(137 days)
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 trachea, which are then used to dilate the trachea.
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 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 provided document is a 510(k) premarket notification summary for medical devices (tracheostomy kits). It focuses on establishing substantial equivalence to previously cleared predicate devices rather than proving a device meets specific acceptance criteria through a clinical study. Therefore, most of the requested information (acceptance criteria table, sample sizes, expert qualifications, adjudication, MRMC studies, standalone performance, ground truth types, training set details) is not applicable or cannot be extracted from this type of document.
The document primarily demonstrates that the BLUperc® and BLUgriggs® Percutaneous Dilation Tracheostomy Procedural Kits or Trays are substantially equivalent to existing predicate devices (UltraPerc Percutaneous Dilation Kit and Portex Percutaneous Tracheostomy Kit).
Here's a breakdown of the available information:
1. A table of acceptance criteria and the reported device performance:
This document does not present a table of specific performance acceptance criteria in the way it would for a new AI/software device or a device requiring new clinical performance data to demonstrate effectiveness. Instead, the "acceptance criteria" are implied by establishing substantial equivalence to predicate devices. The performance testing conducted (bench testing, packaging validation, design validation/human factors, sterilization/microbiology validation, biocompatibility assessment) ensures the device meets its own specifications and is safe and performs as intended, thereby being equivalent to the predicates.
The study proves the device meets the "acceptance criteria" of substantial equivalence to the predicate device.
| Acceptance Criteria (Implied by Substantial Equivalence) | Reported Device Performance (Summary of Testing) |
|---|---|
| Intended Use: Same patient population and purpose. | "Same": For adult patients requiring an artificial airway due to trauma, medical condition, and/or for airway maintenance. |
| Technological Characteristics: Similar design, materials, and operational principles. | "Similar": Same overall design, same base materials, same range of sizes, proprietary procedural components to support tracheostomy insertion. Same principle of operation (Seldinger guidewire dilation technique or Griggs Forceps technique). |
| Performance: Device functions as intended and is safe. | "Acceptable": |
| - Bench Testing: Conducted on applicable components to ensure they met required specifications for performance and functionality. (Results concluded: met specifications) | |
| - Packaging Validation (ISO 11607): Ensured packaging system meets requirements and maintains sterile barrier. (Results concluded: acceptable) | |
| - Design Validation / Human Factors (ISO 62366): Ensured subject device performance is acceptable for its intended use. (Results concluded: acceptable) | |
| - Sterilization/Microbiology Validation (ISO 11135, AAMI TIR28, ISO 11737): Ensured product sterility to the end user. (Results concluded: acceptable) | |
| - Biocompatibility Assessment (ISO 10993-1): Ensured subject device materials are biocompatible and equivalent to predicate devices. (Results concluded: biocompatible and equivalent) |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified for individual tests. The document refers to "applicable components" for bench testing and mentions that tests were "conducted" without providing specific sample numbers for each test.
- Data Provenance: The studies are described as "Non-clinical testing" and include bench testing, packaging validation, design validation/human factors, sterilization/microbiology validation, and biocompatibility assessment. These are laboratory/engineering tests rather than clinical studies with patient data. Therefore, concepts like "country of origin of the data" or "retrospective/prospective" do not apply.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided. The testing described (bench, packaging, sterilization, biocompatibility, and human factors) relies on engineering and scientific principles and product specifications, not on expert consensus for "ground truth" as might be seen in diagnostic imaging studies. Human factors testing involves users, but their qualifications are not detailed beyond "physician (healthcare staff)".
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable. Adjudication methods are typically used in clinical studies where multiple reviewers assess outcomes, which is not the type of study described here.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This is a premarket notification for a physical medical device (tracheostomy kit), not an AI/software device. No MRMC study was conducted or mentioned.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable. This is not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for the performance testing is adherence to predefined engineering specifications, performance standards (e.g., fluid flow, material strength), and regulatory standards (e.g., ISO for packaging, sterilization, biocompatibility). It is based on objective measurements and compliance with recognized standards, rather than clinical expert consensus or pathology.
8. The sample size for the training set:
Not applicable. This is not a study involving machine learning or AI models, so there is no "training set."
9. How the ground truth for the training set was established:
Not applicable (no training set).
