Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The 510(k) summary describes a kit of physical medical devices used for a surgical procedure. There is no mention of software, algorithms, image processing, or any terms related to AI/ML. The testing described focuses on the physical and functional aspects of the components and packaging.

Therapeutic

No
Explanation: The device is used to create an artificial airway for breathing management rather than treating a disease or condition.

Diagnostic

No

The device is described as aiding in a surgical procedure for airway management and does not appear to analyze biological data or provide a diagnosis.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a "Percutaneous Dilation Tracheostomy Tube Kits or Trays" containing "proprietary procedural components" and a "tracheostomy tube." The testing described includes bench testing, packaging validation, sterilization validation, and biocompatibility assessment, all of which are associated with physical medical devices, not software.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is for a surgical procedure (percutaneous insertion of a tracheostomy tube) for airway management. This is a direct intervention on the patient's body.
Device Description: The device is a kit containing components for a surgical procedure, including a tracheostomy tube. It is used to create and maintain an artificial breathing airway.
Lack of Diagnostic Purpose: There is no mention of the device being used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes.

IVD devices are used to perform tests on samples (like blood, urine, tissue) taken from the body to diagnose or monitor medical conditions. This device is a surgical tool used for treatment and airway management.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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. 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.

Product codes (comma separated list FDA assigned to the subject device)

JOH

Device Description

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 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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Adults with average height, weight, and anthropometrics.

Intended User / Care Setting

Hospital environments only

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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.
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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K041348, K060945

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

K040014

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 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.

Summary

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.

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