PORTEX EMERGENCY CRICOTHYROIDOTOMY KIT

K050166 · Smiths Medical · BWC · May 26, 2005 · Anesthesiology

Device Facts

• Record ID: K050166
• Device Name: PORTEX EMERGENCY CRICOTHYROIDOTOMY KIT
• Applicant: Smiths Medical
• Product Code: BWC · Anesthesiology
• Decision Date: May 26, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5090
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Emergency airway access (when endotracheal intubation is not possible) by percutaneous insertion of a cricothyroidotomy tube through the cricothyroid membrane.

Device Story

Kit provides emergency airway access; used when endotracheal intubation is not possible. Components include 6mm cuffed airway tube, dilator, and Veress needle. Veress needle features central spring-loaded protective core; provides visual indication of entry into trachea via hub flag; aspiration confirms placement. Dilator/introducer enlarges stomal opening; airway tube slides off dilator into trachea. Kit includes scalpel, syringe, sutures, neck-strap, and heat/moisture exchanger. Used in emergency clinical settings; operated by trained healthcare professionals. Facilitates rapid airway establishment; prevents patient energy loss; protects airway from blockage.

Clinical Evidence

No clinical data provided. Substantial equivalence based on comparison of technological characteristics and established clinical techniques to predicate devices.

Technological Characteristics

Kit includes 6mm cuffed airway tube, dilator, Veress needle, scalpel, syringe, sutures, neck-strap, and heat/moisture exchanger. Veress needle utilizes spring-loaded protective core for visual entry indication. Sterile, single-use, packaged in rigid blister pack with Tyvek pouch.

Indications for Use

Indicated for patients requiring emergency airway access when endotracheal intubation is not possible, via percutaneous insertion of a cricothyroidotomy tube through the cricothyroid membrane.

Regulatory Classification

Identification

An emergency airway needle is a device intended to puncture a patient's cricothyroid membrane to provide an emergency airway during upper airway obstruction.

Predicate Devices

• Cook Melker Emergency Cricothyroidotomy Sets (K013916)
• Portex Blue Line Ultra Tracheostomy Tube (K010016)
• Portex Blue Line Directional Tracheal Tube (K030381)
• Portex Per-fit Percutaneous Tracheostomy Kit (K931735)
• Mectra Labs Pneumoperitoneum Insufflation Needle (K031057)
• Portex Steri-Cath (K021247)

Submission Summary (Full Text)

{0}------------------------------------------------

MAY 2 6 2005

K050166

# Portex Emergency Cricothyroidotomy Kit 510(k) Notification

# Section 7: Summary of Safety and Effectiveness (k)510 Summary

#### 510k SUMMARY:

### COMPANY INFORMATION:

Smiths Medical International, Hythe, Kent. England CT21 6DB

CONTACT: Barry Smith Regulatory Affairs Manager

PREPARATION DATE OF SUMMARY: 21/01/2005

TRADE NAME Portex Emergency Cricothyroidotomy Kit

COMMON NAME Emergency Airway Needle

PRODUCT CLASS/CLASSIFICATION Class II 73, 21 CFR 868.5090

#### PREDICATE DEVICES

Cook Melker Emergency Cricothyroidotomy Sets. Portex Blue Line Ultra Tracheostomy Tube Portex Blue Line Directional Tracheal Tube Portex Per-fit Percutaneous Tracheostomy Kit Mectra Labs Pneumoperitoneum Insufflation Needle Portex Steri-Cath

(k)013916 & (k)010016 (k)030381 (k)931735 (k)031057 (k)021247 (k)923559

#### DESCRIPTION:

The new cricothyroidotomy kit is designed for introduction of an emergency 6mm cuffed airway tube through the cricothyroid membrane. The airway tube is provided pre-assembled onto a dilator with a Veress needle located in the centre.

The kit employs two well-established and understood techniques:

Firstly: The use of a Veress needle to provide visual indication of entry into a body cavity. (the trachea). (This can be confirmed by aspiration through the needle as with the predicate Cook Melker product ref. IFU in Attachment B(i)) The Veress needle is usually used for insufflation of the abdomen. It has a central sprung-loaded protective core to the needle that guards the cutting point and gives a visual indication via a "flag" at the hub end of the needle tip is

{1}------------------------------------------------

## Portex Emergency Cricothyroidotomy Kit 510(k) Notification

## Section 7: Summary of Safety and Effectiveness (k)510 Summary

passing through tissues. When the needle tip passes through into the abdominal cavity, or tractica, passure in ough assucer ------------------------------------------------------------------------------------------------------------------------------------------------------

Secondly: the use of a dilator/introducer to enlarge a stomal opening and place an airway tube within the traches. The pre-assembled needle/dilator/tube is inserted through the cricothyroid whill the tracether and the tube is then slid off the dilator fully into the trachea. This is the same principle employed by the Cook Melker Cricothyroidotomy sct.

As well as the airway tube assembly, the kit provides the user with scalpel for skin incision, syringe for aspiration to confirm location of the needle in the trachea, sutures and neck-strap to secure the airway tube and a heat and moisture exchanger to reduce patient energy loss and protect the airway from blockage. These are all items that will be well understood by the user.

Packaging comprises a rigid hinged blister pack for protection and a polythene/Tyvek welded pouch as the sterile barrier.

pouch as ale sterilised and individually packed in a carton together with the directions for use.

### INDICATIONS FOR USE:

Emergency airway access (when endotracheal intubation is not possible) by percutaneous insertion of a cricothyroidotomy tube through the cricothyroid membrane.

## TECHNICAL CHARACTERISTICS:

The Portex Emergency Cricothyroidotomy Kit comprises of components and materials that have predicates in similar medical devices currently being legally marketed in the USA.

#### CONCLUSION

The data provided and comparison to the predicate devices demonstrate that the proposed device is safe and effective and substantially equivalent to the predicate device/s.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing wings or feathers. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" is arranged in a circular fashion around the symbol. The text is in all capital letters and is in a sans-serif font.

Public Health Service

MAY 2 6 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Christopher Turnbull Senior Development Manager Smiths Medical International Hythe, Kent ENGLAND CT21 6DB

Re: K050166

Trade/Device Name: Portex Emergency Cricothyroidotomy Kit Regulation Number: 21 CFR 868.5090 Regulation Name: Emergency Airway Needle Regulatory Class: II Product Code: BWC Dated: April 12, 2005 Received: April 15, 2005

Dear Mr. Turnbull:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting (1 ml ), ice 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.

{3}------------------------------------------------

Page 2 - Mr. Turnbull

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies.

You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Chih-Lin, Ph.D.

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

Image /page/4/Picture/0 description: The image shows the words "ATTACHMENT 12" in bold, black font. The words are all capitalized and are arranged on a single line. The text appears to be part of a document or report, indicating that the following content is an attachment numbered 12.

## Indications for Use

r

050166 510(k) Number (if known):

Portex Emergency Cricothyroidotomy Kit Device Name:

Indications For Use:

Emergency airway access (when endotracheal intubation is not possible) by percutaneous insertion of a cricothyroidotomy tube through the cricothyroid membrane.

Yes Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

No Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of ____________________________________________________________________________________________________________________________________________________________________

Sision Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices

510(k) Number K050166

Page 1 of 1