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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
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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
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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
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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
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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):
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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 PredicateDevice Name | FDA 510(k)Number andClearance Date | Classification | Primary Code |
|---|---|---|---|
| UltraPercPercutaneous DilationKit with Single StageDilator , Blue LineUltra TracheostomyTube and Introducer | K041348July 13, 2004Original Applicant:Smiths Medical | Class II | JOH21 CFR 868.5800 |
Primary Predicate: BLUperc® and BLUgriggs® PDT kits or travs
Additional Predicates: BLUperc and BLUgriggs PDT kits or travs
| Additional PredicateDevice Name | FDA 510(k)Number andClearance Date | Classification | Product Code |
|---|---|---|---|
| Portex PercutaneousTracheostomy Kit | K060945Jun 19, 2006Original Applicant:Smiths Medical | Class II | BTO21 CFR 868.5800 |
Reference Device: BLUperc and BLUgriggs PDT kits or trays
| ReferenceDevice Name | FDA 510(k)Number andClearance Date | Classification | Primary Code |
|---|---|---|---|
| Percutaneous DilationKit with Single StageDilator and SoftIntroducer for Sizes 7,8, & 9 mm TubesOnly, withoutTracheostomy Tubes | K040014Feb 13, 2004Original Applicant:Portex Limited | Class II | JOH21 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
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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 DilationTracheostomy Procedural Kit or Traywith or without BLUselect®Tracheostomy Tube | Controlled, elective, subcricoid percutaneous insertionof a tracheostomy tube for airway management using aSeldinger guidewire dilation technique |
| BLUgriggs® Percutaneous DilationTracheostomy Procedural Kit or Traywith BLUselect® TracheostomyTube with or without Forceps | Controlled, elective subcricoid percutaneous insertionof a tracheostomy tube for airway management using aSeldinger technique to guide the specially designedGuidewire Dilating Forceps into the trachea, which arethen 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.
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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.
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- 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 / BLUgriggsComponent(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 & NeedleAssembly | Externally Communicating, Tissue;Limited | ≤24 hours, limited |
| J-tip Guidewire | Externally Communicating, Tissue;Limited | ≤24 hours, limited |
| PEEP Keep Swivel Adaptor | Breathing Gas Pathway; IndirectExternally Communicating, Tissue;Limited | ≤24 hours, limited |
| Tracheostomy Tube Holder withBrush (Neck strap) | Surface Device, Intact Skin;Prolonged | ≤29 Day, prolonged |
| 2/0 (3.0 metric) Polypropylenesutures | 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 / BLUgriggsComponent(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 & Epinephrine1.5% | 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 |
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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,
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Substantial Equivalence Summaries:
BLUperc and BLUgriggs PDT compared to UltraPerc and Portex PDT Kit
| ProductComponent | Subject DeviceBLUperc and BLUgriggs | Primary Predicate: K041348Additional Predicate: K060945Reference Device: K040014 | Compare |
|---|---|---|---|
| Product Code | JOH | JOH | Same |
| ProductClassification | Class II | Class II | Same |
| Device ClassificationName and 21 CFR | Tracheostomy tube and tubecuff§ 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 thatrequire an artificial airway due totrauma or medical condition. | For use with patients that requirean artificial airway due to traumaor medical condition. | Same |
| Indications for Use | BLUperc: Controlled, elective,subcricoid percutaneousinsertion of a tracheostomy tubefor airway management using aSeldinger guidewire dilationtechnique.BLUgriggs: Controlled, electivesubcricoid percutaneousinsertion of a tracheostomy tubefor airway management using aSeldinger technique to guide thespecially designed GuidewireDilating Forceps into thetrachea, which are then used todilate the trachea. | K041348: Create a percutaneousdilational tracheostomy usingguidewire dilator/s andcomponents of these kits thatallow for tracheal access forairway management for use inadults only.K040014: Create a percutaneousdilational tracheostomy usingguidewire, single stage dilatorand components of this productwhich allows for tracheal accessfor airway management.K060945: Create a percutaneousdilational tracheostomy usingguidewire, pre-dilator, forceps,and components of this productwhich allows for tracheal accessfor airway management. | Same |
| Functionality | A percutaneous dilationtracheostomy procedural Kit orTray that allows thepercutaneous insertion of atracheostomy tube using a onestage circumferential dilationalSeldinger guidewire techniqueor The Griggs Forcepstechnique uses a forceps thathas a channel for the guide wireused in the PDT technique | A percutaneous dilationtracheostomy procedural Kit orTray that allows the percutaneousinsertion of a tracheostomy tubeusing a one stage circumferentialdilational Seldinger guidewiretechnique or The Griggs Forcepstechnique uses a forceps that hasa channel for the guide wire usedin the PDT technique | Same |
