following: - BLUperc® Percutaneous Dilation Tracheostomy Procedural Kit or Tray with or . without BLUselect® Tracheostomy Tube - BLUgriggs® Percutaneous Dilation Tracheostomy Procedural Kit or Tray with . BLUselect® Tracheostomy Tube with or without Forceps ## Predicate Device for BLUperc® and BLUgriggs® PDT: Information for the predicate device is provided in the table below for the subject devices, BLUperc® and BLUgriggs® PDT. | Primary Predicate Device Name | FDA 510(k) Number and Clearance Date | Classification | Primary Code | |---------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------|----------------|------------------------| | UltraPerc Percutaneous Dilation Kit with Single Stage Dilator , Blue Line Ultra Tracheostomy Tube and Introducer | K041348 July 13, 2004 Original Applicant: Smiths Medical | Class II | JOH 21 CFR 868.5800 | #### Primary Predicate: BLUperc® and BLUgriggs® PDT kits or travs #### Additional Predicates: BLUperc and BLUgriggs PDT kits or travs | Additional Predicate Device Name | FDA 510(k) Number and Clearance Date | Classification | Product Code | |-----------------------------------------|-------------------------------------------------------------------------|----------------|------------------------| | Portex Percutaneous Tracheostomy Kit | K060945 Jun 19, 2006 Original Applicant: Smiths Medical | Class II | BTO 21 CFR 868.5800 | #### Reference Device: BLUperc and BLUgriggs PDT kits or trays | Reference Device Name | FDA 510(k) Number and Clearance Date | Classification | Primary Code | |---------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------|----------------|------------------------| | Percutaneous Dilation Kit with Single Stage Dilator and Soft Introducer for Sizes 7, 8, & 9 mm Tubes Only, without Tracheostomy Tubes | K040014 Feb 13, 2004 Original Applicant: Portex Limited | Class II | JOH 21 CFR 868.5800 | # General Device Description for BLUperc® and BLUgriggs® The BLUperc® and BLUgriggs® Percutaneous Dilation Tracheostomy Tube Kits or Trays aid in the tracheostomy tube surgical procedure for adult patients; designed to aid adult patients {6}------------------------------------------------ requiring an artificial breathing airway due to trauma, medical condition and/or for airway maintenance. The tracheostomy tubes (kits or trays) maximum recommended period of use is 29 days. The kit or tray contains all the proprietary procedural components to support tracheostomy insertion, including the BLUselect tracheostomy tube for physician's ease during the clinical procedure flow. The BLUperc and BLUgriggs PDT components are manufactured from medical grade materials and have biocompatibility data for use when in-contact with patient tissue/bodily fluids/secretions. ## Indications for Use: | Smiths Medical Product Name | Indications For Use | |-----------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | BLUperc® Percutaneous Dilation Tracheostomy Procedural Kit or Tray with or without BLUselect® Tracheostomy Tube | Controlled, elective, subcricoid percutaneous insertion of a tracheostomy tube for airway management using a Seldinger guidewire dilation technique | | BLUgriggs® Percutaneous Dilation Tracheostomy Procedural Kit or Tray with BLUselect® Tracheostomy Tube with or without Forceps | Controlled, elective subcricoid percutaneous insertion of a tracheostomy tube for airway management using a Seldinger technique to guide the specially designed Guidewire Dilating Forceps into the trachea, which are then used to dilate the trachea. | #### Principle of Operation The BLUperc and BLUgriggs Percutaneous Dilation Tracheostomy Tube Kits or Trays aid in the tracheostomy tube surgical procedure because the kit or trav contains all the proprietary procedural components to support tracheostomy insertion, including the tracheostomy tube for physician's ease during the clinical procedure flow. The BLUperc Kits or Trays are designed for the Seldinger Tracheostomy Technique: A modification of the surgical technique, termed the Percutaneous Dilation Tracheostomy (PDT) technique, allows the placement of a tracheostomy tube using the Seldinger technique. The PDT technique uses a dilator inserted over the guide wire into the trachea to dilate the skin, subcutaneous tissue and tracheal opening, to allow insertion of the tracheostomy tube. The BLUariags Kits or Travs are designed for Grigas Forceps Technique: A modification to the PDT technique (above), instead of advancing the dilator over the quide wire, the