MELKER EMERGENCY CRICOTHYROTOMY CATHETER SET

K013916 · Cook, Inc. · BWC · Dec 20, 2001 · Anesthesiology

Device Facts

• Record ID: K013916
• Device Name: MELKER EMERGENCY CRICOTHYROTOMY CATHETER SET
• Applicant: Cook, Inc.
• Product Code: BWC · Anesthesiology
• Decision Date: Dec 20, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5090
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Melker Emergency Cricothyrotomy Catheter Set is used for emergency airway access. . In patients whom conventional endotracheal intubation and ventilation cannot be performed. The device will be supplied sterile and is intended for one-time use.

Device Story

The Melker Emergency Cricothyrotomy Catheter Set provides emergency airway access. The device consists of a catheter (3.5, 4, or 6 mm inner diameter; 3.8, 4.2, or 7.5 cm length) with a proximal fitting and a coaxial dilator tapered to a 0.038-inch wire guide. It is used in emergency clinical settings by medical professionals when standard intubation fails. The device is supplied sterile for single-use. It facilitates the establishment of an emergency airway, potentially life-saving for patients in respiratory distress.

Clinical Evidence

No clinical data. Performance is assured through adherence to quality system procedures and predetermined design/quality specifications.

Technological Characteristics

Catheter with proximal fitting and coaxial dilator tapered to 0.038-inch wire guide. Materials and physical characteristics are identical to the predicate. Sterilization via Ethylene Oxide (ETO) gas cycle (10^-6 sterility assurance level). Packaging in Tyvek-Poly pouch.

Indications for Use

Indicated for patients requiring emergency airway access when conventional endotracheal intubation and ventilation cannot be performed.

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

• Melker Cuffed Cricothyrotomy Catheter Set (K010016)

Submission Summary (Full Text)

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K013916

Melker Emergency Cricothyrotomy Catheter Set 510(k) Premarket Notification Cook Incorporated

DEC 2 0 2001

## 9 510K SUMMARY

#### Submitted By:

Heidi Masten, RT(T), MBA Regulatory Affairs Coordinator COOK INCORPORATED 925 South Curry Pike P.O. Box 489 Bloomington, In 47402 [phone]

### Device:

| Trade Name: | Melker Emergency Cricothyrotomy Catheter Set |
|-------------------------------|-------------------------------------------------------------|
| Common/Usual Name: | Catheter, emergency airway access needle |
| Proposed Classification Name: | Emergency Airway Needle<br>21 CFR Part 868.5090<br>Class II |

# Intended Use:

The Melker Emergency Cricothyrotomy Catheter Set is used for emergency airway access.

- . In patients whom conventional endotracheal intubation and ventilation cannot be performed.
The device will be supplied sterile and is intended for one-time use.

# Device Description:

The Melker Emergency Cricothyrotomy Catheter with a standard inner diameter of 3.5, 4, or 6 mm and a length of either 3.8, 4.2, 7.5 cm with a proximal fitting and a coaxial dilator tapered to a 0.038-inch wire guide.

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Melker Emergency Cricothyrotomy Catheter Set 510(k) Premarket Notification Cook Incorporated

# Substantial Equivalence:

The device will be manufactured according to specified process controls and a Quality Assurance Program, undergoing packaging and sterilization procedures similar to currently marketed devices. This device is the same with respect to indications for use, material and physical characteristics to the Melker Cuffed Cricothyrotomy Catheter Set cleared under K010016 on 10/09/01.

#### Performance Information:

Specific performance of the device subject of this submission is assured through adherence to the firm's quality system procedures for device quality. Various device design specifications and quality specifications are used to produce a device that meets predetermined acceptance criteria. This is the same as for the Melker Cuffed Cricothyrotomy Catheter Set cleared under K010016 on 10/09/01.

### Packaging Information:

Each unit is packaged and sealed within a Tyvek-Poly pouch and properly labeled.

# Sterilization Information:

The Melker Emergency Cricothyrotomy Catheter Set will be sterilized using an Ethylene Oxide (ETO) gas cycle validated to assure a 10° sterility assurance level.

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Image /page/2/Picture/2 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized image of an eagle with three curved lines representing its wings. The eagle is enclosed within a circular border, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is written around the border of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 2 0 2001

Ms. Heidi Masten Cook Incorporated P.O. Box 489 Bloomington, IN 47402-0489

#### Re: K013916

Melker Emergency Cricothyrotomy Catheter Set Regulation Number: 868.5090 and 868.5800 Regulation Name: Emergency Airway Needle and Tracheostomy Tube and Tube Cuff Regulatory Class: Class II (two) Product Code: 73 BWC, JOH Dated: November 26, 2001 Received: November 27, 2001

Dear Ms. Masten:

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 for abound in the 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 I ou mayy atterest, while 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 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.

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# Page 2 - Ms. Heidi Masten

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html

Sincerely yours,

I Dank Tille

Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### Melker Emergency Cricothyrotomy Catheter Set 510(k) Premarket Notification Cook Incorporated

# INDICATIONS FOR USE

Melker Emergency Cricothyrotomy Catheter Set Device Name

Indications for Use:

..

Used for emergency airway access when conventional endotracheal intubation and ventilation cannot be performed.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)


| Division of Cardiovascular & Respiratory Devices | |
|--------------------------------------------------|---------|
| 510(k) Number | R013116 |

| Prescription Use | X | OR | Over-the-Counter Use |
|----------------------|---|----|----------------------|
| (Per 21 CFR 801.109) | | | |

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