| Sterilization | Ethylene Oxide (EO) Sterile SAL10-6 to End User | Ethylene Oxide (EO) Sterile SAL10-6 to End User | Same |
| ProductComponent | Subject DeviceBLUperc and BLUgriggs | Primary Predicate: K041348Additional Predicate: K060945Reference Device: K040014 | Compare |
| ISO 10993-1: 20093-year shelf life intended | ISO 10993-1: 20095-year shelf life intended | Same | |
| Shelf Life | |||
| Single Patient Use | Yes | Yes | Same |
| Environment of Use | Hospital environments only | Hospital environments only | Same |
| BLUperc TrayProduct Figure/PictureBLUperc KitProduct Figure/PictureBLUgriggs TrayProduct Figure/PictureBLUgriggs KitProduct Figure/Picture | Various ComponentsImage: Various Components | Various ComponentsImage: Various Components | Similar |
| Trach Tube | Included | Included | Same |
| Varied Components | Included | Included | Same |
| Inner Cannula | Included | Included | Same |
| IFU | Included | Included | Same |
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Newly included Components of the Subject Device Kit/Tray
| Component Table | |||||
|---|---|---|---|---|---|
| Component | Picture | Description | US FDA Classification | 510(K) Number | Rationale |
| Lubricating JellySachet | Image: Lubricating Jelly Sachet | A lubricating substanceused to coat and lubricatethe outer diameter andcuff of the tracheostomytube and the obturator. | 876.1500Class IIFHX | K912132 | This device was identified as a kit component in the predicatekit K041348. It is referenced on pg. 234 of K041348. |
| SplitTracheostomyDressing | Image: Split Tracheostomy Dressing | A dressing that is pre-cutto fit around thetracheostomy tube.It is placed between theskin and the tracheostomytube flange after thetracheostomy tube ispositioned in the stoma. | 878.4014Class INAB | Exempt | This device was identified as a kit component in the predicatekit K041348. It is referenced on pg. 173 of K041348. |
| Single HandedGuidewireFeeder Nozzle | Image: Single Handed Guidewire Feeder Nozzle | A clear polypropylenenozzle which is used toStraightens the J-tipguidewire and attaches tothe single hand guidewirefeeder and introducerneedle/cannula such thatthe guidewire may bepassed into the trachea. | Not a medical device | N/A | This component should have been included with the SingleGuidewire Feeder in the original table of this premarketnotification (878.4800, Class 1, FZX, Exempt). |
| CurvedHemostatForceps | Image: Curved Hemostat Forceps | A pair of large stainlesssteel forceps with curvedtips used to dilate thetrachea. | 878.4800Class IHTD | Exempt | This medical device is Exempt. |
| Suture | Image: Suture | Polypropylene thread withcurved needles on theends used to sew thetracheostomy tube to thepatient in order to preventthe tube from beingdislodged | 878.5010Class IIGAW | K001185 | The device was previously cleared in K001185, 06/23/2000 byCP Medical.This device was not identified as a component in the predicatekit(s). This device is part of the proposed kit. |
| Component Table | |||||
| Component | Picture | Description | US FDA Classification | 510(K) Number | Rationale |
| Needle SafetyDevice | Image: Needle Safety Device | A cylindrical tube filledwith foam used to storesharps 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 aconvenience component. |
| PEEP KeepSwivel Adaptor | Image: PEEP Keep Swivel Adaptor | An adaptor that introducesan additional entrance portto the airway circuit.Allows for the passage ofa bronchoscope into thetrachea without losingventilating capabilities. | 868.5810Class IBZA | Exempt | This medical device is Exempt.As a note: This device was identified as a kit component in thepredicate kit K041348. It is referenced on pg. 173 of K041348. |
| Vacuum ControlValve | Image: Vacuum Control Valve | A valve that introduces aport into a vacuum systemline, provides clinicianswith the ability to vacuumup fluids at theirdiscretion. When the portis occluded, suctionoccurs through thevacuum line. | 868.6810Class IOFS | Exempt | This medical device is Exempt.This device was originally identified as a kit component in thepredicate kit K041348. It is referenced on pg. 62 of K060945. |
| Povidone lodine | Image: Povidone lodine | An antiseptic used for skindisinfection before andafter surgery | Not a medical device | N/A | Povidone lodine is a drug classified under Prep Component.The predicate component is identified by lodophor PVP-NDC552380-3101-5. This component will not be included in theproposed kit. |
| HypodermicNeedle22GX1.5" | Image: Hypodermic Needle 22GX1.5" | Two needles with differentlengths and gauges, Usedto deliver drugssubcutaneously. | 880.5570Class IIFMI | K854547 | This device was cleared in K854547, 02/04/1986 by SherwoodMedical. |
{13}------------------------------------------------
Conclusion
Smiths Medical's evaluation concludes the subject devices, are substantially equivalent to the predicate devices.
| Subject Devices | Predicates | 510(k) |
|---|---|---|
| BLUperc PDTBLUgriggs PDT | Primary PredicateUltraPerc PDT | K041348 |
| Additional PredicatePortex PercutaneousTracheostomy Kit | K060945 | |
| Reference DevicePercutaneous Dilation Kitwith Single Stage Dilatorand Soft Introducer | K040014 |
§ 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.