Griggs Forceps technique uses closed forceps to advance into the trachea over the guide wire. The forceps are then opened to dissect the subcutaneous and tracheal tissue creating a hole, stoma, to allow easy placement of the tracheostomy tube. # Summary of Technological Characteristics: The BLUperc and BLUgriqgs PDT subject devices share the similar technological characteristics as their 510(k) cleared predicates, UltraPerc PDT kits or trays. These characteristics include the same intended use of 29 days for the adult patient population, same overall design, same base materials, and same range of sizes, proprietary procedural components to support tracheostomy insertion, including a tracheostomy tube to enhance the healthcare clinical workflow. Both the subject PDT device and predicate PDT devices are available as "Kits" which do not contain medications and as "Trays" which do contain medications. {7}------------------------------------------------ The subject devices and the predicate devices are designed to aid the adult population with an artificial airway due to trauma, a medical condition or airway maintenance. Both have 15mm connectors for attachment to airway circuits, which are compatible with standard healthcare systems for use of humidification and/or ventilation equipment. Both, the subject and predicate devices provide a neck strap (tube holder) for use to secure the tracheostomy tube placement to the patient. The surgical procedure is the same for BLUperc and BLUgriggs regarding the percutaneous dilation tracheostomy kits or trays are designed to aid the physician (healthcare staff) ease during the clinical procedure flow. - The BLUperc Kits or Trays are designed for the Seldinger Tracheostomy ● Technique: The Percutaneous Dilation Tracheostomy (PDT) Seldinger technique uses a dilator that dilates and expands the subcutaneous and tracheal tissue to allow insertion of the tracheostomy tube. - . The BLUgriggs Kits or Trays are designed for Griggs Forceps Technique: A modification to the PDT technique (above); the Griggs Forceps technique uses a forceps that has a channel for the guide wire used in the PDT technique. The BLUperc and BLUgriggs (PDT) subject device(s) and predicate devices are by prescription only, for single use and provided Ethylene Oxide (EO) sterile to the healthcare facility and/or end user. ## Summary of Performance Testing: The BLUperc and BLUgriggs PDT Kits and Trays incorporates the same indications for use, similar technological characteristics, including similar propriety components for the same surgical procedures (Seldinger (PDT) and Griggs Forceps Techniques) as the legally marketed primary predicate device the Percutaneous Dilation Tracheostomy Kit with Single Stage Dilator. Soft Introducer Blue Line Ultra Tracheostomy Tubes, K040014, 510(k) clearance issued Feb 13, 2004; Portex "UltraPerc" Percutaneous Dilation Tracheostomy Kit, K041348; 510(k) clearance issued July 13. 2004 and the Portex Percutaneous Tracheostomy Kit: K060945. 510(k) clearance issued July 19, 2006. Non-clinical testing of the components comprising each configuration of the subject devices BLUperc and BLUgriggs PDT Kits or Trays were assessed and tested appropriately to design controls: i.e. design verification, design validations. The test results conclude the subject products are substantially equivalent to the predicate devices described herein (above). Testing listed below: - . Bench Testing was conducted on applicable components of the BLUperc and BLUgriggs PDT Kits or Trays to ensure they met the required specifications for performance and functionality. - Packaging Validation was conducted per ISO 11607 for the BLUperc and BLUgriggs PDT . Kits and Trays to ensure the packaging system meets requirements and maintains the sterile barrier. - . Design Validation / Human Factors per ISO 62366 was conducted to ensure the subject device(s) performance is acceptable for its intended use. {8}------------------------------------------------ - Sterilization/Microbiology Validation was conducted to ensure the subject device product . sterility to the end user for ISO 11135, AAMI TIR28 and ISO 11737 is acceptable. - . Biocompatibility Assessment per ISO 10993-1 was conducted to ensure the subject devices materials are biocompatible and equivalent with the same base materials of the predicate devices. | BLUperc / BLUgriggs Component(s) | Patient Contacting Type | Duration | |-----------------------------------------------------|---------------------------------------------------------------------------------|--------------------| | Gauze Sponges | Surface Device, Breached Skin; Limited (Transient) | ≤24 hours, limited | | Curved Hemostat Forceps | Surface Device, Breached Skin; Limited (Transient) | ≤24 hours, limited | | Hypodermic Needle(s) | Surface Device, Breached Skin; Limited (Transient) | ≤24 hours, limited | | Griggs Forceps | Externally Communicating, Tissue; Limited (Transient) | ≤24 hours, limited | | 14 FR Short Dilator | Externally Communicating, Tissue; Limited (Transient) | ≤24 hours, limited | | Dedicated Introducer | Externally Communicating, Tissue; Limited (Transient) | ≤24 hours, limited | | Obturator | Externally Communicating, Tissue; Limited (Transient) | ≤24 hours, limited | | Fenestrated Drape | Surface Device, Intact Skin; Limited | ≤24 hours, limited | | Split Tracheostomy Dressing | Surface Device, Breached Skin; Limited | ≤24 hours, limited | | Syringes | Surface Device, Breached Skin; Limited | ≤24 hours, limited | | Introducer Cannula & Needle Assembly | Externally Communicating, Tissue; Limited | ≤24 hours, limited | | J-tip Guidewire | Externally Communicating, Tissue; Limited | ≤24 hours, limited | | PEEP Keep Swivel Adaptor | Breathing Gas Pathway; Indirect Externally Communicating, Tissue; Limited | ≤24 hours, limited | | Tracheostomy Tube Holder with Brush (Neck strap) | Surface Device, Intact Skin; Prolonged | ≤29 Day, prolonged | | 2/0 (3.0 metric) Polypropylene sutures | Surface Device, Breached Skin; Prolonged | ≤29 Day, prolonged | | Single Stage Dilator | Externally Communicating, Tissue; Limited (Transient) | ≤24 hours, limited | | Guiding Catheter | Externally Communicating, Tissue; Limited (Transient) | ≤24 hours, limited | | Soft Introducer | Externally Communicating, Tissue; Limited (Transient) | ≤24 hours, limited | | ChloraPrep Applicators | Surface Device, Intact Skin; Limited (Transient) | ≤24 hours, limited | | Filter Straw | Surface Device, Breached Skin; Limited (Transient) | ≤24 hours, limited | | Introducer Needle(s) | Externally Communicating, Tissue; Limited (Transient) | ≤24 hours, limited | | Safety Scalpel | Externally Communicating, Tissue; Limited (Transient) | ≤24 hours, limited | | BLUselect Tracheostomy Tube | Externally Communicating, Tissue; Prolonged | ≤29 Day, prolonged | | BLUperc / BLUgriggs Component(s) | Patient Contacting Type | Duration | | BLUselect Inner Cannula | Externally Communicating, Tissue; Prolonged | ≤29 Day, prolonged | | Lubricating Jelly | Off-the-shelf drug | Off-the-shelf drug | | 5mL Lidocaine & Epinephrine 1.5% | Off-the-shelf drug | Off-the-shelf drug | | Single handed guidewire feeder | No Patient Contact | No Patient Contact | | Nozzle | No Patient Contact | No Patient Contact | | Needle Driver | No Patient Contact | No Patient Contact | | Needle Safety Device | No Patient Contact | No Patient Contact | | Disconnection Wedge | No Patient Contact | No Patient Contact | | Vacuum Control Valve | No Patient Contact | No Patient Contact | | Patient Label | No Patient Contact | No Patient Contact | | IFUs | No Patient Contact | No Patient Contact | {9}------------------------------------------------ #### Substantial Equivalence Smiths Medical considers the subject devices performance to be substantially equivalent to the predicate device(s), because these devices are intended for same patient population that require an artificial airway due to trauma, a medical condition and/or airway maintenance. Subiect Devices: - BLUperc® Percutaneous Dilation Tracheostomy Procedural Kit or Tray with or . without BLUselect® Tracheostomy Tube - BLUgriggs® Percutaneous Dilation Tracheostomy Procedural Kit or Tray with . BLUselect® Tracheostomy Tube with or without Forceps There are no significant differences in the intended use, mechanical and functional performance and functional scientific technology. Overall and including the difference in the proposed subject kits or trays, Smiths Medical demonstrates there are no different questions of safety and effectiveness raised due to the similarities/differences between the subject and predicate/commercialized devices, as each are used to treat the same clinical condition and represent a similar/basic design concept. Table below provides a substantial equivalence summary of the subject device and predicate devices, including device pictures, {10}------------------------------------------------ # Substantial Equivalence Summaries: # BLUperc and BLUgriggs PDT compared to UltraPerc and Portex PDT Kit | Product Component | Subject Device BLUperc and BLUgriggs | Primary Predicate: K041348 Additional Predicate: K060945 Reference Device: K040014 | Compare | |----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------| | Product Code | JOH | JOH | Same | | Product Classification | Class II | Class II | Same | | Device Classification Name and 21 CFR | Tracheostomy tube and tube cuff § 868.5800 | Tracheostomy tube and tube cuff § 868.5800 | Same | | Invasive or Non- Invasive | Surgically Invasive | Surgically Invasive | Same | | Patient Population | Adults with average height, weight, and anthropometrics. | Adults with average height, weight, and anthropometrics. | Same | | Intended Use | For use with patients that require an artificial airway due to trauma or medical condition. | For use with patients that require an artificial airway due to trauma or medical condition. | Same | | Indications for Use | BLUperc: Controlled, elective, subcricoid percutaneous insertion of a tracheostomy tube for airway management using a Seldinger guidewire dilation technique. BLUgriggs: Controlled, elective subcricoid percutaneous insertion of a tracheostomy tube for airway management using a Seldinger technique to guide the specially designed Guidewire Dilating Forceps into the trachea, which are then used to dilate the trachea. | K041348: Create a percutaneous dilational tracheostomy using guidewire dilator/s and components of these kits that allow for tracheal access for airway management for use in adults only. K040014: Create a percutaneous dilational tracheostomy using guidewire, single stage dilator and components of this product which allows for tracheal access for airway management. K060945: Create a percutaneous dilational tracheostomy using guidewire, pre-dilator, forceps, and components of this product which allows for tracheal access for airway management. | Same | | Functionality | A percutaneous dilation tracheostomy procedural Kit or Tray that allows the percutaneous insertion of a tracheostomy tube using a one stage circumferential dilational Seldinger guidewire technique or The Griggs Forceps technique uses a forceps that has a channel for the guide wire used in the PDT technique | A percutaneous dilation tracheostomy procedural Kit or Tray that allows the percutaneous insertion of a tracheostomy tube using a one stage circumferential dilational Seldinger guidewire technique or The Griggs Forceps technique uses a forceps that has a channel for the guide wire used in the PDT technique | Same | | Sterilization | Ethylene Oxide (EO) Sterile SAL 10-6 to End User | Ethylene Oxide (EO) Sterile SAL 10-6 to End User | Same | | Product Component | Subject Device BLUperc and BLUgriggs | Primary Predicate: K041348 Additional Predicate: K060945 Reference Device: K040014 | Compare | | | ISO 10993-1: 2009 3-year shelf life intended | ISO 10993-1: 2009 5-year shelf life intended | Same | | Shelf Life | | | | | Single Patient Use | Yes | Yes | Same | | Environment of Use | Hospital environments only | Hospital environments only | Same | | BLUperc Tray Product Figure/ Picture BLUperc Kit Product Figure/ Picture BLUgriggs Tray Product Figure/ Picture BLUgriggs Kit Product Figure/ Picture | Various Components Image: Various Components | Various Components Image: Various Components | Similar | | Trach Tube | Included | Included | Same | | Varied Components | Included | Included | Same | | Inner Cannula | Included | Included | Same | | IFU | Included | Included | Same | {11}------------------------------------------------ {12}------------------------------------------------ ## Newly included Components of the Subject Device Kit/Tray | Component Table | | | | | | |---------------------------------------------|----------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|---------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Component | Picture | Description | US FDA Classification | 510(K) Number | Rationale | | Lubricating Jelly Sachet | Image: Lubricating Jelly Sachet | A lubricating substance used to coat and lubricate the outer diameter and cuff of the tracheostomy tube and the obturator. | 876.1500 Class II FHX | K912132 | This device was identified as a kit component in the predicate kit K041348. It is referenced on pg. 234 of K041348. | | Split Tracheostomy Dressing | Image: Split Tracheostomy Dressing | A dressing that is pre-cut to fit around the tracheostomy tube. It is placed between the skin and the tracheostomy tube flange after the tracheostomy tube is positioned in the stoma. | 878.4014 Class I NAB | Exempt | This device was identified as a kit component in the predicate kit K041348. It is referenced on pg. 173 of K041348. | | Single Handed Guidewire Feeder Nozzle | Image: Single Handed Guidewire Feeder Nozzle | A clear polypropylene nozzle which is used to Straightens the J-tip guidewire and attaches to the single hand guidewire feeder and introducer needle/cannula such that the guidewire may be passed into the trachea. | Not a medical device | N/A | This component should have been included with the Single Guidewire Feeder in the original table of this premarket notification (878.4800, Class 1, FZX, Exempt). | | Curved Hemostat Forceps | Image: Curved Hemostat Forceps | A pair of large stainless steel forceps with curved tips used to dilate the trachea. | 878.4800 Class I HTD | Exempt | This medical device is Exempt. | | Suture | Image: Suture | Polypropylene thread with curved needles on the ends used to sew the tracheostomy tube to the patient in order to prevent the tube from being dislodged | 878.5010 Class II GAW | K001185 | The device was previously cleared in K001185, 06/23/2000 by CP Medical. This device was not identified as a component in the predicate kit(s). This device is part of the proposed kit. | | Component Table | | | | | | | Component | Picture | Description | US FDA Classification | 510(K) Number | Rationale | | Needle Safety Device | Image: Needle Safety Device | A cylindrical tube filled with foam used to store sharps safely after use | Not a medical device | N/A | This component is not a medical device. This component is being introduced in the proposed kit as a convenience component. | | PEEP Keep Swivel Adaptor | Image: PEEP Keep Swivel Adaptor | An adaptor that introduces an additional entrance port to the airway circuit. Allows for the passage of a bronchoscope into the trachea without losing ventilating capabilities. | 868.5810 Class I BZA | Exempt | This medical device is Exempt. As a note: This device was identified as a kit component in the predicate kit K041348. It is referenced on pg. 173 of K041348. | | Vacuum Control Valve | Image: Vacuum Control Valve | A valve that introduces a port into a vacuum system line, provides clinicians with the ability to vacuum up fluids at their discretion. When the port is occluded, suction occurs through the vacuum line. | 868.6810 Class I OFS | Exempt | This medical device is Exempt. This device was originally identified as a kit component in the predicate kit K041348. It is referenced on pg. 62 of K060945. | | Povidone lodine | Image: Povidone lodine | An antiseptic used for skin disinfection before and after surgery | Not a medical device | N/A | Povidone lodine is a drug classified under Prep Component. The predicate component is identified by lodophor PVP-NDC 552380-3101-5. This component will not be included in the proposed kit. | | Hypodermic Needle 22GX1.5" | Image: Hypodermic Needle 22GX1.5" | Two needles with different lengths and gauges, Used to deliver drugs subcutaneously. | 880.5570 Class II FMI | K854547 | This device was cleared in K854547, 02/04/1986 by Sherwood Medical. | {13}------------------------------------------------ ### Conclusion Smiths Medical's evaluation concludes the subject devices, are substantially equivalent to the predicate devices. | Subject Devices | Predicates | 510(k) | |------------------------------|---------------------------------------------------------------------------------------------------|---------| | BLUperc PDT BLUgriggs PDT | Primary Predicate UltraPerc PDT | K041348 | | | Additional Predicate Portex Percutaneous Tracheostomy Kit | K060945 | | | Reference Device Percutaneous Dilation Kit with Single Stage Dilator and Soft Introducer | K040014 |

BLUperc Percutaneous Dilation Tracheostomy Kit with BLUselect tube, BLUperc Percutaneous Dilation Tracheostomy Kit with BLUselect Suctionaid tube, BLUgriggs Percutaneous Dilation Tracheostomy Kit with BLUselect tube, BLUgriggs Percutaneous Dilation Tracheostomy Kit with BLUselect Suctionaid tube

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BLUperc Percutaneous Dilation Tracheostomy Kit with BLUselect tube, BLUperc Percutaneous Dilation Tracheostomy Kit with BLUselect Suctionaid tube, BLUgriggs Percutaneous Dilation Tracheostomy Kit with BLUselect tube, BLUgriggs Percutaneous Dilation Tracheostomy Kit with BLUselect Suctionaid tube

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